Press Release

European Parliament vote on Falsified Medicines Directive paves

way for greater protection to patients from counterfeit medicines.

Brussels, 16 February 2011: EFPIA, the voice of the research-based pharmaceutical industry in
Europe, welcomes today‟s plenary vote by the European Parliament on the „Falsified Medicines
Directive‟. The vote follows months of intensive negotiations between the Parliament and Member
States. The next step will be for the Council to formally approve the final text before it can come into
force. This Directive allows for the introduction of several measures to secure pharmaceutical supply
chains in Europe, from the original manufacturer to the dispensing pharmacy. The vote of the
European Parliament is an important move in achieving greater protection for patients from
counterfeit medicines.

The Director General of EFPIA, Brian Ager, said: “This vote clears the way for concrete measures to
help protect patients in Europe from counterfeit medicines. As counterfeit medicines endanger the
health and lives of patients, we now urge that these measures are implemented as rapidly as
possible so that citizens benefit from these added safety provisions”. Mr Ager continued:
“Implementation of the Directive will require the involvement of all key stakeholders - manufacturers,
pharmacists and wholesalers but also patients – to ensure success. With their involvement in the
design, implementation and running of systems, we can deliver the highest possible level of patient
safety, the fastest roll-out in member states at the optimal possible cost.”

One key element of the directive is the introduction a pan-European system to provide unique serial
numbers (such as two-dimensional bar codes) on each genuine medicine pack. This will allow
pharmacists to check whether a pack with that serial number has previously been dispensed,
alerting them to any risk of counterfeiting. However, to ensure maximum effectiveness it is vital that
all medicines are verified systematically at pharmacy level.

The Directive also sets out provisions covering internet sales. The planned measures will protect
patients purchasing online in those countries where it is legal to do so, and will better inform patients
about the dangers of purchasing from illegal online sources. However, EFPIA remains convinced that
a more comprehensive approach to illegal online sales of medicines is needed, and looks forward
to further work in this area by the European Commission.

The risk of counterfeit medicines in Europe is substantial and increasing. In 2009, more than 11 million
counterfeit or illegal medicines stopped at EU borders.

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Contact Useful links

Colin Mackay, Tel: (+32) 2 626 25 71 www.efpia.eu

E-mail: colinmackay@efpia.org

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
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.

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