Recent moves such as by the United States and United Kingdom to negotiate deals to access large quantities of vaccines/medicines for Covid-19 within their territories raise serious questions around access to healthcare and global equitable distribution. Such attempts to secure preferential access, although understandable within the national context, can jeopardise supplies of treatments and vaccines for other countries.
For example, in June the United States purchased 500,000 doses of remdesivir which offers potential as a treatment to help recovery for Covid-19. This was initially reported as almost the entire production capacity of Gilead (the patent-holder) for the drug for the following three months. More recently, at the end of July the European Commission signed a contract with Gilead to secure access to remdesivir within the EU and the UK for 30,000 patients suffering with severe symptoms of Covid-19. Similar moves are evident for Covid-19 vaccines so-called vaccine-nationalism involving (often) opaque agreements between States and pharmaceutical companies for access to specific quantities of proposed vaccines for Covid-19. Such national and regional deals with patent-holders are likely to increase in coming months.
These developments are not simply about States or regions prioritising their citizens. Rather, they highlight the power patent-holders, generally large pharmaceutical companies have, to make key decisions about access to vital lifesaving healthcare, including determining who obtains treatments first and at what price. Patents are generally seen as necessary incentives for the development of medicines. However, questions must be asked around the extent of control currently given to patent-holders for Covid-19, and the role of patents as private governance tools in such contexts.
Patents are intellectual property rights which give the patent-holder the right to stop others from using the patented technology without their license for the duration of the patent (generally 20 years). This right allows patent-holders to develop an income stream and recoup their investment in the technology. Yet patents have significant implications for healthcare. For example, patent-holders can refuse licenses to third parties to produce a patented medicine. This could lead to the patent-holder becoming the only provider of that medicine with knock-on implications for its supply.
Patents can also impact the price of a medicine as patent-holders can charge high prices for licenses or access. The significance of such issues is heightened in the global pandemic context because it is in all our interests to eradicate the virus globally as quickly as possible. This is best achieved by maximising affordable access to future vaccines and medicines globally. However, to do so, the ethical implications of patent rights must be acknowledged and we must ensure that the way patents are used does not obstruct access.
Furthermore, although many patent-holders have offered reasonable licensing arrangements for Covid-19, in future others may not, with risks of profiteering. Mechanisms to facilitate States’ leverage over how patent-holders act in the pandemic are therefore vital. Two key issues must be addressed: Firstly, there is a need to clarify and strengthen national compulsory licensing mechanisms. Secondly, States should support voluntary international patent licensing initiatives to secure favourable access for patented Covid-19 medicines/vaccines globally.
Compulsory licensing and National Access
Under international trade law, avenues exist for States to issue compulsory patent licenses – provided certain legal criteria are met. Compulsory licenses allow the State to grant permission to a third party to produce the patented invention, e.g. medicine, without the patent-holders consent. Compulsory licenses could be used to alleviate concerns caused by other States negotiating deals with patent-holders for significant supplies of life-saving medicines/vaccines. Using compulsory licenses, a State could grant permission to third parties to make similar (generic) versions of medicines for use in that State, if access on reasonable terms cannot be obtained from the patent-holder (provided raw materials and manufacturing capabilities were available).
Traditionally, countries have been reluctant to use compulsory licenses given industry opposition. Nonetheless, Covid-19 provides a strong impetus for change. Some countries have adopted legal measures to facilitate compulsory licensing where needed for Covid-19. Other States should follow suit, and ensure any national or regional barriers to effective use of compulsory licensing are eliminated.
The greater the number of States that show willingness to use compulsory licensing, and ensure compulsory licensing avenues are effective where needed for Covid-19, the greater the likelihood of compulsory licensing becoming more normalized so that States can invoke such measures without fear of industry backlash.
Voluntary Licensing – Towards a Global Solution
Compulsory licensing can address once-off access issues within national States for individual medicines or vaccines. However, arrangements where patent-holders voluntarily license their patents freely or on reasonable terms to address Covid-19 are also vital and must be supported as these can have broader global impacts. For instance, the World Health Organisation (WHO) recently launched the Covid-19 Technology Access Pool (C-TAP) which encourages patent-holders to voluntarily share or pool intellectual property rights, knowledge, and data to tackle Covid-19. Thirty-nine States worldwide have endorsed this pool but the US and UK have opposed it. Other States should take action to endorse this initiative as soon as possible as a commitment to global solidarity in addressing Covid-19.
Put simply, Covid-19 poses a fundamental challenge for global health. Alongside exemplary work being conducted to develop vaccines and medicines, greater consideration is urgently needed over how such vaccines and medicines will be accessed once developed, and the power of patent-holders in such contexts cannot be ignored.
Author: Aisling McMahon
Affiliations: Department of Law, National University of Ireland Maynooth, Maynooth, Kildare, Ireland
Social media accounts of post author: @AislingMMcMahon
Competing interests: The author is a member of Access to Medicines Ireland (AMI)