Strong support for UN panel’s recommendations on access to medicines
Developing-country WTO members have welcomed a recent report by a UN panel which called on governments to make full use of flexibilities allowed by the WTO’s intellectual property rules to promote access to medicines.
by Kanaga Raja
GENEVA: A meeting of the WTO Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) on 8-9 November discussed a recent report of the UN Secretary-General’s High-Level Panel on Access to Medicines, with many developing countries expressing strong support for the panel’s recommendations, which advocate, among others, the full use of flexibilities in the TRIPS Agreement.
The item on the UN panel report had been placed on the agenda of the TRIPS Council meeting by Brazil, China, India and South Africa.
The high-level panel was convened in November 2015 by UN Secretary-General Ban Ki-moon and its final report was released on 14 September 2016. Among its recommendations are that WTO members must make full use of the TRIPS Agreement flexibilities as confirmed by the WTO Doha Declaration on the TRIPS Agreement and Public Health to promote access to health technologies when necessary. Governments are also called upon to adopt and implement legislation that facilitates the issuance of compulsory licences for legitimate public health needs and particularly with regard to essential medicines. The panel also recommended that public-funded research in the pharmaceutical sector must ensure that knowledge generated from such research be made freely available (see TWE No. 625 for details of the panel’s recommendations).
At the TRIPS Council meeting, many developing countries, including Egypt, Indonesia, Bangladesh and Bolivia, welcomed the discussions on the report in the Council and voiced their support for the panel’s recommendations.
The US, the EU, Japan and Switzerland, supported by Korea, differed from developing countries, while some other developed countries said they needed more time to study the panel’s recommendations.
In its statement, India, one of the co-sponsors of the agenda item, noted that the UN Secretary-General had convened the panel “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 panel was co-chaired by Ruth Dreifuss, former President of Switzerland, and Festus Gontebanye Mogae, former President of Botswana, and 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 UN and international organizations, such as the WTO.
According to India, the panel, inter alia, made recommendations on intellectual property (IP) laws and access to health technologies, especially on: (i) TRIPS flexibilities and TRIPS-plus provisions, and (ii) publicly funded research.
India underlined that 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 intellectual property rights (IPRs) 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 research and development (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, said India.
According to India, the TRIPS Agreement also recognizes that the principles of IP protection are based on underlying public policy objectives.
Article 8 of the 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 socioeconomic and technological development, provided that such measures are consistent with the provisions of the Agreement.
Article 8(2) further states that appropriate measures may be needed to prevent the abuse of IPRs by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.
India pointed out that in furtherance of the objectives and principles of the TRIPS Agreement enshrined in Articles 7 and 8, a number of safeguards or flexibilities have become an integral part of the framework of the Agreement.
“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 regimes keeping in mind each country’s individual needs and policy objectives.”
Key TRIPS flexibilities include transition periods for least-developed countries (extended by the WTO last year until 1 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; 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 and compulsory licences, including through the paragraph 6 mechanism and government use.
For pharmaceutical patents, these flexibilities have been clarified and enhanced by the 2001 Doha Declaration on the TRIPS Agreement and Public Health, which states that WTO members have the flexibility to interpret and implement the TRIPS provisions in a manner supportive of their right to protect public health.
Although the TRIPS Agreement provides a substantial degree of flexibility, the full utilization of these flexibilities is in the hands of member states.
However, many developing countries are constrained by limited technical capacity to make full use of the TRIPS flexibilities and therefore need appropriate technical assistance from relevant multilateral organizations in order to fully utilize the 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 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,” said India.
Against this background, said India, the recommendations of the UN high-level panel, especially on TRIPS flexibilities and TRIPS-plus provisions and publicly funded research, are very important with regard to access to health technologies. The panel’s recommendations in these areas are as follows:
TRIPS flexibilities and TRIPS-plus provisions
World Trade Organization (WTO) Members should commit themselves, at the highest political levels, to respect the letter and the 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 must 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 [of patents] to ensure that patents are only 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 licences. Such legislation must be designed to effectuate quick, fair, predictable and implementable compulsory licences 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 licences 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 licence. 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 Review 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 fulfil 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.
(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.
India encouraged WTO members to share their views on the recommendations of the panel at the TRIPS Council session. It encouraged members in subsequent sessions to share their experiences in using the TRIPS flexibilities to address public policy priorities, in particular those related to public health.
Public health commitment
In its statement, Brazil noted that among the panel’s recommendations, some are directly related to the TRIPS Agreement. One of these calls for WTO members to commit, at the highest political levels, to respect the letter and the spirit of the Doha Declaration on the TRIPS Agreement and Public Health, refraining from any action that will limit their implementation and use in order to promote access to health technologies.
Brazil said it has “a strong commitment to the improvement of public health in our country and in our region.”
To increase the bargaining power of governments in the acquisition of essential medicines, Brazil and other countries established, in 2015, a regional system of procurement for these life-saving goods. This arrangement, with the participation of most South American countries, is one sort of innovative mechanism aimed at helping countries to cope with high prices of pharmaceuticals.
According to Brazil, engaging in the discussion of the recommendations by the high-level panel might allow WTO members to consider different aspects of the relationship between access to medicines and the patent system.
Brazil said it is convinced that a balanced and effective IP system would go a long way towards facilitating access to essential medicines without in any way infringing on market principles.
“We all know access to medicines is a challenge for most countries, whether least developed, developing or developed. We present these views in a spirit of dialogue, convinced that they are in the interest of everyone, without exception, and encourage the whole Membership to work constructively towards achieving the goal of universal access to medicines,” said Brazil.
According to trade officials, South Africa said that the panel report calls upon WTO members to commit to and respect the Doha Declaration on the TRIPS Agreement and Public Health, and that countries should make full use of the TRIPS flexibilities.
China said that it was pleased to be a co-sponsor of the agenda item, adding that the high-level panel gave various recommendations and provided valuable information to members.
Public health is one of the most important issues on the agenda, it said, noting that leaders at the Hangzhou G20 summit also made a commitment in this regard.
According to trade officials, the United States said that although it is strongly committed to creating effective and affordable life-saving medicines around the world, it was disappointed by the panel report, which it claimed “distracts from rather than benefits” the objective of achieving universal health.
It maintained that intellectual property protections need to be in place to support new research and innovation. “There can be no access to drugs that have not been developed; support in innovation is essential,” said the US.
The European Union maintained that the work conducted by the panel started from an assumption that there was a “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health”.
“As the European Commission already indicated in its written contribution to the Panel, it does not share this assumption,” it said.
The Commission shared the panel report’s acknowledgement that there are many reasons “why people do not get the healthcare they need, ranging from: under-resourced health systems, a lack of sufficiently qualified and skilled healthcare workers, inequalities between and within countries, exclusion, stigma, discrimination and exclusive marketing rights”. Another important problem is the global medicine shortages and stock-outs.
The EU said this is why the Commission, in its written contribution to the panel, encouraged it to adopt a holistic approach to the problem of access to medicines that could result in a valuable contribution to the wider debate.
“However, due to its limited mandate, the High-Level Panel has focused its proposals exclusively on addressing an alleged conflict between a research and development model that (partially) relies on intellectual property rights and the possibility of providing affordable medicines.”
The EU said it is committed to increasing access to affordable medicines and finding solutions to the world’s pressing public health challenges and inequities, adding that it pursues a rights-based approach to health.
Strengthening all areas of a health system, including the availability of qualified health workers, the provision of affordable medicines and the adequate financing of the sector, is central to moving towards universal health coverage with quality health services accessible and affordable for all. The quality and integrity of the pharmaceutical distribution chain is also essential to improving public health, added the EU.
“The challenge is to strike the right balance between the need to promote and finance the research of new and better medicines for all, ensuring that medicines are accessible and affordable to those in need, while guaranteeing the sustainability of health systems. We believe that these goals are not contradictory and must be pursued jointly,” it said.
The EU claimed that the current innovation model, including the role of trade related to IP, has delivered consistent progress in global public health, leading to key new and improved treatments as well as much-extended life expectancy.
It also said that the panel report underplays the fact that the development of new drugs requires significant investment and long-term research, coupled with clinical trials and regulatory approval procedures.
The EU said that the exclusive right conferred by a patent is an important incentive for innovator pharmaceutical companies to make the necessary investments into that research and development. Without incentivizing the innovator pharmaceutical companies to invest in research, the Sustainable Development Goal of ensuring healthy lives and promoting well-being for all, including achieving universal health coverage, would be severely undermined, it said.
According to trade officials, Switzerland, Japan and Korea expressed similar concerns on the “narrow scope” of the panel report. They argued that the use of compulsory licences must not discourage innovation.
A few countries, including Canada, Chile, Australia and Norway, said that they needed more time to consider the wide array of recommendations highlighted in the report.
The Holy See, an observer, echoed the concerns on access to medicines, highlighting that health is a fundamental human right and “millions are left behind”. Ensuring success of the Sustainable Development Goals includes an end to epidemics and requires global solidarity and initiatives, it said.
Work of UN bodies
According to trade officials, WHO, UNCTAD and the Joint UN Programme on HIV/AIDS (UNAIDS) also highlighted the work that they have undertaken in this area.
The UNCTAD secretariat said that it recently recommended to the UN Secretary-General to consider endorsement of the panel report. As a member of the Expert Advisory Group to the panel, UNCTAD was involved in the expert discussions that fed into the panel report, and it also provided comments on the first draft of the report.
The report makes recommendations in three separate but inter-related areas: (i) intellectual property laws and access to health technologies; (ii) new incentives for research and development of health technologies; and (iii) governance, accountability and transparency.
Within the context of its mandate, UNCTAD said, its technical expertise resides mainly within the first of these areas. The bulk of UNCTAD’s contributions during the technical discussions with the Expert Advisory Group and the panel related to IP laws and access issues.
On IP laws and access to health technologies, the panel report recommends the full use of flexibilities inherent in the TRIPS Agreement as reiterated in the Doha Declaration on the TRIPS Agreement and Public Health.
UNCTAD said its advisory and capacity-building work over the past 10 years shows that these flexibilities, such as the recourse to strict patenting requirements, certain exceptions to patent rights and the availability of compulsory licences, play an important role in promoting generic competition and thus decreasing drug prices.
“According to our research many of those countries that now enjoy a fully developed pharmaceutical sector in the past relied on many of those flexibilities that the High Level Panel Report recommends in order to strike a balance between inventors’ rights and the realization of certain development objectives.”
According to UNCTAD, the panel’s recommendations underline the UN’s commitment to the realization of Sustainable Development Goal 3 (“Ensure healthy lives and promote well-being for all at all ages”), which in its targets expressly refers to the goal of providing “access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all”.
On the new incentives for research and development of health technologies, the panel report recommends increased investment by governments in health technology innovation to address unmet needs, such as neglected tropical diseases and antimicrobial resistance.
The report refers to various ongoing initiatives in this regard and underlines the need to develop new and innovative sources of financing public R&D, in line with the Addis Ababa Action Agenda on Financing for Development, said UNCTAD.
The report is not limited to public funding but underlines the untapped opportunities for increasing private sector funding. The recommendations provide important support to efforts that seek to identify innovative opportunities for both public and private sector funding of health R&D.
UNCTAD said it is willing to contribute its vast experience in investment policymaking and technology issues in this regard.
Finally, on governance, accountability and transparency, the panel report calls for increased collaboration among UN agencies to improve coherence in technical cooperation activities related to public health as well as to monitor the implementation of the panel’s recommendations.
UNCTAD said that, in the delivery of its technical cooperation activities on investment and intellectual property rights as it relates to trade and development, it already cooperates to a large extent with other agencies such as UNAIDS, UNDP, WIPO, WHO and WTO.
In its statement, WHO said that the panel report’s conclusions are sobering. “Millions of people continue to suffer and die from treatable conditions,” the report observes, “because of a lack of access to health technologies.”
Pharmaceutical research still focuses disproportionately on the treatment of diseases that are common in the developed world, neglecting those that primarily afflict the world’s poor.
“The report thus echoes conclusions of previous reports done under the auspices of the WHO, which draw attention to disparities in the R&D system and lack of access to essential medicines,” said WHO.
WHO then went through the different recommendations in the panel report, in particular those that are directly addressed to WHO, and highlighted its relevant activities and future plans in this area.
According to trade officials, members agreed to revert to the matter at the next meeting of the TRIPS Council in February 2017. (SUNS8354)
The full texts of some statements made during the discussion in the TRIPS Council can be found on the website of Knowledge Ecology International: www.keionline.org.
Third World Economics, Issue No. 628, 1-15 November 2016, pp6-9