'Overriding drug and medical technology patents for pandemic recovery: a legitimate move for high-income countries, too' by Katrina Perehudoff, Ellen 't Hoen and Pascale Boulet in (2021) 6(4) BMJ Global Health comments
Compulsory licenses are legal tools to override patent-protection on medicines and medical technologies. Compulsory licenses can help scale up the production and lower prices of patent-protected medicines while still accounting for the patent holder’s interests. Compulsory licensing is making a comeback in high-income countries as a negotiation strategy and a legal tool to remedy high prices and/or supply shortages of medicines and medical technologies. High-income countries that face potential legal hurdles (in world trade law and/or in the regulation of test data and market exclusivity) to effectively use compulsory licensing in the COVID-19 pandemic should consider taking measures now.
The authors state
Scaling up access to new COVID-19 vaccines and therapies (‘medicines’) and medical technologies is essential to move from pandemic response to recovery. One of the key conditions for governments to produce and/or procure a sufficient supply of COVID-19 medicines is access to their intellectual property (IP). Although the research and development (R&D) of many vaccine and therapeutic candidates has been partially or entirely publicly funded, the resulting products will be owned by the companies that bring them to market. Therefore, intellectual property rights will be a significant determinant of global access to COVID-19 medicines.
Intellectual property rules aim to compensate inventors for their investments in R&D, while also making innovations available for use by the public. The underlying premises of this system have been called into question for, among other reasons, the disconnect between growing public-funding for drug R&D resulting in privately-owned medicines. In 1995, a set of global trade rules in the World Trade Organization (WTO) Agreement on the Trade-Related Aspects of Intellectual Property (TRIPS Agreement) established the minimum standards for protecting intellectual property worldwide (see box 1). These trade rules drastically impacted human health: introduced near to the 2000s HIV/AIDS global epidemic, owners of patents and other forms of intellectual property hampered access to lifesaving antiretrovirals to people infected with HIV through excessive monopolistic prices.
Nearly two decades later, the global community faces the all-too-familiar challenge of maximising the supply of affordable, new medicines needed to stave off a pandemic. Generally, there are two courses of action to ensure intellectual property protection does not restrict access to potential pandemic medicines and medical technologies (eg, diagnostics and personal protective equipment). One avenue is for intellectual property owners (eg, companies) to offer affordable prices and adequate supply, to voluntarily license their COVID-19 medicines and share other forms of IP related to these products or to refrain from enforcing their intellectual property rights on their COVID-19 medicines worldwide. Although some companies have taken these steps in response to the COVID-19 pandemic, these decisions remain the exception, not the rule. Only relying on voluntary measures by companies leaves the private sector—and by extension, their shareholders—to decide when and how COVID-19 medicines become widely available and affordable.
The second course of action is for national governments to use the legal tools—compulsory licenses and public non-commercial use (called ‘government use’)—in their national law to override excessive monopolistic prices while still accounting for the patent holder’s interests. These legal tools allow governments to make and/or import the necessary ingredients or the medicines themselves, in generic form. In return, the patent holder receives a royalty payment for the use of its invention. Their use has been widely promoted in low-income and middle-income countries, often as a means to increase the supply and decrease the prices of HIV-related medicines. Even before the COVID-19 pandemic struck, all of the wealthiest countries already had legislation for compulsory licenses and/or government use on their books. International trade law (the WTO TRIPS Agreement and the Doha Declaration), international human rights law and the 2030 Agenda for Sustainable Development endorse using compulsory licenses and government use to increase universal access to essential medicines.
Widely acknowledged as important tools for low-income and middle-income countries, compulsory licenses and government use are also legitimate strategies for high-income countries to secure access to new, expensive, essential medicines. In this analysis, we outline how compulsory licenses and government use can effectively be used by high-income countries when needed, some remaining challenges to their full use in the COVID-19 response, and possible action.