EU patient info proposal falls further behind
This article was originally published in Scrip
The European Commission is still working on a revised version of the draft legislation on information to patients that it hopes will address concerns expressed by the EU member states and allow the draft to move towards final approval.
The controversial proposal, part of the "pharmaceutical package" of legislation, would allow pharmaceutical companies to play a role in providing information on their prescription drugs. But it has hit lengthy delays in the legislative process, while its companion laws on pharmacovigilance and falsified medicines have moved ahead and been approved.
At a meeting in November last year, the European Parliament approved a heavily amended version of the proposal, and the commission was supposed to have produced a new draft, taking these changes into account, by May. However, work is still under way at the commission with a view to adopting an amended proposal for debate by the council of ministers.
The reasons for the delay are not clear, but the commission no doubt wants to produce a text that will survive what is likely to be intense scrutiny at the council. Ministers have been unwilling to debate the proposal before now, mainly because of concern that it is too geared towards the interests of pharmaceutical companies and that it might open the door to direct-to-consumer advertising.
The draft approved by parliament therefore made a clear distinction between "information" and "advertising", as well as putting the emphasis on the right of patients to obtain the information they seek, rather than that of companies to disseminate it (scripintelligence.com, 24 November 2010).
Under the proposal pharmaceutical companies would be able to publish information on their prescription drugs, but this would generally be limited to the approved product information such as the summary of product characteristics and the patient information leaflet.
A written update on progress with the draft was presented by health commissioner John Dalli at a meeting of health ministers on 6 June. The note says that the proposal aims to ensure high-quality of information by applying "clearly defined standards" across the EU, and to allow information to be made available through channels that address the "needs and capabilities" of different types of patient.
It will allow companies to provide "understandable" and "objective non-promotional information" about the benefits and risks of their medicines, and ensure monitoring and enforcement measures are in place to ensure information providers comply with the quality criteria while avoiding unnecessary red tape, the commission says.
Mr Dalli told ministers that the revised draft would take account of the amendments made by the parliament, but he did not say when it would be published, according to a council spokesman.