Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Lord Moynihan Excerpts

Monday 12th July 2021 Grand Committee

[Lord Moynihan (Con)]

My Lords, following on from the speech of the noble Lord, Lord Rooker, and particularly referring to the Secondary Legislation Scrutiny Committee, I shall cover a number of additional points that the committee raised and seek the Minister’s advice on them.

These are welcome regulations providing rigorous quality approval processes for all Covid-19 tests sold in the United Kingdom. It is essential that tests currently sold outside the NHS do not lead to an unregulated black market developing. As we emerge from the lockdown phase and work towards a more open market based on personal responsibility and extensive, easily available testing, confidence, clarity and a strong legal framework need to be the guidelines for all such products.

I have a number of questions for my noble friend the Minister in this context. Are the proposed minimum standards to be employed exactly the same as the standards already in place for tests used by the NHS? If not, will he set out the differences? Will the proposed mandatory processes be clear and well publicised for manufacturers of molecular and antigen tests? In particular, I am interested in the process envisaged for PCR tests since it focuses on genetic material—RNA—and is new in the mainstream pharmaceutical market. In this context, is it envisaged to widen all testing on RNA-based vaccines and medications? This area of medicine impinges on major ethical issues in an area of science that is gathering pace and that many see to have advanced 10 years or more as a result of the substantial investment made in RNA-based vaccines and medicines during the Covid period.

I invite my noble friend to follow up on the intervention by the noble Lord, Lord Rooker, regarding addressing the problems with the accuracy of lateral flow tests. They are disturbing and have rocked public confidence, with 75% not meeting the performance and quality standards of the NHS tests. If we want public support for test and trace, the whole edifice of confidence collapses if there is no confidence in the accuracy of the market-based tests whose failure in turn blurs, and indeed damages, confidence in NHS tests.

Like other noble Lords, I think timing is important. It is difficult to read these regulations and believe them to be, as described, “rapid”. As I understand the position, existing tests will continue to be available in the UK market and will be required to submit their application only by 1 September. The validation process will then have to be completed by 31 October for them to remain on the market on 1 November. That means that potentially substandard products can continue to be supplied to the market for another three months or more before these regulations take effect. It is regrettable that this approach was not considered a year ago, or very early this year at least.

Can the Minister provide an update on the recruitment process required to put the DHSC validation team on a more suitable long-term footing? When do we anticipate that it will be completed? Is £6,200 sufficient to cover the proposed costs? How many applications do the Government expect as a result of these regulations?

In closing, I note that local authority trading standards are being asked to ensure that unapproved tests are removed from sale. From my experience of the Consumer Protection Act and the many hours of debate on subsequent consumer protection legislation—as applicable to, in my case, the secondary ticket market, which trading standards are being asked to oversee—I know that one of the consistent calls from all sides of the House is to increase resources to trading standards. Trading standards are constantly subject to a regular flow of additional responsibilities generated by legislative action taken in Parliament. Is it the Government’s intention to ensure that any additional resources for these purposes will be made immediately available to trading standards? If so, what do they estimate these to be?

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the noble Lord, Lord Lansley.