A Question of Access

The United Nations (UN) has released a long-awaited report on “Access to Medicines”, which provides a number of recommendations that the UN believes will help boost medicines access in both rich and poor countries feeling the strain of the increased costs of new medicines and health technologies (1). 

But does the report take into account the real-world complexity of the pharma and biopharma industries? Critics of the report believe not.

“The UN High Level Panel (HLP) on Access to Medicines was a missed opportunity to address the wide array of barriers to access that far too many people face every day,” said Stephen J. Ubl, president and CEO of Pharmaceutical Research and Manufacturers of America (PhRMA), in a statement (2). “Neither this report nor its recommendations can be a sound basis for further consideration or action by the UN system.”

The origins of the report date back to September 2015, when member states of the UN adopted the 2030 Agenda for Sustainable Development. The agenda includes a number of goals, one of which is to support research, development and access to essential medicines and vaccines. A high level panel was established in November 2015, with a mandate from UN Secretary-General Ban Ki-moon 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.”

The panel was co-chaired by former President of Botswana, Festus Mogae, and Swiss politician Ruth Dreifuss, and included diplomats, legal experts, economists, and academics, as well as representatives from the pharma industry.

The report makes a number of recommendations, including making public grants to pharmaceutical companies, provided there is transparency in trial results and R&D spending. However, the primary focus of the report is on intellectual property. The panel recommended a strict interpretation of patent law to prevent companies “evergreening” patents, and allowing patenting only of technologies that represent “genuine innovation”. Perhaps most controversially, they call for governments to issue “compulsory licenses” for drugs with a public health impact – allowing cheaper generic versions to be produced without the consent of the patent holder, provided “adequate remuneration” is paid. Though allowed under the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights Agreement, most governments have been reluctant to pursue compulsory licensing.

Joseph Damond, Senior Vice President of International Affairs at the Biotechnology Innovation Organization, argues that the recommendations will hinder, rather than help, innovation. “While we are still reviewing the full report released today by the UN High Level Panel on Access to Medicines, it is clear from an initial review that this report ignores the real issues that impact or delay delivery of innovative treatments and cures throughout the developing world, while focusing on policy recommendations in the one area – intellectual property – that would actually undermine ongoing research and development by hundreds of companies, universities and researchers,” he said in a statement (3).

The report has been broadly welcomed by patient advocacy groups and charities, with Doctors Without Borders calling it a “landmark”. However, the US Department of State agreed with pharma industry bodies that the panel’s recommendations could stifle medical innovation.