Industry concern over EU reform
pharmafile | October 24, 2003 | News story | |Â Â Â
A serious lack of progress in EU moves to reform pharmaceutical regulation is now jeopardising key objectives, according to European industry body EFPIA.
Failure to finalise the legislation before EU enlargement in May 2004 could lead to a "substantial and unacceptable delay" to the Commission aims of improving public health protection and strengthening industry's competitiveness, it says.
The delay is largely down to the need for the European Parliament and a council of member state health ministers to examine and agree on reforms with the European Commission.
The council has made little progress with the proposals under the recent Danish presidency, and EFPIA is now demanding they agree among themselves before the current Greek presidency ends in June.
It says if agreement is not reached by then, the laws will not be in place before EU enlargement begins in 1 May 2004, causing further problems.
The Commission and the industry agree that reform of pharmaceutical legalisation is vital if Europe is to compete with the US, but have clashed over some details of the reform.
The Commission main objectives are to:
assure a high level of public health protection, through increasing the efficacy with which medicines are approved and become available, and strengthening pharmacovigilance procedures
increase the competitiveness of the European pharma industry
tackle the challenges of an enlarged EU
streamline and improve the transparency of procedures relating to the authorisation of medicines.
MEPs voted on the legislation for the first time in October, and, despite agreement on many issues, have blocked a number of key Commission objectives, adding scores of their own amendments.
The Commission has now reiterated its determination to introduce its three disease area trials of direct to consumer communication, which the MEPs have rejected.
Meanwhile, the industry is keen to see a 10-year data exclusivity period extended to all EU countries. If introduced, greater market exclusivity in markets such as Spain and Italy would deliver millions of euros more revenue for companies. Indeed, Dr Trevor Jones, Director General of the ABPI, said that the industry was prepared to make concessions on other areas of reform, if the 10-year standard became law.
The Commission has bowed to MEP proposals to halve the time taken to issue Community marketing authorisations to 15 days, changing the composition of the EMEA's management board, and providing support for small and medium-size enterprises to limit costs associated with obtaining marketing approval.
The Commission rejected calls to include comparative efficacy of a new product as a criteria for marketing authorisation, saying only quality, efficacy and safety were required.
It did, however, say that the EMEA should collect information on how individual member state authorities collect information on and monitor the therapeutic progress of each new medicine.
The Commission acknowledged the importance of patients in reporting suspected adverse drug reactions, and recommended they should be encouraged to report them to either their healthcare professional or competent authorities. In the UK, the Government has already announced plans to extend the Committee on Safety of Medicines' 'Yellow Card' scheme to patients in this way.
The Commission's document will now go before Commission health ministers early in the year.
