The European Commission (EC) has submitted a report detailing the application of penalties for those involved in the production and circulation of falsified medicines to the European Parliament on the request of the Falsified Medicines Directive (2011/62/EU).
Article 118a of the Directive calls on EU Member States to adopt “effective, proportionate and dissuasive” penalties regarding the “ manufacturing, distribution, brokering, import and export of falsified medicinal products”, as well as active substances and excipients.
A call for strict enforcement
While the Commission said measures taken by Member States are “satisfactory”, it has called for their strict enforcement.
“…penalties are only effective if they are well-enforced,” said commissioner for health and food safety Vytenis Andriukaitis, adding: “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,” he said.
Medicines for Europe’s concern
Medicines for Europe similarly highlighted the need for Member State cooperation.
The pharmaceutical association “considers the falsification of medicines not as a petty crime, but as a severe criminal activity which can lead to death of patients as a consequence,” market access director Maarten van Baelen told us.
We are “grateful for actions taken by Interpol, Europol, police, customs, health regulatory authorieis and others who are involved in actions to fight the sales of illicit medicines,” he added.
However, van Baelen expressed concern regarding the diverging levels of fees in the different countries.
“Maximum fines range from 4,300 in Lithuania to €1m in Spain, which might lead to organised crime focussing on countries with the lowest fees,” he told us.
Effective?
A lack of data regarding illegal activity in Member States makes it challenging to determine the effectiveness of national penalties, said the EC.
However, experts in ten Member States “considered that all of the penalties in place (criminal, civil and administrative) had at least some effect in reducing the presence of falsified medicines in the legal supply chain,” said the Commission.
“To further reinforce measures in place and strengthen their overall effectiveness, certain Member States could consider introducing additional criminal penalties or administrative sanctions in relation to falsified medicines, active substances or excipients,” it added.
Falsification of medicines
According to the report, all Member States deem at least some activities relating to the falsification of medicinal products a criminal offence. However just 21 EU countries enforce criminal penalties for the manufacture, distribution, brokering, import, export and sale at a distance of falsified medicines.
Bulgaria, for example, imposes criminal penalties for the import or export of falsified medicinal products, but civil penalties (such as fines) for remaining activities.
Conversely, criminal penalties for the manufacture distribution and brokering of such products are enforced in Latvia, but civil penalties for import and export.
Maximum fines for these activities range from €4,300 ($5,350) in Lithuania, to €1m in Spain.
Divergence was also apparent in maximum prison sentences between Member States, which range from one year in Greece, Finland and Sweden, to 15 years in Austria, Slovenia and Slovakia.
Active ingredients and excipients
While all 28 Member States impose imprisonment for the falsification of medicines, just 23 do so for active substances, and 14 for excipients.
According to the report, Bulgaria enforces criminal penalties for the misconduct in the import and export of active substances (and civil penalties for the remaining activities), whereas Latvia applies criminal penalties for the manufacturing and distribution of active substances, and civil for import and export.
No specific penalties for the export of active substances were reported in Finland, Poland and the UK.
With regards to excipients, variations include Ireland’s criminal penalisation of misconduct in relation to the manufacturing of excipients only, and Finland’s decision to not apply criminal penalties to misconduct in relation to the export of excipients.