Reforming The Approach To Pharmacovigilance In Europe - Pharmaceutical Technology

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Reforming The Approach To Pharmacovigilance In Europe
The need to ensure effective pharmacovigilance in Europe has led to the creation of the EudraVigilance system, which helps to manage the risk of medicinal products both in clinical trials and on the market. This approach to pharmacovigilance, however, still has room for improvement that European agencies are working on.

Pharmaceutical Technology Europe
Volume 4, Issue 23

Looking to the future

Despite the sophistication of the European pharmacovigilance systems introduced since 2005, many believe that improvements can still be made. In 2007, the European Commission (EC) conducted a public consultation exercise to identify weaknesses in existing systems.2 The feedback obtained highlighted the lack of clarity over roles and responsibilities for pharmacovigilance, as well as a perception of excessive bureaucracy within the regulatory agencies in different member states.

There were also suggestions that the complex reporting rules were implemented differently by regulatory bodies in the various member states, which was seen as holding back efforts to improve pharmacovigilance in the region, particularly with respect to rapid decision-making. Improvements to existing systems were also seen as representing only an evolutionary approach to pharmacovigilance and there was a sense that new thinking is required; indeed, the continued expansion of the EU and the sophistication of the products emerging from innovative R&D programmes seems to demand it.2

As an initial proposal, those behind the consultation exercise suggested a two-pronged approach, centred on implementing the existing framework and changing the legal framework. To improve systems, collaborations would be encouraged with the EC's Directorate General for Research, so that studies could be funded to examine the safety of medicines, as well as to develop new methodologies to conduct pharmacovigilance. Communication would also be initiated with individual regulatory agencies to resolve the administrative issues raised by those responding to the public consultation. On the legal front, there was a promise to strengthen transparency rules relating to pharmacovigilance data, and to introduce a clear drug safety standard. To achieve this, the EC decided to involve the EMA because of its experience in coordinating region-wide measures, with the hope that it would lead to the development of a responsive system that enabled rapid safety decisions to be applied equally across all member states.

Since the EMA's involvement began, the agency has been promoting the establishment of a European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The idea behind the network is to better coordinate the monitoring of authorised medicines in Europe and to capture the information revealed by ongoing post-authorisation studies on safety and risk-benefit. To achieve these goals, the EMA will collaborate with European experts in pertinent fields. Those behind ENCePP have emphasized that the network aims to complement and not replace existing pharmacovigilance measures in Europe, such as EudraVigilance.3

An initial output of ENCePP was to establish a public, fully searchable electronic index of available EU research resources in the fields of pharmacoepidemiology and pharmacovigilance. At the end of 2010, ENCePP published its Work Plan 2011–2012, which outlined its intended strategy and listed deliverables and target dates.9 A steering group will meet quarterly to oversee delivery and coordination with the EMA.

While there is considerable activity on reforming the approach to pharmacovigilance across the EU, it is not clear how well this has been communicated to the public and physicians. A number of safety scandals over the years have attracted considerable media attention, and made people suspicious about the transparency of regulatory bodies and their interaction with the pharma industry. For example, the TeGenero TGN1412 incident in 2006 in the UK led to considerable public criticism of the MHRA, with some observers believing that existing information in the public domain concerning immunological mechanisms related to the drug's action should have led to a more cautious attitude.5 Presently, there is also controversy in France regarding Servier's Mediator and the failure of the country's regulatory agency to act on prior concerns raised over the cardiovascular safety of the product. On a wider scale, the pain reliever propoxyphene has been subjected to strong criticism regarding its safety; one European physician, who played a role in having the drug withdrawn from the EU market, described it as the "worst drug in history" and claimed that it was responsible for more deaths than any other drug.5

It is precisely because of such safety scandals that the joint December 2010 press release by the HAI, MiEF and ISDB called for a more ambitious approach by the European authorities to pharmacovigilance. If European authorities are to gain the public's confidence, as well as that of physicians, future pharmacovigilance measures should also indicate what the legal sanctions will be for those that fail to meet the necessary safety standards.


1. International Society of Drug bulletins, "Final proposals on pharmacovigilance: Some progress, but a missed opportunity to genuinely strengthen patient safety" (2010).

2. EMA, "Guideline on Risk Management Systems for Medicinal Products for Human Use" (2005).

3. ENCePP, "Strengthening medicines safety monitoring" (2007).

4. C. Horvath and M. Milton, Toxicol. Pathol., 37(3) 372–383 (2009).l

5. Medscape, "Physicians Say Good Riddance to 'Worst Drug in History'" (2011).


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