Statement of Intent

Multiple expert groups and the UK Government’s Life Sciences Industrial Strategy suggest development of the ATMP sector will provide key opportunities for investment and economic growth for the UK. ATMPs are set to transform current care pathways by potentially offering durable and curative outcomes where acute unmet medical need exists. Healthcare services are not currently configured to commission and provide these therapies as mainstream treatment. It is vital to translate the hope and potential of advanced therapeutics, with an immediate focus on cell and gene therapy, into reality to improve outcomes for the people of Wales. This framework will also support and foster strategic partnerships and collaboration between NHS Wales and our academic and industry partners. By working together we will harness the potential of ATMPs to improve health, well-being and prosperity for the people of Wales.

On April 9th 2019, Vaughan Gethin, the Minister for Health & Social Services published a ‘Written Statement: on Precision Medicine’ which included The Advanced Therapies Statement of Intent. This outlined the commitment by Welsh Government to create a sustainable platform to enable NHS Wales to provide patients with equitable access to emerging Advanced Therapy Medicinal Products by focusing on:

• Public and Patient Involvement – Recognising the novel aspects of these therapies and that public engagement that will be required to understand their potential, limitations, applicability, value and cost.
• Clinical Pathways – Addressing the systems, processes and diagnostics that will be required to deliver these therapies and ensure clinical engagement.
• Regulatory Compliance, Quality and Safety – Recognising the requirements that will have to be met and the support required to achieve this.
• Workforce – Ensuring we are able to enable the new knowledge, skills and competencies for each pathway, profession and partner.
• Estates – Covering the NHS Estate requirements for patient treatment as well as the translational research and production needs and potential economic benefit in establishing commercial facilities in Wales.
• Informatics and Information Governance – Identifying the requirements for a coherent vein-to-vein informatics network that is necessary to enable seamless sharing of pertinent information between a care setting and product supplier.
• Research and Innovation – Recognising the opportunity to increase early and ongoing access to clinical trials, the challenges of translation of these products from research to a clinical environment and their place in our innovation aspirations within the health and wealth agenda.
• Hosting and commissioning – Recognising the challenge of the cost and benefit of these therapies and the emerging, but limited, clinical data on their use, how they are commissioned, planned and delivered and how they align with current therapeutic options.
• Strategic Partnerships – Addressing both the need and opportunity for Wales in a leadership role by engaging proactively and ensuring appropriate representation at professional discussions across the UK in terms of adoption, delivery and associated healthcare professional development.

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