Reforming access to new medicines

Health Secretary updates Committee

Improvements have been set out which will allow patients better access to those medicines that are prescribed on an individual and case-by-case basis, helping them live longer, better quality lives.

From February 2018, the new Peer Approved Clinical System (PACS) Tier 2 will replace and build upon existing systems for non-routine access to medicines.

While each health board will operate PACS Tier 2 for their own area, a new National Appeal Panel will be introduced, for individual requests for access to medicines not approved by the Scottish Medicines Consortium.

This will see revised national standards in decision making, which includes making it clear that a decision for non-routine access must not include cost-effectiveness as part of the consideration. This will enhance consistency across the country and remove any potential postcode lottery.

Health Secretary Shona Robison has written to the Health and Sport Committee to update on the introduction of PACS Tier Two, as well as on progress to deliver the recommendations of Dr Brian Montgomery’s Review of Access to New Medicines.

Ms Robison said:

“Every patient deserves access to the very highest level of care and treatment possible, including access to new medicines where appropriate. These reforms will go a long way to ensuring they can.

“Dr Montgomery’s review clearly demonstrated the success that has been made to improve access to new medicines, whilst also recognising there was still more we could do. That is why I immediately committed to taking forward its recommendations and I am pleased to see the strong progress that is being made.

“Taken together, these reforms, along with the ongoing work to implement the review in full, will help more patients get better access to the treatments that can give them longer, better quality lives.”

Gregor McNie, Cancer Research UK’s Senior Public Affairs Manager, said:

“As more innovative and targeted treatments are developed, it’s increasingly important to make sure that patients can get access to new, effective drugs as quickly as possible. The Montgomery review included reforms which allowed patients in Scotland to be treated with promising new drugs, while more data is collected on their effectiveness.

“There’s been good progress on these reforms, and we’re looking forward to further work being done. We really hope that a combination of evidence from patients, and data from clinical trials can become a fundamental part of the medicines approval system as soon as possible. This will help the SMC to offer the best value to patients and the NHS.”


PACS Tier Two will replace and build upon the existing Individual Patient Treatment Request (IPTR) system for all medicines except ultra-orphan. Tier one of PACS will be maintained for access to ultra-orphan medicines.

In December 2016, the Scottish Government welcomed Dr Montgomery’s review into reforming access to new medicines, with a commitment to implement all 28 of its recommendations.

 Progress to date includes:

  • The standardisation of SMC processes to increase patient engagement in its decision-making.
  • Increased patient transparency with clearer messaging for the public.
  • The establishment of a multiagency taskforce which is due to report its findings shortly in relation to some of the data recommendations.
  • Funding for a three year Cancer Medicines Outcome Programme which is developing a dataset for recording and measuring patient outcomes to determine the effectiveness of medicines in the real world.

The Cabinet Secretary’s letter will be available on the Health and Sport Committee’s web pages,


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