Mise à jour : 20 mai 2010 (Rédaction initiale : 6 mai 2010 )

Analyses Sectorielles

II-9.3: On April 27, 2010, the European Parliament proposed an amendment to the European Commission’s Pharmacovigilance and Prescription Medicine Package to regulate the sale of prescription medicine on the Internet

par Alex Raiffe

Main information

On April 27, 2010, the European Parliament’s Committee for Health voted to introduce an amendment to the European Commission’s ‘Pharmacovigilance and Prescription Medicine Package’, which would introduce a strict regime for online prescription medicine sellers.

Thèmes

http://www.europarl.europa.eu/news/expert/infopress_page/066-73508-116-04-18-911-20100426IPR73469-26-04-2010-2010-false/default_en.htm

Context and Summary

 

On December 10, 2008, the European Commission proposed a ‘package’ of legislation to the European Parliament, presenting a number of reforms to European legislation relating to pharmacovigilance and prescription medicine.
The European Parliament proposed an amendment to this legislation on April 27, 2010, which would introduce a strict regulatory regime for online sale of prescription drugs.
 
This amendment would require websites selling prescription drugs to: (i) obtain an authorisation from a member state; (ii) register in a central European database; (iii) be linked to an actual, physical pharmacy.
 
Websites meeting these requirements would be required to display an European Union logo to certify compliance. Clicking on the logo would redirect to a website containing a list of authorised pharmacies, in order to allow consumers to verify that the website they are dealing with is authorised.
 
This regulatory framework would apply only in Member States that authorise prescription medicine sales on the Internet. It would in no way oblige Member States that forbid online prescription sales to authorise such activity within their borders.
 
The European Parliament’s amendment will have to be approved by the European Council in order to become definitively part of the legislation.

 

Brief commentary

The European Parliament’s amendment is certainly a positive step in improving patient safety, especially faced with the increasing number of sites that import repackaged medicine from China or other countries, which can lead to error in repackaging (the medicine ordered comes in the proper box, but has a different medicine inside), or quality problems (the medicine does not correspond to European quality and safety standards).

From a regulatory perspective, it is important and interesting to note that the European Parliament’s amendment does not force Member States to allow online sale of prescription drugs, and they are free to forbid this activity. Therefore, the European Parliament is not usurping Member States’ authority in taking decisions on risk exposure for their populations, but rather, is harmonising and promoting a common framework for risk regulation in countries that have chosen to allow such behaviour.

This approach is one that the European Commission should strive to follow: in numerous cases, the Commission has taken decisions that usurp Member State’s democratic legitimacy in deciding the amount of risk to expose their populations to (cf. thematic reports cited {supra}). Indeed, such decisions have often been stricken down by the European Court of Justice, which is elaborating a doctrine that citizens of each country may alone decide, through a democratically elected government, how much risk they wish to be exposed to.

For this reason, we can only applaud the approach taken by the European Parliament, and hope that the European Commission will be inspired for future decisions in such matters.

Related articles

http://www.regulatorylawreview.com/spip.php?article=227

votre commentaire