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Commission slammed over Internet medicines

Published 18 February 2009
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The MEP responsible for steering the Counterfeit Medicines Directive through the European Parliament has lashed out at the EU executive for failing to include online sales in the scope of the proposal.

Adamos Adamou (GUE/NGL, Cyprus) described the Internet as a "Trojan horse" in the medicines supply chain that the Commission has left the Parliament to deal with. 

He said there were a number of flaws in the proposed directive, including the failure to provide a definition of counterfeit medicines and the omission of excipients such as the capsules used to package active ingredients. 

Adamou said he had drafted amendments which would extend the scope of the directive to include over-the-counter medicines and to harmonise safety features on medicine packaging. 

"Today, there is no guarantee of buying safe medicines. Counterfeit medicines are a form of terrorism against human health. It doesn't matter whether a pill contains sugar or poison. If the safety is compromised, so is our health," he said. 

Severe penalties for counterfeiting and measures designed to raise public awareness of illegal drug supplies are also expected to be added as the directive makes its way through the Parliament. 

Adamou, who is rapporteur on counterfeit medicines in the committee on environment, public health and food safety (ENVI), said he is ready to propose amendments and move the directive through the committee stage as soon as possible. However, he said it is unlikely to be passed in the current parliamentary term. 

Appearing before the ENVI committee, Commission Vice-President Günter Verheugen acknowledged Adamou's concerns on counterfeit drugs originating from online sales, but stressed that Internet pharmacies are already regulated. New legislation would not be needed if member states were simply to enforce existing laws, he said. 

"Many Internet pharmacies are governed by the same rules as high street pharmacies. If you think some are operating as a front, that's where monitoring has to come in. It's up to member states to effect monitoring controls," said Verhuegen. 

Positions: 

At a press conference prior to the commissioner's appearance before the ENVI committee, MEP Jorgo Chatzimarkakis (ALDE, DE) noted that 80% of counterfeits originate from Internet sales. He was also critical of the time taken by the European Commission to bring forward the proposal on counterfeit medicines. 

MEP Françoise Grossetête (EPP-ED, FR) was critical of the delay in producing the directive. "It saddens me that this took so long to come through due to delays caused by other elements of the pharmaceutical package," she said, adding that traceability of medicines is the key to protecting patients. 

Jean François Dehecq, chairman of the board of directors at sanofi-aventis said he had been trying to raise the issue of counterfeiting for ten years but authorities were concerned that highlighting the problem could spark fear among patients. He agreed that traceability is needed and warned that counterfeit drugs can now be found in retail pharmacies as well as online. 

Roxana Radulescu  of the European Patients Forum welcomed the Commission's proposal and urged parliamentarians to take a patient-centred approach when tabling amendments. "It is also essential to have communication strategies to raise awareness about buying counterfeit medicines. Patients must be provided with information in a measured way to avoid panic which could lead to people not taking their medication." 

Radulescu also called for the introduction of a quality label for websites to help consumers identify quality information. 

In a statement, pharmaceutical industry representatives EFPIA said the pharmaceutical package is an opportunity to improve patient safety. 

Brian Ager, EFPIA's director general, said the appearance of Commissioner Verhuegen before the ENVI committee could help fast-track the directive. "This is a pivotal meeting. "e have already experienced delays in getting these measures out, this is the opportunity to re-energise the process and give it the momentum it deserves." 

Next steps: 
  • Oct. 2009: ENVI committee vote.
  • Dec. 2009: Vote at the Parliament plenary session in Strasbourg. 
Background: 

The European Commission unveiled its long-awaited pharmaceutical package on 10 December 2008. It contained several elements, including three new directives and a communication on the future of Europe's medicines industry. 

The directives cover counterfeit medicines, pharmacovigilence and information for patients. The latter proved particularly controversial, as it opens the way for pharmaceutical companies to publish information on their products in consumer media. 

Several stakeholders were frustrated by the decision to bundle the three directives together. It delayed the entire package due to disagreements on information to patients and the issue of parallel trade. 

Successive delays raised questions as to whether the Commission's enterprise directorate should have responsibility for all matters related to medicines, and in particular patient safety issues. 

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