Since the COVID-19 crisis has started, we have seen governments pressuring their own regulatory agencies to speed up the process of marketing authorisation. To make sure that this marketing authorisation process is done independently and transparently, the concept of accountability is key. Over the last year Wemos has conducted a qualitative analysis on the concept of accountability at the European Medicines Agency (EMA) and the perception hereof for different stakeholders in the process of marketing authorisation. Additionally, Wemos has looked into the risk of bias in Pre-Submission Activities (PSAs). This analysis lead to several policy recommendations in order to improve EMA’s accountability and to have better safeguards regarding risk of bias in PSAs.
The EMA plays a central role in the approval of new pharmaceutical products within the European Union. Because of its important role in marketing authorisation of new pharmaceutical products, numerous measures are taken to attain the highest standards. Despite all the policies that the EMA puts in place to safeguard independent decision making, several cases have been identified that raised concerns regarding the approval process. These cases lead to Wemos investigating how the EMA copes with the concept of accountability and stakeholders involved in medicine evaluation perceive accountability.
Several stakeholders mentioned that ad-hoc experts are potentially useful in increasing the performance accountability of the EMA, but that more transparency is required in the selection criteria of these experts. Moreover, there is not always a clear separation between those who provide pharmaceutical companies scientific advice and those who are involved in the assessment of new pharmaceutical products. This could lead to an increased risk of bias. These risks could potentially be extended to national regulatory authorities. If you are interested in more highlights of our findings and policy recommendations please check out our 4-pager.
For the thesis of Wemos’ intern Eunjin Jang; Accountability of the European Medicines Agency in Marketing Authorisation of New Medicines, please check here.
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