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February 2017 Board agenda item 4.2 Falsified Medicines Directive

EAHP, EMVO and Ombudsman Complaint

 

The Board will be updated on the most recent meeting with the European Medicines Verification Organisation (EMVO) and deliberations with the European Commission as to EAHP rights to participate in EMVO. 

Following EAHP’s letter of complaint and subsequent meeting with the European Commission about the FMD Delegated Regulation (August and September 2016 respectively), the Commission actively took up EAHP’s problem with EMVO charging high fees for full (80,000 euro per year) and associate membership (20,000 euro per year). The Commission are resolute that Article 31 of the Delegated Regulation entitles EAHP to “rights to participate” “at no cost”.

A chain of emails followed between EAHP and EMVO, at the end of which a meeting was proposed. Against EAHP wishes, EMVO insisted on the meeting without the Commission present despite their offer to facilitate. The meeting took place on Wednesday 18th January.

 

The meeting can be described further at the Board Meeting by the attendees (Joan Peppard, Rob Moss, Andras Sule, Richard Price). In short summary however, EMVO have resolved to reconsider issues of participation rights at the next Board meeting and GA of EMVO at the end of February 2017. In the meantime, EMVO request a signal from EAHP that they concur with the “10 key principles” and MOU underpinning EMVO.

**UPDATE: EMVO has today emailed a new offer of affiliate membership – 500 euro pa** More information here.

The Board Meeting provides an opportunity to:

–       Review latest developments with EMVO and agree EAHP response

–       Consider the status and future of EAHP’s proposed complaint to the European Ombudsman

 

See also:

–       Report of EMVO’s December meeting for National Competent Authorities here.

–       SecuringIndustry Article on Hospital Pharmacy and FMD

 

 

Work with members on the FMD topic

 

EAHP conducted a series of teleconferences for Member Associations on the FMD at the beginning of January. Presentation slides here. Participant countries and individuals here.

The offer of EAHP support in this manner for national implementation thinking appeared to be appreciated by participants. Interesting headline points include:

–       Current work in Germany to assess the impact for the hospital sector

–       France has formed a hospital platform of many organisations to meet the NMVO subscription fee

 

Asked in what way EAHP could continue to support members, the suggestion of a face-to-face meeting at the EAHP Congress in Cannes was suggested, which will now be held on the evening of Wednesday 22nd March. More information here. Attendee list thus far here.

 

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