By Veronika J. Wirtz, with Anya L. Guyer
Access to essential medicines is a core element of Universal Health Coverage, which in its turn has been described as a necessary component of the Sustainable Development Goals. In November, 2016, a new report entitled Essential Medicines for Universal Health Coverage was published by The Lancet Commission  on Essential Medicines Policies. The report acknowledges that, while in principle many agree that access to essential medicines is a fundamental human right and necessary for functioning health systems, finding long-lasting and sustainable solutions to access has proven difficult.
The Lancet Commission was inspired by the 30th anniversary of a major event in the development of essential medicines policies: the 1985 Nairobi Conference on the Rational Use of Drugs. That conference laid the foundation for many subsequent international efforts related to creating access to essential medicines. Thirty years after the Nairobi Conference, the Lancet Commission on Essential Medicines Policies systematically examined four topics: progress achieved since the 1985 Nairobi Conference; challenges that must be addressed in the coming 20 years; lessons learned to inform future approaches; and, how essential medicines policies can be harnessed to promote UHC and contribute to the global sustainable development agenda.
The Commission’s report, Essential Medicines for Universal Health Coverage, tackles a wide range of topics, linking essential medicines policies with other current global debates, such as creating financial sustainability for universal health coverage, balancing trade and economic policies with access to health technologies, and the protection and promotion of human rights. Throughout, the Commission highlights the importance of paying attention to equity, strengthening institutions to sustain progress, and developing accountability for progress.
Some key messages are:
- Essential medicines policies address challenges faced in all countries: Access to essential medicines has traditionally been perceived as a challenge only for “poor” countries. In fact, however, all countries, regardless of income-level, face challenges in ensuring access to essential medicines. Ensuring access goes far beyond the affordability of medications. For instance, protecting against the overuse of antimicrobial medicines has become an important public health priority in the US and other wealthy nations that have recognized the dangers of emerging resistance to antimicrobials, given the limited arsenal of therapeutically effective alternatives.
- A “health systems lens” on essential medicines is important: Financing, affordability, quality of products, and quality of use are four priority areas that the report identifies; the fifth is addressing gaps in the development of essential medicines. This broad and operational focus differentiated the Commission’s work from the mission of the UN High Panel on Access to Medicines. That panel focused specifically on misalignments between the right to health on the one hand and intellectual property and trade priorities on the other.
- Additional financing is urgently needed to enable access to essential medicines: The report presents the first analysis of the cost of providing a basket of essential medicines. The Commission developed a model that estimated it would cost between US$ 77.4 and US$ 151.9 billion per year – the equivalent of between US$ 12.9 and US$ 25.4 per person per year – to provide 201 medicines (378 different products) from WHO’s Model List of Essential Medicines, to the populations of low- and middle-income countries (LMICs). According to the Commission’s analysis, pharmaceutical expenditure on medicines in low-income countries (LICs) is currently only US$ 8.6 per person per year, with the majority of funding coming from individuals and households. Overall, 28 out of 31 LICs and 13 out of 47 LMICs are spending less on medicines now than the model’s lower threshold.
- Many effective policy options are underutilized: The Commission asserts that creating access to affordable essential medicines cannot simply be left to “the market.” Public policies are needed to promote equitable and affordable access. In addition, increasing transparency is a pre-requisite for the rigorous assessment of the value of medicines. Yet existing policy options that have been demonstrated to expand access to medicines are underutilized.
- An evidence-based and progressive agenda for developing new essential medicines is required: The Commission calls for stronger public-health-based essential medicines policies, including on priority-setting for R&D and use of patent laws. The Medicines Patent Pool should expand into an Essential Medicines Patent Pool (EMPP); secondly, a patent owner’s refusal to license an essential medicine to the EMPP should satisfy the condition for granting a compulsory license under TRIPS Article 31. The Commission also calls for a progressive accountability framework for medicines regulatory agencies.
- Measure progress to ensure accountability. The Commission recommends that mechanisms for independent review and corrective action now be developed. As a starting point, the report proposes 24 indicators for essential medicines policies in five priority areas: financing, affordability, quality and safety, use, and development of new medicines. Active stakeholder involvement is required going forward to set targets and carry out monitoring. In order for accountability mechanisms to work, local and national leaders need to promote transparency in data sharing, making local data a global public good.
- The Commission recognizes that working towards access to medicines as part of UHC requires expanded global discussions that include all stakeholders, not just topic area experts like the Commissioners. The report articulates the issues for a wider audience. We look forward to further explaining and debating our analyses, positions and ideas with policy-makers from around the world. Together, we can implement policies and institutional changes required to truly build essential medicines into effective universal health coverage.
- The work of the Commission was funded by the Bill & Melinda Gates Foundation, World Health Organization, the University Medical Centre Groningen, Boston University, and by all the academic institutions and other organizations that have generously allowed their staff to devote time to the work of the Commission.
- The co-chairs of the Commission were Hans Hogerzeil, University of Groningen, Netherlands, Andrew Gray, University KwaZulu Natal, South Africa, and Veronika Wirtz, School of Public Health Boston University, USA. The Commission was comprised of the three of us and 18 other experts in medicines policy representing different parts of the globe and different professional disciplines. All 21 Commissioners served independently, and did not necessarily represent the views of the organizations with which we are affiliated.