The proposals on falsified medicines and pharmacovigilance, part of a three-part co-decision package proposed by the European Commission in December 2008, were approved by the Environment, Public Health and Food Safety Committee on Tuesday. The third part, on patient information on prescription medicines, will probably be debated by the committee in June.
Safer medicines on line
Environment Committee MEPs deemed it necessary to regulate the sale of pharmaceuticals via the internet. In EU Member States where internet pharmacies are allowed to operate, they would have to obtain a special authorisation. 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 Member State level and listed in a European database. Citizens would also have to be informed about the risks involved in buying medicinal products on the internet.
Mandatory safety features
To counter growing numbers of medicinal products that are "falsified in relation to their identity, history or source" (in December 2008, the European Commission announced that in a two month operation, customs officials had seized more than 34 million illegal pills across the EU), and hence pose a major threat to Europe's patients and pharmaceutical industry, Environment Committee 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 assessment by the European Commission. MEPs also want the Commission 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 by Marisa Matias (GUE/NGL, PT) on falsified medicines approved with 51 votes in favour, 0 against and 3 abstentions.
Stepping up pharmacovigilance
The Commission proposals aim to improve pharmacovigilance systems in companies and ensure better reporting of adverse reactions. A report by Linda McAvan (S&D, UK), says that patients, as well as health-care 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, it adds.
In the chair: Jo LEINEN (S&D, DE)