THIS NEWS STORY is designed to help the public understand developments in the WTO. While every effort has been made to ensure the contents are accurate, it does not prejudice member governments’ positions.
The official record is in the meeting’s minutes.
Brazil, India, China and South Africa had requested putting on the agenda the recent report of the High-Level Panel on Access to Medicines, convened by the United Nations Secretary-General Ban Ki-moon last year. The co-sponsors introduced the report, highlighting the recommendations calling for WTO members to respect the Doha Declaration on TRIPS and Public Health and to make full use of the flexibilities allowed under the TRIPS Agreement for access to medicines. The co-sponsors’ intention in bringing the high-level panel report to the Council was for an exchange of views on the panel’s recommendations and on national experiences regarding the use of flexibilities.
Discussions among WTO members covered recommendations on rigorous definitions of invention and criteria for the granting of patents that are “sensitive” to public health. They also discussed cooperation by international organizations to support governments applying such criteria, including training for patent examiners as well as legislation that facilitates the granting of compulsory licences. The discussion covered concerns about political or commercial pressure that may undermine the right of WTO members to use TRIPS flexibilities and the existence of “TRIPS plus” provisions in bilateral and regional trade agreements and in investment treaties that may interfere with the right to health. They also discussed recommendations that publicly funded research should prioritize public health objectives and be guided by open access policies.
The United States said that although it is strongly committed to identifying practical ways to increase access to safe, effective, affordable and life-saving medicines around the world and to support policies that drive the development of new medicines, it was disappointed by the narrow perspective of the report, which raised fundamental questions regarding the legitimacy of the conclusions. This “detracts from rather than benefits” the objective of achieving universal health. It noted that intellectual property rights and trade are essential to medical innovation, which is fundamental to promoting global health. “There can be no access to drugs that have not been developed; support in innovation is essential,” said the US delegation.
The European Union said that it did not share the panel’s assumption that there was policy incoherence. A “holistic approach” was needed and has been put in place by the EU to integrate a variety of tools, such as intellectual property and financing, and to balance the need to finance research while ensuring that affordable medications reach those in need. The EU also noted that a number of the report’s recommendations were not in line with EU policy.
Switzerland, Japan and Norway signalled similar concerns about the “narrow scope” of the report. Switzerland noted that the report had not been mandated or endorsed by members of the United Nations and duplicated work on intellectual property and public health already taking place.
Egypt, Indonesia, Bangladesh and Bolivia welcomed the report and the ensuing discussion in the TRIPS Council. A few countries, including Canada, Chile, Australia, Korea and Norway, said that they needed more time to consider the wide array of recommendations in the report. Members agreed to revert to the matter at the Council’s next meeting in February 2017.
The Holy See, as an observer, took the floor to “echo the concerns” about access to medicines, stressing that health is a fundamental human right, and “millions are left behind”. Ensuring the success of the Sustainable Development Goals included bringing an end to epidemics, and it required global solidarity and initiatives, the delegation said.
The World Health Organization (WHO) referred to a number of ongoing activities that were already in place and that addressed many of the panel recommendations, noting however that the establishment of a global price database would be very difficult. The United Nations Conference on Trade and Development (UNCTAD) said that it had recommended the UN Secretary General to endorse the report. The Joint United Nations Programme on HIV/AIDS (UNAIDS) called on members to continue the discussion, noting that intellectual property and trade were not the only problems that rendered access to medicines difficult.
The Council also undertook its annual review of the functioning of the Paragraph 6 System, i.e. the mechanism that enables compulsory licences for the production and export of generic medicines for the benefit of countries with insufficient or no manufacturing capacities in the pharmaceutical sector. It also looked at the status of acceptances of the Protocol Amending the TRIPS Agreement.
The Chairperson, Ambassador Modest Jonathan Mero of Tanzania, noted that only five more instruments of acceptance are needed to trigger entry into force of the amendment which will put this additional flexibility on a par with other health-related flexibilities in the TRIPS Agreement.
WTO members in December 2005 approved changes to the TRIPS Agreement making permanent a decision on patents and public health originally adopted in 2003. This decision will formally enter into force when two-thirds of the WTO’s members have accepted the amendment. An up-to-date list and map of members that have accepted the protocol are available here.
The discussion was preceded by a side event organized by the South Centre, where speakers shared their experiences and the challenges in using the decision to allow exports of generic medicines.
During the Council discussions, some delegations cited speakers at the side event who outlined certain points of concern that needed to be reviewed. India also referred to the UN high-level panel recommendation that had called for a revision of the system, while other delegations, such as Brazil, South Africa, the EU, Australia, Switzerland and the United States, urged WTO members concerned to accept the TRIPS amendment. Some noted that the system was only one of the many avenues to secure access to affordable medicines.
A number of delegations welcomed the WTO Secretariat’s efforts to support the use of the Paragraph 6 System through its specialized capacity building activities and the Illustrative Guide to notifying under the Paragraph 6 System.
IP and regional innovation, trade secrets and e-commerce
The meeting included a discussion on regional innovation models to foster intellectual property and innovation. The EU, Australia, Switzerland, Japan, the US, Brazil, Canada and many other members shared their experiences in setting up regional innovation hubs and collaborating across borders.
The US and EU, joined by Canada, Japan, New Zealand and Chinese Taipei, introduced their national legislation to protect trade secrets. It was noted that trade secrets include formulas, processes, technological know-how, commercial data and other information. Protecting these trade secrets is essential for maintaining the competitive edge of American business, the US said. The EU introduced its recently adopted trade secret directive, noting that trade secrets are often used by small companies who do not have the resources to formally file patents.
Several members raised the Work Programme on electronic commerce, and the prospect of continuing discussions of intellectual property issues related to e-commerce and the digital economy at the next Council sessions. Some delegates expressed interest in developing concrete themes that would guide TRIPS Council discussions on e-commerce during 2017, noting the G20 initiative on the digital economy and recent submissions by Canada and others on the subject.
“Triplets” issues and non-violation complaints
Members repeated their established, divergent views as to whether patents should be available for plant and animal inventions. A number of members also reiterated their position that a proposed 2011 decision to enhance mutual supportiveness between the TRIPS Agreement and the Convention on Biological Diversity (CBD) should be the basis of further discussions. Their suggestions that the CBD Secretariat be invited to brief WTO members on developments regarding the convention and that earlier Secretariat summary notes on the review under Article 27.3(b), the relationship between TRIPS and the CBD, and on the protection of traditional knowledge and folklore (the “triplets”) be updated did not garner full support of the membership.
Opinions continue to differ on whether so-called non-violation cases should also apply to intellectual property. The United States and Switzerland argued that such complaints should be allowed under the TRIPS Agreement. Many other members reiterated their position, as outlined in a May 2015 proposal, that non-violation complaints should not apply to the TRIPS Agreement; some also referred to the proposal a number of members had made in 2015 for a ministerial decision that would exclude such disputes permanently.
The chair reported no progress in his consultations with delegations since the Council’s June meeting. “These consultations produced no new thinking or shifts in delegations’ positions, and so we have no indication so far of how we could work towards fulfilling the Ministers’ instructions in the remaining 12 months, and to prepare recommendations for the 2017 Ministerial Conference,” he told members.