Sid Dajani, the RPS elected representative on the Pharmaceutical Group of the European Union, explains what happened at a recent meeting to discuss medicines shortages

An unprecedented meeting of European stakeholders to address the issue of medicines shortages agreed about the urgency and priority setting of this crucially important and controversial issue. The aim of this summit, attended by PGEU, all the major industry associations, parallel distributors and full-line wholesalers, was to explore a possible basis for a European-level stakeholder initiative on shortages.

Central to the discussion was the question of information. Specifically, whether a European shortages information system is viable. Such systems exist in the Netherlands (developed by the Royal Dutch Pharmacists’ Association, KNMP, and presented to the meeting), in Austria, and in a limited form in several other European countries.

PGEU has consistently argued that better information on shortages is necessary to enable pharmacists to fulfil their duty to keep patients properly informed when problems arise. There was widespread agreement that information systems should be stakeholder-led if possible, although there is some sensitivity on the industry side over ‘unfiltered’ information being made generally available.

Some claim that making information publicly available may lead to panic buying or other distortions (although there is no evidence of this from the Netherlands). Predictably, there was less common ground on issues such as quotas and export restrictions.

All industry associations oppose changes in the law to address shortages, although they recognise that implementation of law could be improved. A European Commission sponsored study into how existing implementation affects availability of medicines was published just before Christmas, after months of delay, but says little about Article 81 of the EU medicines code. This requires the industry to ensure a continuous supply to pharmacies, and is sometimes used to argue that quotas are illegal. The European Commission has so far declined to enforce Article 81.

Meanwhile, just after the summit, the European Generic Medicines Association (EGA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Association of the European Self-Medication Industry (AESGP) published their own proposals for a harmonised system of shortage notifications. Their proposal focuses only on manufacturing difficulties (although it acknowledges that this is only one source of problems). The idea is that standardised notification to competent authorities will allow them to develop a more comprehensive and manageable information system.

PGEU understands that the European Medicines Agency, to which the proposals are addressed, wanted to restrict the discussions to manufacturers only. EMA has long taken the view that the scope of its activity on shortages is restricted to manufacturing problems.

Although the proposals acknowledge the need to provide information to all supply chain actors, without wide stakeholder involvement and an extended scope, information systems will be partial and incomplete. Despite being united in the urgency of tackling medicines shortages, many difficult issues remain and we still have a long way to go.