Big support for UN Access to Medicines High Level Panel’s Report
There is an urgent need not only to support but to undertake follow up activities relating to the recently released report of the UN Secretary General’s high level panel on access to medicines.
This was the conclusion at a briefing session on the report organised by the South Centre, in cooperation with the Secretariat of the panel.
The main speaker was Ms. Ruth Dreifuss, Co-Chair of the High Level Panel, and former President of Switzerland. She gave a detailed presentation of the report, with emphasis on its recommendations.
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South Centre meeting calls for action to follow up on report of UN High Level Panel on Access to Medicines
There is an urgent need not only to support but to undertake follow up activities relating to the recently released report of the UN Secretary General’s high level panel on access to medicines.
This was the conclusion at a briefing session on the report organised by the South Centre, in cooperation with the Secretariat of the panel.
The main speaker was Ms. Ruth Dreifuss, Co-Chair of the High Level Panel, and former President of Switzerland. She gave a detailed presentation of the report, with emphasis on its recommendations.
Also speaking were South Centre Executive Director Martin Khor and coordinator of the Secretariat of the high level panel Dr. Mandeep Dhaliwal of UNDP. Dr. German Velasquez of South Centre chaired the meeting.
There were also several questions and comments from the participants.
The briefing for developing country delegations and civil society representatives was held in the Palais des Nations in Geneva on 11 October 2016.
Below is a report of the session by Dr. Viviana Muñoz Tellez of the South Centre.
By Viviana Muñoz Tellez
A South Centre briefing session on the UN Secretary-General’s High –Level Panel on Access to Medicines was held at the Palais des Nations, Geneva on 11 October 2016 to enable diplomats and civil society representatives to hear first-hand from Ms. Ruth Dreifuss, Co-Chair of the panel, on the main points of the report. She gave a detailed overview, especially of the recommendations.
The UN Secretary-General, Mr. Ban Ki-moon, convened the high-level panel in November 2015. The objective was “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 Final Report was released on 14 September 2016.
The High-Level Panel was co-chaired by Ms. Ruth Dreifuss, former President of Switzerland, and Mr. Festus Gontebanye Mogae, former President of Botswana, and was comprised of 15 eminent individuals. 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.
Introductory Presentations
The briefing was moderated by Dr. German Velasquez, Special Adviser for Health and Development of the South Centre. He recalled that the South Centre had submitted inputs to the UN HLP on Access to Medicines and endorsed in a public statement its final report.
Introductory remarks were made by Mr. Martin Khor, Executive Director of the South Centre. He pledged the support of the South Centre to continue its work in line with the goals of the UN HLP on Access to Medicines report and to support countries to implement the report’s recommendations.
Dr. Mandeep Dhaliwal of the United Nations Development Program (UNDP) and who coordinated the Secretariat of the UN HLP on Access to Medicines, gave a detailed background of the HLP and its operations.
(See next article for more details of these two presentations.)
Presentation of the Report by Ms. Ruth Dreifuss
Ms. Ruth Dreifuss, Co-chair of the High Level Panel, presented the highlights of the report. She said that the scope of the HLP mandate was to address policy incoherences, which means to make a priority scale in the different goals decision-takers have to make, in order to achieve human rights and public health.
In access to medicines, there are old and new challenges. The old ones remain, including the lack of research for diseases of the poor and the diseases of the few — until the threat of so called emerging diseases are recognized, such as Zika and Ebola; bad adaptability of treatments to the local settings and conditions of poorer countries; and unaffordable prices for those who pay out of pocket. There is also the question of the sustainability of the progress made through product private partnerships, patent pooling and voluntary licenses.
Some of the new challenges include the growing burden of non-communicable diseases, increasing antimicrobial resistance, high price of new treatments leading to rationalization even in developed country health systems, the need for de-linkage between the cost of R&D and the price of treatments, and the lack of use of the TRIPS flexibilities.
Ten years ago the WHO’s Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH, which Ms. Dreifuss chaired) was full of hope for an increase in the use of intellectual property flexibilities, following the adoption of the WTO Doha Declaration on TRIPS and Public Health. But now there are great obstacles in the use of these flexibilities, said Ms. Dreifuss.
There is a need for a new approach for biomedical innovation. One of the SDG 3 targets is to support R&D of vaccines and medicines for communicable and non-communicable diseases. The lack of biomedical innovation is no longer limited to neglected tropical diseases. It has become a global challenge. There is a need for public health responses as well as medicines, vaccines, diagnostics and all kind of medical devices.
There is a need for a new approach to guarantee access to medical technologies. SDG 3 refers to the goal of universal health coverage, including access to safe, effective, quality and affordable essential medicines and vaccines for all. The availability at an affordable price for all in need depends largely on patent laws (including the criteria for patentability) and on decisions taken by regulatory and procurement authorities. There are other factors, but the scope of the panel was on these issues.
Ms. Dreifuss said the report of the of the high-level panel makes recommendations in the field of intellectual property, publicly funded research, new incentives for R&D, and transparency, governance and accountability. She then elaborated on these recommendations.
Recommendations on intellectual property:
– Make full use of the TRIPS flexibilities. Governments should adopt and implement legislation that facilitates the quick, fair and predictable issuance of compulsory licenses. Many countries don’t have enabling legislation. The WTO members should make full use of policy space available in the TRIPS Agreement to curtain ever-greening and reward only genuine innovation. WTO members must revise the Paragraph 6 system under the WTO Doha Declaration on TRIPS and Public Health to find a solution that enables swift and expedient export of biomedical products from countries with production capacity to countries without production capacity.
– Balancing priorities in free trade agreements. Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the use of TRIPS flexibilities. Instances of undue political and economic pressure should be reported to the WTO Secretariat during the Trade Policy Review of WTO Members. Members should register complaints of political and economic pressure, and take punitive measures against offenders. Governments involved in bilateral and regional trade and investment negotiations should ensure that they do not interfere with the right to health. Governments should undertake public health impact assessments before entering into these agreements.
Recommendations on publicly funded research:
– Publicly funded research serving public health. Public funders of research must require that knowledge generated from such research be made freely and widely available in peer-reviewed literature. Universities and research institutions that receive public funding should adopt policies that promote biomedical research and knowledge that benefits the public health objectives over financial returns in patenting and licensing practices, for example non-exclusive licensing, participation in public sector pools, and donation of intellectual property.
Recommendations on new incentives for R&D:
– Need for new incentives for R&D. It is imperative that governments increase their levels of biomedical investment to address unmet health needs. Governments, the biomedical industry, funders of health care and civil society should establish and implement new and additional models for financing and rewarding public health R&D. The UN Secretary General should initiate negotiations among governments on the coordination, financing and development of health technologies for a binding R&D convention that delinks the costs of R&D from end prices. As a preliminary step, Governments should establish a Working Group to begin negotiating a Code of Principles for Biomedical R&D.
Recommendations for governments on accountability and coordination:
– Government accountability and coordination is needed. Governments must review the situation of access to health technologies in their countries in light of human rights principles and States obligations to fulfil them, with assistance from the Office of the UN High Commissioner on Human Rights. These should be made publicly available. Civil society should be supported to submit shadow reports. Governments should establish national level inter-ministerial bodies to co-ordinate laws, policies and practices that may impact on health technology innovation and access.
Recommendations for the UN system on accountability and coordination:
– UN system governance for assessment and increased coherence. The UN Secretary General should establish an independent review body (with broad membership from various constituencies) tasked with assessing progress on health technology innovation and access. The UN SG should establish an inter-agency taskforce to increase coherence between multilateral organizations working on health technology innovation and access. The UN SG should convene a UN General Assembly Special Session on health technology innovation and access by 2018.
Recommendations on transparency in the biomedical sector:
– There is need for greater transparency in the biomedical sector. Governments should require all manufacturers and distributors to disclose the cost of R&D, production marketing and distribution of their products, with each category separated. Governments should require disclosure of public funding received in the development of health technologies such as tax credits, subsidies and grants. The WHO should establish and maintain a database of prices of patented, generic and biosimilar medicines in countries where they are registered.
Recommendations on transparency in clinical trials:
– There is need for greater transparency of clinical trials. Governments should require that data on all completed and discontinued clinical trials be made publicly available regardless of positive outcome. Governments should require that study designs, protocols, data sets and anonymity protected patient data be made publicly available in order to facilitate open collaboration.
Recommendations on facilitation of access to patent information:
– Access to patent information should be facilitated. Governments should establish and maintain publicly accessible databases with patent information status on medicines and vaccines with support of the World Intellectual Property Organization (WIPO) including standard names for biological products, international non-proprietary names, dates of patent grant and expiry.
Recommendations for biomedical companies on transparency and accountability:
– There is need for biomedical companies to increase transparency and accountability. Private biomedical companies involved in innovation should report annually on steps taken that promote access to health technologies. They should implement a direct board level of accountability to improve access to health technologies. They should also implement a publicly available policy of contribution to improve access to health technologies with specific objectives, timelines and lines of accountability.
In closing her presentation, Ms. Dreifuss said that the ambition of the Panel with the recommendations was to give tools to the various stakeholders including UN agencies, government authorities, patients and private companies, to give answer to the needs of people. Ms. Dreifuss made a call to the stakeholders and the public to make full use of this tool.
Open Discussion
During the debate several delegations took the floor to endorse and comment on the importance and outcomes of the report.
The Ambassador of Cuba expressed full support to the HLP recommendations. Governments have the responsibility to implement and define what is the best way forward. The HLP on Access to Medicines can play a useful role in supporting these policies. What is needed is good will and political will to implement them. There is unfortunately a divergence of views on this issue in the international arena. She recommended to governments to support the report and its approach to do so in the UN General Assembly, the WHO and other fora.
She added that Cuba being a small country with limited resources and subject to an international blockade has nonetheless managed to have a universal and equitable access to health technologies, and demonstrated that it is possible. Some of the key elements of success are its health policies, a legal framework that supports access to health, education and literacy, biotechnology development and a robust national intellectual property system that protects results obtained and takes into account flexibilities in the TRIPS agreement to take actions to protect public health and access to medicines, a close relationship between biotechnology centers and government, State supervision and support, creation of infrastructure, intellectual capital – human and scientific, and the integration of biotechnology and pharmaceutical industries and a focus on strengthening regulatory agencies. All health, education, industrial, technology and intellectual property policies have converged and enhanced each other.
The Ambassador of Brazil noted that his delegation had nothing but praise for the report, that raises all relevant issues in a very streamlined fashion with interesting recommendations. The report has helped to put the issues back on the table. These issues have been discussed for over two decades and efforts are still being made to move forward. There is need to mainstream the recommendations of the report in formal bodies in the UN. The obstacle is the refusal and denial by influential countries that do not wish to accept this report as a basis for moving forward. India, Brazil and others made a proposal to include discussion on the HLP report as an agenda item in the WHO Executive Board. The proposal was not accepted by some members of the Board. Hence, there is no entry point in the WHO right now to discuss the report. Follow up actions are necessary.
Representatives from Venezuela, Pakistan, Tanzania, among others, also expressed support for the report.
A representative from the UNCTAD secretariat expressed willingness to assist in implementing a number of recommendations, and noted that a key point of the report is the need to allow countries to decide how best to find a balance among trade, intellectual property, human rights and public health. There is a need to find new spaces and multilateral bodies that can take ownership of the recommendations, and to foster collaboration among different UN agencies.
Conclusion by the South Centre
In his concluding remarks, Mr. Khor said that the report enjoyed high public legitimacy and strong praise and support from many governments, civil society organisations, which have been able to counter the few negative reactions. He said that the main action points that Ms. Dreifuss had highlighted and that the session had endorsed included the need for health concerns to be given top priority over other objectives, the need for countries to be aware of and make full use of TRIPS flexibilities, the need to beware of dangers of trade agreements that seek to curtail the governments’ policy space to use TRIPS flexibilities, a proposal that the WTO be used to discipline those members that put pressure on others to not make use of TRIPS flexibilities, and the need to increase R and D for neglected diseases while urgently seeking new R and D models that delink the cost of innovation from the price of medicines and that link them instead to affordable access to medicines.
Mr. Khor said it is now important for all governments, international organisations, UN agencies, health groups and civil society and medical professionals to seriously consider the panel’s recommendations and move into action to make them a reality. He affirmed the commitment of the South Centre in promoting the report and in taking forward the recommendations of the report. He thanked Ms. Dreifuss, the other Co Chair and the members of the panel and the expert groups, as well as the Secretariat for producing a very good and remarkable report.
South Centre contributions to the High-Level Panel
The South Centre contributed three submissions to the HLP on Access to Medicines. Dr. Carlos Correa, Special Advisor on Trade and Intellectual Property to the South Centre, was also a member of the Expert Advisory Group which provided overall technical support to the Panel during its work.
Recommended links:
The Report of the High Level Panel and other related information are available at: www.unsgaccessmeds.org/final-report/, www.UNSGAccessMeds.org.
The South Centre submissions to the High Level Panel are available at: www.southcentre.int/south-bulletin-91-18-june-2016/.
The South Centre statement endorsing the report is available at: www.southcentre.int/wp-content/uploads/2016/09/160916_SC-statement-on-the-report-of-the-UN-SG-HLP-on-Access-to-Medicines_EN.pdf.
Viviana Muñoz-Tellez is the Programme Coordinator of the Development, Innovation and Intellectual Property Programme (DIIP) of the South Centre.
Background to the UN High-Level Panel Report
At the briefing session on the report of the UN Secretary General’s High Level Panel on Access to Medicines, organized by the South Centre and the panel’s Secretariat, there were two presentations made before the main speech by the Panel Co-Chair Ms. Ruth Dreifuss. These were made by the South Centre’s Executive Director Mr. Martin Khor and by Dr. Mandeep Dhaliwal of the United Nations Development Program (UNDP) and the Secretariat of the High Level Panel. Below is a report by Viviana Muñoz Tellez on these presentations.
By Viviana Muñoz Tellez
In his introductory remarks, Martin Khor highlighted the importance of the human right to health and the important role that governments are obliged to play in ensuring this right is realised, including by working to provide universal access to medical technologies. This has been recognized in a recent landmark resolution on access to medicines that was adopted by the Human Rights Council and which had been put forward mainly by the developing countries.
He also emphasized the relevance of the discussion on the UN High Level Panel on Access to Medicines report in the context of achieving the Sustainable Development Goals (SDGs). It is a great challenge for governments, especially from developing countries, to provide universal access to health care. Scarcity of resources is a key factor. High prices of medicines are a major impediment to affordable access, and it is now recognized as a problem not only in developing countries but also in developed countries. It is also a challenge for governments to implement rules and policies on trade, intellectual property, health and human rights in a coherent manner. The South Centre had welcomed the establishment of the High Level Panel that was set up to examine how this can best be done.
When the report was issued, the South Centre also made a statement welcoming it and its recommendations, including the need for the full use of the flexibilities under the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), its denunciation of political pressures put on countries not to use these flexibilities, its criticism of provisions in trade and investment treaties that reduce the scope for countries to protect public health, and the need for a research and development (R&D) system that delinks costs of innovation with the price of medical technologies and that links innovation with affordable access.
Mr. Khor reaffirmed the commitment of the South Centre to broaden awareness of the report, promote its use among public health ministries and other government institutions, health organizations and civil society, and to make the report come to life in policies at the national level.
Dr. Mandeep Dhaliwal said that the UNDP was priviledged to have worked with UNAIDS to service the Secretariat for the UN HLP on Access to Medicines. The panel looked more broadly at the relationship between innovation and access to health technologies. Dr. Dhaliwal noted the high global burden of infectious diseases, including HIV/AIDS, TB, malaria and hepatitis B and C. Together these account for over 4 million deaths a year. Neglected tropical diseases as defined by WHO are endemic in 149 countries and account for 12% of global disease burden. Adding to this is the global burden of non-communicable diseases (NCDs), responsible for 38 million deaths a year of which almost 75 percent or 28 million, occurred in low and middle-income countries (LMICs) in 2013.
In addition, there is the challenge of insufficient innovation for many diseases. Many products don’t add new therapeutic advantage over existing ones. Of 850 new therapeutic products registered in 2000-2011, 70% of newly registered medicines show no therapeutic advantage. Moreover, only 4% of new products were for neglected diseases. There is also insufficient innovation into new antimicrobials, including antibiotics, which constitutes a major public health threat. Multi-drug resistant TB is a leading killer. Treatment can take 2 years with toxic side effects and at a cost of 4000 USD per patient per year in the United States.
The UN HLP on Access to Medicines follows the Report of the Global Commission on HIV and the Law in 2012. This report requested the UN SG to convene a neutral, high-level body to review and assess proposals and recommend a new intellectual property regime for pharmaceuticals consistent with international human rights law. The panel also follows the adoption of the 2030 Agenda in September 2015. The Sustainable Development Goal (SDG) 3 is to “ensure healthy lives and promote well-being for all”.
One of the targets under SDG 3 is to achieve universal health coverage, including financial risk protection, access to quality essential health-care services and access to safe, effective, quality and affordable essential medicines and vaccines for all. Another target is to support the research and development of vaccines and medicines for the communicable and non-communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on TRIPS and Public Health. In the Agenda 2030, health and development are linked. Health is an enabler of many SDGs.
The mandate for the high-level panel came out of the report on HIV and the Law and from the SDGs. The UN SG Ban Ki-moon announced the establishment of the HLP on 19 November 2015. The HLP was to address the policy incoherences that are leaving millions of people behind. The 15 Member panel was asked to “review and assess proposals and recommend solutions to remedying the incoherence between international human rights, trade rules and public health that is leaving millions behind when it comes to accessing medicines and health technologies.”
The Panel had three mutually- reinforcing axes. These were a high level panel, global dialogue hearings – held in Johannesburg and London — with calls for multi-stakeholder contributions including civil society, governments and industry to offer ideas on potential solutions which were discussed at the dialogues, and an expert advisory group. Informed by the three axes, the Panel was mandated to make evidence-informed actionable recommendations. The Panel received 182 contributions: from civil society/patient groups, private sector, academia and think tanks, government and related orgs, international organizations , independent.
The Panel was also informed by developments at the Human Rights Council. The 32nd session of HRC in June 2016 adopted a resolution on access to medicines (A/HRC/32/L.23/Rev). It was co-sponsored by Brazil, China, Egypt, Haiti, India, Indonesia, Paraguay, Peru, Senegal, Sri Lanka, South Africa, Thailand and Turkey. The resolution referenced the Panel: “Noting with appreciation also the Secretary-General’s decision to establish a High-level Panel on Access to Medicines”.
The resolution “calls upon States to promote access to medicines for all, including through the use, to the full, of the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights recognizing that the protection of intellectual property is important for the development of new medicines, as well as the concerns about its effects on prices”. The resolution also “reiterates the call upon States to continue to collaborate, as appropriate, on models and approaches that support the delinkage of the cost of new research and development from the prices of medicines. The resolution also “invites Member States and all stakeholders, including relevant United Nations bodies, national human rights institutions, civil society, and the private sector, to promote policy coherence in the areas of human rights, intellectual property and international trade and investment when considering access to medicines”.
The South Centre Endorses the Report of the UN High Level Panel on Access to Medicines
Below is the statement by the South Centre on the Report of the UN Secretary-General’s High Level Panel on Access to Medicines released on 14 September 2016.
The South Centre endorses the report of the United Nations Secretary General’s High Level Panel on Access to Medicines(1) and its call on governments, the United Nations entities and others including the World Trade Organization, to take action on the report’s recommendations.
The report signals that significant progress can be made by the global health community on access to medicines by taking concerted action. As the report notes, access to medicines, vaccines, diagnostics and medical devices is a matter of concern for all countries.
The South Centre encourages the UN General Assembly meeting to welcome the report of the United Nations Secretary General’s High Level Panel on Access to Medicines and to agree to a mechanism for overseeing the implementation of the recommendations.
Under the able leadership of the co-chairs Ruth Dreifuss and Festus Gotebanye Mogae, the panel was able to build consensus across a wide range of opinions. While the debates of the panel were not public, its composition and commentaries by some members suggest that agreement could not be reached on some proposals that would entail significant changes in the current model of pharmaceutical innovation. Yet the panel managed to produce significant recommendations.
Some of the key recommendations of the high level panel report are the following:
WTO Members should make full use of the policy space available in Article 27 of the TRIPS Agreement by adapting and applying rigorous definitions of invention and patentability that are in the best interest of the public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.
Governments should adopt and implement legislations that facilitate the issuance of compulsory licenses.
WTO Members should revise the paragraph 6 decision in order to find a solution that enables swift and expedient export of pharmaceutical products produced under compulsory license.
Governments and private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities.
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.
Universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices.
Stakeholders, including governments, the biomedical industry, institutional funders of healthcare and civil society should test and implement new and additional models for financing and rewarding public health research and development (R&D).
The UN Secretary-General should initiate a process for governments to negotiate global agreements on the coordination, financing and development of health technologies, including negotiations for a binding R&D Convention that delinks the costs of research and development from end prices to promote access to good health for all.
Governments should establish a Working Group to begin negotiating a Code of Principles for Biomedical R&D.
Governments must review the situation of access to health technologies in their countries in the light of human rights principles and States’ obligations to fulfil them, with assistance from the Office of the UN High Commissioner for Human Rights.
Governments should require the disclosure to drug regulatory and procurement authorities of information pertaining to the cost of R&D, production, marketing and distribution of health technology, and any public funding received in the development of health technology, including tax credits, subsidies and grants.
Governments should make publicly available all data on clinical trials, as well as the information and databases on patent information status and data on medicines and vaccines.
The South Centre will step up its support to its Member States and all G77 countries in the implementation of the recommendations. Many are already in line with its current work and reflect the proposals submitted to the High Level Panel. The South Centre also stands ready to collaborate with the independent review body tasked with assessing progress on health technology innovation and access, to be established by the UN Secretary General, as recommended by the report.(2)
(1) The Report of the UN Secretary-General’s High Level Panel on Access to Medicines is available at http://static1.squarespace.com/static/562094dee4b0d00c1a3ef761/t/57d9c6ebf5e231b2f02cd3d4/1473890031320/UNSG+HLP+Report+FINAL+12+Sept+2016.pdf.
(2) The contributions of the South Centre to the UN Secretary- General’s High Level Panel on Access to Medicines are available at http://www.unsgaccessmeds.org/inbox/2016/2/26/south-centre ; http://www.unsgaccessmeds.org/inbox/2016/2/28/south-centerb ; http://www.unsgaccessmeds.org/inbox/2016/2/28/south-centrec.
Developing countries at WTO support UN panel’s report
At a meeting of the WTO’s TRIPS Council, several developing countries spoke in support of the recommendations of the UN high-level panel on access to medicines, while some developed countries were not so favourable. Below is a report by Kanaga Raja, which was published in the SUNS on 14 November 2016.
By Kanaga Raja
A meeting of the WTO TRIPS Council 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 advocates amongst others the full use of TRIPS flexibilities. The item on the panel report was placed on the agenda by Brazil, China, India and South Africa.
During the TRIPS Council meeting, many developing countries including Egypt, Indonesia, Bangladesh and Bolivia, welcomed the discussions on the report in the TRIPS Council and voiced their support for the high-level 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.
India underlined that the TRIPS Agreement tried to strike an appropriate balance between the interests of rights holders and users. 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, said India.
According to India, the TRIPS Agreement also recognizes that the principles of IP protection are based on underlying public policy objectives, and that 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, many developing countries are constrained by limited technical capacity to make full utilization of the TRIPS flexibilities. 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,” said India.
Against this background, said India, 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. India read out the relevant recommendations.
India encouraged Members to share their views on the recommendations of the HLP at this session of the TRIPS Council. At the subsequent sessions of the TRIPS Council, it encouraged Members to share their experiences in using the TRIPS flexibilities to address public policy priorities, in particular, related to public health.
(See separate article on India’s full statement.)
In its statement, Brazil noted that among the high-level panel report’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 TRIPS and Public Health, refraining from any action that will limit their implementation and use in order to promote access to health technologies. Brazil read out some of the report’s recommendations.
(See separate article on Brazil’s statement.)
According to Brazil, engaging in the discussion of recommendations by the High Level Panel might allow 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 toward 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 TRIPS and Public Health, and that countries should make full use of the TRIPS flexibilities.
China said that it is pleased to be a co-sponsor of the agenda item, adding that the high-level panel gave various recommendations and provides 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.
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 report which it claimed “distracts from rather than benefits” the objective of achieving universal health. It maintained that intellectual property protections needed 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”. The European Commission does not share this assumption.
The Commission shares the 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…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 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, both in developed and least developed countries.
It also said that the report under-plays 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.
According to trade officials, Switzerland, Japan and Korea expressed similar concerns on the “narrow scope” of the 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 included an end to the epidemics, and it requires global solidarity and initiatives, it said.
The World Health Organisation (WHO), the United Nations Conference on Trade and Development (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 the High Level Panel Report recommends the full use of flexibilities inherent in the WTO TRIPS Agreement. UNCTAD said its work over the past ten years shows that these flexibilities, such as the recourse to strict patenting requirements, certain exceptions to patent rights and the availability of compulsory licenses 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 High Level Panel’s recommendations underline the United Nations’ commitment to the realization of Sustainable Development Goal 3, 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.”
On the new incentives for research and development of health technologies, the High Level 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.
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 also welcomed the High Level Panel Report’s recommendation to increase inter-agency coordination.
In its statement, the WHO said that the 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 the WHO.
The WHO then went on to go through the different recommendations in the high level panel report, in particular those that are directly addressed to WHO, and highlighted its relevant activities and future plans in this area.
Members agreed to revert to the matter at the next meeting of the TRIPS Council in February 2017.
Kanaga Raja is the Editor of the South North Development Monitor (SUNS).
India’s statement at the WTO welcoming the High-Level Panel report
Below is the statement made by India at the meeting of the WTO’s TRIPS Council on 8-9 November 2016 during the discussion on the agenda item of the UN Secretary General’s High Level Panel Report on Access to Medicines.
In November of 2015, the United Nations Secretary-General, Mr. Ban Ki-moon, convened a High-Level Panel (HLP) on Access to Medicines. 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 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.
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 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 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 the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.
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), defining 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.
Although the TRIPS Agreement provides a 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.
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.
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, 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.
Brazil’s statement at WTO on the High Level Panel report
Below is the statement of Brazil at the WTO’s TRIPS Council during the discussion on the agenda item on the UN Secretary General’s High Level Panel report on access to medicines, held on 8-9 November 2016.
The High Level Panel on Access to Medicines was established to implement one of the recommendations of the Global Commission on HIV and the Law. This Commission, as many will remember, was comprised of eminent authorities and chaired by former Brazilian President Fernando Henrique Cardoso.
This new High Level Panel was co-chaired by the former President of the Swiss Confederation, Ruth Dreifuss, and by the former President of Botswana, Festus Mogae.
Its final report was released last September. Among its 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 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, it recommends:
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 only awarded when genuine innovation has occurred.
Enhanced cooperation among UNCTAD, UNDP, WHO, WIPO and WTO and with other relevant bodies with the requisite expertise to support governments to apply public health-sensitive patentability criteria.
It also recommends these multilateral organizations to 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.
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.
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.
Brazil 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 has 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.
Engaging in the discussion of recommendations by the High Level Panel might allow members to consider different aspects of the relationship between access to medicines and the Patent System. Brazil is convinced that a balanced and effective IP system would go a long way toward 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.
Brazil understands it is important for the TRIPS Council to pay due attention to the issues and recommendations raised by the UN Secretary General’s High Level Panel. We would be most interested in the continuation of the discussion in the next TRIPS Council Session.
Uruguay’s victory over Philip Morris: a win for tobacco control and public health
By Germán Velásquez
In a landmark decision that has been hailed as a victory of public health measures against narrow commercial interests, an international tribunal has dismissed a claim by tobacco giant company Philip Morris that the Uruguay government violated its rights by instituting tobacco control measures.
The ruling had been much anticipated as it was the first international case brought against a government for taking measures to curb the marketing of tobacco products.
Philip Morris had started proceedings in February 2010 against Uruguay at the International Centre for Settlement of Investment Disputes (ICSID) under a bilateral investment treaty (BIT) between Uruguay and Switzerland. The decision was given on 8 July 2016.
Under the BIT, foreign companies can take cases against the host state on various grounds, including if its policies constitute an expropriation of the companies’ expectation of profits, or a violation of “fair and equitable treatment”. These investment treaties and arbitration tribunals like ICSID have been heavily criticised in recent years for decisions favouring companies and that critics argue violate the right of states to regulate in the public interest.
In this particular case, the tribunal gave a ruling that dismissed the tobacco giant’s claims and upheld that the Uruguayan pro-health measures were allowed.
President Tabaré Vázquez of Uruguay, responding to the ruling, stated on 8 July: “We have succeeded to prove at the International Centre for Settlement of Investment Disputes that our country, without violating any treaty, has met its unwavering commitment to defend the health of its people… From now on, when tobacco companies try to undermine the regulations adopted in the con