TOWARDS MORE SUSTAINABLE
HEALTHCARE SYSTEMS IN EUROPE
Innovative Medicines Initiative:
Making a difference for patients
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DITORIAL
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Laurent ULMANN
Editor-in-chief, The European Files
F
or years, the European Commission and the European institutions more
generally have been trying to improve practices and methods linked to health
systems, in order to make the most of each one of them. They can be indeed
very different from one another, depending on cultural and historic backgrounds
proper to each European nation.
At a time when balance in public finances has become one of the biggest
priorities for most Member States, one can legitimately wonder whether the
aforementioned States can afford payment of expensive health systems. Health
being one of the main preoccupations of European countries as well as the European
Commission, it is unthinkable to consider decreasing the quality of health within the
European Union. Thus, the idea of sharing the best health system elements of the
different European countries appears to be a good way of optimizing efficiency of
these systems while enabling savings essential to their survival.
In this new issue of The European Files, sustainability and permanence of health
systems will also be tackled, while evaluating their efficiency in the most objective
possible way. Without jeopardizing European social rights in health, pricing and
reimbursement systems should be re-evaluated, as well as investments and health
innovations.
Furthermore, in order to maintain competitive and quality yet economical health
systems, health should be seen not only as a cost for society, but also as a growth
factor, a point that the many contributors of this edition will try to make.
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ABLE OF CONTENTS
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EDITORIAL
Laurent Ulmann, Editor-in-chief, The European Files
Can Europe Still Afford its Healthcare Model?
Healthcare Systems Must Be Re-Built to Last
6
Guaranteeing the Transparency of Pricing and Reimbursment for Patients and Industrials
7
Adressing Territorial Health Inequalities
8
The Financial Sustainability of Healthcare Systems
9
Tonio BORG, European Commissionner for Health
Vytenis Povilas ANDRIUKAITIS, Minister of Health, Lithuania
Marisol TOURAINE, Minister of Social Affairs and Health, France
Dr James REILLY, Minister of Health, Ireland
European Healthcare Systems in the Present Context
10
Fighting Against Inequalities in Health Throughout Europe
12
How Belgium Can Remain the Market Leader in Biotech
13
Ana MATO, Minister for Health, Social Services and Equality, Spain
Astrid KRAG, Minister for Health, Denmark
Alexander DE CROO, Deputy Prime Minister in the Belgian Federal Government, Belgium
Beyond Sustainability – Transforming Health Into Growth?
Health Systems: Not Only a Cost, Also a Contribution to European Growth
15
Clearing the Framework for Companies in Order to Contribute to European Growth
16
Potential of Personalised Medicines in Addressing Healthcare Systems’ Needs
17
Innovative Orphan Drugs: a Company Perspective on Healthcare Reforms in Portugal
18
The Crisis and the Policy Choices on Health System in Portugal
19
The Healthcare Agenda Ahead: Reducing Inequality, Driving Value, Meeting Priorities
20
How to Combine Competitiveness and Transparency in Clinical Trials
22
Re-thinking the Role of Prevention in Addressing Healthcare Systems Challenges
23
Françoise GROSSETÊTE, MEP, Group of the European People’s Party (Christian Democrats), European Parliament
Marina YANNAKOUDAKIS, MEP, European Conservatives and Reformists Group, European Parliament
Nathalie MOLL, Secretary General of EuropaBio
Fermin RIVAS LOPEZ, Celgene’s Portugal Country Manager
Adalberto CAMPOS FERNANDES, Escola Nacional de Saúde Pública, Universidade Nova de Lisboa
Richard TORBETT, Chief Economist, EFPIA
Philippe JUVIN, MEP, Group of the European People’s Party (Christian Democrats), European Parliament
Andrea RAPPAGLIOSI, President Vaccines Europe
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Regulating Medical Devices: a Harsh Fight for More Patient Safety
24
Pharmaceutical Industry – a Partner to Growth Recovery in Europe
26
How Can the Need for Cost-Effective Spending be Reconciled With Maintaining a High Standard of Care?
27
Dagmar ROTH-BEHRENDT, MEP, Group of the Progressive Alliance of Socialists and Democrats, European Parliament
CORINNE DUGUAY, Vice President European Public Affairs, Sanofi
Philippe DE BACKER, MEP, Group of the Alliance of Liberals and Democrats for Europe, European Parliament
Towards More Sustainable Healthcare Systems
Understanding the Impact of Austerity Measures on Health and Health Systems
29
Towards More Sustainable Healthcare Systems in Europe
30
Breaking Down Access Barriers for Patients in Europe
31
Trends In Public Health and Long-Term Care Expenditures: an OECD Perspective
32
How to Assess the Efficiency of Health Interventions
34
Ageing and Health
36
Making Dementia a European Priority
37
IMI: Delivering Results for Patients
38
Cancer Prevention is an Essential Investment for Sustainable Healthcare Systems
40
The Vicious Circle of Poor Health and Poverty
41
Working Towards a Solution to Address Medicine Shortages in Europe
42
Zsuzsanna JAKAB, WHO Regional Director for Europe
Paul TIMMERS, Director Sustainable & Secure Society, DG CONNECT, European Commission
Anders OLAUSON, President of the European Patients’ Forum
Christine DE LA MAISONNEUVE, Structural Policy Analysis Division, Economic Department, OECD
Joaquim OLIVEIRA MARTINS, Head, Regional Development Policiy Division, OECD
Lieven ANNEMANS, Professor of Health Economics, Ghent University, Brussels University
Nora BERRA, MEP, Group of the European People’s Party (Christian Democrats), European Parliament
Jean GEORGES, Executive Director, Alzheimer Europe
Michel GOLDMAN, Executive Director, Innovative Medicines Initiative (IMI)
Dr. Wendy YARED, Association of European Cancer Leagues (ECL)
Monika KOSIŃSKA, Secretary General of the European Public Health Alliance (EPHA)
Monika DERECQUE-POIS, Director General, GIRP – European Association of Pharmaceutical Full-line Wholesalers
Management : The European Files / Les Dossiers Européens - 19 rue Lincoln, 1180 Brussels - www.lesdossierseuropeens.fr
- ISSN 1636-6085 - email: dossiers.europeens@wanadoo.fr Publication Director and Editor-in-Chief: Laurent ULMANN Assistant: Antoine LESSERTEUR
Copyrights: BVMed picture pool, INSERM
CAN EUROPE STILL AFFORD ITS HEALTHCARE MODEL?
Healthcare Systems Must Be Re-Built to Last
Tonio BORG
European Commissionner for Health
F
or over a century, healthcare advances have
dramatically improved and extended the
lives of citizens across Europe. However this
success story brings with it new challenges, as
increasing life expectancy has resulted in a surge
in chronic diseases, requiring long-term treatment
and considerable costs. In 2010 public spending on
healthcare already accounted for almost 15% of all
government expenditure. If European countries do
not make important efficiency gains in the running
of their health systems, the EU’s healthcare expenditure could increase by one third in 20601.
A case for smarter spending
When asked how to make European healthcare
systems sustainable in the long run, my reply
is clear. We must embrace in-depth healthcare
reforms. Quick fixes will only give our systems
short-term respite and jeopardize the right to quality
healthcare for all, a right which is the hallmark of
our European model. In its recent report "Investing
in Health"2, the European Commission makes the
case for sustainability through better spending,
keeping citizens healthy and active and reducing
health inequalities.
I am convinced that the best way forward is
investing in health. It does not mean we must spend
more on health, but spend better. There are several
areas where countries across Europe can take
action to improve the cost-efficiency of their healthcare systems.
Investing in new technologies is one such area.
New technologies can be used to find innovative
ways of delivering and organising the provision of
health services and goods for maximum efficiency.
State-of-the-art medicines and equipment can also
lead to greater efficiency and savings in the longterm. This is where Health Technology Assessment
can be of immense value, to assess and support the
cost-effective use of new technologies in healthcare.
Examples, like pictures, can replace a thousand
words. One of my favourites is what Sweden is
doing in the area of e-prescriptions. Sweden has
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successfully opted for e-prescription with about
42% of all prescriptions electronically transferred
from the doctor to the pharmacy. The system
has met the expectations of all users, especially
patients who enjoy greater flexibility and a wider
range of services, such as a 24 hour hotline centre
offering advice. Furthermore, the electronic service
generated an estimated annual net benefit of over
€ 95m in 20083. And I am pleased that Member
States are increasingly using e-prescriptions and
reaping its benefits.
Another promising avenue to explore is to try and
find a better balance between providing hospital
care, primary care or care outside of health settings.
E-Health can help reorganize care delivery with
tools to enhance prevention, diagnosis, treatment
and management of health and lifestyle. Telemonitoring and vital signs cameras are examples
of devices that can enable patients with chronic
diseases to manage their health from home, and in
this way both improve their quality of life and free
hospital beds for acutely ill medical patients.
It is up to Member States to make the choices
that best suit their situation and needs. The
Commission’s job is to help them in various ways
including by supporting cooperation on health technology assessment, the uptake of eHealth and other
innovative solutions to transform health systems. I
am pleased that the eHealth network bringing
together all Member States has adopted this autumn
a set of voluntary Guidelines to share patients’ basic
health information across borders that will improve
patient safety and continuity of care in cross-border
settings. Recently, the Commission has also set up
an independent expert panel4 to provide Member
States with advice, on request, on health systems’
sustainability, and a network dedicated specifically
to Health Technology Assessment.
Investing in citizens’ health to reduce the strain
on healthcare systems
Healthy citizens reduce the strain on healthcare
systems and boost economic growth by staying
active for longer. A recent OECD study5 concludes
that just a one-year improvement in a population’s
life expectancy could contribute to a 4% increase
in output.
Devoting resources to prevention, screening,
treatment and care can reduce chronic diseases
and improve people’s well-being, cutting costs in
the long run. Currently, only about 3% of health
expenditure is allocated to prevention. Dedicating
resources to health promotion activities can pay
dividends in terms of keeping people healthy and
active for longer.
Reducing health inequalities to contain
economic losses
Health outcomes vary considerably within and
between Member States. In 2010, the maximum
gap in life expectancy at birth was 11.6 years for
men and 7.9 years for women. These health inequalities not only represent a waste in human potential
but also a major economic loss, estimated to be
between 1.5 and 9.5% of the European GDP6.
Additional efforts are needed to protect the
most vulnerable, such as the older population and
deprived minorities, from the effects of the crisis
and provide broad access to affordable and quality
health services for all.
I acknowledge the massive task facing Member
States. This is why I reiterate my commitment to
helping them and will be discussing sustainability
of health systems with Health Ministers next month.
Last October at the Gastein Health Forum, my call
for an in-depth reform of EU healthcare systems
received a warm welcome from all participants. This
gives me cause for optimism in what lies ahead.
1. http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
2. http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
3. http://www.ehealth-impact.org/case_studies/documents/ehealth-impact-7-2.pdf
4. http://ec.europa.eu/health/technology_assessment/
policy/network/index_en.htm
5. http://www.nber.org/papers/w8587.pdf?new_window=1
6. http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
Guaranteeing the Transparency of Pricing and Reimbursment
for Patients and Industrials
Vytenis Povilas ANDRIUKAITIS
Minister of Health, Lithuania
A
ssuring the availability of pharmaceuticals at
reasonable costs for their citizens is the main
goal of all European policymakers. However,
European countries have been confronted with a
steady rise in pharmaceuticals expenditure over the
last decades, leading to the adoption of complex
policies to manage the consumption of pharmaceuticals, while ensuring the financial stability of
their public health insurance systems. In this rough
financial climate, this question is of even greater
importance.
Many countries, including Lithuania, face considerable difficulties with the practical and pragmatic
implementation of balancing consumption with
expenditure controls. What should be done and
which instruments should be used in order to keep a
balance between these two principles? Could transparency of the decisions on the inclusion of pharmaceuticals into national health insurance systems
be a means of achieving this goal? If so, should it
involve only the policymakers, or should it involve
all parties concerned: government, pharmaceutical
industry and patients?
Of course, guaranteeing the transparency of
pricing and reimbursement is foremost an obligation
of the policymakers. In order to ensure a transparent coverage process, governments usually
adopt the criteria for the inclusion of pharmaceuticals into the national health insurance systems.
In Lithuania, criteria for the inclusion of new international non-proprietary names (INN) into the
reimbursement list are adopted by Orders of the
Minister of Health. These criteria are the same for
all pharmaceuticals, irrespective of the status of
pharmaceutical or its manufacturer, and, the criteria
include an assessment of the therapeutic and pharmacoeconomic value, as well as the budgetary
impact of including the pharmaceutical product into
the reimbursement list. A pharmaceutical product is
only included into the reimbursement list if it fully
complies with the criteria.
In such criteria-based approach, it may appear
that guaranteeing the transparency of pricing and
reimbursement is not too challenging a task for the
policymakers. However, this task does become
quite a challenge when we talk about the reimbursement and pricing of pharmaceuticals, responding
to unmet medical needs, or, used for the treatment
of rare diseases, or, pharmaceuticals with a high
added therapeutic value. Let’s look at some
examples.
Usually orphan drugs have high cost per one
patient treatment, but low impact to the overall
pharmaceutical budget. But, if the rare disease
has an unusually high prevalence, the orphan
drug expenditure could have a high impact to
budget. Currently, we evaluate the application of
drugs for rare disease treatment where the costs
of treating 9 patients with rare diseases are equal
to the Herceptin expenditure for the treatment of
205 women with breast cancer. The conventional
cost-effectiveness criterion currently in widespread
use does not offer a sufficient basis for rejecting
reimbursement of expensive treatments for exceptionally rare disorders, providing that decisions on
reimbursement are intended to reflect public preferences. Therefore, it is important to consider what
society is willing to pay in cases of rare disease.
The use of external reference pricing has been the
most common practice for the calculation of prices
of reimbursed pharmaceuticals in EU countries over
the last decades. This approach reflects the pharmaceutical market conditions which prevailed 10
years ago. However, these conditions have been
changing, for instance, with the development and
growing demand for innovative pharmaceuticals.
This policy leads to a situation when manufacturer’s prices vary across EU Member States.
However, the difference in prices of innovative
products among EU countries is slight, but there are
considerable disparities in the ability of the national
health insurance systems of those Member States
to reimburse innovative products. This situation
effectively limits access to innovative and effective
treatment, especially in countries with lower income,
causes delays or non-launch of new innovative
products.
In those cases, the policy makers in many EU
Member States started negotiations with producers
and started to implement different methods of risk
sharing with the producers and different methods
of claw backs. This leads to the intransparency
of prices, which, in my opinion, is one of the main
disadvantages of this pricing policy. Member States
with lower incomes and small populations have
very limited negotiating power with pharmaceutical
producers, as these markets are relatively unattractive to the producer on a Europe-wide scale.
In that case opportunities to assure accessibility
of innovative drugs in low to mid-income Member
States is lower than for high-income, high population Member States.
Differentiated pricing can be a solution in this
case and there are two main possible approaches
in this area.
Differentiated pricing among countries and, in
some cases, differential pricing among indications.
There must be clear and transparent criteria for
market-entry products with differential pricing,
since a transparent market-entry plan will be very
important in maintaining the confidence of patients
and society. The other very important criterion is
a fixed timeline for the launch of pharmaceutical
products, a transparent amount among Member
States, weighted on the average per capita income
of those Member States. A possible approach could
be the clustering of Member States into categories
or regions based on GDP.
There must be obligations from Member States’
side, too – the Member States should be obliged
to not include such products into international
reference pricing systems. Parallel trade possibilities can be excluded using specific supply
schemes, which can mitigate or eliminate shortages
of the product. The Member State should be free
to confirm the final price of the product and should
also be obliged to keep that price confidential, as
arranged with the producer.
These measures may not only improve the
access to pharmaceuticals, especially in the lower
income countries, but also ensure greater transparency in the whole pricing and reimbursement
process.
During the Informal Council in July in Vilnius,
Member States agreed that in order to create
modern, accessible and sustainable health systems,
countries have to ensure fair and cost-effective
distribution of money and efficient use of public
resources. Moreover, the health systems cannot
be sustainable without satisfaction of patients and
of society. In my opinion, guaranteeing the transparency of pricing and reimbursement is vital for
achieving these goals.
THE EUROPEAN FILES
7
CAN EUROPE STILL AFFORD ITS HEALTHCARE MODEL?
Adressing Territorial Health Inequalities
Marisol TOURAINE
Minister of Social Affairs and Health, France
A
s several of its European neighbours
France is facing the challenge of “medical
deserts”. Although it covers different kinds
of situations, it does match a particular reality: in
some areas, the French have been experiencing
increasing difficulties in seeing a general practitioner, getting an appointment with a specialist
and getting access to emergency care.
The inequalities between territories are
blatant: density differences of one to four are
sometimes observed. The coastlines and city
centres are replete with physicians whereas
rural and mountain areas as well as some
underprivileged urban areas are confronted with
shortages of professionals. In this respect, the
vulnerability of some regions lies both in the lack
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of incentives given to young professionals as well
as in the aging of the physician population which
is hastening the retirement of their elders.
The Government therefore decided to react:
without any response the situation would deteriorate even further for the French who are
regularly calling out to their elected officials
on this major challenge. In December 2012, I
submitted the Pacte Territoire-Santé (TerritoryHealth Pact) in order to combat medical deserts.
Firstly, it focuses on securing the settling
process. To this end, I have created a new status
which guarantees a minimal income during the
first two years of practice for those who decide
to settle in vulnerable areas. In 2013, 200
professionals have benefited from this action.
Furthermore, since February 1st all regions
have set up a “unique supervisor for settlement”.
Thanks to their good knowledge of the territory
and expertise in administrative procedures these
specialists are dedicated to guiding the young
and supporting them in their choices.
The second line of approach is to transform
the working conditions of health professionals.
We must make every effort to encourage team
work today. Here again, this request arose from
young physicians. This organisation of labour
will also make it possible to meet the needs of
patients. Several measures are thus fostering the
development of multi-professional structures. At
the same time, we are supporting the deployment
of telemedicine which represents a unique opportunity to tackle territorial inequalities.
Lastly, the Territory-Health Pact aims to invest
and act directly in the areas under-resourced
in physicians, ensuring access to emergency
care within 30 minutes by 2015 and allowing
hospital professionals and employees to support
outpatient facilities.
“Securing the settling process”; “transforming
the working conditions of health professionals”;
“investing in isolated areas”. Those are the
three targets we have set in order to thwart the
progress of medical deserts. In order to achieve
this, we will rely on the mobilisation of all health
stakeholders, elected officials, public authorities
and professionals. The first results are already
here to be seen!
The Financial Sustainability of Healthcare Systems
Dr James REILLY
Minister of Health, Ireland
D
ue to the global financial crisis, Ireland,
like other EU Member States, has had to
significantly reduce public spending. In
the health sector, we have reduced expenditure
by some 20% and comparative OECD data
indicates a reduction of 8% per capita in health
expenditure in 2010, compared to an average
reduction of 0.6% across EU Member States.
This brings the question of the financial
sustainability of healthcare systems into sharp
relief. Our challenge is to reduce the cost of
health services, not the quality, and as Minister
for Health I have been leading on a major
programme of reform to address that challenge.
Our programme of reform is set out in
Future Health (http://www.dohc.ie/publications/
Future_Health.html). Through Future Health, we
will reshape our health system by restructuring
service delivery and enhancing governance
and accountability systems. Future Health also
encompasses measures to drive down healthcare
costs, such as reducing the costs of medicines,
reducing pay and fees for health professionals
and reducing prices paid to healthcare providers.
Future Health also incorporates Healthy
Ireland (http://www.dohc.ie/publications/Healthy_
Ireland_Framework.html) an important series of
initiatives through which we renew our focus on
keeping our people healthy and driving health
prevention strategies across our public services.
We have made significant progress on these
reforms.
We established the Special Delivery Unit
(SDU) which is tackling problems associated with
delays in accessing care. The SDU sets targets
and monitors them, for both scheduled care and
unscheduled care. We have significantly reduced
– by 34% since 2011 – the number of patients
waiting on trolleys in our accident and emergency
units and have begun the process of tackling
waiting lists for scheduled care.
By addressing pay costs and adjusting fees
paid to health professionals (international data1
suggests that general practitioners in Ireland
have the highest average incomes in the OECD),
we have saved well over €300 million, without
sacrificing service delivery. We will continue to be
rigorous in dealing with pay costs and fees which
is fundamental to ensuring the long-term financial
sustainability of our healthcare system.
We have introduced a number of initiatives in
recent years resulting in significant reductions
in the price of thousands of medicines. New
agreements negotiated with industry in 2012
will result in further prices reductions, generating savings of over €400m over a three year
period. The introduction of generic substitution
and reference pricing in Ireland in 2013 has put
in place a framework to secure further reductions.
For example, just this month, we set a new
reference price for atorvastatin products that
was 70% lower than the price paid six months
ago. These reforms secure savings for our health
services as well as for hard-pressed citizens. I
expect there to be further reductions in the prices
we pay for medicines resulting in Irish prices
moving towards European norms.
Along with reducing public expenditure, we
have reduced staffing in the health services by
some 10%. We have accomplished this as part of
national agreements with public sector employee
representative organisations. It has been a
challenge for our health services to maintain
services with these staffing reductions but all
key services, including maternity, critical care,
neonatal and essential social services continue
to be delivered. In addition, it has facilitated the
redeployment of some 3,500 staff within the
health service.
Despite these pressures, we are improving
and enhancing hospitals and other medical facilities. Since May 2011 we have built 32 primary
care centres to ensure effective and efficient
delivery of services close to people’s homes, at
the lowest level of complexity and at the lowest
cost. Most significantly, we are embarking on
the construction of a new Children’s Hospital,
to the highest international standards, which will
provide high quality care for our children and their
children to come.
We are revamping the way we fund healthcare
using a Money Follows the Patient model, where
each patient will be funded on an individual basis,
with a corresponding charging regime for private
patients. We are reforming the private health
insurance market and we will introduce licensing
legislation and a robust regulatory framework for
healthcare providers.
The ultimate goal of the reforms in Future
Health is to put in place a system of universal
health insurance (UHI), to tackle the core and
fundamental inequity in the Irish healthcare
system. UHI will provide equal access to healthcare for all, based on need, not ability to pay, to
realise the best health outcomes for our people.
Under UHI, mandatory health insurance will
cover a standard package of primary and hospital
care services, including mental health services.
The system will be founded on principles of social
solidarity, including financial protection, choice,
open enrolment, lifetime cover and community
rating. We will ensure affordability by paying or
subsidising the cost of insurance premiums for
people with lower incomes.
The scale of our reform agenda is unprecedented in the history of my country. But it is
necessary, given the unprecedented scale of the
crisis we have faced and which we continue to
deal with. Underlying all these reforms is not just
the need to reduce costs but the need, indeed
duty, to enhance patient safety and make Ireland
a healthier place. The long-term financial sustainability of our healthcare system is fundamental
to this aim and I am confident we will achieve it.
1. WHO (2012), Health system responses to financial
pressures in Ireland: policy options in an international
context, Thomson, S., et al, World Health Organisation on
behalf of the European Observatory on Health Systems
and Policies, November, 2012.
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9
CAN EUROPE STILL AFFORD ITS HEALTHCARE MODEL?
European Healthcare Systems in the Present Context
Ana MATO
Minister for Health, Social Services and Equality, Spain
T
he preservation of the welfare state, which
is of priority concern to all societies, is high
on the agenda of national governments
and international organisations. The significance of this issue is reflected in its growing
presence in the media and in political debate1
[cfr. Health 2020 A European policy framework
and strategy for the 21st century World Health
Organization 2013, available at http://www.euro.
who.int/__data/assets/pdf_file/0011/199532/
Health2020-Long.pdf].
One of the key elements of the welfare state
is the health of the population, and healthcare
systems make a vital contribution in this respect.
In 1998, the European Parliament published a
comparative study of the health systems of the
then 15 Member States of the European Union2.
This study identified certain needs which are still
targeted today, such as promoting cost-effective
preventive approaches, addressing the health
inequalities that persist despite the universality
of health systems, achieving a more efficient use
of resources and establishing priorities for their
allocation.
The timeliness of addressing these issues is
underlined by the present context of economic
recession, accompanied by rising healthcare
costs and the demographic and epidemiological situation of a population that is aging and
increasingly subject to chronic diseases for which
new, but more costly, treatments are available.
Governments are under great pressure to adopt
effective policies, in response to the growing
public demand for affordable, equitable and high
quality healthcare3. This approach is the best
and probably the only one available to ensure the
sustainability of the health system, whilst safeguarding values such as fairness and solidarity,
and maintaining the comprehensive, balancing
role of the State, by fostering a thoroughgoing
modernisation of the structures and instruments
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of public governance, enhancing their efficiency
and involving all stakeholders in the political
debate.
In most if not all countries, health systems have
significant potential for improvement; indeed, the
challenges arising can sometimes be turned into
opportunities. According to a study conducted
in the USA, healthcare costs could be reduced
by 30% without reducing quality, provided
the necessary collaboration is obtained from
patients and healthcare personnel, and with the
introduction of measures such as joint decision
taking, the coordination of care processes and
their optimisation through appropriate diagnostic
and therapeutic procedures.
According to the Report on World Health –
Financing Health Systems: the Path to Universal
Coverage (World Health Organization, 2010),
20-40% of total health spending is wasted,
due to inefficiency. This Report identifies ten
specific areas where more appropriate policies
and practices could make a positive impact on
spending, sometimes dramatically.
While the issues raised are common to many
countries, the strategies adopted to address them
differ widely, as do health systems themselves,
as each society presents unique socio-economic
and political characteristics.
The countries of the European Union offer
practically universal coverage, although obtained
from different models, such as contributory or
Bismarck-model systems, in which the State
guarantees health benefits through a system
funded by mandatory contributions – as is the
case in Germany, Austria, Belgium, Luxembourg,
Holland and France – and tax-based or
Beveridge-model systems, in which the public
health service is funded from general taxation
and is provided universally and free of charge;
this system is applied, for example, in the UK,
Scandinavia, Italy, Portugal and Spain4.
Historically, the countries of northern Europe
have tended to adopt the Beveridge model,
while those of central Europe have preferred
the Bismarck model. However, over time these
differences have narrowed and in Europe the two
systems are now converging. Thus, in the last
decade, the tax funding approach has gained
importance in countries such as France (where
it had been scarcely represented), and the
volume of contributions has increased in some
State-based systems, such as that of Slovakia.
From a macroeconomic perspective, spending
on health by different countries varies considerably. In 2010, the 27 countries of the European
Union (EU-27) spent on average 9.0% of GDP,
ranging from 12% in the Netherlands, Germany
and France to 6% in Estonia and Romania.
Total health spending in Spain accounted for
9.6% of GDP, which is comparable with the UK
and Sweden. The public component of Spanish
spending represented 7.1% of GDP, with
spending per capita of 1,622 euros.5
Health at a Glance Europe 2012 http://
w w w. o e c d . o r g / e l s / h e a l t h - s y s t e m s /
HealthAtAGlanceEurope2012.pdf
However, although Spanish health spending
is considerably less than that of some other
European countries, in 2013 our system was still
ranked at number five of the most efficient healthcare systems in the world, and topped the list of
European countries, according to the Bloomberg
agency.
The Spanish national health system was also
among the highest rated in the WHO World
Health Report 2000. Among other factors, this
reflected its good coverage of the population and
the broad portfolio of health benefits and services
provided.
Indicators of life expectancy in our country are
slightly higher than the average for the European
population. For the whole population, in 2010
the life expectancy at birth in Spain was 82.1
years, while the corresponding EU-27 average
was 79.7 years. By gender, life expectancy
at birth for Spanish women and men was 85.3
years and 79.1 years, respectively. In the EU as
a whole, the figures were 82.6 and 76.7 years.
Life expectancy at age 65 years presents the
same pattern, at 20.8 years in Spain, compared
to 19.1 years in EU-27. By gender, Spanish
women at age 65 have a life expectancy of 22.7
years compared with 20.9 years for EU-27, while
Spanish men have a life expectancy of 18.6
years compared with 17.3 years for the men in
EU-27. [cfr. NATIONAL HEALTH SYSTEM 2011
ANNUAL REPORT, available at http://www.
msssi.gob.es/organizacion/sns/planCalidadSNS/
pdf/equidad/informeAnualSNS2011/Informe_
anual_SNS_2011.pdf].
Since health status is largely determined
by factors external to the healthcare sector, an
effective healthcare policy should involve all
stakeholders: social, regional, fiscal, environmental, educational and scientific. This is the
approach taken under the European initiative,
"Health in All Policies", which under the EU
Treaty, is of obligatory application throughout
Europe. However, to achieve the highest possible
degree of effectiveness, this approach should
also be applied to national, regional and local
policies.6
Healthcare systems are characterised by their
complexity, with multiple agents interacting at
different levels, conducting activities that present
many dimensions – political, institutional, clinical,
professional, financial and legal. An increasing
number of actors are becoming involved, with
patients and other users of the system participating more actively [cfr. Governance for Health
in the 21st Century. World Health Organization
2012 – available at http://www.euro.who.int/__
data/assets/pdf_file/0019/171334/RC62BD01Governance-for-Health-Web.pdf].
In countries with decentralised systems, as is
the case of Spain, decisions must be taken by
many agents other than central government, and
this factor significantly increases the complexity
involved.
A recent publication by the European
Observatory on Health Systems and Policies,
The Changing National Health System Role in
Governance – A case-based study of 11 European
Countries and Australia,7 analyses the impact of
the structural reforms of governance introduced
recently in some EU countries. Although a broad
spectrum of measures has been introduced, it can
be seen that countries with traditionally decentralised systems have tended to reinforce the
role of central governments in decision making
and cost control, while maintaining the quality of
healthcare provision and the universality of the
service. However, the role of central governments
is more complex, since many stakeholders, with
widely varying characteristics, are involved,
including not just the different levels of administration but also patients, professional organisations and the industry, which may offer more or
less valuable products. All of these parties take
health-related decisions that are not controllable
by governments, and so the latter must assume
a new role, that of exercising leadership, and of
working with all stakeholders to ensure that their
actions are oriented toward enhancing the health
of the population – for example, through codes of
good practice in the industry.
Spain has not been immune to these changes
and has responded to changing needs by
promoting a far-reaching health reform. This
began in 2012 with the adoption of Royal
Decree-Law 16/20012, of 20 April, implementing
urgent measures to ensure the sustainability
of the National Health System and to improve
the quality and safety of its services. With this
reform Spain will ensure the future sustainability,
fairness and solidarity of the system and will be
able to maintain universal health coverage. This
legislation provides a landmark reform to the
National Health System, addressing such vital
questions as the population eligible for cover,
the definition of the services provided and their
level of public provision, the rationalisation and
funding of prescription drugs, the introduction
of efficiency-oriented measures such as the
centralised procurement of drugs and medical
equipment, the reorganisation of human resource
management, promoting excellence in training
procedures, the creation of the Spanish Network
of Healthcare Technology Assessment Agencies,
of the Services Network and of Benchmark Units,
and the intensified implementation of e-health
instruments.
Furthermore, the reform makes a notable
contribution to addressing one of the major
challenges facing the countries of the European
Union, namely compliance with the recent
entry into force of Directive 2011/24/EU, of the
European Parliament and of the Council, on
patients’ rights in cross-border healthcare. The
EU countries are called upon to implement a
major reorganisation of their healthcare systems
to ensure that European patients can receive
healthcare in a country other than their own, and
with the necessary safeguards of quality and
patient safety. Spain, with the reform initiated in
April 2012, has laid the foundations to do so.
1. European Academy of Sciences and Arts. White Paper
on the Spanish Health System. 2011.
2. Healthcare systems in the EU. A comparative study.
Public Health and Consumer Protection Series SANCO
101 EN. 11-1998.
3. World Health Organization. World Health Report 2010:
Health systems financing, the path to universal coverage.
4. Gestión sanitaria integral: pública y privada (Comprehensive healthcare management: public and private).
Centro de Estudios Financieros. 2010.
5. Ministry of Health, Social Services and Equality. Sistema Nacional de Salud, España 2012 (National Health
System, Spain 2012). Madrid; 2012. Available at: www.
msssi.gob.es.
6. European Commission. Health in All Policies. http://
ec.europa.eu/health/health_policies/policy/index_es.htm
7. European Observatory on Health Systems and
Policies. The Changing National Role in Health System
Governance – A case-based study of 11 European
countries and Australia. 2013.
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11
CAN EUROPE STILL AFFORD ITS HEALTHCARE MODEL?
Fighting Against Inequalities in Health Throughout Europe
Astrid KRAG
Minister for Health, Denmark
I
n present-day Denmark, the size of your wallet
and the years you spend in school are both
important factors in determining the length and
quality of your life. Or to illustrate more clearly:
the average construction worker will not only live
a shorter life than, say, an economist; he or she
will likely also have fewer healthy years. And the
challenges go beyond the direct health consequences: for a grandparent, for instance, being
able to take part in activities with one’s grandchildren could be significantly limited by serious
illness.
Evidently, this is not solely a Danish
phenomenon. And The European Commission
Report on Health Inequalities from 2013 provides
ample evidence for why we need to address
inequalities in healthcare and health outcomes
also at a European level.
For me, health inequality is a challenge of
paramount political concern due to the healthy
years lost for many European citizens. And this
calls for a comprehensive approach addressing
all the facets of health inequality. But even then,
we are unlikely to make headway from day one.
The battle against health inequality is a battle
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requiring tenacity and perseverance, and the
battle will only be won if policy makers are willing
to let their words become their actions.
My vision for Denmark is a country where
everyone – irrespective of social status – will
benefit from a longer and healthier life. And I see
no reason why this should not be a shared vision
for the entire European Union.
Healthcare
Evidence shows that there are strong links
between the prognosis for illness and the efficacy
of treatment and the level of education of the
patient. Not only does the level of education
predict the resources of the individual patient; it
also influences how the patient is received by the
healthcare system when in need of treatment.
In Denmark we lack knowledge about the
mechanisms needed to achieve a higher
degree of equality in healthcare. Due to this, the
government is now subjecting the entire healthcare system to an “equality check” through the
creation of an Equality Network including – but
not limited to – both hospitals and municipalities.
The Equality Network will focus on the entirety
of the patient journey – from assessment to
treatment to rehabilitation – and will identify any
and all instances of inequality, so that we can
take appropriate political action.
We do not live in a world of pure unknowns,
however. In Denmark we know that patients who
have previously been admitted to a hospital for
psychiatric treatment have a 15 to 20 year shorter
life expectancy than the average individual. This
staggering example of health inequality readily
illustrates why I made the improvement of
psychiatric treatment a top priority when I took
office as Minister for Health. And in the coming
year, the Danish Government will launch a
comprehensive plan for psychiatric treatment,
including initiatives specifically designed to
increase health equality for psychiatric patients
in Denmark.
Outside Hospitals
Addressing health inequality is of course not
solely about illness and the treatment itself
within a hospital setting. Inequality must be
met with a focused approach as early as preschool, progressing through school, social activities and occupation. Consequently, the Danish
government is now setting national standards for
public health and the key health determinants
that are heavily intertwined with health inequality
and the prospects of a healthy life.
And sometimes, even beginning in pre-school
can be too late. If we seek to ensure a good start
in life we obviously need to focus on exactly
that: the start of life. So we are also currently
strengthening our maternal health services with
a specific focus on maternal health in vulnerable
families.
Partnerships
Unhealthy habits lead to poor health. This is
self-explanatory. However, supporting a change
of behaviour is a difficult task for policy makers
and can not be effectively achieved by legislation
alone. So to achieve our goal of defeating health
inequality and fostering healthier lifestyles, I
have allocated € 16 million to establishing strong
partnerships with municipalities, regions, sports
clubs, patient associations and businesses. We
need to involve the community – not just the
healthcare system itself – if we are to reach out
successfully to all citizens.
Furthermore, I have created a corps of
Ambassadors for Equality, a group of dedicated
individuals eager to improve the quality of life of
their peers. Among their ranks we will find the
manager, the colleague and the mother; individuals we all interact with on a daily basis.
The Ambassadors are to gently “nudge” people
towards a healthier life, and such an approach
is more likely to succeed if the incentives come
from people we can relate to and trust. We intend
to create a chain of positive events through
strong community partnerships, where greater
involvement leads to healthier habits, which will
then translate into longer and healthier lives.
A multifaceted approach
Inequality in health is not only a serious challenge.
It is also a complex challenge. This obviously calls
for a comprehensive response at multiple levels. I
am confident that we can achieve greater health
equality through a much needed equality check
and a strengthening of both psychiatric treatment
and maternal healthcare. We will use every tool
in the box to ensure that the benefits of a longer
and healthier life will be equally enjoyed by all,
construction workers and economists alike.
How Belgium Can Remain the Market Leader in Biotech
Alexander DE CROO
Deputy Prime Minister in the Belgian Federal Government, Belgium
T
he OECD is never shy about making new
recommendations to Belgium on occasion,
but when it comes to biotechnology, Belgium
is the recommendation. We are praised for the
quality of our higher education and for our close
collaboration with industry. The Flanders Institute
for Biotechnology brings together 1,300 scientists
and is the absolute world leader in fundamental
research. ThromboGenics, which started life
in 1985 as a spin-off from KULeuven, is now
valued at more than 1.4 billion euro. Thanks to
the right fiscal stimuli, we have also succeeded in
attracting the capital and investments that have
made it possible for Belgium to grow so spectacularly as a biotech country. In 1990 there were
two ‘life sciences’ businesses in Belgium; now
there are more than 120. A recent study carried
out by KBC Bank calculated that the sector as a
whole is valued at more than 11 billion euro, with
a 30% market share in Europe and more than
30,000 highly skilled jobs.
There can be no lifetime guarantee, however,
that things will always continue to go as well as
this. First of all there is increased competition
from dynamic and growing economies like India
and Russia. Secondly, the introduction of Basel III
will hamper bank lending to companies. Thirdly,
grim economic forecasts are continuing to put
pressure on government budgets. In a nutshell,
easier environments are imaginable for a biotech
company to submit a reimbursement application
for a new drug – even if it does offer promising
health benefits.
Despite the difficult budgetary context, this
government has decided to increase the advance
corporation tax exemption for researchers from
75% to 80%. Although there is no doubt that this
represents a whiff of oxygen for the sector, it does
nothing to deal with the second challenge: how
should Belgian biotech companies finance their
future growth?
Developing a biotech drug takes a long time
and involves high costs and substantial risks.
Thrombogenics will probably not report its first
profits until 28 years after its original formation.
Only one in four biotech discoveries actually reach
the market in the end. Testing the effectiveness of
a new drug in clinical settings and ascertaining
the medical added value that it offers (phase III)
can easily require a budget of between 50 and
100 million euro. Our SMEs cannot simply turn
to their house bankers for funding on this scale. If
this means that the company has no other option
than to sell to a foreign pharmaceuticals giant
to allow it to pay for subsequent development
phases, Belgium will miss out on huge added
value in the future.
The government, in its role of providing flanking
support, is therefore aiming to move beyond the
existing advance corporation tax exemption and
the existing patent deduction. It needs to intervene
to address the heart of this issue: the systems of
drug reimbursement. The essential question here
is: how can we reform these so that they offer
greater financial opportunities for
businesses that are working hard to
innovate and developing drugs that
are relevant in our society? We
could, for example, work through
provisional decisions that would
make it possible to bring drugs to
the market more quickly without
sacrificing quality for patients. The
level of reimbursement for the drug
could also evolve in line with the
observed medical benefits.
These are not empty ideas. There
are some very practical reasons for
considering these approaches: from
2015 onwards, biological drugs
valued at more than 500 million
euros will be coming off patent in
the Belgian market. We must take
this opportunity to consult with the
sector to look at the best possible
ways of reinvesting this budgetary
margin in the sector. It can also
be invested in innovative strength
for our biotech businesses and in
ensuring appropriate prices for our
patients and health insurers.
Here is one idea: when a biological drug
comes off patent and a biosimilar equivalent
is available, it will be placed in a new group
of ‘cheap biologicals’ and made subject to an
automatic price reduction of 25%. In this way we
would release up to € 125 million, at least half
of which can be earmarked to flow back into the
sector. This also means that in accordance with
the recent report from the Belgian Health Care
Knowledge Centre, we must ensure that biosimilars continue to be developed and marketed in
Belgium on a sustainable basis through specific
guideline figures, since if there is no biosimilar
equivalent there will be no cheap cluster and no
price reduction.
To safeguard our position as the market leader,
we will all have to pull in the same direction: drug
developers, the generics industry, universities
and the government. It is our responsibility to
work together to ensure the continuation of our
success story in this superb sector.
BEYOND SUSTAINABILITY - TRANSFORMING HEALTH
INTO GROWTH?
Health Systems: Not Only a Cost, Also a Contribution to
European Growth
Françoise GROSSETÊTE
MEP, Group of the European People’s Party (Christian Democrats), European Parliament
G
eneral constraints on public finances
compel to reform health systems in order
to handle expenditures while optimizing
profitability of the sector and innovation. These
reforms are essential to enable health systems
to respond to growing demand in care generated
by population ageing and to keep on supplying
future generations with high-quality medical care.
The financial crisis has made the need for
improvement in health system efficiency more
urgent. More than ever, we have to consider
health as an investment for the future and no
longer as a cost or a variable to balance social
budgets. This sector has to become leverage
for growth, a job provider in times of crisis, and
appear as a real pillar for European economy.
The healthcare sector represents around 10%
of the GDP and 10% of the employment in the
European Union, with a proportion of postgraduates higher than average. In a context where
deindustrialization is ubiquitous, the health
industry is one of the few leading industries widely
located on the European territory, from research
to distribution. As such, it deserves to be recognized as a high-tech industry. As an example,
an antineoplastic medicine uses as much technology as an Airbus. Going from discovering an
active principle to the industrial production of a
medicine is a great challenge to engineering and
technologies.
To win the battle of innovation, someone has
to multiply the strengths at stake and collaborate between public and private stakeholders,
between researchers of different disciplines.
I am currently rapporteur of the health
programme for the European Parliament, with
a budget of 449.394 million euros from 2014
to 2020. This amount, though negligible, has
been spared from budgetary cuts, for which the
new 2014-2020 European multiannual financial
framework has been the target.
This third health programme will emphasize
a limited number of concrete actions, giving
a significant European added value to health
of European citizens. It is included in the 2020
European strategy and encourages innovation
in healthcare and ensures its viability whilst
improving European citizens’ well being.
These financings complete a certain number
of measures related to health through structural
funds and the 2014-2020 Framework Programme
for Research and Development. In comparison to
the previous period (2007-2013), this programme
benefits from a 5.7% raise.
By better targeting objectives, the programme
seeks to avoid duplications and optimize limited
financial resources. It is essential to not push
forward a catalogue of measures since it would
lead to a dispersion of available financings.
Potential candidates for financings are national
authorities, public and private organisms, international organizations and non-governmental organizations via co-financing.
The programme’s budget will be divided into
four main objectives: reinforcing innovation,
improving access to safe and high-quality
healthcare, favouring disease prevention and
protecting citizens from cross-border health
threats. For instance, the Claude
Bernard University of Lyon “1” in
my electoral district benefits from
financings of the health programme
in partnership with several
organisms, one of which is the
Higher Institute of Health in Italy, to
work on a better European solution
to pandemics. The objective is to
help Member States find the best
solutions to protect European
citizens in case of health threats.
As far as prevention is concerned,
risk factors should be identified
more precisely to implement more
efficient strategies. The main risk
factors – including bad food behaviours and sedentary lifestyles –
have to be taken into account for
suitable and efficient prevention of
chronic diseases.
I also wished for, along with my
parliamentary colleagues, a stronger emphasis
on age-related diseases. Indeed, these diseases
affect more and more people (more than 7 million
people suffer from a form of senile dementia in
Europe). It triggers heavy social, health, and
economic consequences. It is crucial to act both
on prevention and innovation.
Increased life expectancy is leading to a
significant rise in the number of elderly persons,
which should reach 40 % by 2030. This process
presents a certain number of stakes and challenges, as for society and economy. Preserving
the health of individuals and their ability to stay
physically and socially active as long as possible
is the best way to optimize their positive impact
on productivity and competitiveness. Not only will
improving the health of our seniors protect them
from the difficulties of ageing, but also lighten
social and medical expenses.
This new health programme for the 2014-2020
period will contribute to strengthening the health
sector’s potential as a driving force for economic
growth and source of employment. It will support
more than ever innovation in health systems, in
order to promote better health for people through
more efficient and sustainable health systems.
THE EUROPEAN FILES
15
BEYOND SUSTAINABILITY - TRANSFORMING HEALTH INTO GROWTH?
Clearing the Framework for Companies in Order to Contribute
to European Growth
Marina YANNAKOUDAKIS
MEP, European Conservatives and Reformists Group, European Parliament
W
ith the fraudulent breast implants
scandal and problems related to
metal-on-metal hip replacements, I
understand why patient safety has been at the
forefront of revisions to the EU’s Medical Devices
Directive. It is essential that medical device regulation guarantees the highest level of safety for
patients, however we must work to allow industry
to bring safe, effective and innovative products to
the market.
Innovation supports the European economy.
Our health services are also major investors and
wealth creators, especially in the science and
engineering sectors. At a time of public spending
cuts, healthcare is coming under increased
pressure. Italy, for example, announced a
5% blanket spending cut on medical devices.
Companies of all sizes are facing constraints
precisely at a time when they need to be investing
in new kinds of innovation and financing has
become increasingly scarce for small companies.
Innovation in the medical devices sector
improves and extends lives. For example,
researchers have recently discovered that multiphoton lasers could be used to remove amyloid
proteins in the brain, which could be used to
treat diseases like Alzheimer’s and Parkinson’s.
Increasingly pharmaceutical breakthroughs go
hand in hand with technological advances.
This is why I have argued that any revision of
the Medical Devices Directive must be proportional. I believe that we need to iron out the flaws
and shortcomings within the current regulatory
framework rather than creating an altogether
new – and possibly burdensome – supervisory
structure.
At a time when the medical technology
sector is feeling the pinch from cuts in health
budgets, we must be wary of creating additional
problems, especially for SMEs. Small businesses
are already weighed down by EU red tape and
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THE EUROPEAN FILES
additional regulatory burdens in the devices
sector may be the deathblow for some medical
technology manufacturers.
As part of my work on the revised medical
devices directive, I visited Eschmann Equipment’s
production facility in the south-east of England.
This manufacturing SME told me that if the regulatory environment were more onerous, it would
be reluctant to invest money in new products
and may even consider choosing to manufacture
outside the European Union. This would mean
the loss of hundreds of British jobs.
This is why we need a regulatory framework
which encourages companies to innovate
and grow. The US, where the Food and Drug
Administration’s (FDA) approval system
is considered more complicated and less
predictable than the current system in the EU,
manufacturers have accused the FDA of jeopardising America’s leadership position in med tech
innovation.
Indeed Europe has benefited from America’s
oppressive pre-market approval procedure with
many American companies choosing to obtain a
CE marking in a European market and then use
patient data from European clinics as part of the
basis for an application to the FDA. Furthermore,
some American patients have had to travel to
the EU for treatment where more innovative,
life-saving medical devices were available years
before they would be licensed in the US.
While respecting the foundation of patient
safety and overall patient well-being, the revised
directive ought to be cost effective, flexible and
ensures that we have an industry which can grow,
attract more investors and ultimately produce
more affordable devices.
While we must be mindful of the scandalous
use of substandard, non-authorised silicone gel –
with at least 4,000 women reporting PIP implants
rupturing – I do not, however, believe that more
legislation is going to prevent acts of criminal
frauds like the PIP scam. More legislation is not
always the same as more scrutiny.
In the European Parliament, I worked to
block some of the proposals which would have
stifled innovation in the medical devices sector.
I also opposed measures to prevent more power
being passed to the EU in the form of giving the
European Medicines Agency control over the
licensing of certain devices. Working with MEPs
from the centre and centre-right we now have
set of legislative proposals which improve on
the original draft, but I still believe that the new
legislation increases the administrative load on
companies without the countervailing improvement in patient safety. How this will affect
innovation in the med tech industry is yet to be
seen, but I hope that Europe is not jeopardising
its economy – to say nothing of the lives of its
citizens – for the sake of over-regulation.
Visiting Eschmann Equipment in Lancing. Revision
of EU Directive on Medical Devices must protect
innovation especially for SMEs like this one.
Potential of Personalised Medicines in Addressing Healthcare
Systems’ Needs
Nathalie MOLL
Secretary General of EuropaBio
I
n Europe, the population is ageing rapidly, which
is already placing greater strains on national
healthcare systems. Economic stagnation
has seriously hampered the ability of Member
States to invest in innovative new treatments
and in world-leading research. However, innovative therapies, such as Personalised Medicine,
might play an important role in facing these challenges and help in addressing the healthcare
systems’ needs. Most importantly, Personalised
Medicine could play a significant role in helping
to ensure a fitter, healthier European population,
lower Europe’s burden of disease and address
currently unmet medical needs.
Personalised Medicine is an area of healthcare that provides the right treatment, to the
right patient, at the right time, by using modern
biology’s new methods and tools. This approach
combines diagnostic and therapeutic tools to
create predictable outcomes and tailor medical
treatment to the individual characteristics of
each patient. As Personalised Medicine offers a
new and more scientific approach to diagnosing
and understanding diseases, they will lead to
more effective treatment decisions for individual
patients. In other words accurate and right
diagnosis will lead to more ‘tailored’ and effective
treatment.
The cornerstone of Personlised Medicines are
predictive biomarkers that can select a patient
group with a higher chance of a favourable
response to a medicine. As a consequence,
the biomarkers have the potential to increase
the research and development productivity by
increasing specific patient response rate to
treatment, and therefore are likely to reduce
development timelines and costs as well as late
stage attrition of the drug development pipeline.
Due to recent improvements to healthcare
provision in the field of Personalised Medicine,
many traditional diagnoses and approaches to
identifying and classifying diseases may have to
be revised. In future we should be able to identify
underlying molecular diseases mechanisms more
precisely and treat a specific disease based on
its molecular mechanism rather than symptoms.
Oncology is a front runner in this field, but lately
biomarker candidates have also been discovered
within rheumatoid arthritis and asthma. Of course,
there is a potential to advance such discoveries
in other disease areas as well.
As a consequence, Personalised Medicine is
expected to have a more favourable risk-benefit
ratio, leading to a better outcome for patients.
Personalised Medicine has the potential to significantly help in addressing currently unmet medical
needs in a more efficient and productive way.
The fact that in the Personalised Medicine
concept, a sub-group of respondents is selected
or screened raises the hope that economic
evaluation will be more straightforward and
positive. As a consequence, healthcare resources
are likely to be used in a more efficient manner. In
other words, Personalised Medicine may provide
more value for money, because of improved
effectiveness, reduced toxicity. Studies on the
effectiveness of Personalised Medicine are on
the way, but there are already some promising
results. For example, a cost-effectiveness
analysis in the area of chronic myeloid leukaemia
showed that the use of FISH reduced treatment
costs by 12,500 Euros. (Gaultney JG, Sanhueza
E, Janssen JJ, Redekop WK, Uyl de Groot CA
(2011), Application of cost-effectiveness analysis
to demonstrate the potential value of companion
diagnostics in chronic myeloid leukemia;
Pharmacogenomics 12(3))
Personalised Medicine may also contribute
to the decrease of the average research and
development costs of a new medicine. Namely,
biomarkers may enhance the efficacy of clinical
trials by investing more heavily in early research
to identify key biomarkers and in targeting
relevant subgroups of patients. Smaller and
potentially shorter clinical trials are likely to
reduce the development costs.
However, these efficiency gains may show
only in the long run. Despite this potential of
Personalised Medicine, there are still a few challenges that will need to be faced, including: difficult
description of the costs of diagnostics and difficult
evaluation of cost-effectiveness. Furthermore,
the regulatory pathway is fragmented.
In conclusions, the personalization of treatment
has the potential to improve the treatment
and contribute to the reduction of costs and
biomarkers may contribute to more successful
research and development projects. However,
the value of the Personalised Medicine will
largely depend on the external environment. This
means that adaptation and flexibility in regulatory
and market access structure might be needed
to encourage the development of Personalised
Medicine.
The future of medicine such as Personalised
Medicine will be a major development but
there are still a few challenges to be faced as
mentioned above and also some new questions
to be asked.
The existing challenges and questions require
an open dialogue between science, industry,
policy and civil society. Personalised Medicine
has a strong potential to play a role of an
essential component in addressing the healthcare systems’ scientific, economic and societal
challenges and help in meeting patients’ needs.
The risk that we run in an age of austerity is to be
short sighted, by not investing in what will give us
gains in the longer term.
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17
BEYOND SUSTAINABILITY - TRANSFORMING HEALTH INTO GROWTH?
Innovative Orphan Drugs: a Company Perspective on
Healthcare Reforms in Portugal
Fermin RIVAS LOPEZ
Celgene’s Portugal Country Manager
P
ortugal has been a diligent follower of
orders to reduce its public spending from
the Troika – the European Commission,
European Central Bank and International
Monetary Fund. To help secure a bailout for
its excessive public debt, the country cut
government spending by 12% between 2010 and
2012, slashing EUR 845 million from healthcare
spending – far in excess of the EUR 550 million
demanded by the Troika1.
At first glance, this looks as if it should be
positive news – as if Portugal is tackling its debt
problem quickly by reducing spending on healthcare, a substantial part of the national budget.
However, there is a danger that these cuts
could hit the most vulnerable. Firstly, the size
and scale of the cuts is bringing hardship of a
kind that should not be expected in 21st century
Europe. The introduction of fees for treatment,
at a time when unemployment is around 16%,
has meant that many patients cannot afford to
pay for consultations or medication. One million
Portuguese citizens avoided seeing a doctor
last year, and 500,000 went without treatment,
according to the Portuguese Nurses Union2.
What’s more, the arbitrary nature of some cuts
will particularly hurt patients with rare, hard-totreat illnesses. That’s because the government
has decided to aim to reduce spending on drugs
to just 1% of GDP. This measure will have a
disproportionate impact on small companies
that focus on unmet needs through making
large investments in research to produce orphan
drugs. Celgene, for example, specialises in
finding treatments for rare diseases, such as
types of cancer, for which there are no effective
treatments. Like many other companies active in
this area, we have a small portfolio of therapies
18
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for treating a small patient base. This means
we have limited scope to diversify our risk
and mitigate the impact of cost-containment
measures.
But our business model depends on our ability
to innovate: we reinvest 30% of our revenues
back into research and development to sustain
this innovation. Any cost-containment measures
that do not take this innovation model into
account will have a major financial impact on
us. This might compromise our ability to sustain
our research in an area that is a well-established
public health priority in Europe.
Such an approach to budget-cutting is counterproductive. Used appropriately, pharmaceuticals can reduce broader – and more significant
– health costs, such as in-patient treatment.
But focussing on a 1% target removes the flexibility to use drugs effectively and therefore can
actually act as a barrier to financially sustainable
healthcare.
Evidence is already mounting of the illeffects of health budget cuts. Countries such as
Portugal, Greece and Spain, which adopted strict
fiscal austerity after the financial crisis, have seen
more outbreaks of infectious diseases, according
to medical journal The Lancet. “The interaction of
fiscal austerity with economic shocks and weak
social protection is what ultimately seems to
escalate health and social crises in Europe,3” the
journal concluded.
This isn’t necessary. Italy has adopted
austerity measures, but has been careful not to
penalize public health objectives or innovation. In
particular, Italy has exempted orphan drugs from
a new pay-back mechanism.
Maintaining spending on drugs is also good
for long-term economic prospects, as mediumsized pharmaceutical companies are a major
source of innovation and of exactly the kind of
high value-added jobs that Portugal needs to
generate. Celgene’s investments in Portugal
support medical education and the capacity of
institutions to participate in research projects
sponsored by industry or academic institutions.
Ten clinical trials sponsored by Celgene are
ongoing, and feasibility processes for new trials
are under review. Because Celgene supports the
study medication and the diagnostic procedures,
the trials represent savings to the national
health system in the cost of treating the patients
concerned. So far, close to 100 patients have
been treated in clinical trials in Portugal using
Celgene medicines.
Such negative fallout from Portugal’s following
Troika instructions would be a tragic irony, as it
would mean the country breaking the spirit of
the EU Strategy for Growth, Employment and
Industrial Development that it signed up to in
April. It also runs counter to other initiatives
such as ongoing negotiations on Horizon 2020,
which aims at boosting investment in research,
including through the development of innovative
drugs to tackle rare diseases.
But the cuts currently proposed and their detrimental effects on healthcare systems, citizens’
health and the economy are not inevitable. We
strongly believe there is a need for a dialogue with
authorities focused on finding creative solutions
to ensure innovation, high-end jobs and muchneeded investment. Medium-sized companies
such as Celgene are willing to be part of these
solutions and to contribute to economic growth
– and the revenues needed afford sustainable
healthcare services.
1. http://www.portugal.gov.pt/media/1229864/20131031%20apres%20OE2014%20ingles.
pdf (P15)
2. http://www.channel4.com/news/portugal-health-crisiswe-do-not-even-have-scrubs
3. The Lancet, Volume 381, Issue 9874, Pages 1323 1331, 13 April 2013
The Crisis and the Policy Choices on Health System in
Portugal
Adalberto CAMPOS FERNANDES
Escola Nacional de Saúde Pública, Universidade Nova de Lisboa
I
n the past two years, Portugal has undergone
an intense process of transformation of its
social and economic conditions. Indeed, the
submission to the hard terms of the memorandum
of understanding, commonly known as (MoU),
under the program of economic and financial
assistance conditioned, deeply, living conditions
and the expectations of citizens in the future.
The health system has not been immune to
the wave of sweeping cuts and restriction that
affect, in general, all sectors of activity. In the
health sector, MoU contributed to achieve a set
of important and necessary measures. Most of
them discussed a long time ago, but recurrently
delayed by lack of political conditions to their
application.
The financial and budgetary crisis has,
however, the advantage of contributing to
a new approach in the health sector, more
based on transparency, accuracy and public
scrutiny of the use of public resources. This
context, inducted a new openness of minds and
cooperation perceived in all different professional
actors, corporate leaderships and institutional
representatives. This new professional and
social environment enabled the implementation
of some important changes as it never happened
before in Portuguese health system.
Considering health policies analysis one must
highlight the measures that intended to improve
the accuracy and transparency of the health
system. Indeed, the budget constraint contributed
to strengthening the tools for monitoring and
internal control. This new attitude contributed to
strengthen a critical analysis of the use of public
resources in the health system.
A quick view of the most important initiatives
places the pharmaceutical policies in a first level
of relevance. In fact, we can identify significant
changes in this area, through a large increase, in
2011, of the reform process initiated in 2009, even
before the signing of the MoU. These measures
introduced profound changes in market conditions
in the field of the pharmaceutical sector. The
price reductions and the development of generic
market took into account the economic and social
reality of the country contributing to reduce the
health public expenditure in this period.
In fact, these measures adjusted an
inappropriate allocation of resources recognized
in the last decades and responsible for an
abnormal proportion of public expenditure on
pharmaceutical products as a percentage of
gross domestic product.
In addition to the administrative measures
concerning prices and margins control, several
measures of fraud fight and reduce of waste were
implemented. At the same time, were applied
measures with a more structural effect such as
standardization, clinical guidelines and electronic
medical prescription.
The balance of cost containment policies, in
the pharmaceutical area, have been globally
positive. In the last three years, there was an
effective reduction in the average cost to citizens,
a remarkable growth on the use of generic drugs
and a more rational prescription. Nevertheless,
it must emphasize that the implementation of
these constraint measures led to an increase
of difficulties in the access of innovative drugs
and to an aggravated process of inequalities in
access to new therapies.
The cost containment policies, in the health
sector, had also another important target –
public expenditure with human resources.
These political measures had a more recurrent
and variable effect, and they have an uncertain
probability of efficacy.
Currently, two years after the beginning
of the adjustment process, there is a lack of
sustainability in structural reforms of the health
system. Most important political measures have
been delayed, either in organization structure or
as management practices. Important questions
such as professional mobility and matters related
to the public-private combination, double funding
and double coverage, clarification of rules and
relations between different sectors have been
postponed.
It is true that the different policies have an
important need of time to allow a serious and
profound analysis. It seems, however, possible
to draw some preliminary conclusions on the
implementation of the main policies concerning
to the health sector.
One of the most sensitive aspects of the
adjustment process done in these last two
years, in the health sector, has to do with the
balance between measures of circumstantial
consequence and structural persistence.
In conclusion, one can refer that the most
relevant issue in this adjustment process is
the apparent difficulty of public governance,
in this area, to achieve effective integration
between budgetary tightening measures and the
improvement of global performance of the health
system in a sustainable and resilient way.
Apparently, the crisis did not accomplish
its more important goal – to be a historical
opportunity to develop health policies based on
public choices able to provide a response to health
needs, in a context of efficiency, productivity and
consolidated quality of healthcare.
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BEYOND SUSTAINABILITY - TRANSFORMING HEALTH INTO GROWTH?
The Healthcare Agenda Ahead: Reducing Inequality, Driving
Value, Meeting Priorities
Richard TORBETT
Chief Economist, EFPIA
D
riving value in healthcare and reducing inequalities in healthcare across Europe – these
are two fundamental objectives increasingly
being discussed among Europe’s healthcare stakeholders. We have seen how austerity
measures impact healthcare spending and health
systems, and the resulting impact on patients who
depend on those health systems. As we look ahead
in the healthcare agenda, there is no doubt that
this trend needs to change. Richard Torbett, Chief
Economist of EFPIA, shows how economic policymakers can influence the future health of Europe
– not only its economic health but also the health
of its citizens – in his article “The need to reduce
inequality and drive value in healthcare”.
Dr. Torbett’s article is complemented by a text
discussing another type of priority for the healthcare agenda – the priorities set by areas of unmet
medical need. The 2013 World Health Organization’s
“Priority Medicines for Europe and the World”
Report provides the latest update on where new
and improved treatments and medicines still need
to be developed. This includes areas of disease
ranging from HIV/AIDS, to Alzheimer’s Disease.
The societal and economic impact of diseases like
Alzheimer’s is expected to increase in accordance
with Europe’s ageing population.
Together, these two texts highlight some of the
key issues in the healthcare agenda ahead. Looking
at this, it’s clear that now is the time for big picture
thinking. Experts need to leave their cosy niche
areas and work together. It’s time for economists to
start thinking about healthcare. It’s time for policymakers to start thinking about innovation. It’s time
for healthcare experts to think about how areas of
unmet need impact not only patients, but societies
as a whole. In short, now is the time for collaboration
– if we want to ensure a healthier future for Europe,
economically, socially, and in terms of health.
1. The need to reduce inequality and drive value
number of people over 65 will rise by 75%. As the
in healthcare
ratio of those in work to those out of work changes,
It is well known that Europe has an ageing popucurrent European welfare models that rely on ‘paylation, with all of the social, economic and fiscal
as-you-go’ will feel the strain. This often leads to
challenges that come with that. Healthcare should
a policy focus on cost containment. Of course, to
be at the heart of the debate on how we deal with
a point, this is entirely reasonable. It is essential
these challenges. But it must not be a debate that
that taxpayers money is properly managed and
leads to panic and short term cost cutting and the
that healthcare systems should be encouraged to
expense of quality and innovation. That would make
be as efficient as possible. But if quality and innomatters worse, not better – for all of us.
vation are neglected we run the risk of missing an
According to the European Commission there
opportunity to both reduce inequalities and drive
is likely
to
be
an
11%
decline
in
the
size
of
the
economic
EU27 Disability Life Years as %growth.
of Total Life workforce by 2050, whilst at the same time the
The fact is millions of people across Europe do
Expectancy EU27 Disability Life Years as % of Total Life Expectancy
Spain Bulgaria Romania Estonia Czech Republic 1990 2010 Lithuania Slovakia Poland Latvia Portugal Greece Hungary Belgium Ireland Germany Italy Slovenia Malta Netherlands Cyprus France Denmark UK Austria Sweden Luxembourg Finland 11,00% 11,50% 12,00% 12,50% 13,00% 13,50% 14,00% 14,50% 15,00% 15,50% 16,00% Source: Lancet: Healthy life expectancy for 187 countries, 1990–2010 (2010)
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not get the same standard of care as the best. This
results in a well-documented drain on productivity.
Apart from the decade’s difference in life expectancy
from the best to the worst across Europe, there is
evidence that absenteeism and early exit from the
work place is partly addressable by more effective
care. This would mean more people contributing
more effectively to GDP rather than creating cost on
health systems.
What’s perhaps less well known is the fact that,
although we’re living longer, we’re spending more of
our lives in some sort of ill health. The chart shows
that, in the 20 years between 1990 and 2010, the
proportion of people’s lives spent with some kind of
illness or disability increased in all 27 countries of
the European Union.
Reversing this trend ought to be a fundamental
objective of mid to long-term growth policies for
Europe. Policies that help us live healthier lives
would help with the sustainability of public finance
by reducing pressure on the costs of retirement. But
they would also help maximise the productivity of
European citizens during their working lives. There
is an urgent need to debate what those policies
might look like and how they can be made coherent
with the rest of economic policy. We’re not starting
from a blank sheet of paper, of course, and there is
much superb commentary on the need to upgrade
our focus on prevention and healthier lifestyles etc.
But the whole area needs more focus and needs
to be recognised by economic policymakers as an
essential enabler of a prosperous future for Europe.
there is no treatment, where treatments lose their
efficiency or are inadequate, or where the form of a
treatment is not suitable for a special group or population (e.g. children or elderly).
For this analysis, four inter-related criteria have
been applied to determine priority disease areas of
research: estimated burden of disease, prediction of
disease burden trends, risk facts amenable to pharmacological intervention, and the principle of “social
solidarity” where there are no market incentives to
develop treatments.
Although a lot has been achieved in preventing or
successfully treating certain diseases, it comes as
no surprise that WHO prioritises conditions certain
conditions including: ischaemic heart disease
(IHD), diabetes, cancer, stroke, HIV/AIDS, TB,
malaria, Alzheimer’s disease and other dementias,
osteoarthritis, chronic obstructive pulmonary
disease, alcohol use disorders (alcoholic liver
diseases and alcohol dependency), hearing loss,
depression, diarrhoeal diseases, lower respiratory
infections, neonatal conditions and low back pain
Pharmaceutical gaps vs. unmet needs
If there is sometimes a mismatch between priorities/
unmet needs and what comes to the market, it
doesn’t mean that companies are not working in
these specific areas. The WHO report points at
elements, which make these investments into new
prevention and treatments more difficult and less
successful today:
• The scientific challenges are increasingly complex
and often cannot be addressed by the industry
alone;
• There are regulatory hurdles and market failures
(with low or no return on investment) that need to be
addressed through changes in the legal framework
and providing adapted incentives.
Time for implementation
On the R&D side, EFPIA will use the WHO report
as a starting point for defining the work programme
of the Innovative Medicines Initiative 2, the largest
public-private partnership in biomedical research.
We hope that this report will be used as a starting
point for governments to set their healthcare policy
priorities. This will help provide more long-term
certainty for the new prevention and treatments to
be used once they are developed.
European Region
World
Percentage of total DALY burden
2. WHO Priority Healthcare Report: Time for
implementation
The 2013 Report Priority Medicines for Europe
and the World published on 9 July provides a great
snapshot on current healthcare and health research
priorities. Surprisingly its release went rather
unnoticed. A coincidence of the summer break? Or
is it maybe seen as stepping on the delicate boundaries of national competencies? In any case, this
report is a useful tool to support healthcare and
healthcare research priority setting based on an
objective and multi-stakeholder review of burden of
disease and research portfolios.
Prioritising healthcare needs and gaps
How to define what is and what is not a healthcare
priority or a biomedical research priority? In its 2013
report the WHO provides some important answers.
• It starts by defining what a global burden of
diseases is – i.e. defining costs to the patient and
to society, beyond the cost of treatment, including:
absenteeism, presenteeism, disability, impact on
families, etc.
• It also indicates what unmet needs are – i.e. where
Source: The Global Burden of Disease: 2004 update, World Health Organization, 2008
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21
BEYOND SUSTAINABILITY - TRANSFORMING HEALTH INTO GROWTH?
How to Combine Competitiveness and Transparency in
Clinical Trials
Philippe JUVIN
MEP, Group of the European People’s Party (Christian Democrats), European Parliament
O
n July 17th 2012, the European Commission
published its draft Regulation on clinical
trials, which was amended by the ENVI
Committee of the European Parliament, and is likely
to be voted next year in plenary session. This draft
was very awaited by the professionals, who wished
the revising and repealing of Directive 2001/20/EC.
The different actors of the sector – whether they
are companies, academics or patient’s association
– wanted a more competitive and transparent
framework for the clinical trials.
Under the current directive, the procedures to
conduct clinical trials are so complex, long and
different from a Member State to another, that
numerous sponsors prefer to organise their clinical
trials in third countries, where the procedures are
simpler or less stringent.
Those dysfunctions are prejudicial to competitiveness of the European clinical trials, but even
more to the European patients, who have the right
to benefit from the best treatments and the most
recent medicines.
Indeed, the authorisation process under the
2001 Directive is stretching up to 180 days, which
provoked a 25% decrease of the number of clinical
trial requests between 2007 and 2011.
This is why a revision of the 2001 Directive was
proposed, by the mean of the draft Regulation on
clinical trials, currently in negotiation.
On the form itself, the choice of a European
Regulation, directly applicable, instead of a
Directive, which necessitate a transposition into
national law, should end the heterogeneity of
applicable rules.
On the content, renewing the competitiveness of
European clinical trials involves a standardisation
of the procedures, its simplification and a reduction
of the authorisation timelines. Those measures
should lead to a reduction of the costs and make the
European Union attractive again.
The procedures will be the same in all Member
States and centralised on a unique European portal,
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which will allow sponsors to request an authorisation for clinical trials in several Member States by
a single application.
The Member States, along with the ethical
committees, in charge of the examination of the
authorisation requests, will have to perform their
assessment within a precise timeline, which is equivalent to the non-European procedures.
Furthermore, in order to ensure the respect of
the deadline and not to handicap a clinical trial by
a lack of response, a system of tacit approval was
introduced by the European Parliament. By this
system, a sponsor who would not be notified of the
final decision regarding his or her clinical trial at the
end of the defined timeframe would be allowed to
start the trial without further delay.
Through these measures, the European competitiveness will be re-established and enable a quicker
development of new medicines for the patients,
who, on their side, will have more visibility on the
clinical trials operated in the European Union.
Transparency is a democratic requirement
which allow citizens, whether they participate in a
clinical trial or not, to know what kind of trials were
conducted and what were their results. For the
academics, transparency is also a way to verify
and cross-reference the results of clinical trials by
performing large scale analysis.
That said, it would be unwise to succumb to the
temptation of absolute transparency, which would
make everything publically available, from the
protocols of the clinical trials to the raw data of these
trials.
This approach would
be counter-productive,
on the one hand for
citizens, who would be
overwhelmed with data
without being able to
understand them, on the
other end for European
companies which would
see their results purely
and simply used by
their competitors, especially from outside the
European Union. This
way of thinking would
therefore be harmful
both for transparency and competitiveness.
Bearing this in mind, it is better to favour a "smart"
transparency, which would make available to the
citizens the relevant information while presenting it
in an understandable manner for a layperson. It also
involves the obligation for the sponsors of clinical
trials to publish their results, whether they are
conclusive or not, contrary to the current practice
where negative results are kept secret.
This last approach is the one the European
Parliament adopted, and which I defend as the
shadow rapporteur for the EPP Group, in the
proposal of Regulation on clinical trials.
Within the year following the end of a clinical
trial, the sponsors will be required to publish on a
European database, publicly accessible, summaries
of the results, one of which having the obligation to
be understandable for a layperson. However, the
commercially sensitive data will remain protected
until the market authorisation for the associated
medicinal product has been granted.
Some oppose competitiveness and transparency,
each one being incompatible with the other. I reject
this simplistic and Manichean vision. In every
modern and democratic society, these two notions
must be treated equally without threatening each
other. The proposal of Regulation on clinical trials is
a good example of the balance that can be reached,
by creating an attractive framework for companies
and academics and a simple access to understandable information for the citizens.
Re-thinking the Role of Prevention in Addressing Healthcare
Systems Challenges
Andrea RAPPAGLIOSI
President Vaccines Europe
H
While there’s no doubt that we’re living longer
than previous generations, we need to do a better
job at keeping people healthier for longer. The most
effective way of doing so is by preventing people
from falling ill and by enabling them to make the right
choices to stay healthy. Health literacy is key in this
regard and more should be done in the prevention
sphere, fostering a culture of health rather than of
treatment and cure.
During the 20th century immunisation has been
one of the public health measures that had the
greatest impact on the reduction of the burden
from infectious diseases and associated mortality,
mainly in children. Vaccination should however not
be regarded as a childhood matter only; adult and
senior vaccination is now as important to the 21st
century as childhood immunisation has been in the
past.
As we grow old, our immune system weakens
and we are more at risk of contracting long-term
chronic conditions – often more than one at the
same time. Vaccinating across all age groups
can help keeping people outside hospital beds by
preventing complications in chronic patients as well
as by protecting vulnerable groups who cannot fully
benefit from vaccination.
Different age groups have different vaccination
needs and there is a need to put in place a strategy
allowing all of them to equally benefit from access to
vaccines. This would not only promote efficient healthcare resource allocation by cutting on avoidable
expenses but it would also allow freeing resources
for treatment.
Sustainability of healthcare systems should first
of all be about maximizing or improving the way we
use the tools we have at hand. This will only happen
if we succeed in establishing a coherent EU health
policy agenda capable of embracing the entire
healthcare spectrum from prevention and early
diagnosis to treatment and cure.
Such responsibility does not only lie with
governments but requires broad stakeholder
collaboration, particularly the involvement of the
healthcare profession as the front line deliverer of
advice and care to the public. The current landscape
appears rather fragmented and we need to foster a
more meaningful dialogue around prevention, why
prevention contributes to smarter growth and how
we can achieve this.
We need to shift our mindset and stop thinking
about patients only. We should start speaking about
people and how to help healthy people to stay
healthy. This may be more a question of improving
population health sustainability than sustainable
healthcare systems.
ealth is a fundamental right of every human
being and is a value in itself. Only with a
healthy population EU Member States can
achieve their full economic potential. Europe is
facing an increase in ageing populations and patient
demand, posing tremendous pressure on healthcare
services and budgets to delivery quality care in an
equitable and efficient manner. In times of austerity,
delivering sustainable and cost-effective healthcare
is at the top of the EU Member States’ agenda.
Cost-effectiveness analyses are a very useful
tool for decision-making to assess the value of
healthcare interventions. Nevertheless when we
look at prevention, we need to make sure that the
formulas used comprehensively take into account
the full benefits of healthcare measures not only
from a healthcare system perspective but also from
a societal point of view. The latter is often difficult to
quantify in monetary terms and, in the field of vaccination, current economic evaluations do not usually
take into consideration a range of long-term
benefits intrinsic to prevention. In addition,
Average growth by main function of public expenditure on health, OECD countries, 2008-2011
they do not capture potential economies of
scale that may be generated as spin-off
)&#$
benefits.
Although health is inextricably linked to
(#$
productivity and therefore the economic
well being of individuals and populations,
in times of austerity prevention is the
'#$
first sector to suffer from budget freezing
or outright cuts. On average estimates
%&&D>&($
"#$
suggest that only 3% of the EU Member
%&&(>&E$
States’ health budget is allocated to
%#$
%&&E>)&$
primary prevention. This covers a wide
array of interventions, ranging from
%&)&>))$
immunisation programmes, to smoking
&#$
cessation, alcohol consumption, and
promotion of healthy life-styles (e.g.
!%#$
nutrition and physical activity). According
-2,4%
to the OECD this small share of spending
-3,2%
!"#$
is being further impacted by the current
*+,-./+0$1-2/$ 340,-./+0$1-2/$ 56+7!0/28$1-2/$ 9:-28-1/4.1-;<$ 92/=/+.6+>94?;@1$ BC8@+@<02-.6+$
financial crisis.
A/-;0:$
Source: OECD Health Data 2013
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23
BEYOND SUSTAINABILITY - TRANSFORMING HEALTH INTO GROWTH?
Regulating Medical Devices: a Harsh Fight for More Patient
Safety
Dagmar ROTH-BEHRENDT
MEP, Group of the Progressive Alliance of Socialists and Democrats, European Parliament
O
n 22nd October this year, we, as Members
of the European Parliament, voted
during our plenary session on my report
on medical devices. The main objective of this
report was to improve the protection of patients
from defective products, as well as to find a more
efficient system to grant market access to new
devices. We only partly achieved this objective
even though this legislative proposal offered
us a unique opportunity to significantly change
the way medical devices are approved in the
European Union, and to increase patient safety
consequently.
In the recent past, several medical devices
from breast to hip implants notably have
reached patients and either put their lives into
danger or rendered those lives more difficult
than they were before the medical intervention
involving those devices. In some – but already
too numerous – cases, this is the consequence
of a general and strong push and demand for
an immediate and unconditional access to what
was presented as the latest medical innovation
by companies. Often, robust clinical evidence
indicating a positive risk / benefit balance was not
yet there. This is the consequence of the current
European conformity assessment procedure (to
bring medical devices on the market) which has
shown substantial weaknesses over the past
years: this procedure is based on insufficient
medical knowledge and understanding from the
supervising bodies, combined with a lack of clear
clinical data and the inability to properly interpret
those data.
My main priorities to increase the safety of
our EU patients
It became clearer that many improvements
not only to the completely outdated legislative
framework, but also to some extent to the
Commission proposal were needed. This is why
I gathered the views of the stakeholders of this
medical sector by inviting them to participate in
two open hearings in the European Parliament
on 26 February and 19 March this year. These
events were a huge success as they were widely
attended and even followed by more than 700
viewers thanks to our internet broadcast, and as
they gave more precise indications on the needed
improvements to the Commission proposal.
In my draft report of 12 April, I had focused on
three following main priorities. Firstly, I wanted
to reinforce the control over the roughly eighty
private companies working as controllers, the
so-called ‘notified bodies’, which are responsible
for assessing the performance and safety of
medical devices before they can be used by
patients, doctors or healthcare providers. A new
category of special notified bodies designated
by the European Medicines Agency was thus
created. Higher qualification requirements for
the staff working for all notified bodies were also
introduced because we wanted and we needed
the best European experts to look at devices
before they are used on or in patients in Europe.
Secondly, it was necessary to change completely
the system of authorisation leading new devices
to enter the EU market. I believed that medical
devices presenting the highest potential risks for
patients such as heart valves, pacemakers or
knee, hip or breast implants for instance should
be subject to a more stringent procedure than a
conformity assessment. My initial intention was
to establish a system of pre-marketing authorisation for those high-risk products listed in class
III, those implanted into the body, incorporating a
substance considered to be a medicinal product,
intended to administer a medicinal product, or
utilising non-viable tissues or cells of human
or animal origin, or their derivatives in order to
ensure that only safe products will be used in
or on patients. This system would have given a
stronger role to the European agency for public
health, the European Medicines Agency (EMA)
which would have made sense as in future we will
see many devices incorporating or administering
medicines. Thirdly, it was crucial to bring more
legal certainty and clarification of the rules which
allow devices to be reprocessed. The aim is to
ensure that the label "single-use" is meaningful,
and consequently to avoid the reprocessing
of such products which is currently tolerated. It
was also necessary to put in place the highest
and most coherent standards for reprocessing
reusable devices in order to make sure patients
will no longer be treated as guinea pigs.
The negotiations in the European Parliament
In these priorities, I received from the very
beginning a firm support from my political group
(the Social-Democrats), from the Greens and from
the Group of the European United Left/Nordic
Green Left (GUE), as well as from Members
from other political groups. We all had in mind
the Resolution on defective silicone gel breast
implants made by French company PIP, which
we, as Members of the European Parliament
voted in the plenary session of 11 June 2012.
In its wisdom, the European Parliament had
"called on the Commission to shift to a system
of pre-market authorisation for certain categories
of medical devices, including, at least, medical
devices of class IIb and III" and stressed "the
need for a marketing authorisation request for
dangerous medical devices which complies with,
or is similar to, the requirements for medicinal
products". Unfortunately, some months later,
when the discussion on the proposed Regulation
on medical devices started the PIP scandal was
already partly forgotten and the momentum was
lost.
Due to some aggressive and uninformed
lobbying from the industry, this needed change
was becoming difficult to obtain within the
European Parliament. Disinformation included
fears on loss of innovation and competition which
have been ridiculously agitated in front of many
of my colleagues who were not so familiar with
the topic. I can only regret that some of my fellow
colleagues and EU political leaders more broadly
tend to quickly react in a context of crisis, but
even more rapidly forget previous problems when
topics are not so much in the news any longer.
This was the reason why, even though I had
proposed a system of pre-marketing authorisation – for the most potentially dangerous
devices only – which I believed would really
improve patient safety, I had to find a compromise
solution which could still improve significantly the
current situation. I therefore proposed alternative
solutions to the shadow Rapporteurs of each of
the political groups. We agreed on a new system
including the designation by the European
Medicines Agency of special notified bodies
responsible for the assessment of high-risk
devices; we also and came to the conclusion that
the best medical specialists in Europe should
be able to re-examine some of these high-risk
devices where new technology is involved or in
cases where many incidents have occurred in
the past. The outcome of the vote in the ENVI
Committee on 25 September included all of the
compromises we had worked upon together.
A detrimental outcome in plenary
However, as compared to the vote in Committee,
the outcome of the plenary vote constitutes a huge
step backwards. The opinion from the abovementioned best medical specialists gathered in
an expert committee on the result of the clinical
tests performed by manufacturers will not be
binding on Member States. More importantly,
we did not manage to include this assessment
for all the devices we wanted. Not all devices
falling in the high-risk ‘class III’ will be assessed,
but only those which are implantable. This means
that additional assessments of clinical tests for
all non-implantable high-risk ‘class III’ devices,
such as cardiovascular catheters, heparin coated
catheters or endoscopes will unfortunately not be
possible. Similarly, it will not be possible either
to assess medium/high risk ‘class IIb’ implantable
devices such as silicone implants other than
breast implants (e.g. male testes, abdominal
muscle implants), as we had originally requested.
Waiting for the Council to move forward
Overall, our vote in plenary was unfortunately
not a milestone, but still a small step in the right
direction. I believe that medical devices would be
monitored much more efficiently in the European
Union when the Regulation passed last October
by the European Parliament will come into force.
Patients can be reassured that safety in Europe
has been the central focus during my work in
recent months. This vote now offers us a good
basis for negotiations with the other co-legislator,
the Council.
The Parliament and more specifically myself –
as Rapporteur for the file – are now waiting to start
negotiations in trilogues with the Council as soon
as possible and to conclude them by the end of
the legislative period. For the moment however, it
still does not seem to be its main priority, unfortunately. I can only strongly call once again for
some ambition and a rapid reaction from Member
States. Patients in Europe deserve a new legislative framework as quickly as possible and this
new legislation should include a more systematic
assessment of clinical data by the best medical
specialists. Once adopted, it will enable us
to improve patient safety and to avoid further
scandals and patient uselessly suffering.
BEYOND SUSTAINABILITY - TRANSFORMING HEALTH INTO GROWTH?
Pharmaceutical Industry – a Partner to Growth Recovery in
Europe
Corinne DUGUAY
Vice President European Public Affairs, Sanofi
W
hat do you see as the key challenges
for health and access to healthcare in
Europe today?
Today’s solidarity-based healthcare systems are
one of post-war Europe’s major achievements.
However, economic slowdown and austerity
policies are putting pressure on the health sector.
We are seeing in 11 of the 34 OECD countries a
fall in total health spending between 2009 and 2011.
The countries which have been most affected are
Greece (11.1% decline) and Ireland (6.6%)1.
This translates in a scaling-down of prevention
policies, policies restricting access to care as well
as reducing the range of reimbursed services and
treatments. This trend is compounding a situation
which existed pre-crisis but is now becoming
critical: the fact that across Europe, citizens are
not receiving similar standards of care. A decade’s
difference in life expectancy separates the best
from the worst across Europe and these inequalities
threaten the sustainability of the European model.
The increase in life expectancy combined with
the impact of chronic conditions and degenerative
diseases are resulting in more people living longer
with some form of medical disability or illness.
This not only affects dramatically their quality of
life, but also negatively impacts upon healthcare
costs. This also results in a well-documented drain
on productivity which in turn will affect Europe’s
chances of regaining growth, attracting R&D and
strengthening its health independence that allow it
to find European solutions for Europe’s problems.
As Europe ages, it needs to remain productive:
existing trends in ageing present a real economic
challenge to healthcare systems. There is evidence
that absenteeism and early exit from the work place
is partly addressable by more effective care and
prevention.
What role do medicines have in addressing the
problems outlined above?
Pharmaceutical industry has a unique role to play,
26
THE EUROPEAN FILES
not only by providing solutions to the health challenges of today and tomorrow, but also by contributing more generally to the return to economic
growth in Europe. Innovative medicines are
estimated to have contributed to 73% of this improvement once other factors are taken into account
(e.g. income, education, immunization, reduction
in risk factors, health system access2). Today,
however, we are facing two types of pressures that
risk mitigating the positive impact that innovative
medicines can have on health outcomes.
Firstly, huge differences exist between countries
and in countries between regions in uptake of
innovation; for example, the usage of innovative
anti- diabetics varies from 3.6 / 100,000 people
in Luxemburg and 3 in Finland to almost zero
in Poland. Some countries have not seen new
medicines on reimbursement lists for several years
and this despite evidence that early and appropriate
use of medicines is one of the most effective interventions a health system can take.
Secondly, despite the fact that medicines expenditure as a proportion of total healthcare has
been declining in Europe, innovative medicines
have been targeted disproportionately for cost
containment. Medicines have only contributed
to 15% of health costs in Europe – with hospitalizations and elderly care being the key drivers. In
a majority of EU member states, medicines expenditure is in fact growing 30% slower than overall
health investment3.
In what areas can industry help to move
forward?
Industry can be a partner for policy makers in helping
to develop a more sustainable and predictable
approach to medicines expenditure, for example
through stability agreements like in Portugal,
Ireland, Romania and Lithuania. Sustainability and
predictability ensure that public funding goes to
areas that provide the greatest returns, that comprehensive disease prevention policies are brought
back onto the agenda and that opportunities for
improved medicines and disease management are
identified. The challenges are hugely complex and
solutions can only lie in having a broader view of the
structural reforms needed within healthcare systems
as a whole but also in how health is impacted by
other policies, such as employment and social
protection. Simply implementing cost control in
the pharmaceuticals sector will not address these
broader issues.
We also need to connect science with health
need and explore new approaches to accelerate
translation of scientific progress and innovation into
patient benefits in a safe and effective way. The
EU’s Innovative Medicines Initiative of which Sanofi
is strongly and actively supportive, is leading the
way in accelerating this translation.
We are seeking to improve the mechanisms for
uptake of new science and technology in regulatory
and decision-making. Regulatory systems need to
be fit-for-purpose and adapted to scientific advances
and novel forms of treatment delivery. We should
seek economies of scale in value-assessments of
medicines through European-level cooperation
and effective dialogue between HTA agencies and
manufacturers as well as with regulators in areas
such as early advice.
What is encouraging is to see the emergence of
new types of bottom-up partnership and dialogue
on access to healthcare at European level between
different actors. They reflect the complexity of the
issues at stake but also a growing realization that
solutions cannot and will not be found unilaterally.
The Vilnius Declaration adopted at a conference on
“Sustainable Health Systems for Inclusive Growth
in Europe” organized under the auspices of the
EU Presidency of Lithuania is a recent and very
relevant example of this dialogue. It is on the basis
of these types of projects that we wish to continue
our dialogue with the European Parliament postelections, the new European Commission and the
national governments.
1. OECD, ‘Health at a glance’, 2013
2. Source: Lichtenberg, F: Pharmaceutical innovation and
longevity growth in 30 developing OECD and high-income
countries, 2000 - 2009 (2012)
3. Source: OECD Health Statistics Database (accessed
2013)
How Can the Need for Cost-Effective Spending Be Reconciled
with Maintaining a High Standard of Care?
Philippe DE BACKER
MEP, Group of the Alliance of Liberals and Democrats for Europe, European Parliament
H
ealthcare in the EU is at a cross-road between
challenges and opportunities. The Member
States are facing common challenges and
European guidance is often lacking. The demand
for healthcare in Europe – as elsewhere among
industrialised countries – is growing as a result of
ageing populations and rising public expectations.
The combination of demographic changes and
technological developments increases the cost of
provision. Both public and private healthcare expenditures are on the rise. Providing that we want to
continue to deliver equal, efficient and high quality
health services at affordable cost in times when the
amount of care to be delivered is starting to exceed
the resource base, a fundamental re-thinking of
healthcare systems is necessary. Without thorough,
structural reforms we risk the unfortunate but
inevitable decline of a system previously renowned
for its quality and accessibility.
Often, healthcare spending is seen merely as
a cost to national budgets. Hence, budgets have
suffered during the economic and financial crisis.
Thinking about healthcare reform is often limited to
this financial or budgetary discussion. We should
surpass this. The most important lesson from
the financial crisis is that those countries which
undertake reforms are laying the foundation for
a more efficient and resilient health system. The
austerity measures have also demonstrated a
key structural problem in healthcare: the failure of
innovation models which contribute to rather than
alleviate cost pressures. In most sectors, innovation
leads to economies of scale and lower production
costs. In health, new innovations have inflated
public budgets.
But strategies employed by the Member States
to meet the challenges and opportunities in health
differ. For one thing they reflect substantial differences in the organisational framework in which
health services are financed and delivered, but
also different attitudes towards health. Hence
each national system has something to learn from
the experience of the other 27. This needs to be
encompassed in European knowledge transfer and
overarching strategy. Thus, several themes can
re-emerge as being key to implement reform.
More health but less healthcare, by systematic
prevention and investing in holistic care. Especially,
an ageing population implies alterations of disease
towards chronic conditions. Thus, increased
focus will have to be on those diseases which are
readily preventable - with or without medical care.
Preventive care potentially offers a cost-effective
alternative to high-cost technology medical care.
Electronic patient records hold out the promise
of numerous benefits. At a very basic level, they
can reduce paperwork, freeing doctors and nurses
to spend more time with patients. They also allow
different healthcare professionals to get a rapid view
of the patient’s entire medical history, and see how
existing treatments might interact with ones they are
considering. This has obvious implications for health
systems where different specialists seek to care for
increasing numbers of patients with multiple chronic
diseases in a coherent way. Finally, these records
can enable other technological developments –
such as outcomes data gathering – to improve care
further. In short, they are essential for an efficient,
integrated healthcare system.
More healthcare with less, but more just
means, through increased efficiency but without
jeopardising the quality guar¬antor of an open
and internally competitive healthcare system.
Here for example more efficient use of resources
is aimed at by introducing management elements
into healthcare and competition is used to enhance
quality care at a lower price. Payment systems are
increasingly reformed to reduce waste of resources
in hospitals and ambulatory care. Also, healthcare
practices and technologies are evaluated more
closely to give some scope for setting priorities.
Solutions for cost containment are searched for
because ageing populations, costly implications of
technological development and increasing expectations of consumers result in inflationary healthcare
systems in all of the EU Member States. Greater
cost effectiveness is seen as a route for more healthcare per Euro spent. The search for increased efficiency implies more responsibility for all healthcare
actors. This might require for healthcare systems to
integrate patients into the process of establishing
standards for quality care. This also requires good
quality comparable information on patients treated,
on outcome and costs of healthcare and from the
reform of the system. But also new payment and
financing schemes have to be devised in order
to guide both patient and medical professional in
evidence based decision making.
Innovation is key, because innovation should
be disruptive. Not everyone will be winners,
some sectors will not gain as much because their
fundamental business models are challenged. The
life sciences industry is starting to respond and to
transform their business models towards health
outcomes. But they need clearer signals from
policymakers on where they are expected to add
value and we are not able to do this yet. Europe
stands at the cradle of the current biotech boom.
For healthcare, important discoveries are constantly
being made within the European research and
development community. But a lack of common
European vision and objectives between member
states threatens the European leadership in several
areas. Therefore we must make sure that we
enable researchers and companies to rise up to
the challenges and opportunities that biotechnology
has to offer by stimulating exciting new research
excellence, enabling collaboration across different
fields of research within and outside biotechnology
and pharma, and ensuring that innovative
start-up companies receive adequate funding.
Europe should develop an active, stimulating and
coordinated policy for a new knowledge economy
where biotechnology receives a prominent place.
We must foster and grow our ecosystem of biotech
research and applications.
These are just some of the elements I believe will
play a key role in reconciling a high standard of care
with cost-effective spending. It is up to European
and national policy makers to put this in action and
start implementing.
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27
TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
Understanding the Impact of Austerity Measures on Health
and Health Systems
Zsuzsanna JAKAB
WHO Regional Director for Europe
F
ive years after the economic crisis began,
its impact on health is being felt more
than ever. In our neighbourhoods, in the
countries in the WHO European Region, people
are experiencing dramatic changes as the crisis
affects the conditions that influence their wellbeing – the social determinants of health such
as income, employment, education, nutrition,
taxation and corporate practices (marketing and
pricing).
Large economic crises and their consequences – rising unemployment and falling
household income – are correlated with a deterioration in health status and an increase in health
needs. In these critical times, a country’s health
and fiscal policy responses (for example, the
extent to which it follows a path of austerity rather
than counter-cyclical spending) are important
in ensuring that effective social safety nets are
in place and that both access to and the quality
of health and social services are protected. Yet
policy responses often exacerbate rather than
address the problem.
The data are limited and attributing particular
health effects to the crisis alone is difficult, but
we can already sketch out the impact of the crisis
on population health. It is clear that mental health
is sensitive to economic downturns, increasing
the likelihood of ill health and slowing recovery
from illness. In the European Union, the number
of suicides among people under 65 years has
increased since 2007, reversing a downward
trend. Both unemployment and the fear of
unemployment are contributing factors. The
incidence of infectious diseases such as HIV has
increased sharply in one of the countries most
heavily affected by the crisis, where preventive
programmes (e.g. needle exchange) and early
treatment services have been scaled back as a
result of budget cuts. Falling household income
also affects health-related behaviour. Many
countries have reported overall reductions in
harmful behaviour such as smoking and high
alcohol consumption, but an equity analysis
shows that some population groups markedly
increase such behaviour, with harmful effects on
their health.
One cannot turn a blind eye to this evidence.
It highlights the importance of ensuring adequate
funding for the full range of health services,
including preventive services, primary care
and mental health services, at a time when the
need for these services is increasing. Similarly,
ensuring that poorer and more vulnerable
groups of people are able to access effective
health services without financial hardship is
critical to protecting health and avoiding further
impoverishment.
Based on our analysis (a collaboration with the
European Observatory on Health Systems and
Policies), we have identified a number of lessons
and recommendations for policy makers facing
financial pressure:
- It is critical to keep in mind the longer-term
challenges to health systems while navigating
a crisis. Short-term policy responses to fiscal
pressure should be consistent with the health
system’s long-term goals and reforms.
- Fiscal policy should explicitly take account of the
probable impact on population health. Maintaining
and improving population health are investments
that contribute to a healthy workforce, economic
growth and human and social development.
- Intersectoral action to maintain active labour
market policies and social safety nets can mitigate
the negative health effects of an economic crisis.
- Health policy responses influence the health
effects of an economic crisis. Budget cuts should
be absorbed through supply-side measures
such as price reductions rather than by shifting
costs onto patients. Funding for essential, costeffective, well-managed services should be
protected at the expense of low-value and poorly
managed services. Across-the-board cuts may
worsen the situation by failing to target areas of
inefficiency, and inappropriate cuts may introduce
new forms of inefficiency.
- Adequate funding for public health services
must be ensured.
- Fiscal policy should avoid prolonged and
excessive cuts in health budgets.
- High-performance health systems are more
resilient during crises. Such systems are more
likely to have protected funding than those with
considerable inefficiencies.
- Deeper structural reforms require more time to
deliver savings.
- Safeguarding access to services requires a
systematic, reliable information and monitoring
system.
- Prepared, resilient health systems primarily
result from good governance. Crises can create
a political opportunity to introduce structural
reforms in health systems, but pressure to make
changes rapidly can lead to adverse effects.
We in the WHO Regional Office for Europe
have engaged intensively with Member States
to support effective policy decisions to improve
health and reduce inequalities during the crisis.
Our engagement is built on the European health
policy framework, Health 2020, and focuses
on solidarity, equity and the improvement of
leadership and governance for health. In addition
to technical assistance, we have provided
countries with tools such as analytical frameworks
to review government policies in response to
the crisis and analyse effects on health and
health system performance; policy dialogues
and other knowledge-brokerage events; and
training courses. We have been eager to work at
the request of Member States in close collaboration with our partners, including the European
Commission, the European Observatory on
Health Systems and Policies, the Organisation
for Economic Co-operation and Development
and the World Bank.
In difficult circumstances, when human lives
are at stake, we cannot afford to fail in our
mission. Leaders should ensure that the best
policies are in place and we, as public health
experts, will be at their side to support evidenceinformed decision-making.
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29
TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
Towards More Sustainable Healthcare Systems in Europe
Paul TIMMERS
Director Sustainable & Secure Society, DG CONNECT, European Commission
E
uropean health systems are challenged
to respond to an ageing population, a
shortage of health professionals, rising
expectations of citizens, an increasing interest to
link wellbeing and lifestyle to health and mobility
of patients and health professionals.
Today we see examples where health organisations, professionals, informal carers and
patients step up the challenge. How? Each of
them is willing to take their responsibility and
work together by finding common interests. They
share a vision of more personalized health and
care, they are open to innovation - from the way
health delivery is organised to social innovation,
the use of new technology and open data.
This is very much the way we think about
eHealth: a way forward to ensure better health
and better and safer care for EU citizens, more
transparency and empowerment, a more skilled
workforce and more efficient and sustainable
health and care systems enabled and catalysed
by ICT (information and communication technologies). This can go together with new business
opportunities and a more competitive European
economy that can benefit from international trade
in eHealth products.
We have an eHealth Action Plan 2012-2020
which we would like to see being taken up by the
Member States and all stakeholders. It includes
actions such as achieving wider interoperability
in eHealth services, supporting research, development, innovation and competitiveness in
eHealth, facilitating uptake and ensuring wider
deployment of eHealth and promoting policy
dialogue and international cooperation on
eHealth at global level.
One example of eHealth that brings many
advantages for both the patient and society is
telemedicine: medical acts between a professional and a patient and/or between professionals delivered at a distance. It improves the
quality of healthcare services by guaranteeing
the continuity of healthcare and increasing
access to healthcare services – it doesn’t matter
how remote you live.
Telemedicine not only ensures a better management of chronic diseases and personalised
care, it also improves patient safety because it
allows a global vision of the process: primary care
and the secondary care sector would be much
better integrated. Last but not least it improves
equity of healthcare systems – the same healthcare for everyone.
Some feel that it is a disadvantage of telemedicine that you miss the direct face to face
contact with the doctor. But on the other side, you
don’t have to travel kilometres to see him or her
– especially an advantage for patients who are
chronically ill and need to see a doctor on a daily
or weekly basis.
Another obstacle to telemedicine would be
that it needs organisational changes, and as
everyone knows, people are sometimes resistant
to change. Both patients and professionals would
need education and training, and they would
need to know how to use a computer. And last, it
is important to consider legal aspects like privacy
issues in order to implement this new model of
healthcare.
At EU level, we are dealing with these legal
issues of telemedicine services. We have
developed a Staff Working Document on
Telemedicine1. It states that, when providing telemedicine services, the healthcare professional
should comply with EU rules on data protection:
The processing of health data is only authorised
when the citizen/patient has given his explicit
consent, and the processing can only be done by
a health professional subject to an obligation of
professional secrecy.
However, EU rules on data protection have
been implemented very differently in the Member
States. That is why the Commission has proposed
a regulation to fully harmonise these rules, which
is being discussed by the EU legislators at the
time we speak. Next to that, the question of reimbursement is crucial for moving forward both in
deploying telemedicine as well as supporting
market developments. However, these are also
competences of the Member States.
Another important issue preventing the uptake
of telemedicine is the lack of recognition by
Member States of the right for healthcare professionals from another EU country to provide
to their nationals telemedicine without being
licenced in their country. This right is recognised
by the Directive on patients’ rights due to be
transposed last month.2
Telemedicine is just one example; We see a
great future for eHealth. From the European
Commission we will not only create legal clarity,
we will also support further advancement of
eHealth, notably by supporting research and
innovation financially through the new Horizon
2020 program.
Interested to know more? Do contact us at
CNECT-ehealth@ec.europa.eu.
1. https://ec.europa.eu/digital-agenda/en/news/commission-staff-working-document-applicability-existing-eu-legal-framework-telemedicine
2. Directive 2011/24/EU on the application of patients’
rights in cross-border healthcare
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THE EUROPEAN FILES
Breaking Down Access Barriers for Patients in Europe
Anders OLAUSON
President of the European Patients’ Forum
A
ccess to quality healthcare is a basic EU
citizens’ right. Yet it is still not a reality
for many of us – a situation made worse
by the economic crisis. The European patients’
Forum (EPF), the umbrella representative body
for patient organisations throughout Europe,
highlights the importance of tackling health
inequalities as a main political priority for the
2014 EU Elections in our campaign “Patient +
Participation = Our Vote for a Healthier Europe”.
What access to healthcare means for patients
Access means the availability of treatment, but
also its affordability. Healthcare is accessible
to patients when it is functionally available to
the patient who needs it, e.g. it is possible to
get an appointment without undue delay and
without having to travel far, and when the cost is
affordable for patients. Access also means nondiscrimination. Treatment should be accessible to
every patient who needs it, not only to those who
can pay. Regrettably, this is not a reality for all.
There are huge disparities within the EU in the
availability of treatments and their affordability,
while health spending has fallen sharply since
2009 in many Member States.
Health inequalities exacerbated by healthcare
cuts
Health inequalities carry a significant economic
cost. This could be as high as 20% of the costs
of healthcare and 15% of the total costs of social
security benefits1. This is exacerbated by cuts
in healthcare spending and social insurance
coverage in response to the economic crisis, at a
time of even greater demand for healthcare and
social support.
Investment in health is therefore crucial in
times of crisis to reduce health inequalities for
the overall health and wealth of society. It has
been shown conclusively that cutting healthcare budgets is counter-productive and will not
contribute to the sustainability of health systems
in the long run. Investment in health is therefore
an investment in our fundamental values, in
social cohesion, and in economic development.
EU Member States should commit themselves
to ensuring adequate investment in health. This
may mean maintaining or even increasing health
budgets. At the same time, EPF supports actions
to increase the efficiency of health investments,
so that resources can go further as waste and
misuse in the system is eliminated and services
are targeted effectively.
Patients can contribute to reducing health
inequalities
Patients acting collectively through patient organisations can be invaluable partners. As healthcare users, they are “experts by experience” on
what works and what does not for them. They can
therefore guide decision-makers on how to offer
good quality care that is also cost-effective. They
can be involved in designing more effective healthcare and in research to deliver new and better
treatments that provide real value.
Many chronic diseases are degenerative,
making early detection and prompt medical
intervention essential to ensure good health
outcomes and quality of life for patients. Lack
of timely treatment results in deterioration of the
condition in the long-term. This can lead to much
more complex and costly medical interventions,
which not only burden the patients and their
families but are also an avoidable cost to the
healthcare system.
Patients groups need to be empowered
to contribute to reducing healthcare costs in
the long run. Empowerment strategies aim to
realise the concept of patients and citizens as
“co-producers” of health and as an integral part
of the entire system. Although empowerment is
much more than “patient education”, the right
information and resources are fundamental tools
for empowerment.
At individual level, when optimally treated
and well-supported, patients are able to make
informed choices about their treatment and care.
They can manage their condition, continue to
function in society and live a full life. This is the
reason why it is vital that patients can access
all the relevant information needed to make
those decisions, in an easily understandable
format. Currently there is across the EU a lack of
accessible, reliable and understandable healthrelated information that meet patients’ needs,
although core quality criteria have been defined
at European level. Investment in high-quality
patient-centred chronic disease management
can maximise patients’ quality of life and optimise
the use of healthcare resources.
Our solution: to support an EU initiative on
equitable access to healthcare
In our campaign for the 2014 EU elections, we
call on European decision-makers to support the
outcomes of the second conference on “Health
Inequalities in the ‘New’ EU Member States
and Candidate Countries” held at the European
Parliament on 26 June 2013.
At that time, we laid the foundations for the
establishment of an EU partnership on patient
access and equity and we are currently developing this idea. Leading MEP champions for
patients’ rights, also launched an MEP interest
group to reiterate the urgency of the situation
which is a European problem.
One of the Partnership’s priorities will be to
encourage an equitable pricing strategy for pharmaceuticals in the EU. This would need to take
into account the capacity of different member
states to pay and their needs. This will require
cooperation and solidarity between all the players
involved.
EPF supports the principle of “equity and health
in all policies” and integrates health inequalities
as a cross-cutting issue in all our work. We
will continue to demonstrate how patients can
be part of the solution to make health systems
more cost-effective and quality-oriented. In other
words, a healthier Europe, as outlined in our
Manifesto “Patients + Participation = Our Vote for
a Healthier Europe”
More information: www.eu-patient.eu
1. JP Mackenbach et al., “Economic costs of health inequalities in the European Union”, J Epidemiol Community
Health 2011:65; 412-419.
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31
TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
Trends in Public Health and Long-Term Care Expenditures:
an OECD Perspective
Christine DE LA MAISONNEUVE
Structural Policy Analysis Division,
Economic Department, OECD
S
pending on health and long-term care
has been putting pressure on public
budgets…
1. Spending on health and long-term care
(henceforth LTC) has long been a first-order
policy issue for most governments. Public health
and LTC expenditure has been rising steadily
relative to GDP for several decades. Since
1970, on average across OECD countries, the
expenditure to GDP ratio has increased by 3.5
percentage points to reach around 6 % in 20062010. In the past decade it has increased by
more than a fifth (see Figure).
…and over the next 50 years, it will continue
to rise
2. According to recent OECD projections1, the
combined public health and long-term care
expenditure for OECD countries may reach
around 10% in 2060 even assuming that policies
act more strongly than in the past to rein it in.
Without such policy action, spending could reach
14% of GDP. In BRIICS countries, spending
ratios will also increase significantly from the
current low levels, reaching around 10% of GDP
by 2060 unless cost-containment policies are
implemented (see Table).
3. A cost-pressure scenario is based on the
assumption that spending growth will continue
to outpace the contributions from income growth
and demographic developments by the same
margin as in the past. The result is that total
health and LTC expenditure more than double
as a share of GDP, increasing to almost 14% of
GDP among OECD countries in 2060. In a costcontainment scenario, based on the assumption
that policy action is undertaken to curb pressures
on expenditure, the ratio would still increase by
more than half, to reach 9.5% (see Table). For
the BRIICS, starting from a much lower level
of around 2.5% of GDP, total public health
expenditure will increase to about 10% in the
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Joaquim OLIVEIRA MARTINS
Head, Regional Development Policiy Division,
OECD
cost-pressure scenario and above 5% in 2060 in
the cost-containment scenario – close to levels
currently observed in OECD countries.
4. Different spending growth across OECD
countries reflects differences in demographic
trends, initial income levels and current reliance
on informal long-term care. For example Korea
and Chile, due to rapid ageing, or Turkey and
Mexico, due to high current reliance on informal
care, are projected to experience above average
increases in public health expenditures. By
contrast, the Nordic countries, as well as the
United States and the United Kingdom, display
lower than average growth over the next 50
years.
Health-care expenditure is mostly driven by
new technologies and rising relative prices…
5. Although they are important for cross-country
differences, demographic and income effects
play only a relatively modest role for overall
spending growth. Demographic drivers relate
broadly to the age structure of the population
and the evolution of its health status, while a
major non-demographic driver is income. The
responsiveness of health expenditures to income
is still an unsettled issue, but independent of
the precise relationship, the combination of
demographic and income effects fail to explain a
large part of the total growth in public health-care
expenditure in the past. Rising relative prices and
technological progress – interacting with health
policies and institutions – are the most likely
candidates for explaining this drift in spending.
… while pressures on long-term care costs
originate mostly from weak productivity gains
6. Long-term care differs radically from
healthcare. While healthcare services aim at
changing the health condition (from unwell to
well), LTC merely aims at making the current
condition (unwell) more bearable. Individuals
need LTC due to disability, chronic condition,
trauma, or illness, which limit their ability to carry
out basic self-care or personal tasks that must be
performed each day. Another difference between
spending on health and LTC is that the cost of
helping a dependent person is more or less the
same irrespective of the age of the dependant.
Moreover, while potentially the entire population
may benefit from healthcare, only dependent
persons will directly benefit from LTC. As for
healthcare, drivers of LTC expenditure can be
separated in demographic and non-demographic.
7. Noteworthy, despite these projections already
point out to significant spending pressures, still
they may underestimate a number of factors.
These relate to an extension of the typical
pre-death period of ill health as longevity
increases; higher than expected costs as
technical progress makes it possible to meet new
demands; and increased dependency due to
obesity trends or dementia. With no doubt, health
systems will remain a first-order policy issue in
most OECD countries over the next decades.
1. See “Public Spending on Health and Long-Term care:
a new set of projections”, OECD Policy Paper no. 6,
2013.
Figure: The rising share of public health and long-term care expenditures in OECD countries1
Share of health and LTC spending in % of trend GDP2
1. Unweighted average of available OECD countries.
2. To focus on the structural factors and smooth the effect of GDP variations, the ratio displayed in this figure uses trend instead of actual GDP (from
the OECD Economic Outlook, No.91) in the denominator.
Source: OECD Health Database (2011) and OECD Economic Outlook database No.91.
Table: Rising public health and long-term care expenditure over the next decades
(As a % of GDP)
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TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
How to Assess the Efficiency of Health Interventions
Lieven ANNEMANS
Professor of Health Economics, Ghent University, Brussels University
T
he conflict between what societies are able
to pay for healthcare on the one hand and
the population’s increasing need for more
and higher quality healthcare on the other hand
is still increasing.
Many countries apply different policies in order
to find answers to this challenge, however, with
variable success. Also, there is a conflict between
the industrial policy in some countries where the
goal is to encourage innovative investments and
employment within the pharmaceutical industry,
and the social policy where the goal is to offer
maximal health benefits to the population within
the limited budgets.
Health economic evaluations may provide
a solution. It appears indeed that there is an
increasing need for assessing new healthcare
technologies in order to decide whether they are
worthwhile to be implemented. The OECD stated
already in 2004 that “the growth norm cannot be a
permanent instrument of healthcare cost control
since it has little if any relation to any notion of
efficiency or optimality. It needs to be replaced
by measures based on cost benefit analysis
or appropriate incentives”. A recent working
document from the European Commission
(February 2013) also stressed the need for
more cost-effectiveness analyses. In fact not
only new innovative technologies and medicines
should be assessed for their cost-effectiveness,
also existing practice should undergo such an
assessment.
A health economic evaluation (sometimes
called cost-benefit study but bpostly called a
cost-effectiveness study, because this is the most
common type of health economic evaluation) is
a comparative analysis of alternative courses
of action in terms of both their costs and health
consequences. Hence, the definition includes
that there is a comparison involved (drug A
versus drug B; no drug versus drug therapy;
prevention versus no prevention…), and that in
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this comparison both the health as well as the
cost consequences are considered.
A key element in healthcare policy – but
often forgotten by policy makers – is that costeffectiveness is not only related to a health technology as such, but to the way this health technology or drug is used in daily practice. In other
words, a new drug, or a prevention strategy may
be cost-effective if correctly used, but may be not
cost-effective at all if not applied in the appropriate patient population.
The current unit to express health gains
is in many countries the quality adjusted life
years (QALY). Figure 1 illustrates the concept.
If a person lives for 10 years at a quality level
of 0.5 (0 = death; 1 = perfect health), then this
person has only 5 QALYs (10 x 0.5). If we
can increase the quality to 0.6, then we gain
(0.6-0.5) x 10 = 1 QALY. If we extend the life by
2 years (but the quality level remains 0.5) then
we gain 0.5 x 2 = 1 QALY. Finally, if we extend
life by 2 years and increase the quality to 0.6
as from the start, then in the new situation the
patient has 12 x 0.6 = 7.2 QALYs, which is 2.2
more compared to the starting situation.
If a new treatment costs 30,000 euros
and leads to a gain of 2 QALYs then its costeffectiveness is equal to 30,000/2 = 15,000 euro/
QALY gained. This is a good result because it is
quite below the threshold value of 40,000 euro
for a QALY.
But several problems arise with the use of
cost-effectiveness analyses
Issues with health economic evaluations in
policy making
Many countries have developed guidelines
to assist researchers in conducting better
assessment studies and assist decision makers
in appraising the quality of the studies. Yet, not
all countries handle the assessment of technologies in the same way. In some countries, health
economic evaluations are mandatory, in others
they are recommended, and still in others they
are not really regarded as important. All countries
face several methodological issues.
For instance, what is the optimal time horizon
of a health economic evaluation? In chronic
diseases the savings and health effects with
better treatments will be relatively stronger when
a 10 years time horizon is applied compared to
Figure 1: illustration of the QALY concept; see text for explanation
An overwhelming amount of published studies
have expressed results in cost per QALY.
In Europe the value of a QALY is estimated
on average at +/- 40,000 euros (Desaiges et al,
2007), but will depend obviously on the ability to
pay of a country.
say a 3 years horizon. But how far should we
predict? Some economists state that for chronic
diseases the time horizon of our cost-effectiveness analyses should be lifetime. But who
are we to predict what will happen in the next 50
years. Several authors therefore reduce the time
horizon of their analyses to 10 or 20 years.
Also, there is increasing awareness that
valuations for QALYs may differ when the QALYs
accrue to different patients. It has been shown
that society is apparently willing to more for a
QALY gained, if this QALY is gained in patients
with more severe diseases. And more questions
arise: how many patients are benefiting from
a treatment, how are the QALYs distributed
(a few QALYs in many or many QALYs in a
few patients)…. Moreover the current way the
QALY weights and thus the benefits to patients
are mostly assessed (namely via the Euroqol
5D) is based on only 5 dimensions of quality of
life: mobility, self-care, daily functioning, pain/
discomfort and anxiety / depression. Many other
aspects, such as cognition, dignity, appearance,
worries about the future... are not accounted for.
We should strive for a new a better parameter
that covers all aspects that matter to patients
and the population; i.e. a kind of “person years of
value” (“peyov”).
Finally, even if a technology or drug is costeffective, its budget impact may compromise
the adoption: indeed, if 70% of the population
is eligible for this cost-effective drug, then the
budget impact of reimbursing it would be that
high that it would be simply unaffordable to
reimburse it.
Hence, it seems that different thresholds apply
for different “disease severities” and that the
budget impact explicitly influences the societal
willingness to pay for a gain in value. The figure
below reflects a possible shape of these relationships on a population level (to express the
role of budget impact) and may serve as basis for
further research.
A good policy needs to ensure that those
diagnostic, curative or caring intervention.
Such a balanced decision should ideally
be taken according to two principles, namely
patients in need for better treatments, and in
whom treatment is cost-effective, and the budget
impact reasonable, do receive treatment, while
those in whom treatment is not cost-effective do
not receive treatment.
accountability for reasonableness and principled
compromise. The first means that decisions &
rationales are publicly accessible, that rationales
for decisions appeal to principles accepted as
relevant by those disposed to co-operate, that
mechanisms for challenge and dispute are in
place, and that there is a clear public regulation
of the process (Huxtable, 2012). Principled
compromise involves aspects such as no
over-claiming, debate between critically robust
positions and negotiation in a democratic spirit.
Discussion
Health intervention need to be efficient, but
other factors also play a role in making health
policy choices. A balance needs to be achieved
between the cost-effectiveness, medical need
and impact on the budget of any preventive,
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TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
Ageing and Health
Nora BERRA
MEP, Group of the European People’s Party (Christian Democrats), European Parliament
L
ife expectancy has greatly improved and will
keep on improving throughout this century.
This is a wonderful human gain. Europe is
particularly well ranked amongst countries with high
longevity rates, thanks to medical progress as well
as life conditions and social rights improvement.
Thus, ageing no longer means poverty, illness and
dependency for the vast majority of
European citizens. In a context where
”active ageing” is promoted throughout
Europe whether in labour, post-professional, daily or social life, a greater
attention is needed to promote good
health and well-being of our citizens. It
is now essential to enhance healthy life
expectancy. This is the ambition of the
“European innovation partnership on
active and healthy ageing”.
This preventive strategy will have to
start in the mid 40’s, taking advantage
of the many years spent at work: enterprises and employers in general will
have an important part to play (reducing
risks, stress, inabilities linked to a job
or to the exposition to bad working
conditions, etc.). The stake is indeed to
favour good health for people at work
and diminish their absenteeism, while
maintaining their employability and
optimizing social welfare resources.
This is especially important since
Europe will have to better rally the
working population in the perspective
of postponing the retirement age. In
the same way, prevention against the
loss of autonomy should be at the heart
of ageing care. Indeed, all geriatrics
and gerontology professionals claim
that most of the pathologies and functional limitations linked to ageing are
responsive to prevention, and that the
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latter fulfils real individual and collective needs. Yet
for many years, we have dedicated growing means
to medical and social care linked to dependency,
while we keep on suffering instead of anticipating
the social and health consequences of ageing and
dependency.
Preventing the loss of autonomy is possible yet,
provided that efforts be focused on people who really
need it given their health conditions (chronic pathologies, disabilities, fragility, etc.). This prevention
strategy should also take into account social and
territorial inequalities in terms of economic, social
and health resources. Promoting “healthy-ageing”
has to be part of a global policy, whose transversal
aspect should match the diversity of the fields
involved (health, nutrition, physical and cognitive
activities, appropriate housing, access to public
and private places, local facilities, digital solutions,
social inclusion, etc.).
As far as I am concerned, prevention of the loss
of independence has to be included within the
framework of our public health policies. It is already
the case in France with national plans on cancer,
chronic diseases, cerebrovascular accidents,
Alzheimer or the nutrition-health plan, completed by
the “Bien Veillir” plan. Detecting high-risk situations,
accompanying chronic patients or the elderly transversally and coordinating interventions between
health and social professionals are indeed essential
actions. Finally, new tools and levers could be relied
on such as telemedicine, Electronic
Health Records and more generally
e-health. These digital tools contribute
positively to risk prevention, maintaining
autonomy at home and well-being of
elderly persons and chronic patients.
Therefore, it is now up to us to
take care of the prevention policy for
the loss of independence. It is for us
to share a common language, prioritize our objectives, better target the
elderly persons concerned, elaborate
efficient tools and protocols of actions
by creating adhesion of professionals,
and optimize our means as well as
coordinate our interventions to better
mobilize the different stakeholders from
all levels.
It is more important than ever to make
our actions more visible and to make
sure that they are shared by a vast
majority of Europeans in order to instil
a culture of prevention in our practices
and behaviours whether amongst
decisions-makers, health professionals
or European citizens.
Tackling ageing in such a transversal,
inclusive and positive way means taking
into account these evolutions full of
future promises and enabling most
people to benefit from major progress
in healthy-ageing and increased life
expectancy as well as to participating
actively in good cohabitation.
Making Dementia a European Priority
Jean GEORGES
Executive Director, Alzheimer Europe
D
ementia is a huge European and national
health, social and economic challenge. The
number of people with dementia in Europe is
estimated at 7.3 million according to research carried
out by Alzheimer Europe (AE) in its Commissionfinanced “EuroCoDe – European Collaboration on
Dementia” project. The same research found that
the cost to society was significant, representing an
estimated EUR 160 billion in 2008. As dementia
is mainly a disease affecting elderly people, the
current demographic challenge experienced by all
EU Member States will exacerbate the issue.
The impact of the disease on families is significant: an AE survey in 2007 revealed that 50%
of carers reported spending over 10 hours a day
caring for the person with dementia in the later
stages of the disease. In a recent public opinion
survey carried out by AE and the Harvard School
of Public Health in France, Germany, Poland, Spain
and the US, respondents rated Alzheimer’s disease
as the second most feared disease after cancer.
It is in this context that AE and its 34 member
organisations from 30 European countries adopted
in 2006 the “Paris Declaration of the political priorities of the European Alzheimer movement”. This
campaign kick-started a series of initiatives that
put dementia firmly on the European health and
research agenda. The declaration called upon the
European institutions to develop a coherent strategy
and for Member States to adopt national Alzheimer
plans. It also called for greater investment in
research, better coordination of national research
efforts and the exchange of information and best
practices between European countries on dementia
policies, approaches to care, legal and ethical
issues which affect people with dementia and their
carers.
The success achieved over the past seven years
can also be attributed to dedicated European and
national policy makers.
At European level, AE is particularly grateful to
the personal commitment of President Sarkozy who,
during the French Presidency of the European Union
in 2008, gave a much needed impetus to greater
European collaboration in the field of dementia.
AE is also most thankful to the 71 Members of
the European Parliament who have joined the
European Alzheimer’s Alliance chaired by Françoise
Grossetête, MEP. Close to 60% of the Members of
the European Parliament adopted in 2009 a Written
Declaration calling upon the European Commission
to start the development of a European Action
Plan against Alzheimer’s disease. Since then, the
Joint Programming Initiative on Neurodegenerative
Diseases (JPND), the European Joint Action on
Dementia funded by DG SANCO (ALCOVE), and
the European Commission’s Communication on a
European Initiative on Alzheimer’s disease are direct
and tangible results of this concerted campaign.
The European Innovation Partnership on Active
and Healthy Ageing is an on-going European
Commission initiative that seeks to provide innovative responses to the age challenges in Europe.
The Partnership brings together stakeholders from
various horizons who agree to work collaboratively in three specific areas: prevention and health
promotion, care and cure, and active and independent living of elderly people. Dementia has been
identified as a major challenge to be addressed in
the Partnership.
At national level, a number of European countries
have acknowledged dementia as a political priority
with national dementia strategies or Alzheimer plans
in place in Belgium, Denmark, Finland France,
Luxembourg, the Netherlands, Norway, Sweden
and the United Kingdom (with separate plans for
England, Northern Ireland, Scotland and Wales)
and in development or having received governmental backing in Austria, the Czech Republic,
Ireland, Italy, Malta and Portugal.
Nevertheless, public investment in Alzheimer’s
disease remains lower than for other major diseases.
The need for European collaboration is as evident
now as it was seven years ago when AE adopted
its Paris Declaration. No new drug treatment for
Alzheimer’s disease has been approved in the past
seven years, despite significant research efforts in
the field and some very high profile failed clinical
trials. The AE/Harvard survey incidentally showed
that significant majorities (from 60% in the US to
85% in France) of the public supported an increase
in funding for research and the care of people with
AD.
Alzheimer Europe and its member organisations
will continue to campaign for dementia to be given
the priority it so justly deserves in the Horizon 2020
and the Health for Growth programmes, as well as
the European Innovation Partnership for Active and
Healthy Ageing.
The status of national dementia strategies in Europe
Countries with national
dementia strategy in place
Countries with government
commitment to develop
a dementia strategy
Countries with other political
support to develop a dementia
strategy
Countries with no support
to develop a dementia strategy
Alzheimer Europe, July 2013
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TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
IMI: Delivering Results for Patients
Michel GOLDMAN
Executive Director, Innovative Medicines Initiative (IMI)
W
idely regarded as the world’s leading
public-private
partnership
(PPP)
in health research, the Innovative
Medicines Initiative (IMI) is delivering scientifically excellent results that promise to improve
Europeans’ quality of life and boost the competitiveness of Europe’s pharmaceutical sector. Key
to IMI’s success is its flexible intellectual property
(IP) policy, which promotes the exploitation of
results while protecting the interests of all project
partners.
Scientific excellence and the power of
collaboration
A recent analysis of IMI projects’ output by
Thomson Reuters highlights both the quality
and quantity of scientific papers produced by IMI
projects. IMI projects have delivered close on 500
scientific publications, and an analysis of how
many times papers from IMI projects were cited in
subsequent papers (the citation index) revealed
that the citation index of papers from IMI projects
is twice the world average, and higher than the
EU average. Furthermore, 20% of IMI project
papers are ranked in the top 10% of papers by
journal category and year of publication.
The Thomson Reuters findings also highlight
the power of collaboration. The citation index of
papers with co-authors from different countries
is higher than that of papers with authors are
from one country, and the citation impact of
papers with authors from different sectors (e.g.
universities, industry, small biotech companies) is
higher than that of papers with authors from just
one sector.
In collaboration with experts from the Centre
for Intellectual Property Rights at the Katholieke
Universiteit Leuven, IMI has reviewed the
business opportunities emerging from IMI
projects. This revealed that projects are developing many highly valuable assets, including
large, well-organised databases and biobanks
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comprising unique collections of biological
materials and associated descriptive data.
Making a difference to people’s lives
However, IMI’s results are not just scientifically
excellent and of relevance to business. They
are set to have a real impact on quality of life in
Europe and beyond. For example diabetes, which
arises when patients’ blood sugar levels are
elevated because the beta cells in the pancreas
fail to produce enough insulin, affects 366 million
people worldwide. Many patients experience
complications, including heart disease, stroke,
and damage to the blood vessels, kidneys and
eyes. There is no cure, and treatment options are
limited.
In a world first, researchers from IMI project
IMIDIA developed a human pancreatic beta
cell line that not only survives in the lab, but
behaves in much the same way as cells in the
body. Elsewhere, the SUMMIT project has identified biological markers that could indicate which
patients are at greater risk of developing complications in diabetes, while the DIRECT project is
paving the way for personalised medicine.
Brain diseases also have an immense impact
on quality of life, affecting 1 in 3 Europeans and
costing the economy €798 billion. Because the
brain is such a complex organ, developing new
drugs for brain disorders takes longer and costs
more than for other diseases. A flagship IMI
project in this area is EU-AIMS, which is working
on autism.
Autism spectrum disorders (ASD) affect 1 child
in 110 and are characterised by difficulties in
social interaction and communication. Despite its
prevalence, there are no drugs designed specifically to treat ASD. EU-AIMS is unravelling the
underlying causes of ASD, and has discovered
that some of the brain changes associated with
autism may be reversible. In 2014, EU-AIMS will
launch two major clinical studies of ASD – one on
the risk of autism in younger siblings of children
with autism, and one on how symptoms change
with age. The project is also contributing to new
treatment guidelines by the European Medicines
Agency.
Medicine safety is another important area for
IMI. The SAFE-T project is has evaluated over
150 biological markers that could improve tests
used to determine whether a potential drug will
be harmful to the liver, kidneys, or blood vessels.
Looking to the future, IMI has a project in development which will tap into social media to detect
cases of adverse reactions to a drug, and provide
patients with the latest information on drug safety.
Towards greater competitiveness in Europe’s
pharmaceutical sector
IMI’s project results are set to boost the competitiveness of the pharma sector in Europe. One
particularly challenging area for companies is
antibiotic resistance. Drug-resistant bacteria kill
25 000 people in the EU every year and cost the
economy €1.5 billion, yet only two new classes
of antibiotics have been developed in the last 30
years. The scientific, regulatory and business
challenges of antibiotic development are so great
that just a handful of companies remain in the
field.
IMI’s New Drugs 4 Bad Bugs programme
represents an unprecedented partnership
between industry, academia and biotech organisations to combat antibiotic resistance by
tackling the many challenges hampering antibiotic development. Within the programme,
the TRANSLOCATION project is tackling the
scientific challenges of getting antibiotics into
bacteria, while COMBACTE has established a
Europe-wide network of almost 300 clinical and
laboratory sites and will start recruiting patients
for clinical trials in 2014. A new project, due for
launch in 2014, will develop a new business
model for antibiotic development to reinvigorate
investments in this area while also addressing
the issue of the responsible use of antibiotics.
IMI also runs education and training projects
which are helping to boost skills in the sector
across Europe. For example, the PharmaTrain
project has created a postgraduate Cooperative
European Medicines Development Course
(CEMDC) for students in countries in central and
southern Europe that currently do not offer highlevel training in pharmaceutical medicine.
Keys to success - IMI’s Intellectual Property
(IP) policy
One of the keys to the success of IMI’s projects is
its flexible IP policy. When IMI was launched, its
IP policy was criticised by people who feared that
it would not protect the interests of academics
and small biotechs in the projects. Today, with
the experience of setting up and managing 42
projects and associated IP agreements, it is
clear that far from being a liability, IMI’s IP policy
is one of the organisation’s greatest strengths
and a driver behind the success of many of our
projects.
The guiding principle behind the policy is IMI’s
objective of making a very practical contribution
to improving the efficiency of drug development.
The IP policy is therefore designed to promote
the exploitation of knowledge generated and
reward innovation, while respecting the interests
of all project partners.
An important aspect of the IP policy is its flexibility, which allows it to be adapted to the needs
of the individual projects and their partners. Of
significance here is the neutral role played by
the IMI Executive Office, which offers impartial
advice to all partners during negotiations on IP,
and ensures that the resulting agreement is in
line with the IMI IP policy and does not leave
some project partners at a disadvantage.
Because the IP agreement is concluded
before the launch of the project, project partners
can be confident that knowledge shared within
the project will be used appropriately.
In practice, the IP policy allows companies
and other organisations to share compounds,
data and knowledge with one another in an
unprecedented way. For example, in the
European Lead Factory, companies are contributing their own compounds to the project to
create a Joint European Compound Collection.
Other companies and organisations will be able
to run tests on the compound collection to see
if they can identify potential drugs within the
collection.
The companies involved in NEWMEDS have
pooled their data to create the largest-known
database of studies on schizophrenia, including
information from 67 studies. The database
represents a unique resource to help industry
and academia alike develop tools and models
that will help identify targeted treatments for
schizophrenia.
IMI – the story continues
Although discussions on IMI 2 are now
underway, the IMI 1 story is far from over. The
11th (and last) IMI 1 Call for proposals will be
launched at the end of 2013, featuring topics on
cancer, osteoarthritis, and Alzheimer’s disease,
to name a few. Next year will see the launch of
new projects resulting from Calls for proposals
launched in 2013.
One thing is clear – if the current trends
continue, IMI’s projects will keep delivering highquality results that will improve both patients’
lives and the strength of Europe’s drug development sector for years to come.
IMI in a nutshell
With a €2 billion budget, the Innovative Medicines Initiative (IMI) is the world’s largest public-private partnership in health. Through collaborative projects
that unite experts from industry, academia, small and medium-sized enterprises (SMEs), patient groups, and regulators, IMI is developing tools and technologies to speed up the development of safer and better drugs for patients.
IMI has 42 ongoing projects. Some focus on specific health issues such as neurological conditions (Alzheimer’s disease, schizophrenia, depression,
chronic pain, and autism), diabetes, lung disease, oncology, inflammation & infection, tuberculosis, and obesity. Others focus on broader challenges in drug
development like drug and vaccine safety, knowledge management, the sustainability of chemical drug production, the use of stem cells for drug discovery,
drug behaviour in the body, the creation of a European platform to discover novel medicines, and antimicrobial resistance. In addition to research projects,
IMI supports education and training projects.
The EU contributes €1 billion to IMI; this is matched by in kind contributions of €1 billion from the member companies of the European Federation of
Pharmaceutical Industries and Associations (EFPIA).
More information:
Website – www.imi.europa.eu
Twitter - @IMI_JU
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TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
Cancer Prevention is an Essential Investment for
Sustainable Healthcare Systems
Dr. Wendy YARED
Association of European Cancer Leagues (ECL)
C
ancer is the second most common cause
of mortality in the EU. In 2008, 2.5 million
citizens in the EU (27) were diagnosed
with cancer, with 1.2 million cancer deaths. With
an ageing population, the number of cancer
cases can only increase. When at least a third of
cancers can be prevented, prevention efforts are
more important than ever for sustainable health
systems.
From 1990 to 1994, EU-wide cancer
prevention efforts first took place during "Europe
against cancer" programme, implemented by
the European Communities. That programme’s
purpose was “to increase knowledge of the causes
of cancer with emphasis on the possible means
of preventing cancer. The programme set a target
at a 15% reduction in cancer deaths in Europe by
the Year 2000. Prevention had a specific strand in
the Europe against Cancer 1990-1994 priorities
which included a) cancer prevention (including
screening), b) health information and education,
c) training of health professions, and d) research
and cancer. An evaluation of the European
Cancer Week, which was a main action in the
prevention strand, concluded that coordination
of the Week increased citizens’ awareness that
cancer prevention was possible with individual
actions. Prior to the campaign, 33% of Europeans
did not think it was possible to prevent cancer.
This fell to 26% after the campaign, translating
to an increase of 20 million citizens who became
aware that cancer could be prevented. The
cancer prevention campaigns of the period also
raised awareness of the European Code Against
Cancer, which provides a list “do it yourself”,
evidence-based messages.
In 2009, cancer control received renewed
investment and attention at the EU in the form of
the launch of the Partnership for Action Against
Cancer (EPAAC). This led to an EU Joint Action
under the same name running from 2011 to
2014. Cancer prevention is again a main pillar
and led by the Association of European Cancer
Leagues (ECL). European cancer leagues were
a key stakeholder in the previous Europe against
Cancer programme especially in coordinating
the European Cancer Week, where almost all
actions were implemented by cancer societies at
the national levels. In the current EPAAC Joint
Action, the Week has been revived by ECL as
the European Week Against Cancer taking place
25-31 May each year with a special emphasis
on tobacco control on World No Tobacco Day
on 31 May. An exclusive focus for the renewed
Week has been on prevention and the dissemination of the messages in the European Code
Against Cancer. In particular, attention is given
to the messages related to healthy lifestyles and
the other primary prevention messages. Cancer
prevention also supported by the European
Parliament via the MEPs Against Cancer (MAC)
group, led by MAC President Alojz Peterle and
other key MEPs. MEP Pavel Poc, for example,
has taken colorectal cancer prevention forward
at the national level, with his annual “Colorectal
Cancer Days” (http://www.crcprevention.eu) in
Brno, Czech Republic.
In 2014, the EU will continue to support cancer
control with a new Joint Action “European Guide
on Quality Improvement in Comprehensive
Cancer Control” being led by Member States
in several key areas of work: a) Integrated
Care, b) Community-level Cancer Control, c)
Survivorship and rehabilitation, d) Screening and
early diagnosis. Thus while primary prevention
will not have its own pillar again, screening
does. It is expected that the new European Code
Against Cancer, currently being revised and to be
launched in 2014, will be communicated through
the dissemination work being led by Finland
around the time of the European Week Against
Cancer mid-year. Additional efforts will be
made to raise awareness among policy makers
that concrete actions are needed for cancer
prevention, especially in relation to the causes
which are responsible for the most disease,
namely tobacco, obesity, and physical inactivity.
The European Partnership for Action against
Cancer has the long-term aim of reducing cancer
incidence by 15% by 2020. It is hoped that this
goal commits the EU to support cancer control
and prevention actions for years to come. It is
high time to recognize the value of investing in
prevention for a healthier Europe.
(For more information on the Health Promotion
and Prevention pillar of the EPAAC Joint Action
and other work packages, see the newly
published book available at http://www.epaac.eu/
news/346-boosting-innovation-and-cooperationin-european-cancer-control.)
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The Vicious Circle of Poor Health and Poverty
Monika KOSIŃSKA
Secretary General of the European Public Health Alliance (EPHA)
D
ifferences in the health status of a population are closely linked to social and environmental determinants of health. In other
words, the conditions in which people are born,
grow up, live, work and age. These conditions
determine the opportunities that an individual has
to be healthy and so develop her full potential
both personally and Professionally.
Health inequalities – the unfair differences in
health status across different socio-economic
groups in society – are the result of several
factors: the uneven distribution of social and environmental determinants; the differential access
to resources such as education, employment,
housing, and health services; the different levels
of participation in society; and the different levels
of control over life.
Poverty, social exclusion and discrimination
are key factors in explaining poorer levels of
health between groups and countries. In general,
the lower the socioeconomic position, the worse
the health status of an individual. People live
longer and suffer less diseases and injuries the
further up they are the social ladder. Each rung
matters – the top 1% of the population is healthier
than the next percentile down.
Relationships between poverty, unemployment, low education and poor mental and
physical health are well documented. Not only
does poor health prevent people from being
economically active, there is also evidence
that being unemployed or in financial difficulty
increases the likelihood of becoming disabled,
and leads to low levels of social inclusion.
Moreover, a higher exposure to environmental
hazards tends to follow a social deprivation
gradient, as people from lower socioeconomic
groups are disproportionately more affected by
tobacco smoke, biological and chemical contamination, air pollution, sanitation and water
scarcity, noise, road traffic, occupational injuries,
and workplace stress. For instance, in Romania,
68.8% people in the lowest income group report
having no flush toilets, as compared to 11.2% of
the highest quarter.
When addressing the link between poverty and
health, specific attention should be dedicated to
children, the elderly, people suffering from mental
ill health, homeless people, migrants, unemployed people, Roma, or people living with disabilities among others.
Nutrition and poverty
Low income groups eat less well, pay more for
what they get in relative terms, and have worse
access to healthy options. Low income is associated with poor nutrition at all stages of life, from
lower rates of breast-feeding to higher intakes of
saturated fatty acids and lower intakes of fresh
fruit and vegetables. Moreover, there is increasing
evidence that poor nutrition in childhood results
in both short-term and long-term adverse consequences such as poorer immune status, higher
caries rates and poorer cognitive function and
learning ability.
Highly processed and fast foods are more
readily affordable, whilst nutrient-dense foods
such as fruit and vegetables have become relatively more expensive. There has been a widening
gap between the levels of obesity prevalence
among adults in higher and lower socioeconomic groups, with those in the lower groups
showing higher prevalence levels. Obesity, and
overweight-related diseases are more common
in poorer countries and populations in Europe.
There is also growing evidence of the link
between poverty and the growing number of
non-communicable diseases (NCD) and cardiovascular diseases (CVD) which are primarily
caused by a non-nutritious diet, tobacco, physical
inactivity and alcohol abuse and tend to primarily
affect people with a more deprived socioeconomic background.
People experiencing poverty are particularly
vulnerable towards developing mental health
problems. Conversely people with existing
mental health problems are more likely to experience poverty. The current economic crisis has a
considerable effect on the mental health and wellbeing of the population. Due to financial hardship
and uncertainties about the future, depression
and anxiety-disorders are more and more
commonplace. Today, one in three people with a
serious mental health condition are thought to be
in debt. It is the poorest in society who suffer the
greatest burden of mental ill-health.
Being healthy (or not) is not an individual
choice but primarily a result of the conditions in
which people are born, grow up, live, work and
age.
Tackling health inequalities requires a ‘Health
in All Policies’ approach
Many European Union (EU) policies and
initiatives affect health and health systems across
the European region. In general, politicians and
decision makers are often not aware of this health
impact from the EU level. This impact relates to
important determinants of health outside the
health policy sector such as from the economic,
environmental, agricultural, employment, housing
or transport areas. Nonetheless, the health sector
can and should input and support other areas
of governmental activity by actively assisting in
analysis of health impact assessment and contributing to non-health policy development and goal
setting and delivery.
Health policy should address health inequalities
by using a more “person-centered” approach that
takes into account the individual’s surroundings
and social structures that subsequently influence
the health status of the individual. Only if the
overall health policy and other policies that affect
health (e.g. social, economic, housing, education
and justice) coordinate together, is it possible to
actively tackle and reduce the disparities in health
status, as opposed to mitigating their effects.
Based on these principles, a new and innovative approach to cross-sectoral health and wellbeing achievement has been developed: Health
in all Policies (HiaP). This means that closing
the health gap becomes a shared goal across
all parts of government and addresses complex
health challenges through integrated policy
responses. It has never been more important
for health actors to understand their roles and
responsibilities in ensuring they are part of the
work to address the causes and drivers of health
inequalities, and not just treat the outcomes.
THE EUROPEAN FILES
41
TOWARDS MORE SUSTAINABLE HEALTHCARE SYSTEMS
Working Towards a Solution to Address Medicine Shortages in
Europe
Monika DERECQUE-POIS
Director General, GIRP – European Association of Pharmaceutical Full-line Wholesalers
G
IRP, the European Association of
Pharmaceutical Full-line Wholesalers
is actively engaged in tackling the challenges of the new reality for patient access
to medicines – shortages. As the body representing the voice of pharmaceutical full-line
wholesalers from across 32 European countries,
GIRP strongly supports coordinated actions
and initiatives aimed at mitigating the negative
impact arising from this increasing phenomenon.
In some cases the problem is so acute that it is
making breaking news headlines from Greece to
Portugal and from Italy to the UK.
Supply chain stakeholders and authorities
are increasingly alarmed about the effects that
unavailability of medicines has on patients and
the significantly increased resources required for
sourcing the medicines for their patients.
It is without question that the availability
and continuous supply of medicines is the
cornerstone of a healthy society and therefore
a key priority for European healthcare systems.
Despite a general level of acceptance that there
is a problem of medicines shortages, there is still
a lack of understanding on their actual causes
and robust solutions for resolving the problem
have yet to be found.
Shortages occur at the different levels of
the medicines supply chain – at manufacturing, wholesaling, retailing, and ultimately at
patients’ levels. There are also different products
shortages involving specialty, branded, generics
and over the counter medicines. And ultimately there are different sources of shortages
ranging from regulatory and manufacturing
(quality standards, recalls, inspections, new
requirements), tendering (one supplier), market
trade (quotas, price decease, loss of product
attractiveness...), and financing (austerity, cost
containment, payment delays...).
All stakeholders are impacted in different
ways. Patients are ultimately affected because
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THE EUROPEAN FILES
of inconvenience, interruptions in treatment,
increased anxiety, reduced adherence with the
intended treatment and eventually unexpected
healthcare outcomes due to the shortage of the
required medicine. Pharmacists are affected
through reduced operational efficiency, additional
workload associated with sourcing of products,
loss of customer loyalty and loss of income.
Wholesalers are affected by reduced operational
efficiency, reputational loss as an on-time trusted
supplier, reduced ability to act as a one-stopshop solution provider for dispensers, and loss of
business. Manufacturers are affected from loss
of reputation, increased competition from parallel
export, costs associated with servicing older
products and loss of sales.
As the root causes are so different from market
to market and country to country it is natural to
assume that the approach has to be different as
well.
Addressing manufacturing and regulatory root
causes might best be achieved through improved
forecasting and increased safety stock levels at
the level of the manufacturers and by allowing
for longer lead times lead times to comply with
new rules (such as the new rules on Active
Pharmaceutical Ingredients - APIs) at the regulators’ level.
Dealing with the tendering cause can take
place at multiple stakeholder level through
balancing the goal of sustainable access to
medicines for all patients with the objective of
pharmaceutical related cost control targets set by
payers and authorities.
Targeting the market related root cause can
also be dealt with by the various stakeholders.
Manufacturers can try to increase transparency,
improve allocation models towards wholesalers
and change product flows building in a greater
degree of flexibility for different markets as
well as installing early warning systems to their
supply chain partners. Wholesalers can improve
their allocation of supplies towards pharmacies,
strictly comply to their public service obligations
and install an early warning system for medicines
shortages for pharmacies. Regulators can work
with stakeholders through open and active
dialogue to improve communication and create a
system of data collection, information and alert
on medicines shortages.
In terms of addressing the financing related
root causes, it is clear that increased budget
allocation could help, but clearly we are living in
an era of severe austerity and hence, increased
spending on medicines may very well be resigned
to history books.
Clearly there is no silver bullet but there are
common approaches and actions that can and
will be taken – real time data exchange and
communication between the stakeholders is key.
Early mapping of experience and best practice
examples on national level on how to best
mitigate the problem of medicines shortages or
at least decrease their impact is producing some
positive results. However, current measures are
targeted more at managing the situation rather
than dealing with the underlying causes.
Increased transparency, the exchange of data
and early communication will help supply chain
stakeholders and authorities to identify more
clearly the main causes and help to manage the
issues of medicines shortages to such an extent
that the long term focus can shift away from mere
management to more sustainable, long term
solutions.
The question we are currently asking – is
whether action can be taken at the European
level. To answer this GIRP is actively working with
PGEU, EFPIA, EGA, AESGP and other concerned
stakeholders to investigate the possible options
available. In the meantime a significant number
of national initiatives have been established at
stakeholder as well as at government level. On
European level the European Medicines Agency
as well as the European Commission are actively
tackling the problem of medicines shortages.
The objective of our association is to provide
the vital link in healthcare and to ensure that
patients in Europe have access to all medicines
needed – whenever and wherever. Therefore the
problem of medicines shortages is core for us.
GIRP stands ready and willing to be an active
driver in the search for solutions by working with
it supply chain partners and authorities and place
the patient at the heart of the search for solutions.
© European Commission
Celgene: Working to improve the lives of patients
with rare diseases
Celgene works to drive clinical advances in overlooked disease areas or where the biggest
unmet need for patients exists. Committed to developing novel therapies that target the
mechanisms of these often debilitating diseases at their source, Celgene has a significant focus
on rare diseases including:
- 4 marketed products in the EU for different types of rare blood cancer;
- 19 EU orphan drug designations to date;
- Active clinical programmes in approximately 40 rare diseases such as: Multiple Myeloma
(MM), Myelodysplastic Syndromes (MDS), Acute Myeloid Leukemia (AML), Lymphomas and
Chronic Lymphocytic Leukemia (CLL)
Celgene ranks second in terms of orphan drug designations and the third in terms of approved
orphan medicinal products in the EU
Celgene is a global biopharmaceutical company committed to
research and development of new treatments that bring value to rare
disease patients and healthcare systems. For more information about
Celgene’s activities, please contact Kevin Loth, kloth@celgene.com