Special Feature: UN High Level Panel On Access To Medicines – First Reactions, Process Explained

A high level panel of experts charged by United Nations secretary general to explore solutions to increase innovation and access to medicines in developing countries gave a briefing today to explain the process of the initiative. Intellectual property is often seen as both a barrier to the diffusion of health technologies and an innovation enabler.

The UN Secretary General’s High-Level Panel on Access to Medicines, spearheaded by the UN Development Programme (UNDP) and UNAIDS, held a briefing at the World Health Organization to present its work to countries and various stakeholders.

The 15-member High-Level Panel held its first meeting in New York on 11 December (IPW, Public Health, 16 December 2015). Its mandate is “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.”

Process, Call for Contribution, Final Report

Ruth Dreifuss, co-chair of the panel and former Swiss president, said the challenge is to find solutions, both innovative and ambitious, that can be implemented and are sustainable.

An appeal for contributions was launched on 21 December (IPW, Public Health, 7 January 2016) to all governments, public institutions, non-governmental organisations, and industry, she said.

The deadline for contributions is 18 February.

Dreifuss said the panel is not meant to create proposals but to bring together various stakeholders and various proposals.

According to Tenu Avafia, UNDP team leader: human rights, law and treatment access, the work of the panel is not intended to replicate or establish a parallel mechanism but to build upon the experience and knowledge of existing initiatives.

The contributions received from stakeholders will be assessed by the high-level panel and selected contributors will be invited to hearing in London and Johannesburg, South Africa to discuss their proposals in detail, he said.

Criteria for contributions are: impact on policy coherence, impact on public health, advancing of human rights, implementation, and evidence, he said.

Public consultations are also planned, he said, on 10 March in London, and on 17 March in Johannesburg.

The final report is expected to be submitted to UN secretary general in June 2016.

A timeline for the panel is available here. The list of the members of the Expert Advisory Group is available here.

Another member state briefing will be held on 4 February at UN headquarters in New York.

Heart of the Discussion: Intellectual Property Rights

World Health Organization Assistant Director General Marie-Paule Kieny said the WHO has been focused on the issue of innovation, public health, and intellectual property. For example, the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), which delivered its report [pdf] in 2012 and is still being implemented.

A number of initiatives have been undertaken in the last 15 years, she said, including the Medicines Patent Pool, the Longitude prize in the United Kingdom, and the trilateral cooperation between the WHO, the World Trade Organization, and the World Intellectual Property Organization on issues around public health, intellectual property and trade.

Antony Taubman, member of the High-Level Panel’s Expert Advisory Group and head of the WTO IP Division, said, “The recent adoption of the Sustainable Development Goals underscores the vital need for coherence, not only at the broad systemic and multilateral level, but also at the practical and national level.”

He mentioned the WTO Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health as a major step in policy coherence. This development was one of several factors acting together which had given considerable momentum towards greater coherence at the multilateral and domestic levels, he said.

“Much has been achieved in understanding the complex linkages between health policy, human rights, trade policy settings, IP, and innovation policy, and it is now more feasible to develop a stronger empirical base for policy discussions,” he said, adding that “coherence is not an end in itself, but is a means of more effectively delivering concrete public health outcomes for all.”

WIPO: Sensitive to Panel’s Assumption of Policy Incoherence

Thomas Bombelles from the Global Challenges Division at WIPO and a former pharmaceutical industry executive, representing WIPO on the Expert Advisory Group, said a growing part of WIPO’s work focuses on the policy aspects of IP, including as it relates to global health.

To provide factual evidence-based information is an important role of the United Nations and other multilateral organisations which is why WIPO joined with the WTO and the WHO in 2009 in a formal trilateral cooperation process, he said. “In fact it is precisely to add light rather than heat to the debate” that in 2012 the comprehensive study was published by the three agencies, he added.

“More light rather than heat is perhaps another way of saying that there is a long-standing and productive process that is focused exactly on policy coherence,” he said.

WIPO is pleased to be included to the process, he said, but added that WIPO “is sensitive” to the assumption in the High-Level Panel mandate that there is a policy incoherence between using intellectual property laws and regulations to encourage innovation and the imperative of delivering medicines and other health services to those in need.

Unquestionably, the cost and difficulty of innovation has been increasing, he said. “I would suggest coherence exists in the recognition that without productive innovation, there is nothing to have access to,” he added.

Challenges of filling the gaps between innovation in neglected medicines versus “non-neglected” and also access “are not necessarily the result of policy incoherence but rather imbalances in wealth, health systems capacities, and many other socio and economic factors with which the United Nations have been occupied since its creation.”

Bombelles cited initiatives to solve the problem of innovation such as product development partnerships, and the WIPO Re:Search initiative. Much progress has been made, he said, “and progresses made in access have been made because the initiatives undertaken by the UN and the multilateral system, member states, and other actors, took on the challenges in all their complexity to find solutions that work.”

“We call the panel’s attention to the need to acknowledge and … consider the complex landscape of access rather than doing it through two narrow prisms,” he said.

UNCTAD, OHCHR Wish List

Christoph Spennemann, legal officer and officer-in-charge, Intellectual Property Unit, Division on Investment and Enterprise at the UN Conference on Trade and Development (UNCTAD), representing the organisation on the Expert Advisory Group, said UNCTAD “implements a technical cooperation program to assist interested developing countries in designing legal and policy frameworks conducive to the local production of pharmaceutical products and improved access to medicines.”

He said UNCTAD’s hope is that the High Level Panel will address three interrelated issues:

• How to use the intellectual property system, including its flexibilities, to better attract investment in the local production of quality pharmaceuticals;
• How to use the intellectual property system, including its flexibilities, to encourage developing countries to develop their existing capacities in health-related incremental innovation;
• How access to medicines can be achieved through coherent and coordinated policies in the areas of health, intellectual property, investment, tariffs and technology

Lynn Gentile, human rights officer, Human Rights and Economic and Social Issues Section, UN Office of the High Commissioner on Human Rights (OHCHR), said universal access to affordable healthcare is a fundamental building block to the right to health. While there has been work on standard-setting in terms of the right to health, the problem is always that the policy implementation is always a few steps behind the norm-setting, she said.

“The realisation of key global commitments depends on unlocking access to medicines for the millions throughout the world who don’t have it,” said Gentile.

The Global Commission on HIV and the Law in its final report [pdf] said that “a growing body of international trade law and the overreach of intellectual property protections are impeding the production and distribution of low-cost generic drugs,” she said.

Gentile added that the report said, “IP is supposed to provide an incentive for innovation but experience has shown that current laws are failing to promote innovation that serves the medical needs of the poor.”

As a result of the panel, the OHCHR will be looking in particular for an endorsement “or something approaching an endorsement” of an interpretation of state obligations and the international IP and trade laws more concordant with the right to health and the right to benefit from scientific progress, she said.

Expert Advisory Group Members

Manica Balasegaram, Médecins Sans Frontières Access Campaign executive director, and Anthony So, director, Center for a Livable Future, Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, praised the timeliness of the High Level Panel. Balasegaram added that MSF would like to see concrete outcomes.

[Update:] So drew attention to “the challenge and opportunity that antibiotic resistance poses.” The very use of antibiotics generates resistance, he said, and “incentivising drug companies to earn returns through volume-based sales is a recipe for greater drug resistance.”

“So the biology and the economics of antibiotic use insist on delinking return on investment from volume-based sales,” he said.

The response to antibiotic resistance is not just one of bringing new drugs to market, “the innovation of a family of health technologies is what is needed,” he said, as “effective point of care diagnostics and vaccines will play an important role in decreasing the selective pressure on existing antibiotics.” [end update]

Dominique Foray, professor at the Ecole Polytechnique Fédérale de Lausanne, said innovation and access often were portrayed as contradictory objectives, but that was not necessarily the case. He cited public-private partnerships, for which “Geneva is a kind of the global capital,” as practical solutions to reconcile innovation and access. He remarked on the necessity to understand the real cost of innovation and ways to reduce those costs. “Nothing is transparent in this area,” he said.

US, India React

The United States said the country had come to the briefing with “pretty serious concerns.” It was very good to hear that the focus of the panel on building on existing processes rather than creating new ones, the US delegate said. It is important that solutions acknowledge the reality that there is not a single way to do this, the representative said. No one sector, such as governments or philanthropy or the private sector, can do it alone. It is important to respect the positive contributions that those different sectors can make as well as the challenging aspects of those actors, he added.

India said the normative input from the panel will provide the first step to ensuring the use of TRIPS flexibilities for public health is not put to question.

The Indian delegate also remarked on the lack of coherence within the UN system. WHO should be the footprint of access to medicines, research and innovation, but unfortunately, its role has been undermined, he said, in spite of the WHO constitution indicating that the organisation should lead research and development to meet needs of developing countries.

Access should not be dealt as an “after path”, he said. “It should be inbuilt in the way we do research and development.” Health cannot be the privilege of the few and global economies should not allow the extreme privatisation of R&D, he said.

According to Avafia, after the report is presented to the UN secretary general, it is expected to be presented to the UN General Assembly next September. However, ultimately, the way forward on the report depends on member states themselves, he said.

 

Image Credits: Catherine Saez