International convention to combat ‘pharmaceutical crime’?

A Council of Europe conference proposes the establishment of an international convention to combat counterfeit medicines.

The Council of Europe (CoE) conference ‘Europe against Counterfeit Medicines’ brought together, on 23-24 October 2006, representatives of the major players involved in the manufacture and sale of pharmaceuticals, health professions, consumer and patient associations and CoE experts to discuss legal means to fight this phenomenon. 

The conference conclusions propose drafting an appropriate international legal document (convention) on co-operation between the 46 Council of Europe member states to combat pharmaceutical crime – counterfeit medicines and other medicinal products included.

The conference participants agreed that the future convention should define pharmaceutical offences as ‘serious crime’ and penalise the manufacture and distribution of counterfeit drugs. At national level, provisions to control the quality of components for pharmaceutical uses, packaging material and manufacturing processes should be adopted in accordance with the standards laid down by the European Pharmacopoeia

The participants also urged the governments to inform the general public of the risks and consequences of taking counterfeit medicines.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) argues that "customers must be educated on how to recognise counterfeit medicines, including how to take advantage of authentication mechanisms at the different dispensing points (traditional pharmacies and other retailers)". It also thinks that it is "necessary to target more resources within national governments and to highlight and prioritise the problem in relevant investigational and enforcement authorities. It is essential to establish special task forces with public authorities to ensure early enforcement and continue to educate enforcement authorities so that they are better equipped to deal with the problem." 

The American Chamber of Commerce to the European Union (AmCham EU) "ultimately thinks that the consumer should be made aware of the potential health and safety risks of counterfeited goods, through well-designed media campaigns in which key active players such as the EU and industry should be involved". AmCham EU "strongly supports the Commission's efforts to step up the fight against counterfeiting and piracy in Europe".

GIRP - The European Association of Pharmaceutical Full-line Wholesalers states that "the highest risks of counterfeits entering the market are certainly the internet and mail-order sales of medicines. Medicines ordered through the internet and delivered by mail are impossible to control. Consumers and patients alike need to be fully informed of the dangers inherent in obtaining medicines from unqualified, uncertified Web-Sites or mail order stores without the actual involvement of a pharmacist." 

"Pfizer is very concerned about the surge in counterfeit medicines, putting at risk the lives and well being of patients in Europe and elsewhere," said Pfizer Senior Director of European Trade, Julian Mount. "However, illegal internet trade is just one part of the story. Counterfeits have also made it into the legitimate medicines supply chain in Europe." Pfizer’s particular concern in Europe is the entry of counterfeit medicines into the legitimate supply chain via the activities of medicines traders. "It is particularly difficult for patients to know if a medicine is counterfeit when it is supplied through trusted sources", said Mount.

Commissioner Günter Verheugen, responsible for enterprise and industry, said that he is "alarmed at the ever-increasing number of counterfeit medicines sold via the internet. This represents a real danger to the health of patients."

The Heads of EU Medicines Agencies (HMA) stress in their Strategy Paper that "although enforcement of medicines legislation is the competency of member states, co-ordination between various national and international bodies involved in fighting counterfeits is necessary". 

According to the Council of Europe, an increasing amount of counterfeit medicines enter the European market and account for up to 20% of all medicines in certain regions. Counterfeit drugs contain no, or few, active ingredients or component totally different from those in the original product. These can have serious health-damaging and even fatal effects on patients. 

Currently, no EU anti-counterfeit measures exist specifically for medicines, but the European Medicines Agency (EMEA) supports anti-counterfeiting activities in co-operation with the Commission and national medicines agencies. The European Parliament recently adopted a non-binding resolution calling on the creation of an international convention to fight the illegal practice. Shortly before, the Commission warned EU citizens about fake drugs on the internet.

The Council of Europe (CoE) was established in 1949 and now has 46 member states. Results of this inter-governmental co-operation take many forms, depending on the topics being dealt with, but include conventions and international agreements binding on states which ratify them are two of those. Perhaps the best known CoE Convention is the European Convention on Human Rights, adopted in 1950 - for others, see the Council of Europe website.

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