E-DRUG: Pharmaceutical companies ¹ DTC communication: No thanks!
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Dear all,
this joint press release (ISDB, HAI Europe, AIM and Medicines in
Europe Forum) is being distributed to the media and policy makers in the EU.
Christophe Kopp
Prescrire staff member
ISDB secretary
Christophe Kopp <ckopp@prescrire.org>
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Pharmaceutical companies¹ direct-to-consumer communication: No thanks!
Press release December 2007, 5
Despite the European Parliament¹s overwhelming rejection of attempts to
legalize direct-to-consumer advertising of prescription drugs in 2003, the
pharmaceutical industry has continuously sought direct access to patients.
Indeed, the public is seen as the strategic key to broadening the market for
pharmaceutical products.
The European Commission is supportive of the industry¹s moves: its
"consultations" are little more than an attempt to sway public opinion. The
underlying risks to health are conveniently overlooked, and the likely
impact on the financial sustainability of member state¹s public health
systems is consistently ignored.
Inevitable conflicts of interest, duly acknowledged by the industry. During
the consultation organized by the Commission in June 2007, drug companies
themselves acknowledged that the frontier between advertising and "patient
information" is not clear-cut (1). This clearly undermines the credibility
of the Commission¹s plans, which are to allow companies to communicate
directly with patients about prescription drugs: the claim to uphold the ban
on advertising for these same drugs would then be no more than a smokescreen
(2).
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 is, by definition, of promotional nature. This
inevitable conflict of interest means that a drug company could never be
expected to provide reliable comparative information.
Make-believe regulations do not protect against infringements. Measures
intended to control direct-to-consumer advertising in the United States and
direct-to-prescriber advertising in Europe have clearly failed. The relevant
regulatory bodies¹ tend to detect infringements too late, often when the
damage has already been done, and have difficulties imposing penalties
(3,4). And who would possibly trust that the not-legally binding measures
being proposed by companies (such as "self-regulation" based on a ³code of
good conduct", etc.) would properly safeguard direct-to-consumer
communication?
Concrete proposals. Tailored patient information should help users to assess
their medical status, to understand when further investigations are
necessary, to know what treatments exist, along with their respective
benefits and drawbacks, and to choose (or participate in the choice) among
the different available options (5).
The following measures would go a long way towards improving the situation:
- enforcing (with proper sanctions) the existing European regulation on drug
advertising, thus bringing a rapid and permanent end to the confusion
between the role of the pharmaceutical companies and other stakeholders;
- upholding articles 86 and 88 of Directive 2001/83/EC, which are the only
safeguards against total deregulation of direct-to-consumer communication by
drug companies (a) (6);
- recognizing that companies already have a defined role to play in
improving drug use, which is simply to provide clear and practical product
labeling and information leaflets, as required by existing European
legislation (b);
- acknowledging the many existing sources of independent and comparative
information in European Union member states, and reinforcing their role (5);
- further strengthening and promoting the role of healthcare professionals
and local care providers in giving patients the information they need;
- guaranteeing the full transparency of medicines agencies, in order to
ensure public access to data on efficacy and adverse effects, both before
and after marketing authorisation is granted;
- establishing provisions for direct consumer reporting of adverse drug
reactions, which will contribute to improved use of medicines.
The Medicines in Europe Forum, Health Action International (HAI) Europe,
International Society of Drug Bulletins (ISDB), and Association
Internationale de la Mutualité (AIM), as well as a large body of European
citizens, are increasingly concerned by the escalating merchandizing of
health, and call on European parliamentarians to protect public health
interests.
The signatories of this press release call on the European Commission to
uphold patients¹ interests above all else, in keeping with its mission to
protect public health (article 152 of the European Treaty). Measures
intended to protect the competitiveness of the European health product
industry must not be allowed to undermine the health of European citizens.
ISDB Medicines in Europe Forum HAI Europe AIM
Contacts:
ISDB: Maria Font (maria.font@ulss20.verona.it)
Medicines in Europe Forum: Antoine Vial (europedumedicament@free.fr)
HAI Europe: Teresa Alves (teresa@haiweb.org)
AIM: Rita Kessler (rita.kessler@aim-mutual.org)
.
Notes:
a- In its current form, article 86 states that the ban on direct-to-consumer
advertising does not concern ³information relating to human health or
diseases, provided that there is no reference, even indirect, to medicinal
products². This opens the way to so-called "awareness campaigns", which are
no more than surreptitious promotional campaigns for new drugs. If article
86 were to be revised, it should take into account one member state¹s
request to integrate the notion of ³prior validation by the national
authorities of information provided by the drugs industry on health
disorders² (ref 7).
b- One important measure expected to contribute to better use of drugs and
to error prevention is the evaluation of information leaflets by patient
panels, as provided for in the Regulation (article 59 of ref 6).
.
References:
1- European Commission Enterprise and industry directorate-general
³Outcome of the public consultation on a Draft report on current practices
with regard to the provision of information to patients on medicinal
products² 19 October 2007: 9 pages.
2- ³Consultation shows no support for DTC advertising in Europe² SCRIP
October 31st 2007; n°3307: 2.
3- GAO ³Prescription drugs: improvements needed in FDA¹s oversight of
direct-to-consumer advertising². Http://www.gao.gov consulted on 6 April
2007: 52 pages.
4- KCE Centre fédéral d¹expertise des soins de santé ³Valeur en termes de
données probantes des informations écrites de l¹industrie pharmaceutique
destinées aux médecins généralistes² 2007; reports 55B . www.kce.fgov.be:
178 pages.e
5- Joint declaration by HAI Europe, ISDB, BEUC, AIM and Medicines in Europe
Forum ³Relevant health information for empowered citizens² 3 October 2006.
www.prescrire.org or www.isdbweb.org: 9 pages.
6- European Directive 2001/83/CE, as modified by Directive 2004/27/CE.
Ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev1.htm.
7- Représentation permanente de la France auprès de l¹Union européenne ³Note
des autorités françaises Réponse à la consultation relative à «
questionnaire relatif à l¹avenir des produits pharmaceutiques à usage humain
en Europe »² 17/10/2007.
Ec.europa.eu/enterprise/pharmaceuticals/pharmacommunication/pubconsult.htm:
7 pages.