European Medicines Agency Public consultation on the revision of the EudraVigilance Access Policy

 

Deadline

Interested parties have until 15 September 2014 to send their comments on the draft policy either two EPF or directly to the Agency.

If you wish to comment by EPF please do so by email by 10 September 2014 (kaisa.immonen.charalambous@eu-patient.eu).

 

What is Eudravigilance?

Eudravigilance is the European-level database on medicines adverse events maintained by the European Medicines Agency since 2001. Following the 2010 new EU Pharmacovigilance legislation, the database is being developed to become the single point of receipt for all pharmacovigilance (medicines safety monitoring) information in the EU. This information is shared by national competent authorities. It also contains reports from serious adverse reactions from clinical trials.

Eudravigilance is used for analysis of safety data and detection of signals, by the Pharmacovigilance Risk Assessment Committee (PRAC) and the HMPC.

Data from EudraVigilance are made partially available to the public through the European online database (www.adrreports.eu).

What is this consultation about?

Transparency of the data held in the EudraVigilance database is enshrined in EU law. EPF contributed actively to the drafting of the first Access Policy (adopted in 2011), which defined levels of access to the information in EudraVigilance for different stakeholder groups: European regulators, healthcare professionals, patients/consumers, companies, and research organisations.

Changes have now been made to this policy based on the provisions set out in Article 24 of Regulation (EC) 726/2004 as amended and the recommendations of the European Data Protection Supervisor.

According to the Agency, the update “takes into account the changes to the system of safety monitoring of medicines introduced by the pharmacovigilance legislation, such as the further increase in transparency, the introduction of direct patient reporting across all EU Member States and the pharmaceutical industry's responsibility for monitoring the data in EudraVigilance for new safety issues, following a simplification of the reporting of adverse reaction reports.”

Key changes include:

• Addition of the Uppsala Monitoring Centre of the World Health Organisation (WHO) as a new stakeholder group that will be provided with individual case safety reports originating from within the EEA in electronic format on a weekly basis;
• Enhanced access of marketing-authorisation holders to reports related to their medicines in support of their signal detection and other pharmacovigilance obligations;
• Access to more detailed individual case report data for researchers in response to justified research requests (and if deemed necessary, a privacy check by the Agency);
• Addition of international regulatory authorities as a new stakeholder group, which can obtain data on an ad-hoc basis;
• Increased emphasis on confidentiality of personal data to protect the identity of patients and reporters of ADRs, in accordance with EU data protection law.

The Agency proposes to implement the revised policy six months after the Eudravigilance database has achieved full functionality (based on an independent audit report).

The proposed revised policy is available by clicking here or in the right-hand column. 

How to send comments?

If you wish to send comments to EPF, please do so by 10 September 2014. Please email kaisa.immonen.charalambous@eu-patient.eu T

he deadline to send comments directly to the EMA is 15 September 2014. Please use the following email address: evaccess@ema.europa.eu