Affordable, Appropriate Access to
High Cost Medicines:
Key Issues
James Fitzgerald
Senior Advisor, Medicines and Health Technologies
PAHO/WHO Washington
Panamerican
Health
Organization
1
Context in the Americas
•
•
•
•
•
•
218 million lack social security in
health
LAC expenditures (2008) estimated
at US$ 73 bn, equivalent to 23% of
National Health Expenditure in
goods and services
Out of Pocket Expenditure (OOP)
of 78% (7.5 USD – 150USD)
Fragmentation and segmentation
leading to persistent inequities
92% of countries have updated
EMLs: however the number of
medicines considered ‘essential’
varies from 346 to over 650
Patent expirations in the US in
2011/2012 offset by introduction
of newest biotechnologies (Brazil
4%, China 24%)
Panamerican
Health
Organization
2
Pharmaceutical expenditure lower middle income countries AMRO
(Evolution on Q1 08)
1.20
1.17
1.15
1.12
1.10
1.05
1.05
1.00
1.00
0.98
0.95
0.96
0.90
0.90
0.88
0.86
0.85
0.80
0.75
0.78
Q1 07
Q2 07
Q3 07
C. AMERICA * (Mul tpl Cty)
Panamerican
Health
Organization
Q4 07
Q1 08
COLOMBIA*
Q2 08
ECUADOR*
Q3 08
Q4 08
PERU*
Q1 09
Q2 09
AMRO AVERAGE
3
Judicial interventions to ensure
Access to Medicines: the case of
Minas Gerais, Brazil, (2005 – 2006)
• Study (Machado et al. 2011 ) examining 827 legal actions involving
1,777 medicines during 2005 and 2006.
• Origin: 70% from the private sector, and 60 % from individuals (as
opposed to class actions).
• Results:
– Appx. 5% of the solicited medicines not approved by the ARN, Anvisa.
– 79% of the medicines requested had a defined therapeutic alternative
within the national health programs (Assitencia Farmaceutica).
• Conclusions: Whereas judicial actions can guarantee the right to
health, they also:
– Can produce distortions in the practice of the rational use of medicines
– Represent a threat to the National Health System (SUS), the
consolidation of the National Pharmaceutical Policy.
Panamerican
Health
Organization
4
Characteristics of High Cost
Medicines
• No universal definition
• Conceptual elements of the approach are similar:
– High priced essential medicines, limited or single
source (exclusivity)
– Specialized medicines for specific or rare diseases,
associated with costly and complex health
interventions
– Long term chronic disease care and management
• Representing an ever increasing (absolute and
relative) portion of pharmaceutical expenditure
Panamerican
Health
Organization
5
A question of Innovation?
• Market driven R&D is not responding to needs in innovation for
health technologies.
• The degree of value-added…..? The evidence base….?
• Public health perspective calls for clear therapeutic benefits
and/or lower cost:
– Comparable to existing treatments
– Based on needs of the society
• The need for the development of integrated national strategies
with the following Actions:
Panamerican
Health
Organization
6
1. Innovation in
Pharmaceutical/HT Policy
Health Policy
Pharmaceutical
/HT
Policy
Science &
Technology Policy
Panamerican
Health
Organization
•Defining innovation strategies
based on public health needs
•Promotion of mechanisms for
R&D and knowledge transfer
•Increase capacity in the production
chain
•Ensuring inter-ministerial
coordination
•Public Health management of IP
Industrial
Policy
7
2. Evaluation and Incorporation
of Health Technologies
• Health Technology Assessment (HTA): Using evidence for
the decision making process / incorporation within the
health system
• Important trends in the Americas:
–
–
–
–
Argentina: creation of a Coordination Unit (UCEETS), sectoral funds.
Colombia: new HTA institute to be created
Uruguay: mandatory EE for medicines to be covered by FNR
Brazil: Price Regulation based on HTA; new Federal Law to regulate
health technology incorporation to the Public Health System
– Subregional networks in Andean and Mercosur Regions
• Policy discussion with Resolution requested by Member
States, PAHO Governing Bodies 2012.
Panamerican
Health
Organization
8
2. HTA Network of the Americas
(RedETSA)
• Launched June 2011, 20 institutions from 13 countries
(Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa
Rica, Cuba, Ecuador, Mexico, Paraguay, Peru, Uruguay), with
PAHO technical support:
• Work Plan:
– HTA Community of Practice; regional dialogue on national and
global experiences.
– regional diagnostic on HTA and decision-making processes;
– joint studies; capacity building; Network meetings; publications
• Cooperation agreements with MOH Brazil/Anvisa (2010),
Canadian Medicines and Health Technologies Agency (CADTH
2011).
Panamerican
Health
Organization
9
3. Linkages with Procurement and
Financing
• Pricing transparency through publicly available pricing data
systems (generic and single/limited source)
• Relationship between HTA and:
– processes for price regulation (price referencing, value-added)
– medicines financing (selective financing, adjusting co-payment
modalities).
• Centralized negotiations for High Cost Medicines with
consolidated public sector procurement
• Evaluate options through international mechanisms (PAHO
Revolving Fund for Vaccines, PAHO Strategic Fund).
Panamerican
Health
Organization
10
4. Promote and Regulate
Rational Use
• Strict application of
treatment protocols and
guidelines for high cost
medicines
• Promote incentives for
rational prescribing:
eliminate perverse
incentives
• Training of prescribers
and pharmacists
supported with
independent and reliable
information
• Role of ARN in Rational
Use
Panamerican
Health
Organization
11
Contact:
James Fitzgerald
fitzgerj@paho.org
Panamerican Health Organization
www.paho.org
525 23rd St NW Washington DC
20037 USA
Panamerican
Health
Organization
12