CoE convention covers online fake medicines
18-Nov-2009
The Council of Europe is drawing up a new international convention to try to end the manufacture and sales of counterfeit medicines and similar crimes involving threats to public health.
In September the CoE's Committee on Crime Problems (CDPC) completed negotiations on the first draft of a convention text that will tackle the problem of counterfeit distribution through both pharmacies and the Internet.
The hope is that EU member states will sign the convention in 2010, after its formal adoption, and it will also be open for signature by other countries around the world.
The objective of the convention is the criminalisation of offenses and the protection of victims, according to Francois-Xavier Lery of the European Directorate on the Quality of Medicines (EDQM).
Lery told a meeting in London last week, just ahead of the formal CoE announcement, that the scope of the convention encompasses the manufacturing, supply, offering to supply and trafficking of counterfeit medical products, as well as falsification of documents. It also covers unauthorised manufacture or supply of medicinal and medical device products.
The convention is intended to promote multi-sectoral and international collaboration on medicines counterfeiting, said Lery, bringing regulators, lawyers and other stakeholders together to tackle the issue.
It will provide for a framework for international co-operation, measures for coordination at national level, preventative measures and protection of victims and witnesses.
"We must empower the consumer with accurate and good quality information that may be valid in different legal frameworks," commented Hugo Bonar, Enforcement Manager of the Irish Medicines Board and a Council of Europe expert, in the wake of a CoE workshop in Egypt focusing on the risks associated with buying medicines on the net.
"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.
Bonar added that prescription medicines should be sold and shipped with a prescription after face-to-face contact with the prescriber, and "any regulations related to this issue need to be international, because products may be offered via a website and bought, shipped or advertised in different countries worldwide."
The inclusion of Internet sales as a source of counterfeit and other illegal medicines in the convention is notable, given that the European Commission's draft Counterfeit Medicines Directive - part of the pharmaceutical package outlined at the end of 2008 - does not address this supply channel.
A report on counterfeit medicines being drafted for the European Parliament by MEP Marisa Matias, due for completion later this month, is also expected to highlight the issue of Internet distribution.
Related articles:
Up to 30 per cent of EU generics 'contain falsified APIs'
Interim EU measures needed to stem counterfeits
Germany debates adding APIs to counterfeit legislation
Generics firms wary of EC anti-counterfeit proposals
