(3 years, 1 month ago)
Commons ChamberI congratulate the hon. Member for Inverclyde (Ronnie Cowan) on bringing forward this debate. As has been said, this is the second day in a row that we are debating this important issue, and I appreciate the depth of feeling on it. I know there are many Members who wished to speak today but who have not been able to, including the hon. Member for Gower (Tonia Antoniazzi) and my hon. Friends the Members for Dover (Mrs Elphicke)—Teagan Appleby is her constituent—and for South Derbyshire (Mrs Wheeler).
As I said yesterday, I have huge sympathy for the issues, problems and struggles that patients and their families are facing. They are trying desperately to access these drugs. No one wants a resolution to this more than me and the Secretary of State, who, as has had been said a number of times, changed the law when he was Home Secretary to try to resolve this situation.
Yesterday, I confirmed the Government’s absolute commitment to take an evidence-based approach to unlicensed cannabis-based products for medicinal use in order to ensure that there is evidence that they are effective but also safe. A number of colleagues have asked why the Government cannot accept non-randomised controlled trials as evidence. The Government are not involved in the process of licensing the medicines; that is done by the independent regulator. The Government’s responsibility is in changing the law, which has already been done, but I very much take the point that we should be able to influence the speed at which the licensing process can take place. I will point out in my remarks how we are doing that.
I am willing to work with colleagues across the House, whether that is the hon. Member for Manchester, Withington (Jeff Smith), with his private Member’s Bill, or SNP Members. This is a non-political issue that we want to see resolved, but the Government are not the body responsible for licensing medication or assessing the worthiness of the research, whether that is randomised controlled trials or any other form of evidence.
Before I set out what is being done, I want to provide an update on the matter of Bedrocan, because the hon. Member for North Tyneside (Mary Glindon), my hon. Friend the Member for Reigate (Crispin Blunt) and the hon. Member for Inverclyde all mentioned it. The commercial agreement between Transvaal Apotheek and UK specialist medicines manufacturer Target Healthcare is progressing, and the MHRA and the Home Office are working with those companies to ensure that all regulatory standards for manufacturing these medicines are met.
On 16 September, the Home Office granted a six-month licence, which will allow Target to move on to testing its equipment and procedures using cannabis from the Netherlands and validating their production of Bedrocan oils. Departmental officials continue to work closely with the Dutch Government, Transvaal, the Home Office and the MHRA to ensure continuity of supply until domestic production can be established, and I will keep the House updated on progress. I hope that is a little glimmer of hope on that issue.
I am aware that there is huge patient demand for access to medical cannabis, and that many are convinced it is helping them with an array of medical conditions from chronic pain to cancer. To date, however, much of the evidence suggesting cannabis could be effective as a treatment is anecdotal. While that has some strength in observational studies, from the regulator’s point of view it often needs more robust clinical data.
There are two licensed cannabis-based products and one synthetic cannabinoid that mimics the effects of THC, which is the element I think most campaigners are looking for. We do have Sativex to treat severe spasticity in adults with multiple sclerosis, Epidyolex for the treatment of two rare forms of epilepsy and Nabilone for nausea and vomiting, so we are making some progress. I hear from campaigners that the THC element remains outstanding. Those products that are licensed are proof that when manufacturers invest in clinical trials, the potential of cannabis as a medicine can be realised. Clinical trials generate the data needed by our world-leading medicines regulator, the Medicines and Healthcare products Regulatory Agency, to assess for safety, and it is then for NICE to approve the NHS funding element of that.
Let me reiterate that this is a multiple-step process. Orkambi has been mentioned; the issue with that was not licensing—it had a licence—but NHS funding. If we get to the licensing stage, the Government can do a huge amount more to fast-track things and be involved in discussions. Licensing, however, is an independent process, and that is the point at which we are stuck.
I used that parallel as an example. I totally respect my hon. Friend’s point about licensing progress—of course she is correct—but this is about thinking imaginatively to work our way through the problems to the right solution. That applies desperately in this situation, as it did with Orkambi.
Absolutely. The Government are committed to trying to resolve the blockage to licensing, which is the main factor hindering the prescription of these drugs. The Health and Social Care Secretary changed the law when he was Home Secretary, but that was not the end of the issue, and that is why we are taking these next steps. It is important not to dismiss the importance of licensed medication. We know from history that when medication that may have a good clinical effect is not tested thoroughly, there can be grave consequences, just as with thalidomide. The safety of a medicine is as important as its efficacy. I am not casting aspersions on cannabis, but the regulator has responsibility for all medicines, and it takes that issue very seriously.