Direct-to-consumer communication by pharmaceutical companies? Europeans deserve better

Brussels, 15 March 2010

Supporting the right choice in health information

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. We welcome this commitment. As of middle of March 2010, the legislative process is ongoing at the European Parliament, generating uncertainties.

The European Commission’s proposals on “‘information’ to the general public on medicinal products subject to medical prescription” were issued in December 2008. The directive and the regulation 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”.(1, 2) 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.(3,4) 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. (5)

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.(6,7)

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 State, ultimately jeopardising the long-term financial viability of the Member States’ health systems.

We 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.(8) 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.(9,10)

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

Concrete proposals to improve access to relevant (independent and comparative) health information

The following 5 key points encapsulate our proposals:

  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 (a).

We urge 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 our concrete proposals in order to ensure a better basis for the improved provision of relevant, independent and comparative information to patients.

Notes:

(a) The scientific exchanges between industry and expert patients’ organisations in the frame of the existing "Community Advisory Boards" are excluded from article 88 which deals with advertising to the general public. The ban on DTCA should not be used as an excuse for secrecy on data towards expert patient organisations that have the acquired expertise to understand them. (back)

  1. It was ‘based’ on an incomplete and biased inventory of available sources of information. (back)
  2. The European Parliament overwhelmingly rejected attempts to legalize direct-to-consumer ‘information’ (DTCI) of prescription medicines in 2003 (by 494 votes to 42), even in the frame of a pilot project, acknowledging the impossibility of distinguishing between advertising and ‘information’ from pharmaceutical companies. (back)
  3. See for example the Joint open letter by 18 organisations "Patient information. by pharmaceutical companies comes up against almost unanimous opposition from civil society" 5 June 2008: 6 pages (available at www.isdbweb.org/pag/documents/1.pdf). (back)
  4. The ‘impact assessment’ on which the proposals are based is unrealistic: according to the assessment of the European Commission, if adopted, direct-to-consumer information on prescription medicines would cost up to 88 billions euros and save up to 329 billions euros over the forthcoming 10 years. But the estimates for “savings” are based on “awareness”, “prevention”, “interaction [with health professionals]” and “compliance”, activities that can all better be achieved through the promotion of independent public health campaigns on specific conditions, driven by public authorities. In fact, “awareness” campaigns by the pharmaceutical industry are often “disease mongering” campaigns aimed at increasing sales for a specific drug when the market seems too narrow (Watters E “How the US exports its mental illness” www.newscientist.com 20 January 2010). (back)
  5. Useful patient information should be comparative to enable users to analyse their concerns, give them a realistic idea of the evolution of their health status, help them to understand when further investigations are necessary, to know what treatments exist and what they can expect from them, and to make informed choices (or participate in the choice) among the different available options. In a highly competitive environment, drug companies must promote their products above the use of other preventive or curative options, thus any ‘information’ they provide will be, by definition, of a promotional nature. This inevitable conflict of interest means that a drug company cannot be expected to provide reliable information. (back)
  6. 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 environnements with and without legal DTCA” CMAJ 2003; 169 (5): 405-412. (back)
  7. 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. (back)
  8. See the Joint AIM, ESIP, HAI Europe, ISDB, MiEF detailed analysis of the proposals “Legal proposals on “information” to patients by pharmaceutical companies: a threat to public health” March 2009 : 6 pages (available at: www.isdbweb.org/pag/documents/En_LegalProposalsInfoPatient_JointPaper_March2009_000.pdf). (back)
  9. Benzing L “In search of the Holy Grail; the quest for brand loyalty in prescription marketing” Patient marketing group. Site internet www.dtcperspectives.com accessed 4 June 2007: 5 pages. (back)
  10. The Directorate General for Competition’s “Pharmaceutical sector enquiry” shows how far pharmaceutical companies are willing to go to delay competition. The proposals on “information to patients” are yet another tactic to delay generic competition by building brand loyalty for their own medicines. (back)

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