A Look At The UNAIDS Board Debate On IP And Medicines; Outcome Fell Short For Some

The discussion on intellectual property-related barriers to access to medicines was one of the most contentious points of the 39th meeting of the UNAIDS governing board last week. After hours of negotiations, the board agreed that the organisation will keep working on the issue. But developing countries and civil society would have preferred a stronger mandate, according to representatives.

The 39th meeting of the Joint United Nations Programme on HIV/AIDS (UNAIDS)  Programme Coordinating Board (PCB) took place on 6-8 December (IPW, Public Health, 9 December 2016), and delivered a set of decisions.

One of the agenda items of the meeting was a “Synthesis report [pdf] of existing research and literature on intellectual property related and other factors impacting the availability, affordability, and accessibility of treatment and diagnostics for HIV and co-infections in low and middle-income countries,” established by the UNAIDS secretariat, and which included recommendations.

The recommendations particularly called for UNAIDS to follow the recommendation of the UN Secretary-General’s High-Level Panel on Access to Medicines (HLP), and to produce reports on the use of intellectual property at country and regional levels, including flexibilities included in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

According to sources, reference to the HLP was the most controversial, and discussions on decisions ran for hours. Some member states did not agree on the fact that IP can constitute a barrier to IP, such as the United States, the United Kingdom, Japan, Canada, and Monaco, according to a developing country source. However, the Benelux countries: Belgium, Luxembourg and the Netherlands, as well as Portugal, agreed to consider recommendations included in the secretariat’s report, but voiced concern about the ability of the secretariat to deliver on the recommendations, due to the ongoing financial crisis, the source said.

The meeting was closed to press.

Developing countries, such as Brazil, Iran, Ecuador, and Ghana, as well as non-governmental organisations, would have preferred stronger language than just taking note of the HLP, and wished for a stronger UNAIDS strategy on IP, the source told Intellectual Property Watch. Those countries also suggested recommendations addressing pricing transparency issues and other issues impacting access, the source added.

Before entering into discussions, members of the PCB voiced their positions regarding the UNAIDS secretariat recommendations and the HLP report, sources told Intellectual Property Watch.

According to a developing country sources, a number of countries supported the recommendations listed in the secretariat’s report, such as Brazil, Ghana, Ecuador, India, Iran, and the Netherlands, while some other countries remarked on the importance of the IP system to promote health innovation, such as the United Kingdom, and the United States.

The United Nations Development Programme (UNDP), a UNAIDS cosponsor, delivered a statement on behalf of several UNAIDS cosponsors and said, “The High-Level Panel’s report has a simple and uncontroversial message: no one should suffer because she or he cannot afford health technologies.”

“Cosponsors, the UNAIDS Secretariat, other international organizations, civil society, governments and private sector partners must act decisively and improve health technology innovation and access. The High-Level Panel’s report can be an accelerator for the UNAIDS Strategy and the broader 2030 Agenda for Sustainable Development, including the targets to end the AIDS and TB epidemics by 2030,” the representative said.

A representative of East Europe and Central Asia Union of People Living with HIV (ECUO)/AIDS Action Europe, a non-governmental organisation, said barriers to access to medicines are many, but IP is a significant one, as it leads to unaffordability of medicines, according to one of the sources.

Support for Delinkage; Charge of WHO Interference

In its statement, the intergovernmental South Centre said the report advances important recommendations, in particular that governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO members to use flexibilities, calling for instances of undue political pressure to be reported to the WTO secretariat during the trade policy review of members. The recent case of Colombia coming under pressure illustrated unjustifiable barriers in making use of flexibilities to promote access to medicines, the South Centre representative said (IPW, Inside Views, 3 December 2016).

The South Centre also said it supports the recommendation of the HLP report to explore and invest in new mechanisms that delink the cost of research and development from the end prices of medicines, and the recommendation that results of publicly-funded research be disclosed. The organisation suggested that UNAIDS explore new mechanisms of delinkage.

According to Germán Velásquez, special adviser for health and development at the South Centre, citing developing country delegates attending the closed drafting group, some developed countries wanted to weaken the importance of the HLP report, and instead referred to a four-year study co-edited by the World Trade Organization, World Health Organization, and World Intellectual Property Organization on the intersection between public health, intellectual property and trade (IPW, Public Health, 6 February 2013).

“The insistence to reference the four year old WHO, WIPO and WTO report (which does not provide any recommendation or conclusions) was attributed by some delegates and observers to a very visible, inappropriate and exaggerated lobby by staff from WHO. This kind of interference in the deliberations of UNAIDS PCB is clearly regrettable,” he said in a post on the ip-health listserv managed by Knowledge Ecology International.

Knowledge Ecology International (KEI), in its intervention, endorsed the recommendation in the UNAIDS report about the UN High-Level Panel on Access to Medicines. The group underlined the “most important recommendation” from the panel: its endorsement of the concept of delinkage, the decoupling of the costs of research and development from the price of health technologies.

Looking forward, KEI said UNAIDS should convene regular regional meetings to initiate efforts to implement progressive delinkage mechanisms to replace monopolies as a reward for innovation.

UNAIDS should ensure further transparency on the costs of R&D, pricing and patent status of HIV-related products by strengthening the WHO Global Price Report Mechanism, KEI said, adding that UNAIDS should advocate for a global agreement on R&D.

MSF Confirms IP Barriers

Médecins Sans Frontières (MSF – Doctors Without Borders), in its intervention to the PCB, said it welcomed the report, which, according to the release, “confirms the challenges that IP barriers create for MSF since we started treating people living with HIV over fifteen years ago.”

“Today, MSF continues to face serious IP barriers to access affordable medicines and diagnostic tools that assure optimal care for our patients with HIV as well as co-infections such as tuberculosis and hepatitis C,” the group said in the release.

The absence of generic competition due to patent and regulatory barriers, can result in the cost of providing a third line ART regiment being about 17.4 times higher than the lowest cost for first line treatment, they said, adding that these barriers will only become more problematic in particular in middle-income countries which will host some 80 percent of all people living with HIV by 2020.

MSF underlined the detrimental effect on access of stricter IP rules for medicines included in free trade agreements, particularly by the US, European Union, and Japan.

“UNAIDS has played a critical role around the world highlighting the challenges of intellectual property barriers, providing a voice to people living with HIV that otherwise cannot have a say in these discussions,” MSF said, urging UNAIDS “to continue to play a central role in ensuring that these IP barriers do not undermine access to medicines.”

“We hope that UNAIDS can look at how IP discourages innovation that addresses the needs of neglected populations, especially children with HIV,” the group said. “In fact the impact of IP on access to medicines and innovation is just starting to be felt by public health program.”

MPP Presents Patent and Licensing Database

The Medicines Patent Pool, providing an overview of their activities, noted in its statement that it launched MedsPaL (Medicines Patent and Licensing database) in October. The database provides transparency on the IP status of HIV, TB and HCV medicines in developing countries, the representative said. MedsPaL includes information on patents, licenses, and data exclusivity in over 100 developing countries, the representative added.