European Medicines Agency hears views from stakeholders on its conflicts-of-interests policy for scientific experts

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Press release

12/09/2013

European Medicines Agency hears views from stakeholders on its conflicts-of-interests policy for scientific experts

"Highest-quality scientific assessment requires the best scientific experts and protection of the assessment process from undue financial or other interests. We need a robust system to get the balance right between managing conflicts of interests and access to the best expertise to deliver high-quality scientific assessment. This must be underlined by utmost transparency to allow public scrutiny," said Guido Rasi, Executive Director of the European Medicines Agency at the Agency’s 'best expertise vs conflicts of interests: striking the right balance' workshop, which took place on Friday 6 September 2013.

The workshop brought together a broad spectrum of stakeholders, in order to seek their views on the Agency’s conflicts-of-interests policy for scientific-committee members and experts. This included a panel of speakers from academia, the pharmaceutical industry, scientific committees, patient groups, non-governmental organisations and the media. Representatives from national competent authorities, European Union institutions and other agencies also participated in the workshop.

Over the last few years, the Agency has taken several initiatives to further enhance the robustness of its policy and to increase transparency. The main challenge in operating the strengthened procedures has been to achieve the right balance between ensuring the impartiality and independence of experts involved in the Agency’s work, versus the need to secure the best-possible scientific expertise. A key aim of the workshop was to gauge how the Agency can maintain a pool of high-quality scientific experts while ensuring that these experts are free from undue financial or other interests.

“We have listened to our stakeholders today and will consider the feedback over the next two months as we review our policy,” said Noël Wathion, Head of Patient Health Protection. “We have certainly no intention of lowering our standards on conflicts of interests, however we are open to further improving our approach.”

Views raised by workshop participants included:

  • better recognition of experts: how the Agency can make it more attractive for experts to participate in its work;
  • defining a methodology for identifying the best expertise within the European Union;
  • moving away from blanket timeframes, e.g. within the past two years, within the past two to five years or over five years, when determining a conflict of interest, towards an approach that first looks at the nature of the interest before determining how long it takes for the interest to be over;
  • prohibiting the use of experts in Agency activities who have, or have had, any involvement with the industry, and having all scientific assessments carried out by employees of competent authorities.

Inputs from the workshop will now be considered by the Agency as it moves into the revision cycle of its policy on conflicts of interests. It is anticipated that proposals will be presented for discussion at the Agency’s Management Board in December 2013.

The Agency has also invited written comments on the Agency’s policy on conflicts of interests for scientific-committee members and experts over the last two months. Comments are still invited until Wednesday 18 September 2013 to coiworkshop@ema.europa.eu.

The Agency will publish a report summarising the key outcomes of the workshop in the next few weeks.

Related information

Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu