On Wednesday, 9 November 2016, India delivered the following statement at the World Trade Organization’s (WTO) TRIPS Council’s discussions of the United Nations Secretary-General’s High Level Panel Report on Access to Medicines.
Agenda item 13: the United Nations Secretary-General’s High Level Panel Report on Access to Medicines
Statement by India
“Thank you Chairman.
At the outset, I would like to thank delegations of Brazil, China and South Africa who are also co-sponsors of this agenda item.
Mr. Chairman, in November of 2015, the United Nations Secretary-General, Mr. Ban Ki-moon, convened a High-Level Panel (HLP) on Access to Medicines with an objective “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” The High-Level Panel was co-chaired by Ms.Ruth Dreifuss, former President of Switzerland and Mr.Festus Gontebanye Mogae, former President of Botswana. The High-Level Panel was comprised of 15 eminent individuals with an understanding of a broad range of legal, commercial, trade, public health and human rights issues central to promoting innovation and access to technologies. Their work was supported by a 25-member Expert Advisory Group constituted from academia, the private sector, civil society and relevant United Nations and international organizations, such as the World Trade Organization (WTO).
The HLP deliberations were informed by and benefitted from a broad consultative process, which included a generous response to a public call for contributions that netted 182 submissions, many of which were of high quality. Hearings and Global Dialogues were held in London and Johannesburg in March 2016 to examine the proposals and incorporate the views and inputs from concerned parties and affected communities. On 14 September 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its Final Report. The HLP, inter alia, made recommendations on Intellectual Property laws and access to health technologies, especially on (i) TRIPS flexibilities and TRIPS-plus provisions and (ii) Publicly-funded research.
Mr. Chairman, before going into the specific recommendations of the HLP, I’ll brief state about the flexibilities in the TRIPS Agreement. The TRIPS Agreement established minimum standards of protection that each government has to give to the Intellectual Property of fellow WTO members. The TRIPS Agreement tried to strike an appropriate balance between the interests of rights holders and users. Article 7 of the TRIPS Agreement entitled “Objectives” recognizes that the protection of intellectual property should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of users and producers of technological knowledge and in a manner conducive to social and economic welfare and to a balance of rights and obligations. The search for a balance between the need to protect IPRs to provide incentives for R&D on the one hand and, on the other hand, to address concerns about the potential impact of such protection on the health sector – in particular its effect on prices – has been an important consideration in the WTO’s work.
The TRIPS Agreement also recognizes that the principles of IP protection are based on underlying public policy objectives. Article 8 of TRIPS Agreement entitled “Principles” states that WTO Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement. Article 8 (2) further states that appropriate measures may be needed to prevent the abuse of IPRs by right holders, or to resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.
Mr. Chairman, in furtherance of the objectives and Principles of TRIPS enshrined in Articles 7 & 8, a number of safeguards or flexibilities have become an integral part of the TRIPS framework. These flexibilities can be used to pursue public health objectives. However, to implement these flexibilities, action is needed at the domestic level by incorporating them into national IP regime keeping in mind each country’s individual needs and policy objectives. Key TRIPS flexibilities include transition periods for LDCs (extended by the WTO last year until 01 January 2033), differing IP exhaustion regimes (international exhaustion allows parallel importation of patented products from other countries where they are the cheapest), refining the criteria for grant of a patent ( patentability criteria), pre-grant and post-grant opposition procedures, as well as exceptions and limitations to patent rights once granted, including regulatory review exception (“Bolar” exception) to facilitate market entry of generics, compulsory licences, including through para 6 mechanism and government use. For pharmaceutical patents, these flexibilities have been clarified and enhanced by the 2001 Doha Declaration on TRIPS and Public Health that WTO members have the flexibility to interpret and implement the TRIPS provisions in a manner supportive of their right to protect public health.
Mr. Chairman, although the TRIPS Agreement provides substantial degree of flexibility to WTO members, the full utilization of these flexibilities is in the hands of relevant member States. However, many developing countries are constrained by limited technical capacity to make full utilization of the TRIPS flexibilities and therefore they need appropriate technical assistance from relevant multilateral organizations in order to fully utilize the TRIPS flexibilities from the perspective of specific sectors of their economies such as agriculture, manufacturing, public health, environment, etc. Moreover, even where some developing countries have used the flexibilities available to them under the TRIPS Agreement to address public interest objectives through measures which are fully consistent with the TRIPS Agreement, these attempts have been challenged legally as well as politically. A slew of regional trade agreements containing TRIPS plus standards of IP protection and enforcement have the potential to significantly undermine the effective and full use of the TRIPS flexibilities. Investor- State disputes under regional or bilateral investment protection agreements are also emerging as a major challenge to the use of TRIPS flexibilities in the public interest.
Against this background, the recommendations of the HLP, especially on (i) TRIPS flexibilities and TRIPS-plus provisions and (ii) Publicly-funded research are very important with regard to access to health technologies.
4.2. TRIPS flexibilities and TRIPS-plus provisions
World Trade Organization (WTO) Members should commit themselves, at the highest political levels, to respect the letter and spirit of the Doha Declaration on TRIPS and Public Health, refraining from any action that will limit their implementation and use in order to promote access to health technologies. More specifically:
(a) WTO Members should make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that curtail the evergreening to ensure that patents are awarded when genuine innovation has occurred.
(i) The United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme (UNDP), the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) should cooperate with one another and with other relevant bodies with the requisite expertise to support governments to apply public health-sensitive patentability criteria.
(ii) These multilateral organizations should strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive standards of patentability taking into account public health needs.
(b) Governments should adopt and implement legislation that facilitates the issuance of compulsory licenses. Such legislation must be designed to effectuate quick, fair, predictable and implementable compulsory licenses for legitimate public health needs, and particularly with regards to essential medicines. The use of compulsory licensing must be based on the provisions found in the Doha Declaration and the grounds for the issuance of compulsory licenses left to the discretion of governments.
(c) WTO Members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform.
(d) Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities. Instances of undue political and commercial pressure should be formally reported to the WTO Secretariat during the Trade Policy Reviews of Members. WTO Members must register complaints against undue political and economic pressure, and take punitive measures against offending Members.
(e) Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfill the right to health. As a first step, they must undertake public health impact assessments. These impact assessments should verify that the increased trade and economic benefits are not endangering or impeding the human rights and public health obligations of the nation and its people before entering into commitments. Such assessments should inform negotiations, be conducted transparently and made publicly available.
4.3. Publicly-funded research
(a) Public funders of research must require that knowledge generated from such research be made freely and widely available through publication in peer-reviewed literature and seek broad, online public access to such research.
(b) Universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices. Such practices may include publication, non-exclusive licensing, donations of intellectual property and participation in public sector patent pools, among others. Sufficient incentives must be in place in these practices to make it attractive for developers to underwrite the cost of bringing a product to market at affordable prices that ensure broad availability.
(c) Universities and research institutions that receive public funding should adopt policies and approaches that catalyse innovation and create flexible models of collaboration that advance biomedical research and generate knowledge for the benefit of the public.”
To conclude Mr, Chairman, we encourage Members to share their views on the recommendations of the HLP at this session of the TRIPS Council. Further, at the subsequent sessions of the TRIPS Council, we encourage Members to share their experiences in using the TRIPS flexibilities to address public policy priorities, in particular, related to public health.