Trade-related policies and access to medicines

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