Medicines and Medical Devices Bill

Debate between Baroness Watkins of Tavistock and Baroness Penn

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Baroness Penn (Con)]

My Lords, Amendment 94A in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic of great difficulty. As the noble Lord has personally testified, patients and families deal courageously with challenging conditions, and I know that the issue of medicinal cannabis is one that has had much debate.

As other noble Lords have pointed out, it is almost two years to the day that the Government changed the law to allow the supply of medicinal cannabis under misuse of drugs legislation. These regulations provide that medicinal products containing cannabis can be prescribed or supplied when certain conditions are met. These conditions are that the relevant cannabis product is a special medicinal product, an investigational medicinal product for use in a clinical trial or a medicinal product with a marketing authorisation.

I do not have specific figures for the noble Baroness, Lady Thornton, on the number of people who may have accessed cannabis drugs since then. I understand that the collection of data on certain private prescriptions was suspended because of Covid-19, but we can go away and look for the latest data and, when it becomes available, update the House. I believe I heard the noble Lord, Lord Field, say that there may have been 204 prescriptions. While I cannot endorse that figure, and noble Lords may feel it is low, it is considerably higher than the figure that the noble Baroness quoted for one year after the approval of medicinal cannabis. Therefore, if it is correct, progress is being made in the right direction.

Noble Lords are right that cannabis remains a controlled drug. I appreciate that the noble Baroness, Lady Meacher, already expressed views on this in our discussions with the MHRA on whether it ought to be a controlled drug at all. The noble Lord, Lord Field, also made that point. However, the changes to its restrictions are set out in the Misuse of Drugs Act 1971, the Misuse of Drugs Regulations 2001, for England, Scotland and Wales, and the Misuse of Drugs Regulations (Northern Ireland) 2002. Those regulations are not within the scope of the Bill.

What is within scope is when those medicinal products are regulated as a human medicine. The noble Lord is asking for regulations to provide for a specific licensing regime for medicinal cannabis. However, I stress that medicinal cannabis products already have a route to market. They fall within the scope of the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. It is entirely appropriate that they are subject to the same standards and requirements of evidence as any other medicine. The MHRA’s licensing process takes into account evidence of clinical efficacy. This includes consideration of all evidence supplied by the manufacturer. The regulators also inspect the factory where the medicine is to be made to make sure that supplies will be of a uniformly and consistently high standard. Companies can and do submit evidence of use from other countries, so there is no need to set an explicit requirement to consider efficacy internationally. If a company wishes to make a product available, it can within this regime.

Medicinal devices that administer medicinal products, including medicinal products containing cannabis, would also need to comply with the relevant provisions of the Medical Devices Regulations 2002. But a medicinal product in the UK must be safe. We have talked throughout the Committee about the critical importance of safety and the need to uphold standards. There is a paucity of evidence to support the quality, safety and efficacy of these products, meaning that very few hold marketing authorisations. To address this, the industry needs to further the evidence base and support the use of their products. Government is supporting this with a programme of two randomised control trials commissioned by the National Institute for Health Research. I hope that reassures the noble Lord, Lord Patel, as the National Institute for Health Research is engaged in assessing the evidence in this matter. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to plan future NHS commissioning decisions for the many patients who may benefit from these innovative medicines.

Just to pick up on the question of how many drugs may already hold licensing, I can say that there are three such licensed products, including Sativex for MS and Epidyolex for rare epilepsies. These drugs are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK. I say to the noble Baroness, Lady Jolly, that the drugs that have been licensed by the MHRA also have NICE approval for use in the NHS in certain appropriate conditions. As we heard in our meeting with the MHRA on Monday, it is able and willing to provide advice to researchers and companies that wish to conduct clinical trials and go through the licensing process for their products.

Cannabis-based products for medicinal use can also be supplied as unlicensed “special” medicines, as noble Lords have noted. A special medicinal product is a product that is manufactured or assembled according to the specifications of a specialist medical practitioner to meet the needs of a specific patient, in accordance with the stringent “specials” regime provided for in the Human Medicines Regulations 2012. Those unlicensed products have not been assessed by the National Institute for Health and Care Excellence for clinical or cost effectiveness. These are the foundations of NHS decisions about routine funding for medicines.

I appreciate that families with ill children, or patients themselves, would dearly love to have greater products available to them for more purposes, but this is not about creating new licensing routes. It is about companies coming forward and undertaking clinical trials and tests and it is about having the appropriate level of assessment and understanding of the impact. We are taking steps to improve the body of evidence available. When marketing authorisations are sought, they will be dealt with by the regulator, as they would for any other medicine. That may not be as quickly as some would like, but it is necessary to protect patients. On that basis, I hope that the noble Lord, Lord Field, is content to withdraw his amendment.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I have received requests from three noble Lords to speak: the noble Baronesses, Lady Finlay, Lady Walmsley and Lady Thornton. I call the noble Baroness, Lady Finlay.

Medicines and Medical Devices Bill

Debate between Baroness Watkins of Tavistock and Baroness Penn

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

Debate on Amendment 27 resumed.

[Baroness Penn (Con)]

My Lords, I thank noble Lords for their patience in waiting a full week to hear the response to what was a very useful and detailed debate. By way of compensation, I hope my response today reassures them that my time has been put to good effect: I am sure they will let me know if that is not the case.

Amendment 27 was tabled by the noble Lords, Lord Patel and Lord Hunt of Kings Heath. I reassure both noble Lords that the Government and the MHRA remain committed to ongoing international collaboration for the benefit of patients and the life sciences sector in the UK. The noble Lord, Lord Patel, set out some of the work the MHRA is doing to deliver on this commitment after the end of the transition period in his opening remarks on this group. I am pleased that noble Lords had the opportunity to hear from and question the MHRA directly on this and other issues this week. The Government heard the request from noble Lords to ensure that this is part of an ongoing dialogue with the regulator and parliamentarians.

In response to the noble Lord, Lord Hunt, I am reluctant to revisit the debate on alignment with the EU, which we have already had in this Committee, as well as in many previous debates. However, I reassure him that the UK is seeking mutual recognition with the EU on a number of areas, including batch testing, good manufacturing practice and continuing co-operation on pharmacovigilance. Certain aspects of medicine regulations are also harmonised at an international level and we are committed to those international standards in all areas. Indeed, to further support the aim of continued international collaboration, we have tabled Amendment 48, which I will come to shortly.

Turning to Amendment 118, tabled by the noble Baroness, Lady Thornton, I reassure her that this amendment is unnecessary. The MHRA and the VMD are both recognised globally as leading regulators and will retain their regulatory sovereignty regardless of any trade deals agreed. This will include the MHRA’s duty to consider the safety and efficacy of human medicines placed on the UK market. We will ensure that our new FTAs provide flexibility for the Government to protect legitimate domestic priorities; we have made this clear in our published approach to trade negotiations with specific trading partners.

On the price the NHS pays for medicines, the Government have made clear that this is not on the table for negotiations. The prices of branded medicines will continue to be controlled through the 2019 voluntary scheme for branded medicines pricing and access—VPAS. To be absolutely clear, the powers in the Bill do not enable regulations to be made that relate to the pricing of medicines or medical devices. In relation to data, the UK has a strong system to protect health and care data, as set out in the Data Protection Act 2018 and covered by the common law duty of confidentiality. Our objectives for trade negotiations are explicit that we will maintain the UK’s high standards of data protection. Again, to be absolutely clear, it would not be within the scope of the powers in the Bill under Clauses 1, 8 and 12 to create exceptions to or modify the provisions of our data protection legislation.

I heard in last week’s debate that questions of safeguards and data protection were at the heart of noble Lords’ concerns about the government amendments in the name of my noble friend Lord Bethell, to which I will now turn. These amendments would allow us to share information regarding these areas with international regulators or networks where this is required to give effect to international agreements or arrangements. I reassure the noble Lord, Lord Clement-Jones, and others about the motivation behind these amendments, which have been identified as necessary as part of the work to support the future relationship with the European Union, and to protect and preserve existing work that the MHRA does. On his question about source codes and algorithms in medical devices, I make two points. The UK-Japan trade deal, as with the EU-Japan trade deal that came before it, provides for safeguards against IP infringement on the question of source code and algorithms. However, to protect patient safety, and for effective regulation, there remains provision for a regulator or conformity assessment body to request source code and algorithms as part of their regulatory responsibilities.

The MHRA and the VMD presently share and receive intelligence from their counterparts through our membership of the European Union, which will come to an end. The MHRA and the VMD will be the UK’s independent, standalone regulators and require appropriate legal powers for their own reciprocal information-sharing arrangements with other nations and forums. Without this, the UK may not be able to comply with its information-sharing obligations under international agreements; nor would it be able to participate in international arrangements facilitating the mutual exchange of intelligence regarding medicines and medical devices. These exchanges of information are of vital interest to UK patient safety. For example, intelligence sourced from international regulators through the EU has ensured access to life-saving medical devices for UK patients during Covid and has enabled the MHRA to trace suppliers of non-compliant testing kits. This is vital and will continue to be so going forward.

Future reciprocal information-sharing agreements with international regulators will help the MHRA and VMD to take swift regulatory action on medicines and medical devices that pose a risk, removing them from the marketplace if necessary. I reassure noble Lords that this data is limited to the data that the MHRA holds. The MHRA will always anonymise patient data before it is shared internationally, under the powers in the Bill. For the purpose of pharmacovigilance, for example, the MHRA might need to share information received through adverse incident reports. However, the information would always be anonymised and is usually kept at a high level—for example, description of the safety signal, or a trend report to identify whether another country has also identified an issue with a particular product or manufacturer.

I appreciate that there has been some concern over the use of the word “person” in the drafting of the amendment. We used that word, rather than specifying particular organisations, because we anticipate that international agreements will require the UK to share information not only with overseas regulators but with other bodies, such as overseas Governments, international organisations such as the World Health Organization, and international networks such as the International Medical Device Regulators Forum.

The wording is necessary because it provides the breadth, for example, to share data with international networks that might not be formalised. If we were to list all the organisations, networks and relationships that might be involved, it would simply not be possible to keep that list live on the face of legislation. Debate has been categorical that the MHRA needs to be a front-footed international regulator, and to limit it to the relationships it has now, rather than being flexible with regard to new regulatory forums or relationships, would restrict that aim.

The noble Lord, Lord Patel, asked pertinent questions about the data protection provisions in the new clauses. I have to admit to noble Lords that I had the same reaction about their potentially circular nature when I first read them, and I hope that I shall be able to unpack their effect here. The GDPR sets out seven key principles for processing personal data, the first of which involves “lawfulness, fairness and transparency”. We are providing a lawful basis for processing personal data by inserting these powers. That does not remove the other protections under the Data Protection Act that apply to the sharing of information under these clauses.

Where personal data are sensitive personal data, which are now called special category data, the GDPR requires further conditions, under Article 9, to be met for the processing to be lawful. Patient health data are a type of special category data. Relevant conditions under the GDPR, of which there are 10 that could be relied on to disclose patient data under the clause, would include “explicit consent”, reasons of “substantial public interest”, health or social care reasons, or public health reasons.

The GDPR also sets out further requirements where personal data are to be shared internationally. There must be an adequacy decision in place confirming that the third country or international organisation ensures an adequate level of data protection. In the absence of an adequacy decision, appropriate safeguards must be put in place that provide enforceable data subject rights and effective legal remedies, which can take the form of a legally binding agreement or contracts between parties. In the absence of an appropriate safeguard, data could be transferred only if it were

“necessary in order to protect the vital interests of the data subject or another natural person where the data subject is … incapable of giving consent.”



Equivalent safeguards for personal data and commercially sensitive information are already in place in Clause 35 for information relating to medical devices. This is solely to facilitate the appropriate sharing of information to give effect to international agreements and arrangements. They are critical to ensuring we can regulate effectively and uphold high standards of patient safety and access.

Amendment 45, in the name of the noble Baroness, Lady Thornton, seeks to achieve what is already standard and long-standing practice. Existing arrangements already ensure that timeliness, openness and transparency are key to the fees regime, and they are published online and available on GOV.UK. We will ensure that the industry and any other interested stakeholders know about any future fee changes in good time. We have laid statutory instruments to implement changes at the end of the transition period, as the cost of providing some regulatory services has fallen, so the fees charged will need to be reduced.

On the basis of the reassurances I have provided on Amendments 27, 45 and 118, I hope the noble Lord, Lord Patel, feels able to withdraw Amendment 27, and that the noble Baroness, Lady Thornton, is similarly assured and will not move her amendment.

[The Deputy Chairman of Committees (Baroness Watkins of Tavistock (CB)]

I have received a request to speak after the Minister from the noble Baroness, Lady Thornton.