European Parliament adopts falsified medicines directive

The European Parliament has given its backing to the proposed Directive on Falsified Medicines, setting the clock ticking on a deadline of around two years for EU member states to implement the new legislation.

The Directive brings a raft of new initiatives into play to help safeguard the medicines supply chain and protect patients, including: the introduction of safety features like serial numbers and tamper evident seals; more stringent rules on importing active pharmaceutical ingredients (APIs); tighter scrutiny of supply chain middlemen such as brokers and traders; greater sanctions against counterfeiters; and the development of a consistent, harmonised approach to GMP inspections.

The headline news of course is the decision to regulate the sale of medicines over the Internet, something which was left out of the European Commission's draft proposal back in December 2008. MEPs deemed it necessary to regulate Internet sales because this is a key route by which fake medicines enter the EU market, and studies have shown that over half of drugs purchased in this way are counterfeit.

Not all EU member states permit Internet sales, but in those that do the legislation will bring in an official authorisation system and certification scheme - including an official logo -  to help the public identify legitimate sites.

The challenge now is for the European Commission, along with EU regulators, industry and other stakeholders, to take the somewhat vague wording of the Directive and translate it into implementable, scalable and inter-operable systems.

Interpretation of the wording may leave some elements open to debate and further refinement by working groups, for example defining the scope of the legislation. This is likely to concern only prescription medicines in the first instance, but the Directive does not exclude the possibility of a risk-assessment approach which could mean medicines deemed to be at low risk of counterfeiting are exempted. The details of the safety feature requirements, as well as the level of traceability that might be required, also need to be fleshed out.

The next step will be for the Council of Ministers to formally approve the final text which will officially kick off an 18-month grace period before member states need to implement the legislation.

Despite the long road ahead, the vote in favour has been warmly welcomed by industry associations and healthcare bodies.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), called the vote "an important move in achieving greater protection for patients from counterfeit medicines," and particularly welcomed the introduction of serialisation. EFPIA ran its own successful pilot on adding unique serial numbers to packs during 2010.

Unique serial numbers allow pharmacists to check whether a pack has previously been dispensed, alerting them to any risk of counterfeiting, and this type of system is already in use in some EU countries such as Belgium.

"However, to ensure maximum effectiveness it is vital that all medicines are verified systematically at pharmacy level," cautioned EFPIA.

Pharmacist groups also welcomed the new Directive, but also had qualms about some elements within it.

The Pharmaceutical Group of the European Union (PGEU) said in a statement that "many of the details of electronic verification are left to be determined by the European Commission, including the type of unique identifier to be attached to medicines packs, the organisation of databases which will support the verification system, and even which medicines are to be covered by the verification process."

The PGEU wants the verification system to be applied as broadly as possible within the prescription medicine category, on the presumption that "all prescription medicines are at risk of falsification." It also has reservations about the use of a logo to certify genuine online pharmacies, pointing to evidence that similar schemes have been compromised in the past and could lull the public into a false sense of security.

The PGEU logo has itself twice been falsified, for the purpose of apparent 'approval' of an illegal internet pharmacy operating from Russia, it points out.

Nevertheless, John Chave, the PGEU's Secretary General, said the Directive would have "considerable impact" on the safety of the EU medicines supply chain. The European Parliament estimates that 1 per cent of medicinal products currently sold to the European public through the legal supply chain are falsified and that the proportion is on the increase.

Meanwhile, the European Generic Medicines Association (EGA) also welcomed the news, although it has long had misgivings about the possible need for generic medicines to be included in the scope of the Directive, arguing that the addition of safety features could make some products uneconomic to produce.

Commenting on the vote, EGA Director General Greg Perry said that any system to validate the authenticity and identification of individual packs "must take into consideration the particularities of certain categories of medicines, such as generics."

The Commission should ensure that the 'white list' approach for all prescription medicines, as well as the risk assessment criteria used to determine the need for safety features, "do not put an unnecessary burden on low risk products, such as generic medicines."

The resolution was comprehensively passed with 569 votes in favour, 12 against and seven abstentions.


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