CeBIL - Collaborative Research program in Biomedical Innovation Law

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 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.