10.2 Medicines shortages

Return to January 2016 Board Agenda here.

A) European Medicines Agency initiatives

The European Medicines Agency hosted a one day workshop with industry and other stakeholders on the issue of medicines shortages on 9 October 2015. The EMA’s report of that meeting is here. 

The meeting was primarily a conversation between industry and the regulatory community, with only two healthcare professional organisations (EAHP, PGEU) represented, and two patient organisations (Eurordis for rare disease patients, and the International Diabetes Federation).

On a positive note, it seems EMA now see a greater role for themselves in the area of medicines shortages, particularly in facilitating work between regulators and industry on the issue. The lack of a European definition for shortages is strongly noted and likely to be a piece of work picked up by the network created.

On the negative side, healthcare professionals and patients are bit-part players in the exchanges and there is no guarantee that outcomes from these initiatives will be along lines we agree with (e.g. definitions). The pace of progress is also slow, with EMA not expecting to pick up issues in a similar workshop again until two years time.

Recommendations and actions from workshop still awaited.

B) Supply Chain Actors initiative

See most recent version of developed paper of this group here, in which EFPIA and EGA are pushing for the use of a restrictive definition in terms of shortages that need to reported and published, seeking to confine it to “Risk Category A”.

EAHP stated its strong opposition to this proposal. Reply here. PGEU and GIRP apparently sympathise but have not yet expressed that in the written exchanges.

As matters currently stand, PGEU are supposed to be consolidating recent remarks on the paper to a latest version. On the definition issue, PGEU favour parking the topic for the time being while EMA initiatives on definition develop.

C) Other

Following approval, the COST Action on shortages is now progressing with the Management Committee under formation and due to meet on 14 April in Brussels. More information here. 

In respect of EAHP’s relationship to the Action, the COST Office has informed us in clear terms that their rules do not permit European Associations to lead the action and that will only correspond with Prof Jenzer on all issues of coordination and management.

As constructed at application stage, the COST Action is also due to make determinations on shortages definition in its early stages.