The current priority for the European Commission is to support the
competitiveness of the pharmaceutical industry. Nowhere is this clearer than in
the recommendations of the EU Pharmaceutical Forum, an advisory group set up by
the Commission (1). European citizens do not see their needs reflected in the
recently published Pharmaceutical Forum's report and recommendations. This
report aims to increase competitiveness in three main ways: expansion of direct-to-consumer
product promotion under the guise of 'patient information'; weakening comparative
evaluation of therapeutic value for new drugs; and continued support for unjustified
and arbitrary pricing policies. The position taken by the Commission and the Forum
poses grave risks to health and sustainability of health care services. Alternative
approaches are needed, as outlined below. Practically
two years' work in total opacity resulted in highly questionable outcomes The
Pharmaceutical Forum's flawed methodology and lack of transparency have already
been widely criticised (2,3). By June 2007 there were still no significant improvement,
and some members of the Forum even felt morally bound not to endorse a few of
the report's findings (4). The Forum's conclusions were based on incomplete lists
of information providers, methodologically unsound surveys and hasty observations
which open up the way to biased proposals heavily favouring pharmaceutical companies.
Patient information: soon to be entrusted to the pharmaceutical
industry? The report on current sources of "patient information"
in the European Union drawn up by the Commission, and based on work carried out
by the Pharmaceutical Forum, omits many independent providers of relevant information
and undermines the role of numerous players who inform patients on a daily basis.
The "quality criteria" developed by the Pharmaceutical Forum do not
guarantee the requisite impartiality and relevance which enables patients to make
informed choices. The "information model" on diabetes is extremely unsatisfactory
and its inadequacy has been widely pointed out (4). And yet the Pharmaceutical
Forum persists, blithely ignoring the numerous criticisms which have transpired
during the external consultation. In short, the Commission's patient information
initiative's sole aim seems to be to support a proposal to deregulate the legislation,
which has been in the pipeline for a long time, and allow the pharmaceutical industry
to communicate directly with the public. The evaluation
of drugs' therapeutic benefits: postponed The conclusions of the Pharmaceutical
Forum on "relative effectiveness" of treatments fall short of the efforts
made in recent years by many Member States to improve methods in the evaluation
of the benefits of new medicines. These conclusions amount to a minimalist platform
and lead the public to believe that a reliable comparison between new drugs and
already available treatments is hardly ever possible. Conversely, all the demands
of the pharmaceutical companies are taken into account, namely the rapid consideration
of the slightest evidence likely to enhance a drug. The report proposes a Europe-wide
"harmonisation" of practices in the comparative evaluation of a medicine's
therapeutic benefit, which is likely to lead to a levelling down to the lowest
common denominator, curbing the most advanced practices. In short, the Commission's
initiative has resulted in a list of wishful thoughts which will be of no help
to Member States attempting to improve their methods when identifying real therapeutic
innovations. The causes for the surge in medicines'
prices: ignored The Pharmaceutical Forum's report on pricing is an opportune
reminder of what is needed: a guarantee of equitable access to medication, controlled
drug expenditure in Member States, and rewards for innovation. Yet the report
does not specify how these objectives are to be met. It does not mention the pharmaceutical
industry's artificial and unjustifiable pricing strategies, when an appropriate
evaluation of research and development costs would enable setting fairer prices.
Concerning the comparative evaluation of therapeutic benefits (relative effectiveness),
another essential criterion for a coherent pricing policy, the report's conclusions
refer to the working group in charge of this issue, whereas this group has not
produced a single consistent report (see above). In short, it would seem that
the Commission's initiative on pricing and reimbursement is not underpinned by
the will to achieve a successful outcome. The citizens'
proposals: deliberately ignored Various actors in the healthcare sector
have already published robust, well-substantiated documents on the three issues
which the Commission has delegated to the Pharmaceutical Forum. They define patients
and consumers' needs, provide lists of the existing measures which fulfil these
needs, and put forward concrete proposals for improvement. The joint Declaration
by HAI Europe, the ISDB, BEUC, AIM, and the Medicines in Europe Forum on Health
Information of October 2006 (5) and the ISDB Declaration on therapeutic advances
of November 2001 (6) are examples of such fundamental documents. Holding these
documents into account would have painted a truer picture of patients' needs.
Yet, these documents have been virtually ignored by the Commission, primarily
concerned with short-term interests of the pharmaceutical industry. The
signatories of this press release call upon the Pharmaceutical Forum to re-focus
its work and take up public health as their overriding priority before any changes
are to be considered in the legislation governing medicines information.
©Medicines
in Europe Forum - ISDB - Health Action International Europe 17 July 2007
_________ References 1- Pharmaceutical Forum
"Second progress report". 26 June 2007. Website http://ec.europa.eu/enterprise:
17 pages. 2- Joint Position of Medicines in Europe Forum, 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. Websites www.prescrire.org or www.isdbweb.org. 3- "Patient-information
in Europe: many concerns" press review and extracts from contributions to
the consultation organised by the "patient information" group (May 2007).
4- ESIP and AIM "Joint Position Statement on Information to Patients
on Diseases and Treatment Options". Website ec.europa.eu/enterprise: 1 page. 5-
Joint declaration by HAI Europe, the ISDB, BEUC, the AIM and the Medicines in
Europe Forum "Relevant Information for Empowered Citizens" 3 October
2006. Website www.prescrire.org ou www.isdbweb.org: 8 pages. |