Healthy Skepticism Library item: 18935

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Publication type: Unpublished Work

AIM, HAI Europe, ISDB, MiEF
Pharmaceutical companies 'informing' the public: one step closer to legalising reminder advertising for prescription drugs?
Joint Briefing document 2010 Oct

Full text:

The proposals improved by ENVI Members of European Parliament
still do not benefit patients and some provisions are even detrimental
On 28 September 2010, the European Parliament’s Environment, Public Health and Food Safety Committee
(ENVI) gave its verdict on the European Commission’s proposals aimed at legalising direct-to-consumer
advertising (DTCA) of prescription drugs. This vote was pivotal (a). The Members of the European Parliament
(MEPs) improved the European Commission’s proposals substantially (1-3). However certain loopholes still
remain.
Prior approval of “information” by Member States. The MEPs have clearly expressed their
reservations about allowing direct communication from pharmaceutical companies to the general public. In
particular, they voted in favour of the prior approval of any “information” from pharmaceutical companies by
health authorities before it is made publicly available (D- AM 13) (b). They also refused to allow the
distribution by health professionals of brochures and “patient-information” from pharmaceutical companies
without any health authority control (D- AM 31).
Yet, at the same time, the MEPs agreed that certain Member States can continue to use control systems
established before 31 December 2008, once they have been approved by the Commission (D- AM 55). This
could lead to de facto approval of a system based on self-regulation (monitoring by associations composed
entirely of pharmaceutical companies), or on co-regulation (if the organisation also involves players other than
pharmaceutical companies).
In the current uncertain economic climate, if Member States are obliged to monitor and approve
“information” from pharmaceutical companies before it is made publicly available, they will inevitably have to
face the following questions: is it better to devote public resources: – to providing the public with independent, comparative information and to increasing the transparency of the
drug regulatory agencies? – or, contrary to that approach, to attempt to enforce laws, and to monitor the pharmaceutical industry? With
the latter approach, is it feasible for the health authorities to check every document, website and its updates
thoroughly? And, while record fines of up to several billion dollars have failed to dissuade pharmaceutical
companies from infringing the current regulations on advertising (4), is it plausible that the health
authorities will manage to impose sufficiently dissuasive penalties? ©.
Several forms of disguised advertising rejected. MEPs clearly rejected several forms of disguised
advertising that were proposed by the Commission to enable pharmaceutical companies to communicate
directly with the public about their prescription drugs, including: – refusing to allow for pharmaceutical companies to execute commercial campaigns claimed to be in the
interest of public health (D- AM 26); – refusing to allow for the dissemination of information in which elements taken from the officially approved
information could be presented “in a different way” (D- AM 33); – refusing to allow for pharmaceutical companies to disseminate medicinal product-related information to the
general public about non-interventional scientific studies, or about preventive or treatment measures; and
refusing to allow for the dissemination of “information” that presents the drug in the context of the
condition to be treated or prevented (d) (D- AM 33); – refusing to allow for “information” from pharmaceutical companies to be published in newspapers,
magazines and similar publications aimed at the general public” (D- AM 34).
However, if the European Commission is left to define the criteria for distinguishing between “information”
and advertising (D- AM 15) as well as numerous other guidelines, particularly the code of conduct on what
types of information can be made available to the public (comitology procedure), it will put an end to
democratic debate – a debate that is surely necessary with such controversial proposals.
Joint Briefing document
October 2010
AIM
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There are still too many opportunities for pharmaceutical companies to reach the public,
giving companies an unacceptable advantage over other players. In addition to the officially
approved information on their product (e), which will have to be presented in a way that “faithfully represents
the officially approved information” (D- AM 33(1)), and oral or written answers to patients’ questions (D- AM
34), the MEPs agreed that pharmaceutical companies can make various other types of “information” about their
products available to the public, including: environmental impact, price, pack changes, adverse-reaction
warnings, instructions for use including through videos (“moving images”), reimbursement, preclinical tests and
clinical trials contained in the public assessment report, and answers to frequently asked questions (D- AM
33(2)).
The media that can be used to disseminate this information are: – printed documents (showing the company’s contact details in case patients have further questions (D- AM
41)); – and any websites that the marketing authorisation holder wishes to use, on condition that the websites are
registered with the health authorities of a Member State, that the websites’ content is identical to the content
of the website that was first registered, and that the pharmaceutical company is clearly identified (D- AM
58 and AM 59).
The company is free to choose which Member State it registers its websites in, and the Member State’s
health authorities are then responsible for monitoring the websites (D- AM 63). The MEPs requested that
modifications to the content of these websites should also be monitored (D- AM 60).
These websites, which can include videos, will allow identification of members of the public who use them,
after requesting their explicit consent, and must not be used to proactively distribute unsolicited content (D- AM
61).
The websites must include a link to the Community database (Eudrapharm), which contains information
about health products (D- AMs 50, 62 and 66). However, there is a risk that the independence of Eudrapharm
will be undermined, particularly with regard to its content, by measures that unacceptably favour “information”
from pharmaceutical companies over information for patients produced by other actors in the healthcare sector
(patients’ organisations, consumer groups, organisations representing health professionals, health insurance
bodies, etc.) (f).
Where is the benefit for patients in these legislative changes? What cost to Member
States? One may wonder what real benefit patients will derive from the “information” that the MEPs agreed
to allow pharmaceutical companies to disseminate: – what is the public health benefit of allowing pharmaceutical companies to inform the public about the price
and reimbursement of prescription-only medicines? Is it not simply a pretext to use reminder advertising as
a marketing strategy? (g) (5); patients need independent comparative information if they are to be enabled
to make informed choices (h). – does it make sense to entrust the task of warning patients about the adverse effects of medicines to the
pharmaceutical companies that sell them, when experience continues to show that companies tend to try to
conceal information that damages the image of their products (examples in the last decade include the
pharmacovigilance scandals involving rofecoxib (Vioxx) in 2004, and rosiglitazone (Avandia) in 2010)?
(6,7); – would it not be better if frequently asked questions were identified during the phase in which the package
leaflet is tested on a sufficient number of representative patients, and the answers were incorporated into the
final package leaflet (implementation of article 59(3) of Directive 2001/83 consolidated)? – in the name of environmental protection, is it a top priority to allow pharmaceutical companies to tell
consumers about the environmental impact of the products they market? Would it not be better, for
example, to organise campaigns to raise public awareness about how medicines cause water pollution and
to encourage citizens to return unused medicines to the pharmacy, so that they can be destroyed correctly?
The current European legislative framework is clear and already allows pharmaceutical companies to make
the officially approved information available, for example, by referring the public to drug regulatory agency
websites, where this information must be accessible.
The changes proposed will not bring significant added value for patients. On the contrary, they will
generate additional bureaucracy, causing a significant increase in expenditure. They will also expose
patients to more risks, and incur higher costs for Member States (i.e. to manage any adverse effects caused
by medicines that patients either did not need, or should have avoided due to drug interactions with their
existing treatments, etc.) (9,10).
Some progress in transparency. One notable advance is the adoption of the requirement for health
professionals who deliver information on a medicine in public or in print to declare their interests (D- AM 29),
as is already the case in France (8).
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The MEPs also assigned a greater role to Member States, and in particular to their drug regulatory agencies,
as proactive providers of health information, by stating that the public should at least have access to (D- AM
79): – the officially approved information on the medicine; – independent information about the diseases and health conditions that are to be treated with the medicine; – measures for preventing these diseases.
Paradoxically, the MEPs did not adopt important amendments to the Regulation that would have truly
increased the transparency of the drug regulatory agencies. Neither public access to the database on adverse
effects (Eudravigilance) nor public access to the clinical trials database (EudraCT) were adopted.
In summary. The MEPs have improved the European Commission’s initial proposals by refusing to
support several forms of disguised advertising, and by proposing that monitoring by the Member States’ health
authorities be the main safeguard. However, despite these palliative improvements, neither the proposed
Directive nor the proposed Regulation represent an advance for European citizens or Member States. On the
contrary, these proposals would mean additional bureaucracy, higher expenses, and greater risks for patients
(9,10,11).
Any product information that is provided by those who sell them must be presumed to be promotional. In
public health terms, given the health risks and the additional cost, the ban on the advertising of
prescription medicines by pharmaceutical companies, even when disguised as “information”, must be
maintained.
Medicines are not other, normal consumer products. In order to protect public health, we urge MEPs to
reject these proposals outright at the plenary session to be held on 23 November 2010. And we urge the
Ministers for Health of the Member States to continue to refuse to consider these unnecessary proposals,
which would damage public health.
_______
Notes:
a- Indeed, in the face of opposition from civil society and Member States, Commissioner Dalli (Directorate General for
Health and Consumers, known as “Sanco”) recognised the need to “re-assess” the European Commission’s initial
proposals, but he indicated that he would wait for the vote on the first reading to learn the European Parliament’s position
(ref. 12).
b- We show in brackets the numbers of important amendments presented in the reports adopted in ENVI Committee.
Amendments (AM) presented in the report on the proposed Directive (ref. 2) are preceded by “D- AM“; and amendments
presented in the report on the proposed Regulation (ref. 3) are preceded by “R- AM“.
c- The fact that the penalties for failure to comply with the requirements regarding the dissemination of information by
pharmaceutical companies are to be determined at the Community level (D- AM 68) and that the authorities are permitted to
publish the names of pharmaceutical companies that infringe regulations (the “name and shame” principle) (D- AM 67) are
interesting approaches, but do not go far enough.
d- However, amendment 22 to the Directive opens the way for reminder advertising of therapeutic classes: information
about health and diseases can be used to refer to classes of drugs, even if individual products cannot be mentioned.
e- The officially approved information on a drug is represented by the labelling (which must always include the international
nonproprietary name (D- AM 19)), mock-ups of packaging items including the package leaflet, the Summary of Product
Characteristics, and Public Assessment Reports prepared by the health authorities, and any updates thereof. One
amendment to the Directive lays down that European Public Assessment Reports prepared by the health authorities must
“list the other available therapeutic options and whether the new medicinal product brings about a therapeutic value” (D- AM
45), whereas the Regulation does not specify this point.
f- Two amendments to the Regulation would undermine the independence of how Eudrapharm is run. Whereas the
Regulation stated that Eudrapharm would be managed “independently of pharmaceutical companies”, an amendment
challenges this independence by specifying that it should be managed “independently of the commercial interests of
pharmaceutical companies” (R- AM 10), which opens the door to pharmaceutical companies taking part in the running of
Eudrapharm.
Another amendment obliges the European Medicines Agency to include in the Community Eudrapharm database
“information” submitted by pharmaceutical companies to national authorities and approved by those authorities (R- AM 12).
While the “information” that pharmaceutical companies want to disseminate to the general public will be promoted on the
Community’s Eudrapharm database, other actors in the healthcare sector (patients’ organisations, consumer groups,
organisations representing health professionals, health insurance bodies, etc.) will be unable to make the independent
information they produce available there.
g- Reminder advertising is a standard marketing practice that aims to remind the general public of the name of a particular
brand by using every possible opportunity to write or talk about the product, using in particular branding and emotive
messages.
h- Useful patient information should 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.
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________
Selected references from the Medicines in Europe Forum’s literature search:
1- Our joint analysis of the Commission’s initial proposals in December 2008:
AIM, ESIP, ISDB, MIEF “Legal proposals on “information” to patients by pharmaceutical companies: a threat to public health” (6 March 2009)
www.prescrire.org/docus/LegalProposalsInfoPatient_JointPaper_March2009.pdf.
2- The version of the Directive as amended by the ENVI Committee (report by MEP Fjellner) (123 pages)
www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPORT+A7-2010-0290+0+DOC+WORD+V0//EN&language=EN
3- The version of the Regulation as amended by the ENVI Committee (report by MEP Fjellner) (37 pages).
www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+REPORT+A7-2010-0289+0+DOC+WORD+V0//EN&language=EN
4- Barrett D “Pfizer to pay record $2.3B penalty for drug promos” Associated Press 2 September 2009.
5- Mintzes B, Morgan S, Wright JM. “Twelve years’ experience with direct-to-consumer advertising of prescription drugs in Canada: a cautionary tale”
PLoS One. 2009 May 27;4(5):e5699. (freely available)
6- Prescrire Editorial Staff “How to avoid future Vioxx-type scandals” Prescrire Int 2005; 14 (77): 115-117.
7- Wang AT et al. “Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review”
BMJ 2010 Mar 18;340:c1344. doi: 10.1136/bmj.c1344.
8- Article L4113-13 du Code de la Santé publique français créé par Loi n°2002-303 du 4 mars 2002 – art. 26 JORF 5 mars 2002.
9- Kravitz et al. “Influence of patients requests for direct-to-consumer advertised antidepressants: a randomized controlled trial” JAMA 2005; 293: 1995-
2002.
10- 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.
11- US Government Accountability Office (GAO) “Prescription drugs. Improvements needed in FDA’s oversight of direct-to-consumer advertising”
November 2006. www.gao.gov: 52 pages.
12- “Publicité grand public pour les médicaments de prescription ? Un automne 2010 crucial” Rev Prescrire 2010; 30 (323): 700 – 701.