Medicines shortages – September 2019

 

The April 2019 Board meeting covered

• the revision of EAHP’s Statement on Medicines Shortages – which was adopted in June 2019 by the GA
• the shortage awareness campaign with +30 patient, consumer, healthcare professional organisations and other patient advocates – a letter was sent to DG SANTE (Director + Commissioner)
• a Brexit press release – HOPE does not want to collaborate at the moment

Shortages awareness campaign – letter to COM

• Letter (see HERE) shared in May
• Meeting with DG Anne Bucher and Commissioner Andriukaitis followed
• Commissioner Andriukaitis also shared his response in a letter (see HERE)
• COM is reluctant to get engaged due to new Commissioner in November

Shortages awareness campaign – letter to ENVI committee

• ENVI committee targeted due to lack of engagement of COM
• Letter shared in early September (see HERE) with chair/vice-chairs and coordinators of ENVI committee
• Follow-up sent on 24th September

Shortages discussion with COM – meeting on 23rd September

• COM invited patients (BEUC, ESMO, EPHA, France Assos Santé, HOPE), pharmacists (PGEU, EAHP), wholesalers (GIRP), parallel traders (EAEPC) and manufacturers (AESGP, EAEPC, EFPIA, MfE) to discuss shortages
• Attendees were asked to present practical solutions to address shortages of medicines
• AS and SK are attending the meeting and will report back during the Board meeting

Shortages event with EAEPC/GRIP/EPHA

• Draft invitation letter for Ministers is being developed
• Event will take place in early 2020 in the European Parliament
• Details will be discussed with shortages Board leads
• PGEU was asked to become involved; it’s members do not want PGEU to join

European shortages website | FEEDBACK NEEDED

• Lexano launched a European shortages website (see HERE)
• Does anyone have any information on this project?

Collaboration with member associations on shortages | FEEDBACK NEEDED

• NM asked for nomination of one shortage expert per member association at the GA; no nominations received
• Call for the expression of interest has been prepared (see HERE)
• Can the call be sent out?

Collection of further evidence | FEEDBACK NEEDED

• During the meeting with Commissioner Andriukaitis, COM request to get more information on the shortage situation from civil society
• Do you think EAHP could provide further data? If yes, what type and how would you want to collect additional data?

Speaker engagement at GIRP’s annual meeting | DECISION NEEDED

Further collaboration on shortages with Amgen

• EAHP was awaiting feedback from Amgen on the possibility of the funding of a survey activity focusing on communication of shortages, the reporting by national competent authorities and other stakeholders as well as the influence that shortages have on patient outcomes
• Amgen is not able to provide EAHP with funding

Supply chain actors’ cooperation | DECISION NEEDED

• PGEU communicated prior to the meeting to EAHP, GIRP and EAEPC that the root cause document is not supported by its members
• A new version (see HERE) of the root cause document was shared ahead of the meeting on 18th September – Please note that there is a small possibility that an updated version of the document, containing changes discussed on 18th September, is shared ahead of the Board meeting. In case such as document is made available it will be uploaded HERE
• The Board has to decide if EAHP would generally be in favour of co-signing the root cause document.
• The Board should keep in mind that parts will still be revised (comments on the revised parts can be provided) and that in addition to PGEU also GIRP and EAEPC might not endorse the paper

HMA/EMA task force

• Guidance documents have been published
• Good practice guidance for communication to the public on medicines’ availability issues (see HERE)
• Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders in the Union (see HERE)

COST Action – Medicine Shortages

• SK attended the COST meeting in September
• No significant progress has been made
• The action is currently discussing the prolongation of the research activity with the help of another grant/other funding