Pfizer & BioNTech’s COVID-19 vaccine has been authorized in the US today, making it the fourth country, following the United Kingdom, Bahrain, and Canada, to make the vaccine available for distribution. Approval of Pfizer’s vaccine in many other countries is soon to come, but many lower-income countries are concerned they won’t be able to provide their citizens with access. Countries like India and South Africa have brought proposals to the World Trade Organization (WTO), asking that it allow countries to suspend the protection of certain kinds of intellectual property (IP) related to the prevention, containment and treatment of COVID-19. Yesterday, the WTO delayed the decision on India and South Africa’s proposal due to ongoing opposition. Regardless of the WTO’s decision, countries have a mechanism to override patents and produce the vaccine: the compulsory license (CL). Countries like Ecuador and Chile have taken steps to attain their own CLs. 

In 1995, the Trade-Related Intellectual Property Rights (TRIPS) agreement of the WTO was created, requiring all member countries to provide a minimum level of patent protection for all types of intellectual property. TRIPS also provides countries with the option of issuing a compulsory license if they are not able to attain access to a drug in a reasonable amount of time, which allows them to override patents. A CL isn’t easy to obtain, and can usually only be issued after a government has attempted to convince a patent holder to issue a voluntary license. In the case of an emergency (e.g. a pandemic), negotiating a voluntary license can be bypassed. A country issuing a CL is required to provide compensation to the patent holder.  However, authorities in the developing country determine whether payment is adequate; a patent holder’s only option to increase royalty receipts is to appeal directly to the issuing country. CLs have been used previously for countries to obtain access to drugs to treat AIDS, heart disease, and cancer.

Though the CL mechanism exists for countries to secure access to drugs, there can still be barriers to development. These can include limited ability to produce the drug themselves, or restricted access to imports. These are pertinent issues for coronavirus vaccines, which are complex and difficult to replicate. If the WTO grants CLs, production of an efficacious vaccine is contingent upon access to necessary technology, data, and cell-lines within recipient countries. If a country possesses the capacity to produce the vaccine, the international market could be flooded with a potentially less efficacious generic product. Through CLs, a country is able to sell the drug they produce to countries who are unable to manufacture the pharmaceutical. This gives the CL mechanism the potential to engender greater competition in international markets for vaccine developers.