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EU urges pharma to act on drug counterfeiting and piracy
  14 May 2008
As the European Commission begins to develop its strategy against counterfeiting and piracy, the pharmaceutical industry has called for a "zero tolerance" policy against fake drugs, which are increasingly being found in the European Union (EU) supply chain.
However, a leading Commission official says he believes that industries should take the lead in protecting their products and services against piracy and counterfeiting. "I am convinced that more legislation is not the solution here," said EU Internal Market Commissioner Charlie McCreevy.
"It is industry that has the inherent knowledge to identify the fake products and to uncover the production and distribution network used to make and sell the counterfeits," said Commissioner McCreevy, speaking at a High-Level Conference on Counterfeiting and Piracy organised by the Commission in Brussels this week. The problem of counterfeiting could well have changed before any new EU regulations reached the statute books, he added.
The conference, which was held as the Commission's public consultation on its proposals for regulatory reform to tackle theses issues came to an end, is not intended to be a one-off event but, rather, "the starting point of a process towards a long-term strategy mobilizing both industry and public authorities to jointly combat counterfeiting and piracy," say Commission officials.
In its response to the consultation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) calls for a total ban on medicine repackaging, stressing that "the number one focus" should be to ensure that the integrity of the original package is "absolutely guaranteed" throughout the entire supply chain, from the time it leaves the original manufacturer to the point that it reaches the end-user. "This is a prerequisite for an effective anti-counterfeiting strategy," says the industry group.
The Commission emphasises that counterfeiting and piracy harm consumers and also pose particularly high risks for industries such as pharmaceuticals, in which R&D costs are high compared to the production costs of the final product. Faced with diminishing turnover in the face of counterfeiting and piracy, industry innovation slows down, which limits development, growth and competitiveness, and forces companies to simply close down or limit production, said officials.
Within the EU, the Enforcement Directive (2004/48/EC) is the cornerstone piece of legislation in the fight against counterfeiting. However it only covers civil measures, and the Commission has adopted a proposal for a Directive and for a Framework Decision on intellectual property (IP) infringements. The proposal, which is currently pending in the Council, would require EU member states to treat all IP infringements on a commercial scale as a criminal offence, the conference heard.
The Commission also proposing steps to improve the collection and quality of data, share best practices and increase public-private cooperation to improvement enforcement, delegates were told. In addition, inter-industry deals to crack down on the most evident forms of counterfeiting and piracy, including those on the Internet, could prove to be a very effective and efficient way to diminish the extent of the problems, officials suggested.
By Lynne Taylor
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