On 1 March 2017, India delivered the following statement during WTO TRIPS Council discussions on the United Nations Secretary-General’s High Level Panel Report on Access to Medicines.
Agenda item 12: the United Nations Secretary-General’s High Level Panel Report on Access to Medicines
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 United Nations Secretary-General’s High-Level Panel on Access to Medicines released its Final Report on 14 September 2016.
The HLP report referred to Sustainable Development Goal 3: “ Ensure healthy lives and promote well-being for all at all ages” and reiterated that the State obligations include duties not only to respect, but to protect and fulfil the right to health.
The HLP report highlighted that neglected tropical diseases (NTDs) continue to receive inadequate funding for R & D and access to health technologies, despite more than a billion people living with one or more NTD. The HLP report also recognized that the costs of health technologies are rising globally and are being felt by individuals and by public and private insurance schemes in both wealthy and resource-constrained countries alike. In this context, it is pertinent to mention that recently, President of a developed Member stated that pharmaceutical companies are “getting away with murder” in what they charge the government for medicines. To address this issue, the Panel report recommended that Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to : (1) the costs of R &D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and (2) any public funding received in the development of the health technology, including tax credits, subsidies and grants.
On Innovation, the HLP report stated that IPRs are “ one policy tool among many for encouraging innovation and technological research and development”. The Panel report emphasized that limiting access to academic discoveries can obstruct follow-on innovation and force taxpayers to pay twice for the benefits of publicity-funded research. The Panel report advocated for strong, enforceable policies on data sharing and data access should be a condition for public grants. The Panel report also underscored that public funding agencies should strongly encourage patenting and licensing practices that benefit public health, including use of non-exclusive licences, the donation of intellectual property rights, participation in public sector patent pools and other mechanisms that maximise innovation while promoting access. The panel report recommended that open access models of innovation can also lower entry hurdles and accelerate the pace of development of health technologies, including those needed to combat emerging infectious diseases.
Mr. Chairman, in furtherance of the objectives and Principles of TRIPS enshrined in Articles 7 & 8, a number of flexibilities have become an integral part of the TRIPS framework. 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, the HLP report recommended that WTO Members must make full use of the flexibilities in the TRIPS Agreement as confirmed by the Doha Declaration to promote access to health technologies when necessary. Some key recommendations of the Panel report, especially on TRIPS flexibilities and TRIPS-plus provisions, are the following:
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.
b) 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.
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.
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.
At the side-event held today during the lunch-break, we have also heard from the co-chair Ms.Ruth Dreifuss, former President of Switzerland and other experts regarding proper implementation of the recommendations of the HLP report 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.
Mr, Chairman, at the last TRIPS Council meeting many Members stated that the HLP report was still under consideration in their Capitals. I would like to urge those Members to provide their comments on the HLP report. At the subsequent sessions of the TRIPS Council, India would like to co-sponsor with like-minded Members sub-agenda items under the main agenda item “the United Nations Secretary-General’s High Level Panel Report on Access to Medicines”. Some sub-agenda items on which Members could share their experiences include specific recommendations of the HLP report like Patentability Criteria, Compulsory Licenses, TRIPS-plus provisions in RTAs, etc.,
Thank you Chair.