EU stakeholders form medicines traceability organisation

A consortium of groups representing Europe’s drugmakers, wholesalers, pharmacists and parallel traders has formed a joint organisation to manage its proposed medicines traceability scheme.

The European Medicines Verification Organisation (EMVO) officially came into being last week as a non-profit group that will oversee a medicines verification scheme designed to check the authenticity of drugs at the point of dispensing.

The European Stakeholder Model (ESM) scheme involves placing a unique serial number on each medicine pack at the point of manufacture and then scanning it in the pharmacy. The number will be checked against a database and – if valid – the medicine will be given to the patient. If not, it will be retained for investigation.

The system will be able to pick up counterfeit, expired or recalled medicines before they reach patients’ hands, according to the European Federation of Pharmaceutical Industries and Association (EFPIA), one of the industry partners behind the initiative.

EFPIA and its collaborators want the system to meet the traceability requirements of the Falsified Medicines Directive (FMD) (Directive 2011/62/EU), which are due to come into effect in 2018. The precise details of the FMD’s requirements will not be finalised until the publication of a delegated act, which is expected to take place later this year.

The organisation has collaborated with the European Generic and Biosimilar medicines Association (EGA), European Association of Euro-Pharmaceutical Companies (EAEPC), European Association of Pharmaceutical Full-line Wholesalers (GIRP) and Pharmaceutical Group of the European Union (PGEU) on the project.

EMVO will assume responsibility for the European hub, which links databases from national verification systems throughout Europe.

Germany will be the first EU member state to contribute fully to the improved Europe-wide verification system under the auspices of EMVO, through its securPharm system, a national scheme that has been piloted and benchmarked since 2013.

TTIP deliberations

Meanwhile, EFPIA director general Richard Bergstrom has downplayed concerns about the Transatlantic Trade and Investment Partnership (TTIP) – a deal to cut tariffs and regulatory barriers to trade between the US and EU countries that has led to protests by civil rights organisations.

Bergstrom told that the TTIP is “about removing duplication”, adding: “The biggest benefit will be that we can bring new medicines to patients faster by simplifying the regulatory procedures without lowering the standards.”

He also suggested that the reduction in red tape would be of particular benefit to smaller pharma companies from Europe and the US by making it easier to enter new markets and – as a result – access investment funding.

Others are not so convinced of the benefits, with opposition focusing on clauses that could allow companies to sue foreign governments for compensation if they believe they have suffered unfair treatment. In a UK context, for example, it has been suggested that TTIP would allow private firms running NHS services to sue the government if it chose to return the services to the public sector.

A Citizens Initiative petition against the TTIP collected almost 1.5 million signatures in 21 countries but was rejected by the European Commission last September.

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