Drug manufacturers propose alert system to mitigate medicine shortages

A group representing European drug manufacturers has developed a communications framework that it claims could help prevent shortages of medicines, or at least lessen their impact.

The organisations involved, which include the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Generic Medicines Association (EGA), are proposing a communications system between drug manufacturers and the European authorities that collate data on quality and manufacturing issues. They believe that harmonising reporting requirements across the European Union would help to mitigate or even prevent shortages of medicines.

Manufacturers would use the system when they think they will be unable to deliver supplies as normal or face disruption. They would provide information about the cause of likely shortages, such as a delay in obtaining an ingredient, or a theft or counterfeiting incident.

The organisations have designed a common template in which notifications would be colour-coded according to their potential impact on patients — red for high impact, yellow for medium, and green for low.

The manufacturers’ aims have been set out in a joint statement [PDF] by the Association of the European Self-Medication Industry (AESGP), which represents European manufacturers of non-prescription medicines; the EFPIA, which represents the research-based pharmaceutical industry; the Plasma Protein Therapeutics Association (PPTA), which represents manufacturers of plasma-derived therapies; and the EGMA, which represents the generic and biosimilar pharmaceutical industries.

But John Chave, secretary general of the Pharmaceutical Group of the European Union, which represents community pharmacists, says the initiative fails to engage with some stakeholders, such as pharmacists.

“A more comprehensive information system should be put in place,” he says. “Also, it only touches on manufacturing problems, whereas there are a whole range of issues linked to medicines supply.”

The development follows a workshop by the European Medicines Agency (EMA) in October 2013 to address problems with the medicine supply chain.