UN rights body holds panel discussion on access to medicines

A panel discussion at the UN Human Rights Council on access to medicines heard calls to ensure that intellectual property protection does not override this fundamental element of the right to health.

by Kanaga Raja

GENEVA: The UN Human Rights Council on 8 March held a panel discussion to review the key challenges to ensuring access to medicines as well as exchange views on good practices, including exploring the recommendations of the UN Secretary-General’s High-Level Panel on Access to Medicines.

The panel discussion took place during the regular thirty-fourth session of the Council, which met here from 27 February to 24 March.

At its thirty-second session last July, the Council had decided to convene at its thirty-fourth session “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 all relevant reports.”

The Council had also requested the UN High Commissioner for Human Rights to prepare a summary report on the panel discussion and to submit it to the Council at its thirty-sixth session.

The panel discussion was chaired by the Vice President of the Council, Ambassador Mouayed Saleh of Iraq, and moderated by Ambassador Maria Nazareth Farani Azevedo of Brazil.

The panellists included Ruth Dreifuss, former President of Switzerland and Co-Chair of the Secretary-General’s High-Level Panel on Access to Medicines; Michael Kirby, former Justice of the High Court of Australia and a member  of  the High-Level  Panel; Marie-Paule Kieny, Assistant Director-General, Health Systems and Innovation, World  Health  Organization  (WHO); Anthony Taubman, Director of the Intellectual Property Division at the World Trade Organization (WTO); Thomas Bombelles, Head of Global Health at the Global Issues Sector, World Intellectual Property Organization (WIPO); Carlos Correa, Special Advisor on Trade and Intellectual Property, South Centre; and James Zhan, Director of the Division on Investment and Enterprise, UN Conference on Trade and Development (UNCTAD).

The right to health

The UN Deputy High Commissioner for Human Rights, Kate Gilmore, who opened the panel discussion, said that the right to health and its associated obligations calls on states to ensure universal access to good-quality healthcare, including essential medicines, on the basis of equality and non-discrimination.

In this, she said, the protection of those who are otherwise marginalized, those with the fewest options, those who routinely are left behind, is essential. Without access to life-saving commodities, the realization of the right to health will remain an unattainable goal for numerous countries and thus for millions of their people.

She said further enjoyment of the benefits of scientific progress is a right in and of itself. It is recognized in the Universal Declaration of Human Rights and the International Covenant on Economic, Social and Cultural Rights, and among its key elements is the affirmation that innovations essential for a life with dignity should be accessible to everyone without discrimination.

These human rights norms are so fundamental and so intertwined with numerous other rights as to be binding on all states. Yet, she noted, today millions live without access to essential medicines not due to an inherent lack of these commodities, but due entirely to policy deficits and entrenched practices and choices that place in the balance the lives and well-being of millions the world over – not only those who are resident in low-income countries.

For example, as of June last year, 18.2 million people were living with HIV but only half of them had access to antiretroviral therapy. That the 50% of those living with HIV have such access is a vast improvement on previous periods, but it is simply not enough.

Referring to International Women’s Day, which was celebrated on the day of the panel discussion, Gilmore said “we are indeed celebrating globally women, their achievements and their contribution and yet today, still falsely packaged as cultural and political preferences, we witness the denial of women’s and girls’ access to essential medicines with the consequence for their well-being of injury and death.”

She said it is unconscionable that today young women can be old enough to catch a sexually transmitted infection but deemed too young to have autonomous access to services for its treatment. “[It is] indefensible that a young woman can be old enough to be pregnant but too young to have access to contraception. It is unconscionable that we condemn young women for becoming pregnant, expel them from schools, and yet refuse to provide them with the medicines, the information, the education and services they need to be in control of their own fertility.”

When medicines are put beyond the reach or means of those who most need them, families and communities are left to manage tragic consequences. Concrete steps can and must be taken to correct course, Gilmore said.

She cited the UN Special Rapporteur on the right to health as pointing out the need for states to shift from the dominant market-oriented perspective on access to medicines towards fulfilment of the right-to-health paradigm. Powerful commercial and other interests should not dictate public health policy to the detriment of the fulfilment of human rights.

This means, said Gilmore, recognizing and responding to a number of challenges, including:

l     The protection of intellectual property rights must not be allowed to trump enjoyment of the right to health. Strong competition laws and policies together with forceful enforcement are required to prevent companies from indulging in anti-competitive practices and to promote competitive pricing of medicines.

l     Human rights and stakeholder participation both must influence trade agreements. Stakeholders do have a right to influence health policy formulation, implementation and its monitoring, and under the human rights-based approach, trade and investment agreements should be negotiated with human rights in mind and concluded with human rights input.

l     The availability, accessibility and acceptability of good-quality medicines for everyone on the basis of non-discrimination must be integrated into all public health policy frameworks.

l     Policymakers and other actors responsible for the implementation of health policy should be made accountable to the users of health services.

For this to take place, “we have the opportunity – not only the responsibility – to undo the power imbalances that lie at the heart of this issue by empowering rights-holders to be partners in health, to claim their health and health-related rights and to enable health policymakers to make people-centred decisions and hold them accountable for delivering on this.”

According to Gilmore, perhaps the greatest obstacle to fulfilling the obligation to ensure access to essential medicines for all is political will. She said it is also a question of health economics, the ethics of the pharmaceutical industry, and the responsibility of healthcare providers and health professionals and their schools.

She called on all these authorities and actors under the banner of the state health plans incorporating human rights to stand up for the right to health.

Ambassador Azevedo of Brazil, the moderator of the panel discussion, explained that based on the request of the Human Rights Council, the panel discussion would provide a platform for states and all relevant stakeholders to review key challenges applicable to ensuring access to medicines and to exchange views on good practices in this regard. The discussion would also explore, from a human rights perspective, the recommendations presented by the High-Level Panel on Access to Medicines.

She said every human being is entitled to the enjoyment of the highest attainable standard of physical and mental health conducive to living a life in dignity. States are obliged to respect, protect and fulfil this right, including ensuring access to medicines, recognizing the essential importance of international cooperation and technical assistance to this effect.

She noted that even with the great potential of science and technology to advance healthcare, at least one-third of the world population have no regular access to medicines. The recent outbreaks of highly infectious diseases and epidemics have demonstrated the importance of developing new and innovative medicines and vaccines.

High-Level Panel

Dreifuss, Co-Chair of the High-Level Panel on Access to Medicines, explained the mandate and work of the High-Level Panel. (The High-Level Panel was established by the UN Secretary-General “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.” It issued its final report, which was submitted to the Secretary-General, in September 2016 – see TWE No. 625.)

Dreifuss said that the panellists had scrupulously confined themselves to the limited mandate that they had been given. She however pointed out that the mandate was not confined only to access to medicines. On the one hand, prevention, treatment, rehabilitation and social integration required access by all not just to medicines but to vaccines, diagnostic tools and all sorts of medical equipment. On the other hand, the mandate also addressed shortcomings in biomedical research and in the development of medicines.

Incentives provided by intellectual property rules are based on the existence of a viable market, and are thus inapplicable to many diseases. In this context, she highlighted as examples neglected tropical diseases and rare diseases, vaccines, child formulas and new solutions to growing antibiotic resistance.

Dreifuss pointed out that when research and development (R&D), particularly for non-infectious diseases which now represent the most serious health burden in both the North and the South, leads to new medicines, the time-limited monopoly afforded by patents and licences leads to prices which prevent many patients from benefiting from the progress in science. This happens not just when the patients have to pay for these medicines out of their own pockets but also leads to problems even in health systems which are designed to guarantee universal coverage but are forced to introduce restrictions and rationing of such treatment and medical technologies.

Dreifuss said the mandate of the High-Level Panel refers to the legitimate rights of inventors. Inventors by their very nature are physical persons and they are entitled to fair remuneration and recognition for their contribution to science. But the legitimate rights of inventors are not the same thing as intellectual property rights, which are usually given to companies that are granted a time-limited exclusive right to use an invention.

She said that trade rules and intellectual property rights were developed in order to promote economic growth and to stimulate innovation. On the one hand, governments seek to get the economic benefits of international trade. On the other hand, the obligation to respect medical technology patents can in some cases be an impediment to public health objectives.

“We therefore must welcome the Doha Declaration [on the TRIPS Agreement and Public Health] introducing flexibilities for states in meeting these obligations,” she said. “But we must also emphasize the fact that there is continuing incoherence particularly because subsequent negotiations have reduced the Doha Declaration flexibilities or put countries under pressure, preventing them from invoking the flexibilities.”

Dreifuss pointed out that the High-Level Panel had recognized that it is a matter of state sovereignty for states to lay down the criteria for granting patents and also for states to determine health emergencies which require them to take particular measures.

“We also emphasized the importance of transparency as an absolute precondition for ensuring the coherence we were called upon to address with proposals in order to achieve that coherence,” she said.

Policy incoherence

Kirby, a member of the High-Level Panel, said that the issue is not just a matter of ethics but also one of international law. He said great developments have been achieved in inventions relevant to the right to health, in the distribution of those inventions and in global solidarity. However, high among the impediments to the attainment of the right to health has been the clash of policy incoherence and the weaknesses of market mechanisms in stimulating invention and in promoting just distribution in accordance with human rights principles.

He said the High-Level Panel conducted public hearings in London, Johannesburg, and with links to Bangkok, so as to listen to the nation states, to industry, to civil society and to individuals effectively denied access to essential medicines. “We will never forget the voices of those who are left behind, who came before our public hearings. Many of them women and girls, representing families forced to beg for charity and the supply of patented drugs that would save lives, but often denied that charity as outside the guidelines for selective assistance.

“We will never forget the people of Africa and Asia who have contracted multi-drug-resistant tuberculosis and who cannot afford the prohibitively costly therapies of limited effectiveness that [are] presently all that is available.”

“It is therefore necessary to say bluntly at this session,” Kirby underlined, “that unless the world and the United Nations and this Council act now, there is no way that we will attain Sustainable Development Goal No. 3 by 2030.” (Sustainable Development Goal 3 is to “ensure healthy lives and promote well-being for all at all ages”.)

“In the High-Level Panel some of us would have gone further than in the report which we produced,” said Kirby. “Some of us would have taken a different path than in this report. But all of us agreed on the core of essential conclusions which represented our consensus.”

Among those conclusions were, firstly, that the WTO members must respect the flexibilities in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and respect human rights protection in the Doha Declaration. “There must be no more pressuring to force countries to surrender their rights ... to invoke compulsory licences and to contest ‘evergreening’ and other misuse of market power,” said Kirby.

Secondly, he said, the international community should negotiate a global R&D treaty to repair the market failures in the invention and availability of essential medicines for all.

Thirdly, the UN Secretary-General should initiate an independent review body for health and technology innovation with a high-level meeting by 2018 to address global market weaknesses once and for all.

The policy incoherence, Kirby stressed, needs to be addressed. The High-Level Panel’s report is the minimum prudent package placed before the Human Rights Council; its foundation is indisputably universal human rights. “And respectfully we suggest it deserves the support of this Council.”

Public health impact assessments

Correa from the South Centre focused on the recommendation contained in the High-Level Panel report which states: “Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health. As a first step, they must undertake public health impact assessments. These impact assessments should verify that the increased trade and economic benefits are not endangering or impeding the human rights and public health obligations of the nation and its people before entering into commitments. Such assessments should inform negotiations, be conducted transparently and made publicly available.”

Referring specifically to these impact assessments, Correa cited a study carried out in 2006 by Thailand’s National Commission for Human Rights on the potential impact on public health of the intellectual property provisions that were being negotiated at that time in a trade agreement with the United States. A number of ex ante academic studies have also been undertaken prior to trade agreements being brokered such as the US-Central America Free Trade Agreement (CAFTA). There have also been methodologies proposed by a number of academics.

Following the recommendation made by the High-Level Panel, it would be important for the Human Rights Council to embark upon the development of some methodologies and guidelines for the realization of impact assessment studies, Correa said.

He underlined that the majority of the impact assessments on public health have been carried out ex ante, i.e., before the negotiation of agreements that increase intellectual property protection and typically extend patent monopolies. As a result of this ex ante approach, there is a lack of appropriate methodologies to address the ex post consequences of the adoption of certain intellectual property rights standards.

Correa said developing countries that accept maximalist intellectual property rights provisions in trade agreements do so in the context of asymmetric power relationships. They do not have the power to resist the imposition of these protectionist provisions.

The outcome of this wave of over-protectionism in the area of intellectual property rights should not be deemed irrevocable. None of this is carved in stone, stressed Correa.

Kieny of WHO highlighted the activities of the organization in supporting access to medicines and the challenges faced in this context. She said that WHO has a long tradition of commitment and activity to support 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.

The WTO’s Taubman described the panel discussion at the Human Rights Council as a welcome step forward in the journey together towards the shared goal of access to medicines for all and promoting the development of urgently needed new medicines, recognizing the centrality of the human rights perspective for this collective effort.

For the WTO, he said, the Doha Declaration was a significant milestone on this journey. Unanimously, at the highest political level, Doha framed the legal, practical and policy context of TRIPS squarely within a public health setting. Doha remains a benchmark for policymakers today, all the more pertinent in the light of the Sustainable Development Goals, the growing complex of regional and bilateral trade agreements, and the renewed multilateral dialogue exemplified by the very resolution that established the Human Rights Council panel discussion.

Bombelles of WIPO said that the promotion of intellectual property as a tool to support innovation, creativity and economic development is central to WIPO’s activity and reason for existing. Importantly, WIPO’s founding documents stress that WIPO should pursue its mandate in coordination with other UN bodies and also participate in the relevant work of other UN bodies.

“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 this context, he said, WIPO and its member states have long understood and appreciated that intellectual property has transcended the confines of legal issues relating to patents, copyrights, trademarks etc. and touches on many of the most important public policy issues of our time, including health, environment, food security and many others.

In the field of global health specifically, the question of how to simultaneously sustain innovation in new medicines and other health technologies while also ensuring access for all, is a central challenge, Bombelles said.

Zhan of UNCTAD highlighted that UNCTAD has been working on access to medicines since 2005, from the specific angle of intellectual property rights and investment in local pharmaceutical production. (SUNS8420)                           

Third World Economics, Issue No. 634, 1-15 February 2017, pp2-5