At the 32nd session (13 June 2016 – 1 July 2016) of the Human Rights Council, a bloc of countries known as the the Core Group (Brazil, Egypt, Indonesia, India, Senegal, South Africa and Thailand) have tabled a resolution on access to medicines “premised on the primacy of human rights over international trade, investment and intellectual property regimes.” The draft resolution complements the work of the United Nations High-Level Panel on Access to Medicines in reviewing and assessing “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” (Source: http://www.unsgaccessmeds.org/theprocess).
The last time the Human Rights Council passed a resolution (23/14) on access to medicines in 2013, there was significant dissent as the United States called for a vote. At the Human Rights Council, it is common practice to pass resolutions by consensus. Here is a breakdown of the vote in 2013:
[Adopted by a recorded vote of 31 to 0, with 16 abstentions. The voting was as follows: In favour:
Angola, Argentina, Benin, Botswana, Brazil, Burkina Faso, Chile, Congo, Costa Rica, Côte d’Ivoire, Ecuador, Ethiopia, Gabon, Guatemala, India, Indonesia, Kenya, Kuwait, Libya, Malaysia, Maldives, Mauritania, Pakistan, Peru, Philippines, Qatar, Sierra Leone, Thailand, Uganda, United Arab Emirates, Venezuela (Bolivarian Republic of)Abstaining: Austria, Czech Republic, Estonia, Germany, Italy, Ireland, Japan, Kazakhstan, Montenegro, Poland, Republic of Korea, Republic of Moldova, Romania, Spain, Switzerland, United States of America] (Source: A/HRC/RES/23/14)
Some of the key highlights from the new 2016 draft resolution include:
P6 Reaffirming also United Nations General Assembly resolution 70/1 (2015), entitled “Transforming our world: the 2030 Agenda for Sustainable Development”, in which the General Assembly adopted the outcome document of the United Nations summit for the adoption of the post-2015 development agenda, recognizing that eradicating poverty in all its forms and dimensions, including extreme poverty, is the greatest global challenge and an indispensable requirement for sustainable development, and envisaging a world free of poverty, hunger, disease and want, a world of
universal respect for human rights and human dignity that includes equitable and universal access to health care and social protection, and where physical, mental and social well-being are assured,
[PP2, WHA resolution 69/11 “Health in the 2030 Agenda for Sustainable Development”]PP10 Welcoming the Secretary General of the United Nations’ decision to establish, based on the recommendation of the Global Commission on HIV and the Law, a High-level Panel on Access to Medicines, with the mandate to make proposals on how to address policy incoherence in public health, trade, the justifiable rights of inventors and human rights, and recognizing the participation of the Office of the High Commissioner for Human Rights in the expert advisory group supporting the referred panel,
[new]PP15 Recalling that the Doha Ministerial Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health confirms that the Agreement does not and should not prevent members of the World Trade Organization from taking measures to protect public health and that the Declaration, accordingly, while reiterating the commitment to the Agreement, affirms that it can and should be interpreted and implemented in a manner supportive of the rights of members of the Organization to protect public health and, in particular, to promote access to medicines for all, and further recognizes, in this connection, the right of members of the Organization to use, to the full, the provisions of the above-mentioned Agreement, which provide flexibility for this purpose,
[PP7, HRC resolution 23/14; PP9, HRC resolution 17/14; OP5, HRC resolution 15/22 and OP4, HRC resolution 12/14]P17 Concerned also that the increasing incidence of non-communicable diseases constitutes a heavy burden on society, with serious social and economic consequences, which represent a leading threat to human health and development, and recognizing the urgent need to improve accessibility to safe, affordable, effective and quality medicines and technologies to diagnose and to treat non-communicable diseases, and to strengthen viable financing options and promote the use of affordable medicines, including generics, as well as improved access to preventive, curative, palliative and rehabilitative services, particularly at the community level,
[PP6, HRC resolution 26/18 and PP11, HRC resolution 17/14; the last part comes from the Political declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, UNGA Resolution 66/2 , para 45, “l”]PP18 Expressing deep concern over recent outbreaks of highly infectious pathogens with epidemic potential, which demonstrate the potential vulnerability of populations to them and, in this context, reaffirming the importance of developing and ensuring access to safe, affordable, effective and quality medicines and vaccines to all,
[based on UNGA Resolution 70/183 on “ Global health and foreign policy”]PP19 Commending the efforts by the WHO of filling gaps in R&D for neglected diseases, such as tropical diseases, through the Consultative Expert Working Group on Research and Development (CEWG), and reiterating the need of further investment in this area,
[new]3. 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 which provide flexibility for that purpose, 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;
[OP7, “g”, HRC resolution 17/14 and OP 5, “h”, HRC resolution 23/14]4. Calls upon States to promote access to comprehensive and cost-effective prevention, treatment and care for the integrated management of non-communicable diseases, including, inter alia, increased access to affordable, safe, effective and quality medicines and diagnostics and other technologies, including through the full use of Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities;
[Political declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, UNGA Resolution 66/2 , para 45, “p”]5. 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, vaccines and diagnostics for diseases that predominantly affect developing countries, including emerging and neglected tropical diseases, so as to ensure their sustained accessibility, affordability and availability and to ensure access to treatment for all those in need;
[based on OP7, UNGA Resolution 70/183 “Global health and foreign policy”]7.Recognizes the innovative funding mechanisms that contribute to the availability of vaccines and medicines in developing countries, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, the GAVI Alliance and the International Drug Purchase Facility, UNITAID, and calls upon all States, United Nations programmes and agencies, in particular the World Health Organization, and relevant intergovernmental organizations, within their respective mandates, and encourages relevant stakeholders, including pharmaceutical companies, while safeguarding public health from undue influence by any form of real, perceived or potential conflict of interest, to further collaborate, including through financing, to enable equitable access to quality, safe and efficacious medicines that are affordable to all, including those living in poverty, children and other persons in vulnerable situations;
[OP8, HRC resolution 17/14 and OP8, HRC resolution 23/14, with changes]8. Urges all States, United Nations agencies and programmes and relevant intergovernmental organizations, especially the World Health Organization, within their respective mandates, and encourages non-governmental organizations and relevant stakeholders, to promote innovative research and development to address health needs in developing countries, including access to quality, safe, efficacious and affordable medicines, and in particular with regard to diseases disproportionately affecting developing countries, as well as the challenges arising from the growing burden of non-communicable diseases, taking into account the World Health Organisation Global strategy and plan of action on public health, innovation and intellectual property; [adopted by resolutions WHA 61.21 (2008) and 62.16 (2009)]
[OP9, HRC resolution 23/14, with changes]10. Invites Member States and all stakeholders, including relevant United Nations bodies, agencies, funds and programmes, treaty bodies, special procedure mandate holders, national human rights institutions, civil society, and the private sector, to promote policy coherence among human rights obligations, intellectual property and international trade and investment regimes, premised on the primacy of human rights over international trade, investment and intellectual property regimes;
[based on the Report of the 2015 edition of the Social Forum (A/HRC/29/44), para 62]11. Decides to convene, at its thirty-fourth session [March, 2017], a panel discussion to exchange views on good practices and key challenges relevant to access to medicines as one of the fundamental elements of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, taking into account the results from the work of the High-Level Panel on Access to Medicines;
[new]
In relation to the new resolution, on Friday, 17 June 2016, the Core Group convened an informal consultation in Room XXI of the Palais des Nations to walk through the proposed text on “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.” These informal consultations were open to member states, intergovernmental organizations and civil society organizations. Note: no interpretation was provided so every delegation spoke in English.
General Comments
The core group – Brazil, Egypt, Indonesia, India, Senegal, South Africa and Thailand – presided at the main dais with Brazil chairing the meeting. The other delegations present (many in national dress) included: Austria, Australia, Botswana, Canada, China, Colombia, Czech Republic, European Union, France, Germany, Greece, Guatemala, Holy See, Islamic Republic of Iran, Japan, Maldives, Mexico, Morocco, Norway, Pakistan, Panama, Portugal, Republic of Korea, Singapore, Switzerland, United Kingdom of Great Britain and Northern Ireland, United States of America, Uruguay and Venezuela. In addition, Knowledge Ecology International and South Centre attended the informal consultations.
From the floor, the most active delegations included Switzerland, Iran, the United States, Mexico, Panama, Colombia and Uruguay. In terms of opposition to the text, Switzerland played the bad cop while the United States played the role of good cop (with Mexico and Australia also joining in at key intervals). The European Union and its Member States, apart from general statements, did not play an active role in the discussions (presumably waiting upon instructions from Brussels and other European capitals).
Brazil opened the informal consultation at 10:09 AM on Friday, 17 June 2016 noting that with respect to the preparation of the text, the Core Group had used agreed language from the Human Rights Council, the World Health Assembly and the United Nations General Assembly in addition to taking stock of new developments since June 2013.
The European Union noted that their delegation “only received the draft yesterday” and as such, “reserved the right to comment” upon receiving further instructions from their capitals.
In its opening remarks, Switzerland noted that the 2013 resolution proved controversial and noted there were elements in the new text that could prove “complicated” for Switzerland but reaffirmed their commitment to engage constructively.
Japan indicated that “Tokyo needed time to examine the text.”
The delegation of China noted “you have our support on this important issue. Our colleague in capital is examining the text. My colleague has given instructions to add new language on children’s medicines.”
The Islamic Republic of Iran provided its unequivocal support for the text.
Mexico indicated “its interest in the text” and the delegation noted that they had received instructions from Mexico City regarding international obligations to protect intellectual property norms.
Pakistan thanked the Core Group for the initiative and expressed its support for the resolution.
Panama indicated its broad support of the resolution and expressed its intention to provide detailed comments from the United Nations Political Declaration on HIV and AIDS: On the Fast-Track to Accelerate the Fight against HIV and to End the AIDS Epidemic by 2030 in relation providing more clarity on bilateral trade pressures and language from the Political Declaration referring to the WTO Extension for LDCS “for certain obligations with respect to pharmaceutical products.”
The United Kingdom of Great Britain and Northern Ireland (currently a member of the European Union) noted, “We don’t have clear instructions yet; we appreciated the references to sources.”
The United States of America capped off the general comments from member states indicated his delegation had received detailed instructions from Washington D.C. and indicated his intent to be “constructive.”
Informal discussions heat up
In terms of paragraph 10 of the preamble which refers to the UN High-Level Panel on Access to Medicines (UN HLP), Mexico proposed replacing “Welcoming” with “Taking note” and proposed “review and make recommendations” in lieu of “make proposals”.
Switzerland proposed rendering violence to paragraph 10 by deleting it in its entirety noting that the UN HLP is an initiative of the UN Secretary-General, NOT endorsed by Member States. In addition, Switzerland proposed alternative language welcoming the 2013 trilateral study of the World Health Organization (WHO), the World Intellectual Property Organization (WIPO and the World Trade Organization (WTO) publication, Promoting Access to Medical Technologies and Innovation.
PP10 Welcoming the Secretary General of the United Nations’ decision to establish, based on the recommendation of the Global Commission on HIV and the Law, a High-level Panel on Access to Medicines, with the mandate to make proposals on how to address policy incoherence in public health, trade, the justifiable rights of inventors and human rights, and recognizing the participation of the Office of the High Commissioner for Human Rights in the expert advisory group supporting the referred panel,
With respect to PP10, the United States noted that his delegation shared the concerns expressed by Switzerland and called for the this paragraph referencing the establishment of the UN HLP to be deleted. However, as a compromise, the United State proposed language from WHA69.23 (Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination) which states: “Noting the establishment of the High-Level Panel on Access to Medicines convened by the United Nations Secretary-General”.
Colombia indicated that her delegation found it critical for the Human Rights Council resolution on access to medicines to refer to the UN High-Level Panel on Access to Medicines and supported the United States’ reference to consensus language from WHA69.23 (adopted in May 2016).
The delegation of of Iran expressed the view that it would “be a pity” to dilute language on the UN HLP, and noted that in fact, the Human Rights Council should draft stronger language in support of the Secretary-General’s initiative.
With respect to the resolution’s reference to the CEWG process, Panama proposed replacing the current text of the proposed HRC resolution – which focuses exclusively on neglected tropical diseases – with a broader scope (as agreed upon in WHA69.23).
After PP19, Panama proposed inserting language from Paragraph 60(j) of the UN Political Declaration on HIV and AIDS:
60 (j): Recognize the critical importance of affordable medicines, including generics, in scaling up access to affordable HIV treatment, and further recognize that protection and enforcement measures for intellectual property rights should be compliant with the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all, and welcome the adoption by the TRIPS Council in November 2015 of the Decision on the Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least Developed Country Members for certain obligations with respect to pharmaceutical products;
The discussions on operative paragraph 3 on the use of TRIPS flexibilities took an interesting turn when Mexico proposed deleting references to “concerns about [the effects of IPR provisions] on prices.”
Brazil asked Mexico to provide rationale for calling for the deletion of language on the effects of IPRs on prices, noting the language contained in operative paragraph 3 was taken directly from HRC resolution 17/14, a consensus document.
In answer to Brazil, the delegate of Mexico indicated the need to confer with her capital.
3. 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 which provide flexibility for that purpose, 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;
[OP7, “g”, HRC resolution 17/14 and OP 5, “h”, HRC resolution 23/14]
Paragraph 3 of the Doha Declaration on the TRIPS Agreement and Public Health states:
3. We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices.
It is curious that trade ministers at a WTO Ministerial in 2001 could acknowledge concerns relating to the effects of intellectual property on prices, but the Mexican delegation to the Human Rights Council would find this language problematic.
Switzerland contended that operative paragraph 3 on TRIPS flexibilities was a duplication of the language contained in the preamble and expressed the view that language on TRIPS flexibilities in the preamble obviated the need for language on TRIPS public health safeguards in the operative section.
PP15 Recalling that the Doha Ministerial Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health confirms that the Agreement does not and should not prevent members of the World Trade Organization from taking measures to protect public health and that the Declaration, accordingly, while reiterating the commitment to the Agreement, affirms that it can and should be interpreted and implemented in a manner supportive of the rights of members of the Organization to protect public health and, in particular, to promote access to medicines for all, and further recognizes, in this connection, the right of members of the Organization to use, to the full, the provisions of the above-mentioned Agreement, which provide flexibility for this purpose,
[PP7, HRC resolution 23/14; PP9, HRC resolution 17/14; OP5, HRC resolution 15/22 and OP4, HRC resolution 12/14]
Colombia countered that the language contained in operative paragraph 3 and preambular paragraph 15 were “minimum elements” of agreed language noting that keeping in the reference to IPR’s “effects on prices” were critical to the delegation of Colombia.
The United States contended that the language in operative paragraph 3 and preambular paragraph 15 duplicated each other, in addition the the language contained in operative paragraph 4. The United States asked the Core Group for a clarification of the text in operative paragraph 4:
4. Calls upon States to promote access to comprehensive and cost-effective prevention, treatment and care for the integrated management of non-communicable diseases, including, inter alia, increased access to affordable, safe, effective and quality medicines and diagnostics and other technologies, including through the full use of Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities;
[Political declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, UNGA Resolution 66/2 , para 45, “p”]
India responded by noting that this language focused on NCD morbidities in both developing and developed countries and noting the role that TRIPS flexibilities could play in increasing access to health technologies for the prevention, treatment and care of NCDs.
Switzerland produced a tortured reading of the operative paragraph 4 (in relation to the TRIPS Agreement and NCDs) by noting that “the Doha Declaration on the TRIPS Agreement on Public Health” only referred to “medicines and diagnostics” and questioned the “expansion” of operative paragraph 4 (taken from the Political declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases, UNGA Resolution 66/2) into “other technologies”. Note: The TRIPS Agreement (which is clearly referenced in operative paragraph 4) is not to limited to just “medicines and diagnostics”.
In relation to operative paragraph 10, the United States, Switzerland and Australia expressed their objection to language which would “promote policy coherence among human rights obligations, intellectual property and international trade and investment regimes, premised on the primacy of human rights over international trade, investment and intellectual property regimes”.
The United States contended that each field of international law – human rights, intellectual property and international trade – stood on an equal footing; the United States said that human rights should not be given primacy over intellectual property and international trade.
The US and Switzerland preferred deleting OP10. US said each field of law (HR, IP and trade) stand on an equal footing and HR should not be given primacy over others.
As Australia is vigorously defending its tobacco plain-packaging legislation at the WTO, it is disappointing that at the Human Rights Council, they reject the primacy of human rights over international trade, investment and intellectual property regimes.
10. Invites Member States and all stakeholders, including relevant United Nations bodies, agencies, funds and programmes, treaty bodies, special procedure mandate holders, national human rights institutions, civil society, and the private sector, to promote policy coherence among human rights obligations, intellectual property and international trade and investment regimes, premised on the primacy of human rights over international trade, investment and intellectual property regimes;
[based on the Report of the 2015 edition of the Social Forum (A/HRC/29/44), para 62]
In relation to access to medicines and the United Nations High-Level Panel on Access to Medicines, the Core Group provided a pro-active role for the Human Rights Council to convene a panel on access to medicines in March 2017, taking into account the recommendations of the UN HLP.
11. Decides to convene, at its thirty-fourth session [March, 2017], a panel discussion to exchange views on good practices and key challenges relevant to access to medicines as one of the fundamental elements of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, taking into account the results from the work of the High-Level Panel on Access to Medicines;
Switzerland and the United States expressed their objections to the convening of a panel in March 2017 on access to medicines “taking into account the results from the work of the High-Level Panel on Access to Medicines”. The Untied States indicated it would be premature to plan a follow-up to the UN HLP process considering the report had not been published.
With the Core Group’s informal consultation having a first reading of the Human Rights Council’s access to medicines resolutions. attention will now be focused on the 2nd informal which will be convened on Wednesday, 22 June 2016 at the Palais des Nations.