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

2. Road map The context The context ICTSD’s Project on trade-related policy coherence and access to medicines 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” MDGs: “To Combat HIV/AIDS, Malaria and other diseases” WTO: the TRIPS and Public Health Declaration WTO: the TRIPS and Public Health Declaration The Amendment process to Art. 31 f) of the TRIPS Agreement 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 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 The CIPIH Report

4. The context WHO Assemblies Resolutions 2006 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? 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? 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 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: 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: 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. General methodology: 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 Trade-related policy coherence and access to medicines

8. Some trade related policies to be analyzed: Market access in goods:Market access in goods: 1.Applied tariffs on bulk active ingredients, finished pharmaceutical products and medical devices 2.Existence of exemptions, waivers or reductions in special cases 3.Non tariff barriers Domestic taxes and price regulations:Domestic taxes and price regulations: 1.VAT, other domestic taxes 2.Price controls schemes FDI regimes:FDI regimes: 1.Enabling environment 2.Investment definition and standards of protection 3.Use of performance requirements Competition law and policyCompetition law and policy Trade-related policy coherence and access to medicines

9. Some trade related policies to be analyzed: Market access and regulation in health related services:Market access and regulation in health related services: 1.Medical and dental services 2.Midwife and nursing services 3.Hospital services 4.Other human health services 5.Health insurance 6.Data transfer Intellectual property regulation:Intellectual property regulation: 1.Parallel imports 2.Compulsory licenses 3.Test data exclusivity 4.The linkage between marketing approval and patent protection 5.Second uses 6.Exceptions and limitations Government procurement regulation:Government procurement regulation: 1.Preferences (price, quality, reliability, local manufactures/providers) 2.Transparency Trade related policy coherence and access to medicines

10. Other parameters to be taken into the consideration within the general framework but not subject to policy analysis include: 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 Trade-related policy coherence and access to medicines

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

12. ICTSD’s project on trade-related policy coherence and access to medicines Outcomes: 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