"Although the current pharmacovigilance system is good and safe, there are now more countries in the EU, and therefore there is a need for an improved system," Ton Van Lierop, a Commission spokesperson told In-PharmaTechnologist.com. The move comes hot on the heels of a consultation conducted by the Commission last year which found that that the current system is "contradictory, confusing, unclear and complex."
The feedback from the consultation suggested that there are complex reporting rules implemented differently by different EU member States, a lack of robust safety studies and complex decision-making at EU-level. The vast majority of respondents, which included industry players, regulators, patient groups and other stakeholders, argued that the drug safety monitoring (pharmacovigiliance) system needs to be "strengthened and rationalised".
They called for a change to the legal framework in the EU, highlighting that the fact that the different member states have slightly different rules is detrimental to public health. "We will improve and strengthen the monitoring of the safety of medicines so that safety issues are rapidly detected, and effectively dealt with based on more robust data," said Günter Verheugen, the Commission vice-president responsible for enterprise and industry policy.
"Rationalisation of the EU medicines safety system will free up resources which can then be directed to better protecting the health of EU citizens." However, Commission spokesperson Van Lierop couldn't give a figure on how much the improvement of the system would cost.
For drugs evaluated by the European Agency for the Evaluation of Medicinal Products (EMEA) and authorised by the European Commission, the funding is separated and is public - as opposed to the drug review process, where three quarters of the budget come from industry fees. Before it is approved to be launched on the EU market, a new drug has to undergo extensive studies to demonstrate that it is safe, of high quality and effective.
However, it is impossible to predict a medicine's potential adverse reactions prior to it being authorised because of the limitations of clinical trials, and sometimes safety issues are detected once a drug is on the market. That is exactly where post-market studies and pharmacovigilance are important.
The Commission's new proposals include more funding of studies into the safety of medicines as well as studies into the methodologies used to conduct pharmacovigilance. A better collaboration between EU members and a higher utilisation of the EU safety monitoring database "Eudravigilance" is also wished for, as well as the implementation of standards - "Good Vigilance Practices - GVP" - by both the industry and regulators.
The Commission also recommends clarifying the roles and responsibilities of member states and the European regulator.
The change to the legal framework will involve an impact assessment during the course of 2007 with a view to a legal proposal in 2008.