A new law to prevent fake drugs from entering the supply chain has been approved by the European Parliament, covering internet sales and introducing new safety and traceability measures, as well as sanctions against counterfeiters.
The directive, which has been in the works for over two years and now needs to be ratified by the Council of Ministers, is designed to tackle the estimated 1% of medicinal products currently sold to the European public through the legal supply chain that are fake. Marisa Matias, a Portuguese MEP and the parliamentary rapporteur, said that "falsified medicines are silent killers" and "the absence of a legal framework encourages counterfeiting, an organised crime". She noted that "we have been witnessing a huge growth of this criminal activity, with an increase of 400% in seizures of fake drugs since 2005".
The initiative was adopted with 569 votes in favour, 12 against and 7 abstentions. Specifically, in terms of internet sales (which were not covered in the original proposal) pharmacy sites will be required to display a common logo. All authorised internet pharmacies will be linked to a central website in each member state which will in turn be connected to an EU site. Citizens will also have to been informed about the risks involved in buying medicines via the net.
The legislation also updates current rules and provides for new safety features to be placed on individual packs in order to identify them, "guarantee their authenticity, and enable pharmacists to check whether the outer packaging has been tampered with". However, these features still need to be developed by the European Commission but could for example include a serialisation number "which can be 'read' by the pharmacy to ascertain that the pack is authentic", the parliament stated.
Member states must also put in place a system to prevent dangerous products from reaching the patient. This system must permit recalls, and if a drug is suspected to present a serious risk to public health, "all actors in the supply chain and in all other member states must be rapidly alerted".
The initiative also notes that "pharmaceutical distribution networks are becoming increasingly complex" and MEPs stipulated that in future, brokers will have to register and may be removed from the register if they fail to comply with the new rules. They also want not only imports but exports to third countries to be better regulated and the rules must apply to the supply of medicines to authorised persons in third countries as well.
Finally the new directive states that "sanctions imposed on those who infringe it must not be inferior to those applicable to infringements of national laws of similar nature and importance". Once it is signed into law, EU countries have 24 months to make any necessary changes to their national legislation.
The European Federation of Pharmaceutical Industry Associations has hailed the vote as "an important move in achieving greater protection for patients from counterfeit medicines". Its director-general, Brian Ager, said that implementation will "require the involvement of all key stakeholders - manufacturers, pharmacists and wholesalers but also patients – to ensure success".
EFPIA applauded the introduction of a pan-European system to provide unique serial numbers on each genuine medicine pack but warns that "to ensure maximum effectiveness it is vital that all medicines are verified systematically at pharmacy level". As for the provisions covering internet sales, the planned measures "will protect patients purchasing online in those countries where it is legal to do so", but the association adds that it "remains convinced that a more comprehensive approach to illegal online sales of medicines is needed".