In mid-March 2007, the European Pharmaceutical Forum's working group
on information to patients released two documents for public consultation: a list
of 'quality criteria' for patient information, and a sample patient information
sheet on diabetes.
We are concerned that the questions that accompany this
consultation frame it in such a way as to prevent any real democratic debate and
to predetermine the type of responses that are likely to be received. This creates
yet another sham consultation process, designed to justify a long-term plan for
legislative change aiming to remove the ban on direct-to-consumer advertising
of prescription drugs.
The Medicines in Europe Forum cannot in all conscience
take part in this consultation. Nevertheless, as key stakeholders with responsibilities
for medicines information policies, we would like to contribute towards an honest,
balanced debate by means of this open letter. Health Action International* (HAI)
Europe and the International Society of Drug Bulletins** (ISDB) support the
content of this letter and shares the concerns expressed by the Medicines in Europe
Both the Pharmaceutical Forum's lack of
transparency and lack of explicitly described methods remain unacceptable
Medicines in Europe Forum, together with Health Action International (HAI)
and the International Society of Drug Bulletins (ISDB), deplore the fact
that since its inception the Pharmaceutical Forum has operated with an almost
total lack of transparency (1). This consultation provides additional evidence
of this lack of transparency: two documents have been submitted for public consultation
with no explanation on methods that were used to produce them, nor any disclosure
of information on authors or their potential conflicts of interest. In fact, many
of the participants of the Pharmaceutical Forum have suggested that no systematic
methods were used to develop these documents, which is even more serious. Under
these circumstances, the poor quality of the results is not surprising.
proposed quality criteria are vague and far removed from patients' best interests
proposed list of criteria is long and uses ambiguous terms that are susceptible
to 'flexible' interpretation. Moreover, the title of this document is likely to
create confusion between 'health information' and 'information on illnesses and
It is important to remember that the sole purpose of patient information
is to provide answers to patients' questions. The information provided should
help patients to better understand their concerns and should provide them with
realistic expectations of their future health status. It should help them to understand
diagnoses and the likely results of different treatment options, as well as the
various choices of treatments and services available. Finally, this information
should help patients to cope with the suffering and to obtain help. (2)
make an informed decision, patients need comparative information that presents
the whole range of available options and, for each option, expected benefits and
harm. Recent tragic examples such as Vioxx° and more recently Zyprexa°
are potent reminders that pharmaceutical companies often minimize or even fail
to disclose adverse effects.
Above all, health information should fulfil
three very simple criteria. It should be:
evidence-based (with references cited to back each claim), totally transparent
as regards to authors and their conflicts of interest, and up-to-date;
presenting benefits and risks for all treatment options, including, if appropriate,
the option not to treat, as well as information on natural disease and symptom
- Adapted to users' needs: understandable,
adapted to patient's social, linguistic and cultural backgrounds, and easily accessible.
a fiercely competitive marketplace, pharmaceutical manufacturers naturally have
an obligation to their shareholders to realize profits from sales. They must therefore
promote their own drugs rather than other preventative or treatment options. As
a result, pharmaceutical companies are utterly incapable of providing the reliable
comparative information needed by patients.
diabetes 'example' is a counterexample of patient information
involved in health care provision, such as health professionals, consumer and
patient groups that are independent of the pharmaceutical industry, health authorities
and reimbursement agencies have not waited for pharmaceutical companies to take
an interest in patient-'information' to produce relevant information for patients.
sources of high quality information are now available to the public in Europe
and internationally. (2) Granted, improvements are still needed, especially
when it comes to helping the public evaluate the ever-growing mass of information
in order to better distinguish between useful and useless information. (a)
the diabetes patient information 'example', the Pharmaceutical Forum asks citizens
to express an opinion on a document when they do not even know how it was produced.
Transparency concerning the methods used to produce patient information is an
essential prerequisite if the people whose opinions are being sought are to be
treated in a responsible and respectful manner.
We have however made the effort
to read the document and are alarmed at the poor quality of its content. It does
not answer patients' basic questions, nor does it prioritize information in terms
of its importance. It does not compare existing treatment options and fails to
provide any information on the amount of evidence available concerning effects
of long-term use, nor does it cite references to back claims. It is pointless
to give a detailed list of the changes required: the entire document needs to
be rewritten if it is to provide the type of information needed to meet patients'
needs. Currently, it patently fails to do.
This purported 'example' demonstrates
-- as if proof were necessary -- that standardised 'information' produced at European
level as part of a public-private partnership without rigorous literature search
criteria or editorial methods, is of no benefit to patients.
We would like
to believe that the European Commission is capable of challenging this process
and will stop funding projects of this type, which are completely unsuited to
the needs of European citizens.
We demand an end
to the skilfully maintained confusion of roles
In recent months, a few
Members of the European Parliament, claiming to defend patients' 'right to information',
have been attempting to sway public opinion by creating the misleading impression
that Europe is devoid of quality health information, and that only the pharmaceutical
industry is capable of remedying this situation. This has been done through a
fanfare of publicity of all kinds including seminars, facilitation of workshops,
conferences opportunely set-up by so-called think-tanks, etc.
in Europe Forum, together with HAI and the ISDB, stresses once again that the
'information' provided by pharmaceutical companies is by definition promotional,
and that the use of the word 'information' in this context is an abuse of the
term: ultimately this is advertising. Patients' and citizens' ability to make
decisions concerning their own care must be protected all the more from the influence
of advertising masquerading as 'information', especially as illness increases
Information needs are complex and vary from person
to person. Differences in physical and/or mental abilities, educational background
and socio-economic status help to determine the type of information expected by
patients and how they will use it. Providing information that meets patients'
expectations as closely as possible implies a relationship of trust that is part
of the day-to-day work of health professionals independent patient groups, families,
and the mission of independent drug bulletins aimed at the public. (2)
manufacturers have a different and very specific role to play: the law requires
them to supply properly labelled medicinal products accompanied by a patient information
leaflet. Directive 2004/27/EC specifies additionally that these leaflets must
be evaluated by patients. (3) This important measure was much needed. The
development of safe, informative packaging and relevant patient leaflets by pharmaceutical
manufacturers can contribute to improved medicine use and to prevention of medication
errors. (4) There is still much room for improvement, and some companies
have begun to make important progress.
Any confusion of roles between these
different actors runs the risk of jeopardizing the quality of care and the freedom
of each person to make choices that meet their own health needs.
we remind you of your mission to protect public health
After an initial
failure to introduce legislation removing the ban on direct-to-consumer advertising
of prescription medicines in 2002, due to overwhelming rejection by the European
Parliament, the European Commission and the pharmaceutical industry, actively
supported by a few Members of the European Parliament (MEP's), appear to
wish to reintroduce this initiative, taking advantage of the fact that more than
70% of MEP's are new. Will this little game, which consists of regularly challenging
democratic choices for the benefit of a small interest group, be repeated with
each new European Parliament? We sincerely hope not.
The Medicines in Europe
Forum, together with HAI and the ISDB, condemns the fact that the European Commission
has overstepped its remit from Parliament, which was merely to present a report
in 2007 on the benefits and risks of current approaches to information provision,
including information on the Internet (Directive 2004/27/EC - article 88a). (b)
The Commission is biasing this debate by clearly supporting direct-to-consumer
advertising under cover of 'public-private-partnerships' in patient information.
This misrepresentation fools no one. (5,6,7) This position fails to take
into account the evidence of harm from direct-to-consumer advertising, nor the
ongoing efforts of health care providers to improve patient information for the
benefit of public health.
The health products market is not a market like any
other. Patients who are facing illness are vulnerable; they are not simply consumers.
In allowing pharmaceutical firms to be competitive the Commission must not forget
the key role it has to play in protecting European citizens' health (article
152 of the Treaty establishing the European Community).
wish to draw your attention to a few simple proposals to improve citizens' access
to relevant information
In practice, improved access for European citizens
to relevant health information requires:
- Guaranteeing the transparency of
drug regulatory agencies to ensure that the public has full access to effectiveness
and safety data on drugs or health technologies both before and after market approval;
- Ensuring that pharmaceutical manufacturers fulfil their drug packaging obligations;
- Developing and strengthening sources of reliable, comparative information
on treatment options in every member state;
- Allowing patients to be directly
involved in reporting drugs' adverse effects and thus contribute to improved drug
- Ensuring that EU regulations on drug advertising are fully implemented;
- And above all, putting an end to the confusion of roles between pharmaceutical
companies and other actors.
The Medicines in Europe Forum, Health Action
International Europe and the International Society of Drug Bulletins call on the
European Commission to fulfil its responsibilities by including these proposals
in the report on patient information in Europe required by Directive 2004/27/EC,
the preliminary version of which has just been made available for consultation. (b)
The Medicines in Europe Forum, HAI Europe and the ISDB thank you for acknowledging
these concerns, which are shared by many European citizens who fear that healthcare
is being treated as a mere commodity.
in Europe Forum 3 May 2007
with the exception of those who are involved
in the work of the Pharmaceutical Forum***.
* HAI Europe provides also an
individual reply to the consultation.
** ISDB also produced a press release
'Patient-'information' by Big Pharma: A threat to public health' (www.isdbweb.org).
*** The members of the Medicines in Europe Forum who are involved in the work
of the Pharmaceutical Forum wish, in accordance with their commitments, to present
objections and proposals to the Commission during the Forum's working parties.
To do this, a number of specific tools for evaluating and measuring the quality
of health information have been developed to identify quality information available (ref.
b- We will be sending you a second open letter on the subject of the 'draft
report on current practices with regard to the provision of information to patients
on medicinal products' in the European Union, available for consultation until
30 June 2007.
1- Joint position of the Medicines in Europe Forum,
the International Society of Drug Bulletins, Health Action International Europe
"Health information: A clear division of roles is needed to protect public
health" March 2007: 4 pages.
2- Joint declaration by HAI Europe, the ISDB,
BEUC, the AIM and the Medicines in Europe Forum "Relevant information for
empowered citizens" 3 October 2006: 9 pages. Website: http://www.isdbweb.org
accessed 30 April 2007: 8 pages.
3- European Commission "Guidance concerning
consultations with target patient groups for the package leaflet" May 2006:
4- European Commission Notice to applicants "Guideline on the
packaging information of medicinal products for human use authorised by the Community"
March 2007 : 34 pages.
5- Verheugen G "Pharmaceutical Forum: delivering
better information, better access and better prices" Brussels 29 September
2006. Website http://europa.eu accessed 23 October 2006: 4 pages.
M "Pharmaceutical Forum: delivering better information, better access and
better prices" Brussels 29 September 2006. Website http://europa.eu accessed
23 October 2006: 5 pages.
7- European Commission "Draft report on current
practices with regard to provision of information to patients on medicinal products,
in accordance with article 88a of Directive 2001/83/EC, as amended by Directive
2004/27/EC on the community code relating to medicinal products" 19 April
2007 : 27 pages.