Council of Europe new international convention to combat counterfeit medicines - including those sold on the Internet

Sharm el Sheikh (Egypt) 16.11.2009 – The Council of Europe is preparing a new international convention against counterfeiting of medical products aimed at protecting public health, that will criminalise the marketing of counterfeit medical products via the Internet.

The convention, which is expected to be open for signature in 2010 after its formal adoption, would to be open for signature for states throughout the world.

The global nature of the Internet makes it an excellent way to promote health literacy. However, it also implies risks the new convention will address, such as the marketing of medicines and healthcare products that can be dangerous.

The offering and marketing of medical products online and the possible legal responses to combat counterfeit and illegal medicines, such as the Council of Europe draft convention, were discussed today at the workshop Medicines on the net – risks and benefits organised by the Council of Europe at the Internet Governance Forum in Sharm el Sheikh (Egypt).

Its key objective was to raise awareness on risks and benefits associated to buying medicines via the Internet. It also aimed to facilitate a multi-stakeholder discussion about the needs of consumers and patients as regards medicines on the web, and on whether and how the safety of medicines marketed on the web can be guaranteed.

Hugo K. Bonar, Enforcement Manager of the Irish Medicines Board and a Council of Europe expert, summed up the conclusions. "We must empower the consumer with accurate and good quality information that may be valid in different legal frameworks. Medical products are different from other commodities offered via the Internet because without the adequate prescription or due to a bad quality, you may die", he said.

He also said that prescription medicines need to be sold and shipped with a prescription after a face to face contact with the prescriber and that any regulations related to this issue need to be international, because the products may offered by a website, bought, shipped or advertised in different countries".

The draft convention

The focus of the draft Convention is on the threat to public health posed by counterfeit medical products and medical products which are manufactured or distributed without proper authorisation and/or in breach of safety standards.

The draft convention obliges States Parties to criminalise:

-   The manufacturing of counterfeit medical products

-   Supplying, offering to supply of, and trafficking in counterfeit medicinal products

-   Falsification of documents

-   Similar crimes involving threats to public health

The draft convention also provides for a framework for international co-operation, measures for co-ordination at national level, preventive measures and protection of victims and witnesses.

Like is the case for a number of other Council of Europe conventions, and considering the global dimension of pharmaceutical crimes, this convention could be open for participation by non-Member States, giving it a potentially universal vocation.

The preparation of the draft convention is supported jointly by the Directorate General of Human Rights and Legal Affairs and the European Directorate for the Quality of Medicines (EDQM), Directorate General of Social Cohesion.

Contact: Jaime Rodríguez;; mob. +33 (0) 6 89 99 50 42