The Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) explores the legal challenges and the rapid developments in the biotechnological area. CeBIL brings together scholars from some of the world’s leading research institutions in interdisciplinary collaboration as well as stakeholders from industry, government and civil society. Alongside other projects, CeBIL hosts the Collaborative Research Programme for Biomedical Innovation Law (CeBIL Programme). This 5-year research programme (2018-22) is supported by a grant of DKK 35 million from the Novo Nordisk Foundation and involves partners from Cambridge, Harvard Law School, Harvard Medical School, Michigan, and the UCPH IFRO.
The CeBIL Programme focuses on innovation inefficiencies on the life science frontiers through five concrete interrelated studies. The common aim of the five studies is to optimize legal concepts into enabling tools that will help bring novel technologies, research, and biomedicine together for radical innovation – thereby providing much-needed contribution to bridging bio-pharmaceutical innovation gaps, enhancing translational medicine, and promoting technology transfer. An overarching study on Policy & Synergy will ensure continuous knowledge exchange and synergy across the five concrete studies:
- Study 1: Antibiotics
- Study 2: Orphan Drugs
- Study 3: Precision Medicine, Big Data & Artificial Intelligence
- Study 4: New Uses
- Study 5: Drug Manufacturing & Biologics
- Study 6: Policy & Synergy
The objective of the CeBIL Programme is to demonstrate how legal science methods that take careful account of interdisciplinary insights and “real world” perspectives can generate new knowledge about key factors driving pharmaceutical innovation. In addition, such methods will be utilised to examine how innovation incentives, other than patents, can be applied, combined, optimised and conceptualised in order to either substitute or complement patent protection in new areas of crucial medical applications. Within this context, special focus will also be laid on the impact of emerging digital technologies, big data and artificial intelligence.
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
PhD supervisors: Sven Bostyn & Timo Minssen
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 (see also here). Antibiotic resistance presents a serious health crisis, from which no one of us is spared, and it requires urgent attention (for more info, see here). 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:
- To what extent is there a need to curtail and combine particular push and pull incentives to different classes of antibiotic resistance?
- What are the pros and cons of purely market-based incentives in comparison to delinkage models in the ﬁght against antibiotic resistance?
- 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?
- 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?
- 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
PhD supervisor: Timo Minssen
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:
- 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?
- 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?
- 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.
Faculty’s Doctoral Training Programme
PhD students at CeBIL are enrolled in the Faculty of Law’s general doctoral training programme, which provides PhD students with a general set of skills for developing their research and career. This programme involves coursework, international networking, a research visit at a relevant research institution abroad, as well as teaching tasks. Details and requirements can be found on the Faculty's website. Some of the requirements can, however, be fulfilled by participating in CeBIL’s own research training activities.
Opportunity is About:
Candidates should be from:
Description of Ideal Candidate:
- Applicants must have obtained a degree that corresponds to the Danish Master of Laws or equivalent qualifications.
- Applicants must have obtained a minimum overall grade average of 8.2 or above at the Master’s level in accordance with the Danish grading scale (for Danish scale, see here);
- Applicants may submit their application before they have completed their Master’s Degree. In that case, they must have submitted their final thesis before applying for this position and receive their final grades before 1 September 2019;
- Applicants must document an aptitude for research through the meritorious assessment of their final thesis, publications or academic recommendations in order to show that they are capable of undertaking the demanding task of writing a PhD thesis;
- Applicants must have excellent language skills in English and have excellent communications skills. Applicants must be able to teach at an academic level in Danish or English and to follow PhD courses in English.
Successful PhD candidates are required to
- Actively engage in the research environment at the University of Copenhagen; participate in international conferences, courses and meetings relevant to their research project;
- Comply with the formal requirements of the PhD programme;
- Contribute to teaching undergraduate and graduate level courses in Danish or English offered by the Faculty of Law;
- Conduct independent and high quality research under the supervision of a senior member of academic staff at the Faculty.