Increasing Access to Medicines – A UN Report
This last week, the United Nations Secretary-General’s High-Level Panel on Access to Medicines (HLP) published their highly anticipated report on global health technologies. Their report addressed some challenges of ensuring that medical innovations reach underserved populations, a topic central to Sabin’s mission. Specifically, the report gives recommendations for resolving policy incoherencies between public health objectives, human rights principles and international trade regulations.
The HLP report was conceived last November when the UN Secretary-General, Ban Ki-Moon, appointed the members to the HLP and tasked them with providing recommendations that address “the incoherencies between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.”
The recommendations developed by the panel cover three central topics: the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and its effect on human rights; the lack of incentive for medical innovations that treat or prevent neglected diseases; and the lack of accountability and transparency in government, publicly funded research and bilateral trade deals. A full summary of the recommendations can be found below.
Some of the report’s 24 recommendations proved to be contentious among HLP members. One such point promoted delinking research and development (R&D) costs from the price of medicines. This can be achieved by using innovative sources of financing for R&D, such as advanced market commitments, which are contracts that can guarantee a future market for drug developers in order to incentivize R&D.
Although the HLP members agreed that delinking is an important supplementary mechanism to traditional market-driven R&D, there was disagreement over any greater potential. Specifically, the panel suggested a binding international R&D Convention that would delink R&D costs from medicine prices. Despite this, some members felt that such a convention is quixotic and that the ability of governments to finance medical innovation is overestimated.
The delinking recommendations have the potential to stimulate funding for innovations that address illnesses with low market incentive — such as neglected tropical diseases. As a nonprofit, the Sabin Vaccine Institute effectively acts as a delinking agent, separating the cost of vaccine development from the price of the vaccines it is producing. Through this mechanism, Sabin is working to close an R&D gap and increase access to needed innovations.
Simultaneously, Sabin also partners with many for-profit biomedical companies, which must link the end prices of medicines to their R&D. These companies are a critical component of Sabin’s vaccine development pipeline. As one HLP member stated, market incentives for the private-sector have been a major pull for the development of many medical technologies because they encourage companies to invest heavily in R&D with the knowledge that they can recuperate costs.
Most of the other contentious recommendations in the report dealt with flexibilities in the 1995 TRIPS Agreement, an international trade agreement that establishes an intellectual property rights framework for World Trade Organization (WTO) members. While intellectual property rights are essential for medical innovation — since they allow companies to recoup heavy investments in R&D — they can also be incompatible with certain human rights principles which call for access to affordable medicines. A poignant example was the lack of affordable access to anti-retroviral drugs for the South African AIDs epidemic in the late 1990s.
In 2001, WTO members created the Doha Declaration, part of which established flexibilities in the TRIPS Agreement in order to obviate future crises like the one in South Africa. However, the HLP makes it clear in their recent report that there is disagreement over the effectiveness of the Doha Declaration and its subsequent amendment. For example, the utilization of these flexibilities may be limited by external pressures from corporations and other stakeholders. Despite the discord on several TRIPS Agreement issues, the HLP did recommend the enforcement of governments’ rights to TRIPS Agreement flexibilities.
Finally, the HLP report also proposed several recommendations for promoting open-access research outcomes. Specifically, the report advocates for open-access to all privately and publicly funded clinical trial information, and for open-access to all publicly-funded research outcomes. Open-access initiatives, such as the Public Library of Science for Neglected Tropical Diseases, which is co-edited by Sabin’s president Dr. Peter J. Hotez, are important for accelerating the development of medical technologies.
This report addressed the incongruent policies that limit access to medicines and that are relevant to Sabin’s mission and programs. Whether or not the disagreements among the HLP members will affect the impact of this report remains to be seen.
Below is an aggregated summary of the HLP’s recommendations.
“Intellectual property laws and access to health technologies:”
- WTO members must recognize the TRIPS flexibilities outlined by the Doha Declaration (2001). Punitive measures should be enacted for those who attempt to undermine such flexibilities.
- Governments should facilitate compulsory licensing of medicines to ensure quick production of compulsory licensed medicines.
- Governments should implement patent criteria that recognizes public health and human rights. This includes limiting evergreening, or the process by which superfluous changes are made to patents, extending their lifespan. This also includes recognizing public health priorities in bilateral or regional trade agreements.
- Publicly funded research should prioritize public health needs over financial rewards. This research should promote collaboration and open-access to information in order to accelerate progress in R&D.
“Incentives for research and development of health technologies:”
- Governments should increase funding for R&D.
- Stakeholders need to develop Innovative financing systems that delink the costs of R&D and the final prices of medicines.
- The UN Secretary-General should begin a process of negotiations for governments on how to coordinate, finance, and implement health technologies. This process needs to be focused on public health needs, but especially on neglected tropical diseases and antimicrobial resistance.
“Governance, accountability, and transparency”
- Governments need to assess and report on the state of access to health technologies within their countries. Furthermore, national level policies should be enacted to address incoherencies between rights to health and intellectual property rights and trade.
- The United Nations should establish a review body to assess the progress of recommendations from this report and to assess progress on health technology access. Additionally, the UN Secretary-General should create a taskforce to oversee implementation of the HLP’s recommendations.
- Private-sector biomedical companies should have publicly available policies on how they are working to increase access to medical innovations. Furthermore, they should report annually on how they are actively promoting access to medical innovations.
- Governments should require increased open-access to information on the distribution of health technology, including costs of R&D, clinical trial outcomes, cost of marketing and distribution, and any public funding involved. Moreover, data from all clinical trials, even trials with negative or neutral outcomes, should be aggregated in a publicly available database.
- Governments should create an accessible database of pharmaceutical patents and their statuses.