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), Professor Alison Strath.
- establish an overall policy framework for the 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
- have issued 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
Access to medicines
We are committed to increasing patients’ access to safe and effective new medicines.
In 2013, we reported on the role of SMC and Review of Individual Patient Treatment Request (IPTR) and Area Drug and Therapeutics Committee (ADTC).
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' medicines for very rare conditions that allows medicines to be available on the NHS for a period of up to three years while information about the outcomes they achieve is gathered. It has also introduced a new process for the interim 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). Work is also underway to drive forward a financial risk share agreement for NHS boards.
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, and has been operating in each health board area since 1 June 2018. A six and 12 month review of PACS Tier 2 has been completed and we will include our response on next steps as part of a refresh of CEL 17 (2010), which will take place during 2021.
We are working with NHS Scotland and other key stakeholders on a Digital Health and Care Strategy for the development of NHS Scotland’s capabilities on medicines data. This follows the 2018 medicines use and digital capabilities report.
Regulation of medicines: licensing, safety and supply
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: the 2020 the Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations 2020 amends the Controlled Drugs (Supervision of Management and Use) Regulations 2013, removing the statutory expiry date and inserting a statutory review clause
- in September 2020, Scottish ministers committed to implementing all of the recommendations of the Independent Medicines and Medical Devices Safety Review 'First Do No Harm' where they relate to the responsibilities of the Scottish Government. Further information on the Patient Safety Commissioner work is available. The Scottish Government published a Delivery Plan on 24 March 2021 which sets out the steps that it is taking to implement the recommendations from the Review
- on medicine safety issues, including those which were considered by the Independent Medicines and Medical Devices Safety Review and we issue medicines recalls to NHS Scotland when necessary
Pricing of medicines
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 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 agreement, we, along with 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).
In Scotland, we use the money received from the VPAS receipts to fund the New Medicines Fund (NMF). The main aim of the fund is to help health boards with the costs of introducing new medicines, including the costs of orphan, ultra-orphan and end of life medicines. The NMF covers medicines approved by the Scottish Medicines Consortium (SMC), or in cases where the medicine is not recommended, for treatment agreed on an individual patient ‘case-by-case’ basis, through PACS Tier One and PACS Tier Two. The fund is intended to ensure that affordability is not a barrier to the implementation of policy to increase access to new medicines. Since 2014/15, £456.5 million has been made available to health boards to fund the cost of new medicines via the NMF.
Single National Formulary
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.
UK exit from the EU
The UK Government is responsible for the UK Border. This means that many of the practical issues connected to medicine supply such as entry and customs are outside the our control. However, we are working closely with the UK Department of Health and Social Care (DHSC) and the other Devolved Administrations to plan for any potential disruption now that the EU Transition Period has ended, including doing all we can to ensure that patients in Scotland will still have access to the medicines they need.
In addition to UK-led arrangements and in response to lessons learnt from the first wave of COVID-19, we have built a national Scottish stockpile of critical care and end of life medicines, as well as supplies of COVID-19 treatments. NHS National Services Scotland National Procurement (NP) is working on our behalf to purchase the majority of NHS Scotland’s share of the identified stocks of COVID-19, critical care and end of life medicines for the national stockpile and this has been fully procured. The NP team is working closely our officials to ensure, where necessary, additional stock is sourced to meet NHS Scotland’s requirements via the UK-led sourcing work streams.
We are continuing to work closely with the Department of Health and Social Care and the other Devolved Administrations to manage the consequences of the end of the EU Transition Period, including doing all we can to ensure that we will still have access to medicines in the event of border disruption as border and custom controls are phased in, in January and July 2022.
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