Rare Cancers Bill 2024-2025

On 16 October 2024, Dr Scott Arthur (Labour) presented his private member’s bill (PMB), the Rare Cancers Bill 2024-25 to the House of Commons. The bill’s second reading is scheduled for Friday 14 March 2025.

The bill’s long title says that it would “make provision to incentivise research and investment into the treatment of rare types of cancer; and for connected purposes”. If passed, the bill would introduce three measures intended to encourage more research. It would do this by:

• placing a duty on the Secretary of State for Health and Social Care in England to promote and facilitate research into rare cancers
• improving patient recruitment into clinical trials for rare cancers through greater data sharing in England
• requiring the government to review UK-wide law on marketing authorisations (product licences) for “orphan medicinal products” that diagnose, prevent or treat cancer. More information about orphan products is provided below.

The bill is accompanied by explanatory notes, prepared by the Department of Health and Social Care with the consent of Dr Scott Arthur.

Rare cancers

Rare cancers are types of cancer that affect relatively small numbers of people. The definition of a rare cancer can vary. The Rare Cancers Bill follows the UK Rare Diseases Framework and defines a rare cancer as a type of cancer that affects fewer than 1 in 2,000 people.

Rare cancers are more commonly defined as cancers where fewer than six in 100,000 people are diagnosed each year. Although they are less frequently diagnosed, they collectively account for almost one in every five of all cancer diagnoses each year.

Cancer registration statistics in England for 2022 indicate 17% of all male cancer diagnoses involved rare cancers and 18% of all female cancer diagnoses involved rare cancers.

There are many different types of rare cancer. They include blood cancers, cancers affecting the female reproductive organs or digestive system, head and neck cancers, and cancers that affect soft tissues, known as sarcoma.

Research on rare cancers

Analysis from the rare cancers charity Cancer 52 and the National Cancer Research Institute has shown that in the financial year 2020-2021, £179 million of UK non-commercial research funding focused on less common or rare cancers, representing 54% of overall cancer research expenditure. Within this, most funding was dedicated to blood cancer research (30%), followed by research on gastrointestinal cancer (cancers of the digestive system) (25%) and brain and nervous system cancers (16%).

Charities and researchers have drawn attention to the difficulties of recruiting participants for research studies on rare cancers that affect relatively small numbers of people. In a 2024 patient survey, the charity Cancer 52 found that 82% of respondents with a less common or rare cancer were not offered an opportunity to be part of a clinical trial.

The Rare Cancers Bill proposes appointing a National Speciality Lead for Rare Cancers, to advise on research design and facilitate collaboration in rare cancer research.

Clinical trial and cancer registries

The Be Part of Research database is the most comprehensive listing of clinical trials and other health research studies being conducted in the UK. It is maintained by the National Institute for Health and Care Research (NIHR). Patients and healthcare professionals can search and browse the Be Part of Research listings to find research studies that are relevant to them. Patients can also register with the service to be matched to studies that may be suitable for them.

When someone is diagnosed with cancer in the UK, their data is collected by the cancer registry service in their part of the UK. These national cancer registries collect information about patients and the cancer they have been diagnosed with, and about their treatment and how well it has worked. The data collected in these registries is used for service planning. Anonymised data can also be accessed and used by researchers.

The Rare Cancers Bill would place a duty on the Secretary of State to facilitate and promote research on rare cancers. This would include taking steps to enable potential participants in clinical trials to be identified and contacted more easily. The explanatory notes to the bill say that this could be achieved by developing a tailored Be Part of Research service for patients with rare cancers, to help meet their specific needs.

In addition, the bill would provide NHS England with the power to share information for the purpose of facilitating clinical trials for rare cancers. It would do this by amending section 261 of the Health and Social Care Act 2012, which sets out the circumstances in which NHS England can share data that it has collected about the health and social are system.

Orphan drugs

Orphan drugs are medicines that are used to treat rare conditions. They are known as orphan because pharmaceutical companies may be unwilling to invest in research and development for new treatments for diseases that only affect very small numbers of people. To help encourage more research and development, governments offer incentives for the development of orphan medicines.

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) decides which medicines are given an orphan designation, based on criteria set out in the Human Medicines Regulations 2012. The MHRA provides market exclusivity rights for these medicines, preventing any similar medicine being licenced for ten years. It also offers reduced fees for marketing authorisation applications for orphan medicines, and refunds all or part of these fees if an orphan marketing authorisation is granted.

The Rare Cancers Bill would require the government to review the current regulations for orphan medicines in the UK and examine the approaches used in other countries to regulate and licence orphan medical products.

Stakeholder views

Cancer charities that focus on rare cancers have expressed support for the bill, and encouraged people to write to their MP to express their support for it in Parliament. These include The Brain Tumour charity,  Brain Tumour Research, Pancreatic Cancer UK, and Neuroendocrine Cancer UK