Human Rights Council panel highlights how access to medicines is impeded by patents

The UN Human Rights Council held a panel discussion on human rights and access to medicines in Geneva.   Panellists included members of the UN Secretary General’s High Level Panel on Access to Medicines.  The panel presentations highlighted how patents have impeded the affordable access to medicines and called for impact assessments to be done on the effects of free trade agreements on the right to health.  (This article  was originally published in the SUNS.)

By Kanaga Raja

Members of an official panel of the Human Rights Council highlighted that access to medicines and the right to health are being impeded by high prices of medicines caused by patent monopolies, and urged that the Council facilitate studies of the human rights impact  of trade agreements that contain intellectual property provisions.

The UN Human Rights Council on 8 March 2017 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 Council had decided in July 2016 to convene “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, and that the discussion shall be fully accessible to persons with disabilities.”

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

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

The UN Deputy High Commissioner for Human Rights, Ms. 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 health care, including essential medicines, on the basis of equality and non-discrimination.

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

She said further enjoyment of the benefits of scientific progress is a right in and of itself. It is recognised 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 – so intertwined with numerous other rights as to be binding on all States.  And yet today, she noted, 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, due to our choices, choices that place in the balance the lives and well being of millions the world over – and not only those that are resident in low-income countries.

For example, as of June last year, 18.2 million people were living with HIV but only one 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, Ms. 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 wellbeing of injury and death.”

She emphasised it is unconscionable that today young women can be old enough to catch a sexually transmitted infection (STI) 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 should condemn young women for becoming pregnant, expel them from schools, and 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 course correct, when course correction is urgently required, she said.

As the Special Rapporteur on health has pointed out, States do need to shift from the dominant more market-oriented perspective on access to medicines towards fulfillment of the right-to-health paradigm. Powerful commercial and other interests should not dictate public health policy to the detriment of the fulfillment of human rights.

This means among other things recognizing, and responding to a number of challenges. Among the challenges cited by the Deputy High Commissioner for Human Rights are:

* 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.

* 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.

* 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.

* Policy makers and other actors responsible for the implementation of health policy should be made accountable – an accountability 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 policy makers to make people-centred decisions and hold them accountable for delivering on this.”

According to Ms. 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, it is a matter of the ethics of the pharmaceutical industry, it’s the responsibility of health care providers and health professionals and indeed their schools.

She added:  “Today we call 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. It’s a call of true poignancy given that today is International Women’s Day and given how many women’s, newborns’, children and adolescents’ lives hang in the balance of this determination, that indeed the right to health should be available to one and all.”

The moderator, Ambassador Maria Azevedo of Brazil, explained that this panel discussion will 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 will also explore from a human rights perspective, the recommendations presented by the United Nations Secretary-General’s 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 fulfill this right, including ensuring access to medicines, recognising 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 health care, at least one-third of the world population has 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.

Ms. Ruth Dreifuss, Co-Chair of the UN Secretary-General’s High Level Panel on Access to Medicines, explained the mandate and work of the High Level Panel. She said that the panellists had scrupulously confined themselves to the limited mandate that they had been given.

She 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 the neglected tropical diseases and rare diseases in particular, vaccines, child formulas, and new solutions to growing antibiotic resistance.

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

She 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, Ms. Dreifuss said.

Intellectual property rights are usually given to companies who are given a time limit to the exclusive right to use an invention. These are intellectual property rights, and not the legitimate rights of inventors, which come under the rules of international trade and which have positive and negative consequences on the development of medical technologies and on access to them.

“That was the focus of our [the High Level Panel’s] deliberations,” she said. Doing its work, the Panel built on the deliberations of the World Trade Organization and of the World Health Organization.

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 the 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 emphasise 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,” Ms. Dreifuss added.

She highlighted that the High Level Panel had recognised 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 emphasised 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.

Mr. Michael Kirby, a member of the High Level Panel on Access to Medicines, said that the issue that is before us is not just a matter of ethics. It is also a matter 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 amongst the impediments for the attainment of the right to health have 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 unusually conducted public hearings in London, Johannesburg, and with links to Bangkok, so as to listen to the nation states, to listen to industry, civil society and 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 is presently all that is available,” said Mr. Kirby.

“It is therefore necessary to say bluntly at this session 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,” he underlined, warning that millions will be left behind and millions will die.

[Goal 3 states: Ensuring healthy lives and promoting the well-being for all at all ages is essential to sustainable development. Significant strides have been made in increasing life expectancy and reducing some of the common killers associated with child and maternal mortality. Major progress has been made on increasing access to clean water and sanitation, reducing malaria, tuberculosis, polio and the spread of HIV/AIDS. However, many more efforts are needed to fully eradicate a wide range of diseases and address many different persistent and emerging health issues.]

“In the High Level Panel some of us would have gone further than in the report which we produced. 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,” he said.

Among those conclusions were, first, that the WTO members must respect the flexibilities in the TRIPS Agreement and respect human rights protection in the Doha Declaration.  “There must be no more pressuring to force countries to surrender their rights in a health necessity, to invoke compulsory licenses and to contest ‘ever greening’ and other misuse of market power,” said Mr. Kirby.

Second, 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 United Nations 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, he said.

“Of all the evidence that I heard during the High Level Panel public hearings, curiously the voice that was most haunting was actually the call in London by the Ambassador of the Netherlands.”  He quoted the Ambassador as saying:  “Don’t assume that this is just a problem for poor countries or poor people. This is a challenge for us all – a challenge for the Netherlands, a rich inventive country. The cost of essential drugs is now excessive for our budget. We must all combine to tackle these excesses and failures in the uncorrected market.”

The policy incoherence therefore needs to be addressed, stressed Mr. Kirby.   The High Level Panel report is the minimum prudent package that is placed before this Council.  Its foundation is indisputably universal human rights, he said, and respectfully we suggest it deserves the support of this Council.”

Dr. Carlos Correa of the South Centre focused on the recommendation contained in page 28 of 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, he said that there is a long tradition of impact studies on the environment, but there are also examples of impact assessments in other areas such as food security.

He then cited a study carried out in 2006 by the National Commission for Human Rights of Thailand 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 academic studies also ex ante have taken place prior to trade agreements being brokered such as CAFTA (the agreement of the US with the Central American countries). 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 this Council to decide to embark upon the development of some methodologies and guidelines for impact assessment studies (on how trade agreements impact on the human right to health).

Correa said that the report also covers access to medicines, which is a concern not only of the developing countries but also developed countries. Many patients in developed countries today cannot have access to treatment as a result of extremely high prices of some medicines.

He underlined that the majority of the impact assessments on public health have been carried out ex ante, in other words, before the negotiation of bilateral or regional trade agreements that typically increase intellectual property protection, extend the term of monopoly of patents and result in countries establishing exclusive rights pertaining to the outcome of clinical studies.

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 protection standards.

Frequently, it is said that developing countries who ratify free trade agreements which contain provisions that raise intellectual property rights protection that can be at odds with human rights also get other trade advantages through these agreements, so there is no overall problem.

In reality that is not the case. Developing countries that accept these maximalist IPR provisions do so in the context of asymmetric power relationships, and they do not have the power to resist the imposition of these protectionist provisions as far as intellectual property is concerned in the agreements they ratify, said Dr. Correa.

The impact assessment must be done ex ante and ex post, and it would need to look at the current effects of intellectual property standards.  Correa said we need to look at the effects of the TRIPS Agreement and also other agreements in which TRIPS-plus standards have been adopted.

He emphasised that the outcome of this wave of over-protectionism in the area of intellectual property rights should not be deemed to be irrevocable. None of this is carved in stone, concluded Dr. Correa.

Correa referred to the statement of the international organizations represented at the panel competent in the area of intellectual property and trade, and indicated that if they would have actually been as efficient as they claimed in promoting TRIPS flexibilities, there wouldn’t be such a large number of developing countries where those flexibilities have not been implemented. He also mentioned that, as noted by the HLP report, countries such as Thailand and Colombia have been subject to pressures when they intended to use those flexibilities. Correa also observed that despite the statements of some developed countries’ delegations, they demanded TRIPS-plus provisions in the FTAs they sign (like in the case of the FTAs under negotiation between the EU and Tunisia and the EU and MERCOSUR) that can negatively affect access to medicines.

Dr. Marie-Paul Kieny of the WHO highlighted the activities of the organisation in supporting access to medicines and the challenges faced in this context. She said that the 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.

Mr. Taubman of the Intellectual Property Division of the WTO said that today’s discussion is 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, the Doha Declaration was a significant milestone on this same 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 SDGs, the growing complex of regional and bilateral trade agreements, and the renewed multilateral dialogue exemplified by the very Resolution that established this panel, he said.

Mr. Bombelles of WIPO said that 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.

He said WIPO and its Member States have long understood and appreciated that intellectual property has transcended the confines of legal issues relating to IP and touched on many of the most important public policy issues.

On 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, he said.

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

Kanaga Raja is the Editor of the South North Development Monitor (SUNS).

An earlier version of this article was published in the SUNS of 14 March 2017.