Healthy Skepticism Library item: 17387
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: Media Release
Direct-to-consumer communication by pharmaceutical companies? Europeans deserve better
Joint press release from 29 organisations 2010 Mar 15
http://www.akdae.de/Stellungnahmen/EU-Kommission/20100315.pdf
Notes:
Notes
[i]- It was ‘based’ on an incomplete and biased inventory of available
sources of information.
[ii]- 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.
[iii]- 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).
[iv]- 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 billion euros and save up to 329 billion 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
[v]- 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.
[vi]- 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.
[vii]- 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.
[viii]- 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_March2
009_000.pdf).
[ix]- 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.
[x]- 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.
International and European endorsing organisations
AGE Platform Europe. AGE Platform Europe is a European network of around 150
organisations
interests of the 150 million senior citizens in the European Union and to
raise awareness on the issues that concern them most. More info:
www.age-platform.eu. Contact: annesophie.parent@age-platform.eu
AIM. The Association Internationale de la Mutualité (AIM) is a grouping of
autonomous health insurance and social protection bodies operating according
to the principles of solidarity and non-profit-making orientation.
Currently, AIM’s membership consists of 41 national federations representing
29 countries. In Europe, they provide social coverage against sickness and
other risks to more than 150 million people. AIM strives via its network to
make an active contribution to the preservation and improvement of access to
health care for everyone. More info: www.aim-mutual.org. Contact:
rita.kessler@aim-mutual.org.
COFACE. Originally founded in 1958, the Confederation of Family
Organisations in the European Union (COFACE) is an international
not-for-profit voluntary organisation, which aims at promoting family
policy, solidarity between generations and the interests of children within
the European Union. COFACE advocates a policy of non-discrimination and of
equal opportunities between persons and between family forms, and
specifically supports policies aiming at equality between women and men.
COFACE links together general and single-issue national family
organisations. In 2010, it has 50 member organisations across 21 Member
States of the European Union. More info: www.coface-eu.org. Contact:
secretariat@coface-eu.org.
EATG. The European AIDS Treatment Group (EATG) is a non profit patient
organisation. EATG members come from 31 European countries. One guiding
principle of EATG is to reflect the diversity of people living with HIV and
their advocates. More information: www.eatg.org. Contact:
nicole.heine@eatg.org.
EFPC. The European Forum for Primary Care is a network of more than 100
organisations and individuals in Europe – and beyond. The aim of the Forum
is to improve the health of the population by promoting strong Primary Care.
In the Forum, practitioners, policy makers and researchers share
experiences, views and information. More info: www.euprimarycare.org.
Contact: d.aarendonk@euprimarycare.org.
EPHA. The European Public Health Alliance (EPHA) is the largest European
Platform, representing approximately 100 not-for-profit organisations across
the public health community: representations of patient groups, healthcare
professionals, public sector bodies, disease-specific organisations,
treatment groups, and representatives of the social society. Their
memberships include representatives at international, European, national,
regional and local level. EPHA’s missions are to protect and promote public
health in Europe and to ensure health is at the heart of European policy and
legislation. More information: www.epha.org. Contact: epha@epha.org.
ESIP. The European Social Insurance Platform (ESIP) represents over 40
national statutory social security organisations in 15 EU Member States and
Switzerland. ESIP’s mission is to preserve high profile social security for
Europe, to reinforce solidarity based social insurance systems, and to
maintain European social protection quality. More info: www.esip.org.
Contact: esip@esip.org.
Note: ESIP members support this position in so far as the subject matter
lies within their field of competence.
EUSP. The European Union of the Social Pharmacies (EUSP) is the professional
Association of the Social Economy Companies aiming to make, services,
medicines and health products accessible to the patients, at affordable
conditions, trough a network of 2.000 city-pharmacies in Belgium, France,
Italy, The Netherlands, Poland, Portugal, United-Kingdom and Switzerland.
More information: www.EuroSocialPharma.org. Contact:
mh_cornely@multipharma.be.
HAI Europe. Health Action International (HAI) is an independent European
network of health, consumer and development organisations working to
increase access to essential medicines and improve rational use. More info:
www.haiweb.org. Contact: teresa@haiweb.org.
HOPE, the European Hospital and Healthcare Federation, is an international
non-profit organisation, created in 1966. HOPE represents national public
and private hospital associations and hospital owners, either federations of
local and regional authorities or national health services. Today, HOPE is
made up of 32 organisations coming from 26 Member States of the European
Union, plus Switzerland. HOPE mission is to promote improvements in the
health of citizens throughout Europe, high standard of hospital care and to
foster efficiency with humanity in the organization and operation of
hospital and healthcare services. More info: www.hope.be. Contact:
sg@hope.be.
ISDB. International Society of Drug Bulletins (ISDB), founded in 1986, is a
world wide Network of bulletins and journals on drugs and therapeutics that
are financially and intellectually independent of pharmaceutical industry.
Currently, it has 80 members in 41 countries around the world. More info:
www.isdbweb.org. Contact: js@bukopharma.de.
MiEF. Medicines in Europe Forum (MiEF), launched in March 2002, covers 12
European Member States. It includes more than 70 member organizations
representing four key players on the health field, i.e. patients groups,
family and consumer bodies, social security systems, and health
professionals. Such a grouping is unique in the history of the EU, and it
certainly reflects the important stakes and expectations regarding European
medicines policy. Admittedly, medicines are no simple consumer goods, and
the Union represents an opportunity for European citizens when it comes to
guarantees of efficacy, safety and pricing. Contact: pierrechirac@aol.com.
National endorsing organisations
AkdÄ. The Drug Commission of the German Medical Association (DCGMA)
(Arzneimittelkommission der deutschen Ärzteschaft) is the scientific expert
committee for drug-related matters of the German Medical Association (GMA).
Relying on the expertise of their 40 full members and approximately 130
associate members from all areas of medicine and pharmacy, the commission
provides the medical profession with a variety of up-to-date information on
rational drug therapy and drug safety. More info: www.akdae.de. Contact:
sekretariat@akdae.de.
AKF. The Working Party for Female Health in Medicine, Psychotherapy and
Society (Arbeitskreis Frauengesundheit) is a German association of committed
female experts. It provides a national and international networking platform
for diverse experiences and competences in female health (i.e. pathogenic
beauty ideals). More info: www.akf-info.de. Contact: buero@akf-info.de.
BAGP. Founded in 1989, the Federal Community for Patients Advice and
Empowerment (BundesArbeitsGemeinschaft der PatientInnenstellen und
-Initiativen) works as a lobby for all patients. BAGP aims to create a
social, solid, democratic, non-hierarchical health-system; and to develop
independent information and advice, patient empowerment and patient
complaints procedures. More info: www.gesundheits.de. Contact: info@bagp.de.
BC Action Germany. Breast Cancer Action Germany project is a non-profit
activist/advocacy group directed by women who have experienced the trauma of
breast cancer, affecting themselves and other close friends, and who are
committed – long-term – to eradicating the disease. More info:
www.bcaction.de. Contact: kemper@bcaction.de.
Bioskop. Bioskop is a non-commercial association concerned with conditions
in biomedical research and public health care. BioSkop-Journal, homepage and
campaigning focus on more equitable conditions in social life, health care
and terminal care. More info: www.bioskop-forum.de. Contact:
info@bioskop-forum.de.
Bremen Forum for Women´s Health. Founded in 1994, the Bremen Forum for
women’s health is an interdisciplinary platform for women’s health issues
and policies which brings together 48 member organisations. Its goals are to
develop strategies for healthcare tailored to women’s needs and to advise
policymakers. More info: www.frauen.bremen.de. Contact:
angelika.zollmann@frauen.bremen.de.
DEGAM. The German College of General Practitioners and Family Physicians
(Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin) is the
scientific association of German primary care doctors. More info:
www.degam.de. Contact: froehlich@degam.de.
Formindep (as FORMation-INDEPendante, formation being the French translation
of education) is a group of French healthcare professionals and citizens
acting for independent medical information and education, free from vested
interests. More info: www.formindep.org. Contact: media@formindep.org.
German Network for Evidence Based Medicine. Founded in Berlin in 2000, the
German EbM Network’s primary mission is to establish a competence and
reference centre on evidence-based medicine. It provides an
interdisciplinary communication platform for the basic principles of EbM
that aims to promote coordination between medical research and clinical
care. More info: www.ebm-netzwerk.de/english. Contact:
david.klemperer@soz.fh-regensburg.de.
IPPNW. Germany- Physicians for Social Responsibility (IPPNW) is a federation
of medical organizations helping to implement a diverse set of programs
designed to build a healthier and more secure future. IPPNW affiliates in
Europe are part of IPPNW’s vast global network of medical professionals and
concerned citizens in over 60 countries. As “Physicians in Social
Responsibility”, IPPNW members work in a number of areas, for example, to
improve the health situation of migrants, access to essential medicine, or
to analyse the influence of the pharma-industry on the health sector. More
info: www.ippnw.de. Contact: wilmen@ippnw.de.
MEZIS. Part of the international “No free lunch” movement, “Mein Essen zahl
ich selbst” (MEZIS) is a German initiative of independent health care
providers, which encourages rational drug use and evidence based medicine.
MEZIS discourages the acceptance of any gifts from industry and promotes
independence on all levels of medical education. MEZIS´s goals are improved
patient care and the development of independent information. More info:
www.mezis.de. Contact: as@schaeffler.cc.
Netzwerk Frauen Gesundheit Berlin. The network “Women Health Care Berlin” is
an organisation campaigning for better and women-specific health promotion
and care. More information: www.frauengesundheit-berlin.de. Contact:
godin@frauengesundheit-berlin.de.
PSOAG. Psoriasis Selbsthilfe Arbeitsgemeinschaft is a German
umbrella-organisation of 12 independent patient-groups. The organisation
receives no funding from the pharmaceutical industry, and provides
independent and critical information, committed only to the interests of
patients. More info: www.psoriasis-selbsthilfe.org. Contact:
info@Psoriasis-Selbsthilfe.org.
Seroxat & SSRI user group. The Seroxat & SSRI user group is a self-funding,
non profit group that was formed in June 2002 to support and advise patients
experiencing problems (side effects and withdrawal symptoms) with Seroxat
and other SSRI antidepressants. More info: www.seroxatusergroup.org.uk.
Contact: janice@seroxatusergroup.org.uk.
USPO. The “Union des Syndicats de Pharmaciens d’Officine” (community
pharmacist union) includes 36 unions of French community pharmacists. One
of its aims is to promote actions favouring the public health mission of
community pharmacists. More info: www.uspo.fr. Contact: auge-caumon@uspo.fr.
VDÄÄ. VDÄÄ (Verein demokratischer Ärztinnen und Ärzte), the Association of
Democratic Doctors aims to create a democratic, fairly financed health care
system, with access to appropriate, and the best possible care for everyone
living in Germany. More info: www.vdaeae.de. Contact: info@vdaeae.de.
VDPP. VDPP (Verein demokratischer Pharmazeuten und Pharmazeutinnen), the
Association of German Democratic Pharmacists, represents pharmacists with
social responsibility. VDPP’s main goals are: democratisation of the health
system, the responsible provision of medicines and consumer-friendly drug
law. More info: www.vdpp.de. Contact: vorstand@vdpp.de.
Full text:
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”. [i],[ii] 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.[iii],[iv] 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.[v]
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. [vi],[vii]
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.[viii] 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.[ix],[x]
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 ( ).
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.
