'The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to end the COVID-19 Pandemic' (LSE Legal Studies Working Paper No. 06/2021) by Siva Thambisetty, Aisling McMahon, Luke McDonagh, Hyo Yoon Kang and Graham Dutfield comments
The structure of global intellectual property law as incorporated in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is implicated in the current lack of COVID-19 vaccines, medical equipment, medicines and diagnostics (hereafter, ‘health-technologies’), which are needed to combat the pandemic. Although equitable access to vaccines is in the moral, political and economic interests of the global public and requires global solidarity, the phenomenon of COVID-19 ‘vaccine nationalism’ has brought into sharp relief the misalignment of current legal and financial incentives to produce and distribute vaccines equitably. The crisis further demonstrates the failure of high-income countries (HICs) to realise the promise they made at the time of the TRIPS negotiations in 1994, that by agreeing to the terms of TRIPS, lower and middle-income countries (LMICs) would benefit from technology transfer and the building of productive capacity. As such, the current crisis is revealing not only of inadequacies of how to deal with global emergencies, but also of deficiencies within the international ‘patent bargain’ itself.
This paper elucidates the legal issues surrounding the ‘TRIPS waiver’ proposal initially put forward by India and South Africa in October 2020, which, as of May 2021, is supported by more than 60 states, and which has received statements of support from the World Health Organisation (WHO). We analyse the different intellectual property rights relevant to the proposal – focusing primarily on patent rights and trade secrets – which are most relevant to the present COVID-19 vaccine context. We explain why the existing TRIPS flexibilities around compulsory licensing are incapable of addressing the present pandemic context adequately, both in terms of procedure and legal substance.
The extent of the current health crisis posed by COVID-19 is as undeniable as the current global response is untenable. Given the ongoing absence of sufficient engagement by the pharmaceutical industry with proposed global mechanisms to share intellectual property rights, data and know-how to address the pandemic, we argue that mandatory mechanisms are needed. The TRIPS waiver is an essential legal instrument in this context for enabling a radical increase in manufacturing capacity, and hence supply, of COVID-19 vaccines, creating a pathway to achieve global equitable access.
We make two arguments to this effect: first, the TRIPS waiver is a necessary and proportionate legal measure for clearing intellectual property (IP) barriers in a direct, consistent and efficient fashion, enabling the freedom to operate for more companies to produce COVID-19 vaccines and other health technologies without the fear of infringing another party’s IP rights and the attendant threat of litigation; and second, the TRIPS waiver acts as an important political, moral and economic lever towards encouraging solutions aimed at global equitable access to vaccines, which is in the wider interest of the global public.
'EpiPen, Patents, and Life and Death' by Jacob S Sherkow and Patricia J Zettler in (2021) New York University Law Review Online comments
Drug pricing disputes, while significant public health concerns, are not typically immediate life or death matters. But they may be for certain emergency medicines, medicines used for potentially lethal and rapidly onset illnesses or injuries. This is especially true for emergency combination drug-device products, like Mylan’s EpiPen, for which patients bear a significant brunt of the products’ cost. Scholarly commentary on the controversy surrounding the pricing of Mylan’s EpiPen, however, has largely elided over this relationship among combination products, emergency medicine, and patient payment, focusing principally instead on classic issues of antitrust and competition. This brief Essay explores how EpiPen’s pricing capacity is a function of a peculiar intersection of emergency medicine, FDA law and policy, and patents, and suggests areas of further analysis for other drug-device emergency products.
