Human Rights Council adopts watershed resolution on Access to Medicines
*(The author thanks Mirza Alas and Alexandre Gajardo for their notes of the 2nd round of informal consultations held on 22 June 2016 and Sophia Simon for transcribing the statements delegations made during the plenary discussions held on 1 July 2016.)
On 1 July 2016, the 32nd session of the Human Rights Council (HRC) adopted a far-reaching resolution on access to medicines which provides the Human Rights Council a strong mandate to examine the relationship between international trade agreements, intellectual property rights obligations and their implications on access to medicines - through the prism of human rights. The Council is directed to convene an access to medicines panel at its 34th session in March 2017. It is expected that the Office of the High Commissioner of Human Rights (OHCHR) will invite the Co-Chairs (Ruth Dreifuss and Festus Mogae) of the United Nations High-Level Panel on Access to Medicines to present their findings to the 34th session of the Human Rights Council. Implicit in this resolution is the principle that the lack of access to medicines, including through the use of external trade pressure, constitutes a violation of the right to health.
The Core Group, chaired by Brazil, showed strong leadership in shepherding this resolution, which was adopted by consensus. The Core Group comprises: Brazil, China, Egypt, India, Indonesia, Senegal, South Africa and Thailand. The European Union, the United States of America, Switzerland, Japan and Australia objected to the central principle of the Core Group's original text "premised on the primacy of human rights over international trade, investment and intellectual property regimes."
The language of the adopted resolution contains language calling upon States to apply the principle of the de-linkage of the cost of biomedical R&D from the prices of medicines, vaccines and diagnostics.
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;
During the adoption of the resolution, India (Ambassador Ajit Kumar) quoted the WHO's World Medicines Situations Report of 2011, noting that health systems in the global North were over-stretched by the high cost of cancer and hepatitis C medicines:
The challenges are no longer limited to developing countries or the so called neglected diseases. It is affecting the health budgets of all governments and impacting treatments to common diseases like hepatitis and cancer. This is indeed a serious human rights issue. The existing global framework does not allow the fruits of medical innovation to be equitably shared, in particular to those who are in the most of them. It has only resulted in skyrocketing prices for lifesaving vaccines and medicines, promoted discriminatory access to medicines based on geographical location or economic status and has further widened health inequities. The increase in health care costs have induced poverty, pushing 150 million people into impoverishment every year. Moreover, innovation models that thrive on the current system have failed to address the health R&D needs from developing countries. This is evident from the lack of any new medicines and vaccines for long known infectious diseases like TB and malaria, which continue to take a huge public health toll. This council has made some seminal contributions in recognizing access to medicines as a fundamental component of right to health. A number of resolutions have reaffirmed the rights of member states to give priority of right to health over trade and IP considerations, as enshrined in the Doha Declaration on Public health and TRIPS agreement. Despite this, barriers to the full use of TRIPS flexibilities have only increased. TRIPS plus standards further threatens the right to health to millions of people by placing further barriers to access to medicines. We need to once again place the human rights dimension of access to medicines at the center of our efforts to create favorable conditions at the international, national, and regional levels to ensure the full realization of the right to health and health related goals of Agenda 2030.
The resolution: 1) recognized the need of "viable financing options" to improve the accessibility to health technologies to "diagnose and to treat non-communicable diseases" and 2) reaffirmed the need for development of new medicines and vaccines to address "recent outbreaks of highly infectious pathogens with epidemic potential."
While the resolution contained good language calling upon States to make full use of the flexibilities contained in the WTO TRIPS Agreement, it was disappointing to observe the hard-line stance adopted by the European Union (represented by the Netherlands) and Switzerland in trying to remove references to TRIPS flexibilities in the operative section of the text. Ultimately, the Core Group's language on TRIPS flexibilities were preserved in the operative text.
During the 1 July 2016 plenary discussions, the Ambassador of the the United Kingdom of Great Britain and Northern Ireland (Julian Braithwaite) remarked:
As a general remark, we regret that this resolution presents a substantial amount of language that has been intricately negotiated by relevant experts in the WHA, the WTO, and the WIPO. Here, those individual paragraphs are transplanted out of context, and take this resolution well beyond the remit of the HRC. While we fully support the right of everyone to the enjoyment of highest attainable standard of physical and mental health...we cannot support the assertion... that creates a responsibility for states to ensure access to medicines, which is unfounded in law.
The report of the UN Secretary General’s HLP on access to medicines is expected to be published next month. Regrettably, this resolution calls for a second panel to address the same topic without waiting for the HLP’s conclusions on how to address the issue going forward. We find that intricate discussion on access to medicines here at the Human Rights Council duplicates the work of the World Health Assembly and reflects an inefficient use of the OHCHR’s valuable time and resources.
Netherlands, on behalf of the European Union, articulated the following points.
I enjoy to speak on behalf of the European Union Member States who are members of the Human Rights Council. This vote has been agreed by the EU as a whole. Dear Mr. President, the EU has a lot to say about access to medicines, so be prepared. We are strongly committed to the full realization of the right to everyone to the enjoyment of the highest attainable standard of physical and mental health. We also support the promotion of access to quality, safe, efficacious, and affordable medicines with review as a complex issue with a multitude of factors affecting it, and they become accessibility, availability and affordability of safe, quality medicines to patients around the world. The EU therefore addresses the access to medicines agenda with health in all policy approaches and through the various initiative programs and policy and financial support.
The EU is a major contributor to health related aid. In this context we do not share the assumption that there is a misalignment between the rights of inventors, international human rights law, trade rules and public health which impedes innovation and access to health technology. This assumption that the rights of inventors are the single or even the main impediment to innovation and access to health overlooks a key finding of the 2012 joint WTO, WHO, and WIPO study on promoting access to medical technologies and innovation. The lack of access to medical technology is rarely due entirely to one single determinant. Therefore, there is no doubt that access to medicines must deal with a wide range of issues, and I will give some examples, including: basic and applied research for neglected and orphan diseases, regulatory capacity building, health systems strengthening, transplant public procurement systems, increased capacity for local production and for the detection of falsified medicines, support for measures to root out corruption and to improve supply and distribution chains for pharmaceuticals. As also reflected in the WTO WHO Access Framework for Essential Medicines, there are many factors affecting the lack of access to quality health care, poor infrastructure, lack of distribution and supply system and a lack of quality. In summary, a lot of different factors play a role which access to medicine.
Therefore, while the HRC can approach this issue from the angle of human rights, it lacks sufficient expertise and competence to address it in a holistic way with all the complexity. However, partial focus in this council may convey a misleading message. From this perspective, we think that the importance of access to medicines has adequately been addressed by the council through specific past resolutions, reports and discussions. We also note the decision of the UN Secretary-General to establish a HLP on Access to medicines. That’s why, while still waiting for the results of the HLP, we have doubts regarding the usefulness of this resolution to focus on this issue. We would also like to express our concerns regarding the risk of duplications of discussions in other forums. There is a significant amount of work being done globally in this area and we encourage all states to engage and contribute to the work of international organizations such as the WHO, WTO, and WIPO on this issue. Nevertheless, we have engaged fully and constructively in the negotiations for this text and would like to thank Brazil and other members of the core group for taking into consideration a large number of our proposals. On this basis, the EU will join consensus on the draft L23 Rev 1 as orally amended. At the same time, the EU believes that other changes should have been made to further improve this resolution, including avoiding selective quotations from the resolutions from other expert forums, as well as the reopening and reinterpretation of language previously agreed upon by the entire UN membership. Thank you Mr. President.
In contrast to the opacity of informal consultations of the World Health Assembly (WHA) and certain committees (excluding the Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore and the Standing Committee on Copyright and Related Rights) at the World Intellectual Property Organization, the informal consultations on the access to medicines resolution were open to non-governmental organizations and intergovenmental organizations. Access to these consultations provided a window into how human rights negotiators deal with the intersection of the right to health and trade rules. The first round of informals are covered by this earlier piece: Human Rights Council heats up during informal talks on the primacy of human rights over international trade and IP regimes.
What follows are selected highlights from the second round of informal consultations held in the Palais des Nations on 22 June 2016
Countries participating in the second round of informal consultations included the Core Group (Brazil, China, Egypt, India, Indonesia Senegal, South Africa and Thailand), Australia, Austria, Czech Republic, Holy See, Ireland, Islamic Republic of Iran, Japan, Latvia, Maldives, Mexico, Mongolia, Netherlands, Norway, Panama, Qatar, Republic of Korea, Russian Federation, Singapore, Slovakia, Switzerland, United Kingdom of Great Britain and Northern Ireland, United States of America and Vietnam.
During the informals, the Netherlands, speaking on behalf of the European Union, objected to the reference in operative paragraph 3 of the resolution which calls upon States to make full use of WTO TRIPS flexibilities. For the European Union, the "full" use of TRIPS flexibilities seemed "unbalanced"; consequently, the European Union proposed replacing this formulation with "appropriate" use of TRIPS flexibilities. The European Union also called for the merging of operative paragraphs 3 and 4 (which focused on NCDs and the full use of TRIPS flexibilities). The Core Group rejected these proposals by by the European Union; Iran dismissed the Dutch proposal on paragraph 3 as "nonsense."
During the second round of informals, Switzerland asked the Core Group to delete the phrase, "effects on prices". Switzerland did not want any reference to States recognizing the concerns about intellectual property's "effects on prices" of health technologies; during the first round of informals, Mexico had requested for the identical deletion of the phrase, "effects on prices."
Operative paragraphs 3 and 4
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;
4. Also calls upon States to take steps to implement policies and plans 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, efficacious and quality medicines and diagnostics and other technologies, including through the full use of Trade-Related Aspects of Intellectual Property Rights flexibilities;
After the Swiss intervention, KEI drew delegates' attention to paragraph 3 of the WTO Doha Declaration on the TRIPS Agreement and Public Health which reads:
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.
KEI declared it would be disappointing if the Human Rights Council would contest something that trade ministers at the WTO Ministerial in Doha recognized, namely, the effects of intellectual property protection on medicines. Qatar supported the intervention of KEI; ultimately, the final text of the resolution contained the phrase, "effects on prices."
In relation to operative paragraph 5 of the resolution calling on States to collaborate on new models of innovation predicated upon the principle of the de-linkage of the cost of new research and development from the prices of health technologies, the Netherlands (speaking for the European Union) called for the deletion of this paragraph. The Netherlands contended the text on R&D and de-linkage "bit far away from [the realm of] human rights, and asserted that language on de-linkage was "redundant" since the UN General Assembly (UNGA) had already passed a resolution which referenced de-linkage. The Dutch request to delete the reference to de-linkage at the Human Rights Council flies in the face of their strong submission to the UN HLP advocating for de-linkage and their forceful statements at the World Health Assembly in support of de-linkage. Perhaps this policy incoherence can be explained as the difference between the national position of the Netherlands and the position of the European Union. The Core Group did not accept the EU proposal to delete paragraph 5; consequently, this language was retained in the adopted proposal.
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;
The final resolution contains a reference to generics in relation to NCDs; curiously, the Netherlands, on behalf of the European Union, requested a deletion to the inclusion of the word "generics" in the text below. The Core Group rejected the EU's demand.
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, efficacious and quality medicines and technologies to, diagnose and to treat non-communicable diseases, to strengthen viable financing options, and to 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, [Emphasis added]
The original draft of the Core Group's resolution contained a reference to the Global Commission on HIV and the Law, an antecedent to the UN HLP on Access to Medicines. As a concession to a request the Netherlands (on behalf of the European Union) and the United Kingdom, the Core Group deleted the reference to the Global Commission on HIV and the Law.
The original draft resolution stated:
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,
The final text of the resolution states:
Noting with appreciation also the Secretary-General’s decision to establish 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 United Nations High Commissioner for Human Rights in the expert advisory group supporting the Panel,
As noted in an earlier piece, during the first round of consultations, Switzerland noted its objections to the mandate of the UN HLP and requested the removal of any reference to the HLP in the access to medicines resolution and its mandate. The US supported Switzerland's objections, and as a compromise, requested that the Human Rights Council use the language of 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".
During the second round of consultations, the European Union, the United States, Japan, Switzerland objected to the gerund in the original resolution, "welcoming" and insisted on using the phrase "taking note"; ultimately they reached agreement on the phrase "Noting with appreciation." During the consultations, Mexico insisted that the full mandate of the UN HLP, "to make proposals on how to address policy incoherence in public health, trade, the justifiable rights of inventors, and human rights" be used.
During the second consultation, Australia expressed concerns over the mandate of the UN HLP. In contrast, Ecuador warned against deleting references to the UN HLP and its mandate asserting that it would be "meaningless to have a streamlined reference to the UN HLP without referring to its mandate, or having a reference in the operative paragraphs." Iran expressed its disappointment at attempts by "some states" to dilute references to the UN HLP. Iran contended that the UN HLP "is one of the most important events" on access to medicines within the UN system and noted that access to medicines is a basic element of the right to health. Ultimately, the adopted text contained a reference the UN HLP and its mandate.
A key issue of contention in the informals revolved around how to promote "policy coherence among human rights obligations, intellectual property and international trade and investment regimes." Many argued that this promotion should be predicated upon the "primacy of human rights over international trade, investment and intellectual property regimes." However, during the second round of informal consultations, the European Union rejected the primacy of human rights over international trade. The United States seconded this viewpoint, stating: "there is no primacy of human rights over international trade" and called for the deletion of this clause
The delegate of Singapore noted that while human rights are part of a set of binding international obligations, his government hesitated to place these commitments above commitments to trade. Also, Singapore noted there was no evidence to suggest that the primacy of human rights over international trade would lead to greater policy coherence. Switzerland, Japan and Australia also joined the chorus of nations calling for the deletion of the language, "primacy of human rights over international trade, investment and intellectual property regimes."
While the Core Group removed the language on the primacy of human rights over international trade and IP obligations from their proposed resolution, it can be argued that the the coalition of Australia, the European Union, Japan, Switzerland and the United States won a Pyrrhic victory at the Human Rights Council, as the adopted resolution contains strong references to the full use of TRIPS flexibilities, de-linkage, UN HLP and a mandate to convene a panel on access to medicines in March 2017 during the thirty-fourth session of the Human Rights Council. As we continue to face global disparities and lack of access to health care, the passing of this resolution reaffirms the global effort to put the fundamental right to health at the forefront of international priorities. As Brazil's delegation expressed, "no effort should be spared to realize this right for all."