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Advancing healthcare policy


Pharmacovigilance: Actions
EMA's policy on pharmacovigilance: access to qualitative data is needed, pharmacovigilance data are not "trade secrets" (September 2014)

Paris, 15 September 2014

Joint response to the EMA consultation by the Cochrane AEMG, HAI Europe, ISDB and MiEF. “Protection of personal data” must not be used as a pretext to strengthen intellectual property over pharmacovigilance data.

> Click here to download the joint response (pdf, 663 Ko)

Summary/Key points

  • In August 2014, the European Medicines Agency (EMA) organised a public consultation on the revision of its 2011 policy on the access to the European pharmacovigilance database EudraVigilance, which created the public interface adrreports.eu.
  • Reports of suspected adverse drug reactions are coded using standardised terminology and then registered in EudraVigilance as "Individual Case Safety Reports, ICSR". In practice, however, this process can strip spontaneous reports of individual cases of clinical significance. That is why access to narrative summaries of individual cases needs to be provided along with quantitative data.
  • Unfortunately since 2012, the public interface Adrreports (www.adrreports.eu) has provided access to only a limited number of quantitative information, e.g. the number of individual cases associated with a given substance, but it does not give access to a listing of case summaries ("Narrative Case Summary").
    • According to Pierre Chirac, Medicines in Europe Forum coordinator:
      "In the EU, health professionals and patients, who are major contributors to the EudraVigilance database through the spontaneous reports they send to their national drug authorities, are paradoxically the actors who access the least information."
  • In its draft revision document, the EMA proposes to share more data with marketing authorisation holders (MAH), which makes sense since they are required to develop periodic benefit-risk evaluation reports about their drugs. Nevertheless, drug regulatory agencies have to closely monitor the MAH pharmacovigilance activities in order to avoid data being misinterpreted or withheld as recently happened on several occasions.
  • The EMA also proposes to give research organisations, on request, "access to ICSR data sets similar to those provided for MAHs in response to justified research requests". However, the EMA sets up restrictive conditions for granting access to researchers, e.g. the signature of confidentiality agreements. The EMA also demands to "view any publication resulting from EudraVigilance data before submission (…). [and that] any issues raised by the Agency (…) must be addressed to the satisfaction of the Agency before submission for publication". However, EMA’s central role does not give it the right to control how the data are used or to censor scientific discussion.
  • Another change of concern is that the description of access for each stakeholder now makes them responsible for applying "appropriate technical and organisational measures to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss".
    • Ancel la Santos, Health Action International (HAI) Europe policy advisor, comments:
      "There are standards in place for de-identifying personal data and additional measures can be explored for particular cases (rare diseases). But data protection cannot be used as a pretext to protect commercial interests. Pharmacovigilance data are not trade secrets, but information that is of the utmost relevance to protect public health."
  • We encourage the EMA in its policy to support public health by:
    • proactively providing public access to useful qualitative data such as anonymised summaries of cases;
    • granting public access to consumption data of drugs in the EU;
    • providing access to all drug regulatory authorities’ assessment reports of MAH’s periodic benefit-risk evaluation reports (former Periodic safety update reports);
    • not forcing researchers to sign "confidentiality agreements".

Cochrane Adverse Effects Methods Group (AEMG)
Health Action International (HAI) Europe
International Society of Drug Bulletins (ISDB)
Medicines in Europe Forum (MiEF)

©Cochrane AEMG, HAI Europe, ISDB, MiEF 15 September 2014

> Click here to download the joint response (pdf, 663 Ko)