Access to COVID-19 vaccines and medicines: patents and compulsory licensing in the spotlight

Aisling McMahon

To date, we have seen over 54.8 million cases of COVID-19 and 1.4 million deaths globally, including 71, 187 cases of COVID-19 and 2033 deaths in Ireland alone. Against this backdrop, the race continues at pace to develop effective vaccines and therapies for COVID-19. Recently, we have had the news that the COVID-19 vaccine being developed by Pfizer/BioNTech has recorded positive results from clinical trials with its latest data reporting it to be up to 95 per cent effective, Moderna’s vaccine recently reported a 94.5 per cent effectiveness rate and the Oxford/AstraZeneca vaccine reported efficacy results of up to 90 per cent. Whilst such reports are undoubtedly very positive news, a note of caution has been urged by the Nuffield Council as uncertainties remain given that the clinical trials are still ongoing, the data has yet to be released fully and peer reviewed and regulatory approval must be granted for vaccines before use.

Nonetheless, with these announcements comes hope that an end to COVID-19 may be in sight, as the race for a proven safe and effective vaccine appears to be nearing the finish line. However, alongside the task of developing an effective vaccine, attention must now also turn to how any vaccines or treatments for COVID-19 will be accessed and allocated once approved for use. In this context, several obstacles to access arise, such as ensuring sufficient manufacturing capacity and infrastructure is in place to roll out vaccine provision globally. However, another potentially significant obstacle is the role of intellectual property rights, including patent rights in how vaccines are accessed. This role  warrants much greater attention because such rights, depending on how they are used, may impede access and equitable allocation of COVID-19 vaccines and treatments.

My recent article published in the Northern Ireland Legal Quarterly focuses on the role of patent rights within the context of access to COVID-19 vaccines and treatments and, specifically, on the avenues for governments to intervene with patent holders’ discretion via compulsory licences where needed. The article argues that patent rights play a significant role in how COVID-19 vaccines/treatments will be accessed first, by whom and at what price. Patents effectively give the patent-holder the right to stop others from using the patented technology without their permission for the duration of the patent (generally 20 years). If the patent holder refuses others the permission to manufacture or sell the vaccine, they can become the sole provider of the vaccine, and this could have knock-on effects on the price and on the quantities of the vaccine available for sale around the world. Such intellectual property rights also give the rightsholder the potential to agree deals with countries for preferential access to the first supplies of the vaccines, which could limit supplies available elsewhere. Indeed, recent reports suggest that over 80 per cent of the supplies for the Pfizer/BioNTech vaccine are already agreed for distribution in higher-income countries accounting for only 14 per cent of the world’s population, which could lead to shortages elsewhere.

Yet, despite this power of rightsholders to determine many aspects of how such COVID-19 treatments/vaccines are accessed, the role of patents and other intellectual property rights is sometimes overlooked within mainstream media discussions of access to COVID-19 vaccines/treatments and warrants closer attention.

To address potential access obstacles arising from intellectual property rights, as I have argued in this article and elsewhere, governments can encourage patent-holders to share intellectual property rights to tackle the pandemic by endorsing voluntary licensing initiatives. One example is the World Health Organization’s COVID-19 Technology Access Pool (C-TAP) which encourages the sharing of data, intellectual property rights, know-how and cell lines related to C OVID -19 health technologies in a spirit of solidarity to bring an end to the pandemic as soon as possible. The C-TAP initiative, if supported by states and pharmaceutical companies, would provide a key mechanism to ensure that intellectual property rights do not impede access to COVID-19 vaccines/treatments. However, to date, C-TAP has received endorsements from just 40 countries globally, and Ireland and other countries ought to endorse this initiative as soon as possible.

Alongside such voluntary initiatives, it is important that states have effective avenues to mandatorily intervene with patent-holders' licensing decisions via compulsory licences if patent-holders refuse to license technology on reasonable terms for COVID-19. A compulsory licence allows use of an invention without the patent-holder’s permission, provided certain criteria are met. In this vein, some patent holders including Moderna, have indicated they will not enforce their intellectual property rights over COVID-19 vaccines during the pandemic, but not all rightsholders have made such commitments. Thus, effective compulsory licensing laws at the national level are vital.

The NILQ article discusses the international framework for compulsory licensing, including the requirements set out for such licences. It argues that, whilst compulsory licences are not the panacea solution for access issues for COVID-19 as, even if third parties can use the patented technology, issues around know-how in reproducing certain technologies such as vaccines may arise. Nonetheless, compulsory licences are still important for small molecule medicines. They can also be used as negotiation tools to encourage patent-holders to provide access to health-technologies on reasonable terms where such terms cannot be agreed with the rightsholder, and they offer a mechanism to re-shift the balance between rights-holders and the wider public who need access to health technologies, thereby offering a solution to one part of the broader access puzzle.

Hence, the article makes the case that it is vital that all national states provide effective mechanisms for compulsory licensing so these can be used where needed for COVID-19. Having built this case, the article uses Ireland as a case-study to examine the extent to which the current laws in Ireland could be used to allow for compulsory licences in the COVID-19 context if needed. It identifies shortcomings evident within Irish law and provides a list of proposals for how Irish law could be reformed to make the compulsory licensing system more effective for use in COVid-19 and other health contexts if needed.

Put simply, it is vital that Ireland and other countries carefully reconsider existing systems for compulsory licensing and make them as effective as possible because such licences may be needed to overcome access obstacles for COVID-19 technologies. Other countries such as Germany, Canada and Chile have already reformed national compulsory licensing laws for COVID-19, and the article makes the case for why Ireland, and other countries, should follow suit as soon as possible.