European drugmakers say they are willing to allow information on their medicines to undergo an independent vetting procedure before being made available to the public.
The move could break the deadlock on European Commission plans to liberalise controls on the provision of information to patients on prescription drugs, which have failed to progress since the health ministers of over 20 European Union (EU) countries expressed strong opposition at a meeting of the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in early June.
Drugmakers’ willingness to allow their proposed patient information to undergo prior approval by an independent authority was announced this week in Brussels by Arthur Higgins, president of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Speaking at an event in the European Parliament, Mr Higgins said that access to “high-quality, non-promotional information on diseases and treatments” would allow to patients to take responsibility for their own health.
“Patients need to be equipped to make informed choices about their condition and possible treatments. Such information should be available from a range of high-quality sources, including the industry,” he said.
Mr Higgins added that the industry had been “disappointed” with the Council discussions on the Commission’s proposals, adding: “sadly, the debate on this issue is still characterised by great mistrust on the intention of the industry.”
However, he also welcomed the “open-minded approach” to the issue expressed by many Members of the European Parliament (MEPs), including French MEP Francoise Grossetete, who told the same news conference that it was “very disappointing” to see France as well as other member states – including Germany and Spain – blocking the proposal, the aim of which, she said, is to “harmonise current practices and ensure all EU citizens have equal access to reliable and quality information on existing medicines.”
“Clearly, we will have to convince these countries of the benefits of this proposal although, at present, this would appear to be a struggle,” said Ms Grossetete, who called on MEPs to join with patient advocacy groups against the health ministers who are blocking progress on the draft directive.
Among the objections held by the health ministers – and other critics including consumer groups – are that the draft does not distinguish sufficiently between “information” and “advertising.” They also believe that the industry should have no role in the provision of information to patients and that the proposals would drive up health costs, by increasing demand and because of the need to set up monitoring mechanisms. There has also been strong criticism of the fact that the proposals have been drafted by the Directorate-General (DG) for Enterprise and Industry – the Commission body whose responsibilities include regulatory and industrial policy for the pharmaceutical industry – rather than DG Sanco, which is concerned with consumers and public health.
“We urge Parliament to adopt a forward-looking opinion on this dossier in the coming months, to prevent this proposal from being diluted or worse still, dropped,” said Mr Higgins, who is chief executive of Bayer HealthCare.
Following the European Parliament elections in June, new MEPs have been appointed as rapporteurs to lead work on the Commission’s pharmaceutical package – which, as well as information to patients, includes proposals and on pharmacovigilance and counterfeiting and the illegal distribution of medicines.
The new rapporteur for the information directive at the Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) is Swedish MEP Christoph Fjellner, who has described the current situation as “utterly unacceptable” and has drafted a report on the issue which is expected to be released next month. He accused the member states of “burying their heads in the sand” and urged them to “at least come back to the negotiating table.”
EPSCO is due to meet to discuss the pharma package on November 30–December 1.
