Joint open letter to Commissioner Vassiliou on pharmaceutical package

The delay in the adoption of the package offers a valuable opportunity to reconsider the industry oriented approach taken so far on this sensitive dossier and to ensure that the new legislation on medicines does genuinely respond to patients’ and consumers’ needs and expectations.

Consumers and patients have a fundamental right to relevant, independent and comparative information not only about medicines, but also about health, and treatments. We will therefore support Commission initiatives that truly enable citizens to make informed choices and promote the rational use of medicines.

When examining the proposal on information to patients, we would like you to acknowledge that it is not possible to make a clear distinction between non-promotional information and advertising. We would urge you to oppose any unsolicited form of direct communication between the marketing authorization holders and the general public on prescription only medicines.

The wider public health community has unanimously stated, in the last public consultation on this topic, that the pharmaceutical industry cannot be considered as a reliable source of unbiased information, due to an obvious and unavoidable conflict of interest .

The existing legislation already allows pharmaceutical companies to provide information to the public on health and diseases (Article 86 of Directive 2001/83/EC). They make the most of the opportunities provided by this provision, often going beyond with disease awareness campaigns and even disease- mongering. On the other hand, several experiences have shown that pharmaceutical companies fail to disclose important information regarding their products and changes in the legislation are indeed needed to oblige marketing authorization holders to disclose all information on clinical trials and pharmacovigilance. Moreover it is essential to require medicines agencies to disseminate the periodic safety assessment reports and the data used when evaluating medicines for market authorisation and monitoring their use.

The proposed changes to the pharmacovigilance legislation are welcomed as they are necessary to ensure patient safety. We would ask the Commission to go further by conferring the risk assessment advisory committee the authority to withdraw medicines from the market without delay - thus ensuring immediate user protection - and by allowing the enforcement of strong dissuasive sanctions in cases of non-compliance. In addition, we believe that the pharmacovigilance activities within medicines agencies should be fully financed by public money.

Regarding the section on counterfeit medicines, we strongly support the Commission commitment to foster the safety and the transparency of the medicines’ supply chain. We ask you to ensure that any new measure is proportionate, based on evidence and on a sound impact assessment. The proposal should also include specific measures to tackle the illegal sales of medicines on the internet which is the major source of counterfeit medicines.

The signatories of this letter ask you to continue to lead in defending patients and consumer in the pharmaceutical package and to ensure that public health considerations supersede industrial interests.

Yours sincerely,

AGE - European Older People’s Platform

AIM - Association Internationale de la Mutualité

BEUC – European Consumer’s Organisation

EATG - European AIDS Treatment Group

EPHA - European Public Health Alliance

HAI Europe – Health Action International

ISDB - International Society of Drug Bulletins

MiEF – Medicines in Europe Forum

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