Medicines play a crucial role in the NHS and to our commitment to supporting people to live longer, healthier lives. Medicines represent the most frequent healthcare intervention and are the second largest item of expenditure for NHSScotland.
The Scottish Government and health boards are responsible for making sure there is a supply of medicines in the NHS. But the regulation of medicines, and in particular their licensing, safety and pricing, are the responsibility of the UK Government. We advise Ministers about these issues, led by the Chief Pharmaceutical Officer (CPO), Dr Rose Marie Parr.
- establish an overall policy framework for Scottish Medicines Consortium (SMC) - the committee of clinical and other experts that advises health boards about what new medicines should be made routinely available in the NHS
- issue guidance to health boards about making new medicines available in their area
- guidance about Cannabis Based Products for Medicinal use (CBPMs)
More information about our work is provided below:
- access to medicines
- regulation of medicines
- pricing of medicines
- Single National Formulary
- UK exit from the EU
- more information
We want to increase patients’ access to safe and effective new medicines.
We also continue to implement the recommendations of the 2016 independent review of access to new medicines, which was led by Dr Brian Montgomery.
The SMC has introduced a new decision making process for 'ultra-orphan' It has also introduced a process for the acceptance of new medicines. We produced guidance for health boards, clinicians, pharmacists, patient groups and pharmaceutical companies on the new approach to the assessment of ultra-orphan medicines (May 2019).
We have introduced a new system for clinicians to apply for their patients to be prescribed medicines not recommended for routine availability by the SMC. This new system is called the Peer Approved Clinical System (PACS) Tier Two has been operating in each health board area since 1 June 2018.
Work is underway to explore how to improve the quality and capture of medicines use and outcomes data. This follows the medicines use and digital capabilities report (September 2018).
The regulation of medicines is a responsibility of the UK Government, and in particular the Medicines and Healthcare products Regulatory Agency (MHRA)
We work closely with the UK Government, MHRA and other relevant bodies on:
- the regulation of medicines, in particular unlicensed medicines such as cannabis based products for medicinal use
- governance arrangements for the use and management of controlled drugs to minimise patient harm, misuse and criminality
- on medicine safety issues, including those being considered by the Independent Medicines and Medical Devices Safety Review and we issue medicines safety alerts to NHS Scotland when necessary
The regulation of medicine pricing is a responsibility of the UK Government. But we are involved in a UK-wide voluntary agreement between the four UK countries and the pharmaceutical industry that caps NHS spending on new branded medicines. This is the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS).
Where companies’ revenue exceeds the cap agreed as part of the VPAS scheme, the Scottish Government and the three other UK Administrations receive rebates from companies that are signatories to the voluntary agreement. There is also a statutory scheme - more information in the Branded Health Service Medicines (Costs) (Amendment) Regulations 2018.
We use receipts from VPAS to provide a specific fund, the New Medicines Fund, to health boards to help with the costs of introducing new medicines.
We are working to develop a Single National Formulary (SNF). The SNF will reduce unwarranted variation in the medicines prescribed in different parts of the country.
There is already a high degree of commonality in prescribing practice across the 11 formularies (prioritised lists of recommended medicines) used by the 14 health boards, but some variability remains in prescribing across some therapeutic areas. Under the SNF, clinicians will continue to have discretion to prescribe for individual patients as they consider appropriate.
In October 2019 the Chief Medical Officer and Chief Pharmaceutical Officer wrote a letter to pharmacists and other health professionals with a management responsibility for medical supplies, to provide information and advice in the event that the UK leaves the EU without a withdrawal agreement being in place (“no deal Brexit”).
We are working with all other UK Administrations to make sure that patients will have access to the medicines and other medical supplies they need, as far as is possible, if the UK leaves the EU without a deal.
We have established a Scottish Medicines Shortages Response Group, led by the Chief Pharmaceutical Officer, to consider and adapt UK-wide measures designed to mitigate any shortages that occur.
If you have any concerns around the impact of the UK’s exit from the EU on your medicine, please see information about Brexit preparations relating to medicines and services.
To report any safety concerns with any medicines, find out more about the yellow card scheme.
Telephone: 0300 244 4000
Pharmacy and Medicines Division
1ER, St Andrews House