Medicines and Medical Devices Bill

Baroness Penn Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Baroness Bennett of Manor Castle (GP) [V]]

Thank you, Madam Deputy Chairman; I resisted the urge to leap in. My contribution, anyway, will be brief. I want to build on my remarks in the previous group and, in particular, to address Amendment 108 in the name of the noble Lord, Lord Patel. I referred then to the article in the British Medical Journal about the medical-political complex. We have seen over the decades, again and again, in respect of medicines, pesticides and herbicides, situations where there has been growing concern about a particular chemical. Critics have come under tremendous pressure, including critics often from Governments—critics in official positions—from very large, powerful commercial interests to remain silent.

The noble and learned Lord, Lord Mackay of Clashfern, asked how anyone could not speak out in a situation where they saw that there was a danger or a serious cause for concern. We have seen again and again, however, situations where people, including Ministers in Governments, have come under tremendous pressure. Does the Minister not think that an amendment such as that proposed by the noble Lord, Lord Patel, would protect the Government, the individual and the public if she or one of her successors were in a situation where there was grave cause for concern but also very powerful multinational company forces at play?

[Baroness Penn (Con)]

My Lords, I thank the noble Lord, Lord Patel, for his amendment, designed to ensure that the public are always warned about concerns relating to a medical device where there is a clear threat to public safety. The Government agree that sharing information with the public—as well as the healthcare system—is important. Safety information is provided already to relevant special interest groups and through social media channels to ensure that messages are accessible and reach those affected who need to be aware or take action. This can include patients, healthcare professionals and members of the public. For example, MHRA recently urged users of Safe and Sound Infrared Ear Thermometers to check their product code and lot number due to a voluntary recall of specific lots because of a two-degree temperature overreading fault. This is a safety concern for members of the public who are monitoring their temperature, particularly in view of the pandemic. However, noble Lords are correct that it is critical that we do more to improve transparency and share more safety information to support patient safety. This has been made even more apparent in the findings of the report by my noble friend Lady Cumberlege.

Clause 35, along with Clause 13(1)(h)(iii), is designed to ensure that in future we can share information with key parts of the healthcare system, academia and the public in a considered and effective way. Under the current medical device legislation, MHRA does not have a clear legal basis to report all incidents involving medical devices occurring in the UK. By contrast, this has been common practice in the USA, via the FDA’s MAUDE database, and in Australia, via its DAEN database. Medicines legislation already enables MHRA to provide its interactive drug analysis prints, or iDAPs. It is therefore right that, via the information-sharing powers in this Bill, we are able to disclose in an appropriate manner all medical-device serious incidents. This will provide greatly improved transparency about the safety of medical devices in the UK.

Amendment 108 would place a legal requirement on the MHRA to disclose information to the public to warn them about concerns relating to a medical device where a clear threat to public safety had been determined. The amendment is unnecessary, as the MHRA would always share safety information with the public where it was necessary to do so. However, issuing warnings and safety information to the public needs careful management, a good understanding of the situation, full verification of the data and consideration of wider complexities. There is a high risk that mandating the disclosure of clear threats to public safety would commit MHRA to regular disproportionate direct communication to the public about safety issues that the public cannot act on.

The great majority of MHRA’s medical device safety alerts require healthcare workers, not members of the public, to take action to remove a public health threat. For example, MHRA’s national patient safety alert of 23 September 2020, addressing a clear threat to public health, instructed all hospital trusts and other healthcare providers on actions to be taken to avoid potential unexpected shutdown, leading to a complete loss of ventilation, when using the Philips Respironics V60 ventilator. Such messages should not be targeted and promoted to the public but should be made available passively to the public; for example, via access to a website. Otherwise, this would likely create unwarranted anxiety in the public about safety issues that they themselves could address because they required the intervention and clinical support of healthcare professionals.

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[Baroness Thornton (Lab)]

My Lords, I thank the Minister for her explanation in response to Amendment 114. My desire to explore the issue slightly more is partly a result of what the noble Baroness, Lady Cumberlege, and others have said. It is also partly a result of the very helpful discussions this morning about the time that it is going to take to get the protection on devices in place. If we have another mesh situation, will that be able to emerge in this period of time? If so, who will be responsible for saying that it is not a safe device?

[Baroness Penn (Con)]

I believe that responsibility will continue to lie with the MHRA. We have existing systems, such as the yellow card reporting system. The report by my noble friend Lady Cumberlege will have made an important difference; as we discussed earlier and in other sittings, not just the systems but the culture will need to change. That culture change has begun already.

We must get the systems right so that they operate as intended and deliver the results that we all want, but the noble Baroness, Lady Thornton, is right: in the space that there will be while we implement these changes, we need to be extra vigilant about these potential issues.

As I have already said, adverse incidents involving medical devices are published on the MHRA website. The job is to take all that information and make sure that it is not just dispersed but that people can build the bigger picture. That is what we are working towards.

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[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I am delighted to follow the noble Baroness, Lady Wheeler, and the noble Lord, Lord Patel, on these amendments dealing with regulatory divergence and Northern Ireland. I am a signatory to Amendment 119 in the name of the noble Baroness, Lady Thornton.

During Second Reading, I stated that there is the issue of potential regulatory divergence in relation to Northern Ireland, as medicines are a devolved power but medical devices are not. The Bill raises the possibility of future regulatory divergence between Northern Ireland and the rest of the UK, and that matter requires clarification, hence my support for Amendment 119. Both amendments seek to ensure greater accountability and transparency, to which the noble Lord, Lord Patel, referred, in that Parliament should receive reports on regulatory divergence as a means of oversight and accountability—with which I totally agree.

In some areas, this also relates back to the Northern Ireland protocol. There is no doubt that we must ensure the highest level of standards in relation to veterinary medicines, human medicines and medical devices. In his response at Second Reading, the Minister indicated to me that the Government intended to implement the Northern Ireland protocol, but I ask how that squares with the UK internal market Bill, this Bill and the need to ensure that we have the highest standards for medicines, medical devices and veterinary medicines—how does this all square?

I note that the NHS Confederation will continue to follow developments, analyse the implications for the health sector in the UK and push for as much clarity as possible on the implementation of the Northern Ireland protocol from 1 January 2021. It has also been stated that Northern Ireland will remain part of the UK customs arrangements constitutionally, so HMRC—not EU officials—and the UK’s Medicines and Healthcare products Regulatory Agency should administer the necessary controls. The MHRA remains responsible for placing the goods on the market and monitoring products once sold, but they will have to be approved through the European procedures because Northern Ireland will be treated as a member state in terms of regulatory decisions.

There is also concern that there will be delays in the import and export of medicines and medical devices, which need to continue to reach patients as quickly as possible, and we must ensure that any such delays are minimised, particularly during a pandemic. Avoiding delays caused by tariffs and regulatory barriers requires the UK and the EU to reach agreement on shared standards, such as manufacturing and inspections, so that goods can be licensed for rapid release into the UK market, or vice versa. With potential new checks and the lack of clarity on how the regulatory framework will apply, this could create unnecessary delays and impact on individual patients but also on medical practitioners.

There is also a need, as the Northern Ireland Affairs Committee said, for the Government to commit to covering all costs to businesses for complying with the protocol, which includes the whole area of medicines. I ask the Minister, the noble Baroness, Lady Penn, what discussions she and the noble Lord, Lord Bethell, have had with Minister Swann in the Northern Ireland Executive, as the Minister responsible for the Department of Health, about these issues, particularly in relation to the measures to minimise and mitigate the impact of divergence and how that will be achieved. We want to ensure the least impact from regulatory divergence on the availability and accessibility of medical devices and any other forms of medicine, whether for humans or for animals.

[Baroness Penn (Con)]

My Lords, we have unfortunately come to the end of our allotted time for this Grand Committee. I am afraid that I will need to adjourn our debate for today.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

That concludes the work of the Committee this afternoon. I remind Members to sanitise their desks and chairs before leaving the Room.