Pace A et al. / Pharmacie Globale (IJCP) 2013, 06 (02)
Available online at www.pharmacie-globale.info
ISSN 0976-8157
Research Article
PHARMACIE GLOBALE
INTERNATIONAL JOURNAL OF COMPREHENSIVE PHARMACY
DEVELOPMENT IN THE EUROPEAN UNION AND ACCESS TO MEDICINES
Amanda Pace*, Lilian M Azzopardi, Anthony Serracino-Inglott, Lilian Wismayer and Maurice Zarb Adami
Department of Pharmacy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta.
Received: 12 April 2013; Revised: 19 April 2013; Accepted: 28 May 2013; Available online: 5 June 2013
ABSTRACT
The problem of reduced access to medicines is being increasingly felt throughout Europe including Malta. A
country’s National Medicines Policy (NMP) must consider accessibility together with other factor such as
affordability, regulation and rational use of medicinal products, financing, and supply and distribution systems.
These areas can all be presented within a framework as exemplified by the World Health Organisation (WHO)
framework which is the most effective in incorporating NMP components and objectives.1 (World Health
Organisation, 2001) The Descriptive Logic Model (DLM) was used as an essential tool to collectively represent
relevant framework areas focusing on the entry of a medicinal product in the Maltese market.2,3 Pharmaceutical
policy is one of the basic elements of an efficient health service and provides guidance as to the standard of
health and pharmaceutical service to be delivered. Pharmaceutical policies may portray an array of aspects
within a given health care system. Policies are by their nature dynamic as they consider the past; strategically
address current patient needs and project future challenges. Thus strategy and pharmaceutical policy form a
dynamic scientific tool which attempts to maximise resources and to provide appropriate pharmaceutical care
whilst being able to evolve and adapt to any changes. Throughout the years Europe has increased its
collaboration among various stakeholders in order to address health care demands such as an increased need
for innovative treatments.
Keywords: Access; Regulation; Policy Framework; Innovation; Health care systems.
INTRODUCTION
Access to medicines has become increasingly debated and
controversial. The problem of access had been discussed
throughout the years with several national policy
documents drafted, one of the first was of the World
Health Organisation (WHO) in 1977 which included a list
of essential medicinal products - this was updated over
subsequent years.4 At the time, the concept of providing
guidance to counties regarding the selection of essential
medicinal products was evolving and such a document
contributed to this. By 2001, WHO had issued a
publication addressing the development of national drug
policies.1 This was followed in 2002 and 2003 by a series
of policy perspectives concerning the selection of essential
medicines, the development and execution of a national
drug policy, effective regulation, and equitable access.5-8
These texts were complemented by a 2004 publication
regarding priority medicinal products and existing
therapeutic gaps in an enlarged European Union (EU).
WHO introduced the concept of “value for money” and
pharmaceutical innovation.9 Malta participated in such
initiatives and took cognisance of the importance of
drafting a national drug policy as a first step. Following
expert assistance from WHO the Pharmaceutical Services
within the Ministry of Health produced a document which
outlined a NMP.3,10
*Corresponding Author:
Amenda Pace
Department of Pharmacy, Faculty of Medicine and Surgery,
University of Malta, Msida, Malta.
Email: apac0011@um.edu.mt
1
In parallel to WHO publications, the European Commission
(EC) also released a series of reports identifying related
issues within the European Union.11 The European
Commission also set up a High Level Group on Innovation
and Provision of Medicines (G10 medicines). The G10
group evaluated concerns within the pharmaceutical
arena and in May 2002, identified fourteen key points.12 In
2005, in response to such recommendations, the EC
established the Pharmaceutical Forum that analysed three
major aspects: Information to Patients, Relative
Effectiveness and Pricing and Reimbursement through
respective
working
groups.
It
formulated
recommendations whilst enabling the industry to thrive
and ensuring maintenance of national health care systems
with the aim of bringing together the EC, EU Member
States (Member States), EU Parliament Representatives,
and stakeholders.13
Early in 2004 the European Medicines Agencies (EMA)
initiated an exercise to establish and formulate a
discussion report entitled, “The European Medicines
Agency Road Map to 2010: Preparing the Ground for the
Future” made publicly available in March 2005. This was
formulated in the context of two key issues, an enlarged
European Union and the challenges posed by an intricate
regulatory framework. The main objectives included
speedy access to safe, efficacious medicinal products,
delivery of adequate information to patients, promotion of
innovation and research, consideration of health issues,
and strengthening collaboration between EMA and
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Pace A et al. / Pharmacie Globale (IJCP) 2013, 06 (02)
national competent authorities (NCAs).14 In 2006, the
European network for HTA (EunetHTA) project was
initiated and launched in November 2008. The EunetHTA
took on board and started to execute sustainable
collaboration for Health Technology assessment (HTA) in
Europe. The network linked together representation from
the Member States, regional agencies and non-profit
organisations to improve sharing of knowledge whilst
enhancing HTA procedures.15 The EUnetHTA was
formulated after recommendations from a High Level
Group on Health Services and Medical Care. It was
supported by the Directorate General of the EC on Health
and Consumer Protection (DG SANCO). This initiative also
aimed at enhancing active participation thereby yielding
effective decision making at a national level.16 In 2007, the
Heads of Medicines Agencies (HMA) set up a Task Force
(TF) on the availability of medicinal products and the lack
of access particularly in context of states with small and
medium sized markets.17 In tandem, the Directorate
General for Enterprise and Industry of the EC funded a
report on the diversity and commonalities in pricing and
reimbursement systems within the EU.18 The HMA drafted
its strategic document (2011-2015) identifying the
difficulties that would be faced over that period. This
report was drafted in parallel with, and complimented the
EMA road map (2010-2015).19 Simultaneously in 2010,
the Belgian Presidency Conference on innovation and
solidarity was held against the backdrop of the promotion
of EU partnership amongst Member States on current
health matters such as chronic diseases, cancer, and
medicinal products.20,21 In March 2011, a report
commissioned by the Directorate General for Internal
Policies analysed medicinal product pricing differences
across different Member States.22 Within this background
in 2008, the High Level Pharmaceutical Forum put
forward and recommended that each patient should have
“equitable access”. These problems were being
experienced in Malta at the time, in part due to its small
market size but also for other reasons.
METHODOLOGY
The study covered the period from 2007-2010 and
focused on issues influencing access within the local
pharmaceutical scenario stemming after Malta’s accession
into the European Union. An aim of the study was to
examine the Maltese pharmaceutical environment and
how this was influenced by various factors in relation to
access to medicinal products. The conducted case study
was based on the local market and the components of
medicines policies explored were:
 Registration of Medicinal Products
 Access and Availability of Medicinal Products
 Procurement and Supply of Medicinal Products
 Medicinal Product Pricing
 Reimbursement of Medicinal Products
A comprehensive review on these aspects and changes
that they underwent throughout the years with respect to
access was developed by means of the Descriptive Logic
Model (DLM). This model utilised in an array of studies is
an appropriate tool as evidenced by McLaughlin and
Jordan2 and Vella Bonanno.3 A longitudinal analysis was
carried out which depicted Malta’s pharmaceutical
situation portrayed over ten years (2001 through to 2010)
by virtue of four Descriptive Logic Models (DLMs) at
designated cut off years for analysis; 2001, 2006, 2009 and
2010. Recommendations and documents within the
European Union were also considered in relation to
2
Malta’s small Member State status.
RESULTS AND DISCUSSION
Registration of Medicinal Products
Upon Malta’s European Union accession, in 2004, the
introduction of a new system for the registration of
medicinal products raised a number of aspects within the
Maltese scenario. The adoption of the European legislation
enhanced and guaranteed the quality, safety and efficacy
of medicinal products that were placed on the market. The
legislation offered manufacturing companies the
opportunity to come into line with EU standards. The new
regulatory environment was attractive to the industry,
offered them protection and opened a window of
opportunity for a number of generic manufacturing
companies to set up base locally. This increased the
number of production facilities as shown in table 1.23
Table 1. Manufacturing Companies Licensed in Malta
Year
Number of Manufacturing Companies
2002
1 company
2003
9 companies
2006
11 companies
2011
24 companies
Figures given by Medicines Authority, Malta.
Malta also began acting as a reference member state
receiving its first application in December in 2007.24
During 2010, Malta starting acting as a Reference Member
State for 17 decentralised procedures out of which 2 were
concluded by 2010. Notwithstanding this, it was being
increasingly felt that Malta as a small Member State, like
others of similar size, was being left out of European
procedures such as Mutual Recognition Procedure and
Decentralised Procedure.25
Access and Availability of Medicinal Products
Medicinal products imported into Malta prior to 2001
were required to possess a valid Certificate of
Pharmaceutical Product (CPP).26 On the derogation list
there were 1823 different active ingredients available and
7020 medicinal products (that were not all locally
marketed), of which 5162 products were also authorised
in European Union.27 Following EU accession, in May 2004,
products’ packaging had to be in line with EU legislative
requirements and registration cost were introduced.
These, coupled with the small dimensions of the local
market were straining accessibility at that time. The
number of products decreased as portrayed by an analysis
of the market in May 2006 as shown in Table 2.27 This
issue was addressed in 2007 through the use of article
126a Directive 2001/83/EC (as amended by Directive
2004/27/EC) which was a means of filling ‘gaps’ in access
to medicinal products. This, together with a reduction in
fees successfully addressed the issue of reduced
availability as depicted in Table 2.28 The local registration
fees were subsidised by the Government.25
The level of access to medicinal products generally
improved throughout the years of study and especially
from 2007 till present, as evidenced by the number of
medicinal products available on the local market in table
two. Notwithstanding this, shortages of specific medicines
was evident in the study and up to date this is still creating
problems both in the private and more so in the public
local sectors. Medicinal product shortages and estimated
time to be back in stock could be made available to health
care professionals to improve utilisation of available
stocks within the given time frame. Currently, the
Pharmacy of Your Choice scheme, which is the process of
dispensing medicines on the National Health Services
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Pace A et al. / Pharmacie Globale (IJCP) 2013, 06 (02)
Scheme through private community pharmacies, utilises a
informed via email when a medicinal product is back in
similar system, where health care professionals are
stock.
Table 2. The number of medicinal products marketed from December 2005 – December 2012
126a authorizations per year
National Marketing
Mutual Recognition
Collective number of authorised
(and cumulative
Authorisations/ Provisional
Procedure/ Decentralised
Medicinal products
(excluding
authorisations 2006 - 2012)
Marketing Authorisation
Procedure
Centralised Procedure)
2005
Not Applicable
2228
57
2288
2006
2
2401
158
2800
2007
295
1856
341
2151
2008
453 (751)
1651
294
2442
2009
256 (1008)
1671
454
3135
2010
297 (1304)
2173
141
3597
2011
250 (1554)
2140
220
3947
2012
285 (1839)
2151
283
4273
Table figures were obtained through Medicines Authority Annual Reports 200529, 200630, 200724, 200825, 200931, 201032, 201133, and 201234. (Collective total
number of medicinal products including national procedures for Malta)
Year
In relation to access and availability to medicinal products
the 2005-2010 EMA roadmap emphasised the need for
scientific evaluation in manufacture of new chemical
entities, well-timed access to efficacious, safe and
innovative treatment through efficient centralised
procedures,
pharmacovigilance
and
monitoring
importance, and access to information. EMA
recommended collaboration among regulatory authorities
and adoption of legal provisions enabling timely access,
safety and innovation.14 In its second formulated road map
(2010-2015). EMA outlined, amongst various areas of
focus, the need for improvement in access to medication
and the importance of increasing safety and rational use of
medicinal products.35
In 2007, the TF on the availability of medicinal products
was set up by the HMA. The HMA TF emphasised the
problem of reduced availability with special reference to
small and medium-sized national markets. The report
examined availability issues relating to marketing
authorisation processes and legislation. The dimension of
a market was linked to the refusal of a marketing
authorisation holder (MAH) to market a product. Parallel
import and export and price diversity were seen as
availability barriers. The TF discussed the pharmaceutical
industry and its crucial role in product availability and this
role was pronounced in small markets. The HMA
recommended sharing of procedural knowledge on
addressing availability concerns, increasing debate on
availability of products among stakeholders, avoiding
parallel import procedures to circumvent Directive
2001/83/EC, removal of cumbersome labelling
bureaucracy, acceptance of multi-lingual language sources,
creation of warning systems regarding the unavailability
of specific medicinal products, use of article 126a, article
5, article 24, and article 81 Directive 2001/83/EC, and
increasing joint collaboration among Member States on
pricing and reimbursement.17 A report funded by the DG
Enterprise and Industry stated that restriction of public
expenditure was common among Member states but
priority setting and processes capping expenses varied.
Emphasis was made on the need for collaboration and
sharing of knowledge on cost containment. The report
discussed common aspects shared by Member States such
as cost capping, enabling adequate access whilst providing
compensation for innovation and the maintenance of
pharmaceutical manufacturing.18 A Ministerial Conference
on solidarity and innovation (September, 2010) debated
EU policy and its relation to valuable, innovative products
whilst ensuring access, promoting research, and defining
and allocating value to innovation.36,37 In 2011, the
Directorate General for Internal Policies recommended a
3
permanent and sustainable collaboration for information
and experience sharing.22
Procurement and Supply of Medicinal Products
The local introduction of the Pharmacy of Your Choice
(POYC) scheme was intended to cut down patient waiting
times at the pharmacy and enables Maltese patients to
obtain reimbursed medicinal products supplied through
public health services from their chosen, privately owned
pharmacies. The scheme commenced in 2007 as a pilot
phase. Prior to such a scheme patients would be given
their entitled medication from Government Community
Pharmacies at designated Health Centres in Malta. The
scheme continued to expand throughout all of Malta and
Gozo whilst considering innovative procurement, storage
and distribution methods.38
Medicinal Product Pricing
Following Malta’s accession into the European Union,
pricing of medicinal product was debated and became a
matter of public concern where such prices were
perceived to be on the increase and no control mechanism
was being utilised to curtail this. Thus an agreement was
reached between the Government and concerned
stakeholders within the public sector on a voluntary
mechanism in 2006.39 During 2007 a pricing comparison
exercise was started by a Working Committee on the
Pricing of Medicinal Products under the Consumer and
Competition Division. Prices were considered in relation
to EU average prices.40 Further discussions were held
during 2010 and in July 2010, the Office for Fair Trading
published a list with reduced prices. Another list of price
reductions was published in April 2011. The mechanism
for price reductions in the private sector remains
voluntary and without any legal basis, yet a number of
prices were reduced, increasing the affordability and
consequently the access to medication.41, 42, 43, 44 It was also
being suggested that a reduction in prices could be
achieved through changes made to the importation of
medicinal products as well as having the government
import essential medicinal products that would be
unavailable.45
Presently Malta does not regulate the prices of medicinal
products for the private sector. As a small Member State is
often faced with reduced levels of access to medicinal
products and furthermore it is often difficult to utilise and
adapt all legislative systems and provisions to be able to
counteract such lack of access.17
Reimbursement of Medicinal Products
In 2007, Legal Notice 165/2007 was drafted to update
Legal Notice 399 of 2003 from transposition of
Transparency Directive 89/105/EC and later amended to
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Legal Notice 58/2009 to increase transparency. These
three Legal Notices related to the government health
services’ availability of medicinal products.46, 47 Over the
years the patient entitlement to reimbursed medicinal
products was improved through addition of the list of
conditions in the Social Security Act’s fifth Schedule and
inclusion of new medicinal products available for
reimbursement. In 2008 there were 1309 medicines on
the Government Formulary List, in 2011, this increased to
1332 items and in 2012 there were 1336 medicinal
products (Figures were obtained through the Department
for Pharmaceutical Affairs within the Ministry of Health)
available on the formulary.48 In March 2012 the Social
Security Act Cap 318 Article 23 and the Fifth Schedule of
the same Act were changed, and resulted in an increase in
the number of conditions that fall under this Act, from a
previous 38 conditions to 79. The Act’s updated conditions
include:
 Cerebrovascular and peripheral vascular disease
 Psychiatric disorders including those occurring in
childhood
 Mood disorders that are chronic
 Down’s Syndrome
 Type I and Type II Diabetes Mellitus49
To aid in access to medicinal products, the prescriber
criteria within the health services were changed and
doctors (both private and National Health Services) could
alter medicinal product doses for items marked as
‘protocol regulated’, ‘medical practitioner’ and ‘consultant’
on the government formulary for specific conditions
(Hypertension, Diabetes Mellitus, Chronic Heart Failure,
Asthma, Chronic Obstructive Pulmonary Disease, Chronic
Mood Disorders, Chronic Neurotic Disorders, and
hypercholesterolaemia treatment according to Schedule V
condition ).50, 51,52 According to the 2012 budgetary speech
approximately 100,000 Maltese citizens now have access
to medicinal products that are completely reimbursed by
the Government.53
One of the High Level Pharmaceutical Forum final
recommendations included the consideration of access to
orphan medication and access in small national markets.
The working group on Pricing and Reimbursement
recommended that access to orphan medicinal products
and to medicinal products in small markets required a
careful approach whereby it suggested that EU Member
States should ensure availability and supply of medicinal
products whilst considering recommendations made by
the HMA TF report. The forum urged all involved
stakeholders to adopt the working group for Pricing and
Reimbursement recommendations. Recommendations
included early discussions on research and development,
the sharing of information on scientific assessment and
pricing and reimbursement logistics coupled with
enhanced orphan disease consciousness. It was suggested
that access occurs in a timely manner and includes
innovative treatment whilst targeting all patients and
following the EU Transparency Directive 89/105/EC.
Member States were counseled to define innovation whilst
considering compensation. National pricing and
reimbursement policies had to recognise and display this.
Pricing and reimbursement policies had to enable
appropriate use of price control measures, coherent
supply and demand procedures whilst having price
regulation that applies to reimbursed products. This
excluded the non-reimbursed or privately sold medicinal
products.13 WHO had been discussing this issue
4
(throughout the years) as well as the diversities among the
pricing and reimbursement in different countries and their
dependence on countries’ perspectives. There were
inconsistencies among EU Member States. Market failures
were leading to therapeutic gaps, and lack of innovation
within certain disease categories both at European and
global levels prompting WHO to urge Europe to address
this.9
In 2004, the European Council considered HTA
collaboration among EU countries as promoting the
sharing of knowledge and capacities. The EunetHTA
project was initiated in 2006. The HTA International
Network of Agencies housed forty six members by 2008.
Member States such as Estonia, Malta, Luxembourg,
Portugal, Slovakia and Slovenia could not possess such an
agency as national expertise and resources were scarce.
The importance of having an ongoing collaboration on
HTA across Europe was increasingly being felt in order to
avoid replication of efforts, making the best use out of the
limited resources, and enhance HTA use.16 In the present
study an isocratic reversed phase-high performance liquid
chromatography (RP-HPLC) method was developed for
checking the Quantity based quality in the formulated
Diclofenac Sodium tablets. The linearity was calculated
0.999, which significant at the level p=0.1% error. The
limit of detection and limit of quantification were
calculated 0.03 and 0.09 µg/mL. The inter-day and intraday average percentage recovery at three concentration
levels were calculated 100.69 % with the coefficient
variation percentage 2.240 (<10) and 0.8351 (<1.0).
Hence, applied method validation was significant.
Therefore this method is acceptable for checking the
quantity based quality from formulated tablets.
CONCLUSION
Policy and similar social systems are often complex and
difficult to define. The Descriptive Logic Model aids the
descriptive evaluation by graphically portraying the
various aspects of the case as well as being a systematic
approach to data collection.54 When vast amounts of data
are obtained, the Descriptive Logic Model displays the
collection of such data in a structured and concise manner
for easier data handling. Since a snapshot of the chosen
time (2001-2010) was desired the Descriptive Logic
Model served as an adequate research tool allowing
comparison of snapshots at chosen years through
longitudinal analysis. The model allows a way of studying
the impact of new policies. It is often useful to use a
Descriptive Logic Model for particular cases since it aids in
evidencing improvement for that case whilst presenting
ways of obtaining results for a study and enhancing the
data collection.55
Healthcare provision is evolving at European Level and
health requirements should be targeted through
innovative medication and EU policy and collaboration
among all involved stakeholders that work jointly for
public protection.20 The major difficulties encountered in
EU policy includes access to innovative therapy for specific
patient needs, whilst maintaining quality and ensuring
equity, solidarity and cost containment.21,36,37 The role of
policy has now shifted to target areas that are not being
covered by legislation.
ACKNOWLEDGEMENTS
The authors are thankful to all those who contributed to
the study by providing information on the framework and
processes reviewed.
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REFERENCES
1. World Health Organisation (WHO). How to Develop
and Implement a National Drug Policy Updates and
Replaces Guidelines for Developing National Drug
Policies 1988. 2nd Ed. Geneva, Switzerland: WHO;
2001.
2. McLaughlin J A, Jordan G B; Logic Models: A Tool for
Telling Your Program's Performance Story. Evaluation
and Program Planning. 1999; 22(1):65-72.
http://www.pmn.net/library/Logic.htm Accessed on
December 18, 2010.
3. Vella Bonanno P; The Managed Entry of New Drugs into
a National Health Service: A Case Study for Malta
[dissertation]. Aberdeen: The Robert Gordon
University; 2003.
4. World Health Organisation (WHO). Guidelines for
Developing National Drug Policies 1988. Geneva,
Switzerland: WHO; 1988.
5. World Health Organisation (WHO). WHO Policy
Perspectives on Medicines: The Selection of Essential
Medicines. Geneva, Switzerland: WHO; 2002.
6. World Health Organisation (WHO). WHO Policy
Perspectives on Medicines: How to Develop and
Implement a National Drug Policy. Geneva,
Switzerland: WHO; 2003.
7. World Health Organisation (WHO). WHO Policy
Perspectives on Medicines: Effective Medicines
Regulation: Ensuring Safety, Efficacy and Quality.
Geneva, Switzerland: WHO; 2003.
8. World Health Organisation (WHO). Equitable Access to
Essential Medicines: A framework for Collective Action.
Geneva, Switzerland: WHO; 2004.
9. World Health Organisation (WHO). Essential Drugs and
Medicines Policy; Priority Medicines for Europe and
the World. Geneva, Switzerland: WHO: 2004.
10.World Health Organisation (WHO). Biennial
Collaborative Agreement between Malta and the
Regional Office for Europe for the World Health
Organisation. WHO; 2010-2011.
http://www.euro.who.int/__data/assets/pdf_file/0009
/107784/MAT_2010_2011.pdf Accessed on December
1, 2012.
11.Gambardella A, Orsenigo L, Pammolli F; Global
Competitiveness in Pharmaceuticals a European
Perspective. European Commission Web site.
http://ec.europa.eu/enterprise/sectors/healthcare/fil
es/docs/comprep_nov2000_en.pdf 2001. Accessed on
October 4, 2013.
12.High Level Group on Innovation and Provision of
Medicines Recommendations for Action. G10 Medicines
– Report. European Commission Web site.
http://ec.europa.eu/health/files/phabiocom/docs/g10
-medicines_en.pdf May 7, 2002. Accessed on January
15, 2013.
13.High Level Pharmaceutical Forum. Final Conclusions
and
Recommendations
of
the
High
Level
Pharmaceutical Forum. 2005-2008.
http://ec.europa.eu/pharmaforum/docs/final_conclusi
ons_en.pdf Accessed on April 5, 2013.
14. European Medicines Agency (EMEA). The European
Medicines Agency Road Map to 2010: Preparing the
Ground for the Future. London: 2005.
http://www.ema.europa.eu/docs/en_GB/document_lib
rary/Report/2009/10/WC500004903.pdf Accessed on
5
November 9, 2009.
15.European network for Health Technology Assessment,
EUnetHTA.
EUnetHTA
web
site.
http://www.eunethta.eu/Public/About_EUnetHTA/
Accessed on August 19, 2010.
16.EunetHTA project, Overview of Results Years 20062008.
March
28,
2009.
http://www.eunethta.eu/upload/Project%20Reportin
g/EUnetHTA%20project_Overview%20of%20Results_
2006-2008.pdf Accessed on January 4, 2010.
17.Task Force of Heads of Medicines Agencies
Management Group (HMA MG). Availability of Human
Medicinal Products, Report of Task Force of HMA MG.
Madeira: 2007.
http://www.hma.eu/uploads/media/Availability_medi
cines_HMAMG_TF_Report.pdf Accessed on December
14, 2010.
18.Espín and Rovira; Analysis of Differences and
Commonalities in Pricing and Reimbursement Systems
in Europe; A study funded by the DG Enterprise and
Industry of the European Commission, final report.
Spain: 2007.
http://ec.europa.eu/enterprise/sectors/healthcare/fil
es/docs/study_pricing_2007/andalusian_school_public
_health_report_pricing_2007_en.pdf
Accessed
on
January 12, 2009.
19.Heads of Medicines Agencies. Developing a Strategy for
the Heads of Medicines Agencies 2011-15. July 9, 2010.
http://www.cbg-meb.nl/NR/rdonlyres/ 677BA EFD7BBB-4AE3-BA1F-9DCE3E147B6E/0/Concept
strategypaperHMA20112015.pdf Accessed on August
29, 2010.
20.Testori Coggi P; Speech by Director General for Health
and Consumers Innovation and Solidarity on
Pharmaceuticals. Belgian Presidency Conference. 2010
September 23.
http://ec.europa.eu/dgs/health_consumer/docs/2010
0923_ptc_h.pdf Accessed on September 25, 2010.
21.Cuypers D; Solidarity and Innovation. The
Parliament.com
Politics,
Policy
and
People.
http://www.theparliament.com/latest-news/article/
newsarticle/solidarity-and-innovation/ October 4,
2010. Accessed on November 20, 2010.
22.Kanavos P, Vandoros S, Irwin R, Nicod E, Casson M;
Medical Technology Research Group LSE Health and
London School of Economics and Political Science.
Differences in Costs of and Access to Pharmaceutical
Products in the EU. Directorate General for Internal
Policies. March, 2011.
http://www.eatg.org/eatg/Global-HIV-News/EU
Policy/Report-Differences-in-costs-of-and-access-topharmaceutical-products-in-the-EU Accessed on April
2, 2010.
23.Galea Debono F; PM Pitches Malta to Pharmaceutical
Industry. The Times of Malta. Jun 21, 2005.
http://www.timesofmalta.com/articles/view/2005062
1/local/pm-pitches-malta-to-pharmaceuticalindustry.86527 Accessed on January 23, 2010.
24.Medicines Authority. Annual Report 2007. Malta: Gzira;
2007.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on January 20, 2010.
Pharmacie Globale© (IJCP), Vol. 04, Issue 06
Pace A et al. / Pharmacie Globale (IJCP) 2013, 06 (02)
25.Medicines Authority. Annual Report 2008. Malta: Gzira;
2008.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on December 12, 2012
26. Department of Environmental Health Port Health
Services
in
Malta.
Importation
of
Pharmaceuticals/Food
Supplements.
2008.
http://www.health.gov.mt/dph/phs2.htm Accessed on
March 15, 2009
27. Bugeja V; The Impact of EU Legislation on Medicines in
Malta. Journal of the Malta College of Pharmacy
Practice. 2008; 32.
28. Vella Bonanno P; Together We Excel: January
extraordinary staff meeting. Medicines Authority Malta.
January 26, 2010.
29. Medicines Authority. Annual Report 2005. Malta: Gzira;
2005.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on January 14, 2013.
30.Medicines Authority. Annual Report 2006. Malta: Gzira;
2006.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on December 21, 2012.
31.Medicines Authority. Annual Report 2009. Malta: Gzira;
2009.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on March 19, 2013.
32.Medicines Authority. Annual Report 2010. Malta: Gzira;
2010.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on February 1, 2013.
33.Medicines Authority. Annual Report 2011. Malta: Gzira;
2011.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on February 10, 2013.
34.Medicines Authority. Annual Report 2012. Malta: Gzira;
2012.
http://www.medicinesauthority.gov.mt/annualreports
?l=1 Accessed on January 5, 2013.
35. European Medicines Agency (EMA). Road Map to 2015,
the European Medicines Agency’s Contribution to
Sciences, Medicines and Health. December 16, 2010.
http://www.ema.europa.eu/docs/en_GB/document_lib
rary/Report/2011/01/WC500101373.pdf Accessed on
January 6, 2010.
36. Ministerial Conference “Innovation and Solidarity”. FPS
Health, Food Chain Safety and Environment.
http://www.health.belgium.be/eportal/Aboutus/eutri
o/health/Innovation_and_Solidarity/?fodnlang=en
Accessed on November 20, 2010.
37.Belgian Presidency of the Council of the European
Union. A Call to Make Valuable Innovative Medicines
Accessible in the European Union. Recommendations
for a Coordinated Action to Stimulate, Measure, and
Valorise Pharmaceutical Innovation. Ministerial
Conference Report. July 2, 2010.
http://www.ispor.org/congresses/Prague1110/docum
ents/PlenaryII-Making-Innovative-MedicineAccessiblein-the-EU.pdf Accessed on November 20, 2010.
38.Ministry of Finance, the Economy and Investment. PreBudget 2011: Ideas, Vision, Discussion. July, 2010.
http://www.finance.gov.mt/image.aspx?site=MFIN&re
f=2011_Pre%20Budget%20Doc%202010 Accessed on
December 2, 2010.
6
39.Mallia S; Cheaper Medicine from November 1. The
Times of Malta [Online]. October 17, 2006.
http://www.timesofmalta.com/articles/view/2006101
7/local/cheaper-medicine-from-november-1.38230
Accessed March 20, 2011.
40.Malta Media; Some Medicine Prices to fall by End of
Summer.
http://www.maltamedia.com/artman2/publish/financ
ial/article_2326.shtml Accessed on August 12, 2010.
41.Efforts to Reduce Medicine Prices to Continue. Times of
Malta
Online
[Online].
October
25,
2010.
http://www.timesofmalta.com/articles/view/2010102
5/budget/medicine-prices Accessed on October 26,
2010.
42.Another 29 Medicines See Price Reductions. Times of
Malta Online [Online]. September 1, 2010.
http://www.timesofmalta.com/articles/view/2010090
1/local/another-29-medicines-see-price-reductions
Accessed on September 4, 2010.
43.Xuereb M; Cheaper Medicines on the Way. January 3,
2011.
http://www.timesofmalta.com/articles/view/2011010
3/local/cheaper-medicines-on-the-way.343643
Accessed on January 4, 2011.
44.Malta Competition and Consumer Affairs Authority.
Operations Directorate.
https://secure2.gov.mt/consumer/operationsdirectorate?l=1 Accessed on March 19, 2013.
45.AD Calls for Lower Prices of Medicine. Times of Malta.
http://www.timesofmalta.com/articles/view/2013022
0/local/AD-calls-for-lower-prices-of-medicine. 458428
February 20, 2013. Accessed on March 21, 2013.
46.Legal Notice 165 of 2007 - Availability of Medicinal
Products within the Government Health Services
Regulations, 2007. MJHA Laws of Malta Justice Services
web site.
http://www.justiceservices.gov.mt/DownloadDocume
nt.aspx?app=lp&itemid=19510&l=1
Accessed
on
January 22, 2013.
47.Legal Notice 58 of 2009 - Availability of Medicinal
Products within the Government Health Services
Regulations, 2009. MJHA Laws of Malta Justice Services
web site.
http://www.justiceservices.gov.mt/DownloadDocume
nt.aspx?app=lp&itemid=19993&l=1
Accessed
on
January 22, 2013.
48.Free Medicines System being Reviewed, Private GPs to
be Included in the Primary Health Care System. Times
of Malta.
http://www.timesofmalta.com/articles/view/2009032
6/local/free-medicines-system-being-reviewed March
26, 2009. Accessed on March 29, 2009.
49.Memo 01/2012. Directorate for Pharmaceutical Affairs
Department of Health Ministry for Health The Elderly
and Community Care.
https://ehealth.gov.mt/HealthPortal/chief_medical_offi
cer/pharm_pol_mon/memo.aspx 2012 Accessed on
December 1, 2012.
50.Legal Notice 165 of 2007 - Availability of Medicinal
Products within the Government Health Services
Regulations, 2007. MJHA Laws of Malta Justice Services
web site.
http://www.justiceservices.gov.mt/DownloadDocume
nt.aspx?app=lp&itemid=19510&l=1
Accessed
on
January 22, 2013.
Pharmacie Globale© (IJCP), Vol. 04, Issue 06
Pace A et al. / Pharmacie Globale (IJCP) 2013, 06 (02)
51. Act No 1 of 2012 - Social Security (Amendment) Act,
2012. MJHA Laws of Malta Justice Services web site.
http://www.justiceservices.gov.mt/DownloadDocume
nt.aspx?app=lp&itemid=22850&l=1
Accessed
on
February 1, 2013
52.Social Security Act Chapter 318, 1987. MJHA Laws of
Malta Justice Services web site.
http://www.justiceservices.gov.mt/DownloadDocume
nt.aspx?app=lom&itemid=8794 Accessed on February
1, 2013.
53. The Ministry for Finance. The Budget Speech 2013.
Ministry
for
Finance
web
site.
7
http://www.finance.gov.mt/image.aspx?site=MFIN&re
f=2013_Budget_Speech_EN Accessed on January 8,
2013.
54. Medeiros L C, Butkus S N, Chipman H, Cox R H, Jones L,
Little D; A logic model framework for community
nutrition education. Journal of Nutrition Education and
Behaviour. 2005; 37(4):197-202.
55.Roughley A; Developing and using program logic in
natural
resource
management
user
guide.
Commonwealth of Australia. 2009.
www.nrm.gov.au/publications/books/pubs/meriprogram-logic.pd Accessed on April 3, 2010
Pharmacie Globale© (IJCP), Vol. 04, Issue 06