European Social Insurance Forums

On 1 February 08, MEDEV submitted its reponse to the Commission's public consultation on its strategy to better protect public health by strengthening and rationalizing EU pharmacovigilance. The consultation specifically refers to the proposals to change the current legal framework as laid down in Regulation (EC) 726/2004 and Directive 2001/83/EC (as amended by Directive 2004/27/CE).

MEDEV believes that a number of the Commission proposals, contrary to the aims of the strategy to better protect public health by strengthening pharmacovigilance,seriously weaken the current legislative framework regarding the placing on the market of safe and effective medicines, thus greatly increasing the risks to the general public In particular, MEDEV opposes the deletion of the conditions referred to in Article 22of Directive 2001/83/EC which would open the way for "conditional" marketing procedures for all new medicines such that medicines are released onto the market on the basis of minimal risk-benefit data. MEDEV demands that exceptional or conditional marketing authorization should reserved for exceptional casesas outlined in Annex 1 of the Directive.

MEDEV congratulates the Commission on its efforts to establish clear roles and responsibilities for the different players and to centralise activities related to the coordination, communication and monitoring of pharmacovigilance data. In particular MEDEV welcomes:

- the establishment of a Pharmacovigilance Committee within EMEA with responsibility for coordinating pharmacovigilance in the EU. Further, MEDEV recommends strengthening the mandate of the proposed Pharmacovigilance Committee by giving it the right of decision on pharmacovigilance issues within the EMEA rather than being limited to an advisory role as proposed by the Commission.

MEDEV recommends that patients are encouraged to report adverse effects directly to their national competent authority, and not to the marketing authorisation holder as proposed by the Commission (Article 59). Direct reporting by patients should be preferably with the support and advice of a health professional and could be facilitated by including a pre-printed form in the product package.

MEDEV calls to preserve the rule of public financing of pharmacovigilance activities by authorities in order to guarantee their independence as conferred by REG (EC) 726/2004 (Art 67.4).

Finally, MEDEV calls for complete transparency regarding information on pharmacovigilance and easy access tosafety information on medicines for all stakeholders(health professionals, patients, consumers, carers).

The Medicine Evaluation Committee (MEDEV) is a subcommittee of the European Social Health Insurance Forum, one of three European Social Insurance Forums established in the early 90's to promote transnational dialogue between social security organisations working in the various areas of social insurance. ESIP maintains a close alliance with the "Euroforums", hosting a number of its Committees including the MEDEV Committee, as part of its "Synergy" activities.