Medical cannabis – battles and brick walls

In his latest NZ POLITICS DAILY up Bryce Edwards looks at The Battle over medical marijuana, which has many useful links on the topic.

This focusses on Helen Kelly’s battle with cancer and her other battle, with medical bureaucracy in trying to get access to a medical cannabis product that’s unavailable in New Zealand.

Kelly has highlighted a very contentious issue, particularly as there seems to be accelerating moves towards allowing the growing of cannabis and the production of medical products, most notably for us in Australia and the US.

One of the biggest problems here is the lack of available credible research on the effectiveness and the safety of medical cannabis.

However for someone who is dying of cancer safety shouldn’t be too much of an issue, and allowing some alleviating of suffering and comfort of mind should be much higher considerations.

It’s a bit bizarre that they don’t want us to be able to take lethal drugs to end our lives if we so wish, but they don’t want us to be able to take comfort drugs that have long proven to be virtually non-lethal.

One of the best posts on Kelly and medical cannabis is by Russell Brown at Public Address – Helen Kelly’s letter.

While looking at Kelly’s situation specifically Brown also considers the wider situation.

In particular, there should be some better thinking around palliative care. It doesn’t make sense to treat every application to improve the quality of life of a dying person the same as a bid to give a sick child an experimental treatment. The criteria are ostensibly specifically dedicated to cannabis products, but they’re actually entirely general. We need this to be done better and more transparently.

As I’ve noted before, the use of cannabis in palliative care represents a particular ethical case. If a patient testifies that the treatment does in fact improve their quality of life and ease suffering in a way that approved pharmaceutical products have not, that should count for a great deal. The case for preventing access becomes much, much harder to make.

But many doctors and the Ministry of Health seem reluctant to go there.

Peter Dunne has previously said to me that the criteria are only guidelines and don’t determine his ministerial decision. But he’s a minister who likes to emphasise that he acts on expert advice. And perhaps he has no choice, given his limited stock of political capital in this area.

This is, after all, a government that has chosen to brand itself on never changing the law – either the Misuse of Drugs Act or the Medicines Act – no matter what the evidence. That was, remember Justice Minister Simon Power’s response to the Law Commission’s view that there was “no reason why cannabis should not be able to be used for medicinal purposes in limited circumstances” by declaring ”There is not a single solitary chance that as long as I’m the Minister of Justice that we’ll be relaxing drug laws in New Zealand.”

Power is no longer Ministry of Justice, but every single initiative to improve the way we deal with drugs in New Zealand still has to climb around this entirely political edict. It’s the key reason we have little prospect of dealing sensibly with a fast-changing environment.

During the last election campaign, Prime Minister John Key paid visits to several Kapiti Coast and Porirua schools. When he wasn’t insisting that his favourite music was One Direction, Key fielded this question from a student at Kapiti College:

Asked whether he would legalise medical marijuana, he told the school assembly: “This is the fundamental message. Drugs are bad for you.”

Yes, the Prime Minister really did say “Drugs are bad, m’kay?”

Dunne cops much of the flak for Government unwillingness to address medical cannabis or the wider issue of recreational use.

But there’s nothing Dunne can do about changing laws on this if National won’t allow it, and they are the ones with the most votes by far, and the most reluctance to do anything. I don’t think we will get cannabis law reform, nor any meaningful attempt to consider any change to our stance on the drug, while National are in government.

It seems that National doesn’t want to give a medical inch for fear of a recreational mile. But that’s out of touch with the world that is quite rapidly changing it’s attitude to cannabis and criminality.

Dunne seems to be trying to move things as far as he can under existing law, and Brown believes that medical cannabis could be easily allowed under the current laws.

The good part is that the criteria for applications like Helen’s can be improved without changing the law. They’re not part of the Medicines Act. I think Peter Dunne needs to ensure,  as minister, that the process is fundamentally improved. Because a process so designed as to frustrate all medical cannabis applications will not prevent the use of cannabis in this way.

If the process was improved then access to medical cannabis could be made much easier for those who seek it.

In the end, we do need to revisit the law – as the Law Commisison and two Parliamentary select committee inquries have already said. Palliative care is not the only element of medical cannabis policy. But it’s certainly the place we should start, given the growing use of cannabis this way in defiance of the law. When we fail to do this, we impose risk and stress on desperately ill people and their doctors – and we’re saying we don’t care enough to properly regulate for their safety.

No one is going to prosecute Helen Kelly for treating her symptoms with cannabis. But what the system currently says is that it can’t and won’t make that safer for her. We need to do better than this. A lot better.

And it really shouldn’t take much to make things better for people like Kelly who are suffering as they die.

And there are potentially many people who are not living through death sentences whose lives could possibly be substantially improved, or at least given some hope, if the Ministry of Health re-thought and improved their processes for approving medical cannabis.

Kelly’s cannabis request rejected

Helen Kelly’s oncologist applied to the Ministry of Health to be legally allowed to ease her discomfort as she dies with cannabis related products. This has been rejected, with the MoH asking for more information and claiming the oncologist hasn’t provided it.

This has been a rapidly evolving story that I haven’t had time to cover properly.

Some links to information as the story unfolds:

Stuff: Former union boss given two months to live – nearly a year ago

“But it doesn’t cure me, it just gives me time … I don’t know what the prognosis is now, but it’s still death and it’s still months.”

Kelly continues to source cannabis illegally while she awaits the outcome of her application to the Ministry of Health for medicinal cannabis.

Currently her application has been deferred while the ministry waits for more information from her oncologist.

But Kelly says she’s been asked to provide things she doesn’t have access to, and the ministry should be stepping up and helping source information.

“Why doesn’t the Ministry of Health have a list, which they’re satisfied meets their criteria? Instead you have all these people Googling away and Skyping American producers trying to work out what they’re saying.

“I’ll try and find the information they want and see whether that goes through and, if it doesn’t, then I don’t know what I’m going to do.”

Kelly’s situation is very sad – she’s dying. And it’s also sad that the Ministry of Health is making it hard for her to obtain what she wants legally.

Russell Brown has a good post at Public Address on developments: Helen Kelly’s letter.

There’s some concerning issues but some possible positives:

The good part is that the criteria for applications like Helen’s can be improved without changing the law. They’re not part of the Medicines Act. I think Peter Dunne needs to ensure,  as minister, that the process is fundamentally improved. Because a process so designed as to frustrate all medical cannabis applications will not prevent the use of cannabis in this way.

In the end, we do need to revisit the law – as the Law Commisison and two Parliamentary select committee inquiries have already said. Palliative care is not the only element of medical cannabis policy. But it’s certainly the place we should start, given the growing use of cannabis this way in defiance of the law. When we fail to do this, we impose risk and stress on desperately ill people and their doctors – and we’re saying we don’t care enough to properly regulate for their safety.

But the situation with Kelly is awful.

No one is going to prosecute Helen Kelly for treating her symptoms with cannabis. But what the system currently says is that it can’t and won’t make that safer for her. We need to do better than this. A lot better.

Surely we can do a lot better.

Brown attributes most of the blame on the National caucus and by implication John Key.

 

Ministry of Health approves medicinal cannabis treatment

The parents of 7 year old girl Zoe Jeffries have obtained Ministry of Health approval fore 6 months use of Sativex. This is one of a total of 97 ministerial approvals for the cannabis derived medicine. It shows that it is possible now to get medicinal cannabis, although it isn’t easy.

And it isn’t cheap – Zoe’s parents are fund raising to try and cover the costs. See the bottom of this post for details.

It’s also far from easy caring for a girl with uncontrolled epilepsy, spastic quadriplegia cerebral palsy, microcephaly, cerebral visual impairment, is tube fed and who has had severe seizures since birth.

It shouldn’t be this difficult getting medicines that may help.

NZ Herald reports Ministry approves cannabis treatment for 7-year-old girl:

The parents of a 7-year-old girl have the green light to use medicinal cannabis to control their daughter’s severe seizures.

Karen and Adam Jeffries have Health Ministry approval to give their daughter Zoe the cannabis oil-based mouth spray Sativex for the next six months.

“It has been a long time coming, it’s great news,” mum Karen Jeffries told the Herald on Sunday.

The Jeffries began researching medical cannabis in 2013 in the hope of finding a drug to reduce the hundreds of seizures their daughter suffers each day.

Two years is a long time to obtain a medicine that may help. And there is only one cannabis based medicine currently available in New Zealand. It may or may not be the most appropriate to try.

The Rotorua girl is understood to be one of the youngest in New Zealand to receive the medicine. Another child, a 5-year-old, has been approved use.

“We have been on it for a couple of weeks so it is early days but she is a lot more settled already.”

“You want to try to control the seizures that cause additional brain damage, but also you want to allow your child a life, to be awake and not drowsy, or have the strength to stand or just hold their head up high,” her father Adam said.

The medicine hadn’t dramatically changed the number of seizures Zoe suffers but this week, teachers at Glenholme School in Rotorua said she returned to school happier.

“When she started school this week they saw a completely different child,” Karen Jeffries said. “She was a lot more settled and was able to cope with noise and was a lot less distressed.”

It’s a lot to hope for a miracle cure for such serious medical problems, but parents should be able to hope for some improvement in their child’s condition. It’s good to see that that may be being achieved.

But it is expensive for the Jeffries.

Sativex is the only approved cannabis-based medicine registered with Pharmac but is not funded. It can be prescribed by a doctor but each case needs Health Ministry approval. To date, there have been 97 ministerial approvals, and there are currently 27 users of Sativex.

Each bottle lasts around four weeks and costs $1050. The Jeffries paid for the first script with a well-timed tax return and have set up a Givealittle page to help fund repeat scripts.

Givealittle ‘Meds for Zoe’: Please help Zoe continue with the chance at a better quality of life…

For information on medicinal cannabis in New Zealand: United in Compassion

United In Compassion NZ is a non profit lobby for the re-introduction of Medicinal Cannabis and a community for patients and carers. We are on a journey to access medicinal cannabis through Education, Compassion and Logic.

Dunne on the medical cannabis situation

Associate Health Minister Peter Dunne has blogged this week on the current situation regarding the availability and prospects for future availability of medicinal cannabis in New Zealand.

Forget the past and facts and fiction about Dunne and his position on drugs. There are people trying to establish a better way of dealing with medicinal cannabis that are finding that Dunne is receptive to positive change as much as our current law allows and as much as the reluctance of our current Parliament may allow.

In New Zealand, medical practitioners can prescribe medicines approved and registered under the Medicines Act. Registration occurs after a rigorous clinical testing process, and PHARMAC separately decides whether to fund the product. One medicinal cannabis product, Sativex, is currently so registered, and PHARMAC is currently considering whether to subsidise it. No other medicinal cannabis products have been submitted for registration in New Zealand.

Where medicines are unregistered and therefore unapproved, there has been a procedure set out in the Medicines Act for many years now to allow the Minister to approve the prescription of such an unapproved product, upon the application of a medical practitioner or specialist.

That application has to be lodged with the Ministry of Health, stating the product, the purposes for which it is being sought, the dosage, along with general clinical assessments of its likely clinical efficacy and safety. The Ministry then makes a clinical assessment of the case, and recommends a course of action to the Minister. To date, only one application ever has been made for a medicinal cannabis product, which was the case I approved earlier this year.

I am not a clinician, so therefore, in considering any such applications, I have made it very clear that I will be strongly guided by the clinical advice which I receive. The reason for the decision in such cases being made at a Ministerial level has nothing to do with cannabis, but is simply because the applications are being made as an exception to the existing law.

This is the current law and it requires Ministerial approval, but in effect the doctors and the Ministry of health determine whether medicinal cannabis can be used or not.

So, patients seeking access to medicinal cannabis products need to consult their medical advisers in the first instance. If Sativex is not deemed suitable, then they need to discuss what other alternatives might be best for them, and whether an application under the Medicines Act is the appropriate way to proceed.

If patients or parents of patients want to obtain cannabis products for genuine medicinal purposes then they should find a doctor who is prepared to seek approval for them.

Again, there is nothing unusual or particular to medicinal cannabis in that – we do not make any prescription medicines available without the support of the specialist or medical practitioner, for obvious reasons, and medicinal cannabis should be treated exactly the same way.

However, I would be concerned if it became clear that personal antipathy to cannabis was causing some doctors not to seek approval for medicinal cannabis products for their patients, in cases where it was potentially beneficial. My strong plea to them is to always put the best interests of their patients ahead of any personal views they might hold, when considering such cases.

We are watching closely the clinical trials being conducted in the United States and Australia, but they are not likely to produce results before 2016-2017 at the earliest. It is possible that were the FDA or the Therapeutic Goods Agency to approve medicinal cannabis products as a result of these trials our regulator Medsafe would look to follow suit here, but that is still some time away.

Things are moving fairly quickly now on testing and potentially approving of cannabis products, but it takes time to ensure it is done properly.

One of the worst things that could happen would be to rush access to a product that turns out to be ineffective or worse, detrimental to health.

What is clear, however, is that any approval is likely to be for a very limited range of products in highly specific and regulated circumstances, and certainly not the open slather situation some seem to be expecting.

The current attention is towards medicinal products that exclude intoxicating ingredients. This is not a back door to widespread smoking of cannabis.

Meantime, the provisions of our Medicines Act will continue to apply, including the opportunities for doctors to seek access to these products in the general interests of their patients. For my part, I will consider any case that comes before me on its particular merits, and without any reference to whatever external noise there might be at the time.

So anyone who wants medicinal product should try to find a doctor who will seek approval and will present a good case for it.

Historical Medical Cannabis Policy Briefing with New Zealand Healthcare Officials

From PRNewswire:

United Patients Group Participates in Historical Medical Cannabis Policy Briefing with New Zealand Healthcare Officials

The New Zealand Drug Foundation in conjunction with United in Compassion New Zealand call upon United Patients Group to contribute to a first-of-its-kind collaboration between US and international experts to further explore cannabis as a possible therapeutic treatment in New Zealand for a range of conditions

SAN FRANCISCO, July 23, 2015 /PRNewswire-USNewswire/ — United Patients Group, the leading medical cannabis information and education site, disclosed their participation in a history-making policy briefing held last week in Wellington, New Zealand with key members of the New Zealand Drug Foundation, United In Compassion New Zealand, world-renowned researchers and leading medical cannabis physicians.  United Patients Group will act in an ongoing advisory and consultative capacity to the New Zealand working group in conjunction with the Ministry of Health, to further explore and initiate potential phase 1 medical trials to examine cannabis as a possible therapeutic treatment in New Zealand.

The esteemed invitation-only panel are made up of experts from across the medical cannabis care pathway and included New Zealand and Australian participants, along with several key experts from the United States, including United Patients Group.

John Malanca, founder of United Patients Group commented, “We are honored to be a part of such a ground-breaking and historic effort and are incredibly impressed that the New Zealand government has listened to its constituents and are making a concerted effort to explore thoughtfully and swiftly the benefits of cannabis for medicinal purposes.”

Background
In May 2015, after intense petitioning by United in Compassion NZ, recent media coverage of high profile medical cases and resulting public pressure, New Zealand’s Associate Minister of Health, Peter Dunne, agreed to start a dialogue in order to become better informed about the process of bringing medical cannabis into New Zealand for potential research and development purposes.

Dunne set up a team to explore the current climate regarding medical cannabis in New Zealand and formed a Ministry of Health Working Group, led by Dr. Stewart Jessamine, current Director of Public Health for the Ministry of Health in Wellington.  Jessamine also heads up Medicines Control which functions as a regulatory team within the Ministry of Health that oversees the local distribution chain of medicines and controlled drugs within New Zealand.  Jessamine is also an executive board member for the World Health Organization.

With a marked shift in public opinion toward legalization of cannabis for medical purposes worldwide, New Zealand (like the US) is re-examining its long-standing policies toward the (currently illegal) drug.

Compassion Melds with Science
Malanca further commented, “Fundamentally, it’s difficult to ignore the daily barrage of stories coming from all over the world where medical cannabis is cited as having an effective impact on the relief and treatment for patients living with chronic and life-threatening conditions such as Dravet Syndrome to brain cancer.”

It was Malanca’s own personal experience with the devastating diagnosis of his father-in-law’s lung cancer (which had metastasized to the brain), that led he and co-founder, Corinne Malanca to medical cannabis as a last lifeline for their family member, Stan Rutner.  Five years later, Stan Rutner remains cancer free (both brain and lung scans are clear).  The duo formed United Patients Group in 2010 in order to provide reliable, comprehensive information on medical cannabis to individuals around the world.  The online site has expanded to include information for caregivers, physicians and treatment facilities throughout the US as well as online CME (continuing medical education) courses in medical cannabis .

New Zealand Seeks US Expertise
Toni-Marie Matich is a mother of a teenage daughter suffering from Dravet Syndrome.  Matich also has an early education in science and horticulture. They live in New Zealand, where like many other countries, cannabis is illegal.  She had heard the story of young Charlotte Figi, the Colorado child who was suffering from 300 grand mal seizures per week that was being successfully treated with medical cannabis.

After exhausting all options available in New Zealand, and her daughter still suffering hundreds of seizures a day, Matich  began working behind the scenes for several years to try and raise the issue (and awareness) of medical cannabis, gaining the support of the NZ Children’s Commissioner, and the CEO of the NZ Drug Foundation along the way.  She became the New Zealand representative to United in Compassion Australia in 2014.

“Due to the laws criminalizing cannabis in New Zealand, it isn’t a treatment that our doctors or other health professionals are familiar with, therefore the ability for a doctor to have an open mind and discussion with their patient is non-existent and we would like that to change. I recognized that United Patients Group was leading the way in information across the entire spectrum of the medical cannabis movement in the US, as well as providing the educational resources for clinical and medical professionals, so I sought them out.”

Matich secured a meeting with (Associate Health Minister) Dunne, known for his vehement opposition to legalizing cannabis.  “Dunne listened and showed compassion.  To my surprise he immediately tasked a working group within the ministry to meet with us and engage in developing our initiatives.   A key component was to educate individuals on medical cannabis, so we immediately brought in United Patients Group.”

The policy briefing was hosted by the NZ Drug Foundation which functions as a charitable trust dedicated to advocating for evidence-based drug policies.  Ross Bell, Executive Director for the NZ Drug Foundation said, “Across the globe there’s a tremendous amount of new research coming up surrounding medical cannabis, and some of the research appears to be very promising.”  Bell stresses that at the core of the matter are the people of New Zealand, who are living with medical conditions that many of them feel may benefit from medical cannabis. “We’re thrilled to be working with experts from around the world, like United Patients Group, to address how to specifically deliver a medicine such as cannabis and to what type of medical condition while working through some of the political realities we face, just like any other nation at this time.”

In addition to United Patients Group, participants from the historic policy briefing included:

  • Toni-Marie Matich – Co-Founder and CEO, United in Compassion NZ Charitable Trust
  • Ross Bell – Executive Director of the NZ Drug Foundation
  • Dr. Russell Wills – The Children’s Commissioner (New Zealand)
  • Dr. Alan Shackelford  Harvard-trained physician and medical cannabis researcher who came to worldwide prominence as the doctor who successfully treated Charlotte Figi, the Colorado child suffering from 300 grand mal seizures a week
  • Dr. Bonni Goldstein – Medical Director of Canna-Centers, a medical practice in California devoted to educating patients about the use of cannabis for serious and chronic medical conditions
  • Lucy Haslam – Co-Founder and Director, United In Compassion Australia
  • Troy Langman –  Co-Founder and Director,  United In Compassion Australia and New Zealand
  • Knut Ratzeberg – Laboratory Director, Medical Cannabis Services (AU)
  • Dr. Helga Seyler – Liaison between The University of Sydney and Commonwealth Scientific and Industrial Research Organization (CSIRO)
  • Nevil Schoenmaker – Founded ‘The Seed Bank’ in Holland in 1984, and was one of the first legal producers of cannabis seeds

About United Patients Group
United Patients Group (UPG) is the unparalleled online resource and trusted leader for medical cannabis information and education for physicians, patients and health-related organizations.

Learn more about United Patients Group at www.unitedpatientsgroup.com

About United In Compassion NZ
United In Compassion is a non-profit charitable trust whose purpose is to educate the public on Medicinal Cannabis, supporting and facilitating NZ based research into the therapeutic effects of cannabinoid based medicines, as well as providing support to New Zealanders who would like to access legal medicinal cannabis, as well as to lobby government for legislation changes regarding the use of cannabis for medicinal purposes  http://unitedincompassion.org.nz/

About NZ Drug Foundation
A charitable trust dedicated to evidence-based alcohol and other drug policy.  http://www.drugfoundation.org.nz/

Pressure on Dunne – another mother wanting medicinal cannabis

There is pressure on Peter Dunne with another mother applying pressure to be able to use medicinal cannabis to treat her 7 year old daughter.

The Rotorua Post (via NZH) reports: Hope for Zoe in cannabis oil

Zoe has neurodevelopmental disorder and refractory seizure disorder, due to her brain being deprived of oxygen during birth.

Mrs Jeffries said doctors had given her 24 hours to live but, seven years on, Zoe was still fighting. “It’s the ups and downs that make it hard. You can only live each day as it comes … As a family, we are extremely happy Mr Dunne has shown considerable compassion and approved the use of Elixinol for Alex (Renton).

“In regards to Zoe, she has had a list of seven pharmaceuticals to trial this year. There is one left to try and she still continues to have hundreds of seizures daily”.

Dunne has made it clear that approval for Alex didn’t set a precedent:

Mr Dunne stressed the use of Elixinol in Mr Renton’s situation wasn’t a precedent and shouldn’t be seen as a “significant change in policy”.

But that is contradicted.

Mr Dunne said doctors had been able to apply for medicinal cannabis products for many years but it was the first time that avenue had been used for that product.

More products are available now, and more testing is being done, and more anecdotal evidence is becoming available. And there’s quite a bit of research pending.

What Mrs Jeffries will need to do is apply to the Ministry for approval to use a product.

Ministry of Health advice was “50/50 saying that there’s no compelling evidence that this product will work. On the other hand there’s no compelling evidence it will do significant damage to him”.

She needs to show that there is reasonable evidence the product might work, and that there is no compelling evidence it will not do any damage to Zoe.

Ideally approval for the product in general can be obtained to save parents from going through procedures and more stress.

It will help if more doctors and specialists ask for these relatively safe products too.

Mrs Jeffries said UICNZ was working constructively with the Ministry of Health to change that. “We hope to be able to implement a methodical regime here in NZ. Ideally compassion for one can equate to compassion for all in need.”

” Zoe is my inspiration for becoming a trustee with United in Compassion NZ (UICNZ), a sister branch of the Australian organisation who worked with Rose Renton on Alex’s case. As a non-profit we are working towards the goal of medical cannabis in NZ, and doing so from an angle highlighting education, compassion and logic.”

UICNZ now has charity status and has set up a Givealittle page to raise funds. For more information visit unitedincompassion.org.nz/2015/06/13/united-in-compassion-is-officially-registered-and-seeking-donations/

Karen Jeffries is far from the only parent desperate for something that will effectively treat their child.

Hope for Alex Renton

Some hope for Alex Renton – or at least for his family, who have been watching over him in a coma for 57 days now.

Stuff reported recently: Family’s desperate quest for cannabis oil 

Nelson teen Alex Renton was hospitalised in early April after a serious seizure. He has been in an induced coma in Wellington’s intensive care unit since April 8.

Alex remains in ‘status epilepticus’, a kind of prolonged seizure.

With a recommendation from one of Alex’s neurologists, his family are now keen to try something new – a cannabinoid oil (CBD) extracted from marijuana that international research has endorsed as a treatment for seizures. But accessing the oil, even with the support of a neurologist, has proved nearly impossible.

This was covered on Seven Sharp tonight. They said the problem was inaction by the DHB, who need to submit a request to use CBD to the Ministry of Health.

They have also said that the DHB agreed today to submit a request to the Ministry of Health. Once they get that in it will be up to the Ministry and Peter Dunne as Associate Minister of Health as it’s his responsibility.

Cannabis oil isn’t guaranteed to be successful, one report was that it gave a 30% chance of improvement.  But for Alex and his family any chance is better than what they are having to endure at the moment.

Drug Foundation responds to MOH “underwhelming” evidence on medical cannabis

Ross Bell from the Drug Foundation has queried Ministry of Health advice to Peter Dunne that evidence supporting the effectiveness of medical marijuana is “underwhelming”.

Bell says he fears the information is outdated and says comprehensive research has been done evidence available and “the drug foundation has concluded that cannabis has therapeutic benefits”.

This is inresponse to a speech Dunne has given to the United Nations Commission on Narcotic Drugs in Vienna – see On Peter Dunne’s speech to the Commission on Narcotic Drugs.

NZ Herald reports in Ministry of Health investigates medicinal cannabis use.

An investigation into the use of cannabis for medical purposes has been carried out by the Ministry of Health.

Growing numbers of jurisdictions allow cannabis for medical use and the Government has come under pressure to re-examine its use here.

Associate Health Minister Peter Dunne, who oversaw New Zealand’s innovative regulations on so-called legal highs, asked officials to look into the issue.

“My office receives regular correspondence seeking legislative change … cannabis, I am told, is apparently the panacea for a plethora of ailments, some of which, sadly, are painfully debilitating,” Mr Dunne said.

“For those suffering from such ailments I have enormous sympathy … the evidence [supplied by officials], however, has been underwhelming.”

Bell’s response:

However, NZ Drug Foundation director Ross Bell, who attended the meeting, said he feared advice provided to Mr Dunne was outdated.

“There are lots of countries that have quite well-established medical cannabis regimes, they have experience with this and they have seen some benefit.”

Mr Bell said comprehensive research had been done on the issue.

However, the drug foundation has concluded that cannabis has therapeutic benefits for conditions such as multiple sclerosis and some cancers.

“We should be looking at delivering that benefit through proper medical products … it’s not smokable cannabis.”

Mr Dunne also spoke about how “compassion, innovation and proportion” should be front of mind in the development of drug policy.

“We, as a global community, must continue to move away from rigid law and order responses, and apply a health lens when dealing with those adversely affected by drug use,” Mr Dunne told the gathering.

That message was bold, Mr Bell said, and clearly aligned New Zealand with countries moving beyond a “war on drugs” punitive approach.

However, he was concerned at the dismissal of cannabis for medical use. Mr Bell was told of the ministry’s investigation in a meeting with Mr Dunne in late January.

Sativex mouth spray is the only form of medicinal cannabis currently available, but is not funded by Pharmac and costs about $1300 a month.

Dunne is still in Vienna and unavailable for comment, but his comments have initiated comment an issue of growing importance to many people.

In particular it’s important to find out why the Ministry of Health is so luke-warm on the use of medical cannabis.

Problem for Problem Gambling Foundation

There was a flurry of criticism this morning when the Problem Gambling Foundation advised it was losing Ministry of Health funding for the bulk of it’s current services.

Trevor Mallard was quick off the mark.

Govt silences casino deal critic by axing funding

The Problem Gambling Foundation is being forced to shut its doors after losing government funding because it has vocally opposed National’s dodgy convention centre for pokies deal, Labour’s Internal Affairs spokesperson Trevor Mallard says.

It also appears that Mallard was wide of the mark. Criticisms have been premature.

The funding hasn’t been cut, it is being moved to a “superior” provider. From the Problem Gambling Foundation’s media statement Statement on Ministry of Health contracts:

While the Ministry describes PGF as a valued provider of quality services it has told PGF it has a superior offer for the clinical and public health services PGF provides.

Mallard acknowledges the change of service provider despite his “axing” headline:

“The Ministry of Health has said it has received a ‘superior contract bid’ but as the Foundation is the largest provider of problem gambling services in Australasia, it is hard to imagine a more qualified organisation to do this work.

“The Government’s deal with SkyCity stinks and the public knows it. An additional 350 pokie machines in Auckland will cause significant harm to the community.

“The Problem Gambling Foundation has spoken out about the dangers of this deal and are now paying the price.

“Internal Affairs Minister Peter Dunne and the Ministry of Health need to explain the reasons for this outrageous decision,” Trevor Mallard says.

Stuff explain in Problem Gambling Foundation loses Govt funding:

A spokesman from Associate Health Minister Peter Dunne’s office confirmed today that the other organisation was the Salvation Army.

The spokesman said the Salvation Army bid for the contract was more efficient, and offered more services and value for money.

It’s tough on the PGF but funds for services should be contestable. The Salvation Army have a record of providing a wide range of services – and they have also been critical of the Government.

Internal Affairs minister Peter Dunne and the Ministry of Health both “emphatically deny” any political involvement.

Dunne: drug law reversing onus of proof on way

Media Release

Cabinet has agreed key details of new psychoactive substances drug legislation that will require distributors and producers of party pills and other legal highs to prove they are safe before they can sell them, Associate Health Minister Peter Dunne announced today.

“As promised, we are reversing the onus of proof. If they cannot prove that a product is safe, then it is not going anywhere near the marketplace,” Mr Dunne said.

“The legislation will be introduced to Parliament later this year and be in force by around the middle of next year.

‘In the meantime, the Temporary Class Drug Notices – the holding measure we have successfully put in place – will be rolled over as required so there is no window of opportunity for any banned substances to come back on the market before the permanent law comes in,” he said.

 “The new law means the game of ‘catch up’ with the legal highs industry will be over once and for all.

“I have been driving this for a considerable time. None of these products will come to market if they have not been proven safe – and the cost of proving that will be on those who make and sell them, as it should be,” he said.

“Quite simply they will now have to do what any manufacturer of any product that is consumed or ingested already has to do – make sure it is safe.”

Mr Dunne said that in the past year the Government had put a serious dent in the synthetic cannabis market with the Temporary Class Drug Notices.

“We have seen a 75 percent fall in the number of emergency call incidents around synthetic cannabis products according to National Poisons Centre data.

“That decline began the very month the Notices came into effect,” he said.

“We have banned more than 28 substances and effectively taken more than 50 products that contain them off the market. The latest four substances were just banned on Friday.

“We are winning the battle and we are about to deliver the knockout blow with this legislation,” he said.

Mr Dunne said Cabinet has agreed to establish a new regulator within the Ministry of Health which will be responsible for issuing approvals.

“Companies wishing to sell these products will need to apply to this regulator with scientific data similar to that which is required for the assessment of new medicines.

“For example, they would need to provide toxicology data and results of human clinical trials,” Mr Dunne said.

These tests will prevent products which cause common adverse reactions from being approved for legal sale.

“However, in the end these are pharmacologically active substances, and there is always some degree of risk in taking such products because people can have varying reactions to them,” he said.

Even once approved, any such products are likely to be subject to retail restrictions which will further reduce their potential to cause harm, he said.

“The details of these restrictions have not yet been agreed, but I fully expect that they will involve a legal minimum purchase age and restrictions on the types of premises where they can be sold.

“The legislation will be introduced later this year and will be in place by August 2013. In the meantime all of the existing Temporary Class Drug Notices will be rolled over for a further 12 months so there will be no slippage between them and the coming legislation,” Mr Dunne said.

The Cabinet paper and the regulatory impact statement can be found at
www.health.govt.nz/about-ministry/legislation-and-regulation/regulatory-impact-statements/new-regulatory-regime-psychoactive-substances

Ends.



Questions and Answers



What are low risk psychoactive substances?

This refers to new psychoactive substances for which the risks are low enough that they meet the approval criteria set by the regulatory. We say ‘low-risk’ to avoid implying that they will be entirely safe, as there will always be some risk. This is because different people have different reactions to pharmacologically active substances.

Why are we doing this?

We are doing this because the current situation is untenable. Current legislation is ineffective in dealing with the rapid growth in synthetic psychoactive substances which can be tweaked to be one step ahead of controls. Products are being sold without any controls over their ingredients, without testing requirements, or controls over where they can be sold. The government must prove a risk of harm before controlling a substance. The new regime will require a supplier or manufacturer to apply to a regulator for a safety assessment before any product can be sold.

Are we legalising drugs?

No. The regime will provide stronger controls over psychoactive substances. At the moment, these products are unregulated, with no control over ingredients, place of sale, or who they can be sold to. Because they are synthetic substances, there are a huge number of potential ingredients, which makes it unfeasible to deal with them individually.
It will be illegal to sell any product which has not been through an assessment. There will be strict restrictions on where products can be sold, the purchase age, and marketing restrictions.
What would it cost a manufacturer to take a product through the approval process, and how long would it take?

Based on initial proposals, it is estimated that the cost of testing any product will be in the range of $1 million to $2 million and will take between one and two years.

What will the implications of the new regime be for cannabis?
The legal status of cannabis will not change. This is because the regime will only cover new psychoactive substances that are not already classified under the Misuse of Drugs Act 1975.
Why don’t you just ban everything?
Legislation should not be used to restrict behaviour that cannot be proved to be harmful. Products that meet the approval criteria will be approved. However, our position will still be that not using these products is the safest option.
Is this a stealth way of banning everything and never approving any product?

No. Clear testing requirements are being established to determine the risks of psychoactive products. Products that meet the approval criteria will be approved.

How will risk/safety be determined?

Consistent toxicological and behavioural testing will be required for every product seeking approval. A new regulator will be established to consider the data from this testing for each product. Products that meet the approval criteria will be approved.

What do you mean by the regulator?

A regulator will need to be established for psychoactive substances. This regulator will oversee the approval of products, monitor for compliance with post market restrictions, and reassess products in light of any new evidence of harm that might arise.

How many drugs will get approved?

We don’t know this yet. Products that meet the approval criteria will be approved. This will require toxicological and behavioural testing.

How much will this cost?

Modelling of the start-up costs for the new regime is currently being worked on. A detailed report on fee-setting and costing will be provided to Cabinet by 1 October 2012.

We expect that over time, the costs of this regime will be recuperated through applications fees paid by industry.

Who will do the risk assessments?

The new regulator will consider toxicological and clinical data for each product.

Does this mean the Government is endorsing drugs?

No. At the moment these products are available without any information regarding their risks to health. We are changing the system to require industry to prove they do not pose a greater than a low risk of health before they may be sold.
Will there be controls to stop children buying these drugs from dairies?

Yes, it is intended that there will be restrictions on where substances can be sold and a minimum purchase age. I will provide Cabinet with full details of these restrictions by 1 October 2012.

What happens when the legislation comes into force? Will everything be pulled from the shelves?

Decisions have not been made on this yet but there will likely be a lead in time for industry to obtain the testing results needed.

Will this just backfire and create a bigger black market?

No. We expect that having low risk psychoactive products legally available will discourage consumers from using the black market.

Hon Peter Dunne
Associate Minister of Health