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.
