More work needed to ease EU medicine shortages, concludes workshop

A report on industry-regulator discussions held last year on how to prevent, ease and better manage medicine shortages within the European Union (EU) has concluded that common agreement on defining such problems would be valuable.

The proposal comes from discussions held during a European Medicine Agency (EMA) workshop in October 2015. Conclusions from the meeting have now been released and include a recommendation that a 'harmonised definition of a medicine shortage and a common understanding of the evolution of potential supply disruptions' would help the pharma industry identify and deal with such problems.

'It is important to identify at what point a manufacturing or quality issue becomes likely to lead to a meaningful disruption as well as when it should trigger a report,' said these conclusions.

That said, the workshop agreed that a harmonised reporting template would be too rigid, with regulators preferring that 'common trigger points' are approved for a system of alerts about medicine shortages that would be based on EU-wide harmonised data requirements.

'This would allow information to be gathered in a consistent manner and to facilitate the coordination between assessing competent authorities,' said the conclusions. Such alerts should be 'transparent, simple and consistent', so that responses can be effective and not cause unexpected problems elsewhere in the industry.

As a result, the workshop conclusions suggested that a single contact point for receiving and making medicine shortage alerts should be appointed in EU member states and in EMA, who would form a rapid alert network for circulating information.