Safety of Medicines and Medical Devices

Earl of Dundee Excerpts

Thursday 28th February 2019 Lords Chamber

[The Earl of Dundee (Con)]

My Lords, it is a great pleasure to follow the noble Baroness, Lady Finlay of Llandaff; and, while listening to her guidance today, also to recall her enormous contribution to better health standards, made both inside and outside Parliament, not least in her capacity as a past president of the Royal Society of Medicine.

Intervening between Committee and Report on the Healthcare (International Arrangements) Bill, this debate comes at a useful moment. I join others in thanking my noble friend Lord O’Shaughnessy for introducing it. I congratulate the noble Lord, Lord Carrington, on an extremely interesting and well-informed maiden speech.

On the approved safety of medicines and medical devices, I will comment briefly on three aspects: current risks to the United Kingdom following Brexit; necessary expedients to help contain these risks; and, to raise medical safety levels both at home and overseas, initiatives and directions that the UK should pursue in any case.

Several adverse consequences appear to be threatened by Brexit. A recent government impact assessment already concedes that firms will be subjected to further costs arising from duplicate authorisations from the two regulatory bodies, the MHRA and the EMA. These extra costs in turn are also deemed to prevent or delay the availability of certain medicines in the UK.

Then the British Medical Association identifies an erosion of safety standards. That follows if the United Kingdom should fail to negotiate a withdrawal agreement next month. For, as alleged, much of what is now developed for the UK market would then go elsewhere instead, thus undermining the UK’s present access to new medicines; as well as setting back its own industries which produce medicines and medical devices. Additionally, it would become far more difficult for the UK and the EU together to supervise and monitor as competently as they now do. Safety standards would deteriorate as a result.

To seek to redress those unwelcome outcomes, the BMA offers sound advice. This calls for United Kingdom licensing to be consistent with that of the EMA, for a formal agreement between the MHRA and the EMA—a point also made by the noble Lord, Lord Carrington—so that they work closely together over medicine approvals, and for mutual recognition of medical device criteria.

Can the Minister endorse these recommendations? If so, that would give comfort to many who harbour misgivings, such not least deriving from a recent government Statement, which avoids mention of specific post-Brexit measures to uphold standards. Instead, it only comments rather vaguely that the UK and the EU would,

“explore the possibility of cooperation of United Kingdom authorities with”,

EU agencies,

“such as the European Medicines Agency”.

Post Brexit, to enhance medical safety at home and overseas, there are perhaps two relevant and parallel routes: that to be taken by the UK together with the EMA, and that to be directly followed here, thus in any case also benefiting the United Kingdom along with other countries internationally. The Royal College of Surgeons warns that the regulatory system across Europe is insufficiently thorough. Device manufacturers can quite easily shop around notified bodies in various countries until their own product receives approval. Therefore, the RCS advises that all new surgical procedures should be registered, with related data collected within relevant national audits before they are given to patients. Wisely too, the RCS urges the use of barcodes so that anything which might develop a fault in future can be traced to identify when it was used and by which surgeon.

Among various expedients to reduce other deficiencies, does my noble friend the Minister agree that here are two which the MHRA and the EMA together should be encouraged to deploy, and that the Government ought now to give that clear message pre Brexit and straightaway?

The EMA is to be congratulated on its launch of an adapted approach to clinical trials. By augmenting transparency of information its new provision, called the clinical trial regulation, will assist collaboration, information-sharing and decision-making between and within member states. However, the MHRA observes that this measure will not be enforced before the UK leaves the EU. In view of that, can the Minister assure us that the UK will definitely be part of this valuable scheme, nevertheless?

Several UK initiatives already stand to promote medical safety levels. Following much better data technology, the Royal College of General Practitioners correctly draws attention to the opportunity for simplification. To predictable advantage, a whole host of medical databases could be connected together. Equally, and where in the first place based on notes from doctors, reporting drug safety issues would become much more efficient whenever multiple systems are replaced by a single one.

To reflect a theme touched upon by my noble friend Lord O’Shaughnessy, so-called adaptive pathways, already alluded to by my noble friend Lord Bethell, represent the notion of bringing some new medicines to market more quickly than would normally happen otherwise—initially only for those in urgent need, yet where afterwards their results can supplement clinical trials all the same. On the preparedness in general to learn from medical errors and near mistakes, to which my noble friend Lady Cumberlege referred, there may now be, if perhaps belatedly so, a growing realisation that thereby not only will patients receive better treatment but vast sums of money can be saved.

All these are hopeful developments within the UK. However, what is needed is a pulling together of their different strands; and, not least, a proper attempt by the Government to achieve such co-ordination. A draft Bill to try to achieve this started in 2017, but that good intention may have drifted into the sands a bit, with a recent government comment that they will bring forward legislation when parliamentary time allows.

Does my noble friend concur that the introduction of such legislation, or, at any rate, an unequivocal commitment by the Government now, well before Brexit, to help promote essential co-ordination, as outlined, would be of considerable relevance and comfort to all concerned?

If also somewhat belatedly, at least there is too a new willingness to pay proper attention to feedback from patients about medical safety and its perceived inadequacies: a priority implied by the noble Lord, Lord Hunt of Kings Heath, the noble Baroness, Lady Masham of Ilton, and others. As a result, every NHS trust may be expected to appoint a patient safety director at senior level. Be that as it may, a final version of the strategy will not be published for another few weeks. Meanwhile, can the Minister assure us that the Government will give full backing to the proposal so it can still be expedited in the first part of 2019 without unnecessary delay?

In summary, my Lords, medical safety standards have to depend on solid and determined teamwork. To date, the Government may have been too laissez-faire. Instead, as necessary and to a far greater extent, they should now take a much firmer lead in assisting proper co-ordination, to the mutual advantage of all, both here and elsewhere.