The effectiveness of changes to the process and the organisation that regulates new medicines is to come under further scrutiny by MSPs on the Health and Sport Committee.
The Committee is asking for views on whether the changes that have been made to the Scottish Medicines Consortium (SMC) process on accessing new medicines, Individual Patient Treatment requests and the piloted Peer Approved Clinical system have delivered improved access.
The Committee undertook an inquiry in 2013 which made recommendations on improving access to new medicines, including on the process undertaken by the SMC to regulate new medicines. A number of changes to the system have since been taken forward by the Scottish Government and implemented by the Scottish Medicines Consortium.
Convener of the Committee Duncan McNeil MSP said:
“Access to new medicines has long been a controversial issue. We have all heard or read about distressing stories of individuals who have a terminal condition who have had to fight to access drugs that they believe would help them.
“Two years ago, the Committee was able to shine a light on some of the difficulties within the system which led to changes being made. We now want to return to the issue to identify if these changes have led to real improvements on the ground especially on the length and quality of life for those living with rare conditions.”
The Committee will also consider the impact of the New Medicines Fund and the effectiveness of the monitoring of NHS Boards Area drug and Therapeutic Committees.
Bob Doris MSP, Deputy Convener of the Committee said:
“The Scottish Government has shown that it is committed to change in this process given the two reviews that it has commissioned and the number of changes that have been implemented as a result.
“The new medicines fund specifically provided on-going funding to make access to new medicines for rare and end of life conditions easier. This piece of work will allow MSPs to find out what difference that investment has made.”
The Committee is asking the following views on the following areas:
• To what extent have the new SMC process (implemented in April 2014) for approving medicines, current Individual Patient Treatment Requests and the new Peer Approved Clinical System (PACs) for rare conditions and end of life medicines become more transparent, less complex and delivered improved access to new medicines?
• The effectiveness of any monitoring of the NHS boards Area drug and Therapeutic Committees including the transparency of their operations and their timeliness in publishing local responses to SMC’s published advice?
• How the New Medicines Fund has been used and the extent to which it has improved access to new medicines for those with rare conditions?
• The progress towards developing value based assessments of new medicines and the Scottish model of value?
3 July 2013 the Committee published its report entitled Access to new medicines.
8 October 2013 the Scottish Government responded to Committee report
9 October 2013 Chamber debate on access to new medicines
20 December 2013 Publication of Assessment of medicines for end of life care and very rare conditions (orphan and ultra-orphan medicines) in Scotland Rapid Review Report by the Task and Finish Group Chaired by Professor David Webb
April 2014 the SMC’s changed approach to considering new medicines was implemented. This approach consists of a number of changes in its operation (such as timescales for decision taking and holding meetings in public) as well as new steps for considering medicines for rare conditions.
The call for views is open until Wednesday 20 January.