Open letter to the President of the European Commission

Mr. José Manuel Barroso
President of the European Commission
Rue de la Loi 200
B-1049 Brussels

19 November 2008

Pharmaceutical Package

Dear President,

As representatives of a wide range of organisations of patients, consumers, health professionals and social health insurers, we would like to express our concerns vis-à-vis the « Pharmaceutical Package », which is expected to be adopted by the European Commission on 26 November. The proposed changes to the existing legislation will have a substantial impact on European patients, consumers and national health care systems. Any attempts to alter the current legislative framework should be guided by and based on an in-depth assessment of patients’ and consumers’ needs.

The three important matters at hand, namely information to patients, pharmacovigilance and counterfeit medicines are extremely complex and politically sensitive. Not only it is crucial to separate these issues – there is no compelling reason for their linkage in the manner the Commission is proposing - but it is imperative that their overall implications on public health are seriously evaluated.

We invite you to carefully reconsider the approach taken so far on this dossier, and ask you to refocus its objectives towards providing patients and consumers with:

• Relevant, independent, comparative, unbiased and non-promotional information about health, treatments and medicines. Ill-considered deregulation of the current rules on information about prescription medicines is likely to lead to higher expenditures while any additional benefits to health or health care quality are yet to be established.

• Accessible, affordable and safe medicines, with added therapeutic value and adequate riskbenefit balance.

Moreover, we encourage you to make sure that any proposals adopted are based on a sound impact assessment and in line with the principles of better regulation. At a time of economic uncertainty, legislation that will ultimately lead to more bureaucracy and increase the financial burden of governments and their health authorities would be injudicious and counter productive. Finally, in order to better ensure that public health considerations are put before industrial interests, we call for competence on medicines to be transferred from DG ENTERPRISE to DG SANCO, and to become a responsibility of the EU Health Commissioner.

The signatories of this letter respectfully request you to uphold the defence of public health interests when discussing the “pharmaceutical package”.

Yours sincerely,

The signatories

AGE
AIM
BEUC
EAHP
EATG
ECCH
EFN
EFPAM
EFPC
EHN
EPHA
ERS
ESIP
HAI Europe
ISDB
IVAA
MiEF
PGEU
Picker Institute
UEMS

©Medicines in Europe Forum, 19 November 2008

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