Seòmar agus comataidhean

I refer the member to the answer to question S6W-40323 on 11 September 2025. All answers to written Parliamentary Questions are available on the Parliament's website, the search facility for which can be found at https://www.parliament.scot/chamber-and-committees/written-questions-and-answers.

Vorasidenib (Voranigo®) does not currently have a marketing authorisation (sometimes referred to as a licence) from the Medicines and Healthcare products Regulatory Agency (MHRA) which means it cannot be marketed or sold in the UK. The marketing authorisation process involves the MHRA reviewing and assessing the evidence supporting a medicinal product’s quality, safety and efficacy.

As a result, vorasidenib is being offered for a limited time by the pharmaceutical company, Servier, through a free-of-charge (FOC) pharmaceutical company-led early access programme. Health Boards have processes for considering the use of an unlicensed medicine, including through FOC early access programmes, on an individual case-by-case basis where the clinician feels it would benefit an individual. The Scottish Government does not hold data on these decisions.

Individual Health Boards are responsible for decisions on the implementation and availability of medicines in their area. The Scottish Government has committed to investing rebates from the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) to fund the New Medicines Fund (NMF), which provides additional top-up funding to territorial Health Boards to support the cost of introducing new medicines. Since 2014/15, £906 million has been made available to Health Boards via the NMF.

I wrote to Ashley Dalton MP, Parliamentary Under-Secretary of State for Public Health and Prevention at the Department for Health & Social Care (DHSC) on 8 Aprill 2025 in order to outline the Scottish Government’s position on Clauses 2 and 3 of the Rare Cancers Bill.

Over the last year, my officials have been engaging in active conversation with the UK Government and the other devolved nations on the implementation of the provisions of the Bill.

The Scottish Government is committed to increasing the availability of safe and effective medicines that people in Scotland would benefit from. The Scottish Medicines Consortium (SMC) assesses the clinical and cost effectiveness of newly licensed medicines on a once for Scotland basis and publishes advice for Health Boards to consider. It is expected that Health Board Area & Drug and Therapeutics Committees (ADTCs) will consider making an SMC recommended medicine, or an equivalent, available on their local or regional formulary for routine prescribing within 90 days of SMC advice being published.

Health Boards are expected to apply common principles and processes in the introduction of newly licensed medicines to facilitate consistency of approach to local decision-making. The decision to prescribe a medicine, and which medicine to prescribe, is entirely for the clinician in charge of a person’s care, having considered their clinical condition, their safety, and any relevant clinical guidance.

There are studies that show a developing evidence base for the use of mifepristone in breast cancer prevention as outlined in the opinion piece in The Lancet.

The regulation for the licensing, safety and efficacy of medicines is currently reserved to the UK Government and is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA is also responsible for enabling innovation, research and development that is beneficial to public health, including overseeing clinical trials which underpin evidence based practice. Clinical trials are an important part of the pathway by which a new medicinal product or a new use of an existing medicine can be marketed for use as a new treatment.

Before a medicine can be marketed, a pharmaceutical company must be able to demonstrate its safety, quality and efficacy. A marketing authorisation (sometimes called a licence) is granted to market a medicine for a specific indication (condition) and not to the medicine itself. The decision to apply for a marketing authorisation for a new medicine or new indication is for a pharmaceutical company to make. In doing so they must include data from clinical trials and other studies demonstrating the quality, safety and efficacy of the medicine. After detailed assessment and providing the data is satisfactory, a marketing authorisation may be granted.

All cancers, including breast, remain a national priority, within the Scottish Government and across NHS Scotland. That is why we published our Cancer strategy 2023 to 2033 - gov.scot along with an initial three year Cancer action plan 2023 to 2026 - gov.scot on 15 June 2023.

The strategy and plan take a comprehensive approach to improving patient pathways from prevention and diagnosis through to treatment and post-treatment care.

We know that the earlier cancer is diagnosed the easier it is to treat and even cure which is why we continue to invest in our Detect Cancer Earlier (DCE) Programme, initially launched in 2012.

The Programme takes a whole-systems approach to early detection and encompasses primary care, diagnostics, public education, data, innovation and screening.

A Detect Cancer Earlier campaign – Be The Early Bird - launched on March 2023 aiming to reduce fear of cancer and empower those with possible symptoms to act early. This campaign ran for a second time in March 2025 and is due to run again in the coming months.

Scottish Government has also commissioned the Scottish Cancer Network to collaboratively develop national clinical management pathways. One of the first, addressing breast cancer, was published in 2023.

Clinical management pathways are developed through consensus and outline the patient journey from diagnosis through to follow-up or end of life care. The pathways describe the treatment options at the various points in each pathway to support shared decision making. The use of these pathways throughout NHS Scotland supports clinicians in their decision making enabling them to improve outcomes for patients with breast cancer.

Further to this, Scottish Government is continuing to take action to improve waiting times with £14.23 million of the £110 million in additional planned care funding for 2025-26 to Cancer Waiting Times, with a focus on colorectal, urological and breast as our most challenged pathways.

Significant Adverse Event Reviews are conducted at a local level within each NHS Health Board and the learning and improvement actions that are identified as part of that review process are considered within the Health Board to reduce the risk of the same event recuring in the future. When relevant this will include actions to ensure that findings inform related professional development or training plans and delivery. The Scottish Government is clear that this learning should be shared nationally to enable other Health Boards consider if their processes can be improved as a result.

The Scottish Government has funded the Joint Commission for Safety, Openness and Learning – delivered by NHS Education for Scotland (NES) – which has developed Compassionate Communication Skills training to support staff in having difficult conversations after adverse events, reinforcing a commitment to learning and patient-centred care. NES has developed professional development and training resources, such as Human Factors/Ergonomics (Safety Science for Patient Safety), which can be accessed by all NHS Scotland staff.

Significant Adverse Event Reviews (SAERs) are conducted at a local level within each NHS Health Board. NHS Boards are required to notify Healthcare Improvement Scotland on a monthly basis of the number of SAERs that have been commissioned, including the event type and specialty. HIS recently reviewed and published an updated version of A national framework for reviewing and learning from adverse events in NHS Scotland: February 2025 – Healthcare Improvement Scotland in February this year. This provides templates to support NHS Health Boards to consistently report and learn from SAERs. The Scottish Government does not monitor NHS Boards responses to SAERs.

I refer the member to the answer to question S6W-38163 on 17 June 2025, on the UN Committee on Economic, Social and Cultural Rights report as regards to the provision of maternity services in rural areas.

The Scottish Government expects all NHS Boards to provide maternity services that are delivered as close to home as practicable, balanced with ensuring the safety of mother and baby. Within the policies we set, it is for NHS Boards to determine the model of service delivery best suited to meet the needs of their local areas and population.

Maternity services continue to be provided for women in Wigtownshire, including local antenatal and postnatal care, scanning and the option of midwife-supported home birth for women who choose to birth locally. Women who require more complex maternity care continue to be supported by the full clinical team at Dumfries and Galloway Royal Infirmary. Responsibility for the design and delivery of local services lies with NHS Boards and Integration Joint Boards in line with their duties to deliver safe, effective and sustainable care. NHS Dumfries and Galloway has reaffirmed its commitment to the delivery of safe, high-quality maternity care for all families in Wigtownshire.

All answers to written Parliamentary Questions are available on the Parliament's website, the search facility for which can be found at https://www.parliament.scot/chamber-and-committees/written-questions-and-answers.

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