European Stakeholder Model partners move forward with implementation of the European Medicines Verification System
Brussels 16.04.13: The European Federation of Pharmaceutical Industries and Associations (EFPIA), with the support of its European Stakeholder Model partners, yesterday signed a contract with IT service provider Solidsoft to implement the European Medicines Verification System (EMVS), marking a new step in the fight against counterfeit medicines.
The European Stakeholder Model (ESM) partners –EFPIA, EAEPC (the European Association of Euro-Pharmaceutical Companies), GIRP (Groupement International de la Répartition Pharmaceutique), and PGEU (Pharmaceutical Group of the European Union) – respectively represent Europe’s research-based manufacturers,the pan-EU licensed parallel distribution companies, wholesalers and pharmacists. EFPIA, with the strong support of its ESM partners, has signed a five-year contract with Solidsoft, a UK IT service provider, to implement the EMVS.
Richard Bergström, Director General of EFPIA stated: “We are delighted to enter the next phase of our ESM partnership and look forward to the start of the implementation of the European Medicines Verification System. All partners in the ESM believe that patient safety must come first and that counterfeiting must be dealt with in an efficient way by the whole supply chain. Patients need to be able to trust in the medicines they take and we are allproactively engaged in ensuring patients have access to medicines of the highest quality. It is a timely solution to the urgent problem of counterfeiting in the EU: just this past March, Germany experienced one of its most significant counterfeiting scares to date, when it was discovered that a common heartburn counterfeit or sub-standard medication had made it onto the market.[1] ”
Dave Ricks, Senior VP and President Lilly Bio-Medicines and EFPIA Board member overseeing supply chain issues said: “Yesterday’s announcement marks an important milestone in the development of a pan-European system to effectively combat counterfeit medicines. Patient safety is paramount for the European Stakeholder Model partners. This is why we are proactively investing to build the first elements of a medicines verification system for Europe. Working in partnership with governments, we intend to deliver a system that is robust, secure and cost-effective.”
The way forward
The ESM was created in 2011 with the aim of establishing a system for verifying pharmaceutical products that would be in compliance with the EU Falsified Medicines Directive (FMD - 2011/62/EU). With the implementation of the EMVS, this goal can be attained.
The recommendation to award the contract to Solidsoft is the result of an extensive tender process by the ESM technical work stream, which initially saw bids from 20 service providers further to a request for information launched in April 2012. The negotiation process was carried out in November and December 2012 by a team appointed by the various stakeholders. The team was further supported by a procurement consultant and legal advisors. Results of the negotiations were endorsed by the EFPIA Board since EFPIA will be the sole contractor with Solidsoft at this stage. The contract with the technology provider will be novated to the European Medicines Verification Organization (EMVO) that should be set up by the various stakeholders in the coming months. The statutes of the EMVO are expected to be endorsed by the various stakeholders General Assemblies later this year. Besides the fact that Solidsoft proposed the most cost-effective solution, it has received strong support from the technical community which views its technologies at the forefront of what the IT community could provide. The partners are confident in this choice of service provider.
Garth Pickup, Solidsoft’s CEO, stated: “The EMVS is an important new solution that will give patients greater protection and peace of mind. Solidsoft is proud to be working with the ESM partners to combat the threat of counterfeit medicines across Europe for the ultimate benefit of so many people."
About the European Medicines Verification System EMVS
The EMVS was successfully tested in 2009-2010 during a pilot in Sweden. It offers a modern technology solution to ensure verification of product authenticity by professionals at the point of dispensing. The European Hub will be connected to a series of national data repositories, which serve as verification platforms, and can be used by pharmacies and other registered parties to check a product’s authenticity. The system will be harmonised and interoperable between the various countries and will allow for the reconciliation of products traded between EU member states (known as parallel traded products) as well as for multi-country pack management through the European Hub. Additionally, it will also offer those countries who do not want to set up their own national system the opportunity to join an existing product verification infrastructure (national Blueprint System Template).
Background: Solidsoft is a software development company specialising in bespoke application development, application integration, portals and collaboration, application lifecycle management and mobile solutions. Solidsoft has many years’ experience developing secure systems for enterprise, government and defence agencies. They focus on the development of innovative, unique solutions that cannot be bought off the shelf with an emphasis on the delivery of complex, internet based systems with sophisticated integration requirements.
About EFPIA:
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 39 leading pharmaceutical companies, EFPIA provides the voice of 1,900 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. The pharmaceutical industry invests 27.5 billion on research and development per year in Europe and directly employs 660,000 people including 116,000 in R&D units in Europe.
EFPIA members 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.
About EAEPC:
EAEPC regroups the European licensed parallel distribution industry. Through national associations and individual company membership, it encompasses over 70 firms from 22 countries in the EEA. All products handled by EAEPC members have national or EU regulatory approval and are exclusively sourced from and sold to EEA countries using authorised trade channels.
About GIRP:
GIRP is the European umbrella organization of pharmaceutical full-line wholesalers. Pharmaceutical full-line wholesalers ensure the safe, efficient and timely delivery of all medicines whenever and wherever they are needed. GIRP and its members play a vital role in the healthcare supply chain, by supplying about 170,000 retail pharmacies as well as hospitals and other healthcare professionals with more than 100,000 different medicinal products.
About PGEU:
The Pharmaceutical Group of the European Union (PGEU) is the European association representing more than 400,000 community pharmacists. PGEU’s members are the national associations and professional bodies of pharmacists in 32 European countries, including EU Member States, EEA members and EU applicant countries.
Media Contact:
Communications Team
EFPIA
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1050 Brussels
TEL: 0032.2.626.25.55
Email : communications@efpia.eu