Medical Protection Society
PO Box 8035
19 July 2014
Re Support from Medical Profession for Licences to Cultivate a Prohibited Plant (cannabis) under section 14 Misuse of Drugs Act 1975
I refer to our letter from GreenCross NZ to Dr Cameron dated 20 May 2014 which I understand he forwarded to you for your advice. (Copy of our communication with Dr Cameron is attached hereto and also includes the GreenCross Membership Application Form which we seek doctors to complete in support of our GreenCross members’ applications for a licence to cultivate cannabis under section 14 of the Misuse of Drugs Act 1975.)
We understand that your advice to Dr Cameron was that he should not support his patient with either a prescription for cannabis or to complete Part 2 of the GreenCross NZ Application form in respect of any Application to the Ministry of Health for a licence to cultivate cannabis, under section 14 of the Misuse of Drugs Act 1975, on the basis that cannabis is not listed on the pharmaceutical list and that you thought it would be illegal.
It is my opinion that it would not be illegal to prescribe tetrahydrocannabinol or cannabidiol in the form of cannabis or CBD oil and in the doses recommended to him as set out in my letter to him for the reasons set out below.
The pharmaceutical list that the Medical Protection Society refers to is the NZULM list which has been compiled as a collective reference for medical practitioners to prescribe approved prescription medicines that are government subsidised approved medicines. It has no legal authority nor any relevance to prescribing unapproved medicines or our request to prescribe an unapproved medicine under section 25 Medicines Act 1981 for Dr Cameron’s patient (and our many other patients who are GreenCross NZ members including children suffering from Dravet’s Syndrome and other medical conditions that involve seizures whose parents would like to cultivate low THC cannabis in order to make their own CBD oil for their children).
As such, we do not consider that it is illegal to write a prescription for tetrahydrocannabinol or cannabidiol as these are legally defined “prescription medicines” as listed in Part 1, Schedule 1 of the Medicines Act 1981.
We also do not consider that there can be any legal implications for a doctor in writing a prescription in order to supply or procure an unapproved medicine under section 25 of the Medicines Act 1981 in support of an Application to the Ministry of Health to grant a licence to cultivate cannabis under section 14 of the Misuse of Drugs Act so that the supply of these prescription medicines in this form may be lawful. I can find no section in the Medicines Act 1975 or the Misuse of Drugs Act 1975 that prevents a doctor so doing. If the Medical Protection Society can state otherwise I would be pleased to learn on which section of either Act you rely.
Although Regulation 22 of the Misuse of Drugs Act does state that a doctor may not supply or prescribe a controlled drug without the consent of the Minister of Health, because the definition of controlled drug under section 2 of the Misuse of Drugs Act 1975 excludes prescription medicines, we do not consider that the Minister’s consent is required for any prescription of cannabis or CBD oil.
Section 2 Misuse of Drugs Act 1975
controlled drug analogue means any substance…. that has a structure substantially similar to that of any controlled drug; but does not include—
(a) any substance specified or described in Schedule 1 or Schedule 2 or Parts 1 to 6 of Schedule 3; or
(b) any pharmacy-only medicine or prescription medicine or restricted medicine within the meaning of the Medicines Act 1981;
Even if you disagree with our interpretation of the definition of controlled drug to exclude tetrahydrocannabinol and/or cannabidiol as listed as a prescription medicine under Part 1, Schedule 1 of the Medicines Regulations 1984, the Minister’s consent would be required (and therefore provided) in any event upon any licence granted under section 14 since his consent is a requirement to the granting of any licence under this section. If the Minister refuses his consent to issue the licence to cultivate cannabis then the patient will not have lawful supply and the prescription will not be able to be fulfilled in this way.
It may be of interest to you to know that one of our GreenCross members has been prescribed cannabis products containing THC and CBD under section 25 of the Medicines Act 1981 for the last four years by his doctor in Auckland and this prescription has been approved by his pain specialist. The Ministry of Health have also approved his use of cannabis products in writing and which are imported in his case.
Under section 25(1)(b) of the Medicines Act, a doctor is entitled to prescribe and procure the supply of an unapproved medicine without the consent of the Minister provided that the Minister has not prohibited that prescription medicine by notice in the Gazette under section 48. It is implicit that the unapproved medicine must be lawfully supplied. The Minister has not prohibited THC or CBD or cannabis or cannabis products in the Gazette. Due to the inadequacy of the legislation, as earlier stated, the only means for lawful supply of this unapproved medicine is found through either importing cannabis products (as is the case of our Auckland Green Cross member and his doctor and specialist who support cannabis for his pain relief) or through the granting of a licence by the Ministry of Health for a patient to grow his or her own supply of medicinal cannabis. Since the granting of this licence requires the consent of the Minister of Health or his delegate i.e., an officer from the Ministry of Health, there can be no legal implications to a doctor in supporting an Application and a doctor’s endorsement for the treatment of pain by the use of the prescription medicines THC and CBD in the form of cannabis or cannabis products.
Medsafe reports under its publication Use of Unapproved Medicines and Unapproved Use of Medicines as follows:
“Section 25 of the Act permits registered medical practitioners, midwives and designated providers (hereafter referred to collectively as “practitioners”) to procure, administer and arrange the administration of an unapproved medicine. Section 29 permits an authorised supplier or a medical practitioner to supply or sell an unapproved medicine to a medical practitioner provided the Director-General of Health is notified. Both sections of the Act need further explanation.
“Section 25 of the Medicines Act permits use of unapproved medicines
“The terms of section 25 are inclusive and permissive, allowing the practitioner to “procure the sale or supply of any medicine” for a particular patient in his or her care. “Any medicine” includes approved and unapproved medicines. For dentists “any medicine” applies only to medicines for dental treatment, and for midwives it applies only to medicines for antenatal, intrapartum and postnatal care (Regulation 39, Medicines Regulations 1984).
“”Procure the sale or supply” refers to obtaining the medicine through the usual channels such as a pharmacy or a pharmaceutical company, and it also permits the practitioner to use other means of obtaining a medicine such as importation. However, section 25 does not envisage bulk purchase by the practitioner. The use is to be for the treatment of a particular patient in the care of that or another practitioner.”
It is worth mentioning, at this point, the use of approved medicines for unapproved uses. Section 25 permits a practitioner to use any medicine (approved or unapproved) for the treatment of a particular patient in his or her care. The Act puts no restriction on the use of a medicine, even in a situation in which it is contraindicated. However, whether the practitioner uses approved or unapproved medicines, he or she must provide care of an adequate professional and ethical standard (see the discussion of the Code of Health and Disability Consumers’ Rights later in this article).”
Chapter 24 of Cole’s Medical Practice in New Zealand, regarding the medico-legal position of Complementary and Alternative Medicine (CAM), states:
“The Medical Council issued an updated statement on CAM in March 2011 and it is strongly recommended that doctors who recommend or practise CAM therapies are familiar with the contents.
” The statement was written to inform doctors of the standards of practice that are expected of them by the Council should they choose to practise CAM or if they have patients who use CAM.
It may be used by the Health Practitioner’s Disciplinary Tribunal, the Council and the Health and Disability Commissioner as a standard by which a doctor’s conduct is measured.
The key points are that when CAM therapies have demonstrated benefits for the patient and have minimal risks, and patients have made an informed choice and given their informed consent, the Council does not oppose their use, and that no doctor:…
will be found guilty of a disciplinary offence under the Health Practitioners Competence Assurance Act 2003 merely because that person has adopted and practised any theory of medicine or healing if, in doing so, the person has acted honestly and in good faith.
“Therefore the key issue is the strength, if any, of research evidence that supports the practice, as this underpins whether it has “demonstrated benefits”.. “
I list below some studies that support the “demonstrated benefits” in the use of cannabis for the treatment of pain.
Nabilone – a synthetic mimic of cannabinoids found in cannabis and FM
Pharmacological treatments found to be of modest benefit for fibromyalgia
With these supporting studies of the demonstrated benefits of medicinal cannabis in the treatment of fibromyalgia and pain it is the legal opinion of GreenCross NZ that no doctor would face any medico-legal problems from supporting a patient suffering from fibromyalgia or chronic pain by supporting any of our proposed Applications.
Cole’s Medical Practice in New Zealand also states that:-
Prescriptions for some controlled drugs must be written on a proscribed form and require additional information. (Misuse of Drugs Regulations 1977. Regulation 29.)
Regulation 29 does not require any additional information to be supplied in respect of a Class C controlled drug and so would be a prescription of the usual sort that any doctor would present to a pharmacy. Because there is no lawful supply in NZ for cannabis other than through a licence to cultivate under section 14, GreenCross is asking that this prescription be included merely to support the Application for a licence to cultivate cannabis. The most important support the doctor can offer any patient for this licence, however, is in completing Part 2 of the Membership Application which includes his agreement to supervise the patient’s results and medical condition whilst the patient uses cannabis for a medicine since this is the definition of the “study” as required by the Ministry of Health for any granting of the licence. Since this practice would be performed by the doctor (with any assistance required to be provided by GreenCross) in the ordinary course of his occupation of investigating, supervising and detailing his patient’s condition we do not consider this support from a doctor to be outside his ordinary professional practice.
Cole’s Medical Practice in New Zealand continues:
If you prescribe an unapproved medicine (or a medicine for a purpose for which it has not been approved) you should advise the patient of the unapproved status of the medicine and be frank about the standard of support for the use of the medicine and any safety concerns.
You are also required to pass certain details relating to the supply of that medicine to the Director General of Health. (Refer to Rights 6 – the Right to be fully informed – and Right 7 – the Right to Make an Informed Choice and Give Informed Consent – of the Code of Health and Disability Services Consumers’ Rights and to the advice provided by Medsafe at www.medsafe.govt.nz/profs/RISS/unapp.asp)
GreenCross patients are well informed about these two consumer’s rights and have already exercised their rights to become fully informed about the medicinal benefits of cannabis in relation to pain and fibromyalgia prior to attending the doctor and requesting that he sign the GreenCross NZ Application Form. Their wish to use the prescription medicines as described in Part 1, Schedule1 of the Medicines Regulation is an informed choice and a choice that is supported by the studies listed above regarding THC and CBD in cannabis and its therapeutic benefits to fibromyalgia and chronic pain. There are also many other studies supporting cannabis for the treatment of seizures and other medical conditions, some of which are recorded in the form to apply for Sativex.
In addition to the above an international consortium of medical cannabis organisations are demanding that humans, regardless of state or allegiance and without qualification, be able to use cannabis therapeutically.
“In a joint declaration, the organisations from EURope and North America refer to Article 3 of the Declaration of Human Rights adopted by the United Nations in 1948. The declaration is the beginning of a worldwide campaign on the use of cannabis for therapeutic purposes.
The declaration was published in ten languages on a dedicated Web site (www.medical-cannabis-declaration.org), and it states: “Every medical doctor has the right to treat his or her patients with cannabinoids and cannabis products according to the rules of good medical care” and “every patient has the right to access cannabis and cannabinoids for medical treatment supervised by a medical doctor, regardless of social status, standard of living or financial means.
The declaration is based on overwhelming scientific evidence. It takes a strong stance against the prejudices and untruthfulness of lawmakers, other political players and ‘experts’ with limited medical knowledge on the issue,” says Franjo Grotenhermen, MD, Executive Director of the International Association for Cannabinoid Medicines (Germany).
It is the aim of the declaration to generate worldwide support and allow organizations around the globe to adopt a more definitive position. “The joint declaration and related Web site form the nucleus of a worldwide movement regarding the human right to use cannabis for therapeutic purposes,” adds Al Byrne of Patients Out of Time (USA). The declaration is the product of knowledgeable experts from multiple countries who are working to challenge anti-cannabis forces.
Cannabis has established medical use throughout the world’s history and, coupled with the recent discovery of the role of the endogenous cannabinoid system in the human body, must be made available to all citizens of all countries. The creators of the declaration designed it to encourage and allow both organizations and individuals to join them by signing the document in support of the common goal to create a worldwide campaign to end the wrongful prohibition of therapeutic cannabis. Many scientists, doctors and other experts in the field have already offered their support by adding their signatures.”
The UN Single Convention on Narcotic Drugs 1961, the Misuse of Drugs Act 1975 and the Medicines Act 1981 were drafted prior to the discovery of the endocannabinoid system in 1988 and the 30 years of research in to medicinal cannabis that followed this discovery. Because the Misuse of Drugs Act 1975 and the Medicines Act 1981 were not written with the knowledge of the endocannabinoid system, the studies that show that cannabis has a therapeutic value and function or the intention that cannabis could one day be considered a medicine, the Misuse of Drugs Act 1975 is out of date and it is inconsistent and illogical in this respect with regard to the Medicines Act 1981 (as amended in 2012).
The Law Commission discovered much confusion, errors and an Act seriously out-of-date in their 2010 Report on the Misuse of Drugs Act 1975.
My own analysis adds that there is also illogic and inconsistency between the UN Single Convention on Narcotic Drugs 1961, the Misuse of Drugs Act 1975 and the Medicines Act 1981 and its Regulations (as amended in 2012), which can be illustrated as follows:
1. Cannabis is classed as either a Class B controlled drug (if processed) and a Class C controlled drug (in its plant form) under Schedules 2 and 3 respectively of the Misuse of Drugs Act 1975 and its use under this Act is considered to be an offence liable to a conviction and penalty of up to 7 and 10 years imprisonment respectively.
2. The only reason cannabis was classed as a “controlled drug”, prohibited, and its use deemed an offence under the Misuse of Drugs Act 1975, is because Cannabis was condemned by the 1961 Single Convention on Narcotic Drugs as a psychoactive drug with “particularly dangerous properties” and hardly any therapeutic value. This same Single Convention expressly permits the use of all drugs that do have therapeutic value or functions to be able to be prescribed by doctors and excluded from its ambit however.
3. In 2012 an amendment to the Medicines Act was passed to include both THC and CBD (the other vital cannabinoid found in cannabis to treat pain and other medical conditions) as a “prescription medicine” under Part 1, Schedule 1 of the Medicines Act 1981 so that THC and CBD are now legally classified and held to be of therapeutic value and possess a therapeutic function.
4. Section 2 of the Misuse of Drugs Act 1975 defines “controlled drug” to exclude any medicine classed as a “prescription medicine” under the Medicines Act 1981.
5. Thus THC and CBD are not “controlled drugs” under the Misuse of Drugs Act 1975 yet cannabis – whose constituent compounds are THC and CBD – is defined as a “controlled drug” under the same Act.
Given that cannabis was only deemed to be a controlled drug by the UN declaring THC to be “a particularly dangerous property” and have “hardly any therapeutic value” this is an entirely illogical, absurd and contradictory state of affairs. Given also that the UN Single Convention on Narcotic Drugs 1961 states that any drug that has a therapeutic function is not to be included in its prohibitive ambit and may be prescribed by doctors, the illogical, absurd and contradictory state of NZ law and drug policy is complete.
In light of all of the above GreenCross asks you to please reconsider your position and advice with regard to doctors signing the Green Cross Application Form, writing a prescription for THC and CBD, and offering their patients the opportunity to relieve suffering from pain and suicidal ideation by providing them with the medical support required to proceed with an Application to the Ministry of Health for a licence to grow cannabis. Patients will only grow her own cannabis upon that Application being granted (which requires the consent of the Minister of Health or his delegate). This support is not illegal. The specialist in Auckland offers this same support to another of our GreenCross patients and the Ministry of Health have approved his use of cannabis products albeit in the form of importing them. In signing the GreenCross Application Form, all a doctor will be doing is confirming that he or she will supervise his or her patient’s medical condition while using cannabis to treat pain, so as to conform to the requirement of the “study” (and with which GreenCross agrees to assist the doctor in any way he seeks) and which presumably would be asking the doctor to do no more than to perform the ordinary course of his/her occupation as a doctor.
The other point that may be of concern to you is that presently cannabis is not taken in to account by your actuaries in assessing the premium for any indemnity the Medical Protection Society offers its doctors. Our GreenCross members and patients of doctors willing to support their Applications for a Licence to Cultivate a Prohibited Plant (cannabis) are happy to sign a waiver of claim in respect of any potential liability in respect of their use of cannabis as they are fully aware that it has no long term side effects or harms to them. We hope that this fact as well as the above explanation will enable the Medical Protection Society to support the medical profession in either supporting any Application for a Licence to Cultivate a Prohibited Plant or a prescription for THC and/or CBD in support of any such Licence.
I am more than happy to have you contact me to discuss the legal position more fully.
I look forward to hearing from you.
With kind regards.
R M A Purchas
I am the legal adviser to GreenCross NZ – an international support organisation for the promotion of laws to enable medicinal cannabis for those patients whose medical conditions have been shown to be assisted by the use of medicinal cannabis – either in its raw form by juicing or through the use of a vaporiser.
We understand from our members’ doctors that the Medical Protection Society have been advising caution with regard to the doctors wishing to support their patients in their Applications to the Ministry of Health for a licence to cultivate a prohibited plant under section 14 of the Misuse of Drugs Act 1975.
We are writing to you, therefore, to seek your support with this and to invite a conversation between our two organisations in order to resolve any potential differences of opinion you may have with our position as described in the attached letter to you below. We would really like to enlist your support for our GreenCross members whose situations are, in most cases, extremely dire and who suffer from suicidal ideation as a result of either prolonged pharmaceutical use and have built up a resistance to these pharmaceutical drugs or are suffering badly from the side effects from prolonged use and wish to use medicinal cannabis to alleviate these side effects and improve their quality of life.
Many of our GreenCross patients have experienced intermittent use of cannabis at some point in the past but are unable to obtain a ready and ongoing supply for obvious reasons of illegality and confinement. They therefore would like to be able to grow their own medicinal cannabis lawfully by way of a licence to cultivate under section 14 of the Misuse of Drugs Act. They support the claims of many studies that medicinal cannabis abates their pain and other symptoms to the point that they are able to get out of bed and, in some cases, almost able to function normally. For the main part, these patients and GreenCross members are invalids and are under the care of paid caregivers. They are on an invalid’s pension and in receipt of ACC in most cases. Although they would qualify for Sativex, the cost of this product is outside their budgets. To achieve an ongoing supply of affordable medicinal cannabis for these people, therefore, they would require a licence to cultivate. This, in turn, requires the support of their medical practitioner and a study as defined by the Ministry of Health as set out in Part 2 of the attached GreenCross Application Form. Most of our patient’s doctors are very happy to support their patients in this way but they have recently expressed concern that the Medical Protection Society has been cautious in their advice to the point that they are now reluctant to support their patients.
It is with a sincere desire to improve the quality of life for these people, therefore, that we are writing to you to seek your support of the doctors and their patients who desire to apply to the Ministry of Health for a licence to grow their own cannabis under section 14 of the Misuse of Drugs Act 1975 and to address any concerns that you may have in a reasonable way.
To this end we attach:
1. Our formal letter to the Medical Protection Society setting out the legal position with regard to the assistance our members seek from their doctors which we hope you will find persuasive and reasonable to condone your medical profession’s assistance in supporting their sick patient’s Applications;
2. Our GreenCross Application form – Part 2 of which we ask that the patient’s doctor complete, which we trust you will find satisfactory to approve in order to allow your medical profession to complete;
3. Our letter dated 20 May 2014 to Dr Cameron of the Waikanae Health Centre which we understand he forwarded to you and which was the initiating letter to which your advice that followed it was to not give your approval to him to support any Application to the Ministry of Health for a licence on behalf of his patient either by way of offering a prescription in the form requested in our letter or by completing Part 2 of the GreenCross Application Form.
I would be grateful if you would reconsider your position after reading the attached documents and following any further discussions you may wish to have with me.
I look forward to hearing from you.
With kind regards,
3 Attachments: Legal Opinion, GreenCross Membership Form, Letter to Doctor