19 December 2018

1) CTF

Steering Committee
The Steering Committee met in December. Ian suggested to hold a ‘small meeting’ before Christmas to discuss some of the open issues (i.e. planning for the meeting with authorities). SK to report back on this meeting in case it takes place on 18 December as currently envisioned.

WG 1
The first mapping documents (i.e. comparison between existing programme and CTF) are being shared. GML is wondering if we should involve a Belgian representative in the activities of WG1. Please advise. The issue was brought up by Belgium (i.e. Olivia asked who is doing the mapping for Belgium). When checking the participants of WG1, we also realised that we do not have a representative from Slovakia. In case we add a Belgian representative, we also need to consider adding a Slovakian one.

WG 2
WG2 will have a call on 18 December. SK will report back from the call.

WG3
GML is following up with WG members on the action items. In January we will seek input on the documents for the CTF meeting @ Congress.

CTF meeting @ Congress
We received final positive responses from 10 countries (BE, DE, FR, EL, IE, MT, NL, SK, ES and RO). GML is still waiting on a final confirmation from CZ, EL, IT and PT. WG 3 members for the 10 confirmed countries have been contacted.

Commission
Sophie acknowledged the receipt of the email. She is busy and will either get back to me before Christmas or in January.

2) Policy updates

Medical devices/HTA
Daniel Widmer drafted a letter to the BMJ editor regarding the piece on the regulation of medical devices (see HERE). He is seeking comments from the associations in the HTA Stakeholder pillar before presenting it to patient organisations. Do we want to engage?

AMR
The ECDC survey will be shared in January with members, after distribution by ECDC.

FMD
The Commission was informed of the implementation status at the meeting on 13 December. A follow-up will be organised in late January. In addition, HOPE has set up a meeting for the ‘hospital sector’ in early January with the Commission.

Shortages – supply chain actors
The meeting with supply chain actors took place on 17 December. SK will report back during the policy call.

Compounding
Given that we declined the involvement in EAASM’s compounding survey, can I disregard the survey engagement request (see HERE)?

Grants/funding opportunities
During our call with OSF, we learned that the funding always requires a human rights component. The OSF representative highlighted during the call that the compounding initiative that they founded in the Netherlands could be interesting. In essence, OSF provided funding for a campaign in the Netherlands mainly led by patient seeking to have their rare disease medication compounded by HPs.
No detailed guidance on the application procedure and the type of funding exists since this is being decided on a case by case basis. Both full or partial funding is possible.

3) Consultations – state of play

17/02/19	Public consultation a draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders	Clinical trial board leads
14/03/19	eSource Direct Data Capture (DDC) qualification opinion	Clinical trial board leads + FV
31/03/19	Draft concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury	Short statement expressing agreement.
15/05/19	Guideline on the quality of water for pharmaceutical use	We won’t comment.
31/05/19	Draft guidelines on excipients in the label and package leaflet of medicinal products for human use (see HERE)	eHealth/mHealth Board leads
30/06/19	Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease	Short statement expressing agreement.
30/06/19	EMA discussion paper: Use of patient disease registries for regulatory purposes – methodological and operational considerations	RM and JP
30/06/19	EMA – Paediatric addendum on the guidelines on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease
30/06/19	EMA public consultation on a draft guideline on the non-clinical requirements for radiopharmaceuticals
30/06/19	EMA – Regulatory Science to 2025
31/07/19	Public consultation a draft guideline onquality, non-clinical and clinical aspects of medicinal products containing genetically modified cells	Clinical trial board leads
31/07/19	Public consultation – Draft questions and answers on Data Monitoring Committees issues	Clinical trial board leads
31/08/19	Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)	Clinical trial board leads
30/09/19	EMA public consultation on a draft reflection paper on the qualification of non-genotoxic impurities
31/10/19	CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products	We won’t comment.

4) Board meeting/ Congress

BM: Industry advisory group meeting
For the policy part I would like to focus on the following items: CTF, FMD/barcoding, shortages, AMR and emerging issues. Are you ok with the scope of the policy part or do you want to add additional topics?

Congress: Presidents guests
The finalised schedule is ready (see HERE). Anne Cecile will send the confirmations before Christmas.

The South African association cannot attend as international guests, but they have highlighted that they would like to ‘to have more engagements and future partnering
with EAHP’.

5) Miscellaneous

EAASM – FMD event speaker invitation
EAASM share a speaker invitation with PH. It concerns a meeting on FMD on 19 February. PH do you want to attend or shall I reach out to FMD Board leads?

Research inquiry: SC1-DTH-09-2019: Scaling up the univocal Identification of Medicinal Products
David Schwartz wants to know if someone is looking at leading or is involved in the call on scaling up the univocal Identification of Medicinal Products. He sees a protentional for this call to also address shortages (see HERE).

ESNO meeting invitations
As shared by email with PH, ENSO invited me as speaker to an ESNO-HOPE event (see HERE) as well as to the ESNO Congress (see HERE). Both events are paid events as far as I can see.

EPSA Annual Congress April 2019
Shall we contact Piera as suggested by Nenad?

 

Next policy call? Mid-January (week of 7th or 14th of January)?