WTO Decision on Implementation of Paragraph 6 of DOHA Declaration on TRIPS Agreement and Public Health

Meeting report

The Chairperson welcomed everyone to the meeting. She asked members to introduce themselves. She thereafter directed the Department of Trade and Industry to make its presentation.

Briefing by Department of Trade and Industry (dti)

Ms Xolelwa Mlumbi-Peter, Deputy Director General: International Trade and Economic Development (ITED) Division, dti, made the presentation. She stated that the presentation was in respect of Paragraph 6 of the Doha Declaration on the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health which provided flexibility in ensuring that South Africa was able to get access to cheaper medicine. TRIPS was an international agreement administered by the World Trade Organisation (WTO). TRIPS was the most important and comprehensive agreement dealing with intellectual property rights. The TRIPS agreement had introduced intellectual property law into the international trading system for the first time. South Africa was a member of TRIPS because of the Single Undertaking Rule in the WTO.

The key flexibility provided by the TRIPS agreement was that it addressed the impact of the TRIPS agreement on access to drugs, local manufacturing capacity and the development of new drugs.Paragraph 6 was an initiative that was driven by the Africa Group including South Africa, to ensure that developing countries had access to medicine that would deal with key challenges that were facing various communities. The group’s proposal ensured that the TRIPS agreement did not undermine the legitimate right of WTO members to formulate their own public health policies. The emphasis was on access to medicines for the prevention and treatment of diseases predominantly affecting people in developing countries.There had been an initial resistance by developed countries (United States, Japan, Switzerland, Australia and Canada) to the flexibility relating to Paragraph 6. They had stressed the importance of intellectual property protection for drugs and that intellectual property contributed to public health. However, despite the initial resistance, the Doha Declaration was adopted by consensus. There was the recognition that the high prices of medicines caused by patent protection were part of the grave problems that afflicted developing countries and this was a concern that had to be addressed.

In respect of the 2001 Declaration that was undertaken at the November 2001 Doha meeting, developing countries demanded a reassessment of TRIPS. The purpose was to address the high prices of medicines charged by developed countries’ pharmaceutical companies and to ensure that developing countries could either produce affordable generic drugs (compulsory licensing) or buy them from elsewhere (parallel imports) at reasonable prices, especially in a national health emergency situation. The Declaration recognised the gravity of public health problems, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. There was also the recognition that intellectual property protection was important for the development of new medicines and recognised concerns about its effects on prices. Therefore there was an agreement that TRIPS would not and should not prevent members from taking measures to protect public health. There was the reaffirmation that TRIPS could and should be interpreted and implemented in a manner supportive of members’ right to protect public health and, in particular, to promote access to medicines for all. The Declaration clarified that ‘public health crisis’ could represent a national emergency or other circumstances of extreme urgency and that an emergency might be either a short-term problem or a long-lasting situation. This placed the burden on a complaining member to prove that an emergency or urgency did not exist. It was implicit within the Declaration that differentiation in patent rules might be necessary to protect public health – recognition that public health-related patents might be treated differently from other patents. It made it easier for developing countries to adopt measures necessary to ensure access to health care without the fear of being dragged into a legal battle. The Declaration also provided more flexibility for Members in certain respects such as: in utilising parallel import mechanism and in the granting of compulsory licenses; to determine through their own national legislations the grounds upon which such licenses were to be granted; to decide what constitutes a national public health emergency; and to cover any public health problem – not limited to specific diseases.

The 2003 decision gave effect to the 2001 Declaration and called for the amendment of the TRIPS agreement. The 2005 decision found its basis from Paragraph 11 of the August 2003 decision which instructed TRIPS Council to initiate work on amendment by the end of 2003 with a view to its adoption within 6 months. The aim was to adopt the Protocol amending the TRIPS agreement and submit it to Members for acceptance. The Protocol would take effect upon acceptance by two thirds of membership. However, so far only 86 countries had ratified the Protocol and there was a need for 21 more countries to ratify the Protocol for it to come into force. The Protocol had initially been open for acceptance until 1st December 2007. However, the period had been extended a number of times due to the low number of instruments of acceptance deposited with the WTO secretariat. The latest deadline would expire on 31st December 2015 but would be extended at the 10thMinisterial Conference to be held in December 2015.It was therefore imperative for South Africa to ratify the Protocol.

The ratification of the Protocol by South Africa was also aligned with the Constitution. Section 27 (1) provided that everyone had the right to have access to health care services, including reproductive health care. Section 27 (2) provided that the State must take reasonable legislative and other measures, within its available resources to achieve the progressive realisation of each of these rights. Section 27 therefore placed a positive obligation on the State to accept the 2005 Protocol. The acceptance by South Africa would contribute to the current number of acceptances in order to reach the two thirds majority threshold for the Protocol to come into force (Article X (iii)).

The WTO agreement also fell under section 231 (2) of the Constitution which provided that an international agreement would bind the Republic only after it had been approved by resolution in both the National Assembly and the National Council of Provinces, unless it was an agreement referred to in subsection (3). Any amendment to an agreement referred to in section 231 (2) would also have to follow the same process. Legal opinions from the Department of International Relations and Cooperation (DIRCO) and the Department of Justice (DOJ) had confirmed this position. The instrument of acceptance was to be deposited with the WTO to confirm the acceptance of the amendment. Government would be able to fully implement flexibilities provided by such amendments. Full and effective implementation of flexibilities would enable government to provide access to cheaper and better health care. Work on the intellectual policy review was already underway to come up with proposals on how to effectively take advantage and implement these flexibilities.

The presentation ended.

At this stage, striking workers of Parliament barged into the Committee room and disrupted the proceedings. They chanted battle songs into the microphones and demanded that everyone should vacate the room. Members became irritated and angrily left the room.

 The meeting ended abruptly.