[Reposted with author’s permission from TWN Info] The United Nations Human Rights Council has adopted a resolution on access to medicines despite opposition from the United States and the European Union.
This was at the 23rd session of the Council held in Geneva on 27 May-14 June 2013. The resolution was sponsored by developing countries as a follow-up to the Report of the UN Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Anand Grover, on access to medicines (see SUNS #7599 dated 6 June 2013).
The resolution titled “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” was adopted on the basis of a vote on 13 June (now officially available as A/HRC/RES/23/14 dated 24 June 2013). Out of 47 members of the Human Rights Council, 31 voted for the resolution while 16 abstained from voting.
[The following countries voted in favour of the resolution: Angola, Argentina, Benin, Botswana, Brazil, Burkina Faso, Chile, Congo, Costa Rica, Cote d’Ivoire, Ecuador, Ethiopia, Gabon, Guatemala, India, Indonesia, Kenya, Kuwait, Libya, Malaysia, the Maldives, Mauritania, Pakistan, Peru, the Philippines, Qatar, Sierra Leone, Thailand, Uganda, United Arab Emirates, and Venezuela.
[The following countries abstained from voting: Austria, Czech Republic, Estonia, Germany, Italy, Ireland, Japan, Kazakhstan, Montenegro, Poland, Republic of Korea, Republic of Moldova, Romania, Spain, Switzerland, and the United States of America.]
According to a developing country delegate, the EU and the US led the abstention. It was learnt that the US proposed nearly five amendments to the resolution with the objective of limiting the scope of the resolution to essential medicines and also to dilute the wording on local manufacturing.
Disagreement during the informal negotiations led to the decision of the US, the EU, Japan, Republic of Korea, Switzerland and Kazakhstan to abstain from voting.
Another developing country delegate termed the EU’s abstention decision as “backstabbing” because the EU had proposed a series of amendments during the informal negotiations and consensus was reached on many issues raised by the EU. However, the EU decided to back-track from the consensus and joined with the US decision to abstain from voting.
The US proposed the following five amendments.
First, to delete “the highest attainable level of health for all including through” before “access,” and add “to all” after “access” in Operational Paragraph 3 (OP 3) that reads: “Stresses the responsibility of States to ensure the highest attainable level of health for all, including through access, without discrimination, to medicines, in particular essential medicines, that are affordable, safe, efficacious and of quality”.
The US proposal would have changed OP 3 to read: “Stresses the responsibility of States to ensure access to all, without discrimination, to medicines, in particular essential medicines, that are affordable, safe, efficacious and of quality.”
Thus, the US proposal intended to dilute the language by removing the words that link access to medicines to the goal of highest attainable level of health for all. In effect, it means restricting state responsibility to ensure access to medicine mainly in the essential medicines context.
Secondly, the US proposed to add the words “in particular essential medicines,” after the words “to medicines” in OP 5(a).
OP 5(a) urges States as appropriate, “To implement, or where they do not exist, to establish, national health frameworks that ensure access for all, without discrimination, to medicines that are affordable, safe, efficacious and of quality”.
The US proposal would have changed OP 5(a) to limit the scope primarily to essential medicines: “To implement, or where they do not exist, to establish, national health frameworks that ensure access for all, without discrimination, to medicines, in particular essential medicines, that are affordable, safe, efficacious and of quality.”
Thirdly, the US proposed to add the words “where appropriate” after the word “including” in OP 5(h) that reads: “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”.
The US proposal would have changed the sentence to: “To promote access to medicines for all, including, where appropriate, 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”.
Thus, the US intended to dilute the language on the use of TRIPS flexibilities by introducing the condition of appropriateness, which is not found in other international documents such as the UN General Assembly Resolution on HIV/AIDS, the General Assembly Political Declaration on Non-communicable Diseases, etc.
Fourthly, the US proposed to delete the words “measures and” in OP 5(j) that reads: “To apply measures and procedures for enforcing intellectual property rights in such a manner as to avoid creating barriers to the legitimate trade of affordable, safe, efficacious and quality medicines, and to provide for safeguards against the abuse of such measures and procedures”.
The US proposal would have reduced the scope of OP 5(j) by removing the measures used for the enforcement of intellectual property rights (a matter of considerable controversy) from the scope of the resolution.
Fifthly, the US proposed to add the word “promoting” before the words “access to medicines” in OP 6 that reads: “Calls upon the international community to continue to assist developing countries in promoting the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including through access to medicines that are affordable, safe, efficacious and of quality, and through financial and technical support and training of personnel, while recognizing that the primary responsibility for promoting and protecting all human rights rests with States”.
By adding the word “promoting”, the role of the international community would only be to promote access to medicines, a very diluted role in the context of ensuring access to medicines.
It is noteworthy that the US did not oppose OP 7(a), OP 7(g) and OP 7(i) of Human Rights Council Resolution 17/14 dated 14 July 2011 that are verbatim reproduced in OP 5(a), OP 5(h) and OP 5(j) of the June 2013 resolution.
According to an observer, the US might have purposefully proposed the textual changes at the last minute to avoid consensus on a resolution containing language to develop a policy framework on local production of medicines.
(The 2011 Resolution 17/14 is titled: “The right of everyone to the enjoyment of the highest attainable standard of physical and mental health in the context of development and access to medicines”.)
It was also learnt that the EU, apart from suggesting more than 25 textual amendments to the first version of the June 2013 resolution, also raised three broad comments, which indirectly questioned the very idea of the resolution.
The first comment suggested that even though access to medicines is a health and human rights issue, the Human Rights Council is not “well-placed” to discuss the “specialized technical issues” on health, trade and intellectual property. According to the EU, such discussion may lead to “undesirable duplication of efforts”.
Secondly, the EU expressed the view that the scope needs to consider all the determinants of access from the production to the delivery of the medicines, integrating essential elements such as quality or rational use.
These elements, the EU said, are currently under the mandate and ongoing work of the World Health Organisation (WHO).
Thirdly, the EU stressed that the right to health extends far beyond the access to medicines and includes a wide range of factors that can help us to lead a healthy life.
It was learnt that even though some of the EU amendment proposals were limited to language edit without altering the substance of the resolution, many proposals for amendments were also aimed at diluting/limiting the content of the resolution. For instance, the EU proposed the replacement of the word “ensure” with “promote” in OP 5(a).
It proposed the words “quality, safe, efficacious and affordable” to be added before the word “medicine” in various operating paragraphs such as OP
5(f) that reads: “To strengthen, or where they do not exist, to establish, national monitoring and accountability mechanisms for policies relating to access to medicines.”
Further, it is also learnt that the EU proposed two amendments to OP 5(h) that reads: “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”.
First, the EU proposed to add the words “quality, safe, efficacious and affordable” after the words “access to”. Secondly, it proposed deletion of the words “as well as the concerns about its effects on prices”.
The EU also proposed the deletion of OP 5(j): “To apply measures and procedures for enforcing intellectual property rights in such a manner as to avoid creating barriers to the legitimate trade of affordable, safe, efficacious and quality medicines, and to provide for safeguards against the abuse of such measures and procedures”.
In the final resolution, these EU proposals were not accepted.
The resolution contains 11 preamble paragraphs (PP) and 10 OP.
PP 7 recalls the confirmation of the Doha Ministerial Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health 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”.
PP 8 regrets the fact that a high number of people are still without access to affordable, safe, efficacious and quality medicines and underscores that improving such access could save millions of lives every year. It also notes with deep concern that more than one billion people still do not have access to essential medicines.
PP 10 expresses concern that the growing 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 recognizes the urgent need for further measures at the global, regional and national levels to prevent and control such diseases in order to contribute to the full realization of the right of everyone to the highest attainable standard of physical and mental health.
OP 1 takes note of the study of the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health on existing challenges with regard to access to medicines in the context of that right, ways to overcome them and good practices.
OP 2 recognizes that access to medicines is one of the fundamental elements in achieving progressively the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
OP 3 stresses the responsibility of States to ensure the highest attainable level of health for all, including through access, without discrimination, to medicines, in particular essential medicines, that are affordable, safe, efficacious and of quality.
OP 4 emphasizes the central role of prevention, the promotion of healthy lifestyles and the strengthening of health systems.
OP 5, which is the central element of the resolution, urges States, as appropriate, to take the following 16 measures to fulfill their obligations on access to medicines within the right to health framework:
(a) To implement, or where they do not exist, to establish, national health frameworks that ensure access for all, without discrimination, to medicines that are affordable, safe, efficacious and of quality;
(b) To develop a policy framework on medicines, including, where appropriate, local production of medicines, with the aim of ensuring long-term accessibility and affordability of medicines;
(c) To adopt regulation measures with a view to providing access of the population, and particularly individuals in vulnerable situations, to affordable medicines.
(d) To raise awareness about the responsible use of medicines, including through the wide dissemination of information in that regard, taking into account the potential risks to health;
(e) To promote the informed participation of relevant stakeholders, as appropriate, in formulating national medicines policies and programmes, while safeguarding public health from undue influence by any form of real, perceived or potential conflict of interest;
(f) To strengthen, or where they do not exist, to establish, national monitoring and accountability mechanisms for policies relating to access to medicines;
(g) To ensure that procurement practices and procedures for medicines are transparent, fair, competitive and non-discriminatory;
(h) 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;
(i) To foster the development of technology and the voluntary transfer of technology to developing countries, on mutually agreed terms aligned with national priorities, bearing in mind the specific needs of least-developed countries in this regard;
(j) To apply measures and procedures for enforcing intellectual property rights in such a manner as to avoid creating barriers to the legitimate trade of affordable, safe, efficacious and quality medicines, and to provide for safeguards against the abuse of such measures and procedures;
(k) To strengthen, or where they do not exist, to establish, national health regulatory systems that ensure the quality, safety and efficacy of medicines;
(l) To promote the improvement of health infrastructures necessary for access to affordable, safe, efficacious and quality medicines, such as storage and distribution systems;
(m) To ensure that investment, industrial or other policies promote development and access to medicines, in particular their affordability;
(n) To explore and promote a range of incentive schemes for research and development, including addressing, where appropriate, the delinkage of the costs of research and development and the price of health products, in accordance with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property;
(o) To improve domestic management capacities in order to improve delivery and access to quality, safe, efficacious and affordable medicines;
(p) To promote universal health coverage in national systems as one of the efficacious means to promote access to medicines for all.
OP 6 calls upon the international community to continue to assist developing countries in promoting the full realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including through access to medicines that are affordable, safe, efficacious and of quality, and through financial and technical support and training of personnel, while recognizing that the primary responsibility for promoting and protecting all human rights rests with States.
OP 7 invites relevant United Nations programmes and agencies, in particular the WHO, as well as other relevant international organizations, within their mandates, to consider the findings of the study of the Special Rapporteur.
OP 8 recognises 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 WHO, 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 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.
OP 9 urges all States, United Nations agencies and programmes and relevant intergovernmental organizations, 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.
According to an observer, the resolution is a step forward in addressing the issue of access to medicines within the right to health framework.
This is the first time a comprehensive resolution covering most of the determinants of access to medicines within the human rights framework is articulated in a stronger language than the earlier Human Right Council Resolution 17/14 of 2011.
The Resolution 17/14 used the word “encourages States” and listed down 11 measures. This resolution is stronger than “urging”. Further, the resolution recognizes access to medicines as one of the fundamental elements in the realization of the right to health in OP 2.
Secondly, unlike some earlier resolutions, the scope of the June 2013 resolution is not limited to essential medicines and covers all medicines.
Thirdly, the resolution clearly addresses the issue of prices of medicines and urges States in the regulation of prices in OP 5(c), “To adopt regulation measures with a view to providing access of the population, and particularly individuals in vulnerable situations, to affordable medicines”. This clearly means the regulation of prices of medicines to make them affordable for people. This is important in the context of developing countries where people incur out-of-pocket expenditure to buy medicines.
Fourthly, the resolution through OP 5(b) and OP 5(m), clearly establishes the link between local production and the right to health framework.
Fifthly, OP 5(n) of the resolution also addresses the research and development question within the right to health framework, especially referring to a new R&D model based on de-linking of cost of R&D from the price of health products.
Sixthly, the resolution also establishes the link between access to medicines and universal health coverage in OP 5(p).
OP 10 also refers to this important linkage by inviting “the Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, within his existing mandate, while considering the many ways towards the full realization of the right to health, including universal health coverage, to continue to focus on the issue of access to medicines, including in his regular country missions.”
Seventhly, unlike the earlier resolution, this one reflects the conflict of interest issue while referring to engagement with stakeholders. OP 5(e) and OP 8 clearly state that the engagement with stakeholders is based on the principle of safeguarding public health from undue influence by any form of real, perceived or potential conflict of interest.
Another observer points out some of the shortcomings of the resolution.
First, the OP 5(a) language does not convey the message clearly because it urges States to develop a national framework to ensure access to “medicines that are affordable, safe, efficacious and of quality”.
According to the observer, even though the intention is clear, it conveys a meaning that the framework should ensure access to only those medicines that are affordable, safe, efficacious and of quality. In other words, it conveys a meaning that the framework need not address the medicines which are not affordable but safe, efficacious and of quality.
Secondly, OP 5(h) dealing with the use of TRIPS flexibilities also states that the protection of intellectual property is important for the development of new medicines. This is a highly contested assertion. There is enough evidence to show that the current IP framework, especially patent protection, is not a necessity to develop new medicines, especially to develop medicines to meet the needs of developing countries.
Thirdly, OP 5(j) on IP enforcement conveys a meaning that restrains the application of IP enforcement only if the measures and procedures create a barrier to the legitimate trade of affordable, safe, efficacious and quality medicines. In other words, the resolution does not apply in the context when the medicine is not affordable.
However, the language in OP 5(h) and OP 5(n) dealing with use of IP flexibility and IP enforcement is taken from the Human Rights Council Resolution 17/14 of 2011.
Fourthly, OP 9 urging states and international organizations to promote innovative research and development to address health needs in developing countries omitted the de-linkage of the costs of research and development from the price of health products, mentioned in OP 5(n).
Fifthly, the resolution does not contain any mention of curbing the unethical promotion of medicines. The Report of the Special Rapporteur identified it as one of the important issues affecting access to medicines.
The Report recommended to “Prohibit unethical commercial marketing and promotion of medicines by pharmaceutical companies through legal accountability measures based on strict penalties and cancellation of manufacturing licenses.”
Similarly, the resolution is also silent on the transparency of clinical trial data. The Special Rapporteur’s Report recommended to “Ensure transparency of data related to quality, safety and efficacy of medicines, including the mandatory publication of adverse data.”
