Amendment 15

Part of Medicines and Medical Devices Bill - Report (1st Day) – in the House of Lords at 9:00 pm on 12th January 2021.

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Photo of Baroness Penn Baroness Penn Baroness in Waiting (HM Household) (Whip) 9:00 pm, 12th January 2021

My Lords, Amendment 15 in the name of the noble Lord, Lord Field of Birkenhead, deals with a topic that has been discussed at length in both Houses. The noble Lord spoke eloquently in Committee, sharing his experience of medicinal cannabis and the benefits he obtains from it.

I will first address a separate but related matter that a number of noble Lords raised concerning the supply of certain cannabis-based medicines from the Netherlands. I know that the noble Baroness, Lady Walmsley, and others in the House have received distressing calls from patients and families who have relied on these imported medicines. The Parliamentary Under-Secretary of State for Prevention, Public Health and Primary Care, Jo Churchill, met Alfie Dingley’s family and the patient group End Our Pain on Saturday to provide reassurance and an update on the action that we are taking.

I reassure noble Lords that we are working urgently with the Dutch Government to find a solution that will enable patients to access the medications they need. I cannot discuss the details of the proposals today, but I commit to provide noble Lords with a further update when I can.

Returning to the matter at hand, I reassure noble Lords that the issues raised by the noble Lord, Lord Field, in his amendment sit firmly with the Department of Health and Social Care, not the Home Office. While I am pleased that the noble Lord finds some relief with this medicine, the fact remains that the vast majority of cannabis-based medicines have not been assessed by the MHRA for safety, quality and efficacy, nor by the National Institute for Health and Care Excellence for clinical and cost effectiveness. I believe that that is the nut that the noble Lord is trying to crack with his amendment. We are also trying to crack it as a Government, but from a slightly different approach.

As the noble Baroness, Lady Meacher, noted, the Government changed the law on 1 November 2018, to reschedule cannabis-based products for medicinal use in humans. This moved these products from Schedule 1 to the Misuse of Drugs Regulations 2001—no legitimate use—to Schedule 2, to permit the lawful prescribing and supply of cannabis-based medicines when certain criteria are met. In particular, cannabis-based medicinal products can be prescribed by one of three routes: as a “special medicinal product”, subject to the “specials regime” contained in the Human Medicines Regulations 2012, prescribed by a specialist medical practitioner; as an investigational medicinal product for use in a clinical trial; or as a medicinal product with a marketing authorisation.

Given that there is insufficient evidence on the safety, quality and efficacy of these unlicensed medicines, it is entirely appropriate that these products are subject to these stringent conditions. It would be inappropriate to establish parallel arrangements or to subject medicinal cannabis to any less stringent assessment than is the case for other medicines used for serious or chronic conditions. To do so would undermine the integrity of our medicines regulation in the UK. Also, it would run counter to the noble Lord’s objective to see the placing on the market of high-quality, standardised cannabis-based medicinal products that are safe and effective.

As noble Lords heard in Committee, we have removed some of the barriers to how these products are imported into the UK and we now see a wider range of products available to prescribers. I reassure noble Lords that we are also taking steps to improve the body of evidence available. NHS England and NHS Improvement have made good progress to establish a national patient registry for patients receiving medicinal cannabis. This has been developed with clinicians and aims to cover all clinical indications and all licensed and unlicensed medicinal cannabis products prescribed on the NHS and privately. The registry will be an important step forward in the collection of uniform data to support monitoring and evaluation of prescribing activity, patient safety and clinical outcome data. This data, and that produced from clinical trials, will help inform future NHS commissioning decisions. The registry is currently being piloted, with a view to further rollout next year.

On clinical trials, the National Institute for Health Research and NHS England are working together to set up a programme of two randomised controlled clinical trials. These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to inform future NHS commissioning decisions for the many hundreds of patients in the UK with refractory epilepsy. This is a pioneering area of research and we hope the trials will start as soon as possible. However, I must emphasise that industry also needs to step up and invest in robust clinical trials to improve understanding of how patients might benefit from these products.

I must say to noble Lords that it is not the job of the independent regulator to generate evidence. To do so would undermine the independence and objectivity of medicines regulation in this country, including the pharmacovigilance of medicines. The safety of the public will always come first, and the producers of medicinal cannabis must be prepared to subject their products to scrutiny by the MHRA and by NICE.

When marketing authorisations are sought, they will be dealt with by the regulator, as with any other medicine, taking into account their herbal origin. The MHRA offers, and has given, regulatory and scientific advice to companies and researchers to support their research and development of these products. I reassure noble Lords that the MHRA is committed to using the latest techniques and takes a patient-centric approach to medical regulations.

Regarding further discussion of this with the MHRA, I will take that request away. I think we all welcomed June Raine’s approach in the meeting with Peers last year on this Bill. I am also conscious at this exact moment in time of the pressures on the MHRA to support our national effort on vaccination rollout. I am sure we will get a positive response, but there might be a small issue around timing that we will have to take away and address.

As we have seen with the Pfizer and BioNTech Covid vaccine, and, indeed, with the other Covid vaccines that have come online, the MHRA upholds the highest standards and will authorise the use of medicines only following the most rigorous scientific assessment. This is essential to ensure that the public can have trust in the regulator and the medicines they use. Licensed products, such as Sativex for multiple sclerosis and Epidyolex for rare epilepsies, have gone through this process and are proof that cannabis-based products can meet the high standards of quality, safety and efficacy that we rightly expect in the UK.

On that basis, and on the basis of the Government’s ongoing efforts to ensure that we have a strong evidence base to provide further access to these medicines, I ask the noble Lord, Lord Field, to withdraw Amendment 15.