Safety of Medicines and Medical Devices

Baroness Thornton Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I congratulate the noble Lord, Lord O’Shaughnessy, on initiating this important debate—which, of course, a few weeks ago he would have been answering himself. I declare my interests, which are in the register: my long association with the British Healthcare Trades Association and as a lay member of a clinical commissioning group. I also congratulate the noble Lord, Lord Carrington, on his spirited maiden speech and welcome him to the House. I thank all the organisations which have sent us briefings on this issue, and indeed our own Library. They have been very helpful indeed.

While my sympathies are totally with the mesh campaign, I am not going to refer to it because several noble Lords have spoken about it with enormous passion. My heart is with them but I am going to talk about other issues. In that regard I particularly welcome the contributions of my noble friends Lady Bryan and Lord Hunt. The House is aware that these matters are close to the heart of the noble Lord, Lord O’Shaughnessy, and his record of taking action to deal with issues of safety is to be commended, including the establishment of the commission of inquiry which is being chaired and led so wonderfully by his noble friend Lady Cumberlege. She has given us an up-to-date briefing and, indeed, enormous cause for hope.

This is a good time to reflect on the infrastructure that safeguards the introduction of medicines and devices into the UK as Brexit looms. The noble Earl spoke knowledgeably about this and I am grateful to him for his remarks. Like other noble Lords, I believe that we have a legislative and regulatory structure in the UK which is designed to protect patients and which has been material to the development of Europe-wide regulation from which we have all benefited. Several noble Lords have suggested that it is creaky, which I think is right, and that it has to keep up. That sentiment was well expressed by the noble Baroness, Lady Masham. Following a question posed not so long ago by the noble Baroness, Lady Walmsley, about the protection of patients from counterfeit medicines after the UK has left the EU, it was quite clear from the briefings that arrived in my mailbox that the UK pharmaceutical and biotechnology industry and organisations such as the Association of the British Pharmaceutical Industry and the UK BioIndustry Association are warning that leaving the EU without a deal would increase the risk of counterfeit medicines entering both the UK and EU supply chains.

The first issue that I would like to raise with the Minister is this. She will know that the falsified medicines directive—FMD—was published on 1 July 2011 and the legislation became effective on 8 February this year. It introduces tougher rules to ensure that medicines are safe and that the trade in medicines is rigorously controlled. This directive is being introduced to tackle the counterfeit high-price medicines that are a threat to public health worldwide. Does the Minister agree that a no-deal Brexit is likely to see the UK’s access to EU databases revoked, including the European Medicines Verification System, which is the heart of EU-wide compliance with the falsified medicines directive? Those proposals also present a risk to UK patients as unilaterally revoking FMD legislation in the UK would make the country a target for counterfeiters. Both the bodies involved in this area are very concerned indeed. Post Brexit we need to be assured that keeping fake or fraudulent medicines out of our supply chain is an absolute priority.

In this context, three things are important: making specific reference to the importance of co-operating on the regulation of medicines in the political declaration; making it clear that the UK and the EU will co-operate on protecting citizens from infectious disease and counterfeit medicines; and making it clear that the UK and the EU will agree closer collaboration on science and innovation.

The second issue I wish to raise stems from my support over many years for the British Healthcare Trades Association, which, having been founded in 1917, is one of the UK’s oldest and largest healthcare associations. My connection with the association arises partly because many years ago I met stoma nurses and discussed with them the work they do. I had conversations with them about the design and importance of support for stoma patients. Those conversations led to me getting to know the BHTA and realising that a lot of the devices, innovation and design we have in this country rest with small and medium-sized enterprises, which need our support. The BHTA provides them with the controls and regulatory framework that are so important in their relationship with the NHS and individuals. It deals with class 1 and some class 2 devices.

I also want to ask the Minister about the suppliers of other equipment and devices. The wide availability of medical devices from places such as Argos and through Amazon, and the purchase of apps and other monitoring devices, concern me greatly. Last summer I was sent copies of an Argos leaflet, available in a GP surgery outside London, advertising a whole range of equipment, including monitoring devices available in its stores. There was no suggestion in any of these leaflets that it might be a good idea to get professional advice before forking out on these items. We would want a physio to assess us before using walking aids—sticks and rollators—and to be measured up to make sure that we get the correct ones. A shower stool could be dangerous if you had Parkinson’s or a one-sided weakness or found it hard to stand. You would need an occupational therapist to work out whether you needed a chair with a back or with arms.

While we wish people to take responsibility for preventive care and self-care, and monitoring your own health and progress is to be encouraged, effective self-help is a complex thing. It requires ongoing education and support from health and social care workers. Done well, it is fantastic. I ask the Minister her view of the ease with which people can buy medicines and devices, either online or in places such as Argos. For example, is there any research to inform issues of patient safety, knowledge, usage or whether there are enhanced outcomes in terms of prevention or well-being?

Thirdly, I will briefly mention access to new devices for diabetics. Technology plays a key role in diabetes care, particularly for people with type 1 diabetes but also for people with type 2. Over the last few decades new technologies have transformed that. However, it is a postcode lottery. I ask the Minister: what are the Government doing to ensure that there is fair distribution and access to these very important technologies?

Finally, I think I need to ask the Minister about a recent leak concerning the NHS app, which is designed to be a digital front door, and the fact that it would appear it is not able to connect with any other providers of online GP consultations. The leaked NHS Digital briefing shows that a survey of 32 online consultation suppliers, such as LIVI and Babylon Health, found that none of the technology was able to integrate with the NHS app. This is quite a serious matter, because the NHS Long Term Plan commits to building the app into a single digital front door for patients to,

“provide advice, check symptoms and connect people with healthcare professionals—including through telephone and video consultations”—

all brilliant stuff. This is a serious issue of patient safety. I would like assurance from the Minister, given that she, her predecessor—the noble Lord, Lord O’Shaughnessy—and their boss have embraced this technology with such huge enthusiasm. I hope we are not heading into another technological black hole.

I congratulate all noble Lords on their contributions. This has been an absolutely excellent debate, one that I hope will provide support for those people campaigning on a variety of very important issues around patient safety, and will take the debate forward.