Medicines and Medical Devices Bill

Lord Willis of Knaresborough Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Willis of Knaresborough (LD) [V]]

My Lords, I suspect that much of my contribution will echo that of other noble Lords as this vital piece of legislation makes its way through our House. I say “vital” not simply because the overall market in pharma-medical devices and medical products is worth some £74 billion a year, but because without this legislation the chaos that derived from a no-deal Brexit would be catastrophic for patients and their families.

Let us be clear: this Bill is short on detail and accountability and places far too much power in the hands of the Secretary of State. The one overriding consequence is to deliver a system of regulation that is inferior to and more expensive than the one that currently exists. That is quite a triumph.

That said, there are elements of the Bill I welcome, particularly the registry of medical devices, and the greater enforcement powers over rogue operators, which are so clearly needed, following the excellent report by the noble Baroness, Lady Cumberlege—a report, incidentally, whose recommendations are embarrassingly absent from the Bill.

I welcome a more realistic approach to prescribing and extending the ability to prescribe to more healthcare professionals. What is not clear is how this is to be achieved. Will the Human Medicines Regulations 2012 be amended by a new clause in the Bill? Will a common framework for competency, based on the Royal Pharmaceutical Society’s competency framework, be included as a requirement for any new professional prescribing group? If not, where will its standards come from? Do the Government intend to address the issue of competency for those who do not prescribe but who administer drugs to patients? A safe administering practice is crucial, particularly in community settings, where often prescribing colleagues are in short supply.

Like many Peers, I am deeply concerned about aligning future regulatory systems. I welcome assurances given by Ministers, but we have to anticipate a situation where divergence of regulation may lead to the non-compliance of either our products or those of the EU and the US, our two major suppliers. Currently, the UK is a key player in the global regulation of medicines. Despite having only 3% of the global market, compared to the rest of Europe with 25%, we are able, through the MHRA, to punch well above our weight, as the noble Baroness, Lady Masham, so clearly stated. Three years ago, the UK was a rapporteur, assistant rapporteur or scientific advice co-ordinator for one in five EMA regulatory decisions—decisions that were accepted across the globe. The UK is a global player because of our excellent science but also because it has access, through the EMA, to the EU. Should we not retain the closest possible alignment with the EU, when the regulatory cost and impact burden might see huge problems for the UK medicines industry, with a rapid decline of market authorisations?

Finally, given the surge in personalised medicine which will drive so many novel treatments, I hope that the Bill can be amended to make it a requirement that, should a health professional offer a patient treatment using a fast-track drug, therapy or device with which they have had or will have a pecuniary interest, it must be declared. That is not the case today and it certainly should be. The report by the noble Baroness, Lady Cumberlege, looked particularly at areas such as fertilisation treatment, where there are some very important differences to be made. I look forward to further examination of the Bill in Committee but regret the fact that we have to have this at all.

Health Protection (Coronavirus, Restrictions) (Leicester) Regulations 2020

Lord Willis of Knaresborough Excerpts

Wednesday 29th July 2020 Lords Chamber

[Lord Willis of Knaresborough (LD) [V]]

My Lords, no doubt these regulations are technically competent, and no doubt they will be used as other communities—perhaps Oldham or Peterborough—become the latest virus hotspots. What they do not do is to put into legislation the tools that would give local health authorities and local councils the data to act more confidently and effectively to minimise disruption to lives, businesses and social structures in some of our poorest communities.

On 6 June, the Covid-19 Clinical Information Network recommended the co-ordination of all clinical and health records of patients admitted to hospital with suspected Covid. Has this happened in Leicester, and has it been published? Is this data available to those who require it, and why is there not a requirement to do so via this SI? On 22 June, the Scientific Pandemic Influenza Group on Modelling recommended linking health with clinical data and data from other systems, including employment and social security. Why has this recommendation not appeared in the SI? It would enable a much more vigorous examination of outbreaks, something Leicester has urgently needed, yet nothing has appeared in these regulations. Why is there no requirement for all healthcare workers, patients and care home residents in Leicester to be repeat-tested for Covid-19 during the lockdown? Why has universal serological testing not taken place to seek out antibody carriers in Leicester?

Research data will increasingly play a vital role in managing future outbreaks of Covid, and these regulations were an opportunity to grasp that. Sadly, we have missed that glorious opportunity.

[The Deputy Speaker (Lord Faulkner of Worcester) (Lab)]

The noble Lord, Lord Cormack, has withdrawn from this debate, so I call the noble Baroness, Lady Uddin.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) Regulations 2020

Lord Willis of Knaresborough Excerpts

Friday 24th July 2020 Lords Chamber

[Lord Willis of Knaresborough (LD)]

My Lords, I understand the difficulty the Minister has in dealing with these regulations and have great sympathy for him, but I hope the Government note what has been said about having a better way of scrutinising them. The current system is clearly not fit for purpose and we need something different for September.

However, my key frustration is the almost total lack of published evidence to support any of the regulations at all. Those on 17 and 20 July still have no published evidence. Those coming out today, on face masks, and particularly those on visitors to care homes, have no evidence whatever. I ask the Minister to commit to publishing evidence for ministerial announcements alongside those announcements. This is clearly possible; he does not need to come here to do it. That gives confidence to the public and to those who want to adhere to the regulations.