Scottish Parliament: Health Committee
Thursday, 6 February, 2014

Further to its inquiry ‘Access to newly licensed medicines’ and the recent SMC report, the Health and Sport Committee will be holding a follow-up meeting on 25 February at 9:45 am.  The aim of this session is for the Committee to hear feedback from stakeholders following the publication of the Scottish Medicines Consortium report to the Scottish Government, ‘Assessment of medicines for end of life care and very rare conditions (orphan and ultra-orphan medicines) in Scotland’.

The Inquiry page on the Committee’s website includes relevant documents, including the Committee’s Report, the SG responses to the report and debate, and the recent SMC report.

The Committee would like to hear the views of stakeholders on the new approach set out in the SMC report.

You are being contacted following your previous input into the Committee’s inquiry. The meeting on 25 February will take the form of a ‘round table’. The Committee seeks notes of interest from organisations and individuals interested in taking part. The Committee will agree a final invitation list after which we will contact everyone who has indicated their interest to participate in the meeting.

All witnesses selected will be invited to provide a short written submission in advance of their appearance. Although we are not issuing a general ‘call for evidence’, brief written submissions from non-participants would also be welcomed.

Comments Scottish Parliament: Health Committee
Assessment of medicines for end of life care and very rare conditions (orphan and ultra-orphan medicines) in Scotland - Report for the Cabinet Secretary for Health and Wellbeing

The committee has significant input from Fellows of the College on this and related subjects and we regret that we are unable to provide a representative on 25th February.  However the following additional comments may be of help as you continue your deliberations.

  1. The report provides a very sensible summary of a way forward, particularly in terms of the PACE approach.
  2. For the EoL and orphan medicines categories, it may be quite difficult to predict how many patients/conditions within conditions (particularly subtypes of cancers) this will cover and careful monitoring of which conditions are included and how this is decided might be needed to keep the scheme affordable (while recognising that the ethos of the scheme is to be inclusive).
  3. The choice of membership of the PACE groups is critical. In particular, it will be important to ensure that any biased opinions are well balanced and that there is a spread of views included from the specialist clinicians as some may have conflicts of interest (presumably these will all be declared and recorded). Will the manufacturer be allowed to nominate members of the PACE groups or will this responsibility lie entirely with SMC? Including clinicians from outwith Scotland to broaden the opinion base would be helpful, particularly for the most rare conditions.
  4. The 3 month ‘pause’ in the SMC process could have significant impact for some patients particularly those with EoL requirements. If there is to be a parallel peer approved clinical system this might counteract the impact on individual patients.

We hope the round table event is productive and these additional comments are useful to you.