Medicinal cannabis products to be legalised

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Medicinal cannabis products to be legalised

Post by notsofasteddie » Thu 26th Jul 2018 10:12 pm

Medicinal cannabis products to be legalised

July 26, 2018

Billy Caldwell and Alfie Dingley both have a severe form of epilepsy
Image caption Billy Caldwell and Alfie Dingley were granted licences to allow them access to cannabis oil

Specialist doctors in the UK will be able to legally prescribe cannabis-derived medicinal products by autumn, the home secretary has announced.

Those that meet safety and quality standards are to be made legal for patients with an "exceptional clinical need", Sajid Javid said.

As it is a devolved matter, it will require legislative change before it is enforced in Northern Ireland.

Legalisation follows high-profile cases involving severely epileptic children.

Many had previously been denied access to cannabis oil.

Others forms of cannabis will remain illegal.

'Exceptional circumstances'

Mr Javid's decision was made after the chief medical officer for England, Prof Dame Sally Davies, and the Advisory Council on the Misuse of Drugs said patients with certain medical conditions should be given access to the treatments.

Their advice was part of a review into medicinal cannabis launched by the home secretary following an outcry over Billy Caldwell and Alfie Dingley being denied access to cannabis oil.

The parents of the boys, who have rare forms of epilepsy, say it controls their seizures.

Charlotte and Billy Caldwell
Image caption Charlotte Caldwell said her son, Billy, would now be able to live a "normal life"
Image: Reuters

The Home Office recently granted them licences to access the treatments.

Mr Javid said: "Recent cases involving sick children made it clear to me that our position on cannabis-related medicinal products was not satisfactory.

"That is why we launched a review and set up an expert panel to advise on licence applications in exceptional circumstances.

"This will help patients with an exceptional clinical need but is in no way a first step to the legalisation of cannabis for recreational use."

Cannabis-derived medicines: What you need to know

Billy Caldwell's mother, Charlotte, said Mr Javid's announcement had been made on her son's 13th birthday.

"For the first time in months I'm almost lost for words, other than 'thank you Sajid Javid'," she said.

"Never has Billy received a better birthday present, and never from somebody so unexpected...

"But, crucially, my little boy Billy can now live a normal life with his mummy because of the simple ability to now administer a couple of drops a day of a long-maligned but entirely effective natural medication."

Stormont with a sign saying 'no entry'
Image caption The Department of Health says legalising medicinal cannabis in NI is a devolved matter for local politicians
Image: Pacemaker

A Department of Health spokesperson said: "The rescheduling of cannabis-derived medicinal products is a devolved matter and requires legislative change.

"The Department of Health notes the advice provided by experts during the two-part review commissioned by the Home Secretary.

"Consideration will be given to rescheduling cannabis-derived medicinal products in Northern Ireland in line with the rest of the UK

"In the interim, clinicians may still apply to the Home Office Expert Panel should they wish to use a cannabis-based medicine in the treatment of a patient."

Cannabis plant
Gareth Fuller/PA Wire
Image caption The government and medicines regulator are to develop a clear definition of what constitutes a cannabis-derived medicinal product

Cannabis is classed as a Schedule 1 drug, meaning it is judged to have no therapeutic value but can be used for the purposes of research with a Home Office licence.

The decision by the Home Office will put certain cannabis-derived products into Schedule 2 - those that have a potential medical use - and will place them in the same category as cocaine and heroin, among other drugs.

The Department for Health and Social Care and the Medicines and Health products Regulatory Agency (MHRA) will now develop a clear definition of what constitutes a cannabis-derived medicinal product so they can be rescheduled and prescribed, the Home Office said.

In the meantime, clinicians will still be able to apply to an independent expert panel on behalf of patients wishing to access these products.

The home secretary said licence fees for applications made to the panel will be waived, and those already granted will not be charged.

'Safer medicines'

The home secretary's decision was welcomed by campaigners and health experts.

Donna Kinnair, from the Royal College of Nursing, said the decision was "very welcome".

Dr Tom Freeman, senior academic fellow at King's College London, said Mr Javid's decision would have a "substantial impact on research by facilitating the development of safer and more effective medicines".

Former justice minister Sir Mike Penning, who was among those appealing for Alfie Dingley to be given a special licence for medicinal cannabis, welcomed the announcement but said there were still unanswered questions about which treatments would be rescheduled.

"Any move to restrict medical cannabis in the UK to a very narrow range of derived products, each requiring full pharmaceutical trials, thereby blocking out the many products available overseas, will lead to great disappointment and be a missed opportunity."


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Re: Medicinal cannabis products to be legalised

Post by notsofasteddie » Wed 8th Aug 2018 02:39 pm

Canada Update - Medical Marijuana to be permitted in UK

Jonathan Deverill
Published 7 August 2018

Following the recent high-profile case of Billy Caldwell, the British Home Secretary announced recently that medical cannabis is to be made available to UK patients on prescription.

Cannabis-derived medicines that meet certain safety and quality standards will be reclassified by fall 2018, so that they can be prescribed by specialist clinicians without the need for a Home Office licence. All fees for permits to use medicinal cannabis are to be waived in the interim. There will be no change in the law on the recreational use of cannabis in the UK, which will remain illegal.

The proposed changes to UK legislation in relation to medical cannabis will of course be of particular interest to medical cannabis companies based in Canada.

Before any medicinal cannabis medicines could be sold or prescribed in the UK they would, under the current statutory framework, need to receive the relevant market authorisation. In this context, the following steps are relevant.

Step 1 – choice of licensing authority / intended market for medicine

A marketing authorisation may be obtained from either the UK Medicines and Healthcare products Regulatory Agency (MHRA) or the EU European Medicines Agency depending in part on where the producer wishes to market their medicine: the UK only or throughout the EU.

Step 2 – engagement with Home Office

A Canadian cannabis-based drug manufacturer may need to bring their drug into the UK for clinical trials (see step 3 below). Early engagement with the Home Office in anticipation of any clinical trials may be prudent if a licence for importation is required.

Step 3 – clinical trials

A marketing authorisation will only be issued if clinical trials have proved that the medicine: a) successfully treats the condition it was developed for; b) has acceptable side effects; and c) meets high safety and quality standards.

Step 4 – re-evaluation

If granted, initial marketing authorisations are valid for five years, and then may be renewed on the basis of a re-evaluation.

Notwithstanding the changes announced last week, the marketing authorisation process is demanding. Any overseas medicinal cannabis company wanting to take advantage of the recent change in policy would be wise to start ensuring now that it can prove the efficacy of its product.


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