MEPs look for progress on patient information
pharmafile | November 28, 2003 | News story | |Â Â Â
MEPs have put forward new proposals to provide patients and the public with greater information on medicines, in an attempt to break a deadlock over the highly contentious issue.
European Commission plans to reform the current rules to allow pharma companies to provide limited and closely monitored information to patients was thrown out a year ago by the MEPs, but the Commission has insisted the issue is central to new legislation.
As the deadline for agreement nears, the European Parliament health committee has now called for the Commission to undertake further research and put forward a new nformation strategy.
In a significant breakthrough on previously disputed detail, the committee said information and market canvassing should be excluded from the definition of advertising, and that the difference between information and publicity on medicines should be more clearly defined.
It requested the Commission consult patient groups, doctors, consumers and pharmacist representative groups before producing a report on "current practice with regard to information provision – particularly on the Internet – and its risks and benefits for patients." It concluded: "If appropriate, the Commission should make proposals setting out an information strategy to ensure sound, objective, reliable and non-promotional information. The question of the information source liability should also be addressed."
The proposals are part of the draft legislation aiming to produce a European 'Community code' on medicines products, and is being reviewed in tandem with plans to reform how medicines are approved in Europe.
The committee also made two significant amendments to these proposals. Firstly, it recommended going one further than agreed by member states by accelerating a move towards a single approval route for medicines through the EMEA.
Meanwhile, the issue of data protection periods remained contentious, the MEPs rejecting a 10 year period of complete data exclusivity, to one in which generic companies could begin developing version of a drug after eight years in preparation for launch two year later. The proposal, known by the shorthand of 8 2 1 includes one extra year of exclusivity for additional therapeutic indication of ignificant clinical benefitto patients.
The full European Parliament will vote on the proposals on 11 December, with industry group EFPIA pushing for final legislation to be passed before EU enlargement in April 2004.
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