Cannabidiol (CBD) can now be prescribed by doctors

A small but important step towards making it easier to access the medicinal cannabis extract cannabidiol (CBD), which is a non-hallucinogenic extract and believed to be beneficial for a number of ailments and for pain relief.

There are very few products available in New Zealand, but was they become available the way is clear for doctors to prescribe them. Currently approval has to be sought through the Ministry of Health.

Australia has already dome something similar so it will allow New Zealand to access the same CBD based drugs that become available in Australia.

Peter Dunne has driven this, getting the approval of the National dominated Cabinet.

Beehive notice:


Government to ease restrictions on Cannabidiol

Associate Health Minister Peter Dunne says New Zealand is to remove restrictions around cannabidiol (CBD), in line with international developments.

CBD is a substance found in cannabis that has potential therapeutic value. It has little or no psychoactive properties, yet it is currently a controlled drug under the Misuse of Drugs Act.

“At present CBD products for therapeutic use are only available if approval is given by the Ministry of Health.

“I have taken advice from the Expert Advisory Committee on Drugs (EACD) that CBD should not be a controlled drug and am pleased Cabinet has now accepted my recommendation to make this change.  Therefore, I am now taking steps to remove restrictions accordingly.

“In practical terms, the changes mean CBD would be able to be prescribed by a doctor to their patient and supplied in a manner similar to any other prescription medicine.

“Australia has already taken a similar step while other countries are also responding to emerging evidence that CBD has a low risk of harm when used therapeutically.

“This change is about future-proofing access to CBD products, as the reality is that there will continue to be barriers beyond New Zealand’s control to people accessing such products from overseas,” says Mr Dunne.

Currently there is a limited range of CBD products made to a standard where prescribers can be sure the products contains what is claimed – and strict import and export restrictions on products sourced from other countries, which will continue to impact the supply of CBD products in New Zealand.

“However, we do know of at least one CBD product in development made to high manufacturing standards that will contain two per cent or less of the other cannabinoids found in cannabis,” said Mr Dunne.

The changes will include removing requirements for:

  • Ministerial approval to prescribe;
  • pharmacies, prescribers, and wholesalers to have an import licence, and to meet certain requirements for storage, and the maintaining of controlled drug records and stock keeping.

Prescriptions would be allowed for up to three months’ supply, rather than one month. These measures can be achieved by amending the Misuse of Drugs Regulations 1977 in the first instance, pending any future amendment of the Misuse of Drugs Act.

Legal challenge of MoH on medical cannabis

A post by Russell Brown at Public Address asks Is the Ministry of Health acting outside the law on medical cannabis?

The key barrier to the use of medical cannabis – or to even discovering what its uses might be – has long been marijuana’s illegality under the Misuse of Drugs Act. But what if it transpired that a key component of cannabis is not, and has never been, controlled by the act? And that heavy restrictions on its use and importation are in fact taking place outside the law?

…it’s the subject of an intended legal challenge notified by Nelson lawyer Sue Grey.

From a letter from Grey to Associate Minister of Health Peter Dunne outlines her claim.

NOTICE OF INTENDED LEGAL CHALLENGE RE STATUS OF CANNABIDIOL “CBD” UNDER THE MISUSE OF DRUGS ACT

I write on behalf of various interests who seek urgent clarification of the legal status of Cannabidiol “CBD” under the Misuse of Drugs Act.

In summary:

  1. CBD is not explicitly scheduled under the Misuse of Drugs Act.
  2. CBD does not meet the statutory criteria under Section 3A for scheduling under the Misuse of Drugs Act1 as there is no evidence that it poses a very high, high or moderate risk of harm to individuals or to society.
  3. Information obtained under the Official Information Act and from the Ministry of Health website identify a significant disagreement within the New Zealand government officials over the status of CBD under the Misuse of Drugs Act.!!Some from the Ministry of Health claim CBD is indirectly covered by Schedule 2 (1)(2)2 as a Class B drug based on their assessment that it is “an isomer of tetraDhydrocannabinols” (THC). In contrast, the government’s leading expert analytical chemist, Dr Keith Bedford and his expert team at Crown Research Institute Environmental Science and Research, “ESR”, have published a paper explaining why THC is not within this definition, because CBD has a different chemical formula, structure and function to THC and accordingly it is not caught within the definition of “an isomer within the same chemical designation”
  4. Dr Bedford’s expert view has been made clear to the Ministry of Health and to his colleagues on the government’s Expert Advisory Drug Committee (“the EADC”). The minutes of the EADC’s April 2016 identify no scientific or legal reason why Dr Bedford’s view is wrong. It appears the different views relate solely to policy consideration and perhaps vested interests, although it remains unclear to me why some members of the committee would prefer to continue to treat CBD as if it is illegal. Clearly government policy cannot override the law that was written by Parliament, and in particular s3A of the Misuse of Drugs Act.

Grey also claims.

  • Medicines containing CBD are (in my view unlawfully) treated as if Ministerial approval is required under Regulation 22 of the Misuse of Drugs Regulations, resulting in considerable bureaucratic hoops and hurdles, delay in access and unnecessary cost for patients who are typically already very ill, and their families who are typically already very stressed.
  • The complex situation is compounded by the apparent policy of Medsafe (disclosed in documents obtained under the Official Information Act) to attempt to prohibit foods or other products which contain CBD from being sold as foods or dietary supplements, apparently because CBD is also scheduled under the Medicines Regulations. I can find no lawful basis for this policy and do not understand how Medsafe can reconcile this with the law or with the FSANZ proposal to approve the sale of hemp seed foods for human use.
  • I understand from other Official Information Act responses and from recent coverage on TV3’s Story (on the use of CBD as a supplement for managing Alzheimers by Mr Robinson, father of Nicky Evans) and other documentation that I have been shown, that NZ Customs have been instructed to seize products that contain CBD at the NZ border. This is despite the expert advice to the Ministry of Health that CBD has no known harmful effects to individuals or society and it is outside the scope of the Misuse of Drugs Act schedules.
  • The current policy of Ministry of Health, and adopted by NZ Customs to treat CBD as if it is covered by the Misuse of Drugs Act to try to justify the seizure of products which contain CBD, is in my view unlawful, unreasonable and unjustified as CBD is not covered by the Misuse of Drugs Act.

Grey asks for the Court to make declarations on:

A) CBD is not explicitly prohibited under the Misuse of Drugs Act

B) CBD has a different chemical formula and different structure and function to THC and accordingly it is not restricted as “an isomer within the same chemical designation as tetrahydrocannabinols”and is not covered by Schedule 2 of the Misuse of Drugs Act ;

C) CBD does not meet the criteria of section 3A for classification under the!! Misuse of Drugs Act, as it does not cause a very high, high or moderate risk of individual or social harm;

D) Products containing CBD do not require Ministerial approval to be prescribed or recommended under Regulation 22(1) of the Misuse of Drugs Act because CBD is not subject to that Act.!!Regulation 22(1) of the Misuse of Drugs Act does not apply or is being unlawfully applied to medicines and other products containing CBD

E) The actions of NZ Customs in seizing or restricting access into or out of New Zealand of products because they contain or may contain CBD is unlawful.

It will be very interesting to see how the Court deals with this, if it has to go that far. Brown posts:

Grey has received a response from Customs minister Nicky Wagner, explaining that Customs – which has been seizing medical CBD products at the border –  is guided by the advice of the Ministry of Health, which is that “CBD is a class B1 controlled drug as it is an isomer of tetrahydrocannabinol. Customs has acted on that basis.”

“How long do we have to wait? We’ve got people who are sick now,” Grey said. “They don’t want to have to wait another six months or two years for the advisory committee to align itself with what the law already says.

“I’m still hoping that the Minister of Health will get some control over his officials and ask what are you guys doing, why don’t we just listen to what the experts are saying and accept that it’s not covered by the Misuse of Drugs Act and it doesn’t need to be? Then we won’t need to go to court. But if they don’t come to that conclusion fairly quickly, then we will file in court.”

 

 

Mother admits giving daughter medicinal cannabis

One News previews an item they will show on Sunday tonight (7 pm) – ‘I have no regrets’ Mum says medicinal cannabis was the only thing to help her daughter

A Hawke’s Bay mother has come clean about giving her daughter cannabis for a severe medical condition.

Toni Matich says the number of her daughter’s seizures dropped dramatically and her quality of life improved when taking medical cannabis.The teenager suffers from Dravet Syndrome, which causes her to suffer hundreds, sometimes thousands, of seizures a day.

Mum Toni Matich says the number of seizures dropped dramatically, and her daughter’s quality of life improved when taking medical cannabis.

Ms Matich, who has four other children, is speaking for the first time about her decision to break the law and give her daughter the drug.

“I have no regrets about what I did for my child. She had the best quality of life from her illness for that two years’’.

Ms Matich says her cannabis mixture was created with the help of professionals, including botanists and pharmacologists.

“I also consulted with medical cannabis specialists to understand (any interactions) with the medication she was on.”

Ms Matich says she had the cannabis mixture, rich in a compound called cannabidiol,  tested to make sure it was free of any toxins before she gave it to her daughter.

Other medications before that had caused horrific side effects, she says.

“One of them schizophrenic type behaviour, so violent, extremely violent.’’

Ms Matich speaks about her efforts to obtain medical cannabis, and the impact it had on her daughter, tonight on Sunday.

It’s going to be interesting to see this tonight. Matich is a leading campaigner for the safe use of medicinal cannabis

Now Ms Matich has set up a lobby group, United in Compassion New Zealand, to establish legitimate trials for medical cannabis.

Health officials are working closely with Ms Matich on her proposals.

The group is raising money through the ‘’Givealittle’’ website to fund its work. Details can be found at here.

New Zealand Drug Foundation has helped give that a good kick start with a $2,000 donation – Givealittle page.

Dunne approves medicinal cannabis for teen in coma

Just breaking –

Assoc Health Minister Peter Dunne has approved cannabidiol (medicinal cannabis) for Alex Renton

Good news for Alex and his family.

Minister approves one-off use of Cannabidiol product

Hon Peter Dunne
Associate Minister of Health

9 June 2015

Minister approves one-off use of Cannabidiol product ‘Elixinol’

Associate Minister of Health Hon Peter Dunne has today approved on compassionate grounds the one-off use of Elixinol, a cannabidiol (CBD) product from the United States to be administered by clinicians treating Wellington patient Alex Renton.

The Minister said that “despite the absence of clinical evidence supporting the efficacy of CBD in patients with Mr Renton’s condition status epilepticus, my decision relies on the dire circumstances and extreme severity of Mr Renton’s individual case”.

“I have considerable sympathy for the family of Mr Renton who face an incredibly difficult situation. Understandably they want to do the best for their son, and they believe that this option is worth trying.

“I have also considered the absence of any other treatment options, the low risk of significant adverse effects, and the conclusion reached by the hospital ethics committee from an individual patient perspective.

“Ministerial approval in this case does not extend beyond Mr Renton’s application and should in no way be construed as setting a wider precedent,” he said.

Mr Dunne said the advice he has received was that there remains a lack of clinical evidence supporting the use of CBD products in sufferers of Mr Renton’s condition.

“The fact that Elixinol does not have a supporting pharmaceutical testing regime means this application has been reviewed as a stand-alone case and weighed against the severity of his condition.

“My officials will be closely following the outcome of studies overseas, including those due to commence next year in Australia, on the efficacy of different products. Those results will help to inform future legislative and regulatory considerations here in New Zealand.

“I am satisfied with the way the DHB and the Ministry have handled this matter. After exhausting all recommended and standard treatment options, CCDHB made a clinical decision last week to complete the necessary documentation to apply for approval to use a non-standard medicinal cannabidiol treatment for Mr Renton. That application was lodged with the Ministry yesterday afternoon. Ministry officials considered the application as a matter of priority and briefed me this morning.

“I hope for a positive outcome for Mr Renton and his family,” Mr Dunne said.