PhD Scholarship at the Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) 2019, University of Copenhagen, Denmark

The PhD researcher will be expected to work on either Study 1 or Study 6. The CeBIL management reserves, however, the right to recruit candidates for one of the other four studies instead should their academic profile and research plan provide an even better fit for the CeBIL Programme as a whole.

 

Study 1: Antibiotics   

 

Antibiotic resistance is the ability of bacteria to combat the action of one or more antibiotics. Humans and animals do not become resistant to antibiotics, but bacteria carried by humans and animals can. Each year, 33,000 people die from an infection due to bacteria resistant to antibiotics. The burden of infections with bacteria resistant to antibiotics on the European population is comparable to that of influenza, tuberculosis and HIV/AIDS combined . Antibiotic resistance presents a serious health crisis, from which no one of us is spared, and it requires urgent attention. For a variety of reasons, innovation in antibiotics has stalled, which compounds even more the health crisis we are faced with. One of the main obstacles (apart from scientific challenges) seems to be the lack of incentives for the pharmaceutical industry to invest in the development of new antibiotics. Against the background of increasing antibiotic resistance and inadequate market incentives, Study 1 will evaluate the legal implications of a number of “push” and “pull” options to tackle these challenges. This includes financial incentives, such as specific IP protection and market exclusivities, health impact funds, crowd-funding, pre-competitive collaborations, PPPs between academia and the industry, and other innovative alternatives, such as “integrated” strategies based on prizes administered by reimbursement systems that require compliance with conservation targets. Some of the key questions which need to be addressed are the following ones:   

a) To what extent is there a need to curtail and combine particular push and pull incentives to different classes of antibiotic resistance?   

b) What are the pros and cons of purely market-based incentives in comparison to delinkage models in the fight against antibiotic resistance?   

c) To what extent would so-called complementary approaches, more public-private collaboration, or “integrated strategies” be helpful in European settings compared to the US and what legal changes would be required to implement such approaches?   

d) Do we need to reconsider the already available incentives and definitions in the current “antibiotics” legislation in light of new scientific insights and bio-medical applications?   

e) What potential do new forms of therapies based on gene-editing, such as CRISPR-Cas 9 and gene drive, and phage technologies have in the fight against AMR and what are the legal and ethical dimensions?   

This is an exciting opportunity for someone who is interested in pursuing doctoral research which can make a difference in society. It is a research project of immense relevance. As a PhD researcher, you will have the opportunity to contribute to the quest for a solution to this health crisis. Moreover, you will be able to work in an intellectually very stimulating and pleasant environment, and you will have the opportunity to work under the supervision of and with some of the finest experts in the area of biomedical innovation law, both in Copenhagen and in partner institutions such as Harvard University.

Study 6: Policy & Synergy

Study 6 aims to develop a framework that integrates law, ethical considerations, economics, science, business, and policy to support biomedical innovation. It includes a legal sub-study entitled “Towards an Improved and Sustainable Legal Framework for Biomedical Innovation”, which will address the following key research questions:

a) What common legal principles can be derived from each of the five concrete studies and how can they be synthesised and organized to form a conceptual framework with a sound underlying legal theory that can be translated into recommendations for new legislation?

b) How can those legal findings be applied to inform and shape both general innovation policy debates and more specific debates, such as on the role that alternative R&D incentives could play in the raging controversy over the patentability of biomedical products and methods?

c) What is the proper role for ethical considerations, e.g. on patient rights and access to medicines?

In that context, Study 6 considers also potential disruptions of the existing biomedical value chains through digitalization and artificial intelligence, and assesses the opportunities and risks that these new technologies entail. A question that merits particular attention is: To what extent may digital technologies help enhance innovation, address innovation inefficiencies, and adopt an adaptive governance of the emerging technologies addressed in Studies 1-5 and what are the legal issues? While offering amazing possibilities, there is no doubt that these technologies raise many legal questions with regard to intellectual property, liability, patient involvement, bias, discrimination, competition etc. The successful candidate is expected to focus on this cross-cutting AI dimension of Study 6 in collaboration with senior researchers at CeBIL and its partner institutions.