Commissioner makes final plea for drug information directive


European Commission Vice-President Günter Verheugen has called for the revival of the stalled directive on providing information to patients, which has been held up by EU health ministers.

Speaking to the European Parliament’s environment committee, which deals with public health issues, Verheugen acknowledged that progress on the directive is unlikely to come before the end of the year, saying it had proven to be a “difficult and very emotional” issue. 

He said breaking the impasse at European ministerial level would fall on Spain, which takes over the six-month rotating EU presidency in January. The Swedish Presidency is currently focusing on securing agreement on counterfeit medicines and pharmacovigilence while disagreements over the Information to Patients Directive rumble on. 

Current policy in this area is being influenced by the decisions of the European Court of Justice and politicians should be concerned by this, the commissioner said. 

Verheugen, whose responsibility for enterprise policy includes medicines, said he was “more convinced than ever” of the necessity of updating rules on communicating to patients about medicines. “This isn’t based on the interests of the pharmaceutical industry. It’s based on supporting patients.” 

He said the Commission was proposing a “controlled step” forward which would embrace advances in information technology, and berated the medicine industry for dubious marketing practices. 

“It is necessary to have a clear border between information and advertising. In the pharma industry there are marketing practices which are not acceptable. The ban on advertising is being circumvented by industry which is exploiting a grey area. In print and online media there are contributions behind which are the interests of the industry – but the patient doesn’t know it because it is hidden.” 

He said a code of conduct would be necessary to curb questionable information campaigns conducted by pharmaceutical companies. “We want to protect patients from hidden advertising,” he said. 

Verheugen told MEPs there had been significant progress on tackling the growing problem of counterfeit medicines. “I don’t envisage any problems with this but I would hope it can be wrapped up as soon as possible so that the pharmaceutical industry knows what’s ahead.” 

Ministers are expected to discuss the issue at a meeting in Brussels in December and may be in a position to reach agreement on counterfeit medicines. EU sources indicated that ministers are not satisfied with the Commission’s proposal on information to patients as it stands, but could return to the issue if the proposal is amended. 

The legislation will be decided upon jointly by MEPs and EU governments, and member states are watching closely for developments in the European Parliament. 

German Socialist MEP Dagmar Roth-Behrendt said she could not understand the aversion to providing controlled information to patients. 

"There is information on medicines in pseudo-scientific journals and women's magazines. It shouldn't be the case that accurate information on medicines is only available to people who understand English and can read American websites," she said. 

Roth-Behrendt said EU member states have deliberately shelved the proposal which she said was sensible but could be improved. 

"Member states have buried this and I think it is a great scandal. We should be ashamed we haven't done more for patients," she said. 

Frédérique Ries, a Belgian liberal MEP, said there was a "totally incomprehensible taboo" about providing information to patients, and she proposed establishing an independent website which would provide consumers with access to accurate data on medicines. 

Swedish Green MEP Carl Schlyter  said magazines with health sections frequently include advertising and announcements related to prescription health products. He called for sanctions to be imposed on the editors of such publications and on those who "seek economic benefit" from such magazines. 

French liberal MEP Françoise Grossetête said counterfeit medicines were a "very pressing matter", particularly in light of recent seizures of fake drugs. She said the entire distribution chain poses a problem in addition to the threat of internet sales. Grossetête called for interim measures to be introduced to guarantee safety as it could take some time before action is taken. 

Current EU legislation allows advertising of non-prescription medicines that are not reimbursed, but bans direct-to-consumer advertising (DTCA) for prescription medicines. 

A December 2007 report from the European Commission on current practices with regard to information provision for medicines in the EU 27 concluded that the lack of a Community legal framework for rules and practices on the issue results in unequal access to information and variable quality of information. 

Moreover, the growing number of counterfeit medicines on the European market worries industry and EU leaders alike. 

The EU 'pharma package' of legislation, unveiled in Brussels, focuses on three priority policy areas (EURACTIV 11/12/09): 

  • Protecting the European market from counterfeit medicines; 
  • Improving pharmacovigilance to reduce the adverse effects of medicines, and; 
  • Improving information for patients on prescription medicines. 

It emerged earlier this year that EU health ministers appeared to be holding up the directive on providing information to patients (EURACTIV 25/05/09). The issue was discussed at a meeting of ministers on 9 June and it was agreed to focus on the other two legislative elements of the package, according to diplomatic sources in Brussels.

  • 23 Oct.: Health Action International to host conference on 'Unwrapping the Pharma Package'.
  • 1 Dec.: EU health ministers to discuss pharmaceutical package in Brussels.

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