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.