Oct 01, 2011
Volume 23, Issue 10

Pharmacovigilance: have your say

The European Commission's (EC) recently announced public consultation means that you can have your say on pharmacovigilance. The EC has released a concept paper, Implementing Measures In Order To Harmonise The Performance Of The Pharmacovigilance Activities Provided For In Directive 2001/83/EC And Regulation (EC) No 726/2004, which will be available for public comment until 7 November 2011. As the title suggests, the paper provides details about implementing measures that will be necessary as part of the EC's new pharmacovigilance legislation, which was amended in 2010.

The new legislation is part of the three-piece 'pharmaceutical package', which concerns pharmacovigilance, fasified medicines and information to patients, although the latter two parts have yet to be adopted by the European Parliament and the European Council. According to the EMA, the main driver for amending the pharmacovigilance legislation was the incidence of adverse drug reactions, which contribute to more than 190000 deaths per year in the EU. The legislation aims to strengthen Europe's safety monitoring system through better prevention, detection and assessment of adverse reactions to medicines. Among other points, the amended legislation rationalises the current framework, addresses duplicate reporting and assessments, and increases the use of IT systems. In addition, patients will be able to report adverse drug reactions directly to the competent authorities. The European Commission has estimated that the new legislation will save up to 5910 lives every year across the EU.

"This new public health legislation is far reaching in scope and in depth and goes far beyond any narrow concept of pharmacovigilance," said the EMA in the legislation's implementation plan. "The legislation strengthens safety monitoring, rationalises reporting and increases the use of studies including pharmacoepidemiology, makes clear roles and responsibilities, sets out decision-making, increases participation, reinforces transparency and strengthens the action that can be taken to protect and promote public health."

According to an implementation plan, most of the provisions in the pharmacovigilance legislation will come into force by the end of July 2012. The concept paper describes several implementing measures covering the following topics:

  • pharmacovigilance system master files
  • the quality system for the performance of pharmacovigilance activities
  • the use of internationally agreed terminology, formats and standards
  • monitoring data in the EudraVigilance database
  • the electronic transmission of suspected adverse reactions
  • electronic periodic safety update reports and risk-management plans
  • postauthorisation safety studies.

The EC believes that these measures will "supplement essential aspects of the new pharmacovigilance system". As such, it is important that they "strike" the necessary balance between the fundamental objective of the current legislative framework for medicinal products, which is to safeguard public health, and general internal market requirements.

The Commission is seeking the views of all stakeholders with regards to the consultation paper, who can respond via email or post. Full details on how to participate in the consultation are available on the EMA's website.

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