UN panel backs moves by developing countries to protect access to medicines

A high-level UN panel has put its weight behind developing and poorest countries and their right to ensure access of their populations to affordable and accessible medicines and health technologies by fully using the flexibilities in the World Trade Organisation (WTO)'s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

D Ravi Kanth

THE United Nations High-Level Panel on Access to Medicines (UNHLP) has asked developing and poorest countries not to succumb to political and economic pressure from major industrialised countries and their powerful pharmaceutical companies to refrain from implementing the flexibilities provided in the TRIPS Agreement, particularly the use of compulsory licensing provisions and the freedom to determine patentability criteria based on 'genuine innovation'.

In a path-breaking report submitted recently to the UN Secretary-General Ban Ki-moon, the Panel reminded the developing and poorest countries that they must strive to introduce and implement 'public health-sensitive intellectual property rules and mechanisms' so as to strike a credible balance in 'the misalignment between profit-driven innovation models and public health priorities'.

The Panel repeatedly emphasised existing TRIPS flexibilities, which include 'the freedom to determine patentability criteria' and further define concepts such as 'novelty', 'inventive step' and 'industrial capacity' to ensure that patents are only awarded for 'genuine innovation'.

In addition, the ability to determine the terms for issuing compulsory licences, according to the Panel, 'allows governments to fulfil their human rights obligations by securing the availability and affordability of health technologies'.

Undue pressure

The Panel expressed concern that undue 'political and economic pressure placed on governments [in the developing and the poorest countries] to forego the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement, as reaffirmed by the Doha Declaration [on the TRIPS Agreement and Public Health]'.

The Panel said that pressure by the major industrialised countries on developing and poorest countries to forego TRIPS flexibilities 'undermines the efforts of states to meet their human rights and public health obligations'.

The unprecedented pressure exerted on countries like South Africa, Thailand, India and Brazil not to invoke compulsory licence provisions in the TRIPS Agreement is well documented.

There are several studies and reports that the United States on behalf of its powerful pharmaceutical giants such as Pfizer, Merck and Bristol-Myers Squibb; Switzerland on behalf of Novartis and Roche among others; and the United Kingdom on behalf of GlaxoSmithKline among others, have exerted such pressures.

The world's leading pharmaceutical giants treat the use of compulsory licences to address grave public health challenges as a weapon of mass destruction, according to analysts familiar with the arm-twisting and coercive tactics deployed by governments of major industrialised countries.

Against this backdrop, the Panel exposed the lie that pharmaceutical research and development (R&D) is mostly funded by private companies. The Panel suggests that much of the funding for R&D is provided by public sources. 'Public funding agencies should strongly encourage patenting and licensing practices that benefit public health, including the 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 recommended.

Over the course of the UNHLP's proceedings that began last year, powerful US industry and business lobbies had launched a campaign to undermine its work. In a letter addressed to Senator Orrin Hatch, the chair of the US Senate Committee on Finance, in February, six leading American industry and business lobbies demanded an 'effective inter-agency approach' - such as was adopted by the US delegation in the Paris UN climate talks last December - to other UN initiatives, particularly the UNHLP.

The six American lobbies that mounted pressure on the US Congress were the Biotechnology Innovation Organisation (BIO), National Association of Manufacturers (NAM), National Foreign Trade Council (NFTC), Pharmaceutical Research and Manufacturers of America (PhRMA), US Chamber of Commerce, and US Council for International Business (USCIB).

They cited the 'effective inter-agency approach' under the leadership of the US State Department to 'secure a final UNFCCC [UN Framework Convention on Climate Change] text [in Paris] that does not mention IP [intellectual property] and thus removes uncertainty that could have discouraged continued investments by US companies in clean technology'.

The pharma and business lobbies mounted pressure on the US Senate, maintaining that IP protection is facing many challenges, particularly from the UNHLP.

Challenging mandate

The UNHLP was established by the UN Secretary-General to 'remedy the policy incoherence between justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies'. Faced with an ever-expanding disease burden because of new pathogens and epidemics all over the world, particularly in developing and poorest countries, the UNHLP embarked on a challenging project to help remove the distortions caused by monopoly patent provisions and burdensome IP rules.

The Panel is co-chaired by former Swiss President Ruth Dreifuss and former President of Botswana Festus Gontebanye Mogae. Dreifuss is respected all over the world for her sustained campaign against pharmaceutical giant Novartis, which refused to accept India's compulsory licence for the Glivec cancer drug issued on public health grounds. Mogae provided leadership in tackling the HIV problem by ensuring antiretroviral treatment to the citizens of Botswana.

Other members of the Panel include Andrew Witty, former chief executive officer of GlaxoSmithKline; Sakiko Fukuda-Parr, a development economist; Awn Al-Khasawneh, former prime minister of Jordan; Celso Amorim, former foreign minister of Brazil; Winnie Byanyima, executive director of Oxfam; Shiba Phurailatpam, an HIV patient and treatment activist; Malebona Precious Matsoso, director-general of the South African National Health Department; Yusuf Hamied, executive chairman of leading generic drug company Cipla; Michael Kirby, a retired Australian judge; Ruth Okediji, a law professor at Minnesota University Law School; Jorge Bermudez, former head of UNITAID; Kinga Goncz, a law professor from Hungary; Maria C Freire, executive director of the US Foundation for the National Institutes of Health; and Stephen Lewis, an official of the advocacy organisation AIDS-Free World.

In its 70-page report, the Panel touched on several issues such as 'new incentives for research and development of health technologies' based on identifying 'global health priorities' for distributing scarce health resources; and 'governance, accountability and transparency' mechanisms to address the incoherence between human rights, trade, intellectual property and public health.

The Panel's major recommendations cover 'intellectual property laws and access to health technologies', in which it urged WTO member states to 'commit themselves, at the highest political levels, to respect the letter and the spirit of the Doha Declaration on TRIPS and Public Health', and to refrain from any action that will limit their implementation and use in order to promote access to health technologies.

Specific policy guidelines suggested by the Panel include:

(a) WTO members must make full use of the TRIPS Agreement flexibilities as confirmed by the Doha Declaration to promote access to health technologies when necessary.

(b) WTO members should make full use of policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that are in the best interests of the public health of the country and its inhabitants.

(c) Governments should adopt and implement legislation that facilitates the issuance of compulsory licences for legitimate public health needs, particularly with regard to essential medicines.

(d) 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 licence.

(e) 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.

(f) Instances of undue political and commercial pressure should be reported by the WTO secretariat during the Trade Policy Review of members. Further, punitive measures must be taken against countries exerting undue political and economic pressure.

(g) Public-funded research in the pharmaceutical sector must ensure that knowledge generated from such research must be made freely available.

(h) Governments must provide new incentives for research of health technologies by increasing their current levels of investment in health technology innovation to address unmet needs.

(i) Governments must review access to health technologies in the respective countries in light of human rights principles and states' obligations to fulfil them.

(j) The UN Secretary-General should establish an independent review body tasked with assessing progress on health technology innovation and access under the ambit of the 2030 Agenda for Sustainable Development.

(k) Biomedical private sector companies involved in health technology innovation and access should report, as part of their annual reporting cycle, on actions they have taken that promote access to health technologies.

(l) 'Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to: (i) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and (ii) any public funding received in the development of the health technology.'

(m) Governments should require that the unidentified data on all completed and discontinued clinical trials be made publicly available in an easily searchable public register established and operated by existing mechanisms such as the World Health Organisation (WHO) Clinical Trials Registry Platform.

(n) Governments should establish and maintain publicly accessible databases with patent information status and data on medicines and vaccines.

The credible recommendations set out in the Panel report can only be implemented if the major pharmaceutical companies and their home governments do not resort to predatory practices, including mud-slinging and smear campaigns, according to analysts familiar with the recommendations.

'It is a ringing endorsement of TRIPS flexibilities from the report and now the public debate must force the governments to implement the recommendations,' said an analyst who asked not to be quoted.        

D Ravi Kanth writes for the South-North Development Monitor (SUNS) published by the Third World Network. This article is reproduced from SUNS (No. 8313, 16 September 2016).

*Third World Resurgence No. 312/313, Aug/Sept 2016, pp 5-7