The European Commission has announced plans to strengthen the European Union’s system of drug safety monitoring, following a public consultation which has revealed significant problems with the current arrangements and the need for changes to the system’s legal framework.

The EU system of drug safety monitoring (pharmacovigilance) has evolved slowly over the past 40 years, and it now needs to be rationalised and strengthened, says the Commission. The public consultation described the current legal framework as complex and duplicative, and pointed to a need to clarify roles and responsibilities. Differing implementation by EU member states has led to complex and diverse reporting requirements for the industry, and EU-level decision-making has become overly complicated, the consultation has also revealed.

Announcing the proposed changes and improvements, Commission Vice-President Gunter Verheugen said these will focus on clarifying roles and responsibilities, simplifying reporting rules and ensuring that robust safety studies are carried out to support rapid decision-making at EU level.

Specifically, the Commission’s proposals to improve implementation will involve it working with:

- the Commission’s Directorate General for Research, on the funding of studies into both the safety of medicines and the methodologies used to conduct pharmacovigilance;

- the member states, to resolve implementation issues including administrative practices which complicate the reporting rules for industry; and

- the European Medicines Agency (EMEA), to strengthen its coordinating role, including efforts to ensure full compliance with and maximum utilisation of the Eudravigilance pharmacovigilance database.

The planned changes to the legal framework will include:

- strengthening the rules on transparency relating to pharmacovigilance data, assessment and decision-making, and involving stakeholders such as patient and health professional groups in the processes, including reporting;

- establishing clear Good Vigilance Practice (GVP) standards for industry and regulators;

- freeing-up resources by rationalising and simplifying the reporting of suspected adverse drug reactions (ADRs), making the best use of current information technology (including Eudravigilance) and matching reporting requirements with the level of knowledge about a specific product’s safety;

- making the respective roles and responsibilities clear, and minimising duplication of effort while maintaining the current split of competences between the member states and the EMEA;

- stimulating innovation by establishing a clear legal requirement to conduct post-authorisation safety studies, including those in risk-management systems; and

- rationalising EU decision-making on drug safety issues to deliver fast, robust decisions that are implemented fully and equally for all relevant products and across all markets.

Industry responses

The public consultation received responses from: patient, consumer and victim groups; health care professionals; regulators; and pharmaceutical industry associations, individual companies and spokesmen. The responses of the European Federation of Pharmaceutical Industries and Associations (EFPIA), EuropaBio (representing the EU biotechnology industry) and the German pharmaceutical industry association (BPI) all call for the establishment of a single EU Council regulation on pharmacovigilance to replace all existing EU laws, while the Association of the European Self-Medication Industry (AESGP) proposes a period of stability with harmonisation at the level of EU guidance – despite the fact, says the Commission, that this might contradict EU and national laws.

The Danish Association of the Pharmaceutical Industry (LIF) says that companies would be prepared to translate case reports into English, forwarding them electronically to the EMEA. “Translation into English would result in better surveillance, as all information would be in a language understandable for everybody, rather than in 20 different languages,” it says.

The European Association of Pharmaceutical Full-Line Wholesalers (GIRP)’s response points out that, currently, there is no information system in place for product recalls or pharmacovigilance concerns. The Association suggests that it would be “advantageous” to communicate such recalls and concerns to GIRP, which could inform all national associations and the pan-European wholesaling companies, in addition to the national systems already in place.

GlaxoSmithKline’s response comments that the way in which regulation relating to the industry is drafted, implemented and administered “can be unnecessarily prescriptive, which leads to unintended outcomes.” However, it adds: “when such issues arise, industry stands ready to work with the Commission and member states to find a way forward.” The Commission has a key leadership role in this respect, says GSK, and it calls for a greater focus on: how legislation/regulation is developed; overlap and duplication between regulations, particularly as new ones come into force; how regulations are transposed and interpreted; the fact that some regulation simply becomes out-of-date as technology improves and business models evolve; and that some regulation is “simply excessive.”

The Commission hopes to introduce its planned improvements in a legal proposal next year. “We will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected, and effectively dealt with on the basis of more robust data,” said Commissioner Verheugen. “Rationalisation of the EU medicines safety system will free up resources which can then be directed to better protecting the health of EU citizens,” he added.

For further details of the strategy and the public consultation, and to read the individual responses, visit