PHARMACEUTICAL PATENTS AND ACCESS TO MEDICINES IN GLOBAL PANDEMICS. MUTUALLY EXCLUSIVE OR MUTUALLY REINFORCING? A POST COVID-19 INQUIRY INTO THE TRIPS AGREEMENT AND HUMAN RIGHTS.
Doctoral Dissertation
Publication Date:
2026
Citation:
PHARMACEUTICAL PATENTS AND ACCESS TO MEDICINES IN GLOBAL PANDEMICS. MUTUALLY EXCLUSIVE OR MUTUALLY REINFORCING? A POST COVID-19 INQUIRY INTO THE TRIPS AGREEMENT AND HUMAN RIGHTS / J. Natali ; tutor: N. Boschiero, S. Silingardi, M.A. Rossi
coordinatrice: D. U. Galetta. - Milano. Dipartimento di Diritto Pubblico Italiano e Sovranazionale, 2026 Jan 16. 37. ciclo, Anno Accademico 2024/2025.
abstract:
The COVID-19 pandemic struck the world in 2020 causing an unprecedented global public health crisis and economic disruption. The deep inequalities that characterised the distribution of vaccine among States rekindled longstanding debates that have surrounded the role and effects of patent protection for pharmaceuticals on access to medicines. Pharmaceuticals are an extremely socially sensitive area of patents from both the legal and economic perspective: on the one hand, the monopoly it confers is arguably a necessary incentive to develop medicines which we would not have otherwise; on the other hand, the scarcity and high prices it implicates result in access to life-saving medicines being denied to millions of people worldwide. The outbreak of a global pandemic spawns the urgent need for rapid innovation and distribution of vaccine and antivirals, and for countries to cooperate to rapidly achieve both these public health objectives on a global scale. The TRIPS Agreement has globalised patents as the model for pharmaceutical innovation in 1995. At the same time, access to medicines is increasingly recognised as a human right which States are obliged to ensure to everyone under the ICESCR and the ICCPR. The tragedy of the HIV pandemic at the turn of the century led to the adoption of the Doha Declaration on the TRIPS Agreement and public health and to new public health approaches to medical patents in domestic and international law, mostly relating to the use of public interest safeguards inbuilt in the TRIPS – the so-called flexibilities. However, how the structure of international patent law affects the development and distribution of vaccines and antivirals at the global level, as well as whether patent law mechanisms developed for protecting public health and the human right to access to medicines can apply successfully to ensure the development and access to medicines, when the public health challenge is a global infectious disease pandemic is largely unexplored.
This thesis combines a legal analysis with an analysis of the relevant economic, law and economics, and epidemiological literature to respond to the fundamental question of whether the patent-access balance, as currently regulated in international law, facilitates or hinders the pharmaceutical response strategies required by a global pandemic public health response. It argues that improving the global pandemic response requires a new international IP law norm that reshapes the incentives for States towards cooperating for a broader global allocation of pandemic medicines.
This thesis combines a legal analysis with an analysis of the relevant economic, law and economics, and epidemiological literature to respond to the fundamental question of whether the patent-access balance, as currently regulated in international law, facilitates or hinders the pharmaceutical response strategies required by a global pandemic public health response. It argues that improving the global pandemic response requires a new international IP law norm that reshapes the incentives for States towards cooperating for a broader global allocation of pandemic medicines.
IRIS type:
Tesi di dottorato
List of contributors:
J. Natali
Link to information sheet: