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Data Transparency in Pharmacovigilance: European regulators give increased access to adverse drug reactions

Posted on March 16th, 2016 by in Pharma R&D

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On 17 December 2015, the European Medicines Agency (EMA) adopted the revised policy on access to Eudravigilance. According to the press release, the EMA will give increased access to reports of adverse reactions with medicines authorized in the EU, while guaranteeing full protection of personal data. The adoption of the revised policy was the result of extensive public consultation, which resulted in almost 400 comments that needed to be taken into account when preparing the final version. The results from the extensive public consultation were published on January 12th 2016.

Increased access to adverse reaction report data gives rise to a number of opportunities, including improved transparency and signal detection, support of academic research activities and promotion of safe use of medicines worldwide — but it will also give rise to challenges, as stakeholders must ensure information and personal data is protected.

Access to data in Eudravigilance

Eudravigilance is the centralized European database of all suspected adverse reactions reported with medicines in the European Economic Area since 2001. Eudravigilance receives more than one million adverse drug reaction reports (ADR) per year and is the cornerstone of the ongoing safety monitoring activities in the EU. Since the introduction of the new pharmacovigilance legislation (2010), the database is being changed to become the single database for all pharmacovigilance information in the EU, including reports of serious adverse reactions from clinical trials. The information from Eudravigilance is shared between the national regulatory authorities.

Data from Eudravigilance have been partially accessible for stakeholders via the European online database since 2011. The first Access Policy (2011) described the levels of access to the information in EudraVigilance for different stakeholder groups: European regulators, healthcare professionals, patients/consumers, companies and research organizations.

Scope and purpose of the Revised Access Policy

According to the EMA, the revised policy on access “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:

  • The public gets access to more information, including line listings of the side effect reports and summary presentations for individual adverse reaction reports received in EudraVigilance. While ensuring that patients and those who have sent in reports of suspected side effects are not identifiable, this access represents a significant increase in transparency for the users of medicines;
  • Academia will be allowed to get extended access to data sets upon request in support of their research activities;
  • The Uppsala Monitoring Centre(UMC) of the World Health Organization (WHO) will be added as a new stakeholder group and will be provided withindividual case safety reports (ICSRs) originating from within the EEA;
  • Medicines regulatory authorities in countries outside the EEA will be provided with data, in line with the WHO dataset, upon request;
  • Marketing-authorization holdersof medicines authorized in the EU will be given enhanced access to reports related to their medicines in support of their signal detection and other pharmacovigilance obligations;
  • The need to maintain the confidentiality of the identity of individuals such as patients and reporters in accordance with EU data protection law is being further emphasized including the responsibility of concerned stakeholders to apply appropriate technical and organizational measures to protect information and personal data processed against unauthorized or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss (text integrated in the description of access for each stakeholder)..
  • The data elements for ICSRs have been reviewed an updated in line with the ISO ICSR standard and the ICH E2B(R3)/EU ICSR Implementation Guide.

Stakeholders for open access to Eudravigilance

The stakeholders who will gain access to EudraVigilance data are:

  • Medicines regulatory authorities in EEA Member States
  • The European Commission and the Agency
  • Healthcare Professionals and the Public
  • Marketing Authorisation Holders
  • Academia
  • WHO – Uppsala Monitoring Centre
  • Medicines regulatory authorities in third countries

Data transfer agreement with World Health Organization

The EMA and WHO have agreed to allow the transfer of data on suspected adverse reactions occurring in the EEA. The data will be transferred electronically to WHO’s UMC on a daily basis. The start of this data transfer in 2017 will follow the introduction of the new reporting rules within the EEA which take effect after a successful audit of the improved EudraVigilance

The transferred reports on suspected adverse reactions occurring in the EEA will contribute to VigiBase, the WHO Global Individual Case Safety Report database, on behalf of the WHO Programme on International Drug Monitoring. Better global knowledge on the safety of medicines will also help to promote the safe use of medicines for the benefit of patients worldwide.

Protecting information and personal data

All stakeholders will gain access to a defined level that meets stakeholder’s interest and needs, taking into consideration that compliance to EU personal data protection legislation (Regulation (EC) No 45/2001 and Directive 95/46/EC) is guaranteed. Therefore, the access is further defined in different levels to avoid a potential re-identification of data subjects.

According to the revised policy of access to Eudravigilance, all stakeholders using information from Eudravigilance are responsible for ensuring confidentiality of ICSR data and protecting personal data in accordance with the applicable law on personal data protection.

Therefore, all stakeholders are expected to implement appropriate technical and organizational measures to protect information and personal data processed against unauthorized or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss in accordance with the applicable law on personal data protection.

Are you one of the stakeholders with the appropriate technical and organizational measures in place already or a stakeholder who needs to implement new measures to guarantee protection of information and personal data? Your experiences might be relevant for other stakeholders — I invite you to share your experiences with us to let others benefit from your experiences.



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