European perspectives on global health: a policy glossary

28.11.2014 Views
2. Europe must include global health in all fields of policy Trade policy and health Trade policies are plans and actions affecting international commercial exchange of goods or services, and in particular the regulation of exchanges and multilateral agreements governing the application of tariffs or non-tariff barriers to trade. Europe needs a coherent strategy on trade and health in relation to trade within the EU and with other countries. The World Trade Organization ( WTO ) is the principal international institution for the management of international trade. It was created at the Uruguay round of trade talks in 1994 when it was agreed to transform the General Agreement on Tariffs and Trade ( GATT ) into a permanent institution. WTO is an intergovernmental institution of 149 member states, with responsibilities for providing a forum for trade negotiations, handling trade disputes and monitoring national trade policies. The leading normative organisation on trade regulation is WTO and the key agreements affecting health are : • Trade-Related Aspects of Intellectual Property Rights ( TRIPS ) • General Agreement on Trade in Services ( GATS ) • Technical Barriers to Trade Agreement ( TBT ) • Agreements on Sanitary and Phytosanitary Standards ( SPS ) • Trade in agricultural products is also covered by WTO agreements. Since the inception of GATT more than 50 years ago, Article XX guarantees a member’s right to take measures to restrict imports and exports of products when those measures are necessary to protect the health of humans, animals and plants. Similarly, Article XIV of the GATS authorises members to take measures to restrict services and service suppliers for the protection of human, animal or plant life or health under relevant conditions. These health exceptions indicate the importance that WTO Members assign to national autonomy in the protection of health. This has been clearly established in WTO jurisprudence and reiterated in the TBT and SPS agreements. To make use of the health exceptions, WTO agreements generally require the health measures be no more traderestrictive than necessary. Determining whether a measure is “necessary” involves a process of weighing and balancing a series of factors which include the importance of the interests protected by the measure, its efficacy in pursuing the policies, and its impact on imports or exports. Trade liberalisation can affect health in various ways. The impact may be direct, as when a disease crosses a border together with a traded good or when a disease outbreak causes disruptions in trade and traffic. The impact may equally be indirect, for example, reducing trade tariffs may lead to lower prices for medical equipment and health-related products, such as drugs and blood products ; or changing international rules concerning patent protection affects access to essential medicines, diagnostic devices and transfer of technology, potentially affecting national health systems. Conversely, national and international health standards and rules can have important implications for trade, such as the Codex Alimentarius standards, the International Health Regulations, or the Framework Convention on Tobacco Control. The TRIPS Agreement affects public health to the extent that it may limit access to affordable medicines in some countries. The areas of intellectual property covered by the TRIPS Agreement relevant to health include : patents, trademarks, copyrights, and undisclosed information, including trade secrets and test data. In respect of each of these areas, the Agreement defines the minimum standards of protection that must be adopted by each member. Yet, while it introduced a multilateral framework for intellectual property rights, and obliges WTO members to adhere to minimum standards of intellectual property protection and enforcement, it does not prescribe a universal or harmonised intellectual property regime. In each area of intellectual property rights, it allows governments to provide for exceptions, exclusions and limitations to these rights, for example in relation to patent rights whereby the TRIPS Agreement permits 28 ong>Europeanong> Foundation Centre – ong>Europeanong> Partnership for Global Health

2. Europe must include global health in all fields of policy compulsory licensing, parallel imports and other exceptions to exclusive patent rights. In this manner, the provisions in the TRIPS Agreement may be used to strike an appropriate balance between creating incentives for innovations, and the need for access to technology and information. Although it was generally acknowledged that the TRIPS Agreement contained sufficient flexibility to permit implementation consistent with public health , developing countries faced difficulties in their attempts to implement safeguards such as parallel imports and compulsory licensing in their domestic legislation. The legal challenge by the pharmaceutical industry of a provision that enabled parallel imports in South Africa’s Medicines and Related Substances Amendment Act ( Act No. 90 of 1997 ) and the USinitiated complaint against Brazil in the WTO dispute settlement system over a provision in the Brazilian domestic legislation on compulsory licensing, were two of the better-known cases that prompted developing countries to demand a clarification in the WTO. The interpretation and scope of the flexibilities in the Agreement and the use of these flexibilities to improve access to essential medicines were the main source of debate, which culminated in the adoption of the Doha Declaration on the TRIPS Agreement and Public Health. This declaration clarified that countries were within their rights to make use of measures, such as compulsory licensing and parallel imports, for public health purposes and to ensure access to medicines. Compulsory licensing, for instance, would allow countries to enable generic production of new products, and thus create the necessary pressures for price competition. Equally important, WTO Members, in singling out pharmaceutical products for special treatment, have also recognised that health products need to be treated differently in certain circumstances. The Doha Declaration thus represents an agreement between WTO Members that public health considerations should condition the extent to which patent protection is implemented. The EU and its Member States played an active role in Doha discussions concerning access to medicines. The proposal which it put forward would have taken a broader view of health needs providing access to a range of drugs and not just those defined as meeting the needs of specific medical emergency conditions. The declaration represented a compromise reached with the US which had demanded more stringent controls on intellectual property rights. However, the Doha Declaration had left one issue unresolved. In Paragraph 6, the Doha Declaration had recognised that developing countries without manufacturing capacity would face difficulties in making effective use of compulsory licensing. Since the TRIPS provision restricts exports of products manufactured under compulsory licence, countries without manufacturing capacity dependent on foreign generic producers would have a problem sourcing adequate supplies of generic medicines produced under compulsory licence. To resolve this problem, the WTO General Council Decision on the Implementation of Paragraph 6 of the Doha Declaration on TRIPS and Public Health established a system to permit the production and export of generic versions of patented medicines by waiving the restriction on exports under compulsory licence. The system permits countries wishing to import generic medicines, to do so from a foreign producer under certain conditions of eligibility and notification of the TRIPS Council. Members recently agreed to convert the WTO Decision on Paragraph 6 into an amendment of the TRIPS Agreement. The TRIPS Agreement, the Doha Declaration and the WTO Decision on Paragraph 6 ( and subsequently, the amendment of the TRIPS Agreement when it comes into effect ), now collectively comprise the international legal framework governing the rights of countries to take measures to protect public health. Since intellectual property rights are territorial and governed by domestic laws, it will be necessary for specific provisions, where none exists, to be effectively enacted in domestic law to enable their use within each country. For this reason, it is important for countries to implement the TRIPS flexibilities appropriately within their domestic legislation. The GATS may be applied to the international trade in health services, including health insurance and health care provision. The definition of trade in services in the Agreement hinges on four types of transactions or “modes of supply”, namely : the cross-border supply of services ( e.g., telemedicine, Global Health Policy Glossary 29

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Page 70: About the Editors Ilona Kickbusch s

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