Safety of Medicines and Medical Devices

Baroness Finlay of Llandaff Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, like others I congratulate the noble Lord, Lord O’Shaughnessy, on securing this debate, and welcome the illuminating contribution from my noble friend Lord Carrington in his maiden speech.

I will focus in this debate on the role of the National Institute for Health and Care Excellence, which is building on its 20 years of experience, and will look forward to what needs to be done. I declare that I am vice-chair of a guideline review group on ME and chronic fatigue syndrome, a review that was precipitated by patient voices and has good patient representation on it. I should also declare that my husband has done a great deal of work on patient and family-reported outcome measures, which may be relevant here.

NICE guidance covers, as we all know, the safety and efficacy of interventional procedures and the managing of specific conditions and medicines in different settings. Its technology appraisals of new pharmaceutical and biopharmaceutical products, procedures, devices and diagnostic agents are recognised around the world. Any device under consideration must have a valid and current certification, which comes from the EU at the moment, and be registered with the Medicines and Healthcare products Regulatory Agency. But the EU certification process itself seems at times to be flawed.

NICE has now gone into formal partnership with the MHRA to try to share intelligence and understanding, and to monitor key issues. However, adverse event reporting is a major problem for them in this work because it relies on clinicians notifying such events, as through the yellow card scheme. As with any voluntary reporting system, reporting is incomplete—sometimes woefully so. There is an inherent bias to report the positive benefits of interventions in research papers and underreport adverse effects. There were 62,000 adverse incidents reported over the last three years, a third of which had serious repercussions. However, this is only a small number compared with those that have happened across Europe.

In recognition of this, NICE rigorously reviews its current guidelines and seeks the sources of adverse events. Unfortunately, safety outcomes are poorly addressed in randomised trials; large numbers of treated patients are needed to reliably detect uncommon yet serious events from sources such as large case series, surveys, registers and individual case reports. Sometimes unpublished evidence is the sole source of such information. There are databases, including the US Food and Drug Administration’s manufacturer and user facility device experience database, called MAUDE. Importantly, this is available to the public and is used by sources in this country.

It is essential that safety information and evidence of harm are collected and rapidly disseminated. NICE’s medicine awareness service, with its network of prescribing associates and monthly digest of important new evidence in medicine, aims to reach out widely. But it must be strengthened, and it must have a database to draw on.

Changes to NHS structures in recent years have made dissemination more difficult because responsibility for the implementation of such guidance does not fall to any single body—hence NICE’s agreement with the four nations, a document on safely introducing new procedures. But we need to do much more to strengthen this. All NHS providers should ensure their governance structures require reporting of outcomes, including adverse events, as well as dissemination of information. Clinicians undertaking any interventional procedure, and the suppliers of devices and equipment, should be routinely asked whether any complications have arisen in the short or longer term rather than just leaving it up to them to decide whether such complications are serious enough to report. Patients must be asked too.

All this data can be entered on a mandatory relevant national register, maintained to a sufficiently high standard to deliver evidence to clinicians for decision-making and for informed funding decisions. The quality of registers at the moment seems to be disappointingly variable. Without efficacy and safety information, problems will continue to go undetected and unpublicised.

I turn briefly to another aspect of the control of medical equipment, which is the problem of purchasing. The review by the noble Lord, Lord Carter, highlighted the wastage of duplication and variable pricing—but price is not the only determinant. I will relate a simple problem that concerns syringes. The bulk buying of cheaper syringes seemed to be a good idea. However, they had to be discarded because the plunger was loose-fitting, which meant that, on injection, the contents of the syringe were bypassed and we did not know how much of the drug had been injected into the patient. Contracting had to revert rapidly to a previous, reliable supplier.

Many pieces of tubing, wiring, cannulae et cetera are used every day in clinical practice. They must be of the highest standard and must not break or fracture inside a patient, because major surgery might be required to remove them. I suggest that the light-touch regulation that we have had in the EU should be replaced by a tighter, more rigorous system, so that things are manufactured to a higher standard and we know where the components have come from.

In the last moments of my speech, I remind the House of a speech by Baroness Jowell, to which the noble Lord, Lord O’Shaughnessy, also referred in his opening remarks. She was inspiring on 25 January last year when she called for adaptive clinical trials and the right of patients to try novel therapies. The parents of Charlie Gard, who had type 2 mitochondrial DNA depletion syndrome, wanted him to try nucleoside therapy, which had been tested on type 1 but not type 2 of the condition. The drug would have been taken orally and dissolved in milk—with the only known side-effect being diarrhoea—at an estimated cost of around £5,000. Charlie died before his first birthday, having been denied the possibility of trying this, and his parents, with whom I have had several conversations, live in their bereavement with the haunting thought, “If only we could have tried it”.

In her speech calling for a new approach to novel therapies, Baroness Jowell said:

“It is about the power of kindness, support for carers, better-informed judgments by patients and doctors, and sharing access across more and better data to develop better treatments”.—[Official Report, 25/1/18; col. 1169.]


Sometimes we must allow people to take risks for the benefits of others, because data is critical. Safety sometimes means that we have to allow carefully assessed risks rather than resort to inactivity, so that we can develop new evaluation processes.