Following several months of intense discussion and negotiations, the High-Level Panel on Access to Medicines has published its report today.
The 15 members of the panel, representing a wide range of experts and stakeholders in the health innovation area, have not found consensus on remedies to change the current IP system for medicines, but agreed on a number of recommendations that have the potential to challenge the current pharmaceutical market.
The creation of the panel was announced by United Nations Secretary-General Ban Ki-moon in November 2015 with the mandate to “recommend solutions for remedying the policy incoherence between the justifiable rights of investors, international human rights law, trade rules and public health in the context of health technologies”. In other words, the panel based its work on the assumption that access to medicines is hindered by intellectual property rights and trade rules.
This mandate was greatly criticised by a number of governments and international organisations, including the United States and the European Commission, leading to a three-month delay in the publication of the report.
The report presents recommendations in three key areas:
- Intellectual property laws and access to health
- New incentives for R&D of health technologies
- Governance, accountability and transparency
In particular, the report calls on governments to make full use of the existing flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and adopt and implement legislation that facilitates compulsory licenses for medicines.
With regard to publicly funded research, the report recommends that knowledge generated must be made freely available; a call that is in line with the recent EU Council Conclusions on strengthening the balance of the pharmaceutical system.
The report also recognises the need for increased incentives to fund innovation in medical areas that are less commercially attractive, for example neglected tropical diseases and antimicrobial resistance. In this regard, the report invites governments to negotiate a binding R&D convention that delinks the cost of R&D from the end price and to agree on a Code of Principles for Biomedical R&D to be applied by public and private R&D funders.
A number of other recommendations directly challenge the current functioning of national pharmaceutical markets. For instance, governments are recommended to require manufacturers to disclose R&D and marketing cost to drug regulatory authorities as well as the public funds they have received. The report also calls for the establishment of databases of medicines’ prices, clinical trials’ data and information on medicines’ patent status.
The report fails to capture the complexity of access, which underpins multiple determinants: from the quality of health systems and workforce to health inequalities and education. By focusing narrowly on the patent system, the panel’s recommendations not only fail to address a great part of the access challenge, but risks to produce important unintended consequences. Innovators need assurance that they will receive a fair return on the long-term investments incurred to develop new medicines. The short and medium-term effect of some of these recommendations, however, could have the unintended consequence of dis-incentivising investments in R&D and restricting patient access.
Ban Ki-moon is now expected to present the report to the next UN General Assembly, which may convene a special session on the issue of access and innovation by September 2018.
Andrea Corazza is Director in FTI Consulting’s healthcare team in Brussels.