AFRICA GROUP STATEMENT ON
TRIPS, ACCESS TO MEDICINES AND PUBLIC HEALTH
(Presented by the Delegation of Zimbabwe)
1.0 Two weeks ago, world attention focused on the Heroes Acre in South Africa where young Nkosi Johnson was laid to rest. In a special way, young Nkosi had become the personification of the plight of millions of people who have died and millions more waiting to die because of HIV/AIDS. Indeed, young Nkosi reminded us of the plight of millions of young children orphaned by AIDS and of many who will not celebrate their fifth birthday; of families robbed of the source of their livelihood and societies robbed of their future due to the scourge of HIV/AIDS and other life threatening diseases.
2.0 The death toll from preventable and treatable infectious diseases is unacceptably high. 11 million people, most of them in developing countries, die each year from such diseases. In the case of HIV/AIDS, a human tragedy of horrific dimensions is now at hand. In some countries in Africa, more than a quarter of the adult population has HIV. Life expectancy is projected to fall dramatically. In industrialised countries AIDS deaths have been significantly reduced partly because of the availability of life-saving medicines to many patients. Patients in developing countries also deserve access to medicines at affordable prices, to treat AIDS and other diseases.
3.0 The TRIPS Special Discussion provides a crucial opportunity to address mounting public perception that implementation of the TRIPS Agreement has hampered people's access to affordable medicines. Members must affirm that the TRIPS Agreement does not stand in the way of urgently-needed solutions to the deepening health crisis. By agreeing to this discussion in the TRIPS Council we believe Members have taken cognisance of increasing public criticism and civil society campaigns against the perceived negative effects of the TRIPS Agreement, and are ready to respond positively.
4.0 Members should reach a common understanding that asserts and confirms the balance in the TRIPs Agreement that recognises the importance of patent protection and provides that Governments may adopt all appropriate measures to protect the health and lives of their people. This is the assurance and guarantee that Governments need, to enable them to adopt such measures, without fear of litigation (either at national level or at the WTO) or that bilateral pressures will be applied on them. The Africa Group is convinced that all members, as a matter of right and at their discretion, can take advantage of the existing provisions and safeguards in the Agreement.
5.0 The purpose of the Special Discussion is to begin to identify the relevant provisions of the Agreement, and exchange views in order to forge a common understanding of the TRIPS Agreement. As this important and vital task cannot be completed in one Special Session, Members need to agree on a Work Programme to complete this work in the shortest time possible, befitting a serious response to the current crisis.
6.0 We believe that the Ministerial Conference in Qatar in November 2001, will be an opportunity to demonstrate Members' commitment and contribution to preventing further deaths and saving lives through facilitating easier access to medicines at affordable prices. Therefore, we propose that Members issue a special declaration on the TRIPS Agreement and access to medicines at the Ministerial Conference in Qatar, affirming that nothing in the TRIPS Agreement should prevent Members from taking measures to protect public health. The 4th WTO Ministerial Conference will provide an ideal opportunity for Members to affirm this common understanding.
7.0 Rather than being seen as an end in itself, intellectual property rights protection is intended as a means to benefit society as a whole. The mere existence and the protection of intellectual property rights, such as patents, does not necessarily result in the fulfilment of the objectives of the TRIPS Agreement. The experience of the past 6 years since the Agreement was established provides clear evidence of this.
8.0 In the context of public health, patent rights should be exercised coherently to the mutual advantage of patent holders and the users of patented medicines, in a manner conducive to social and economic welfare and to balance rights and obligations.
9.0 Article 7 is a key provision with respect to interpreting the Agreement, as it establishes that the protection and enforcement of intellectual property rights does not exist in a vacuum. The objective of the promotion of technological innovation and the transfer and dissemination of technology locates the protection and enforcement of IPRs in the wider interests of society. With regard to public health, protection of intellectual property rights, in particular patent protection, should encourage the development of new medicines and the international transfer of technology to promote the development of manufacturing capacities of pharmaceuticals without restraining policies on access to medicines.
10.0 Article 8 explicitly recognizes that Members may adopt measures to protect public health, among other overarching public policy objectives, such as nutrition and socio-economic and technological development.
11.0 We believe that each provision of the TRIPS Agreement should be interpreted in the light of the objectives and principles set forth in Articles 7 and 8.
12.0 Consequently, the Agreement does not prevent Members from taking measures against abuses of intellectual property rights or anti-competitive practices.
13.0 Compulsory licences are an essential tool for Governments to carry out effective public health policies. Such licences are a crucial element in the prevention of abuses of patent rights, the promotion of domestic manufacturing capacities in pharmaceuticals production, as well as in situations of national emergency or extreme urgency. The Paris Convention, which is part and parcel of the TRIPS Agreement, explicitly provides for the grant of compulsory licences as a means of countering abuses of intellectual property rights. The mere existence of a legal provision on compulsory licence may be enough to curb anti-competitive practices. Indeed, in the use of compulsory licences we look towards the rich experience of our developed country partners, which have employed compulsory licences to great effect.
14.0 In the light of Articles 7 and 8, it is our understanding that Members can grant compulsory licenses on a range of grounds, including those based on public interest, including health, or to protect the environment. We, therefore, affirm our understanding that nothing in the TRIPS Agreement limits the grounds for Governments to issue compulsory licences.
15.0 The Group affirms that legitimate grounds for the issuance of compulsory licences include: (1) where there is non-working or insufficient working of a patent; (2) for the importation of a product under patent protection; and (3) for the export of a product under patent protection. It is also affirmed that Members should undertake to recognise and give due effect to a compulsory licence issued by another Member, to a manufacturer in their territory for the production of goods intended for the market of the Member issuing the licence.
16.0 Parallel importation is also an important tool to ensure adequate access to medicines. It should be recalled that the Preamble and Part 1 sets out that an important goal of the Agreement is to reduce distortions and impediments to international trade. In this context, parallel importation of a patented medicine from a country where it is sold at a lower price will enable more patients in the importing country to gain access to vitally-needed medicines. In this regard, parallel importation must be regarded as a legitimate measure, which Members can adopt to protect public health and nutrition. Article 6 allows each Member the freedom to incorporate the principle of international exhaustion of rights - the legal basis for parallel importation. Members should therefore refrain from imposing any limitations on the right of other Members to apply the principle of international exhaustion, and thus allow them to exercise their right to parallel importation without hindrance.
17.0 While the Group favours the establishment of differential pricing arrangements provided this is done in a fair manner within a comprehensive and multilateral framework, these arrangements can only be part of a broader set of initiatives to improve access to medicines. Nevertheless, we reaffirm that such arrangements must not prejudice the rights of Members under the TRIPs Agreement.
18.0 It is crucial that Members be given the opportunity and sufficient time to acquire the necessary expertise, to incorporate the best possible elements and principles which they deem to be in their national interests when formulating national laws and policies, in order to take advantage of the inherent flexibility in the TRIPS Agreement. For many developing country Members, the implementation process requires development of capacity and expertise in what is a new field for them. This will take time. For this reason, developing country Members should be allowed a reasonable period of time to put into place legal frameworks which properly reflect their understanding of the TRIPS provisions, consistent with their national priorities and needs. Therefore, the Group urges Members to seriously consider:
¨ extending the transition period for the implementation of their TRIPS obligations by developing country Members in relation to patent protection (both product and process) regarding pharmaceutical drugs.
¨ undertaking, through a Ministerial Declaration, to adopt a moratorium in the dispute settlement mechanism to allow Members to take measures to protect public health.
¨ observing with immediate effect a moratorium on dispute settlement action against developing country Members that hinder their ability to promote access to medicines and protect public health (including compulsory license and parallel import) measures.
19.0 In addition to the above measures, improvements to the TRIPS Agreement are required to take into account recent developments and problems that have arisen in the more than six years of implementation of the TRIPS Agreement. The seriousness of these problems were not anticipated at the time the Agreement was negotiated and concluded. With the benefit of hindsight, Members are now in a position to improve on the Agreement and thus be able to contribute more effectively to dealing with the crisis of AIDS and other infectious diseases.
20.0 The issue raised in this paper are not exhaustive. According to the developments in this exercise of interpreting the TRIPS Agreement, we may wish to bring (collectively or individually) further clarifications and complements to this document. All elements and views presented in the document are without prejudice to individual positions that Members may take in further discussions in the TRIPS Council or in other WTO bodies, including dispute settlement procedures.
20 June 2001