1. Trade-related policies and access to medicines
ICTSD Consultation on trade policy coherence and access to medicines
Geneva
November 7th 2006,

2. Road map
The context
ICTSD’s Project on trade-related policy coherence and access to medicines
Objectives of the project
General methodology
Relevant policies and parameters
Outputs and outcomes

3. The context MDGs: “To Combat HIV/AIDS, Malaria and other diseases”
WTO: the TRIPS and Public Health Declaration
The Amendment process to Art. 31 f) of the TRIPS Agreement
Proposals in the WTO Negotiating Group on Market Access (industrial goods) and various requests in the special sessions of the Services Council
The CIPIH Report

4. The context WHO Assemblies Resolutions 2006
“to consider the interplay between international trade and health; to take advantage of the potential opportunities and address the potential challenges that trade and trade agreements may have for health”
to apply or establish, where necessary, coordination mechanisms involving ministries of finance, health and trade, and other relevant institutions, to address public health related aspects of international trade”
and (…) to continue collaborating with the competent international organizations in order to support policy coherence between trade and health sectors”

5. The context What is trade related policy coherence?
“Trade policy coherence involves the systemic promotion of mutually reinforcing policy actions across government agencies creating synergies toward achieving agreed objectives” (OECD)
What is access to medicines?
“Drugs and medicines that satisfy the health needs of the majority of a country’s population and ought to be available at all times, in adequate dosage, and at prices that all individuals can afford” (WHO)
The need for a two fold perspective in trade policy coherence:
the transformation and adequate implementation of international trade obligations into national law and policy bearing in mind national development goals (i.e. health welfare);
the adequate design of domestic policies given the policy space available in WTO Agreements and FTAs.

6. ICTSD’s project on trade related policy coherence and access to medicines
Objective of the Project:
“enhancing trade related policy coherence in order to facilitate the
creation of an enabling framework for sustainable access to essential
medicines in developing countries”
More specifically the project seeks to:
Provide a better understanding of the interface between different trade-related policies impacting access to essential medicines in selected developing countries
Identify mechanisms and policy options for improving trade-related policy coherence in promoting access to medicines in selected developing countries

7. Trade-related policy coherence and access to medicines
General methodology:
The specific objectives of the project will be achieved through applied policy, legal and economic research and informal multi-stakeholder dialogues at the national level
The project will focus on 3-4 developing countries in Latin America, Asia and Africa
Pre-selected countries could include: Ghana, Jordan, Peru and South Africa
Engagement by national governments and relevant stakeholders is needed for the success of the project

8. Trade-related policy coherence and access to medicines
Some trade related policies to be analyzed:
Market access in goods:
Applied tariffs on bulk active ingredients, finished pharmaceutical products and medical devices
Existence of exemptions, waivers or reductions in special cases
Non tariff barriers
Domestic taxes and price regulations:
VAT, other domestic taxes
Price controls schemes
FDI regimes:
Enabling environment
Investment definition and standards of protection
Use of performance requirements
Competition law and policy

9. Trade related policy coherence and access to medicines
Some trade related policies to be analyzed:
Market access and regulation in health related services:
Medical and dental services
Midwife and nursing services
Hospital services
Other human health services
Health insurance
Data transfer
Intellectual property regulation:
Parallel imports
Compulsory licenses
Test data exclusivity
The linkage between marketing approval and patent protection
Second uses
Exceptions and limitations
Government procurement regulation:
Preferences (price, quality, reliability, local manufactures/providers)
Transparency

10. Trade-related policy coherence and access to medicines
Other parameters to be taken into the consideration within the general framework but not subject to policy analysis include:
Geographical and environmental related factors
Political and macroeconomic stability
The rule of law
Population and cultural / anthropological factors
Purchasing capacity
Overall disease burden
Availability of health infrastructure
Availability of human resources in the health sector
Supply capacity in the drug sector
Level of (health related) technological development
Existence of health service delivery systems

11. Trade-related policy coherence and access to medicines
Outputs:
Prepare a methodological note and expert consultations:
Identify trade-related policies that have an impact on access to medicines
Explore ways to measure impact in an empirical manner
Undertake national case studies:
Map national trade-related policies at the national level
Identify areas where synergies or lack of coherence
Evaluate impact to the extent possible
Organize national dialogues:
Expose national stakeholders to the findings of the studies
Generate policy recommendations based on the dialogue
Prepare synthesis report:
Comparative analysis of national experiences
Compilation of findings and policy recommendations arising from the dialogues

12. ICTSD’s project on trade-related policy coherence and access to medicines
Outcomes:
Clearer understanding of national trade-related policies and their impact on access to medicines by relevant stakeholders
Identify of mechanisms and policy options for improving trade-related policy coherence in promoting access to medicines
Ultimately, if stakeholders decide to take action based on the recommendations made, there could be domestic policy reform and adjustment for the creation of an enabling trade-related framework for attaining sustainable access to essential medicines
Other international organizations that could also assist in the process of reform and adjustment process include the WHO, UNCTAD, WTO, WB and various civil society organizations