8/2/2019 MoU Endorsement Press Release EFPIA 2 May 2012 Final

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Press Release

EFPIA Board Moves to Next Phase in Setting Up a Cost-Effective SystemFor Medicines Verification with Stakeholders

Brussels, 2nd May 2012: EFPIA, the voice of the research-based pharmaceutical

industry in Europe, is pleased to announce that on 27 April 2012 its Board formally

adopted a Memorandum of Understanding (MoU) on medicines verification

developed jointly with key supply chain partners representing pharmacists (PGEU),

wholesalers (GIRP), and parallel distributors (EAEPC) at EU level.

EFPIA Director General, Richard Bergstrm, says: The EFPIA Board endorsement

illustrates the strong commitment of the industry in setting up a harmonised system

across the EU based on international standards that provides a high level of security

for patients while being cost-effective and integrating into existing structures in thedistribution chain.

The joint MoU outlines the provisions of the stakeholder vision for establishing a

modern technology solution for point of dispensing verification of pharmaceutical

products in Europe. The aim of this European Stakeholder Model (ESM) is to set up a

cost-effective and scalable system to meet the requirements of the EU Falsified

Medicines Directive (FMD) and ensure patient safety.

The system has the potential to generate additional benefits in the future. These

benefits include the possibility for automated checking of expiry dates, better

pharmacovigilance, a reduction in the number of fraudulent reimbursement claims,

higher effectiveness in preventing recalled products from reaching the patient, more

efficient handling of product returns, and improved stock management processes forpharmacies. The ESM also envisions working closely with governments in order to

ensure that all these benefits come alive.

In their joint response to the European Commissions public consultation on the

Delegated Act on safety features, the stakeholders specified the technical

components of their proposed ESM while highlighting the inherent cost-effectiveness

of the system. Thorough cost estimates indicate overall system cost (annually and EU

wide) at 120m to 205m, with an estimated per pack price between Cent 1.3 - 2.2,

for a system covering all prescription products, generics included. The ESM

stakeholders are confident that the system could be delivered against these

estimates. Indeed, the costs have been established through the use of actual real life

examples rather than theoretical estimates, says Richard Bergstrm.

EFPIA is convinced that the way forward to ensure patient safety in the EU is to make

sure that the legitimate supply chain is as safe as possible. All prescription-only

medicines must therefore bear safety features. It seems outdated to sustain that only

high-priced products should be protected. Indeed, the cost of manufacturing

falsified medicines is close to zero, therefore any medicinal product, no matter its

price, is likely to generate a profit for the counterfeiter, underlines Richard Bergstrm.

Last month, EFPIA and its partners launched the tendering process for key

components of their European medicines verification system.

The EFPIA response and the joint submission to the public consultation on the

Delegated Act can be downloaded by clicking on the above hyperlinks(underlined).

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http://www.efpia.eu/content/default.asp?PageID=559&DocID=12920http://www.efpia.eu/content/default.asp?PageID=559&DocID=12920http://www.efpia.eu/content/default.asp?PageID=559&DocID=12921http://www.efpia.eu/content/default.asp?PageID=559&DocID=12921http://www.efpia.eu/content/default.asp?PageID=559&DocID=12921http://www.efpia.eu/content/default.asp?PageID=559&DocID=12920

8/2/2019 MoU Endorsement Press Release EFPIA 2 May 2012 Final

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Contacts Useful Links

Richard Bergstrm

Tel. (+32) 2 626 25 55

E-mail:newsroom@efpia.org

www.efpia.eu

The EFPIA response to the Delegated Act

Joint Stakeholder response to the Delegated Act

Press release on the tender launch

~About EFPIA~

EFPIA represents the pharmaceutical industry operating in Europe. Through its direct

membership of 31 national associations and 35 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.

EFPIA members are committed to delivering innovative medicines to address unmet

needs of patients and reducing the burden of chronic diseases for Europes ageingpopulation. 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 in 2010. 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 46,800 million in 2010, and has contributed significantly

to reducing the European Unions trade deficit in high-tech products. 27,000 million

were spent on research and development in Europe in 2010. Almost a quarter of the

EUs high-tech exports are pharmaceutical products.

mailto:newsroom@efpia.orgmailto:newsroom@efpia.orgmailto:newsroom@efpia.orghttp://www.efpia.eu/http://www.efpia.eu/content/default.asp?PageID=559&DocID=12920http://www.efpia.eu/content/default.asp?PageID=559&DocID=12921http://www.efpia.eu/content/default.asp?PageID=559&DocID=12845http://www.efpia.eu/content/default.asp?PageID=559&DocID=12845http://www.efpia.eu/content/default.asp?PageID=559&DocID=12845http://www.efpia.eu/content/default.asp?PageID=559&DocID=12921http://www.efpia.eu/content/default.asp?PageID=559&DocID=12920http://www.efpia.eu/mailto:newsroom@efpia.org