E-DRUG: Joint open letter to EU President José Manuel Barroso
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Joint open letter to José Manuel Barroso, President of the European Commission from The Association Internationale de la Mutualité, Health Action International (HAI) Europe and Medicines in Europe Forum
Brussels, 5 December 2008
Concern: Legal proposal on information to general public on medicinal products
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.
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
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 42 national federations representing 27 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.
HAI Europe. Health Action International (HAI) is an independent global 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.
Medicines in Europe Forum (MiEF), launched in March 2002, covers most European Member States. It includes more than 70 member organizations representing the four key players on the health field, i.e. patients groups, family and consumer bodies, social security systems, and health professionals. (Contact: pierrechirac@aol.com).