Development of the directive has taken several years but yesterday the European Parliament quickly, and overwhelmingly, approved the document. Despite some misgivings, speakers in Parliament were very supportive of the directive and the safety benefits for European patients.
"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 Marisa Matias, a member of the European Parliament (MEP) who had a key role drafting the directive.
Now, with a legal framework, recognising the falsification of medicines as a crime, in place and preventative measures in the pipeline Matias, and other MEPs, believe a “huge step” has been taken.
Industry is also broadly supportive of the directive. Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), welcomed the directive and called on all key stakeholders to commit to making it a success.
Others, while welcoming the directive, raised concerns about the specifics. For instance, the European Generic medicines Association (EGA) called on the Commission to adopt a risk-based approach to avoid placing “unnecessary burden on low risk products, such as generic medicines”.
The Pharmaceutical Group of the European Union (PGEU) also has concerns about details the Commission is still to determine, in particular the electronic verification system. PGEU will work with the Commission to ensure the verification system is comprehensive and efficient.
MEP concerns in the pre-vote debate focused on whether the directive is bold enough or too much of a compromise. Internet sales, inspections of ingredient suppliers outside the European Union and traceability were three areas in which some MEPs wanted stronger measures.
For instance, Amalia Sartori, an MEP who authored an opinion on the directive, said the final document fails to cover some of the fundamentals, such as mandatory overseas inspections. Matias has also sought mandatory inspections but others felt it was unviable.
John Dalli, the European Commissioner for Health and Consumer Policy, said the quantities of ingredients coming from overseas make it impractical to inspect all sites. Instead Europe must cooperate with nations that have high quality standards and conduct risk-based inspections.
The directive “is a major step forward”, Chris Oldenhof, president of APIC (Active Pharmaceutical Ingredients Committee), told in-PharmaTechnologist. APIC called for mandatory inspections but believes the combination of a number of initiatives may be sufficient.
In recent years the focus on API issues has “dramatically increased”, said Oldenhof, and joint inspections, Medicrime, Rx-360 and draft drug safety legislation in the US could all contribute to quality.