Updated: Sept. 25, 2012 (Initial publication: May 6, 2010)
Sectorial Analysis
II.4-4: 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
http://www.thejournalofregulation.com/spip.php?article229
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.
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.
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.
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