A committee of the European Parliament voted yesterday to regulate online pharmacies to prevent falsified medicines from entering the legal supply chain. The committee agreed that the provision should be included in new draft EU legislation regarding falsified medicines and pharmacovigilance.
Most people in Europe’s pharma industry are aware of the European Commission’s Pharmaceutical Package, which was introduced in December 2008. For those of you not up to date, the package contains three legislative proposals regarding access to reliable information on medicines, pharmacovigilance and fake medicines. The overall aim of the package is to provide European citizens with safe, innovative and accessible medicines.
However, not everyone was completely satisfied with the new legislative proposals — particularly since the legislation concerning fake medicines did not address internet sales. According to research conducted by the European Alliance for Access to Safe Medicines, more than 60% of drugs purchased online are fake, substandard and illegal. In a statement issued at the end of last year, the European Public Health Alliance described the legislation as “insufficient to protect consumers and patients from this source of danger”.
Patient safety communications company Aegate also agreed that online pharmacies in Europe were a problem. “The use of online pharmacies is undoubtedly a serious risk to the integrity of prescription drugs and should be tackled at a European level,” said Gary Noon, CEO of the company. “We must ensure that the urgency of protecting the legitimate medicines supply channel is not undermined by the complexities of illegal online pharmacies.”
Also agreeing that this issue needed to be addressed, Portuguese GUE/NGL MEP Marisa Matias wrote a report detailing amendments to the proposed legislation for fake medicines — chief amongst the amends was that internet sales should fall within the scope of the legislation.
“On several counts, the original EC proposal was simply not up to the mark,” said Matias in a press statement. “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.”
To tackle the problem, the report explains the need to distinguish between legal and illegal online pharmacies. In EU member states where online pharmacies are allowed to operate, they would have to obtain special authorisation and would have an EU logo. All authorised internet pharmacies would be linked to a central website at member state level and listed in a European database.
Matias’s report was approved yesterday by the EC’s Environment Committee MEPs, with 51 votes in favour, 0 against and 3 abstentions. The Committee also agreed to advocate the introduction of mandatory safety features, such as seals or serial numbers. In principle, these would be required for prescription medicines, but could be waived for certain medicines subject to assessment by the EC. After 4 years, the EC may also assess whether this requirement should be extended to non-prescription medicines too.
It’s good news that the issue of online pharmacies is finally being tackled. However, speaking to Pharmaceutical Technology Europe, Noon did note that regulators would have to be careful not to bite off more than they could chew. “I urge EU lawmakers to ensure that protection of the legal supply chain is not hindered in anyway by broadening the scope of this directive,” said Noon. “A phased approach to this legislation may be in the best interests of patients and the healthcare industry – focusing on the legal supply chain, in particular high street pharmacies as a priority and then broadening the scope to include online.”