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Ireland’s HSE to offer first medical cannabis products from October

CannEpil was announced as the first drug to be made available through the programme

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Ireland HSE offer medical cannabis
CannEpil was announced as the first drug to be made available through the programme

The Irish Health Service Executive (HSE) has announced that the first cannabis-based products will be available through the Medical Cannabis Access Programme from next month.

In a joint committee meeting held on Wednesday 29 September, CannEpil was announced as the first drug to be made available through the program from mid-October.

Ireland’s Health minister Stephen Donnelly announced funding for the Medical Cannabis Access Programme (MCAP) in January, almost two years since the legislation was signed off in June 2019.

The programme will offer access to cannabis-based medicines to people living with one of three qualifying conditions. These include intractable nausea and vomiting associated with chemotherapy, severe treatment-resistant epilepsy and spasticity associated with multiple sclerosis (MS) where patients have failed to respond to authorised treatments.

The meeting saw officials from the Department of Health and the Health Products Regulatory Authority (HPRA) outline the current state of the MCAP programme and the Ministerial License system.

The suppliers of two products, CannEpil and Tilray are said to have confirmed their prices to the HSE, but Tilray has yet to announce its availability date.  Two more cannabis-based products have been added to the schedule but suppliers are not thought to have current plans to supply the Irish market.

Morris O’Connor, the assistant national director of primary care reimbursement, announced that two additional products were expected to be added to the schedule in the coming weeks and that the programme may be extended for longer than the initial five year pilot period.

He stated: “There are currently four cannabis products on the schedule and two more to be added to schedule one of the regulations in the coming weeks. I understand that one of the products in the schedule namely CannEpil is expected to be available in October, subsequent to the introduction of the necessary legislation.”

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According to Lorraine Nolan the chief executive of HPRA, since the MCAP regulations came into force in June 2019, 34 applications have been made for cannabis-based products.

Of these four cannabis oils have been placed in schedule one of the regulations, and two dry herb products have completed the final HPRA review and are awaiting a ministerial decision. Five are currently under active review.

Nolan commented: “The first cannabis-based products are expected to be made available to Irish patients through MCAP in October 2021. Once these are accessed by Irish patients, the HPRA will receive any reports of suspected adverse events and review them for any signals of concern regarding the safety of the product.

“The HPRA will also have a role in investigating any quality issues that may arise and coordinate any action that might be subsequently required.”

Doctors are asked to register patients who may benefit from this treatment to the HSE including the condition they are being prescribed for.

The HPRA will be monitoring patients for adverse effects over the coming weeks once the medication is available.

The MCAP programme has been criticised by patients who are still waiting for access to products despite the introduction of the scheme in 2019 under then Minister for Health, Simon Harris.

O’Conner also highlighted that 192 ministerial licenses have already been issued for 67 individuals who access medication from the Netherlands.

In July a direct funding scheme was announced to remove the need for patients to pay for these prescriptions up front and then apply for reimbursement from the Government.

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Advocacy

Medical Cannabis Awareness Week returns with call for real world evidence

Three years since the law changed supporters call for regulators to consider real world evidence

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Medical Cannabis Awareness Week returns from 1-7 November

Medical Cannabis Awareness Week will return to mark three years since the law changed, with a fresh call for regulators to consider real world evidence and ensure fair access for patients. 

Led by patient advocacy group, PLEA (Patient-Led Engagement for Access), Medical Cannabis Awareness Week takes place in the first week of November and brings together patients, doctors, supporters and stakeholders across the sector to raise awareness of the plea for fair access to medical cannabis.

Medical Cannabis Awareness Week logo

On 1 November 2018, medical cannabis was made available on prescription in the UK. Three years on, only three prescriptions have been issued by the NHS.

Out of desperation, patients are now funding private prescriptions and up to 1.4 million patients are forced to turn to illegal methods. 

Patients unable to afford and access treatment are suffering due to the fear, stigma and financial barriers preventing them accessing this safe, and potentially life-changing, treatment. 

The first Medical Cannabis Awareness Week to take place last year saw over 50 speakers and 1500 live attendees, with 60,000 people reached. 

This year, taking place from 1-7 November, Medical Cannabis Awareness Week 2021 aims to highlight the real need for real-world evidence in evolving access to this new treatment, calling for fair access to medical cannabis treatment on the NHS.

Patients from across the UK will be sharing their stories about the life-changing impact of medical cannabis and their difficulties in accessing a prescription.

medical cannabis patient Gillian Flood

Medical cannabis patient, Gillian Flood

Gillian Flood, member of PLEA’s Management Committee who is prescribed medical cannabis for fibromyalgia and PTSD, commented:“Life before and after cannabis medicine really is like night and day, before constant pain left me feeling hopeless and depressed, unable to function, trying all different medications, dealing with awful side effects. After, well, I feel like me again, I can enjoy a meal, go for a walk, sleep and manage my pain better while having a clear head.

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“While all this is amazing the financial cost bring a whole new anxiety around how I afford my medicine, every month I struggle to pay for it, I don’t want to go back to my life before, not now I know I don’t have to suffer so much, there is a relief available, my plea is that this medication becomes available through the NHS so no patient has to endure the pressure of trying to fund a private prescription.”

How you can get involved

There are several ways supporters can get involved, with virtual events taking place each day, aimed at patients, doctors, supporters and anyone else with an interest in medical cannabis.

Join patients, advocates and organisations to help raise awareness, address the stigma and call for change by sharing a video or audio clip or written post of your PLEA on social media using the hashtag #MCAW2021. 

Have a conversation about medical cannabis. Ask questions, and connect with medical cannabis supporters, patients, and allies via the #MCAW2021 hashtag on social media.

Help spread the word about fair access to medical cannabis treatment by writing to your MP.

Abby Hughes, chair of PLEA commented: “Having witnessed the transformation of quality of life for many patients like myself, it is hard to accept that the only access many have to medical cannabis treatment is through the private sector. Why is there enough evidence for a private pain consultant or psychiatrist to prescribe unlicensed cannabis medicines, yet the same treatment is not afforded to patients via the NHS, which was created to provide universal, comprehensive and free health care?

“With only three NHS prescriptions having been issued three years on from Sajid Javid’s promise to make medical cannabis treatment accessible, my plea for Medical Cannabis Awareness Week 2021 is that the real need for real world evidence is explored and accepted in evolving access to this new treatment.”

We’ll be sharing more details of all the events and how you can get involved in the coming days. 

For full event listings and to access resources for patients, doctors and supporters visit www.pleacommunity.org.uk/mcaw

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Cannabis and driving – Calls for urgent law reforms to protect patients

A new report highlights the myriad of issues facing medical cannabis users on the road. 

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Campaigners are calling for urgent reforms to driving laws

Campaigners are calling for urgent reforms to legislation around cannabis and driving as patients risk criminalisation.

A new report, published by the Seed Our Future campaign, highlights the myriad of issues facing medical cannabis users on the road. 

The group, which lobbies for the decriminalisation of cannabis, is calling for the removal of THC from Section 5 and reverted to Section 4 of the Road Traffic Act 1988 (RTA), where evidence of impairment would be required to convict.

Following an amendment to the RTA in March 2015, any driver who is stopped by the police can expect to be swabbed and if THC is identified, a blood test is enough to secure a conviction. 

This means that anyone who has consumed cannabis within the last few days – or has been subject to passive smoking – may be over the zero-THC limit and at risk of prosecution, regardless of whether there is evidence of impairment.

According to the report, the effects of THC have generally gone after two to four hours when inhaled, longer when orally ingested. And the research conducted by Seed Our Future has found no cases of any serious vehicle accidents which conclusively shows cannabis as the primary cause.

Patients facing criminalisation

Although patients who hold a legal prescription have a right to a medical defence, this is not always taken into account and those who are unable to afford one are being criminalised and having their licences removed without any evidence of driving impairment, argues the report.

In 2021 alone, Seed our Future has supported four people with legal cases in relation to cannabis driving offences. All four suffer from long-term conditions and fit the criteria for obtaining medical cannabis prescriptions, with one holding a legal prescription at the time and two accessing one shortly after arrest. 

In all cases, the subjects had taken cannabis several hours before driving and there was no evidence of any sign of driving impairment. 

According to the report, in 75 per cent of the cases, the police had “no idea” that the law had changed regarding medical cannabis in 2018.

Seed our Future claims that the inclusion of cannabis in Section 5 of the RTA was based on “political and financial  motivations” and not “conclusive road safety data”. 

The report concluded:  “The concept that a laws exists which leads to a criminal record, fines and a driving disqualification  without any evidence of the defendant being a risk to road safety, whom  with all likelihood is practicing their inalienable human right to health by utilising globally recognised essential medicine risks jeopardising the fabric and integrity of the judicial system and exposes the incompetence of the police force in being able to gather evidence sufficient to constitute criminal intent.”

Calls for standardisation

Guy Coxall, the groups founder is also asking for standardisation of labelling for medical cannabis prescriptions and health practitioner advice in regard to guidance for driving.

He has called on the Cannabis Industry Council to ensure all importers of cannabis-based products have the correct labelling, in line with UK regulations, and all practitioners provide advice to patients in line with guidance from the Medical Cannabis Clinicians Society (MCCS).

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It states: “Patients, on higher THC products especially, should be warned not to drive or operate heavy machinery whilst under the influence of side effects of a cannabis product… Like any other medications that may cause impairment, do not drive or operate a vehicle if feel impaired or are unsure if you feel impaired and follow your physician’s advice.”

Coxall said:This lack of standardisation places a number of UK patients in danger of criminalisation and penalties.

“We would also like to see discussions surrounding basic educational programmes for Police Officers, CPS solicitors and Judges to update on legislative changes and provide information to reduce stigma and medical and financial discrimination against medical cannabis users/patients, as identifying ways of protecting medical cannabis users who are at present unable to afford private medical prescriptions until availability is made accessible on the NHS.”

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GMC must address “serious concerns” over BPNA guidelines on prescribing medical cannabis

An open letter has been signed by more than 30 parents and carers of children with intractable epilepsy

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Ben Griffiths, 11, who suffers from treatment-resistant epilepsy

Dozens of parents whose children rely on medical cannabis have written to the General Medical Council (GMC) outlining their concerns about the blocks to access.

More than 40 parents and carers of children who are prescribed medical cannabis to treat conditions such as intractable  epilepsy have signed an open letter to the GMC outlining a number of issues.

Earlier this week, 50 medical professionals issued a letter  from the Medical Cannabis Clinician’s Society, expressing their concerns over the British Paediatric Neurology Association (BNPA) guidelines on prescribing unlicensed cannabis medicines.

The letter, which was published in the Times,  claims that the guidelines play a part in denying medical cannabis treatment for children with epilepsy, many of whom have had their lives significantly improved it.

It includes a comment from an expert witness in a case brought to the GMC by the BPNA, reported as stating that: ‘The BPNA position that only paediatric neurologists should initiate treatment is not supported by other national guidance, and probably not in the best interests of children, as it may impede debate and research into the appropriate use of Cannabidiol (sic) in refractory epilepsy’.

In response the parents of these children say they felt moved to write directly to the GMC to express “serious concerns”.

In the letter they stress that they feel the guidance issued by the BPNA plays a significant role in preventing doctors from prescribing.

It states: “The quote from the GMC expert witness highlights that the BPNA guidance is ‘not supported by other national guidance’.

“From our knowledge of these matters, we believe that this other national guidance may well be that from NHS England, NICE and indeed, to some extent, your own.

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“If a professional medical body is producing guidance that is ‘probably not in the best interests’ of the patient cohort at issue, surely that matter should be investigated and then appropriate steps taken to ensure that the guidance in question is corrected?

GMC must address families denied access

Ben Griffiths, 11, who suffers from treatment-resistant epilepsy, and mum Joanne.

Speaking with Cannabis Health, Joanne Griffiths, mother of Ben, 11, who suffers from treatment-resistant epilepsy, said: “We felt moved, as a group of parents and carers with loved ones affected by intractable epilepsy, to write to the GMC to ask that they address what we believe to be serious concerns relating to the BPNA position on the prescription of medical cannabis following the recent article in The Times.”

Joanne added: “This is clearly extremely concerning and needs to be addressed. The almost total block on NHS prescriptions is causing untold huge emotional and financial distress to our families.”

Open letter

The parents also highlight the ‘dramatic’ benefits of medical cannabis for these children, but says that the lack of prescriptions on the NHS means parents are facing the ‘daunting and emotionally and financially draining’ burden of finding the money to fund the medication privately.

The letter states: “Without exception our loved ones have shown very significant improvements in their symptoms following the administration of medical cannabis.

“In many cases, the improvements could more accurately be described as ‘dramatic’ with children who were suffering up to hundreds of seizures a day and being rendered semi-comatose due to the effects of conventional pharmaceutical drugs being able to lead almost normal drugs.

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“However, since the law change, to the best of our knowledge, there have only been three NHS prescriptions for whole-plant extract medical cannabis for cases of paediatric epilepsy. The rest of us have had to face the daunting and emotionally and financially draining burden of having to find up to £2,000 a month to fund the medicine privately

“Raising this money is a massive challenge in normal times. During Covid, it has been impossible.”

The parents have now called on the GMC to address their concerns, stating that failure to do so may mean doctors may be “unwittingly failing” in their ethical duty to patients.

The letter is open for other parents to sign and can be accessed through the Boisterous Ben Facebook page or Twitter.

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