Research Student: Adam Buick
An Analysis of the Protection of Pharmaceutical Test Data as Intellectual Property and its Impact on Access to Medicine
To receive marketing approval, the developers of a new medicine must submit data to regulators proving the safety and efficacy of the product through costly clinical trials. Subsequent developers of ‘generic’ versions of the drug generally do not replicate these trials when seeking marketing approval of their own, instead relying on bioequivalence tests and the data submitted by the drug’s originator to gain approval for a fraction of the price. Since the 1980s the US and Europe have protected originator’s data for a time-limited period through a form of exclusive proprietary right known as ‘data exclusivity’. Western countries, where almost all research-based pharmaceutical firms are based, are eager to spread this protection of test data, and data exclusivity provisions are a common feature of free trade agreements (FTAs) between developed and developing countries.
This is concerning - the basic logic of data exclusivity is to delay generic competitors from entering the market and thus extend a pharmaceutical firm’s monopoly over a medicine after patent expiration. Those in developing countries can often only afford these cheaper generic medicines - and perversely, the developing world bears the burden of the majority of global disease. This topic is literally a matter of life and death for millions of people worldwide.
My research project aims to add to the existing understanding of data exclusivity and in particular the potential negative effects it may have on access to medicines in the developing world. The project seeks to examine the continued spread of US and European standards of data exclusivity to developing nations through FTAs, as well as answer fundamental questions about the nature of this sui generis intellectual property right. In addition to evaluating the nature and proliferation of data exclusivity, the project also seeks to provide and analyse empirical data on the effects of data exclusivity on access to medicine.
This research is funded by a scholarship from the White Rose College of the Arts and Humanities.
I hold an LLM in international and European intellectual property law from Trinity College Dublin and an LLB from Queen’s University Belfast.
What motivated me to undertake PhD study?
Throughout my undergraduate studies the aspect of law that interested me the most was researching and writing about the theories and motivation behind regulation. I had a strong desire to engage in such ground breaking research myself; the PhD programme and a career in legal academia are an ideal way to fulfill that desire.
What makes me passionate about my subject?
Intellectual property law has always interested me because it concerns the regulation and control of information. Controls over information have the potential to profoundly affect the lives of many, perhaps never more obviously than when they impede access to medicines.
New intellectual property rules such as data exclusivity work to the obvious benefit of a small group of powerful individuals in the pharmaceutical industry, at the potential expense of some of the most vulnerable groups in the world, the poor and the sick. I think that is therefore critical that such rules be subject to careful, critical and independent scrutiny to determine their impact.
What are my plans once I have completed my PhD?
When I have finished my PhD I would like to continue to research and study law through a career in academia.