Medicines and Medical Devices Bill

Written evidence submitted by Healthy.io (MMDB02)

Medical technologies and the Medicines and Medical Devices Bill

1. The Medicines and Medical Devices Bill will grant the Government new powers over medicines and medical devices following the UK’s departure from the EU. Healthy.io believes the Bill offers an opportunity to make the NHS a world leader in medical device technology.

2. However, in order to do so, the provisions of the Bill need to be further strengthened to enhance patient access to cutting-edge medical technologies. This briefing sets out what the Medicines and Medical Devices Bill proposes, issues with the funding and regulatory environment for medical devices and how the Bill could be further improved.

3. Healthy.io is a health-tech company with a mission to improve healthcare outcomes by turning the smartphone camera into a regulatory approved clinical device which can be used at the home and with greater accuracy.

Our products range from:

3.1. ‘Dip UTI’, a home testing kit for Urinary Tract Infections (UTI) for women – a condition which 60% of women develop in their lifetime. It makes UTI testing easier for women, whilst reducing UTI-related GP appointments

3.2. Our ‘ACR’ test, which is used to detect chronic kidney disease in people with diabetes and/or hypertension. This test has been able to achieve 72% adherence to testing in consented previously non-compliant patients, helping to avoid more costly complications caused by late diagnosis

3.3. The ‘SPOT’ wound management solution, a digital tool to support NHS staff in analysing and managing pressure sores and leg ulcers, which is already in use across local health systems and impacting patient care

4. The Medicines and Medical Devices Bill is designed to give the Secretary of State for Health and Social Care broad powers over the reimbursement and regulation of medicines and medical devices post-Brexit. Whilst the Bill has a welcome intention of using these powers to create a healthy life sciences sector in the UK, it takes no specific steps to address the funding and reimbursement environment for medical technologies. This environment can be challenging and leads to patients missing out on new technologies.

5. The medical technology sector is a key and growing part of the UK’s thriving life sciences industry, and is responsible for 127,000 jobs (40% of total life sciences employment) and has a national turnover of £24 billion. [1] It is essential that this sector is supported if the Medicines and Medical Devices Bill is to meet its welcome ambitions for life sciences.

6. There is scope for the Bill to be more ambitious for the UK’s medical devices sector, and address the following issues with the current access environment for medical devices:

6.1. Unlike with medicines, proven medical technologies are not guaranteed funding following a successful NICE appraisal. Whilst medical treatments are required to be funded and commissioned within three months following a successful NICE appraisal, most medical technologies are instead approved through guidance to commissioners rather than technology appraisals. This carries no requirement to commission them and no mandatory funding. Whilst NHS England is consulting on establishing a MedTech Funding Mandate to fund some NICE-approved technologies, this is limited and restricted in scope

6.2. There is scope to explore ways to streamline and simplify the way that NICE assesses and issues guidance on medical devices. This assessment process needs to be clear, consistent and create certainty for providers of tech solutions, minimising delays in order to enhance patient access to innovative medical technologies

6.3. The processes for securing patient access to proven medical technologies can be complex, hard to navigate and time consuming. Pathways are unclear, can often require engagement with a wide range of organisations, and there can be long delays to secure funding, For example, the Medical Technologies Evaluation Programme takes on average 38 weeks to develop medical technologies guidance; [2] whilst the MedTech Funding Mandate Panel plans to meet just once a year to decide which products to fund [3]

6.4. There is scope to be more innovative in how medical technologies are made available, untapping the potential of community pharmacies. At present, in order to access many of Healthy.io’s technologies, patients have to navigate access to overly-stretched GP services to access treatments. More could be done to relieve pressure on general practice by untapping the potential of community pharmacies

7. In order to address these issues, we propose that the opportunity of the Bill is taken to:

7.1. Bring the commissioning and funding process for medical technologies more in line with that of medicines, building on the MedTech Funding Mandate

7.2. Address inconsistencies with in NICE’s evidence requirements and guidance for medical technologies , addressing issues with the NICE appraisal process

7.3. Simplify and speed up processes to support the adoption and spread of proven medical technologies, ensuring the health service is just as ambitious about supporting adoption of innovative medical technologies as it is for innovative medicines

8. Taken together, these additional measures would help the Government fulfil its ambitions for NHS patients as well as enabling the UK to become a world leader in medical technology.

9. We would welcome the opportunity to discuss how we can work together to strengthen the provisions of this Bill during its Committee Stage and help address issues with the access environment for medical devices.

March 2020