by Bram van Wiele
On 14 September the United Nations (UN) released the long-awaited report by the UN High Level Panel on Access to Medicines. The panel, comprised of eminent and respected individuals from diverse stakeholder groups, was constituted in November 2015 with the mandate “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”. A key issue raised in the report is that the prices of drugs need to be de-linked from the cost of research and development (R&D).
The report addresses four major areas: Health Technology Innovation and Access, Intellectual Property Laws and Access to Health Technologies, New Incentives for Research and Development of Health Technologies, and Governance, Accountability and Transparency. The report provides 30 recommendations—mainly for governments and private actors involved in R&D of health technologies.
In the field of intellectual property, the report calls on WTO members “to commit to the letter and spirit of the WTO Doha Declaration on TRIPS [The Agreement on Trade Related Aspects of Intellectual Property Rights] and Public Health, and refrain from any action that will limit their implementation and use in order to promote access to health technologies.” It calls on countries to make full use of the public health-related TRIPS flexibilities by, among other things, adopting and applying “rigorous definitions of invention and patentability that curtail the evergreening to ensure that patents are only awarded when genuine innovation has occurred” and “legislation that facilitates the issuance of compulsory licenses”. Moreover, the panel recommends that several UN agencies and other relevant bodies collaborate with each other to support governments in applying public health-sensitive patentability criteria.
The report also engages extensively with free trade agreements, which often contain far-reaching patent and data protection clauses on health technologies that nullify the flexibilities that were envisaged in TRIPS and the Doha Declaration, hereby blocking access to such technologies.
Regarding publicly funded research, the panel provides several recommendations for making such research more widely available, and calls for universities and research institutions that receive public funding to prioritise public health objectives over financial returns in their patenting and licensing practices. This, of course, is particularly interesting against the backdrop of South Africa’s legislative mandate to commercialise the output of publicly financed research and development activities, as stipulated in the country’s Intellectual Property from Publicly Financed Research and Development Act (2008).
The panel urges governments to increase their current levels of investment in health technology, strengthen national level policy and institutional coherence between trade and IP, the right to health and public health objectives. Broadly, it requests from governments to enter into negotiations concerning a binding R&D Convention that de-links drug prices from R&D costs.
“You cannot rely upon high drug prices to finance R&D without harming patients and creating unequal access. Policy coherence means making innovation and access happen at the same time. Delinkage is key to policy coherence”, says James Love, Director of Knowledge Ecology International.
Stakeholders, on the other hand, are urged to test and implement new and additional models for financing and rewarding public health (R&D).
The panel also calls for greater transparency in drug pricing, i.e., the costs of developing the drugs as well as marketing, distribution and advertising.
To take the recommendations forward, the panel called on the UN Secretary-General to establish an inter-agency task force on health technology innovation and access, which would “work toward increasing coherence among United Nations entities and relevant multilateral organizations like the WTO”. They also called for the creation of an independent review body, which would monitor, among other things, the progress made in implementing the recommendations of the panel.
While the majority of civil society responded positively, the report received much criticism from the industry. Moreover, the United States says it is “deeply disappointed by the Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines, which detracts from, rather than advances, those critical objectives.”
The full report is available here. Interesting background documents are available here.
Bram van Wiele is a graduate student at the Commercial Law Department and a research assistant at the IP Unit of the University of Cape Town