Aisling McMahon: COVID-19, patents and healthcare – the need for (bio)ethics
Dr Aisling McMahon, assistant professor at Maynooth University Department of Law and an expert in medical and intellectual property law, makes the case for a (bio)ethics space within patent law.
COVID-19 was declared a pandemic on 12th March 2020 and by 9th April had claimed 81,580 lives. COVID-19 has also brought to stark reality broader inequalities and impediments in the delivery of healthcare, including the potential impacts of patents.
Patents are intellectual property rights which allow the patent holder to stop others from using the patented invention for the duration of patent grant (generally 20 years) without their permission (license). The patent holder can refuse third-parties permission to use a technology, or only allow permission with restrictive conditions on access, including high charges. This has the potential to limit who can access a technology and how that technology is used. When patents relate to medical technologies this has the potential for significant implications for human health, demonstrated in the COVID-19 context at various levels of the healthcare provision.
Firstly, in the diagnostic context, Labrador Diagnostics LLC initially issued a legal action (which was subsequently abandoned amid public backlash) for patent infringement against BioFire Diagnostics for making COVID-19 diagnostic tests and also sought an injunction to stop them making such tests. This in turn would have had potential implications for provision of diagnostic testing for COVID-19.
Secondly, in the treatment context, claims (later proven incorrect) alleged that a patent holder challenged a group who were 3D-printing ventilator parts for use in Italian hospitals to treat COVID-19 patients. These claims were subsequently denied by an individual involved and refuted by the patent holder. However, it is entirely legally plausible (although it would undoubtedly be inadvisable as it would be likely to cause significant reputational damage to the patent holder) that a patent holder could mount such a patent infringement challenge, with the potential to limit provision of much needed 3D printed devices.
Thirdly, concerns have arisen around the potential impact of patents on future treatment or vaccines for COVID-19, including whether such patents could be used to charge high costs for such treatments/vaccines which could deny or limit access for many individuals/countries. These issues have already prompted some countries to adopt legal provisions ensuring that compulsory licensing of patents (where countries do not need to seek patent holders permission to use the invention under patent i.e. the medicine, medical-device or vaccine) of COVID-19 treatments will be allowed or made easier.
These examples demonstrate the potential for patents to be used in a way which directly conflicts with healthcare. Many instances may be resolved by patent-holders changing their position and facilitating access often as a result of public pressure, and there have also been considerable exemplary developments using voluntary licensing proposals to address such issues. For example the Open-Covid Pledge encourages patent holders to make intellectual property (including patents) available free of charge for use in ending COVID-19, and the World Health Organisation has endorsed the development of a voluntary pool of patented technology related to COVID-19. Nonetheless, ultimately, considerable discretion still rests with patent holders even where human health, or life is at stake. Arguably, in the healthcare context the extent of this discretion given to patent holders needs greater scrutiny, and alongside this, the role of (bio)ethics within patent law needs to be reconsidered.
Bioethics has been marginalised within patent law to date, where the focus has tended to be on the economic role of patents to encourage innovation, rather than the potential ethical implications of patents for human health. Yet, arguably there is an under-explored scope for engagement with bioethics within European patent law. For example, Recital 16 of the European Biotechnology Directive 98/44EC, states that patent law should be applied in a way which respects “fundamental principles safeguarding the dignity and integrity of the person.” This has the potential to include considerations related to patents impact on healthcare. Recital 43 also recognises that European patent law should be applied in consideration of broader fundamental rights under the European Convention on Human Rights (ECHR). Such rights include the right to life (Article 2 ECHR), within which the right to access healthcare for COVID-19 could be argued. Furthermore, Art 53(a) of the European Patent Convention (EPC) excludes patents where their commercial exploitation is against ordre public or morality. This provision has been interpreted restrictively to date by the European Patent Office. However, arguably there is scope for this provision to be used to incorporate considerations such as human rights and the ethical implications of patent grant on medical technologies.
We must also bear in mind that patents and the interpretive rules which exist within patent law were designed in the context of mechanical inventions. The main European patent legislation, the EPC was adopted in 1973. Since then we have had significant advances in health-technologies which arguably justify an alternative approach. Furthermore, traditionally countries had more discretion to refuse to allow patents on some technological areas, such as medicines. This discretion was removed in 1995 by the TRIPS Agreement, which must be signed by all World Trade Organization States. It provides that patents should be granted on all fields of technologies, including medicines. The different technological context we are now in, and the lack of State discretion on providing patents on medical technologies, provides further impetus for a reconsideration of the role of bioethics in patent law.
In short, COVID-19 illuminates again the potentially immense power of patent holders, and whilst many patent holders will exercise this power responsibly, others will not. Patent law, as currently interpreted, arguably gives considerable unfettered discretion over how an invention is used to patent holders despite the significant potential health and ethical implications arising. A reconsideration of the role of bioethics within patent law is needed and long overdue, and COVID-19 provides us with an important opportunity to reframe this relationship between health and patents.