UN High-Level Panel On Access To Medicines Takes Next Step At Human Rights Council

by , Intellectual Property Watch:

The United Nations Human Rights Council held a panel discussion yesterday to exchange views on good practices and key challenges relevant to access to medicines. The panel gave a large part of the discussion to the recent report of the United Nations Secretary General’s High-Level Panel on Access to Medicines, much to the chagrin of the European Union and the United States.

Opening the panel discussion, UN Deputy High Commissioner for Human Rights Katie Gilmore said the right to physical and mental health is a fundamental right, remarking for example, that only half of those living with HIV/AIDS have access to anti-retroviral medicines.

She also pointed out, on international Women’s Day, that many women and girls lack access to medicines, calling for them to be able to be in control of their fertility. The right to health is an enabler of other rights, she said, and among other things, intellectual property rights must not be allowed to override the enjoyment to the right to health. She called for a human rights-based approach to trade and investment policies.

Amb. Maria Nazareth Farani Azevêdo, Ambassador of Brazil to the UN, noted that states have an obligation to respect and fulfil their populations’ right to health, adding that currently one-third of the global population does not have regular access to medicines.

Dreifuss: IP Rights Not Used as Legitimate Rights of Inventors

Ruth Dreifuss, former president of Switzerland, chair of the Global Commission on Drug Policy, and co-chair of the Secretary-General’s High-Level Panel on Access to Medicines, said the current innovation system is inadequate to address certain areas such as formulation for children, neglected tropical diseases, and antimicrobials.

There is a point that needs to be made on fundamental rights, she said. The High-Level Panel’s mandate was to look into the policy incoherence between the justifiable rights of inventors, international human rights law, trade and public health in the context of health technologies. Inventors are physical persons and are entitled to fair remuneration, she said, but the same cannot be said about IP rights. IP rights are most usually given to moral persons, to companies, not individual inventors, she said. These IP rights are not the legitimate rights of inventors, she added.

She said the panel was aware that IP rights are but one aspect of many obstacles to accessing medicines and health technologies. The focus of the panel was put on the tension between IP rights and the right to health, she explained.

Kirby: Millions Will Be Left Behind, Millions Will Die

Michael Kirby, former justice of the High Court of Australia and member of the High-level Panel, said the Panel “unusually” conducted public hearings to listen to nation states, industry, civil society, and individuals denied access to medicines.

“We will never forget the voices of those who are left behind, many of them women or girls, families forced to beg for charity for patented medicines…,” he said. “Unless the world and the UN, and this Council act now, there is no way” that Goal 3 (on Right to Health) of the UN 2030 Sustainable Development Goals will be reached, he said. “Millions will be left behind and millions will die,” he added.

He said some of the panel members would have gone further than the current recommendations, and some would have taken a different path, but all agreed on the core recommendations, he said, including the fact that World Trade Organization members must respect the flexibilities included in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

He called for the UN secretary-general to initiate an independent review body on health innovation to address market weaknesses “once and for all.”

WHO Supports Access to Medicines, Transparency

Marie-Paul Kieny, assistant director-general, Health Systems and Innovation at the World Health Organization, underlined the “long tradition” of WHO’s commitment to support access to medicines, one of which is the WHO Prequalification Programme through which countries can access generic medicines and vaccines of assured quality, she said.

She added that the WHO provided advice to Colombia in May 2016 on the use of the TRIPS flexibilities to make cancer treatments more affordable, and helped Ethiopia to build its national strategy and plan of action for pharmaceutical manufacturing. The High-level Panel recommendations echo the conclusions of a WHO previous expert commission and the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, she said, adding that the WHO welcomes the call for more transparency on prices.

In her concluding remarks, Kieny said the issue of transparency is important for the WHO. However, she said, there is a need to have openness of industry to disclose information on prices in two ways. The first is to get transparency on the cost of production. The other one is to get transparency about prices, she said. Governments have a big role to play, as many countries have “secret advantages and cannot disclose them, so they remain secret,” she said.

Governments have to make the price they pay public, Kieny said.

On the de-linkage between the cost of R&D and the price of medicines, she said WHO has been advocating de-linkage but there is already a de-linkage she said, as prices “have nothing do to with costs,” but are based on “social value”. The price of hepatitis C medicines was based on the price of a liver transplant, she said.

WTO: Doha Declaration Benchmark

Antony Taubman, director of the WTO Intellectual Property Division, said that the Doha Declaration framed the legal, practical and policy context of the TRIPS Agreement, and remains a benchmark for policymakers today.

He said in opening that the trilateral cooperation between the WHO, WTO, and the World Intellectual Property Organization manifests a holistic, inclusive approach, “a conscious effort by three specialised agencies, led directly by their directors general, to work towards policy and practical coherence for public health, including recognition of the human rights dimension.”

Taubman, in concluding remarks, said “like charity begins at home, coherence begins at home too.” The ideal role of the IP system should be to function at the mutual advantage of producers and users of technological knowledge, he said. Trade is for most countries the prominent way they access medicines, he said, adding that the obstacles disproportionately fall on poor countries.

WIPO: Sustaining Innovation and Access for All Central Challenge

Thomas Bombelles, head of Global Health at the WIPO Global Issues Sector, said the promotion of intellectual property as a tool to support innovation, creativity, and economic development and is central to WIPO’s activity, and its reason for existing. “Our mission is to lead the development of a balanced and effective international intellectual property system that enables innovation and creativity for the benefit of all.”

In the field of global health, he said, the question of how to simultaneously sustain innovation for new medicines and other health technologies, while also ensuring access for all, is a central challenge. He described activities of WIPO directly relevant for the work of the High-level Panel and the broader issues of innovation and access. In particular, he cited the work of the Global Challenges division, for which he said he works, which he said addressed cross-cutting issues of innovation and access in global health.

WIPO Re:Search is a major programme of the division and its purpose is to catalyse more research and development for neglected diseases, he said. By creating a result-oriented real world project, WIPO and its partners aim “to use more than words to show that intellectual property can and does deliver innovation to all those in need,” he said, adding that “it does not do so with perfection.”

South Centre, UNCTAD

Carlos Correa, special advisor on trade and intellectual property at the South Centre, focused on the report’s recommendations on bilateral and regional trade and investment agreements. He said the majority of impact assessments of IP on health were carried out before the negotiations on bilateral and regional agreements started extending IP protection.

There is a lack of appropriate methodology to address consequences of IP, he said. Countries which ratify agreements with raised IP provisions do not have the power to resist those provisions.

James Zhan, director of the Division on Investment and Enterprise at the UN Conference on Trade and Development (UNCTAD), said UNCTAD has been helping to build capacity to produce essential medicines in low-income countries. He said building production capacity leads to less dependence from medical importations and helps adaptation to specific local needs and conditions.

UNCTAD has found six major challenges in their capacity building programme, said Zhan, including: weak regulatory frameworks; lack of financing; poor policy coherence and fragmented institutional setup; weak local productive capacity and supply network; and inadequate international support measures.

He underlined the need for more effective international support investment in low-income countries to produce affordable medicines, and said there should be regional cooperation for production and distribution to achieve economy of scale and enlarge the market.

Countries Underline Persistent Challenges

Countries taking the floor underlined the persistent challenges in the way to universal access to medicines, such as Brazil, speaking on behalf of Portuguese-speaking countries, and the importance of the universal right to health.

El Salvador, speaking on behalf of the Community of Latin American and Caribbean States, said it hoped the panel will be able to contribute to convening a special session of the UN General Assembly no later than 2018 on health technology innovation and access.

EU, US Want Strong IP Environment; Portugal Says Prices Shocking

The European Union said it is committed to increasing access to quality and affordable medicines and recognised that a balanced, strong, functioning and effective intellectual property environment “that is in line with our international commitments is important for supporting and promoting access to innovative safe and effective quality medicinal products in the EU.”

The current innovation model has provided progress both in developed and developing countries, he said.

The EU delegate remarked on the fact that the Human Rights Council panel only focused on the High-Level Panel’s report in contradiction with the Council’s resolution last June, which indicated that “all relevant reports” should be considered, and regretted that mention was not made of the trilateral cooperation between WHO, WTO, and WIPO, or of the WHO GSPOA (IPW, Public Health, 1 July 2016).

EU member Portugal, meanwhile, said high prices are threatening the sustainability of health care systems, and hepatitis C prices have been “particularly shocking.” The delegate said last week the EU Parliament welcomed the report of the High-Level Panel. [Clarification: the Parliament resolution adopted on 2 March only notes the High-Level Panel report, while an earlier draft version of the resolution did say the Parliament welcomed the report.]

According to a European Parliament press release, the Parliament adopted a resolution on 2 March on access to medicines.

The US also regretted the focus of the panel on the High-Level Panel, which the delegate said operated “under a flawed premise,” as it failed to consider critical barriers to access to medicines. The panel, the US delegate said, could not reach consensus on key recommendations, “with two of the Panelists – the two who had the most extensive experience in research and development – warning that the Report’s recommendations could result in serious negative unintended consequences for R&D.”

The US asked that the panel not be used as a basis for the Human Rights Council to further consider the High-level Panel report or for other future work.

Nothing is preventing member states from taking immediate domestic actions to reduce existing barriers to access to medicines, such as insufficient health systems, inadequate access to financing, or lack of essential procurement systems, the US speaker said.

Answering to the US, Kirby, in his concluding remarks, said that the High-level Panel had considered non-intellectual property barriers in the report at length and suggested the US delegate to judge the report on its content, and that if it is going to criticise it, it should read it.

To access a number of oral statements, such as Portugal, US, EU, and WIPO, it is necessary to register to be able to log in to the HRC Extranet: http://www.ohchr.org/EN/HRBodies/HRC/Pages/HRCRegistration.aspx

Then go to: 34th session (27 February to 24 March 2017). The oral statements tab is on the top of the left hand column.