Chapter 13: Exemptions to prohibition

Background

Many controlled drugs also have a legitimate, legal, medical purpose. Current laws prohibiting supply and use must therefore contain specific ‘exemptions’ that allow for the production and supply of drugs, and also their medical use by people who need them. Exemptions are also required to allow for controlled drugs to be used in medical and scientific research and for industrial purposes.

In this chapter the Law Commission describe the legislation currently used to assist legitimate supply and use, while also controlling misuse and diversion. The Law Commission examines the current system and present suggestions that would improve its performance. They also offer several options that could develop access to medicinal (raw unprocessed) cannabis, and discuss which is most desirable.

Key questions to consider

Are all the current exemptions (contained in the Misuse of Drugs Act and regulations made under it) still needed or are some obsolete?

The Drug Foundation note that there are anomalies within the Act and agree with the Law Commission that changes are required. The Drug Foundation’s recommendations are outlined below.

Exemptions are needed to allow for the legitimate supply and medical use of controlled drugs to patients, in the form of medicines. While such exemptions must not unduly prevent doctors prescribing them, it is equally important that they also minimise the risk of inappropriate use, including drugs being diverted to illegal markets.

The Law Commission outline the range of medical exemptions; this is an extensive and varied list including prescribers, pharmacists, and others. The Law Commission query whether all of the various exemptions are still required and if any different exemptions might be needed; and if some of the separate exemptions could be combined to produce a simpler and clearer list of authorisations.

The Drug Foundation considers that clarity and usability are of most importance to the Act. The Drug Foundation agrees with the Law Commission that many of the separate exemptions could be combined to produce a simpler and clearer list of authorisations.

Specific changes are required to:

The Misuse of Drugs Regulations 1977: The regulations house additional exemptions, described as ‘permissions’. These apply to controlled drugs that are approved medicines. The Law Commission considers that allowing significant matters of policy to be implemented by regulation is inappropriate. While acknowledging the need for flexibility to address new and changing circumstances, the Law Commission state that regulation-making powers be more limited, and should typically deal only with emergencies. The Drug Foundation agrees with the Commission.

The Medicines Act & the Misuse of Drugs Act: Both Acts have exemptions for controlled drugs that are medicines. These are often framed differently, making it unclear, in some circumstances, what the precise powers of the exemptions are. The Law Commission suggests that controlled drugs exemptions applying to medicines should be in one act (with cross-references) and subject to one consolidated set of conditions. The Drug Foundation agrees with this.

Are the legislative controls currently in place adequate to address the diversion and misuse of prescription drugs? What further controls do you think are needed?

The Drug Foundation note that the current legislative controls surrounding diversion and misuse are not adequate, and that further controls are needed.

The misuse and diversion of controlled drugs that are medicines represents a big challenge to the regulatory authorities and medical industry. The drug-related harm associated with the misuse and diversion of medicines is similar to that for other types of drugs.

Currently there exist a number of restrictions on prescribing controlled drugs. Most are aimed at reducing the opportunity for drug seeking for misuse or diversion to sale in the black market.  

The Law Commission recognises there are limits on what can be done to deal with the misuse and diversion of medicines by way of regulatory controls and prescribing limitations. Current laws must therefore be supplemented by prescribers and pharmacists applying professional and personal judgement whenever they provide controlled drugs to a patient.

The Drug Foundation agrees with the Law Commission that professional training and guidance, appropriate administrative systems, and monitoring and review would go a long way to further reducing the misuse and diversion of medicines.

In this chapter the Law Commission highlights research which proposes that New Zealand needs:

• national guidelines to cover prescribing and dispensing
• support for problematic patients and strategies to minimise prescription drug misuse
• better education and information resources for primary care practitioners
• and improvements to the electronic and online systems used for monitoring and reviewing prescribing.  

The Commission state while legal controls must underline these types of approaches, they must also allow health practitioners flexibility and discretion when assessing and treating their patients.

Is section 24 too restrictive? If so, what changes are needed?

The Drug Foundation recognises that the restrictions of Section 24 aim to minimise controlled drug misuse, and that there are limitations to the capacity of primary healthcare to manage high risk patients.

In New Zealand select medical practitioners, under Section 24 of the Act, are permitted to supply controlled drugs as a treatment for drug dependence. This is predominantly in the form of methadone. It is an offence for any other medical practitioner or prescriber to provide controlled drugs for this purpose, unless they obtain an authorisation and have specialist (alcohol and drug clinic) oversight.

The aim of restricting the range of medical practitioners who can prescribe drugs for dependence is to limit access and more closely monitor drug dependent patients. The Law Commission recognises that methadone is amongst the most widely diverted prescription drug in New Zealand. The Law Commission asks whether Section 24 is too restrictive and whether other medical practitioners (primary healthcare) should play a greater role in drug treatment.

The Drug Foundation recognise that primary healthcare is the generally the first point of contact for most to the health sector. It also provides the ability to treat other health conditions which are often associated with drug misuse and abuse. Recent New Zealand research identifies limitations within the health sector. This specifically relates to the ability of primary care physicians to consider and open dialogue with their patients on drug and alcohol issues. Education on alcohol and drugs for undergraduate medical students is also underprovided. These fundamental limitations need to be considered before drug treatment is opened up to the wider health sector; especially outside the scope of specialist oversight.

Should the law authorise the medicinal use of cannabis by people suffering from chronic or debilitating illness? If so, how should any new regime work?

The Drug Foundation agrees that the law should authorise the medicinal use of cannabis for people suffering from chronic or debilitating illness.

Cannabis based medicines have been shown to be effective in the treatment of a number of diseases; they also extend the current therapeutic options available to clinical practice. Cannabis medicines are available in two forms. These are either products that are based on ‘raw’ forms of cannabis (smoked or inhaled in vaporised form) or pharmaceutically derived forms of cannabis, for example Sativex®.

Currently in New Zealand cannabis medicines are only lawfully available for medicinal use if produced, supplied or used under the exemptions of the Act. Cannabis based medicines are available to patients that fit select criteria, and may be administered to those patients according to the clinical guidelines made available in 2007 – these are specific to the pharmaceutical product Sativex®.  

The Drug Foundation think that the medicinal use of cannabis should be clearly separated from any consideration of its legal status as a recreational drug; the same as currently applies to opiate and opioid drugs such as codeine, morphine and oxycodone.  

The Law Commission considers in this chapter whether further exemptions in the Act are required, and offer several suggestions as to possible changes. These changes would make ‘raw’ cannabis for medicinal use more available. If a scheme allowing the medical use of ‘raw’ cannabis was considered, a number of regulatory issues would exist.

Regulation for production

The Law Commission presents three possible options for the regulation of cannabis production for medical use. The Law Commission’s preliminary view is that Option 1 – to grant one or more cultivating licences to allow cultivation and production of cannabis plant for medial use – is the best alternative.

The licensing option is a closely controlled model and therefore minimises the risk of diversion. It would allow for the production of a limited supply of ‘raw’ cannabis material in a standardised way, which addresses at least some of the health issues.

The Law Commission also considers that this approach would be better than licensing users and their carers to cultivate their own supply. Under Option 1, there would be relatively few licence holders and they would exist under stringent controls.

The current regulatory infrastructure would ensure a credible supply of pharmaceutical grade cannabis. The controls would include a limit on the number of plants, the type of plant, the content of THC and other cannabinoids, and other important quality standards that ensure a standardised product suitable for medicinal use. Other important regulatory controls would include the locations at which cannabis could be grown, and put in place security requirements.

Option 1 is a commercial model which would require commercial viability. This, however, leads to the issue of whether the model would produce cannabis for supply at a reasonable cost. Given that only relatively small numbers of people are likely to be eligible to use cannabis medicinally, this is uncertain. Nonetheless, Option 1 remains the most suitable available to produce pharmaceutical quality medicine, appropriate for patients with chronic illness.

Supply to patients

Like many medicines, the supply of medicinal cannabis would require a medical prescription. This would better enable a health professional to maintain clinical oversight and to alter treatment when necessary.

The Law Commission suggests a central register of authorised users be established, primarily because a register would detail the numbers of users, and make medicine use more easily monitored. One disadvantage is that maintaining a central register would result in further regulatory costs.

The Drug Foundation has developed a formal policy position on the medicinal use of cannabis. The policy position aligns with the Law Commission’s view that if cannabis is to be used medicinally, structures and processes would need to be developed. This includes regulations to permit use and set conditions; guidelines for medical practitioners; and a licensing system for users, growers/processors of natural cannabis, and distributors.