Parliament takes aim at illegal online pharmacies

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A key European Parliament committee has backed new measures against the illegal sale of medicines over the Internet.

A report by leftist Portuguese MEP Marisa Matias was approved by an overwhelming majority on the environment and public health committee, although some members said it did not go far enough.

MEPs insisted on legislating for Internet sales of medicines, citing this as a conspicuous failing in the original directive proposed by the European Commission in 2008. The committee also decided to beef up rules governing the pharmaceutical supply chain.

Matias said her report had refocused the original proposal towards public health and protecting consumers from dangerous products. She hailed the new clauses on Internet medicines as a major breakthrough.

"Without our amendments, the Internet would have operated as the 'Trojan horse' for fake medicines. We can not leave the largest gateway for counterfeit drugs in Europe out of this legislation," she said.

Matias drew a distinction between legal and illegal online pharmacies, calling for consumers to be steered towards approved e-pharmacies which would carry a new EU logo.

Authentic Internet pharmacies will also be listed in a user-friendly database and public awareness campaigns will help explain the risks of buying from unaccredited pharmacies, according to the rapporteur.

Generics could be exempt

New safety features on medicine packs such as seals or serial numbers could cause problems for the generic medicines industry and may be "waived", subject to an assessment by the European Commission.

MEPs also want the Commission to assess after four years whether these requirements should be extended to non-prescription medicines.

The Matias report, unlike the Commission proposal, addresses the control and distribution of falsified medicines to third countries.

"It is difficult to explain why we have stringent provisions for medicines that enter the European market but no provisions for medicines which are exported to third countries in Africa, South America or Asia," Matias said.

The 15 compromise amendments made the directive "stricter and stronger," she said, adding that the almost unanimous support at committee level will strengthen the Parliament's hand in negotiating with national governments.

French MEP Françoise Grossetête (European People's Party) said she was "half satisfied" with the compromises reached by the ENVI committee, although she voted in favour of the report.

She suggested the drive to reach a compromise that might be accepted on first reading meant some of the tougher measures she had proposed were watered down.

"It's a pity we're not as demanding of medicines as we are on food. We allow medicine boxes to be repackaged but you cannot do that with spaghetti under the new food legislation. I don't know why we're tolerating this," she said.

Grossetête said there is not enough clarity on generic medicines, adding that all medicines should be dealt with in the same way, including off-patent and non-prescription drugs.

However, she said the measures on Internet medicines are "serious progress".

German MEP Dagmar Roth-Behrendt (S&D) said she was not convinced a first-reading agreement would be possible but said the report was a "good result" even if it does not go far enough on some points.

She said the main challenge would be to encourage EU member states to embrace the changes set out in the directive.

The report contains important clauses on falsification across the pharmaceutical supply chain, and will have major implications for parallel trade, Roth-Behrendt said, adding that the most important feature of the amended directive is its emphasis on internet sales.

UK MEP Marina Yannakoudakis (European Conservatives and Reformist Group) said counterfeiting is a criminal offence and consumers should be protected against falsified medicines.

"This is just the first step. Things that look as though they are missing today might not seem so important in future," she said.

Yannakoudakis said criminals would look for ways around the proposed measures and the Parliament would have to stay on top of the issue. She added that it was important for the Parliament to present a united front on this subject.

Greek MEP Michail Tremopoulos (Greens) said his group was focused on strengthening and expanding the safety features on prescription and non-prescription medicines. He said it was important to regulate legal online pharmacies and to block illegal sales.

He warned that restrictions on parallel trade would hurt governments struggling to keep the costs of medicines under control.

The European Union is cracking down on the sale of fake online medicines as part of a regulatory overhaul of the pharmaceutical sector. 

Last year, the European Commission published its 'pharma package', which included a proposal for a new directive on counterfeit medicines (EURACTIV 11/12/08). 

MEPs indicated from the outset that the failure to legislate against fake medicines sold over the Internet was a major weakness in the draft new law (EURACTIV 01/10/09). 

The European Medicines Agency warned that criminal gangs were cashing in on the swine flu pandemic by pedalling fake vaccines and antiviral medicines (EURACTIV 27/10/09).

  • July 2010: European Parliament plenary to vote on Falsified Medicines Directive.

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