September’s UN special session on antimicrobial resistance (AMR) was a vivid reminder of the shared responsibility of governments to promote research and development (R&D) combat global health threats. The complexity of the AMR threat made clear that a combination of market forces, policy incentives, and regulation, as well as norms and standards was needed to ensure innovation that would deliver accessible and affordable treatments.
The report of the UN Secretary-General’s High-Level Panel on Access to Medicines offers an important opportunity for national governments, UN organizations, philanthropies, civil society, and pharmaceutical manufacturers to move forwards and address this challenge. AMR is just the latest global health priority that cannot be resolved with the current incentive system for investing in medical R&D. AMR threatens to render a whole range of treatments ineffective and reverse 20th century advances in medicine. Numerous other health priorities are neglected because they do not present a business potential for investment, and millions of people lack access to medicines and treatments that are priced out of reach.
In a world of unprecedented medical advances, these unmet needs present a moral dilemma, and one of the most critical challenges for humanity. The Panel, on which I had the privilege to serve, makes a number of concrete proposals to promote needs-driven R&D financing and to expand access to medicines for people in need. As a whole, the report makes short-term and long-term recommendations towards introducing more systematic and sustainable approaches to meeting unmet needs in innovation and access.
Over the past two decades, enormous progress has been made to fill these gaps through initiatives that involve public, philanthropic, non-profit, and private sector actors. They include investment in R&D on neglected tropical diseases spearheaded by such programmes as the Drugs for Neglected Diseases Initiative (DNDi) and the Global Health Innovative Technology Fund (GHIT).
A major breakthrough in efforts to expand access was the generic manufacture of antiretroviral drugs to treat HIV/AIDS, price discounts and voluntary licences offered by pharmaceutical companies, and mobilization of large amounts of donor funding through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Access to effective HIV treatment has expanded dramatically since it was invented 20 years ago, and the price of the drugs has dropped from over US$10,000 a year in developing countries to around $100 today.
These are huge achievements but do not constitute a sustainable solution to the fundamental problem of misalignment between public health priorities and current market dynamics that drive innovation and shape access. The old problem of lack of access to existing life-saving drugs remains, and new challenges are emerging such as access to new lines of HIV antiretrovirals, new threats like Ebola and Zika viruses, and the rising price of life-saving treatments for disease such as cancer and hepatitis C.
These new threats affect people worldwide, not just in low-income countries. Prices of these treatments have risen to levels that are increasingly unaffordable for household budgets and insurance schemes even in the world’s wealthiest countries, such as the USA, Japan, and Switzerland. In the USA, 11 out of 12 cancer medicines approved in 2012 were priced above $100,000 per year and the cost of EpiPen dominates the front pages of daily newspapers.
This is why the Panel report recommends sustainable solutions through shifts in policy and their implementation. For example, we urge governments to consider the public health consequences of the intellectual property and other provisions included in trade agreements, such as the recently negotiated Trans Pacific Partnership agreement, that could lead to further raising prices of medicines, and further reduce the scope of policy choice for national governments in pursuing public health priorities.
We recommend stronger action against retaliatory action when national governments use the flexibilities in the World Trade Organization’s trade agreements that make life-saving medicines accessible. To facilitate decision making in both investors and governments, we propose greater transparency on pricing of medicines and the costs of R&D and manufacturing, as well as registry of patents. And we propose that countries create alternative incentives for R&D—“delinked” from having to charge high prices—that would build affordability of the medicines into the process from the start.
Taking action on these issues poses hard political choices. Critics have charged our report with undermining innovation by questioning the role of patents. This critique is wrong: in fact, our recommendations would deliver more innovation of public health value by addressing what the existing patent system does not. Critics have also attributed lack of access to poverty and inadequate health systems, denying the relevance of monopoly pricing under patents. What is at stake goes beyond the challenge of poverty to the health of all humanity.
According to international human rights law, access to health care is a human right that governments have an obligation to fulfil by taking necessary legislative and other policy measures. The misalignment between public health priorities and incentives cannot be addressed by charitable action of foundations and corporations alone. Nor can it be left to each government to cope with its own health emergencies. Unmet priorities in innovation and access are a global challenge and need an international response involving collaboration amongst governments, businesses, civil society, and patients.