8/14/2019 Open Letter to Health Council

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European Federation of PharmaceuticalIndustries and Associations

Leopold Plaza BuildingRue du Trne 108 Bote 1B-1050 Bruxelles

T +32 2 626 25 55F +32 2 626 25 66www.efpia.eu

Comment on EU Health Council meeting, 30 November 1st December 2009

EFPIA welcomes progress on patient safety proposals but regrets

blockage on information for patientsBrussels, 1 December 2009

Sir,

EFPIA, the voice of the research-based pharmaceutical industry in Europe welcomes todays

adoption by EU Health Ministers of progress reports on some of the major legislative proposals

contained in the pharmaceutical package.

Whilst welcoming those reports on proposals to prevent counterfeit medicinal products in the legal

supply chain and improving pharmacovigilance, EFPIA calls on the Health Council to show urgency

on all the Commission proposals, to ensure rapid adoption of legislation which will benefit EU citizensand patients.

EFPIA is pleased to see that some progress has been made, and certain measures are a positive

step forward and have the potential to improve patient safety. Properly implemented, they could

deliver major public health benefits. However to be truly effective, they need to be strengthened in

a number of crucial areas. In particular, the anti counterfeiting proposals should ensure pack

integrity from manufacturer to patient; the simplest way to achieve this would be a ban on

repackaging.

We are disappointed by the Health Councils decision to freeze the debate on the Commissions

proposal to give citizens and patients improved and equal access to information on their health and

medicines. This is not in the best interest of citizens; the Commission proposal is relatively narrow in

scope, leaving most of the oversight to Member States. Given the strictly defined content and

delivery channels of information and the proposed stringent approval, monitoring and enforcement

mechanisms, the unwillingness to discuss this constructively is disappointing.

EFPIA urges the European Parliament to provide a platform for a proper debate on these proposals.

They offer the potential to make patients better informed about their disease and treatment,

improving compliance and outcomes to the benefit of both public health and healthcare

resources.

In addition to the pharmaceutical package measures, EFPIA welcomes the Council's adoption

wide-ranging proposals to address the growing threat of antibiotic resistance. This inability to treat

resistant strains of infection undermines many aspects of hospital care, threatening the future of

many routine procedures. These proposals provide a first step towards building a sustainable

research and development platform to address current and future medical needs for effective

antibiotics.

Yours faithfully

Brian AGER

Director General

European Federation of Pharmaceutical Industries and Associations