Conference Responsible Innovation 18-19 April 2011 - Debate New modes of governing pharmacovigilance
New modes of governing pharmacovigilance
Dr Ellen Moors Project leader
University of Utrecht,
Department of Innovation & Environmental Studies
Dr Wouter Boon
Rathenau Instituut
Dr Armand Voorschuur Member valorisation panel
Nefarma
The need for fast drug innovation and the public demand for risk-free drugs create a dilemma for regulatory authorities: rapid market access conflicts with uncertainty about benefit/risk profiles of new drugs. Legal frameworks for post-marketing surveillance, or pharmacovigilance, have been developed, but resulting practices are not in line with the intentions underlying these forms of regulation. There is a governance problem: present arrangements for stimulating collective action into the direction of responsible pharmaceutical innovation fall short.
This project contributes to the (re)development of a governance arrangement for pharmacovigilance. The empirical research focuses on 'conditional approvals', medicines intended to be used for a disease for which no treatment is readily available, which are therefore granted early market access. Consequently, one of the key conditions is adequate post-marketing surveillance. How can this system be improved?
This project borrows its theoretical background from two strands of thinking about regulation and innovation. Firstly, the conceptualization of post-marketing surveillance as a crucial element in the process of innovation is based upon theories in the field of innovation studies. Secondly, ideas about new forms of regulation are adapted from the growing field of governance studies.
Qualitative and quantitative research involving significant input from stakeholders forms the basis for this design-oriented research. The ethical analysis includes equity, social solidarity and moral responsibility issues regarding accelerated approvals. The validity of the research output, i.e. the institutional design guidelines, will be tested in a series of workshops with stakeholders and experts from alpha, beta and gamma background.
- The effectiveness of pharmacovigilance increases when users are more involved in post-marketing drug innovation, e.g. through patient reporting, social media or disease-specific patients initiatives.