Perm is best – patents exist as an ex ante incentive for R&D, but they’re compatible with government distribution policies like compulsory licensing – that solves distribution problems while preserving innovation
Adigwe and Oturu 22 – Obi Peter Adigwe is the head of Health Policy Research and Development at the National Assembly of Nigeria; PhD in Health Care and Policy from the University of Leeds. Davidson Oturu is a partner at AELEX’s Intellectual Property practice; LLM in international business law from the University of Cumbria.
Obi Peter Adigwe and Davidson Oturu, “The role of patent waivers and compulsory licensing in facilitating access to COVID-19 vaccines: Findings from a survey among healthcare practitioners in Nigeria,” PLOS Global Public Health, 7 July 2022, https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0000683.
Although majority of the participants in this study agreed that patents are targeted at promoting inventions, their responses appear to be affected by their level of education. The respondents were however in consensus that waiving intellectual property rights can increase access to COVID-19 vaccines. This is an important finding to help address vaccine inequality which has occurred as a result of vaccine nationalism and scramble by developed countries [19]. TRIPS agreement was made in order to protect intellectual property rights, however, it was observed that the agreement had some shortcomings especially in the promotion of access to medicines. It would appear that the lacuna TRIPS agreement left was initially filled during the Doha Declaration [20, 21]. This declaration was adopted by the WTO Ministerial Conference two decades ago in Doha and it reaffirmed flexibility of TRIPS member states in circumventing patent rights for better access to essential medicines. The Doha Declaration sheds light on two mechanisms that can be used in emergencies to facilitate access to medicines, which include patent waiver and compulsory licensing of pharmaceutical products.
A considerable proportion of the sample indicated that waiver of intellectual property rights in pandemic situation can reduce cost. As the law of demand and supply states, the higher the price of goods, the lower the demand [22]. Thus, by enforcing monopolistic rights, pharmaceutical firms would exclude others from producing generic replicas of their products and consequently making the cost of pharmaceuticals unaffordable for most developing and low-income nations [23]. There must be a deviation from the orthodoxy towards the prioritisation of public health in order to flatten the curve of COVID-19 globally. In addition, local production of these biological products can help address vaccine hesitancy challenges in developing nations [24], as this can increase uptake by building more confidence.
Findings from this study suggests intellectual property over COVID-19 can restrict scale-up of manufacturing. This position is similar to previous reports [25, 26], and therefore brings the need for invoking compulsory licensing for all COVID-19 commodities especially in this critical time. Compulsory licensing means the non-voluntary acquisition of a patent from the owner combined with the payment of remuneration based on its economic value [27]. The use of compulsory licensing to address health crisis is not novel. It was used during the human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) epidemic in the early 2000s where compulsory licensing was secured in order to import generic anti-retroviral medicines by low-income nations [28]. For governments to invoke compulsory licensing provision of the TRIPS agreement to combat COVID-19, it is important that they must first domesticate these provisions or have allowances for them in their local laws. In a pandemic situation like this, prioritising the development of strategy that can save lives is not out of place. Therefore, it is important to promote policies such as suspension of patents for COVID-19 related health commodities so as to facilitate access to such products.
Following World Health Organisation declaration of the coronavirus as a global public health emergency, some countries immediately issued compulsory licences and started amending existing laws to accommodate the issuance of compulsory licences in response to the ongoing pandemic. For instance, in early 2020, the legislative arm in Canada, Chile and Ecuador began to lay the groundwork for the issuance of compulsory licences [29]. Canada in response to the pandemic amended their Patent Act to allow for a faster process in issuing compulsory licences by granting the licences first and negotiating remuneration later [30]. Chile similarly passed a resolution granting the use of compulsory licensing for the prevention and treatment of COVID-19. The resolution declares that the ongoing pandemic suffices as a national emergency to invoke compulsory licensing of COVID-19 related inventions. Additionally, in March 2020, Israel issued compulsory patent licencing for the importation of lopinavir/ritonavir, which is one of the approved testing drugs by WHO, for the management of coronavirus patients [31]. Despite all these preparations, no country has invoked compulsory licensing in relation to vaccines yet.
In this study, there were also concerns about the negative effects of waiving intellectual property rights, as slightly above half of the participants indicated that such practice could reduce innovations in the pharmaceutical sector, a third of the respondents were however indifferent in this regard. Similarly, more than half of the study participants indicated that waiving intellectual property rights has the tendency to hamper research and development activities in the pharmaceutical sector. It is important that, access to essential health commodities be prioritised so as to prevent avoidable loss of lives. Addressing concerns raised in this study is critical to improving access to essential health commodities in future pandemics. Respondents were however of the opinion that innovators whose intellectual property rights had been waived need to be remunerated by governments, and this implies that individual nation that wishes to produce items in this category locally will need to provide some forms of remuneration to the inventor before pharmaceutical companies in such countries can manufacture such products. This is an important strategy to ensure continuous innovation and research activities in the pharmaceutical sector. The critical factor for intellectual property rights waiver is to save lives. It is therefore important for governments to consider developing strategy for incentives so as to facilitate patents waiver in the pharmaceutical industry. This will serve as a way to encourage research and development activities in the health sector.