Current and Emerging Pharmaceutical Policy Issues in NonIndustrialized Countries

1
Current and Emerging Pharmaceutical Policy Issues
in Non-Industrialized Countries

• Pharmaceutical Policy Seminar
• October 4, 2004

2
Overview

• Pharmaceuticals in health systems
• Current pharmaceutical policy issues
• Health sector reform
• Decentralization
• Globalization and trade
• ICIUM2004 Global agenda for improving medicines
  use

3
Global Pharmaceutical Market of 466 Billion in
2003
N America, Europe, Japan 88
4
Pharmaceutical Spending as of Total Health
Spending
Greece
Germany
Italy
Developed countries
France
Spain
(7 - 20)
Denmark
UK
United States
Netherlands
Norway
Bulgaria
Czech Rep.
Transitional countries
Hungary
Croatia
(15 - 30)
Poland
Estonia
Slovenia
Lithuania
Mali
Egypt
China
Indonesia
Thailand
Developing countries
Tunisia
Jordan
(24 - 66 )
Argentina
South Africa
0
10
20
30
40
50
60
70
5
Health and Pharmaceutical Expenditures by Region
(1990)
6
Current Pharmaceutical Policy Challenges and
Changes

• Challenges
• Government inefficiency, poor management,
  corruption
• Limited access to essential medicines
• Changes in health system context
• Health reform
• Decentralization
• Implementation of WTO/TRIPS
• New emphasis on access programs

7
Health Reform Increasing Shift in Services to
the Private Sector

• Character of the private market and types of
  providers vary by country
• Established insurance markets
• Emerging insurance markets
• Private purchase markets
• Government role also varies
• Degree of engagement as policymaker
• Market power as purchaser
• Setter and enforcer of standards

8
Private Pharmaceutical Sector in Developing
Countries
Government (MOH)
Professional Organizations
lobbying
support,
lobbying
Drug Industry
taxes
payments
marketing
promotion
payments
Consumers
Providers
treatment
9
Decentralization Rhetoric and Reality

• Intended benefits
• Decisions are more locally appropriate
• Services are more efficient
• Greater financial accountability
• Inherent problems
• Lack of political commitment to health
• Technical capacity at district level
• Decentralization of corruption?

10
Influence of Pharmaceutical Companies

• Intense marketing pressure
• Sponsorship of educational programs
• Promotional material and product samples
• Detailing visits
• Indirect-to-consumer advertising
• Weak regulatory control
• Content of ads and product inserts
• Ethical practices

11
Open Markets WTO and TRIPS

• World Trade Organization (WTO)
• Begun in 1995, now 147 Members (April 2004)
• Rules of trade between nations
• Trade-Related Aspects of Intellectual Property
  Rights (TRIPS)
• Before TRIPS Diversity in patent laws
• Patents for products, processes, or both
• Patent term varied from none to gt 20 years
• After TRIPS Uniformity in patent laws
• Minimum 20 years
• Both product and process patents required

12
Implications of WTO and TRIPS

• Expansion of private sector markets
• Flood of foreign products
• Potential decreased access to essential drugs
• Reduced generic competition
• Increased prices
• Less government financing
• Pressures for inappropriate use
• Increased marketing and promotion
• Lack of relevant product information
• Inappropriate incentives

13
ICIUM 2004
14
ICIUM 2004 Global Agenda for Policy and Research
in Use of Medicines
15
Background and Context

• International Conference on Improving Use of
  Medicines, Chiang Mai, 1997
• 272 participants from 46 countries
• Milestone in defining global agenda
• Joint Research Initiative on Improving Use of
  Medicines (JRIIUM), 1997-2004
• Research in ICIUM 1997 priority areas
• Build capacity for intervention research
• Global context
• Health reform, privatization, decentralization
• Access initiatives, financing innovations

16
Objectives of ICIUM 2004

• Review past and current initiatives to improve
  use of medicines
• Evidence-based consensus on which interventions
  are successful
• Prioritized global agenda
• Short-term policy implementation
• Long-term policy development
• Key research gaps
• Dissemination and implementation

17
ICIUM 2004 Accomplishments

• 472 policymakers and researchers from 70
  countries
• 322 abstracts posters, 290 oral presentations
• Recommendations for implementation and research
  in over 20 topic areas including access to
  essential medicines, AMR, adult health, child
  health, malaria, TB, HIV
• All materials available at www.icium.org

18
Top 10 ICIUM Recommendations

• Involve all stakeholders in developing,
  implementing, and monitoring National Medicines
  Policy and National AMR Policy
• Expand health insurance and medicines coverage to
  vulnerable populations
• Implement tailored interventions and systems
  changes to improve public private sector
  prescribing
• Establish policies and incentives to promote use
  of generic medicines, and develop systems to
  guarantee product quality
• Implement short-course therapy for pediatric
  pneumonia and evaluate for other infections

19
Top 10 ICIUM Recommendations

• Monitor essential medicines prices and price
  components
• Support consumers with unbiased information about
  medicines medicines prices
• Enforce regulations concerning drug promotion and
  consumer advertising
• Improve quality of service in private pharmacies
  using standards of care, regulation, enforcement,
  training
• Implement systems to assure adherence as an
  integral part of expanded access programs (ARV,
  TB, malaria)