MEPs want to target online sales of counterfeit medicines
European Parliament committee supports new measures against the illegal online sale of medicines
An overwhelming majority on the Environment, Public Health and Food Safety Committee approved a report by Portuguese MEP Marisa Matias outlining new measures against the illegal sale of medicines online.
MEPs said Internet sales should be included in draft EU legislation to prevent counterfeit medicines from entering the supply chain, and mandatory safety features should be introduced for prescription medicines. The committee also approved measures to improve pharmacovigilance in the EU.
The proposals on ‘falsified’ medicines and pharmacovigilance are part of a three-part package proposed by the European Commission (EC) in December 2008. The committee is expected to debate the third part, on patient information on prescription medicines, in June.
MEPs said the sale of pharmaceuticals via the Internet should be regulated and Internet pharmacies should obtain special authorisation to operate in EU countries. Their sites would bear an EU logo to help the public to ascertain that they are linked to an authorised pharmacy. All authorised Internet pharmacies would be linked to a central website at country level and listed in a European database. Citizens would also have to be informed about the risks involved in buying medicinal products via the Internet.
To counter growing numbers of medicinal products that are ‘falsified in relation to their identity, history or source’ (in December 2008, the EC reported that in a two-month operation, customs officials had seized more than 34 million illegal pills across the EU), MEPs advocate the introduction of mandatory safety features, such as seals or serial numbers, for certain medicines.
In principle, these features would be required for prescription medicines, but this obligation could be waived (e.g. for generic medicines) subject to an EC assessment. MEPs also want the EC to assess, after four years, whether this requirement should be extended to non-prescription medicines.
MEPs also inserted amendments on sanctions, inspections, patient data protection and the definition of ‘falsified medicinal products’.
The report was approved with 51 votes in favour, 0 against and 3 abstentions.
The EC proposals also aim to improve pharmacovigilance systems in companies and ensure better reporting of adverse reactions. A report by Linda McAvan (S&D, UK), said that patients, as well as healthcare professionals, should be encouraged to report these reactions. In the case of intensively monitored products, the package leaflet should state the product is ‘subject to additional safety monitoring’ and that suspected adverse reactions should be reported.