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Medicines access and regulation (including HTA, Biosimilars) – February 2018

EMA Update

There are a few things to report from EMA. Unfortunately, the EMA cannot join us as a president’s guest at Congress due to the measures that have been put in place for the pending move to Amsterdam. Every year, EAHP has to undergo an eligibility check. For 2018 we have passed this check and are consequently able to join all activities of EMA. The mandate of Adamos Hadjipanayis (European Academy of Paediatrics) has been extended. He will continue for the next 3 year as a member of the coordinating group of the European Network of Paediatric Research at the EMA (Enpr-EMA).

Biosimilar medicines

Review of the Biosimilar Medicines position paper
To be discussed under agenda item 11.7.1 on Saturday afternoon.

Commission event on Biosimilar Medicines – September 2018
On 7th September 2017 the Commission held its kick-off meeting for the next multi-stakeholder biosimilar workshop. A second meeting – during which the ideas for the 2018 Commission event on Biosimilars were discussed took place on 13th November 2017. Hilda Juhasz – the policy officer at the Commission responsible for this event – used this opportunity to introduce all stakeholders to her successor Chloé Spathari.

The 2018 event will take place on 14th September. 3 topics will be covered: oncology, education and procurement. EAHP is participating in the organisation of the procurement and the education session. Work for the procurement session is progressing much better than for the education session due to the smaller size of the organisation group. Europa Bio and Medicines for Europe are co-organisers of the procurement session, while in the education session there are ECCO, ESOP, ESNO, ESMO, Medicines for Europe and EONS.

     Procurement session

We (EAHP, Europa Bio and Medicines for Europe) had several discussions with the Commission about the Procurement session. Overall, the Commission would like to have a mixed panel that showcases the sustainability of procurement. Scandinavian countries are not a good example in the eyes of the Commission since they did not implement the European procurement legislation as envisioned by the Commission (i.e. there should be less the winner takes it all procedures). Some issues remain open, since we are still looking for the following panellists:

  • a moderator (preferably someone from academia/ a journalist that has general knowledge about the topic);
  • hospital buyer (Commission would like to have someone from a public body, e.g. someone form the Netherlands or a statutory health insurance; representatives from individual hospitals might be too biased).

Draft session outline HERE

     Education session

The education session misses a few more panellists, since a lot of components are unknown (i.e. is the ESNO document on biosimilars ready, who will present the ESOP biosimilar curricular, which country should be selected to present national attitudes). A meeting/conference call is planned in early 2018 (no date has been set yet) to discuss the following open issues:

  • a moderator (somebody who knows and is interested on the topic, it could be a representative from a competent authority active in the policy area, potentially also a patient or healthcare professional representative);
  • presenter of ESOP biosimilar curricular;
  • ESNO paper;
  • Is the participation of EMA possible;
  • Which 2 countries could present their national perspective on education (Dr Vulto was suggested by COM, because he was a panellist in the last year).

Draft session outline HERE

Procurement

During the last Board meeting it was decided to start the development of a Procurement Position Paper. The field of procurement is quite large, wherefore we need to agree on a direction for our position paper. The following document (HERE) outlines ideas for our position paper.

HTA

HTA proposal
The European Commission is planning to publish a draft legislative proposal concerning HTA on 31st of January. The proposal is expected to focus on clinical aspects and the strengthening of cooperation between Member States. Overall, the proposal aims at addressing the issue of having multiple national assessments for the same products with sometimes different results for patients and industry. Moreover, it should address current challenges that a posed to health systems (i.e. ageing society, rapid increase of innovative medicines, cost effectiveness and accessibility). More information will be provided to the Board during the meeting.

The proposal has been published as expected. More information is available HERE

HTA Stakeholder Group
The HTA Stakeholder Group met in November 2017 to discuss coordination and cooperation. Meeting minutes HERE It was agreed that our permanent representative Daniel Widmer (UEMO) will be joined by either Piotor or Elena, as both have gathered the second largest number of votes in the selection exercise which was undertaken in March 2017. Elena has confirmed her availability. The group will get together again, once the HTA proposal by the Commission has been published.

In light of the Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU, Elena and Daniel have suggested to discuss the positions of each member of the stakeholder group prior to the next HTA meeting with the Commission which will take place on 9th February. Do we want to form an opinion on the proposal and if yes, shall I see with Gunar if he can provide me with comments by early next week?

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EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.