Collaborative Research program in Biomedical Innovation Law
The overall aim and ambition of CeBIL is to contribute to the translation of groundbreaking biomedical research into safe, effective, affordable and accessible therapies by analyzing the most significant legal challenges to pharmaceutical innovation and public health from a holistic cross-disciplinary perspective.
CeBIL addresses fundamental legal challenges in the pharma and life sciences taking into account the eco-system of bio-pharmaceutical innovation and health-care. The Research Program’s unique focus on biomedical innovation law that cuts across various legal disciplines and brings in interdisciplinary, industry and policy perspectives provides an important contribution to the future of the bio-pharmaceutical innovation system. During the first 5 years, CeBIL focuses on Innovation Inefficiencies on the Life Science Frontiers through 5 concrete interrelated studies complemented by a 6th synergy study.
This study evaluates the legal implications of a number of “push” and “pull” options to tackle challenges related to antibiotics. These include financial incentives, such as specific IP protection and market exclusivities, health impact funds (Grootendorst 2011, Hollis & Pogge 2008), 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. Among the key questions that will have to addressed are the following (1) In how far is there a need to curtail and combine particular push and pull incentives to different classes of antibiotic resistance? (2) What are the pros and cons of purely market based incentives in comparison to delinkage models in the fight against antibiotic resistance? (3) In how far would-so-called complementary approaches, more public-private collaboration or ”integrated strategies” be helpful in European settings as compared to the US and what legal changes would be required to implement such approaches?; (4) 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; and (5) What potential have new forms of therapies based on gene- editing, such as CRISPR-Cas 9 and gene drive (Warmflash 2016), and phage technologies in the fight against AMR and what are the legal and ethical dimensions?
Analysing the FDA’s and EMA’s rapid responses to the recent Ebola and Zika outbreaks, and taking into account recent legislative developments, such as the US 21st Century Cures Act or the EU Commission’s integrated approaches in the battle against rare diseases, this study evaluates the legal implications of a number of “push” and “pull” options to tackle these challenges. These include financial incentives, such as specific IP protection and market exclusivities, health impact funds (Grootendorst 2011, Hollis & Pogge 2008), 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. Key research questions will be: (1) In how far is there a need to curtail and combine particular push and pull incentives to different classes of orphan drugs, such as rare and neglected diseases? (2) What are the weaknesses of purely market based incentives in comparison to delinkage models in the fight against antibiotic resistance and Ebola? (3) Would-so-called complementary approaches, more public-private collaboration or “integrated strategies” be helpful in European settings as compared to the US and what legal changes would be required to implement such approaches? (4) Do we need to reconsider the already available incentives and definitions in the current “orphan drug” legislation in light of new scientific insights and the dramatic Ebola and Zika Outbreaks?
This study provides a comparative analysis of black-box personalized medicine driven by artificial intelligence and big data. The study will explain the shortcomings of the current innovation policy landscape in Europe and the US, and provide a comprehensive examination of various policy options to better align incentives. This will include a detailed discussion of regulatory exclusivities and prize systems within the context of the ongoing development towards a more open, more transparent and more collaborative innovation paradigm. Hence, this study will have to address a variety of key research questions, such as: What exactly are—or will be—the distinguishing features and added benefits of “black-box” personalized medicine in comparison to traditional personalized medicine and in how far are these features relevant for the legal analysis? What are the concrete scientific and legal hurdles to the further development of “black box” personalized medicine and in how far do these relate to failures of the current intellectual property regime and new case-law developments? How does the legal framework differ in the US and Europe and could we learn from each other? What alternative or complementary incentives can be considered, how do these interrelate and what are their advantages and drawbacks in different settings? How much control should patients have over how their data is used to produce “black box” personalized medicine models and the deployment of these models in their health care?; and finally: What role should patient consent, patient governance, and transparency play in that context?
This study scrutinizes the European legal framework and court decisions that are relevant for enhancing innovation within the area new uses. How widespread are IP enforcement difficulties with regard to patents and trademarks? Have enforcement difficulties emaciated the patent incentive? Is this apparent in patent landscaping studies? What sorts of policy responses directed at prescribing doctors or dispensing pharmacists might address the difficulty of enforcement? Having pricing policies in Europe evolved appropriately to incentive new medical uses? How is the problem addressed in other countries? Are prescribing doctors and pharmacists willing to assist? There is also an emerging issue in the US whether new use patents will survive recent US Supreme court decisions narrowing eligible subject matter for patent protection. In Europe, the trend is in the opposite direction, towards wider boundaries of patentability and Supplementary Protection Certificates (SPCs) (e.g. new dosage regime; same medical condition but different mechanism of action).
This study evaluates the possibility that the incentive/innovation landscape may contain multiple equilibria. The current equilibrium is one of low disclosure/high secrecy and relatively low innovation. A different equilibrium, that has existed in some technical industry contexts (Pedraza-Farina 2017), results from industry norms that include sharing of technical details that helps drive cumulative innovation. Such a high disclosure/low secrecy and high innovation equilibrium could improve the entire industry. And while product-competition between competitors might raise resistance to such an equilibrium, the markets for small-molecule drugs and biologics has numerous other incentives and limits available to preserve market-share while driving competition. This study will therefore examine the feasibility of paths to shift from the current equilibrium to a high-disclosure equilibrium, including the likelihood of stakeholder buy-in, potential public benefits, and mechanisms such as regulator-facilitated disclosure.
This study provides a first step towards developing a multi-level conceptual framework that integrates law, ethical considerations, economics, science, business and policy. This will form the basis for a holistic trans-disciplinary perspective to address and synthesize the most significant legal challenges to pharmaceutical innovation and public health with the aim to contribute to the translation of ground-breaking biomedical research into safe, effective, affordable and accessible therapies. Three interrelated studies will provide a sound foundation for new proposals on alternative innovation incentives in the pharmaceutical sector in the context of the overarching legal framework, the economics of innovation, and a broader outlook on science, business and policy.
Sub-study a) synthesises and conceptualizes the legal findings derived from the 5 concrete studies, whereas the Sub-study b) combines the emerging legal theory with the economics and management of biomedical innovation. Finally, Sub-study c) focuses on a deeper holistic examination and – ultimately – understanding of science, business and policy aspects of legal changes in biomedical innovation. The primary goal is to synthesize the scientific, business and policy aspects into a holistic, synergistic framework that acknowledges similarities and differences of the respective domains and thus provides the basis for more sustainable and informed solutions to innovation challenges in the biomedical sector. In that way, study 6 will contribute to developing a platform for interaction between different stakeholders within the complex eco-system of biomedical innovation, which CeBIL can further grow upon.
Michael Sinha, Research Fellow, Harvard Medical School, PORTAL
Aaron S. Kesselheim, Professor, Harvard Medical School, PORTAL
Jonathan J. Darrow, Harvard Medical School, PORTAL
I. Glenn Cohen, Professor, Harvard Law School, PFC
Sara Gerke, Research Fellow, Harvard Law School, PFC
John Liddicoat, Professor, University of Cambridge, LML
Mateo Aboy, Professor, University of Cambridge, LML
Kathleen Liddell, Professor, Director and and Senior Lecturer, University of Cambridge, LML
Laura Bradford, Senior Research Associate, University of Cambridge, LML
Nicholson Price, Professor, University of Michigan, Michigan Law
CeBIL is supported by a grant of DKK 35 million from the Novo Nordisk Foundation.
PI Director of centre, professor
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