Intellectual property rights are hindering access to medicines by maintaining monopolies and high prices, according to speakers at an annual United Nations forum on human rights last week. Flexibilities enshrined in the World Trade Organization intellectual property agreement are hampered by political and economical pressure, they said, and a new system should be devised for pharmaceutical products.
The 2015 Social Forum organised by the UN Office of the High Commissioner for Human Rights (OHCHR) took place from 18-20 February and focused on “access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, including best practices in this regard.”
Several panels were organised over the three days around the issue of access to medicines, gathering a number of panellists coming from developing countries, as well as representatives of United Nations Agencies, such as the World Health Organization, UNAIDS and the UN Conference on Trade and Development (UNCTAD), as well as the World Trade Organization. The agenda of the forum is here [pdf].
On 19 February, a panel was dedicated to intellectual property rights and access to medicines, and another one on lessons learned and emerging challenges in the global response to AIDS.
Lisa Forman, assistant professor, Dalla Lana School of Public Health, University of Toronto, said, “the question of access to medicines is arguably one of the most explicit examples of how economic and trade rules can derogate from human rights to health and life.”
The global drug gap is huge, she said, as one billion people cannot access essential medicines, either for accessibility or for affordability reasons, and they are faced with “terrible choices,” such as choosing between food and healthcare or healthcare and impoverishment.
The introduction of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995 “was a major game changer,” she said, as before this introduction, some 50 countries did not give patent protection to pharmaceuticals, including India.
The flexibilities included in TRIPS allow policymakers to ensure that high prices resulting from exclusive patenting rights do not negatively impact public health, she said. However, the use of those flexibilities has attracted opposition from companies and some governments through litigation, trade sanctions and diplomatic pressure, she added.
TRIPS flexibilities are further undermined by regional and bilateral free agreements, she said, limiting market entry for generic medicines, for example.
UN Responses Unclear, Forman Says
According to Forman, the policy response of the UN system has been mixed. For example, access to medicines was included in the original Millennium Development Goals, but its formulation “reflected an institutional mindset at the time that was very reluctant to upset the political and commercial interests at stake.”
“This response took at face value corporate arguments that strict intellectual property rights in developing countries were critical to protect the innovation cycle that produced new medicines,” she said, adding that a number of studies and reports have shown since that this is not the case.
Forman added that the WHO Global Strategy and Plan of Action on Intellectual Property, Innovation and Public Health (GSPA), which lists some 100 actions to address medicines access and innovation in eight areas and recognises countries’ authority to use TRIPS flexibilities, does not however mention compulsory licensing, nor parallel imports or restriction of data exclusivity to allow generic market entry.
The current proposals for the UN Sustainable Development Goals are showing an improvement, she said, as the Open Working Group has proposed a health target on medicines calling for states to provide access to affordable essential medicines and vaccines and affirms the right to use TRIPS flexibilities.
Current global policy has had little impact on primary barriers to affordability, she said, with the rise of TRIPS-plus IP rights expanding and getting more stringent, and TRIPS flexibilities threatened.
TRIPS flexibility, she observed although the primary solution that is available for bettering access to health, is nonetheless a poor solution, she said, turning “the fundamental human right to health and affordable medicines into a rigidly restricted exceptions to a property right.”
UNCTAD, WTO Views
Thamara Romero, legal officer, Intellectual Property Unit, Division on Investment and Enterprise at UNCTAD, described the work of UNCTAD on access to medicines, in particular local production of medicines. She said the main rationale for the work of the agency in this domain is health security through diversification of supply.
Local production of medicines may increase access to medicines, as increased competition may lower prices and local production may benefit from existing distribution networks. UNCTAD’s work on local production goes in two directions: advisory work, and the training of judges, government officials and patent officers in the field, she said.
Intellectual property rights are not necessarily in contradiction with human rights, Romero said, but full awareness of policymakers and judges on how to use the TRIPS flexibilities is essential.
Antony Taubman, director, WTO Intellectual Property Division, underlined the importance of the trilateral cooperation between the WTO, the WHO and the World Intellectual Property Organization on the issue of access to medicines. He also described the WTO Doha Declaration on TRIPS and Public Health as a “landmark” in WTO work, as it addresses two core IP issues: the fact that IP protection is important for the development of new medicines, and the concern about IP on prices.
He further said it is essential for IP experts to develop stronger understanding of public health policy and the broad human right context.
In the audience, Jorge Bermudez, vice-president of health production and innovation, Fundação Oswaldo Cruz, Ministry of Health, Brazil (and former executive secretary of UNITAID), said that monopoly allows for high prices and hinders access to medicines. He cited new cancer drugs and the hepatitis C sofosbuvir treatment, both innovative but unaffordable.
New IP Regime for Pharma, Report Says
Tenu Avafia, policy adviser, HIV, Health and Development Practice, Bureau for Development Policy for the UN Development Programme, mentioned the report of the Global Commission on HIV and the Law, issued in 2012 (HIV and the Law: Risk, Rights & Health).
The Global Commission on HIV and the Law, according to its website, is an independent body, convened by UNDP on behalf of the Joint UN Programme on HIV/AIDS. It consisted of 14 individuals advocating on issues of HIV, public health, law and development, and was chaired by Fernando Henrique Cardoso, former president of Brazil.
In the report, the group suggested that the UN Secretary General convene a neutral, high-level body to review and assess proposals and recommend a new intellectual property regime for pharmaceutical products, which would be consistent with international human rights law and public health requirements, “while safeguarding the justifiable rights of inventors.”
The report further suggested that the said body include “representation from the High Commissioner on Human Rights, WHO, WTO, UNDP, UNAIDS, and WIPO, as well as the Special Rapporteur on the Right to Health, key technical agencies and experts, and private sector and civil society representatives, including people living with HIV.”
“Pending this review, the WTO must suspend TRIPS as it relates to essential pharmaceutical products for low-and middle income countries,” the report said, adding that high-income countries, including donors, should “immediately stop pressuring low and middle-income countries to adopt or implement TRIPS-plus measures in trade agreements that impede access to life-saving treatment.”
High-income countries should stop seeking to impose more stringent, TRIPS-plus intellectual property obligations on developing country governments, the report suggests, adding that high-income countries should “desist from retaliating against countries that resist adopting such TRIPS-plus measures…”
The report also requested that WTO members indefinitely extend the exemption for least developed countries from the application of TRIPS provisions in the case of pharmaceutical products.
“TRIPS has failed to encourage and reward the kind of innovation that makes more effective pharmaceutical products available to the poor, including for neglected diseases,” the report said. “Countries must therefore develop, agree and invest in new systems that genuinely serve this purpose, prioritising the most promising approaches including a new pharmaceutical R&D treaty and the promotion of open source discovery.”