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.