Twenty-one EU countries have made falsifying medicines a criminal offence, carrying a potential jail sentence of 15 years, according to a new report published on Friday (26 January) by the European Commission.
Maximum prison sentences for the falsification of medicines range from one year in Sweden, Finland and Greece to 15 years in Austria, Slovenia and Slovakia. Meanwhile, maximum fines range from €4,300 in Lithuania to €1 million in Spain and ‘unlimited’ in the UK.
The 2011 Directive on Falsified Medicines requires anti-tampering devices and identifiers to be put on drug packages, rules on the import of ingredients for medicines, and a common, EU-wide logo to identify legal online pharmacies.
“While the report published today finds measures taken by member states to be satisfactory, penalties are only effective if they are well-enforced. Falsified medicines can kill,” said EU Health Commissioner Vytenis Andriukaitis.
“Therefore, I urge all EU countries to make sure that criminals falsifying medicines are punished. I seize the opportunity to remind that thanks to the common EU logo which helps identify legal online pharmacies that sell authentic and safe products, citizens can be helped to steer clear of falsified medicines..”
The 2011 directive requires all EU countries to put in place penalties for those involved in the production and circulation of falsified medicines. The practice costs the industry almost $40 billion each year.
Fake Valium (diazepam) has been implicated in several recent deaths in Scotland, while stolen vials of breast cancer drug Herceptin (trastuzumab) were reintroduced to the supply chain in Italy.
As part of the directive, governments and stakeholders are working on a pan-EU authentication system for medicines that will come into force in February 2019. This will require every prescription medicine pack to feature a 2D barcode containing unique identification data before they are dispensed to patients.
However, Marc-Alexander Mahl, president of Medicines for Europe, which represents generics manufacturers, has argued that the directive is likely to drive up costs faced by the pharmaceutical industry.