E-DRUG: Pharmacovigilance data are not "trade secrets"
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Dear E-druggers
I would like to bring to your attention a joint response by the Cochrane Adverse Effects Methods Group (AEMG), Health Action International (HAI) Europe, the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) to an European Medicines Agency public consultation on its access policy to pharmacovigilance data. We are concerned about the inclusion of data protection wording in the EMA's draft revision policy and have therefore emphasised that pharmacovigilance data are not “trade secrets”.
Key points in our joint response:
* 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 limited quantitative information, e.g. the number of suspected adverse reactions associated with a given substance, but it does not provide access to listings of case summaries (“Narrative Case Summary”).
* 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 to avoid data being misinterpreted or withheld.
* The EMA also proposes to grant access to research organisations, on request, “to ICSR data sets similar to those provided for MAHs in response to justified research requests”. However, the EMA puts forward restrictive requirements in order to grant 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”.
* Another worrying change is that stakeholders accessing data are 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”.
* 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 European Union and in Member States (in order to estimate the incidence of a given adverse drug reaction);
- 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”.
For more information, please read the full joint response available at: http://english.prescrire.org/Docu/DOCSEUROPE/20140915JointResponseAccessPolicy.pdf
Best regards,
Teresa Leonardo Alves
International Policy Adviser
La Revue Prescrire
Email: talves@prescrire.org