Healthy Skepticism Library item: 15716
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Taylor L.
EU drug info plans 'set to fail' this month
Pharma Times 2009 Jun 1
http://www.pharmatimes.com/worldnews/article.aspx?id=15949
Full text:
European Union (EU) member states will this month throw out plans by the Commission to ease restrictions on drugmakers communicating information about prescription drugs to the public, a leading pharmacy spokesman has forecast.
The Commission’s proposed Information to Patients Directive, which was included in last December’s EU pharmaceutical sector reform package, would permit companies to provide patients with information on products appearing in Summaries of Product Characteristics (SPCs), labelling and package leaflets, and to notify them of issues relating to prices, pack changes and adverse reaction warnings. The current EU-wide ban on direct-to-consumer (DTC) advertising would however remain.
Announcing the proposals, the Commission claimed they would allow more patients to access “high-quality objective and non-promotional information,” but they were attacked immediately by industry critics, who said they made no clear distinction between “advertising” and “information” and would permit the introduction of DTC “in disguise.” And last week John Chave, secretary-general of the Pharmaceutical Group of the European Union (PGEU), forecast that the information directive will be thrown out by the Council of Ministers at the meeting of the Employment, Social Affairs, Health and Consumer Affairs Council (EPSCO) in Luxembourg on June 8-9.
“I do expect it to be kicked out to be honest,” said Mr Chave, speaking to EurActiv. “Most countries really do not see the need for it, and despite the proposed safeguards in the text, it is still perceived as being too close to the agenda of the pharmaceutical industry, which, to be frank, has a credibility problem on information issues.”
Mr Chave also criticized the long-running legal action launched by the Commission against German and Italian national laws which state that only pharmacists may own and run pharmacies. In May, the European Court of Justice threw out the Commission’s case that Community law overrides such national controls, but the case had been a major reason for pharmacists in some parts of European feeling “a little bit under siege” over the last few years, he said, adding that if the Commission had won its case, “then there would have been a revolution in European pharmacy, literally overnight.”
“At PGEU, we have always taken the view that it is for each member state to decide what is best for its own citizens, and that is why we have been critical of the European Commission’s attempts to deregulate the entire European market,” he said.
Mr Chave went on to note the growing “Europeanisation” of cost issues related to medicine costs, with EU governments increasingly ready to compare notes on exactly how costs can be controlled, as demand for medicines continues to rise and national budgets come under increasing pressure. These measures have included moves to squeeze pharmacists and wholesalers, he said, and warned that further margin squeezes, even when the credit crunch is over, cannot be ruled out. Moreover, “there are those in the pharmaceutical industry who are all too ready to blame supply chain costs for excess expenditure,” while new forms of distribution such as direct-to-pharmacy are threatening to shake up traditional remuneration structures, he added.
“I also think governments will look at ways of both driving down the prices of generic medicines, which has been done very successfully in Germany and the Netherlands, and increasing generic use. Depending on the remuneration system in place, falling generic prices can have a significant negative impact on the bottom line for pharmacists, and this a major concern,” he said.
