The Quality Standard for Rare Diseases is the first of its kind to be developed collaboratively between National Institute for Health and Care Excellence (NICE) and the patient community. It sets out clear, nationally consistent expectations for the diagnosis, treatment, and ongoing care of people living with rare diseases, helping clinicians and services deliver high-quality, equitable care across England and Wales.
The standard also plays an important role in improving accountability. It encourages better data collection and use, helping to demonstrate progress in outcomes and address long-standing inequalities in care. Importantly, it recognises and gives a voice to people who are living with a suspected but undiagnosed rare disease.
For patients and families, the Quality Standard provides a practical tool to help advocate for better care and support. While individual rare diseases are uncommon, together they affect around 5% of the population – approximately 3.5 million people in the UK. Until now, there has been no consistent benchmark for what good care should look like; this standard helps to change that.
The Rare Diseases Quality Standard was published by NICE on 27th February 2026, you can find it here.
What is a Quality Standard?
A Quality Standard is defined by the National Institute of Health and Care Excellence (NICE) as a “a set of specific, concise statements which act as markers of high-quality, cost-effective care across a pathway or a clinical area.” They cover a specific pathway or clinical area and are based on the best available evidence.
They are produced by NICE and can be used by commissioners, service providers, practitioners, partner organisations and charities. They can be referred to by partner organisations who want to follow a consistent approach when defining, measuring and delivering high quality care.
Quality Standards aren’t mandatory, but they support the development and improvement of health and care.
How can people with a rare disease or with a suspected rare disease use the quality standard?
- To understand the care pathway and what the next steps should be
- To know when treatment is not in line with the standard it should be
- To understand your rights as a patient
Why did we need a Quality Standard for Rare Disease?
A Quality Standard for Rare Disease will drive improvements in care, address existing gaps in nation specific action plans, and establish clear actions for commissioners and healthcare providers.
Prior to the Rare Diseases Quality Standard, there were no real measures to demonstrate progress over time, in addressing issues that we know really matter to people living with a rare disease. Quality standards have been shown to improve care by demonstrating what good looks like, and they provide measures that can be audited to show how individual services are performing.
The Quality Standard is particularly timely, because of the increasing pressures on NHS services across the UK. When staff time is limited, and waiting lists are high, it is easier for rarer and more complex conditions to be overlooked. A quality standard for rare disease is vital to ensure that there is an incentive to focus on rarer diseases, and to prevent the gap in outcomes between common and rarer conditions continuing to grow.
Background to the project
Following a meeting of the Rare Disease Forum, the Rare Autoimmune rheumatic Disease alliance (RAIRDA) convened a project group to develop quality statements for rare disease, which would then be used by relevant authorities to set a quality standard for rare disease. These statements were used by the National Institute for Health and Care Excellence (NICE) to form a quality standard for rare disease in February 2026.
You can read more about the process behind this project here.