COVID-19: vaccine development and compulsory licensing
As the race to find treatments and ultimately a vaccine for COVID-19 intensifies, questions are being raised regarding the mechanisms available to governments and policymakers that may unlock potential solutions.
Intellectual property protections
To date, most of the promising treatments for COVID-19 that are being tested in clinical trials already have patents attached to them, for example:
- Favipiravir (used to treat influenza)
- The combination of iopinavir and ritonavir (sold under the brand name Kaletra to treat HIV/Aids)
- Remdesvir (a medicine developed for Ebola by the biotechnology company Gilead).
This means that, depending on what drug(s) is approved in the fight against COVID-19, intellectual property protections may negatively influence the price and accessibility of treatment.
There have been examples of EU and US pharmaceutical companies waiving their rights to patent protection in response to the pandemic. For example, AbbVie, the pharmaceutical company behind Kaletra, has waived patent rights associated with the drug. This means that generic companies are able to begin production of these potentially antiviral drugs on a wider scale.
However, such a move is the exception rather than the rule. Governments in Chile and Costa Rica have declared that the pandemic justifies the need for extreme measures to ensure intellectual property rights do not prevent global access to treatments.
Costa Rica has called for pharmaceutical companies to voluntarily pool the necessary intellectual property in order for companies to collaborate on treatment research. This follows the model created by the Medicines Patent Pool, a United Nations-backed public health organisation, established in response to treating HIV, hepatitis C and tuberculosis. Such an initiative would provide patent licences to manufacturers under a blanket agreement, thereby creating the means for companies to manufacture drugs even if they do not own the patent.
Policy makers in the UK support this idea. Chile however, has called for pharmaceutical companies to forego their patent rights altogether in what is known as compulsory licensing.
Compulsory licensing of patents is a legal measure that can be utilised by governments to suspend patents on a product in times of emergency or in the public interest. It allows governments to grant itself, and third parties, the right to use a patent (and therefore manufacture a patented drug) without the consent of the patent holder, and is therefore seen by some as a possible mechanism to obtain equal and affordable access to COVID-19 treatment worldwide.
There are, however, some sticking points.
Market exclusivity is a regulated activity in the EU, and compulsory licensing would require a waiver of market exclusivity that is not possible under EU law. There is an exception to this, under the Compulsory Licensing Regulation (Regulation (EC) No 816/2006), which allows for compulsory licencing for the sole purpose of exporting patented pharmaceutical products to a developing country with a particular public health problem.
This is further addressed in The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), a legal agreement between all World Trade Organisation (WTO) members. Three years ago, following a formal amendment, 37 WTO member countries, including the UK, declared themselves ineligible to import medicines manufactured in another country under a compulsory license. In other words, TRIPS allows for WTO Members to issue compulsory licences specifically for export, but they are not bound to adopt compulsory licensing in terms of imports, thus protecting their own pharmaceutical industry by declining to import (competing) generic versions of the patented medicine.
An open letter was sent to these 37 countries on 7 April 2020 from health, law and trade experts requesting that they reconsider their position, as it is seen as a barrier to widespread medical intervention during the pandemic.
Whilst some governments and the WTO have taken steps in this area, it has yet to be determined whether compulsory licensing is one of the weapons in the global armoury with the potential to provide a COVID-19 treatment that is affordable and accessible worldwide.
Unprecedented measures may need to be considered in these challenging and uncertain times. Although not known for their agility, regulators and lawmakers will need to take decisions on these measures relatively quickly, balancing legal, medical and ethical considerations that may have potential long term and global implications.