4 February 2021

1) CTF

Activity update

• An update was shared with the Steering Committee. GML is checking with SEFH about the replacement of the Spanish Steering Group member.

2) Policy updates

COVID-19 vaccines

• Vaccination campaign: Request from AS during Board meeting (testimonials for social media) – GML is collecting feedback from ambassadors.
• Shortage of syringes (question from AS) – information gathered by SK: COM is aware; they are talking regularly with Member States in the Health Security Council meetings; there are still some supplies that could be accessed via the joint procurement mechanism; not all Member States are making use of this offer

SIG Hazardous Medicinal Products

• AS and SK will speak on Thursday afternoon with JP. More individuals need to be targeted since the applications we received are not very diverse.

Exchange with France on Council Presidency

• Question on terminology was shared with EDQM. Awaiting response.

Request of Ireland (sharing COVID 19 vaccine vials across a dose)

• How do you want to proceed with the Irish request? (see email HERE)

EDQM – Online Meeting for Stakeholders, CMED and PC Committees

• EDQM has invited us to join their online Stakeholder meeting. SK shared the information with NM since he attended the last CMED/PC stakeholder meetings. NM is wondering what an EAHP presentation could focus on (see email HERE)

Invitation to nominate an expert for Patient Access Partnership’s initiative: Model Access Solutions

• PACT is looking for experts for forming a team of knowledgeable experts to assess a selection of evidence-based, workable solutions for better access to healthcare (see email HERE | see supporting document 1 HERE | see supporting document 2 HERE)

ESOP – continuation of discussions started in July 2020

• Should we attempt to continue the discussions with ESOP that we started in July (see report HERE)?

MoU – PGEU

• SK plans to follow up this week with PGEU.

Procurement event with authorities

• @ AB and AS – do you have any comments on the suggestions for the virtual event with procurement authorities? (see email HERE | see draft agenda HERE | see list of authorities HERE)

NEW Exchange with EMVO (08/02)

• SK will put together a short briefing document on Friday for the call with EMVO on Monday. We will be speaking about alert handling, aggregation and EMVO’s Strategic discussion. Andreas Walter (General Manager) and Tobias Beer (COO) will join the call. From EAHP’s side PH, AB and the FMD leads will join. @ AB & PH – as non-FMD leads, do you have any specific points that you would like me to cover in the briefing document.

NEW Europe’s Beating Cancer Plan

• MA would like to have a small quote for twitter since today is World Cancer Day.

3) Consultations – state of play

Due date	Type of consultation	Action
11/02/2021	COM – Evaluation of patient rights in cross-border healthcare	eHealth will be reviewed separately. SK advises against engaging.
24/02/201	COM – Roadmap and IIA: European Health Emergency Preparedness and Response Authority (HERA)	SK is reviewing the document.
26/02/2021	EMA- Survey to EMA eligible healthcare professional organisations/ learned societies	SK has put together draft responses for TS & DM.
07/03/2021	EMA – ICH reflection paper on proposed ICH guideline work to advance patient focused drug Development	DM & TS will comment.
31/03/2021	EDQM – Issue 3 of Pharmeuropa PaedForm	PP and SA are reviewing the consultation document.
16/04/2021	COM Public Consultation – Blood, tissues and cells for medical treatments & therapies – revised EU rules	PH, AB & AS should we engage?
16/04/2021	COM Targeted Consultation – Blood, tissues and cells for medical treatments & therapies – revised EU rules (see email)	PH, AB & AS should we engage?
22/04/2021	COM Public Consultation – Demographic change in Europe – green paper on ageing	AS, NM and PP have been alerted. SK is preparing a draft response.
28/04/2021	EMA – Guideline on good pharmacovigilance practices (GVP): Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)	Relevance being discussed with TS and DM
28/04/2021	EMA – Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum II – Methods for effectiveness evaluation	Relevance being discussed with TS and DM

Next policy call – Thursday 18th of January at 2 PM CET?

 

@ AS – if needed we can speak at the end of the policy call about your engagement in EFCCA’s webinar on Friday.