Medicines and Medical Devices Bill

Written evidence submitted by the Association of British HealthTech Industries (ABHI) (MMDB15)

About ABHI and Reason for Submitting

1. The Association of British HealthTech Industries (ABHI) is the leading health technology industry association in the UK. We are a community of over 280 members, from small UK businesses to large multi-national companies. We champion the use of safe and effective medical devices, diagnostics and digital health technologies. The work of our members improves the health of the nation and the efficiency of the NHS.

2. The health technology (HealthTech) industry makes a vital contribution to economic growth in our country. The industry employs over 127,400 people across 3,860 companies, mostly small and medium sized enterprises (SMEs). Many companies are working closely with universities and research institutions. The industry is generating a turnover of over £24 billion and has achieved employment growth of greater than 5% in recent years. ABHI’s members account for approximately 80% of the value of the sector as measured by sales to the NHS. As the most highly regarded universal healthcare system in the world, the NHS in turn is dependent on technology produced by the industry to enhance the efficiency of services and drive continuous improvement in their delivery. The NHS has grown and developed partly on the basis of the UK’s historic ‘can do’ approach to engineering and problem solving.

3. HealthTech is accordingly an engineering-based industry, characterised by rapid, often iterative product design and development, and a large number of SMEs. It is one of two distinct subsectors of the broader Life Sciences. Future growth and success will mean the HealthTech sector being recognised in its own right. The sector has evidence, regulatory and adoption needs that differ significantly from those of the other, biopharmaceuticals.

4. We wish to comment on an amendment tabled by Alex Norris and Dr, Philippa Whitford relating to Clause  12,  page  7,  suggesting to leave out lines 26 and 27. We believe that this would be unfortunate, given that the Bill has been promoted by the Bill team as being pro innovation, enabling the UK to remain at the forefront of the global life sciences industry and leverage the potential of the NHS to demonstrate the value of health technologies in real world settings. Indeed, in the Bill’s Explanatory Notes, the only related document cited is the Life Sciences Sector Deal

5. We would also like to make suggestions to the proposed new clause tabled by Anne Marie Morris. Specifically, "National Medical Devices Registry and governance

(1) The Secretary of State must by regulations establish a national registry of medical

devices the purpose of which shall be-

(a) to record-

(i) every medical device implanted in, or

(ii) inserted into

a patient."

We suggest the word "inserted" is removed, as we believe that this will bring many technologies into scope that do not merit the maintenance of a registry, such as catheters, guidewires, needles, scalpels, orthopaedics plates and screws as well as dental implants, instruments and amalgams.

We also believe that the definition of "implanted" requires further clarification, to similarly exclude technologies not appropriate for a registry. We suggest consolidation of a(i) and a(ii), by using of the definition within Chapter 3 of Rule 8 of the Medical Device Regulation (EU Regulation 2017/725), and to restrict registry inclusion to those devices which would be considered as high risk, i.e. "All long term, surgically invasive devices, specifically those classified as Class III".

6. In addition, we suggest deleting clause (3) of the new clause, in light of any amendment made as a result of considering the above.

As tabled,

"… Manufacturers of such devices or components of such devices shall be required to provide the identification data of every device or device component to the registry on manufacture, and on its sale or change of ownership...",

would appear to be redundant, when amending the original wording to include only those products considered as Class III according to Rule 8. In all cases, the manufacturer will be affixing UDI onto the labelling of the product, again according to the Medical Device Regulation. This detail will be included into the registration of such products, either onto the European-wide database (EUDAMED) or the national database being proposed by the MHRA at time of leaving the EU.

June 2020

 

Prepared 10th June 2020