Compulsory Patent Licensing and Access to Medicines: A Silver Bullet Approach to Public Health?
I am beyond happy to announce that my first monograph, “Compulsory Patent Licensing and Access to Medicines: A Silver Bullet Approach to Public Health?” is now available for pre-order. Compulsory licensing allows the exploitation of a patent during its protection term without the right holder’s consent. However, in this book, I argued a compulsory licence could, in certain situations, respond to short-term healthcare issues, but granting a compulsory licence is not like flipping a switch that opens the floodgates for affordable medicines.
My journey of being an author
This book is a concise version of my PhD. It has a turbulent history, the one that, in a sense, is the history of my teaching career so far. I signed the book contract in the summer of 2018 while working at Durham, my first workplace. I submitted the book manuscript at the end of April 2020, not long after the UK entered the first national lockdown. At that time, I was teaching at Warwick.
After more than a year, I was contacted by the publishing house in the summer of 2021 to inform me that they were given the green light to publish my book. Several months later, while my book had been under review before it went to the production stage, I was offered the position of Departmental Lecturer in Intellectual Property Law. Ultimately my book was published having Oxford as an affiliation. What is a journey!
Authoring this book was like riding a roller-coaster. I had a lot of ups and downs, excitement followed by frustration, particularly during the pandemic when communication with the publishing house was disrupted. The journey was long and winding at some points. It was getting more challenging when I had to balance my workload, personal life, editing this book, and resisting the attraction of UK summer weather. But I pride myself on not giving up, and now I am ready to reap the fruit of my labour.
What is this book about?
This book centres around the debate of access to medicines and the patent system under the TRIPS Agreement. The debate that the WHO described as the most heated, sometimes divisive, and potentially explosive of all the issues discussed at WHO governing bodies
While medicine patents have been viewed as a major cause of the lack of medicine accessibility in developing countries, pharmaceutical companies have considered the patent system an essential component of business operations. While I acknowledged the ideological differences of the patent system, the theme of this book is compulsory licensing, a legal tool that allows a government or a third party to exploit a patented product during its protection term without the patent holder’s consent. In exchange, the patent owner will be given some remuneration. Compulsory licensing can be given to any IP. But in no other field has it been more debated, contextualised and disputed than in the case of pharmaceutical patents. Compulsory licensing is controversial because it touches upon a patent’s core value, exclusivity. Lyon-Caen, a French lawyer, likened the patent owner subject to a compulsory licence to a man who owned his house, but he was required to allow anyone who requested the house to live with him on a rental payment.
Compulsory licensing, regulated by Article 31 of TRIPS, is one of the most controversial legal mechanisms. There is no better time than now to revisit this debate, which has intensified in light of the COVID-19 pandemic. Since the beginning of the outbreak, many developing and developed countries, such as Chile, Ecuador, Israel, France, Canada, and Germany… have either modified or adopted their national laws to readily employ compulsory licensing when the treatment for COVID-19 was found. Nevertheless, no compulsory licence has been issued so far, even though thirteen vaccines against COVID-19 have been approved in at least one jurisdiction. Such inaction from countries’ governments thus invites a thorough examination of compulsory licensing.
The controversial nature of compulsory licensing, the tension between patents and public health, and my background as someone from a developing country who grew up in a medical family prompted me to do the research and write this book.
This book explored how India and Brazil used compulsory licensing to solve their public health. India and Brazil serve as case studies due to the legal implications and the uniqueness of their use. Their geopolitical clout played an essential role in a process that is inherently influenced by politics and economics rather than solely based on a pre-defined legal framework. I found that both countries have only issued one compulsory licence so far, and in this book, I argued that it is unlikely that these two countries will issue any more compulsory licences in the future.
In addition, I analysed the view of several multilateral organisations, namely, the EU, the WIPO, the WHO, and the NGOs. The EU has built an image as a quiet and diplomatic player because it has used diplomacy to settle controversies. WIPO leans towards supporting a more robust patent regime while subtly opposing compulsory licensing. If the WHO attempts to maintain a neutral stance, the NGOs are vocal opponents of medicine patents and support developing countries in the battle against compulsory licensing.
To judge from the political, practical, and economic perspectives, the effectiveness of compulsory licensing varies from situation to situation. So to answer the question of whether compulsory licensing is a silver bullet to public health, my answer is no. It is true that a compulsory licence can, in certain situations, respond to short-term healthcare issues. It is equally true that granting a compulsory licence ‘is not like flipping a switch that opens floodgates for affordable medicines’. Other factors, such as poverty, poor healthcare infrastructure, and shortage of human resources, all play a role in ensuring adequate access to medicines.
The book has been reviewed here in the Asian Journal of International Law.
Links to purchase this book
This book is available to order on Palgrave, Amazon, and Springer.
