Press release

“Legislation to strengthen and rationalise EU pharmacovigilance

system is welcome”

Brussels, 22 September 2010: EFPIA, the voice of the research-based pharmaceutical industry in
Europe, welcomed today’s adoption by the European Parliament of the Commission’s proposal on
pharmacovigilance. The proposal is the first section of the ‘pharmaceutical package’ of legislation
to be adopted.

Commenting on the vote today, Brian Ager, Director General of EFPIA, said: “EFPIA has consistently
been supportive of these efforts to strengthen and rationalise EU’s pharmacovigilance system. Whilst
some of the provisions raise concerns, and will require carefully considered implementing measures
be adopted in order to deliver the stated objectives of the legislation, on balance it is a positive
move. EFPIA is fully committed to helping implement the new legislation.

Mr. Ager went on to point out that this was only one part of the pharmaceutical package, and
urged MEPs to act decisively on the other sections of legislation. “We hope that the EU’s decision
makers will demonstrate the same decisive action in adopting the proposals on Information to
patients and on measures to reduce counterfeiting.”

The revisions to the legislation will more clearly define the roles and responsibilities for the key
responsible parties. This will bring about a number of provisions aimed at improving transparency
and communication on medicine’s safety issues. To ensure availability of the necessary expertise
and resources for pharmacovigilance assessments at Community level, a Pharmacovigilance Risk
Assessment Committee will be created within the European Medicines Agency. The Community
pharmacovigilance database, “EudraVigilance” will also be further developed and strengthened,
becoming the single point of receipt for pharmacovigilance information. In addition, the direct the
reporting of suspected adverse reactions (ADRs) by patients to medicinal products will be facilitated

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Contact
Useful links
Colin Mackay, Tel: (+32) 2 626 25 57
E-mail: colinmackay@efpia.org
www.efpia.eu

About EFPIA
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national
associations and 40 leading pharmaceutical companies, EFPIA provides the voice of 2,200 companies
committed to researching, developing and bringing new medicines to improve health and quality of life
around the world.

EFPIA member are committed to delivering innovative medicines to address unmet needs of patients and
reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation
with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health
threats in Europe.

The pharmaceutical sector directly employs some 635,000 people in Europe including 117,000 working in
research and development. The industry also generates around three to four times more employment both
upstream and downstream.

Leopold Plaza Building T +32 2 626 25 55

European Federation of Pharmaceutical
Rue du Trône 108 Boîte 1 F +32 2 626 25 66
Industries and Associations
B-1050 Bruxelles www.efpia.eu
Europe’s research-based pharmaceutical industry generates a substantial trade surplus, estimated at about
€48,000 million in 2008, and has contributed significantly to reducing the European Union’s trade deficit in high-
tech products. Almost a quarter of the EU’s high-tech exports are pharmaceutical products.

Fédération Européenne d’Associations et Leopold Plaza Building T +32 2 626 25 55

d’Industries Pharmaceutiques Rue du Trône 108 Boîte 1 F +32 2 626 25 66
B-1050 Bruxelles www.efpia.eu