European Parliament votes on counterfeits

The European Parliament is meeting today (February 16) to vote on legislation which aims to limit the entry of counterfeit medicines into legal distribution channels across the EU.

Once passed, the new Directive will introduce a number of specific measures. Among these, the penalties for counterfeiting will be made equivalent to those typically applied for illegal acts related to narcotics, information campaigns will be initiated, aimed at educating the general public on the dangers of falsified medicinal products and internet pharmacies, in Member States where they are permitted, will require a special authorisation to operate. These internet pharmacy sites will be required to display an EU logo, helping the public to identify authorised websites.

In addition, safety features will become mandatory for all prescription medicines, unless exemption is permitted under specific risk assessment criteria.

Such safety features will allow for tamper evidence and verification of the authenticity of prescription medical products.

It will become mandatory for 'each medicinal product to be unequivocally identified by means of a serial number on its individual packaging'. Rather like a passport for each pack, a unique number in the form of a barcode will be placed on the outer packaging. This number will be authenticated before dispensing, as well as within the distribution chain, with the aim of substantially reducing the economic gains that can be achieved by counterfeiters.

Companies will have just 12 months to implement the aspects of the Directive relating to internet pharmacy, liabilities and penalties.

Regarding the safety features, a second phase of the legislation will have to be agreed whereby the European Commission will decide which harmonised safety feature will be adopted for Europe. Following this decision, the industry will have 24 months to implement it across manufacturing lines.

Find out what the implications of this legislation could mean for your company in the news analysis pages of the upcoming March issue of PME.

Update:
The Directive has been approved by a majority of 569 votes.

MEP Marisa Matias, who led discussions in the European Parliament on this subject, commented: "Falsified medicines are silent killers, either because they are devoid of effect or because they contain toxic substances that may harm, or even kill, those who take them. The absence of a legal framework encourages counterfeiting, an organised crime. We have been witnessing a huge growth of this criminal activity, with an increase of 400 per cent in seizures of fake drugs since 2005. Protecting patient safety is the core aim of this Directive."

Her report was adopted with 569 votes in favour, 12 against and 7 abstentions.