Intellectual property is a field of law that is critical to be aware of in understanding inequities in access to medicine and especially relevant in the time of Covid. Before understanding how Intellectual Property (IP) law intersects with medicine and vaccines, a brief primer on what IP is and what purpose it serves is instructive: the World Intellectual Property Organization (WIPO) defines IP as “Products of the human mind, the fruits of human creativity and innovation” (1). IP has long been protected by a variety of mechanisms such as patents, copyright, trademarks and other tools, and its importance is highlighted by its inclusion in the U.S. Constitution, giving Congress regulatory authority to “promote the Progress of Science and useful Arts'' (2). Patents are critical to advancing science because they provide legal protection to the inventor to exclusively profit off their newly-created technology for a period of time. This provides companies and individuals with an incentive to invest in research and development without fear of competitors making generic versions of their product (1).
While these provisions are undoubtedly necessary, the use of patents to protect pharmaceutical drugs that are life-saving, necessary, and frequently very expensive, has been controversial. Companies insist that they need to retain exclusive license to manufacture their drugs in order to recoup the high cost of developing and testing. However, patients insist that the lack of affordability and thus lack of access created by the steep price is immoral due to the pain and suffering experienced by those who can’t afford certain drugs. In the U.S., public scrutiny of drug pricing is epitomized by the eye popping prices and lack of access to Insulin, the drug diabetics live by. While the health economics behind Insulin pricing are complex and affected by multiple variables other than patents, the patents on new types of insulin have a major contribution to its high price. One estimate puts the cost of generic modern insulin as potentially 20-40% less than the patented version (3).
Covid-19 has upended innumerable areas of life, many of which previously thought to be intractable. But despite Covid-19 being the most serious global medical crisis in living memory, a more recent global medical epidemic also upended the world: HIV/AIDS. Crises, for all their horrific human costs, are valuable learning moments for how the world can shift rapidly in new and unexpected ways, or alternatively, remain frustratingly mired in urgent need. HIV/AIDS IP sharing agreements reveal much about the limits and challenges of international IP cooperation.
The HIV/AIDS crisis differed from the Covid-19 pandemic in two primary dimensions: scope and urgency. HIV/AIDS was concentrated among a subsection of society — initially in LGBTQ communities and then later in developing countries rather than developed ones — which meant that the world did not perceive the urgency of fighting AIDS to be the same as the fight against Covid-19. When AIDS drugs finally became available they initially had a steep cost, placing them out of reach of many in rich nations like the US and wholly unaffordable for the overwhelming majority of those in developing countries (4).
In response to the lack of affordability of life saving medications that HIV/AIDS patients needed, advocates pressed for a better system. The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an agreement with specific provisions that aims to provide affordable medicine in the face of patent barriers, with an emphasis on HIV/AIDS drugs. After this agreement was implemented, the continuing lack of drug affordability in many countries led to the 2001 Doha Declaration that encouraged more public health-focused interpretation of the TRIPS agreement and a small loosening of pharmaceutical patent rules. While this agreement did help—for instance, Zimbabwe declared an AIDS emergency in May 2002 which allowed patents to be suspended in order to get crucial ARV drugs—ultimately there remain huge issues with people in lower income countries not having access to drugs they desperately need.
The TRIPS provisions allow for countries to create systems for improving access, but these provisions are not being fully taken advantage of. A 2006 WHO bulletin quotes Cecilia Oh, from the WHO Department of Technical Cooperation for Essential Drugs and Traditional Medicine: “developing countries are not moving fast enough to put in place the legal framework and systems to ensure they have access to affordable medicines in the future”. Foot-dragging by richer countries, who are reluctant to deprive their pharmaceutical industries of profits, has a serious effect on the creation of new rules and also makes developing countries reluctant to utilize the existing agreements. As Ellen ‘t Hoen, the former Director of Policy and Advocacy at Médecins Sans Frontières, stated in the 2006 bulletin, while countries have more legal leeway to bypass patents after the Doha Declaration, “countries are hesitant to do so because they are afraid of provoking the anger of the United States. The political pressure is enormous.” (5).
Presently, the ongoing IP tug of war between rich, developed countries and poorer ones continues amidst Covid-19. In October 2020, India and South Africa submitted a proposal to waive some provisions of TRIPS, thereby suspending IP protections surrounding Covid-19 vaccines and drugs in order to accelerate their diffusion. However, the United States, the European Union, and other developed nations opposed this move. Vaccine development was primarily led and funded by high income countries with most of the supply being pre-purchased by these governments, leaving slim supplies for other, poorer nations. The UK, a prominent opponent of this particular proposal, justified its position by stating that the existing IP system was sufficiently robust to fulfill the needs of the crisis, and that “we have not identified clear ways in which IP has acted as a barrier to accessing vaccines, treatments, or technologies in the global response to Covid-19” (6). The lack of consensus led to a decision being postponed indefinitely, effectively killing the proposal (7). The heart of the argument is somewhat abstract; the existing provisions of the TRIPS agreement are considered technically capable of fulfilling the need to share technology in a health emergency, but it is insufficiently flexible for the preferences of poorer countries that desperately want to use any means possible to accelerate access to vaccines and medicine.
While the existing IP law may potentially prevent some technology transfers or vaccine production, the diplomatic impasse in the WTO hasn’t prevented the largest pharmaceutical companies from making voluntary and significant steps towards increasing global access to their products at an affordable price: Moderna has said it won’t enforce vaccine patents during the pandemic (8) and AstraZeneca has agreed to make their vaccine available at cost “in perpetuity” in lower income countries (9). As wealthy countries begin to complete vaccination of their population and vaccines start to flow to poorer countries, the existing vaccine inequality will begin to slowly shrink. Unfortunately however, even when the globe is vaccinated against Covid, the persistent possibility of variants that require further vaccination efforts means that vaccine inequality will continue to persist into the future.