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European Federation of PharmaceuticalIndustries and Associations

Leopold Plaza BuildingRue du Trne 108 Bote 1

B-1050 Bruxelles

T +32 2 626 25 55F +32 2 626 25 66

www.efpia.eu

Press statement

EFPIA statement on today's publication of the Commission'srevised proposals on information to patients

Brussels, 11 October 2011: EFPIA, the voice of the research-based pharmaceutical industry in

Europe, welcomes today's release of the long-awaited Commission's modified proposal on

information to patients. Following European Parliament's first reading in November 2010, this

represents an important next step in the legislative procedure.

With its vote in November, Parliament took a constructive and overall pragmatic approach to

improve European patients' access to information on prescription medicines. We note that the

Commission follows this approach. It is also good to see that Commission seems to have found a

solution for the constitutional concerns raised by some Member States, such as relying on ex-post

controls and self-regulation.

We urge Member States to adopt a similarly pragmatic approach to address the existing inequality

of access to quality information. Modern society already has access to a great deal of information

via the internet; future discussions should examine ways to ensure that high-quality information is

accessible to all in their own language, to benefit Europe's patients and public health.

EFPIA maintains that to achieve real progress for patients, it is vital that any new legislation provides

a viable legal framework. It should not require added and unnecessary bureaucracy; instead it

should build on existing best practice within the EU.

EFPIA also continues to support the application of quality criteria that will distinguish information from

advertising and ensure patients can receive helpful, non-promotional information on medicines.

Robust control systems are important; these can be complemented by a Europe-wide code of

practice. This would outline quality assessment procedures, including pre-approval of all

communications by registered physicians or pharmacists, ex-post monitoring systems (involving third

parties) as well as effective enforcement procedures.

EFPIA and its member companies have made it clear that they do not wish to see any "push" of

information on specific prescription medicines via TV, radio or print mass-media. However, those

citizens seeking information on their disease or therapy should be able to access it in both user-

friendly formats and in their own language.

EFPIA will now analyse the Commission's modified proposal in greater detail, including new elements

to strengthen the EU pharmacovigilance system, and is looking forward to provide further input

where appropriate.

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Contact

Richard Bergstrm, Tel: (+32) 2 626 25 55

E-mail:newsroom@efpia.org

Useful links

www.efpia.eu

About EFPIA

EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national

associations and 38 leading pharmaceutical companies, EFPIA provides the voice of 2,000 companies

committed to researching, developing and bringing new medicines to improve health and quality of life

around the world.

mailto:newsroom@efpia.orgmailto:newsroom@efpia.orgmailto:newsroom@efpia.orghttp://www.efpia.eu/Content/Default.asp?PageID=499http://www.efpia.eu/Content/Default.asp?PageID=499http://www.efpia.eu/Content/Default.asp?PageID=499mailto:newsroom@efpia.org

8/3/2019 Press Statement Info to Patients

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Fdration Europenne dAssociations et

dIndustries PharmaceutiquesLeopold Plaza Building

Rue du Trne 108 Bote 1B-1050 Bruxelles

T +32 2 626 25 55F +32 2 626 25 66

www.efpia.eu

EFPIA member are committed to delivering innovative medicines to address unmet needs of patients and

reducing the burden of chronic diseases for Europes 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 640,000 people in Europe including 115,000 working in

research and development. The industry also generates around three to four times more employment both

upstream and downstream.

Europes research-based pharmaceutical industry generates a substantial trade surplus, estimated at about

58,800 million in 2009, and has contributed significantly to reducing the European Unions trade deficit in high-

tech products. More than a quarter of the EUs high-tech exports are pharmaceutical products.