Falsified medicines law approved by European Parliament

Home/Policies & Legislation | Posted 01/04/2011 post-comment0 Post your comment

Following many months of negotiations, a new law to prevent fake medicines from entering the supply chain was finally approved by the European Parliament on 16 February 2011. Internet sales will also be covered by the law, which introduces new safety and traceability measures as well as sanctions against counterfeiters. The law, which has been in the pipeline for over two years, still needs to be formally approved by the Council of Ministers.


‘Falsified medicines are silent killers, either because they are devoid of effect or because they contain toxic substances that may harm, or even kill, those who take them,’ said Ms Marisa Matias, who led discussions in European Parliament.

The sale of fake medicines has become a huge concern for Europe, where seizures have increased by 400% since 2005. The directive aims to protect patient safety and was adopted by a huge majority of 569 votes, with only 12 votes against and seven abstentions.

It is estimated that 1% of medicinal products currently sold to the European public through the legal supply chain are falsified and the share is growing. In other parts of the world, up to 30% of the medicines on sale may be fake.

The law hopes to achieve greater protection for patients from counterfeit medicines. Adoption of the law will see serial numbers and tamper evident seals being required on drugs, as well as stricter sanctions on those who create the counterfeit products in the first place. A common logo will also be necessary for websites, which are seen as a major route for falsified medicines.

Both the European Generic medicines Association (EGA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed the decision.

Mr Greg Perry, EGA Director General, declared that ‘the EGA is keen to co-operate with the European Commission and responsible stakeholders to develop a cost-effective system to validate the authenticity and identification of individual packs, which must take into consideration the particularities of certain categories of medicines, such as generic medicines, both during and after the implementation phase.’

The Director General of the EFPIA, Mr Brian Ager, said ‘This vote clears the way for concrete measures to help protect patients in Europe from counterfeit medicines. As counterfeit medicines endanger the health and lives of patients, we now urge that these measures are implemented as rapidly as possible so that citizens benefit from these added safety provisions.’

What’s next?

The next step will be for the European Council to formally approve the final text before it can come into force. Once it is signed into law, Member States have 18 months to make any necessary changes to their national legislation.

Related article

EGA welcomes MEPs decisions on falsified medicines and pharmacovigilance reports

Source: EFPIA, EGA, European Parliament

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