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Access to New Medicines in Scotland: The Scottish Government’s Response

Posted on: November 28th, 2017 | 0 comments

The Scottish government has responded to the Montgomery Review of access to new medicines, in a letter from Shona Robison MSP, Cabinet Secretary for Health and Sport, to Neil Findlay MSP, convener of the Health and Sport Committee.

On data recommendations: the Scottish government has established a ‘multi-agency scoping taskforce’, who are consulting and developing recommendations.  Action Duchenne has already responded to this consultation.

On patient and clinical engagement in decision-making: Action Duchenne have raised a concern with the Scottish Medicines Consortium (SMC) that patients should have the right to address meetings of the SMC directly and should have the right to choose their own representatives.  This is the only way that the SMC decision-makers can gain a clear understanding of the experience of patients and the impact of their conditions.  We welcome the Scottish government response that the public partner is no longer required to present the patient group submissions and that patient groups have been attending SMC meetings from July 2017.  However, we still await clarification that patient groups have the right to choose their own representatives.

On end-of-life, orphan, and ultra-orphan medicines:  the Scottish government has responded that they have reviewed the definitions, are working on a new pathway, and plan to announce any revisions by Spring 2018.  Action Duchenne would like to see more detail here both on timing and on stakeholder consultation on the new pathway.

On Managed Access Schemes and Conditional Acceptance options:  work is underway to enable the SMC to have an additional decision option of ‘recommend for use subject to ongoing evaluation and future assessment’.  Initially this will be applicable only to medicines which have received conditional acceptance from the European Medicines Agency.  Again, we would like more detail on the timing and also on the future of Managed Access schemes and conditional acceptance options after Brexit.

On learning from other Health Technology Assessment (HTA) processes:  Action Duchenne welcomes the Scottish government’s comparative review of HTA processes across the world and the development of a Scottish Model of Value.  We would like to see detail on stakeholder involvement in this review and the timing of the review report.

On the Peer Approved Clinical System (PACS Tier Two) this will replace the Individual Patient Treatment Request and will be implemented from February 1st 2018.  We welcome the government’s commitment to improve approval rates and make the system more consistent and their introduction of a National Appeal Panel, refreshed guidance, and standardised national paperwork to facilitate this.

For more details contact Kathy Wedell our Campaigns Officer kathy@actionduchenne.org

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