Less than a year after the global outbreak, the pharmaceutical and biotechnology industries, with assistance from many wealthy governments, were able to complete multiple vaccines to combat the novel coronavirus. Despite hundreds of millions of doses being produced, only 0.1 percent were administered in low-income countries. While vaccine manufacturers fulfill bulky pre-orders placed by wealthy nations like the U.S. and the U.K., poorer nations have struggled to afford the steep cost of purchasing doses from the diminishing global vaccine supply. In response, more than 50 developing countries have come out in favor of a WTO proposal that would expand vaccine manufacturing and accessibility for poorer nations. Unfortunately, the proposal has received little support from wealthy nations. This is because the proposal at its core asks countries home to COVID-19 vaccine manufacturers to temporarily waive their sacred intellectual property rights.
Intellectual property (IP) rights protect people from having their creations being used or copied without their authorization. It gives creators exclusive rights over the usage of their work for a limited period of time designated by their government. Most IP rights consist of copyright, which protects literary or artistic works; trademarks to protect distinctive signs of a good or service; and patents to protect inventions. These rights are individually developed by nations, but all members of the World Trade Organization must adhere to a basic minimum standard of enforcing IP rights as mandated by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. For many WTO members, the TRIPS Agreement outlined the various facets of IP rights and procedures and time periods for enforcing them domestically. Indeed, the assurance of IP rights can incentivize technological innovation as individuals and companies are motivated to compete with another for exclusive creator rights, but it also adversely affects the pricing of pharmaceutical products.
For the 159 members of the WTO, when a pharmaceutical product is patented by the government, other companies are unable to create the ‘generic,’ bioequivalent version until at least twenty years later when the patent expires. Strict adherence to this policy can be dangerous during a public health crisis when access to affordable medicine is crucial for recovery. In 2001, this concern was raised at the WTO Ministerial Conference in Doha during the peak of the global HIV and AIDS epidemic. Just a year earlier, more than 4 million new HIV infections were reported across sub-Saharan Africa while HIV prevalence in China was as high as 82% among drug users from 1998 to 1999. As this epidemic rampaged through many developing countries with weak healthcare infrastructure, the U.S. and Western Europe saw significantly fewer resulting deaths due to the introduction of costly antiretroviral therapies.
In response to this inequity in HIV treatment, WTO members adopted the Doha Declaration which expanded the TRIPS Agreement to be more flexible during public health crises. One notable measure is that countries could now issue “compulsory licenses” which allowed governments to license the use of a patented invention without the approval of the patent-holder, under whatever conditions they deemed fit. This emergency power can accelerate the reach of potentially life-saving medicine and technology to countries bearing the brunt of a health crisis. Furthermore, manufacturing can expand beyond the country of the patent-holder and give other nations an opportunity to benefit from exporting medicine or producing it at a lower cost domestically. Within a decade of adopting the Doha Declaration, the normally $10,000-$15,000 antiretroviral therapy treatment had been reduced to less than $120 per person in many countries and millions of more people in low and middle-income countries were able to receive HIV treatment.
In the context of the COVID-19 pandemic, low-income countries should not have to wait nearly a decade for more equitable access to the vaccine. Fortunately, there are a multitude of vaccine options available, with the frontrunners in the global vaccination campaign being the Oxford-AstraZeneca vaccine administered in 135 countries, the Pfizer-BioNTech vaccine administered in 89 countries, and the Moderna vaccine administered in 37 countries. Of the three frontrunners, the Oxford-AstraZeneca vaccine reaches comparatively more countries in the South American and African continents, which can also be attributed to the low cost of the vaccine–no more than $6 USD per dose in any country. Although, the Oxford-AstraZeneca vaccine was actually meant to be distributed on an open-license platform so that any manufacturer could freely produce it without violating patent rights. It was reportedly only after the insistence of the Bill & Melinda Gates Foundation that Oxford University partnered with pharmaceutical company AstraZeneca and obtained an exclusive license to sell their vaccine.
The Gates Foundation evidently played a role in once again reinforcing the status quo of bolstering the pharmaceutical industry at the expense of consumers. The organization itself is also set to financially gain from its multiple investments in companies working on COVID-19 vaccines, including a $40 million stake in CureVac, a biopharmaceutical company working on a mRNA vaccine for COVID-19. Thus, because this industry is so lucrative, especially now when the need for vaccines is universal, providers like Oxford-AstraZeneca and Pfizer-BioNTech are financially less inclined to donate rights to their vaccine.
In October 2020, Moderna released a statement vowing not to enforce their COVID-19 vaccine patents, and received praise for their decision to prioritize public health. However, modern patents rarely contain enough information required to manufacture the protected invention. Instead, that crucial information, like technical designs and production procedures, is considered “undisclosed information” which is still protected by the law, even if it is not included in a patent. Thus, Moderna is not necessarily combating vaccine inequity, but giving up its patents for positive publicity.
The proponents of the WTO proposal to temporarily waive intellectual rights recognize this loophole, and that is why they insist on the temporary suspension of “patents, copyrights, industrial designs, and undisclosed information” until the coronavirus pandemic is under control. But this proposal has been poorly received by wealthier countries like the U.S. and the U.K. who have to this point sided with the pharmaceutical companies. Ostensibly, these countries are concernedthat even a temporary suspension of IP rights will disincentivize medical research, innovation, and reduce interest from investors. While the pharmaceutical industry makes a valid argument, it is hard to ignore the potentially massive profits from selling coronavirus vaccines if they refuse to change their stance. Their alternative suggestion, to provide vaccine donations to developing countries, may not suffice, especially if leading manufacturers are honoring pre-orders from wealthier nations.
Ultimately, the issue with upholding IP rights at this critical point of the pandemic is that pharmaceutical companies cannot guarantee fair access to the vaccine because they are free to decide the prices for doses and determine who receives them. Governments of wealthier nations have a responsibility to ensure equitable access to vaccines because without a cohesive global vaccination campaign, the rapidly mutating coronavirus will outpace any vaccination effort.