In December 2008 the European Commission (EC) released its proposal for a Directive on direct-to-patient information which triggered a heated debate that led to a block for the Council of Ministers (Member States). The Spanish government holding the 6 month rotating presidency of the Union has clearly indicated that it will not reopen the dossier during its term – see: EUM February 2010, Issue 38.

In addition, earlier this year, during his hearing at the European Parliament, the new Commissioner for Health and Consumer protection, John Dalli, stated that the proposals on patient “information” needed to be reassessed.

Meanwhile the European Parliament is continuing its legislative work on the adoption of the Directive, creating uncertainty. In response to this action from the Parliament, 29 healthcare organisations signed a press release on 15 March 2010, calling on the Commissioner for Health to start reassessing the proposal for a new Directive now.

EAHP, as member of the European Public Health Alliance (EPHA) supported this initiative. Below is an extract from the press release.

“The European Commission’s proposals on “‘information to the general public on medicinal products subject to medical prescription” are based on an incomplete report that failed to fulfil the demand of the European Parliament and the Council for a report on “the benefits and risks of information currently available to the public”. Moreover, the proposals contradict the views of the wider health community, as expressed in responses to the public consultations in 2007 and 2008, which stated that the pharmaceutical industry cannot be considered a reliable source of unbiased information due to an obvious and unavoidable conflict of interest. During the Council meetings and discussions on this topic, Member States have also repeatedly echoed strong concerns.

Should Members of the European Parliament work on such inadequate proposals?

The current Commission proposals do not meet the needs of citizens for relevant, independent and comparative health information tailored to users.

Moreover, the proposals endanger specific Treaty rules that aim to ensure a high level of health protection. European citizens would be exposed to intensive promotion of new medicinal products, and this would lead to increased public demand for medicinal products that they may not need or that they should not take (contra-indications, drug interactions, etc.), thereby putting public health at risk [1] [2].

The Commission proposals pose additional hurdles for Member States to put in place efficient and affordable pharmaceutical policies. In fact, the burden of drug-induced harm and unwarranted health spending created by increased consumption of medicines (notably the cost of managing adverse drug reactions) would be borne by the States, ultimately jeopardising the long-term financial viability of the Member States’ health systems.

The signatories of the press release therefore consider the current proposals on “information’ to the general public on medicinal products subject to medical prescription” to be of no added value to European citizens. Their only rationale seems to be to benefit the commercial interests of pharmaceutical companies by expanding their markets and helping them to build brand loyalty.

Europeans deserve better. Any compromise on such controversial proposals could in fact hamper improved access to relevant patient information for European citizens in future.

Instead, the 29 organisations propose to:

1. Make the officially approved leaflet more useful and accessible for patients by ensuring that pharmaceutical companies consistently abide by their obligations relative to drug packaging and patient leaflets (i.e. consultations with target patient groups) (enforcement of article 59 of Directive 2001/83/EC modified by Directive 2004/27/CE) ;
2. Optimise communication between patients and health professionals : informing patients and fulfilling their needs implies a relationship of trust and interpersonal dialogue, which are the core responsibilities of the healthcare professions ;
3. Encourage national agencies to become proactive and more transparent providers of information so as to guarantee full public access to data on the efficacy and safety of medicines and other healthcare products both before and after a product is marketed ;
4. Develop and reinforce existing sources of comparative, unbiased information on treatment choices ;
5. Put a rapid and permanent end to the confusion of roles between the pharmaceutical companies and other actors in the healthcare sector: full implementation and enforcement of the European regulation on Pharmaceutical promotion, including measures to ensure that article 88 of Directive 2001/83/EC, is not weakened or undermined."

The press release concluded on urging the Commissioner for Health and Consumer protection to start the reassessment of the current legislative proposals on patient “information” now, and to take into account the concrete proposals put forward in order to ensure a better basis for the improved provision of relevant, independent and comparative information to patients.

[1] Kravitz et al. “Influence of patients requests for direct-to-consumer advertised antidepressants: a randomized controlled trial” JAMA 2005 ; 293 : 1995-2002 ; Mintzes B et al. “How does direct-to-consumer advertising (DTCA) affect prescribing ? A survey in primary care environments with and without legal DTCA” CMAJ 2003 ; 169 (5) : 405-412.

[2] See informative examples of misleading messages provided by pharmaceutical companies in Barbara Mintzes’ presentation at the European Parliament expert meeting chaired by MEP Dr Thomas Ulmer (EPP, Germany) and MEP Carl Schlyter (Greens, Sweden) the 3 December 2010 : www.aim-mutual.org/index.php ?page=17&id=200.