Assessing progress with the implementation of the New Zealand Medicinal Cannabis Scheme
View Article PDF
In 2017, the Labour coalition government committed to making cannabis-based medicinal products more readily available to patients. The decision to legalise cannabis for medical purposes followed growing public demand, including by terminally ill and epileptic patients who advocated for greater access to cannabis-based products.[[1]] A market research panel survey conducted in May 2019 found over 30% of New Zealanders were interested in accessing medicinal cannabis products when they became available.[[2]] Following public consultations, the Medicinal Cannabis Scheme (MCS) commenced in April 2020 with a central objective to improve patients’ access to affordable, quality medicinal cannabis products. Under the scheme, patients with a prescription from a New Zealand-registered doctor can access medicinal cannabis products, both THC and CBD.
When the MCS commenced, the medicinal cannabis product range available in New Zealand was largely limited to imported products. The scheme aimed to reduce reliance on imports by facilitating local manufacture and distribution of medicinal cannabis products, and to support health professionals to confidently prescribe these products to patients.[[3]] While New Zealand’s domestic industry worked to achieve the new MCS standards, the Ministry of Health (MOH) approved a six-month extension to a temporary scheme to give patients continued access to CBD imports.
Eight medicinal cannabis products now meet the MCS standards, including 4 Canadian products (Tilray) and 4 products with domestic NZ medicinal cannabis company license holders (SubDrops™ CBD100, SubDrops™ CBD25, ANTG Eve, and RUA CBD100). As far as we can ascertain, three of the four products licensed to domestic medicinal cannabis companies consist of imported flower or other active ingredients with final processing in New Zealand.[[4]] The MCS continues to experience implementation issues following the end of the interim scheme (Figure 1). This editorial provides an update on the MCS and reviews key issues to date.
Figure 1: Regulation of medicinal cannabis products in New Zealand and the Medicinal Cannabis Scheme implementation timeline. View Figure 1.
Domestic industry: minimum quality standard
Under the MCS, a Medicinal Cannabis Licence is required to commercially participate in the sector. Producers must meet the Good Manufacturing Practice (GMP) code, a near-pharmaceutical-grade compliance standard that applies to all medicines available in New Zealand, to receive the additional Licence to Manufacture Medicines.[[5]] During the MCS public consultations, industry stakeholders and medical practitioners received the GMP standard positively, reflecting the focus on consistency and quality of products. Patients preferred a mixed model of GMP and Good Production Practice,[[6]] a less stringent compliance standard Canada applies to non-prescription cannabis products.[[4]]
The current situation of a small number of product approvals, however, raises several concerns as to whether enforcing a single compliance framework remains the preferred pathway to achieving the MCS’s objective. Medsafe has issued several companies a GMP licence,[[7]] and three domestic medicinal companies obtained MCS “approval” for four products that meet the minimum quality standards (MQS) outlined in the Misuse of Drugs (Medicinal Cannabis) Regulations.[[8]] Medicinal cannabis products include dried components like cannabis flower and dosage products like capsules containing cannabis-based ingredients. Of the 71 product applications the Medicinal Cannabis Agency (MCA) received between April 2020 and December 2021, only four cannabis-based ingredients and six dosage products met the MQS.[[9]] Manufactures have expressed frustration with GMP accreditation, describing the requirement to prove final products will sustain their quality over a six-month period as a roadblock in the approval process.[[10]] The MCA’s recent decision to allow laboratories to comply with the ISO/IEC standard for testing specific materials (rather than only relying on the GMP-accredited laboratories) may help reduce barriers for industry in the product approvals process.
The demands of GMP compliance have discouraged small-scale suppliers from seeking to provide products. This may result in a few companies monopolising the domestic market, and although this could provide better compliance and professional standards, it risks inequitable access for some patients if products are priced too high. Our recent survey of 3,634 medicinal cannabis users found that affluent and Pākehā users were more likely to procure medicinal cannabis through the MCS than low-income earners due to the anticipated high prices of prescribed products.[[11]] During the MCS consultations, the medicinal cannabis advisory committee highlighted concerns about mark-ups on cannabis products creating access barriers for patients.[[6]] In April 2021 the MOH anticipated products that meet the GMP standard would likely cost more than products that don’t.[[12]] As MCS products will not be subsidised by Pharmac, the issue of financial barriers to access is likely to persist in the immediate future for patients, even with domestic products entering the market.
Informal black-market supply
Most cannabis used for broadly defined therapeutic purposes in New Zealand is accessed via the illegal, unregulated market. Before the MCS, a survey of medicinal cannabis users found less than 5% of respondents procured medicinal cannabis with a prescription, the majority choosing to source via drug dealers, relatives or home-growing.[[13]] Groups like the Green Fairies provide an underground supply of cannabis products to people who may not otherwise have contacts and supply networks in the “street” illegal cannabis market. While in many cases they may be dedicated to medical cannabis provision, there is no official testing of levels of CBD, THC and potential contaminants in these illegal market products, which raises concerns about safety and highlights how delays with the MCS have not addressed reliance on illegal supply and untested products.[[1]] Though currently cannabis-based products can still be imported for named individual patients outside of the MCS, there have been media reports of doctors and clinics being investigated for exercising this option too liberally.[[14]] The slow progress on product approvals may undermine patients’ confidence in the MCS and may mean patients will re-engage with grey and black-market supply routes.[[15]]
Health professionals’ engagement
Currently, general practitioners have eight CBD and THC products at their disposal. Data on legal market purchases suggest CBD-only products are increasingly prescribed; 16,678 prescriptions were made for CBD products by mid-2021, 75% of the total CBD prescriptions made in all of 2020 (21,964) (Sep 21, personal communication with the Ministry of Health). Despite more prescriptions, there is evidence that prescribing practices may not be uniform. A 2020 exploratory study of 76 general practitioners found 79% of them were hesitant to prescribe medicinal cannabis in the future. Over a third stated there was no evidence to support cannabis-therapy for specific conditions and just over half had consulted any resources on medicinal cannabis.[[16]]
The limited scientific clinical trial evidence for the use of cannabis in clinical treatment has been a major issue in implementing similar regimes overseas affecting doctors’ willingness to engage with cannabis prescribing.[[17]] There is moderate-quality evidence for the use of cannabis to treat chronic pain, chemotherapy-induced nausea and vomiting and spasticity as a result of multiple sclerosis, as well as insufficient evidence for several other conditions, including epilepsy (better evidence from paediatric samples than adult trials),[[18]] post-traumatic stress disorder and anxiety symptoms.[[19]] Reluctance to prescribe cannabis as a medicine may also be influenced by its historical status as a prohibited drug with related stigma. On the other hand, prescribing of new medicines is often slow if colleagues are uncertain and/or there is no recent history of prescribing of the therapeutic class of cannabinoids.[[20]] As the MCS regime matures, products approved under the scheme may become more normalised. The Medical Council’s statement on good prescribing practice requires doctors to be informed on drug profiles when prescribing them to patients.[[16]] Medicinal cannabis deviates from this requirement as products under the MCS don’t require efficacy data to be approved and available on prescription; and without a list of eligible conditions, prescriptions are administered at the clinician’s discretion.[[13]] Medsafe also considers products under the MCS as “unapproved” medicines, which means they are prescribed as exceptions to the Medicines Act.[[16]] The Best Practice Advocacy Centre New Zealand is currently developing an information resource on medicinal cannabis to help health professionals facilitate conversations with patients.[[21]] Though this is a progressive step towards supporting health professionals’ engagement in the MCS, the lack of clinical evidence outlined for using medicinal cannabis to treat commonly enquired about conditions (eg, chronic pain and nausea) is likely to remain an important barrier to expanding prescribing.
At present, prescribers may feel cautious about exploring medicinal cannabis as a treatment option as it deviates from the standard regulations for medicines and requires individual doctors to assume personal liability when prescribing these products. Overseas, gaps in general practitioner prescribing have provided physicians interested in cannabis medicines with the opportunity to forge speciality clinics in this area.[[16]] Despite patients’ significant interest in medicinal cannabis products in New Zealand and easing of regulatory barriers in recent years, only a third of requests for a medicinal cannabis prescriptions via general practitioners are successful,[[13]] and cannabis clinics have increasingly met this need. If implemented and received well, the MOH’s educational resource could reduce the risk of patients compartmentalising their health by seeking separate medical advice from cannabis clinics.
Conclusion
The implementation of New Zealand’s MCS has been slower than many expected. Four years on, the scheme’s objective of greater access to medicinal cannabis has progressed in some ways, yet inequitable access to products remains a significant issue for many patients. Compliance standards, black-market activity and inconsistent prescribing practices are gaps that are relevant for health professionals, policymakers and industry stakeholders to consider as the MCS matures. The recent consensus to approve ISO/IEC-accredited laboratories for testing, development of BPAC resource for prescribers and the approval of four products linked to domestic medicinal cannabis companies are positive responses to delays. There is a need for further investment in general practitioner information and training to improve confidence in prescribing cannabis products, and further lateral thinking and innovation to overcome current procedural challenges. Reclassifying non-intoxicating cannabidiol products from prescription to over-the-counter products could improve equity in the MCS by reducing access barriers put up by the current prescription-only system.[[15,22]] Currently, the slow implementation of the MCS illustrates challenges in reconciling the views of patients, industry and health practitioners on the best way to implement the new scheme.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1. Raymond O, McCarthy MJ, Baker J, Poulsen H. Medicinal cannabis - The Green Fairy Phenomenon. Aust J Chem. 2021; 74(6):480-94.
2. Horizon Research. Auckland (New Zealand): Potential market for medicinal cannabis: 1 million adults; 2019 [cited 2021 Dec 3]. Available from: https://www.horizonpoll.co.nz/page/545/potential-market-for-medicinal-cannabis-1-million-adults
3. Ministry of Health. Medicinal Cannabis Scheme: Consultation document; 2019 [cited 2021 Aug 18]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-consultation
4. Brown, R (2021). More tales from the Medicinal Cannabis Scheme. Available from: https://publicaddress.net/hardnews/more-tales-from-the-medicinal-cannabis-scheme/#comments and https://publicaddress.net/hardnews/medicinal-cannabis-2022-will-be-a-better/
5. Ministry of Health. Medicinal Cannabis Scheme guidelines and forms. Part 4: Guidance for Applicants for a Medicinal Cannabis Licence; 2020 April [cited 2020 Sep 13]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-guideline-and-forms
6. Medicinal Cannabis Agency - Background information – MCAG Meeting Minutes 4 September 2019; 2020 April [cited 2020 Sep 15]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-background-information
7. Ministry of Health. Medicinal Cannabis Agency - Information for consumers; 2020 April [updated 2021 Oct 1; cited 2021 Sep 22]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-consumers
8. Ministry of Health. Medicinal cannabis products that meet the minimum quality standard; 2020 April [updated 2021 Oct 4; cited 2021 Oct 10]. Available from https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/medicinal-cannabis-products-meet-minimum-quality-standard
9. Ministry of Health. Applications received for assessment against the minimum product quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019; 2020 April [updated 2021 Sep 27; cited 2021 Oct 3]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/applications-received-assessment-against-minimum-product-quality-standard-under-misuse-drugs
10. Brown, R. D-Day approaches for new medicinal cannabis scheme. Drug Foundation; 2021 Aug [cited 2021 Sep 10]. Available from: https://www.drugfoundation.org.nz/matters-of-substance/whats-up-with-the-new-medicinal-cannabis-scheme/?fbclid=IwAR3qa1TF3UqCzBIwEqSAM22xtvLvvUuXFKnrKpz0Rob3MPcWp8KArLfq-WU#.YVOVXgiP32E.facebook
11. Rychert M, Parker K, Wilkins C, Graydon-Guy T. Predictors of medicinal cannabis users' willingness to utilise a new prescription Medicinal Cannabis Scheme in New Zealand. N Z Med J. 2021;134(1534): 66-75.
12. Ministry of Health. OIA reports. Documents released as part Response to Official Information Request for any information supplied to Minister of Health Andrew Little about medicinal cannabis – 4 documents released. Released 14 June.
13. Rychert M, Wilkins C, Parker K, Graydon-Guy T. Exploring medicinal use of cannabis in a time of policy change in New Zealand. N Z Med J. 2020; 133(1515):54-69.
14. Dennet, K. Medsafe investigates doctors and clinics for importing unapproved medicinal cannabis. Stuff. 2021 Oct [cited 2021 Oct 26]. Available from: https://www.stuff.co.nz/national/health/300424013/medsafe-investigates-doctors-and-clinics-for-importing-unapproved-medicinal-cannabis
15. Rychert M, Wilkins C, Withanarachchie V. Why it’s time to treat medicinal cannabis as an alternative therapy, not a pharmaceutical. The Conversation. 2021 Oct [cited 2021 Oct 30]. Available from: https://theconversation.com/why-its-time-to-treat-medicinal-cannabis-as-an-alternative-therapy-not-a-pharmaceutical-169458
16. Oldfield K. Framing the use of cannabis as a medicine in New Zealand: Regulatory, Clinician and Patient contexts [Doctoral thesis]. Wellington: Victoria University of Wellington; 2021 [cited 2021 Sep 2]. Available from: https://openaccess.wgtn.ac.nz/articles/thesis/Framing_the_use_of_cannabis_as_a_medicine_in_New_Zealand_Regulatory_Clinician_and_Patient_contexts/14633439
17. Lake S, Kerr T, Montaner J. Prescribing medical cannabis in Canada: Are we being too cautious? Can J Public Health. 2015; 106(5):328-330
18. Stockings E, Zagic D, Campbell G, Weier M, Hall WD, Nielsen S, Herkes GK, Farrell M, Degenhardt L. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. Journal of Neurology, Neurosurgery & Psychiatry. 2018 1;89(7):741-53.
19. National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: The National Academies Press; 2017 [2021 Dec 1]. Available from: https://www.nap.edu/catalog/24625/the-health-effects-of-cannabis-and-cannabinoids-the-current-state
20. Lublóy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014; 14(469)
21. The Best Practice Advocacy Centre New Zealand. An overview of medicinal cannabis for health practitioners; 2021 [cited 2021 Sep 22]. Available from: http://web.archive.org/web/20211028053843/https:/consult.health.govt.nz/medsafe/c6374abc/supporting_documents/Medicinal%20Cannabis%20primer.pdf
22. McGregor IS, Cairns EA, Abelev S, Cohen R, Henderson M, Couch D, Arnold JC, Gauld N. Access to cannabidiol without a prescription: A cross-country comparison and analysis. International Journal of Drug Policy. 2020. 1;85:102935.
For the PDF of this article,
contact nzmj@nzma.org.nz
Assessing progress with the implementation of the New Zealand Medicinal Cannabis Scheme
View Article PDF
In 2017, the Labour coalition government committed to making cannabis-based medicinal products more readily available to patients. The decision to legalise cannabis for medical purposes followed growing public demand, including by terminally ill and epileptic patients who advocated for greater access to cannabis-based products.[[1]] A market research panel survey conducted in May 2019 found over 30% of New Zealanders were interested in accessing medicinal cannabis products when they became available.[[2]] Following public consultations, the Medicinal Cannabis Scheme (MCS) commenced in April 2020 with a central objective to improve patients’ access to affordable, quality medicinal cannabis products. Under the scheme, patients with a prescription from a New Zealand-registered doctor can access medicinal cannabis products, both THC and CBD.
When the MCS commenced, the medicinal cannabis product range available in New Zealand was largely limited to imported products. The scheme aimed to reduce reliance on imports by facilitating local manufacture and distribution of medicinal cannabis products, and to support health professionals to confidently prescribe these products to patients.[[3]] While New Zealand’s domestic industry worked to achieve the new MCS standards, the Ministry of Health (MOH) approved a six-month extension to a temporary scheme to give patients continued access to CBD imports.
Eight medicinal cannabis products now meet the MCS standards, including 4 Canadian products (Tilray) and 4 products with domestic NZ medicinal cannabis company license holders (SubDrops™ CBD100, SubDrops™ CBD25, ANTG Eve, and RUA CBD100). As far as we can ascertain, three of the four products licensed to domestic medicinal cannabis companies consist of imported flower or other active ingredients with final processing in New Zealand.[[4]] The MCS continues to experience implementation issues following the end of the interim scheme (Figure 1). This editorial provides an update on the MCS and reviews key issues to date.
Figure 1: Regulation of medicinal cannabis products in New Zealand and the Medicinal Cannabis Scheme implementation timeline. View Figure 1.
Domestic industry: minimum quality standard
Under the MCS, a Medicinal Cannabis Licence is required to commercially participate in the sector. Producers must meet the Good Manufacturing Practice (GMP) code, a near-pharmaceutical-grade compliance standard that applies to all medicines available in New Zealand, to receive the additional Licence to Manufacture Medicines.[[5]] During the MCS public consultations, industry stakeholders and medical practitioners received the GMP standard positively, reflecting the focus on consistency and quality of products. Patients preferred a mixed model of GMP and Good Production Practice,[[6]] a less stringent compliance standard Canada applies to non-prescription cannabis products.[[4]]
The current situation of a small number of product approvals, however, raises several concerns as to whether enforcing a single compliance framework remains the preferred pathway to achieving the MCS’s objective. Medsafe has issued several companies a GMP licence,[[7]] and three domestic medicinal companies obtained MCS “approval” for four products that meet the minimum quality standards (MQS) outlined in the Misuse of Drugs (Medicinal Cannabis) Regulations.[[8]] Medicinal cannabis products include dried components like cannabis flower and dosage products like capsules containing cannabis-based ingredients. Of the 71 product applications the Medicinal Cannabis Agency (MCA) received between April 2020 and December 2021, only four cannabis-based ingredients and six dosage products met the MQS.[[9]] Manufactures have expressed frustration with GMP accreditation, describing the requirement to prove final products will sustain their quality over a six-month period as a roadblock in the approval process.[[10]] The MCA’s recent decision to allow laboratories to comply with the ISO/IEC standard for testing specific materials (rather than only relying on the GMP-accredited laboratories) may help reduce barriers for industry in the product approvals process.
The demands of GMP compliance have discouraged small-scale suppliers from seeking to provide products. This may result in a few companies monopolising the domestic market, and although this could provide better compliance and professional standards, it risks inequitable access for some patients if products are priced too high. Our recent survey of 3,634 medicinal cannabis users found that affluent and Pākehā users were more likely to procure medicinal cannabis through the MCS than low-income earners due to the anticipated high prices of prescribed products.[[11]] During the MCS consultations, the medicinal cannabis advisory committee highlighted concerns about mark-ups on cannabis products creating access barriers for patients.[[6]] In April 2021 the MOH anticipated products that meet the GMP standard would likely cost more than products that don’t.[[12]] As MCS products will not be subsidised by Pharmac, the issue of financial barriers to access is likely to persist in the immediate future for patients, even with domestic products entering the market.
Informal black-market supply
Most cannabis used for broadly defined therapeutic purposes in New Zealand is accessed via the illegal, unregulated market. Before the MCS, a survey of medicinal cannabis users found less than 5% of respondents procured medicinal cannabis with a prescription, the majority choosing to source via drug dealers, relatives or home-growing.[[13]] Groups like the Green Fairies provide an underground supply of cannabis products to people who may not otherwise have contacts and supply networks in the “street” illegal cannabis market. While in many cases they may be dedicated to medical cannabis provision, there is no official testing of levels of CBD, THC and potential contaminants in these illegal market products, which raises concerns about safety and highlights how delays with the MCS have not addressed reliance on illegal supply and untested products.[[1]] Though currently cannabis-based products can still be imported for named individual patients outside of the MCS, there have been media reports of doctors and clinics being investigated for exercising this option too liberally.[[14]] The slow progress on product approvals may undermine patients’ confidence in the MCS and may mean patients will re-engage with grey and black-market supply routes.[[15]]
Health professionals’ engagement
Currently, general practitioners have eight CBD and THC products at their disposal. Data on legal market purchases suggest CBD-only products are increasingly prescribed; 16,678 prescriptions were made for CBD products by mid-2021, 75% of the total CBD prescriptions made in all of 2020 (21,964) (Sep 21, personal communication with the Ministry of Health). Despite more prescriptions, there is evidence that prescribing practices may not be uniform. A 2020 exploratory study of 76 general practitioners found 79% of them were hesitant to prescribe medicinal cannabis in the future. Over a third stated there was no evidence to support cannabis-therapy for specific conditions and just over half had consulted any resources on medicinal cannabis.[[16]]
The limited scientific clinical trial evidence for the use of cannabis in clinical treatment has been a major issue in implementing similar regimes overseas affecting doctors’ willingness to engage with cannabis prescribing.[[17]] There is moderate-quality evidence for the use of cannabis to treat chronic pain, chemotherapy-induced nausea and vomiting and spasticity as a result of multiple sclerosis, as well as insufficient evidence for several other conditions, including epilepsy (better evidence from paediatric samples than adult trials),[[18]] post-traumatic stress disorder and anxiety symptoms.[[19]] Reluctance to prescribe cannabis as a medicine may also be influenced by its historical status as a prohibited drug with related stigma. On the other hand, prescribing of new medicines is often slow if colleagues are uncertain and/or there is no recent history of prescribing of the therapeutic class of cannabinoids.[[20]] As the MCS regime matures, products approved under the scheme may become more normalised. The Medical Council’s statement on good prescribing practice requires doctors to be informed on drug profiles when prescribing them to patients.[[16]] Medicinal cannabis deviates from this requirement as products under the MCS don’t require efficacy data to be approved and available on prescription; and without a list of eligible conditions, prescriptions are administered at the clinician’s discretion.[[13]] Medsafe also considers products under the MCS as “unapproved” medicines, which means they are prescribed as exceptions to the Medicines Act.[[16]] The Best Practice Advocacy Centre New Zealand is currently developing an information resource on medicinal cannabis to help health professionals facilitate conversations with patients.[[21]] Though this is a progressive step towards supporting health professionals’ engagement in the MCS, the lack of clinical evidence outlined for using medicinal cannabis to treat commonly enquired about conditions (eg, chronic pain and nausea) is likely to remain an important barrier to expanding prescribing.
At present, prescribers may feel cautious about exploring medicinal cannabis as a treatment option as it deviates from the standard regulations for medicines and requires individual doctors to assume personal liability when prescribing these products. Overseas, gaps in general practitioner prescribing have provided physicians interested in cannabis medicines with the opportunity to forge speciality clinics in this area.[[16]] Despite patients’ significant interest in medicinal cannabis products in New Zealand and easing of regulatory barriers in recent years, only a third of requests for a medicinal cannabis prescriptions via general practitioners are successful,[[13]] and cannabis clinics have increasingly met this need. If implemented and received well, the MOH’s educational resource could reduce the risk of patients compartmentalising their health by seeking separate medical advice from cannabis clinics.
Conclusion
The implementation of New Zealand’s MCS has been slower than many expected. Four years on, the scheme’s objective of greater access to medicinal cannabis has progressed in some ways, yet inequitable access to products remains a significant issue for many patients. Compliance standards, black-market activity and inconsistent prescribing practices are gaps that are relevant for health professionals, policymakers and industry stakeholders to consider as the MCS matures. The recent consensus to approve ISO/IEC-accredited laboratories for testing, development of BPAC resource for prescribers and the approval of four products linked to domestic medicinal cannabis companies are positive responses to delays. There is a need for further investment in general practitioner information and training to improve confidence in prescribing cannabis products, and further lateral thinking and innovation to overcome current procedural challenges. Reclassifying non-intoxicating cannabidiol products from prescription to over-the-counter products could improve equity in the MCS by reducing access barriers put up by the current prescription-only system.[[15,22]] Currently, the slow implementation of the MCS illustrates challenges in reconciling the views of patients, industry and health practitioners on the best way to implement the new scheme.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1. Raymond O, McCarthy MJ, Baker J, Poulsen H. Medicinal cannabis - The Green Fairy Phenomenon. Aust J Chem. 2021; 74(6):480-94.
2. Horizon Research. Auckland (New Zealand): Potential market for medicinal cannabis: 1 million adults; 2019 [cited 2021 Dec 3]. Available from: https://www.horizonpoll.co.nz/page/545/potential-market-for-medicinal-cannabis-1-million-adults
3. Ministry of Health. Medicinal Cannabis Scheme: Consultation document; 2019 [cited 2021 Aug 18]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-consultation
4. Brown, R (2021). More tales from the Medicinal Cannabis Scheme. Available from: https://publicaddress.net/hardnews/more-tales-from-the-medicinal-cannabis-scheme/#comments and https://publicaddress.net/hardnews/medicinal-cannabis-2022-will-be-a-better/
5. Ministry of Health. Medicinal Cannabis Scheme guidelines and forms. Part 4: Guidance for Applicants for a Medicinal Cannabis Licence; 2020 April [cited 2020 Sep 13]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-guideline-and-forms
6. Medicinal Cannabis Agency - Background information – MCAG Meeting Minutes 4 September 2019; 2020 April [cited 2020 Sep 15]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-background-information
7. Ministry of Health. Medicinal Cannabis Agency - Information for consumers; 2020 April [updated 2021 Oct 1; cited 2021 Sep 22]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-consumers
8. Ministry of Health. Medicinal cannabis products that meet the minimum quality standard; 2020 April [updated 2021 Oct 4; cited 2021 Oct 10]. Available from https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/medicinal-cannabis-products-meet-minimum-quality-standard
9. Ministry of Health. Applications received for assessment against the minimum product quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019; 2020 April [updated 2021 Sep 27; cited 2021 Oct 3]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/applications-received-assessment-against-minimum-product-quality-standard-under-misuse-drugs
10. Brown, R. D-Day approaches for new medicinal cannabis scheme. Drug Foundation; 2021 Aug [cited 2021 Sep 10]. Available from: https://www.drugfoundation.org.nz/matters-of-substance/whats-up-with-the-new-medicinal-cannabis-scheme/?fbclid=IwAR3qa1TF3UqCzBIwEqSAM22xtvLvvUuXFKnrKpz0Rob3MPcWp8KArLfq-WU#.YVOVXgiP32E.facebook
11. Rychert M, Parker K, Wilkins C, Graydon-Guy T. Predictors of medicinal cannabis users' willingness to utilise a new prescription Medicinal Cannabis Scheme in New Zealand. N Z Med J. 2021;134(1534): 66-75.
12. Ministry of Health. OIA reports. Documents released as part Response to Official Information Request for any information supplied to Minister of Health Andrew Little about medicinal cannabis – 4 documents released. Released 14 June.
13. Rychert M, Wilkins C, Parker K, Graydon-Guy T. Exploring medicinal use of cannabis in a time of policy change in New Zealand. N Z Med J. 2020; 133(1515):54-69.
14. Dennet, K. Medsafe investigates doctors and clinics for importing unapproved medicinal cannabis. Stuff. 2021 Oct [cited 2021 Oct 26]. Available from: https://www.stuff.co.nz/national/health/300424013/medsafe-investigates-doctors-and-clinics-for-importing-unapproved-medicinal-cannabis
15. Rychert M, Wilkins C, Withanarachchie V. Why it’s time to treat medicinal cannabis as an alternative therapy, not a pharmaceutical. The Conversation. 2021 Oct [cited 2021 Oct 30]. Available from: https://theconversation.com/why-its-time-to-treat-medicinal-cannabis-as-an-alternative-therapy-not-a-pharmaceutical-169458
16. Oldfield K. Framing the use of cannabis as a medicine in New Zealand: Regulatory, Clinician and Patient contexts [Doctoral thesis]. Wellington: Victoria University of Wellington; 2021 [cited 2021 Sep 2]. Available from: https://openaccess.wgtn.ac.nz/articles/thesis/Framing_the_use_of_cannabis_as_a_medicine_in_New_Zealand_Regulatory_Clinician_and_Patient_contexts/14633439
17. Lake S, Kerr T, Montaner J. Prescribing medical cannabis in Canada: Are we being too cautious? Can J Public Health. 2015; 106(5):328-330
18. Stockings E, Zagic D, Campbell G, Weier M, Hall WD, Nielsen S, Herkes GK, Farrell M, Degenhardt L. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. Journal of Neurology, Neurosurgery & Psychiatry. 2018 1;89(7):741-53.
19. National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: The National Academies Press; 2017 [2021 Dec 1]. Available from: https://www.nap.edu/catalog/24625/the-health-effects-of-cannabis-and-cannabinoids-the-current-state
20. Lublóy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014; 14(469)
21. The Best Practice Advocacy Centre New Zealand. An overview of medicinal cannabis for health practitioners; 2021 [cited 2021 Sep 22]. Available from: http://web.archive.org/web/20211028053843/https:/consult.health.govt.nz/medsafe/c6374abc/supporting_documents/Medicinal%20Cannabis%20primer.pdf
22. McGregor IS, Cairns EA, Abelev S, Cohen R, Henderson M, Couch D, Arnold JC, Gauld N. Access to cannabidiol without a prescription: A cross-country comparison and analysis. International Journal of Drug Policy. 2020. 1;85:102935.
For the PDF of this article,
contact nzmj@nzma.org.nz
Assessing progress with the implementation of the New Zealand Medicinal Cannabis Scheme
View Article PDF
In 2017, the Labour coalition government committed to making cannabis-based medicinal products more readily available to patients. The decision to legalise cannabis for medical purposes followed growing public demand, including by terminally ill and epileptic patients who advocated for greater access to cannabis-based products.[[1]] A market research panel survey conducted in May 2019 found over 30% of New Zealanders were interested in accessing medicinal cannabis products when they became available.[[2]] Following public consultations, the Medicinal Cannabis Scheme (MCS) commenced in April 2020 with a central objective to improve patients’ access to affordable, quality medicinal cannabis products. Under the scheme, patients with a prescription from a New Zealand-registered doctor can access medicinal cannabis products, both THC and CBD.
When the MCS commenced, the medicinal cannabis product range available in New Zealand was largely limited to imported products. The scheme aimed to reduce reliance on imports by facilitating local manufacture and distribution of medicinal cannabis products, and to support health professionals to confidently prescribe these products to patients.[[3]] While New Zealand’s domestic industry worked to achieve the new MCS standards, the Ministry of Health (MOH) approved a six-month extension to a temporary scheme to give patients continued access to CBD imports.
Eight medicinal cannabis products now meet the MCS standards, including 4 Canadian products (Tilray) and 4 products with domestic NZ medicinal cannabis company license holders (SubDrops™ CBD100, SubDrops™ CBD25, ANTG Eve, and RUA CBD100). As far as we can ascertain, three of the four products licensed to domestic medicinal cannabis companies consist of imported flower or other active ingredients with final processing in New Zealand.[[4]] The MCS continues to experience implementation issues following the end of the interim scheme (Figure 1). This editorial provides an update on the MCS and reviews key issues to date.
Figure 1: Regulation of medicinal cannabis products in New Zealand and the Medicinal Cannabis Scheme implementation timeline. View Figure 1.
Domestic industry: minimum quality standard
Under the MCS, a Medicinal Cannabis Licence is required to commercially participate in the sector. Producers must meet the Good Manufacturing Practice (GMP) code, a near-pharmaceutical-grade compliance standard that applies to all medicines available in New Zealand, to receive the additional Licence to Manufacture Medicines.[[5]] During the MCS public consultations, industry stakeholders and medical practitioners received the GMP standard positively, reflecting the focus on consistency and quality of products. Patients preferred a mixed model of GMP and Good Production Practice,[[6]] a less stringent compliance standard Canada applies to non-prescription cannabis products.[[4]]
The current situation of a small number of product approvals, however, raises several concerns as to whether enforcing a single compliance framework remains the preferred pathway to achieving the MCS’s objective. Medsafe has issued several companies a GMP licence,[[7]] and three domestic medicinal companies obtained MCS “approval” for four products that meet the minimum quality standards (MQS) outlined in the Misuse of Drugs (Medicinal Cannabis) Regulations.[[8]] Medicinal cannabis products include dried components like cannabis flower and dosage products like capsules containing cannabis-based ingredients. Of the 71 product applications the Medicinal Cannabis Agency (MCA) received between April 2020 and December 2021, only four cannabis-based ingredients and six dosage products met the MQS.[[9]] Manufactures have expressed frustration with GMP accreditation, describing the requirement to prove final products will sustain their quality over a six-month period as a roadblock in the approval process.[[10]] The MCA’s recent decision to allow laboratories to comply with the ISO/IEC standard for testing specific materials (rather than only relying on the GMP-accredited laboratories) may help reduce barriers for industry in the product approvals process.
The demands of GMP compliance have discouraged small-scale suppliers from seeking to provide products. This may result in a few companies monopolising the domestic market, and although this could provide better compliance and professional standards, it risks inequitable access for some patients if products are priced too high. Our recent survey of 3,634 medicinal cannabis users found that affluent and Pākehā users were more likely to procure medicinal cannabis through the MCS than low-income earners due to the anticipated high prices of prescribed products.[[11]] During the MCS consultations, the medicinal cannabis advisory committee highlighted concerns about mark-ups on cannabis products creating access barriers for patients.[[6]] In April 2021 the MOH anticipated products that meet the GMP standard would likely cost more than products that don’t.[[12]] As MCS products will not be subsidised by Pharmac, the issue of financial barriers to access is likely to persist in the immediate future for patients, even with domestic products entering the market.
Informal black-market supply
Most cannabis used for broadly defined therapeutic purposes in New Zealand is accessed via the illegal, unregulated market. Before the MCS, a survey of medicinal cannabis users found less than 5% of respondents procured medicinal cannabis with a prescription, the majority choosing to source via drug dealers, relatives or home-growing.[[13]] Groups like the Green Fairies provide an underground supply of cannabis products to people who may not otherwise have contacts and supply networks in the “street” illegal cannabis market. While in many cases they may be dedicated to medical cannabis provision, there is no official testing of levels of CBD, THC and potential contaminants in these illegal market products, which raises concerns about safety and highlights how delays with the MCS have not addressed reliance on illegal supply and untested products.[[1]] Though currently cannabis-based products can still be imported for named individual patients outside of the MCS, there have been media reports of doctors and clinics being investigated for exercising this option too liberally.[[14]] The slow progress on product approvals may undermine patients’ confidence in the MCS and may mean patients will re-engage with grey and black-market supply routes.[[15]]
Health professionals’ engagement
Currently, general practitioners have eight CBD and THC products at their disposal. Data on legal market purchases suggest CBD-only products are increasingly prescribed; 16,678 prescriptions were made for CBD products by mid-2021, 75% of the total CBD prescriptions made in all of 2020 (21,964) (Sep 21, personal communication with the Ministry of Health). Despite more prescriptions, there is evidence that prescribing practices may not be uniform. A 2020 exploratory study of 76 general practitioners found 79% of them were hesitant to prescribe medicinal cannabis in the future. Over a third stated there was no evidence to support cannabis-therapy for specific conditions and just over half had consulted any resources on medicinal cannabis.[[16]]
The limited scientific clinical trial evidence for the use of cannabis in clinical treatment has been a major issue in implementing similar regimes overseas affecting doctors’ willingness to engage with cannabis prescribing.[[17]] There is moderate-quality evidence for the use of cannabis to treat chronic pain, chemotherapy-induced nausea and vomiting and spasticity as a result of multiple sclerosis, as well as insufficient evidence for several other conditions, including epilepsy (better evidence from paediatric samples than adult trials),[[18]] post-traumatic stress disorder and anxiety symptoms.[[19]] Reluctance to prescribe cannabis as a medicine may also be influenced by its historical status as a prohibited drug with related stigma. On the other hand, prescribing of new medicines is often slow if colleagues are uncertain and/or there is no recent history of prescribing of the therapeutic class of cannabinoids.[[20]] As the MCS regime matures, products approved under the scheme may become more normalised. The Medical Council’s statement on good prescribing practice requires doctors to be informed on drug profiles when prescribing them to patients.[[16]] Medicinal cannabis deviates from this requirement as products under the MCS don’t require efficacy data to be approved and available on prescription; and without a list of eligible conditions, prescriptions are administered at the clinician’s discretion.[[13]] Medsafe also considers products under the MCS as “unapproved” medicines, which means they are prescribed as exceptions to the Medicines Act.[[16]] The Best Practice Advocacy Centre New Zealand is currently developing an information resource on medicinal cannabis to help health professionals facilitate conversations with patients.[[21]] Though this is a progressive step towards supporting health professionals’ engagement in the MCS, the lack of clinical evidence outlined for using medicinal cannabis to treat commonly enquired about conditions (eg, chronic pain and nausea) is likely to remain an important barrier to expanding prescribing.
At present, prescribers may feel cautious about exploring medicinal cannabis as a treatment option as it deviates from the standard regulations for medicines and requires individual doctors to assume personal liability when prescribing these products. Overseas, gaps in general practitioner prescribing have provided physicians interested in cannabis medicines with the opportunity to forge speciality clinics in this area.[[16]] Despite patients’ significant interest in medicinal cannabis products in New Zealand and easing of regulatory barriers in recent years, only a third of requests for a medicinal cannabis prescriptions via general practitioners are successful,[[13]] and cannabis clinics have increasingly met this need. If implemented and received well, the MOH’s educational resource could reduce the risk of patients compartmentalising their health by seeking separate medical advice from cannabis clinics.
Conclusion
The implementation of New Zealand’s MCS has been slower than many expected. Four years on, the scheme’s objective of greater access to medicinal cannabis has progressed in some ways, yet inequitable access to products remains a significant issue for many patients. Compliance standards, black-market activity and inconsistent prescribing practices are gaps that are relevant for health professionals, policymakers and industry stakeholders to consider as the MCS matures. The recent consensus to approve ISO/IEC-accredited laboratories for testing, development of BPAC resource for prescribers and the approval of four products linked to domestic medicinal cannabis companies are positive responses to delays. There is a need for further investment in general practitioner information and training to improve confidence in prescribing cannabis products, and further lateral thinking and innovation to overcome current procedural challenges. Reclassifying non-intoxicating cannabidiol products from prescription to over-the-counter products could improve equity in the MCS by reducing access barriers put up by the current prescription-only system.[[15,22]] Currently, the slow implementation of the MCS illustrates challenges in reconciling the views of patients, industry and health practitioners on the best way to implement the new scheme.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1. Raymond O, McCarthy MJ, Baker J, Poulsen H. Medicinal cannabis - The Green Fairy Phenomenon. Aust J Chem. 2021; 74(6):480-94.
2. Horizon Research. Auckland (New Zealand): Potential market for medicinal cannabis: 1 million adults; 2019 [cited 2021 Dec 3]. Available from: https://www.horizonpoll.co.nz/page/545/potential-market-for-medicinal-cannabis-1-million-adults
3. Ministry of Health. Medicinal Cannabis Scheme: Consultation document; 2019 [cited 2021 Aug 18]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-consultation
4. Brown, R (2021). More tales from the Medicinal Cannabis Scheme. Available from: https://publicaddress.net/hardnews/more-tales-from-the-medicinal-cannabis-scheme/#comments and https://publicaddress.net/hardnews/medicinal-cannabis-2022-will-be-a-better/
5. Ministry of Health. Medicinal Cannabis Scheme guidelines and forms. Part 4: Guidance for Applicants for a Medicinal Cannabis Licence; 2020 April [cited 2020 Sep 13]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-guideline-and-forms
6. Medicinal Cannabis Agency - Background information – MCAG Meeting Minutes 4 September 2019; 2020 April [cited 2020 Sep 15]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-background-information
7. Ministry of Health. Medicinal Cannabis Agency - Information for consumers; 2020 April [updated 2021 Oct 1; cited 2021 Sep 22]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-consumers
8. Ministry of Health. Medicinal cannabis products that meet the minimum quality standard; 2020 April [updated 2021 Oct 4; cited 2021 Oct 10]. Available from https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/medicinal-cannabis-products-meet-minimum-quality-standard
9. Ministry of Health. Applications received for assessment against the minimum product quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019; 2020 April [updated 2021 Sep 27; cited 2021 Oct 3]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/applications-received-assessment-against-minimum-product-quality-standard-under-misuse-drugs
10. Brown, R. D-Day approaches for new medicinal cannabis scheme. Drug Foundation; 2021 Aug [cited 2021 Sep 10]. Available from: https://www.drugfoundation.org.nz/matters-of-substance/whats-up-with-the-new-medicinal-cannabis-scheme/?fbclid=IwAR3qa1TF3UqCzBIwEqSAM22xtvLvvUuXFKnrKpz0Rob3MPcWp8KArLfq-WU#.YVOVXgiP32E.facebook
11. Rychert M, Parker K, Wilkins C, Graydon-Guy T. Predictors of medicinal cannabis users' willingness to utilise a new prescription Medicinal Cannabis Scheme in New Zealand. N Z Med J. 2021;134(1534): 66-75.
12. Ministry of Health. OIA reports. Documents released as part Response to Official Information Request for any information supplied to Minister of Health Andrew Little about medicinal cannabis – 4 documents released. Released 14 June.
13. Rychert M, Wilkins C, Parker K, Graydon-Guy T. Exploring medicinal use of cannabis in a time of policy change in New Zealand. N Z Med J. 2020; 133(1515):54-69.
14. Dennet, K. Medsafe investigates doctors and clinics for importing unapproved medicinal cannabis. Stuff. 2021 Oct [cited 2021 Oct 26]. Available from: https://www.stuff.co.nz/national/health/300424013/medsafe-investigates-doctors-and-clinics-for-importing-unapproved-medicinal-cannabis
15. Rychert M, Wilkins C, Withanarachchie V. Why it’s time to treat medicinal cannabis as an alternative therapy, not a pharmaceutical. The Conversation. 2021 Oct [cited 2021 Oct 30]. Available from: https://theconversation.com/why-its-time-to-treat-medicinal-cannabis-as-an-alternative-therapy-not-a-pharmaceutical-169458
16. Oldfield K. Framing the use of cannabis as a medicine in New Zealand: Regulatory, Clinician and Patient contexts [Doctoral thesis]. Wellington: Victoria University of Wellington; 2021 [cited 2021 Sep 2]. Available from: https://openaccess.wgtn.ac.nz/articles/thesis/Framing_the_use_of_cannabis_as_a_medicine_in_New_Zealand_Regulatory_Clinician_and_Patient_contexts/14633439
17. Lake S, Kerr T, Montaner J. Prescribing medical cannabis in Canada: Are we being too cautious? Can J Public Health. 2015; 106(5):328-330
18. Stockings E, Zagic D, Campbell G, Weier M, Hall WD, Nielsen S, Herkes GK, Farrell M, Degenhardt L. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. Journal of Neurology, Neurosurgery & Psychiatry. 2018 1;89(7):741-53.
19. National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: The National Academies Press; 2017 [2021 Dec 1]. Available from: https://www.nap.edu/catalog/24625/the-health-effects-of-cannabis-and-cannabinoids-the-current-state
20. Lublóy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014; 14(469)
21. The Best Practice Advocacy Centre New Zealand. An overview of medicinal cannabis for health practitioners; 2021 [cited 2021 Sep 22]. Available from: http://web.archive.org/web/20211028053843/https:/consult.health.govt.nz/medsafe/c6374abc/supporting_documents/Medicinal%20Cannabis%20primer.pdf
22. McGregor IS, Cairns EA, Abelev S, Cohen R, Henderson M, Couch D, Arnold JC, Gauld N. Access to cannabidiol without a prescription: A cross-country comparison and analysis. International Journal of Drug Policy. 2020. 1;85:102935.
Contact diana@nzma.org.nz
for the PDF of this article
Assessing progress with the implementation of the New Zealand Medicinal Cannabis Scheme
View Article PDF
In 2017, the Labour coalition government committed to making cannabis-based medicinal products more readily available to patients. The decision to legalise cannabis for medical purposes followed growing public demand, including by terminally ill and epileptic patients who advocated for greater access to cannabis-based products.[[1]] A market research panel survey conducted in May 2019 found over 30% of New Zealanders were interested in accessing medicinal cannabis products when they became available.[[2]] Following public consultations, the Medicinal Cannabis Scheme (MCS) commenced in April 2020 with a central objective to improve patients’ access to affordable, quality medicinal cannabis products. Under the scheme, patients with a prescription from a New Zealand-registered doctor can access medicinal cannabis products, both THC and CBD.
When the MCS commenced, the medicinal cannabis product range available in New Zealand was largely limited to imported products. The scheme aimed to reduce reliance on imports by facilitating local manufacture and distribution of medicinal cannabis products, and to support health professionals to confidently prescribe these products to patients.[[3]] While New Zealand’s domestic industry worked to achieve the new MCS standards, the Ministry of Health (MOH) approved a six-month extension to a temporary scheme to give patients continued access to CBD imports.
Eight medicinal cannabis products now meet the MCS standards, including 4 Canadian products (Tilray) and 4 products with domestic NZ medicinal cannabis company license holders (SubDrops™ CBD100, SubDrops™ CBD25, ANTG Eve, and RUA CBD100). As far as we can ascertain, three of the four products licensed to domestic medicinal cannabis companies consist of imported flower or other active ingredients with final processing in New Zealand.[[4]] The MCS continues to experience implementation issues following the end of the interim scheme (Figure 1). This editorial provides an update on the MCS and reviews key issues to date.
Figure 1: Regulation of medicinal cannabis products in New Zealand and the Medicinal Cannabis Scheme implementation timeline. View Figure 1.
Domestic industry: minimum quality standard
Under the MCS, a Medicinal Cannabis Licence is required to commercially participate in the sector. Producers must meet the Good Manufacturing Practice (GMP) code, a near-pharmaceutical-grade compliance standard that applies to all medicines available in New Zealand, to receive the additional Licence to Manufacture Medicines.[[5]] During the MCS public consultations, industry stakeholders and medical practitioners received the GMP standard positively, reflecting the focus on consistency and quality of products. Patients preferred a mixed model of GMP and Good Production Practice,[[6]] a less stringent compliance standard Canada applies to non-prescription cannabis products.[[4]]
The current situation of a small number of product approvals, however, raises several concerns as to whether enforcing a single compliance framework remains the preferred pathway to achieving the MCS’s objective. Medsafe has issued several companies a GMP licence,[[7]] and three domestic medicinal companies obtained MCS “approval” for four products that meet the minimum quality standards (MQS) outlined in the Misuse of Drugs (Medicinal Cannabis) Regulations.[[8]] Medicinal cannabis products include dried components like cannabis flower and dosage products like capsules containing cannabis-based ingredients. Of the 71 product applications the Medicinal Cannabis Agency (MCA) received between April 2020 and December 2021, only four cannabis-based ingredients and six dosage products met the MQS.[[9]] Manufactures have expressed frustration with GMP accreditation, describing the requirement to prove final products will sustain their quality over a six-month period as a roadblock in the approval process.[[10]] The MCA’s recent decision to allow laboratories to comply with the ISO/IEC standard for testing specific materials (rather than only relying on the GMP-accredited laboratories) may help reduce barriers for industry in the product approvals process.
The demands of GMP compliance have discouraged small-scale suppliers from seeking to provide products. This may result in a few companies monopolising the domestic market, and although this could provide better compliance and professional standards, it risks inequitable access for some patients if products are priced too high. Our recent survey of 3,634 medicinal cannabis users found that affluent and Pākehā users were more likely to procure medicinal cannabis through the MCS than low-income earners due to the anticipated high prices of prescribed products.[[11]] During the MCS consultations, the medicinal cannabis advisory committee highlighted concerns about mark-ups on cannabis products creating access barriers for patients.[[6]] In April 2021 the MOH anticipated products that meet the GMP standard would likely cost more than products that don’t.[[12]] As MCS products will not be subsidised by Pharmac, the issue of financial barriers to access is likely to persist in the immediate future for patients, even with domestic products entering the market.
Informal black-market supply
Most cannabis used for broadly defined therapeutic purposes in New Zealand is accessed via the illegal, unregulated market. Before the MCS, a survey of medicinal cannabis users found less than 5% of respondents procured medicinal cannabis with a prescription, the majority choosing to source via drug dealers, relatives or home-growing.[[13]] Groups like the Green Fairies provide an underground supply of cannabis products to people who may not otherwise have contacts and supply networks in the “street” illegal cannabis market. While in many cases they may be dedicated to medical cannabis provision, there is no official testing of levels of CBD, THC and potential contaminants in these illegal market products, which raises concerns about safety and highlights how delays with the MCS have not addressed reliance on illegal supply and untested products.[[1]] Though currently cannabis-based products can still be imported for named individual patients outside of the MCS, there have been media reports of doctors and clinics being investigated for exercising this option too liberally.[[14]] The slow progress on product approvals may undermine patients’ confidence in the MCS and may mean patients will re-engage with grey and black-market supply routes.[[15]]
Health professionals’ engagement
Currently, general practitioners have eight CBD and THC products at their disposal. Data on legal market purchases suggest CBD-only products are increasingly prescribed; 16,678 prescriptions were made for CBD products by mid-2021, 75% of the total CBD prescriptions made in all of 2020 (21,964) (Sep 21, personal communication with the Ministry of Health). Despite more prescriptions, there is evidence that prescribing practices may not be uniform. A 2020 exploratory study of 76 general practitioners found 79% of them were hesitant to prescribe medicinal cannabis in the future. Over a third stated there was no evidence to support cannabis-therapy for specific conditions and just over half had consulted any resources on medicinal cannabis.[[16]]
The limited scientific clinical trial evidence for the use of cannabis in clinical treatment has been a major issue in implementing similar regimes overseas affecting doctors’ willingness to engage with cannabis prescribing.[[17]] There is moderate-quality evidence for the use of cannabis to treat chronic pain, chemotherapy-induced nausea and vomiting and spasticity as a result of multiple sclerosis, as well as insufficient evidence for several other conditions, including epilepsy (better evidence from paediatric samples than adult trials),[[18]] post-traumatic stress disorder and anxiety symptoms.[[19]] Reluctance to prescribe cannabis as a medicine may also be influenced by its historical status as a prohibited drug with related stigma. On the other hand, prescribing of new medicines is often slow if colleagues are uncertain and/or there is no recent history of prescribing of the therapeutic class of cannabinoids.[[20]] As the MCS regime matures, products approved under the scheme may become more normalised. The Medical Council’s statement on good prescribing practice requires doctors to be informed on drug profiles when prescribing them to patients.[[16]] Medicinal cannabis deviates from this requirement as products under the MCS don’t require efficacy data to be approved and available on prescription; and without a list of eligible conditions, prescriptions are administered at the clinician’s discretion.[[13]] Medsafe also considers products under the MCS as “unapproved” medicines, which means they are prescribed as exceptions to the Medicines Act.[[16]] The Best Practice Advocacy Centre New Zealand is currently developing an information resource on medicinal cannabis to help health professionals facilitate conversations with patients.[[21]] Though this is a progressive step towards supporting health professionals’ engagement in the MCS, the lack of clinical evidence outlined for using medicinal cannabis to treat commonly enquired about conditions (eg, chronic pain and nausea) is likely to remain an important barrier to expanding prescribing.
At present, prescribers may feel cautious about exploring medicinal cannabis as a treatment option as it deviates from the standard regulations for medicines and requires individual doctors to assume personal liability when prescribing these products. Overseas, gaps in general practitioner prescribing have provided physicians interested in cannabis medicines with the opportunity to forge speciality clinics in this area.[[16]] Despite patients’ significant interest in medicinal cannabis products in New Zealand and easing of regulatory barriers in recent years, only a third of requests for a medicinal cannabis prescriptions via general practitioners are successful,[[13]] and cannabis clinics have increasingly met this need. If implemented and received well, the MOH’s educational resource could reduce the risk of patients compartmentalising their health by seeking separate medical advice from cannabis clinics.
Conclusion
The implementation of New Zealand’s MCS has been slower than many expected. Four years on, the scheme’s objective of greater access to medicinal cannabis has progressed in some ways, yet inequitable access to products remains a significant issue for many patients. Compliance standards, black-market activity and inconsistent prescribing practices are gaps that are relevant for health professionals, policymakers and industry stakeholders to consider as the MCS matures. The recent consensus to approve ISO/IEC-accredited laboratories for testing, development of BPAC resource for prescribers and the approval of four products linked to domestic medicinal cannabis companies are positive responses to delays. There is a need for further investment in general practitioner information and training to improve confidence in prescribing cannabis products, and further lateral thinking and innovation to overcome current procedural challenges. Reclassifying non-intoxicating cannabidiol products from prescription to over-the-counter products could improve equity in the MCS by reducing access barriers put up by the current prescription-only system.[[15,22]] Currently, the slow implementation of the MCS illustrates challenges in reconciling the views of patients, industry and health practitioners on the best way to implement the new scheme.
Summary
Abstract
Aim
Method
Results
Conclusion
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1. Raymond O, McCarthy MJ, Baker J, Poulsen H. Medicinal cannabis - The Green Fairy Phenomenon. Aust J Chem. 2021; 74(6):480-94.
2. Horizon Research. Auckland (New Zealand): Potential market for medicinal cannabis: 1 million adults; 2019 [cited 2021 Dec 3]. Available from: https://www.horizonpoll.co.nz/page/545/potential-market-for-medicinal-cannabis-1-million-adults
3. Ministry of Health. Medicinal Cannabis Scheme: Consultation document; 2019 [cited 2021 Aug 18]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-consultation
4. Brown, R (2021). More tales from the Medicinal Cannabis Scheme. Available from: https://publicaddress.net/hardnews/more-tales-from-the-medicinal-cannabis-scheme/#comments and https://publicaddress.net/hardnews/medicinal-cannabis-2022-will-be-a-better/
5. Ministry of Health. Medicinal Cannabis Scheme guidelines and forms. Part 4: Guidance for Applicants for a Medicinal Cannabis Licence; 2020 April [cited 2020 Sep 13]. Available from: https://www.health.govt.nz/publication/medicinal-cannabis-scheme-guideline-and-forms
6. Medicinal Cannabis Agency - Background information – MCAG Meeting Minutes 4 September 2019; 2020 April [cited 2020 Sep 15]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-background-information
7. Ministry of Health. Medicinal Cannabis Agency - Information for consumers; 2020 April [updated 2021 Oct 1; cited 2021 Sep 22]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-consumers
8. Ministry of Health. Medicinal cannabis products that meet the minimum quality standard; 2020 April [updated 2021 Oct 4; cited 2021 Oct 10]. Available from https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/medicinal-cannabis-products-meet-minimum-quality-standard
9. Ministry of Health. Applications received for assessment against the minimum product quality standard under the Misuse of Drugs (Medicinal Cannabis) Regulations 2019; 2020 April [updated 2021 Sep 27; cited 2021 Oct 3]. Available from: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/medicinal-cannabis-agency/medicinal-cannabis-agency-information-health-professionals/applications-received-assessment-against-minimum-product-quality-standard-under-misuse-drugs
10. Brown, R. D-Day approaches for new medicinal cannabis scheme. Drug Foundation; 2021 Aug [cited 2021 Sep 10]. Available from: https://www.drugfoundation.org.nz/matters-of-substance/whats-up-with-the-new-medicinal-cannabis-scheme/?fbclid=IwAR3qa1TF3UqCzBIwEqSAM22xtvLvvUuXFKnrKpz0Rob3MPcWp8KArLfq-WU#.YVOVXgiP32E.facebook
11. Rychert M, Parker K, Wilkins C, Graydon-Guy T. Predictors of medicinal cannabis users' willingness to utilise a new prescription Medicinal Cannabis Scheme in New Zealand. N Z Med J. 2021;134(1534): 66-75.
12. Ministry of Health. OIA reports. Documents released as part Response to Official Information Request for any information supplied to Minister of Health Andrew Little about medicinal cannabis – 4 documents released. Released 14 June.
13. Rychert M, Wilkins C, Parker K, Graydon-Guy T. Exploring medicinal use of cannabis in a time of policy change in New Zealand. N Z Med J. 2020; 133(1515):54-69.
14. Dennet, K. Medsafe investigates doctors and clinics for importing unapproved medicinal cannabis. Stuff. 2021 Oct [cited 2021 Oct 26]. Available from: https://www.stuff.co.nz/national/health/300424013/medsafe-investigates-doctors-and-clinics-for-importing-unapproved-medicinal-cannabis
15. Rychert M, Wilkins C, Withanarachchie V. Why it’s time to treat medicinal cannabis as an alternative therapy, not a pharmaceutical. The Conversation. 2021 Oct [cited 2021 Oct 30]. Available from: https://theconversation.com/why-its-time-to-treat-medicinal-cannabis-as-an-alternative-therapy-not-a-pharmaceutical-169458
16. Oldfield K. Framing the use of cannabis as a medicine in New Zealand: Regulatory, Clinician and Patient contexts [Doctoral thesis]. Wellington: Victoria University of Wellington; 2021 [cited 2021 Sep 2]. Available from: https://openaccess.wgtn.ac.nz/articles/thesis/Framing_the_use_of_cannabis_as_a_medicine_in_New_Zealand_Regulatory_Clinician_and_Patient_contexts/14633439
17. Lake S, Kerr T, Montaner J. Prescribing medical cannabis in Canada: Are we being too cautious? Can J Public Health. 2015; 106(5):328-330
18. Stockings E, Zagic D, Campbell G, Weier M, Hall WD, Nielsen S, Herkes GK, Farrell M, Degenhardt L. Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence. Journal of Neurology, Neurosurgery & Psychiatry. 2018 1;89(7):741-53.
19. National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: The National Academies Press; 2017 [2021 Dec 1]. Available from: https://www.nap.edu/catalog/24625/the-health-effects-of-cannabis-and-cannabinoids-the-current-state
20. Lublóy A. Factors affecting the uptake of new medicines: a systematic literature review. BMC Health Serv Res. 2014; 14(469)
21. The Best Practice Advocacy Centre New Zealand. An overview of medicinal cannabis for health practitioners; 2021 [cited 2021 Sep 22]. Available from: http://web.archive.org/web/20211028053843/https:/consult.health.govt.nz/medsafe/c6374abc/supporting_documents/Medicinal%20Cannabis%20primer.pdf
22. McGregor IS, Cairns EA, Abelev S, Cohen R, Henderson M, Couch D, Arnold JC, Gauld N. Access to cannabidiol without a prescription: A cross-country comparison and analysis. International Journal of Drug Policy. 2020. 1;85:102935.
Contact diana@nzma.org.nz
for the PDF of this article
Assessing progress with the implementation of the New Zealand Medicinal Cannabis Scheme
The decision to legalise cannabis for medical purposes followed growing public demand, including by terminally ill and epileptic patients who advocated for greater access to cannabis-based products.
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