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Policy Call – 24 May

1) Declaration on good off-label use

Tajda compared the old and the new version. Even though the texts are different the message remains the same.

She highlighted that you mentioned at the BM that you don’t agree with the part of the text, referring to “delay in market entry; use of off-label alternatives for economic reasons”. You gave the examples of Lucentis / Avastin. In this regard Tajda would like to know if you have any other proposal?

Tajda thinks off-label should indeed stay as an option for the cases where there is no other way of treatment, like pediatrics. It should be carried out under supervision of physician, patients should give informed consent and outcomes and adverse events should be reported. There should however not be the rule of “economic reason”. If we say that off-label is only for individual patients after thorough examination by a physician, we cannot prepare pharmacy preparations for off-label in batches (like Avastin for ophthalmic use).
In Tajda’s pharmacy Avastin for ophthalmic use is still prepared, but only for the  indications (in ophthalmology) which are not covered by Lucentis (so Lucentis would be used off-label, too, but 10-times more expensive). 
Moreover, Tajda pointed out that we should consider the situation when the drug that is used off-label (at a regular – low price) is authorized for the same  indication but as an orphan drug (10times or more higher price).

Lastly, Tajda provide two comments on the text itself.

Overall, the problem that we do not fully agree with the paper remains, especially in regard to “economic reasons”. Thus, should we refrain from endorsing. 

2) EPC Workshop

The workshop itself focused mainly on the needs of Member States and their competent authorities (i.e. exchange on how it works in practice, what can be changed, how the online tool used by authorities can be improved). Only a few European/International associations (mountain guides, physical therapy, real estate) reported on the practical implementation of the card, while the Polish chamber of physicians and dentists was questions on alert mechanisms.

During one of the breaks I spoke with Caroline Teugels (Belgian Association of Podiatrists). She was very interested in the CTF since her organisation is considering to start work on a CTF. She was thinking of approaching health associations developing a CTF.

3) FMD/EMVO

EMVO
We are affiliate members. Currently, high number of emails. We need to discuss how to best organise our engagement (i.e. Rob and Andras cannot come constantly to Brussels for short meetings with EMVO).

Meeting with HOPE
Andras and I will be meeting HOPE on 29th May to discuss our cooperation on FMD matters.

FMD survey
Currently, 17 countries have submitted a reply. I am still waiting for information from Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Spain and the UK.
Iceland sent me an email explaining their particular situation (1 hospital that covers 95% of all hospital pharmacy activity in Iceland).
I am planning to send a reminder to the missing countries on Wednesday.

FMD – Meeting in Leuven
The Belgian Association of Hospital Pharmacists is organising an information session for hospitals together with the Belgian NMVO on 1st June. Luxembourgish representatives will also be attending. I will be going as well.

4) Open Letter to DG Sante

A group of organizations (HAI, EPHA, EPF and other patient groups) is planning to issue a letter to Juncker this week with a straightforward message about the added value of EU health policy & the need for continued cooperation (and DG SANTE). This letter will be send in the context of the Commission’s White Paper that outlines the future of the EU as of 2025.

The White Paper implies that the EU27 should stop acting in the area of public health (see p. 22 “[…] the EU27 stops acting or does less in domains where it is perceived as having more limited added value […]. This includes areas such as […] public health […]”

According to intel from SANTE itself, the letter should be issued as soon as possible. The letter will be shared this week. Other associations are encouraged to endorse it.

5) CTF

I am still waiting on Neal’s report for round 2. Once, he sends the report, I will be holding a conference call with him and Andreia.
After the call we need to determine how the analysis of round 2 data will be carried out (i.e. I will check with Andreia if she has time to go through the data to categorize it).
Moreover, we need to decide how WG1 members should finalise the work on the framework.

6) Health First Europe

Tajda is coming to Brussels for the launch event of the White Paper by Health First Europe. We will be meeting with Melina from Health First Europe after the event.
Potentially we could discuss future cooperation with Health First Europe.

7) EU operating grant application

EAHP applied in 2014 for the EU operating grant under the third health programme. The application was not successful. The call for 2017 (covering the period 2018 to 2021) was issued end of March. We just found out that the call is already open, since Patricia thought that it will only be opened in September like last time.
We will be applying. I am currently preparing the application together with Patricia. Deadline 15th June.

8) Consultations

EMA “How are we doing” survey – 31st May
IMDRF: “Terminologies for Categorized Adverse Event Reporting: terms, terminology and codes” – 31st May
Medical devices: “Process for developing Device Specific Guidance documents” – 2nd June
FIP: Women empowerment – 7th June
FIP: Harm reduction – 15th June
EMA – pharmacokinetics – 31st July

All consultations except for the one on harm reduction are currently being worked on.
We need to find hospital pharmacists/board members that would like to contribute. (Note: document on harm reduction is 60 pages long)

9) Miscellaneous

Labour mobility survey
I am currently finalising the survey. I still need to fine-tune the foreword, the background and the conclusion.
In addition, we need to design a cover page. I am planning on asking Catarina.

Conference on cross-border healthcare in Europe
The conference focuses on patients’ rights and boosting cooperation. It takes place on 12th September in Brussels. Registration costs 295 Euros for one participant or 255 Euro per participant (if 2 or more persons of the same organisation attend).

Letter by DK on EMA
DK sent a letter to us regarding the relocation of EMA. Do you have any questions on the relocation or the Danish candidacy?

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