Healthy Skepticism Library item: 14755

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Publication type: report

Health Action International Europe
Concern: Legal proposal on information to general public on medicinal products
2008 Dec 5

Abstract:

Dear President Barroso,
We would once again like to convey to you our grave concerns about the legal proposal on “information to
patients” on pharmaceutical products, which will be submitted to the Commission for adoption as part of the
pharmaceuticals package in the coming days.
DG Competition’s recently released Pharmaceutical Sector Inquiry Preliminary Report has demonstrated
the extent to which originator companies are engaged in practices aimed at delaying or blocking market
entry of competing and generic medicines.
The proposals on “information to patients” represent yet another tactic to delay generic competition
by enabling the pharmaceutical companies to communicate directly to the public on their respective
prescription-only medicines, thereby building “brand loyalty” and market share for their own
originator products at the expense of affordable medicines for the public.
Anti-competitive practices carried out by pharmaceutical companies clearly have a negative impact on
public health budgets, taxpayers and patients, and detrimental effects on other essential health care needs.
These practices also distort the balance between incentives for innovation (intellectual property rights) and
affordable access to essential medicines (after patents expire and generic competition begins). The
European pharmaceutical industry seems to have prioritised patent evergreening and marketing (23 % of
their turnover) over research (1,5 % devoted to basic research, and 17 % overall).
In the consultation organised by DG Enterprise on this topic, the wider health community unanimously
stated that the pharmaceutical industry is not a reliable source for unbiased information, due to an obvious
and unavoidable conflict of interest. The current legal provisions already offer many opportunities for
pharmaceutical companies to provide information on diseases and medicines should they choose to,
notably via the summary of product characteristics, “factual information”, answers to specific and individual
questions, and disease-related information in the media (Article. 86 of Directive 2001/83/EC).
Asymmetrical enforcement of article 86 across Member States can be tackled by the Commission
without any further legislative changes.
Relaxing the current rules would, on the contrary, assist originator-companies in building brand loyalty to
their medicines, potentially delaying generic competition as shown by marketing studies and corroborated
by evidence from the US and New Zealand.

AIM
European patients need relevant, independent, comparative, unbiased and non-promotional information
about health, treatments and medicines, not an exercise in building brand loyalty.
The Association Internationale de la Mutualité, Health Action International (HAI) Europe and Medicines in
Europe Forum request that the Commission address the current imbalance between public health and
commercial interests and ensure that the decision on the pharmaceuticals package prioritises the public
health of EU citizens over commercial interests. Adopting the legal proposal on “information to patients” on
prescription-only medicines would be detrimental for patient health, taxpayers and public health systems
across Europe.

Yours sincerely,
Association Internationale de la Mutualité
Health Action International Europe
Medicines in Europe Forum