Subtitled Promoting innovation and access to health technologies, the United Nations Secretary-General has now published its High-Level Panel on Access to Medicines report.
The High-Level Panel’s terms of reference (see page 66) called for it to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.
Michael Kirby, a former justice of the High Court of Australia, chaired the 25 person Expert Advisory Group. He was also a member of the 15 person High-Level Panel.
An executive summary sets out various convention, research and incentive recommendations. Legal recommendations include that:
- Governments should strengthen national level policy and institutional coherence between trade and intellectual property, the right to health and public health objectives by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access. (Page 9)
- Governments should require that the unidentified data on all completed and discontinued clinical trials be made publicly available in an easily searchable public register established and operated by existing mechanisms such as the WHO Clinical Trials Registry Platform, clinical trials.gov or in peer reviewed publications, regardless of whether their results are positive, negative, neutral or inconclusive.
The report is structured in four chapters:
- Health Technology Innovation and Access examines the problem at the heart of the High-Level Panel’s mandate: asymmetries of power between institutions and the incoherencies in law, policy and practice between the right to health, international trade and intellectual property rules and public health objectives and their effect on health technology innovation and access.
- Intellectual Property Laws and Access to Health Technologies discusses the prevalent international intellectual property regime, the flexibilities contained therein that can be used to promote access to health technologies and examines why flexibilities have not been systematically used, as well as developments such as free trade agreements that may impede the use of TRIPS flexibilities.
- New Incentives for Research and Development of Health Technologies highlights the role that increased coordination, priority setting and R&D can play in systematically addressing unmet health needs and examines some of the new models that can be used by various actors.
- Governance, Accountability and Transparency examines governance and accountability mechanisms needed to promote health technology innovation and access, including the roles of key stakeholders. It highlights the need for transparency in the various stages of health technology innovation and access in order to strengthen coherence at all levels of policies and actions.