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‘No-one is Safe Until Everyone is Safe’ – Patent Waiver, Compulsory Licensing and COVID-19 journal article open-access

Behrang Kianzad, Jakob Wested

European Pharmaceutical Law Review, Volume 5 (2021), Issue 2, Page 71 - 91

Recent months have seen intensified global calls for an intellectual property waiver of COVID-19 related vaccines, treatments and related products. Where one side of the debate elevates Intellectual Property Rights as on obstacle to affordable and expeditious global access to vaccines and treatments, the other side of the debate points to the existing TRIPS flexibilities such as compulsory licensing, the necessity of Intellectual Property Rights for future innovation as well as other factors such as manufacturing capacity and know-how being of greater importance. This dualistic approach risk ignoring the manifold law, economics, and policy nuances inherent in the intersection of intellectual property law and Right-to-Health, as well as innovation and health policy. A balanced approach guided by real world indicators regarding law and economics of pharmaceutical innovation, procedural feasibility of compulsory licensing and legal applicability of an IPR waiver is needed. Thus, the key to understanding the current debates lies in a holistic approach to ratio legis of intellectual property rights, innovation policy and health policy. The innovation inducing facets of monopoly rights, and interconnected monopoly profits, need to be balanced against public policy rationales such as Right-to-Health, but also against the ratio legis of IPRs, which focuses on maximizing societal welfare. After the introduction framing the background regarding unequitable global access to COVID-19 vaccines and treatments paving the way to the current debates on patent waiver and compulsory licensing, the Article proceeds as follows. Section II briefly sketches the main contours of the debate on right-to-health and intellectual property rights from a law and policy perspective. Section III details the legal, historical and procedural background of international codification of patents and the compulsory licensing instrument within the TRIPS agreement, as well some instances of compulsory licensing during COVID-19. Section IV recounts the patent waiver proposal at TRIPS Council and the arguments for and against the proposal. Section V concludes with some law and policy reflections on the balance between Right-to-Health, intellectual property rights and innovation policy.


How Much is Too Much? Defining the Metes and Bounds of Excessive Pricing in the Pharmaceutical Sector journal article

Behrang Kianzad, Timo Minssen

European Pharmaceutical Law Review, Volume 2 (2018), Issue 3, Page 133 - 148

Excessive pharmaceutical pricing represents one of the most contentious issues in legal and political discourse and has recently gained renewed attention by courts, competition authorities and political forces on both sides of the Atlantic. Balancing the public demand for affordable and accessible health-care with the need for sufficient incentives and a sustainable innovation system in the field of medicines also attracts a great deal of media and scholarly attention. Facing what seems to be a revival of competition law enforcement in this highly sensitive and complex environment it is of vital importance to keep up to date with the most recent developments. It is further crucial that the necessary debates are taking place within a well-informed and transparent environment that takes into account multiple factors, interests, responsibilities and concerns. This entails inter alia to consider various types of diseases (rare, neglected or blockbuster) treatment outcomes (cure or long dependency), as well as the economic complexities of successful innovation systems and higher societal goals such as sustainability, solidarity and fairness . Only then, will it be possible to devise well-balanced policies that allow relevant stakeholders to align their policies in order to achieve what society expects from the pharmaceutical innovation system: life-saving new therapies that are safe, efficient and accessible. This article depicts and discusses some of the latest cases and the underlying legal-economic and policy considerations.

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