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Policy Call – 12th July

1) Off-label use

Marc Dooms approached me regarding the use of the European Reference Network (ERN) for the exchange on off-label use. He would like EAHP to establish a contact list of interested hospital pharmacists that are working with the ERN on different initiatives. The contact list could be used by Marc and interested EAHP members to exchange on topics related to off-label use. ERN initiatives that should be targeted first are ERN EpiCare (epilepsies), ERN Skin (Skin dosorders), MetaERN (metabolic disorders) and ERN PaedCan (pediatric cancer). EAHPs role in this would be contacting the different initiatives and asking them for providing us with contact details of hospital pharmacist that are active within the initiative. Do you think we could help Marc?

2) Biosimilar medicines

Andras pointed out that a lot of people are only reading the summary of our positions on the first page of the position paper. I already updated the website and included a mention that these positions should be read in conjunction with the supporting information in the paper. In addition, I will include a more elaborate article in the next EU Monitor.

3) CTF Labour mobility survey

Catarina finished the front and the back cover of the publication. For the print version, I would suggest using the new address on the back cover. Please find here the different covers: front – July; front – August; back – old addressback – new address
Do you like the covers?

Follow-up from the CTF Stakeholder Meeting TBC if there is anything that needs to be done over the summer in accordance with the points discussed during the CTF Stakeholder Meeting.

4) EMVO/FMD – Meeting with COM

EAHP, HOPE and Andreas Walter from EMVO will be meeting with Unit B4 of the European Commission to discuss hospital integration. The meeting will take place on 12 July at 11.00 am. I will provide you with a short report during the policy call.

5) Statute and SOP review committee

Did you have time to check the draft document containing information on the selection of members for the “Statute and SOP Review Committee” that I sent to you at the beginning of July?

6) Consultations

We still need somebody that could respond to the EMA clinical data publication survey. The person that provides comments must have used the clinical data available on EMAs website. The submission deadline is 31st August.

Regarding the other 2 consultations which are due by the end of August (Commission – tissue and blood legislation/ EMA – chronic non-infectious liver diseases) I have not yet heard back from Kees or the SC. I will follow up with Kees.

For those EMA consultations due at the end of July, I will ask Petr to check the final comments, since you will be on holidays. For the FIP consultation on mHealth I am waiting on input from Rob regarding mHealth applications used by pharmacists.

7) Miscellaneous

RPP-Group – call for action on skin disinfectants
I spoke to RPP about the call for action. The initiative is supported and funded by BD. The first step of the initiatives aims at closing the regulatory gap by issuing guidelines/ recommendations on the distinction between biocidal products and medicinal products regarding the classification of disinfectants to be used for skin antisepsis before surgery and injection. The call for action will be issued by a letter from an MEP to the Commission. Alternatively or additionally RPP is also open to approaching other institutions such as EMA. RPP is also open for comments on the call or other suggestions. They aim at issuing the call in September. Follow up actions, i.e. initiatives relating to the correct use of skin disinfectants are not yet planned. They are however open to ideas once the call for action takes off.

German event on access to medicines
On Monday I went to an event hosted by the representation of the German region Bavaria on the access to medicines – Challenges and perspectives for Europe. The Bavarian Minister for Health and Care and the Director General of DG SANTE gave each a keynote speech before a panel – consisting out of representatives from the German pharma industry, one MEP (Dr Peter Liese) and one patient representative (European Patients’ Forum and Director European Federation of Allergy and Airways Diseases Patients’ Associations) – started a discussion on the topic. The group covered a large number of topics, i.e. shortages, procurement, pricing and reimbursement, innovation, moving the production to Europe, raising production standards of medicines/ active substances in China/India, streamlining of data requirements for marketing authorisations and reimbursement, FMD and HTA. The MEP pointed out that the ENVI committee spoke to Juncker recently to bring his attention to the fact that his Commission has not produced one legislative proposal on health. Especially shortages are of importance for the MEP. He mentioned in his interventions that an industrial strategy for the supply of medicines could be a first step towards raising awareness on the issue.

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