Queensland Parliament
Estimates Hearings - Health Committee
Health, Communities, Disability Services and Domestic and
Family Violence Prevention Committee
Tuesday 31 July 2018
PLEASE EMAIL OR CALL THESE MPs TODAY
Health Minister's and Committee Member's Email Addresses:
health@ministerial.qld.gov.au,
Thuringowa@parliament.qld.gov.au,
Caloundra@parliament.qld.gov.au,
Nicklin@parliament.qld.gov.au,
Rockhampton@parliament.qld.gov.au,
Telephone Numbers:
Mr Aaron Harper MP, Thuringowa - 4766 3100
Mr Mark McArdle MP, Caloundra - 5329 4100
Mr Michael Berkman MP, Maiwar - 5406 4100
Mr Martin (Marty) Hunt MP, Nicklin - 3737 4100
Mr Barry O'Rourke MP, Rockhampton - 4994 2100
Ms Joan Pease MP, Lytton - 3915 1100
MCAG AND MCUA Australia - Letter to Committee Members and the Minister for Health
Chair: Mr Aaron Harper MP, Member for Thuringowa
Deputy Chair, Mr Mark McArdle MP Member for Caloundra
Mr Michael Berkman MP, Member for Maiwar
Mr Martin (Marty) Hunt MP, Member for Nicklin
Mr Barry O'Rourke MP, Member for Rockhampton
Ms Joan Pease MP, Member for Lytton
Dear Members of the Health, Disability Services and Domestic and Family Violence Prevention Committee,
Re: Estimates Hearings: Questions on Notice for Mr. Miles, Minister for Health and Ambulance Services
1. Costs of Queensland Health’s Agreements with GW Pharmaceuticals (UK) and Zynerba (US)
2. Other Costs and Delays with Access to Botanical Cannabis Products & other issues
The Medical Cannabis Advisory Group (MCAG) and the Medical Cannabis Users Association of Australia (MCUA) have been advocating tirelessly for the introduction of sensible and compassionate cannabis law reform measures in Queensland that will ensure that patients have safe, affordable,and efficient fast tracked access to cannabis products from licenced suppliers; and for provisions for exemptions for patients and carers so that they are not arrested and prosecuted for growing or possessing their own cannabis.
Since 2015, we have been highlighting a number of issues concerning Queensland Health delaying access to whole plant cannabis products however no or no adequate measures have been taken to remedy these issues. The Queensland Government changed laws in Queensland in December 2015 to include provisions for any general practitioner or specialist in Queensland to be able to apply for approval to prescribe cannabis through the Special Access Scheme and research trials. Further changes were made in June 2016 to give certain specialists an as of right authority to prescribe cannabis without the need for Queensland Health approval.
However to date less than 50 patients have obtained cannabis through the Special Access Scheme (SAS) and there are only 2 authorised prescribers. These figures are appalling given the number of patients that need access to cannabis in Queensland.
In April 2015 the Queensland Government also announced Queensland Health would be joining New South Wales Health in GW research trials for children with epilepsy. The GW trials did not proceed. Instead in December 2016 Queensland Health entered into an agreement with GW to supply its Epidiolex on a compassionate basis for 30 children only until TGA registration. It was not until March 2017, that the first child in Queensland received Epidiolex. There are 128 children on the waiting list.
In June 2015 Queensland Health also granted the QIMR approval to conduct trials at Q Pharm Pty Ltd using synthetic CBD supplied by Zynerba (US). Since then Queensland Health have approved several other trials using Zynerba’s CBD and its THC. Queensland Health refuse to release the agreements it has made with Zynerba. Dr. Young, the Chief Health Officer sits on the commercilisation of arm of QIMR and was a member of Q Pharm. In 2017 the former general manager of Q Pharm resigned to join Zynerba US and has also started up Zynerba Pty Ltd Australia.
We are seeking your assistance with this important issue that is impacting on the health of thousands of Queenslanders and would be grateful if you could ask the Minister for Health, Mr. Miles the following questions on notice regarding the agreements that Queensland Health have entered into with GW Pharmaceuticals (UK) and Zynerba (US and Aust.) as they have not been in the interests of Queensland patients who need access to cannabis, and also your assistance with the ongoing issues with patient access to cannabis products from other suppliers. Please see below for more information on GW and Zynerba and a brief overview of some of the legislation and timeline of events around cannabis in Queensland.
MCAG & MCUA Questions on Notice for Mr. Miles: Department of Health, Queensland Hospital & Health Services and Children’s Health Services
1. Zynerba’s Synthetic CBD and THC
a) What are the terms of agreements that Queensland Health, QIMR, Q Pharm have made with Zynerba US and Zynerba Australia.
b) From January 2015 a breakdown of figures and costs relating to the research and supply of Zynerba’s synthetic CBD and THC products for clincial trials conducted at Q Pharm and in public and private hospitals in Queensland including the following:
i. research trial or study site;
ii. age and medical conditions of the patients;
iii. form of synthetic CBD or THC product supplied;
iv. whether any Zynerba products have been supplied via the SAS or an authorised prescriber;
v. whether any cases were referred to the expert panel;
vi. time for Queensland Health to process all applications for research and supply of Zynerba’s synthetic CBD and THC products;
vii. details of any prescriptions for Zynerba’s synthetic CBD or THC supplied through community doctors or pharmacies.
c) For the last 5 years, figures of all current and former employees of Queensland Health and QIMR and their relatives that are partners, directors, or
former partners or directors of Q Pharm Pty Ltd, Zynerba US or Zynerba Australia.
d) For the past 5 years, all current or former employees of Queensland Health or their relatives that are or have been employed by QIMR, Q Pharm,
Zynerba US or Zynerba Pty Ltd Australia.
2. GW Pharmaceuticals - Epidiolex and other GW Cannabinoids
From April 2015, a breakdown of all figures and costs relating to Queensland Health's agreements with GW including the establishment of the research centre and the supply of Epidiolex and other GW cannabinoids for research trials, studies or compassionate access schemes including:
a) number of authorised prescribers for GW products;
b) trials and studies in Queensland using GW cannabinoids;
c) number, age and medical condition of patients receiving GW products and the type of GW products being supplied;
d) number of patients receiving a free supply of Epidiolex or other GW products;
e) number of patients receiving GW products through the SAS;
f) number of patients paying for GW products;
g) whether any GW cases have been referred to the expert panel; and
h) time to process all applications relating to the research and supply of GW products.
3. Access to Botanical Cannabis Products
A breakdown from June 2015 to March 2017 under the Health (Drugs and Poisons) Regulations 1996, and from March 2017 under the Public Health (Medicinal Cannabis) Act 2016 figures relating to all applications and notifications for botanical forms of cannabidiol (CBD), dried cannabis, nabiximols, tetrahydrocannabinols (THC) and other cannabinoids or combination of cannabinoid products (collectively referred to as cannabis or cannabis products) through the following:
a) Research trials
b) Studies
c) Category A of the Special Access Scheme
d) Category B of the Special Access Scheme
e) Authorised prescriber scheme.
4. Free Supply of Cannabinoids or Cannabis Products
A breakdown of all children and adults in Queensland receiving or who have received in the past a free supply of a synthetic or botanical cannabis product including the age and medical condition of the patient, form of cannabis product, duration of free supply, name of supplier and whether the product was supplied through the following:
a) Compassionate access schemes
b) QLD Hospital's Individual Patient Approval Scheme (Public Hospitals only)
c) Corporate sponsors
5. Illegal/Unauthorised Cannabis
Breakdown and number of children and adults in Queensland using unapproved/unauthorised cannabis for medical use; the types of conditions and symptoms being treated; and what provisions has Queensland Health made for these patients to be able to use their own cannabis in hospitals or other health facilities if they are ineligible for research trials, compassionate access schemes or if they are unable to access or afford the commercially manufactured products through the Special Access Scheme or Authorised Prescriber Scheme.
6. QLD Wholesale, Cultivation & Manufacturing Licences
Breakdown of all applications received by the Department of Health for cultivation, manufacturing and wholesale supply licenses and permits including the following:
a) number and form or types of cannabis product, seed or plants;
b) whether approved, rejected or pending approval;
c) costs of applications and time to process.
7. Administration Costs of Queensland Health & Other Health Services
From June 2015 all figures and costs relating to Queensland Health’s administration of cannabis including costs for the Health Department, Medical Cannabis Team, Queensland Hospitals and Children’s Health Queensland including costs for salaries, bonuses, conferences and workshops held or organised by the department; staff attendance at conferences and workshops, intrastate, interstate and overseas travel and accommodation, preparation an printing of brochures, manuals and guidelines etc., education of staff, doctors and pharmacists and other stakeholders in the public system and private sector, education of patients and carers, website and social media and legal costs.
8. Research Grants and Funding
For the last 4 years, a breakdown of all grants, fellowships, scholarships or any other funding for clinical trials, research or studies involving cannabis whether for medical use or other that Queensland Health has granted to or for the following:
a) Cannabinoid research centre into neurodevelopment disorders and GW Pharmaceutical’s Epidiolex (CBD), Sativex (THC &
CBD) and any other GW cannabinoids;
b) QIMR, Q Pharm Pty Ltd, Zynerba US & Zynerba Australia - synthetic CBD and THC;
c) Lambert Initiative, Pelican Studies - testing of illicit cannabis used on children in QLD;
d) other private or publicly listed company;
e) people employed at Queensland Health public hospitals;
f) universities and colleges;
g) individuals.
9. Gifts received by Queensland Health Employees
For the last 3 years, a breakdown of all gifts, donations, funding, grants, meals, travel and accommodation or otherwise received by Queensland Health and its employees from pharmaceutical companies and medical cannabis companies or other related organisations.
For Mr Miles as the Minister for Queensland Ambulance Services
1. A breakdown of the number and costs for the past 3 years for ambulance call outs to patients having seizures, including the number of seizure
patients transported to public and private hospitals and number of patients admitted to hospital and length of admission.
2. A breakdown of numbers and costs relating to ambulance call outs and hosptial admisisions relating to adverse reactions and fatal and non fatal
overdoses from the use of the following:
a) botanical cannabis - no other substance involved;
b) synthetic cannabis;
c) alcohol;
d) heroin;
e) amphetamines and other syntheti substances;
f) botanical opioids i.e. morphine; codeine;
g) synthetic opioids i.e. fentanyl, tramadol;
h) benzodiazepine type drugs;
i) a combination of the above substances.
Brief Overview: Access to Cannabis in Queensland, Australia
This is a very brief overview of the timeline of events relating to the GW and Zynerba Agreements, patient access and some of the laws governing cannabis. Since 1989, sections 18 and 19(1)(a) of the Commonwealth Therapeutic Goods Act 1989 (TG Act) have provided access to unapproved medicines such as cannabis for actual use in the treatment of a patient via Categories A & B of the Special Access Scheme (SAS). Section 19(5) provides for access for actual use via the authorised prescriber scheme. Section 19(1)(b) of the TG Act provides for approvals and notifications for the "experimental use" of unapproved medicines in human research trials.
In June 2015 the TGA scheduled Cannabidiol (CBD) under Schedule 4 of the Poisons Standard (SUSMP) as a prescription medicine. In October 2015, when cannabis and THC were still listed in schedule 9, the Therapeutic Goods Administration gave the first interim approval under SAS Cat B to a doctor in Queensland to treat a patient with dried cannabis bud and a 4:1 full extract cannabis oil. Under the SAS patients can access potentially any cannabis product including dried cannabis bud from any supplier.
In December 2015 the Queensland Government amended Regulation 270A of the Health (Drugs and Poisons) Regulations 1996 ("HDPR") to allow any general practitioner or specialist in Queensland to apply for approval to prescribe cannabis supplied through research trials and the SAS under the TG Act. Prior to December 2015, Regulation 270A of the Health (Drugs and Poisons) Regulations 1996 prohibited the Chief Executive of Health from granting approvals to a person to cultivate, manufacture, supply, prescribe, dispense or use schedule 9 substances. In June 2016 the Queensland Government included further provisions were included in the HDPR to give some specialists i.e. neurologists, oncologists, palliative care specialists an as of right authority to prescribe cannabis without needing to apply to QLD Health for approval.
In February 2016 Queensland Health released their Public Health (Medicinal Cannabis) Bill ("PHMCA"). Patients and carers started lobbying against the Bill as it gave Queensland Health excessive and unjustified powers to unreasonably delay patient access to cannabis medicines such as 90 days for the chief executive to give doctors a decision, duplication of Commonwealth processes for the SAS and wholesale and manufacturing licenses at a state level, and further unnecessary delays by referral of cases to an expert panel, and unlimited requests to doctors to provide more information. Without addressing any of these issues, in August 2016 the Queensland Parliament passed the PHMCA.
In March 2017 the 8 pages of cannabis regulations under HDPR were repealed when the 140 pages of the PHMCA and its 100 pages of regulations came into effect. After 2 years, in December 2017 Queensland Health had granted only 21 approvals for cannabis under the SAS with some of them being repeat supplies. More recent figures suggest that less than 50 approvals have been granted with some of these repeats. Under the PHMCA doctors also need approval to prescribe CBD, whereas approval was not required under the HDPR. The first supply of Epidiolex was not dispensed at the Lady Cilento until March 2017.
In February 2016 the Federal Government amended the Narcotic Drugs Act 1967 to include provisions for cultivation and manufacture licenses with provisions for supply to remain under the Therapeutic Goods Act through research trials, SAS and authorised prescribers on the condition that state requirements were also met. The SAS Cat A and B have no restrictions on the age of the patient or medical conditions that can be treated and under Cat A of the SAS doctors do not need TGA approval. There are still no locally produced products available. Commonwealth Bulk Supplies of Cannabis – State Wholesale Licences Commencing in early 2017 the Commonwealth Office of Drug Control commenced approving a number of wholesale importers of bulk supplies of cannabis products for supply in research trials, the Special Access Scheme and the Authorised Prescriber Scheme.
This change of policy was meant to provide quicker access to cannabis products especially through the SAS as the patient’s pharmacist no longer needs to apply for an import licence on a case-by-case basis. There are now 12 wholesale importers approved by the TGA that collectively have a range of almost 40 cannabis products sitting in warehouses across Australia. Along with Queensland Health delaying the patient access process, wholesalers are also been thwarted. Under the PHMCA, Commonwealth approved manufacturers and wholesalers also need to apply to Queensland Health for a wholesale licence before they can supply their products in Queensland to pharmacies and hospitals and according to some MPs Queensland Health have only granted 2 wholesale licenses. Queensland is the only state requiring wholesalers and manufacturers with Commonwealth approval to also go through an approval process at a state level. Please see the Office of Drug Control website for suppliers of cannabis products at https://www.odc.gov.au/manufacturers-and-suppliers-medicinal-cannabis-products.
QIMR & Q Pharm Pty Ltd – Zynerba US and Zynerba Pty Ltd Australia
The QIMR was established under the Queensland Institute of Medical Research Act 1945 for the purpose of research into any branch or branches of medical science. QIMR is under the control and management of the QIMR Council. The Chief Health Officer Jeanette Young sits as a member on the commercialisation arm of the Council. According to QIMR Annual reports Dr. Young was a board member of Q Pharm, a private company that was founded in 2002 by academics from the University of Queensland. Recently QIMR acquired full shares in Q Pharm.
In June 2015 QIMR was granted TGA, QLD Health and ethics approval to conduct experimental trials at Q Pharm using Zynerba's "synthetic" CBD. Zynerba's synthetic CBD and THC have since been trialed at other sites in Queensland and in other states of Australia. Terry Hurst, the former General Manager of Q Pharm for 15 years was one of the founding members of Q Pharm in 2002. Mr. Hurst resigned from Q Pharm in 2017 to take up a position on the management board of Zynerba US. Mr. Hurst is also the General Manager of Zynerba Pharmaceuticals Pty Ltd (Australia), a privately owned company registered in Victoria with ASIC in October 2017.
Queensland Health’s Agreement with GW Pharmaceuticals (UK)
In April 2015 the Queensland Government announced that Queensland children would be joining in with children in the New South Wales in a
research trial using GW’s Epidiolex (CBD). The trials in NSW and Queensland did not proceed as GW conducted their Epidiolex trials in the US. The Chief Health Officer of NSW flew to the UK and made arrangements with GW for a compassionate supply of Epidiolex for 40 children in NSW only. In February 2016 the Chief Health Officer of Queensland Dr. Jeanette Young, and Mr. Greg Perry from the Medical Cannabis Unit flew to the UK for meetings with GW about a compassionate supply for 30 children in Queensland. This trip alone cost taxpayers almost $25,000.
In December 2016 Queensland Health entered into an Agreement with GW as follows: i) GW will supply Epidiolex free of charge, until TGA registration for not more than 30 patients at any one time in Queensland; and ii) CHQ must ensure that no more than 30 patients are enrolled into the Compassionate Access Scheme at any one time. ii) Q Health to fund all costs involved with the establishment of a "cannabinoid research centre' to conduct research trials and studies approved by GW using the cannabis products that are being researched and developed by GW for rare neurodevelopment conditions; and Queensland Health to pay all costs involved with importing and supplying the Epidiolex. It was not until March 2017, that the first child received Epidiolex.
We are also calling for an inquiry into Queensland Health's agreements with GW and Zynerba and the PHMCA. If you require any further
information or have any queries please do not hesitate to contact Grace Sands of the MCAG on 0418 521 296 or Debra Lynch of the MCUA on 0401 979 092. We look forward to your assistance with this very important health and public interest matter.
Kind regards
Debra "Grace" Sands LLB, President, Medical Cannabis Advisory Group
Debra Lynch, President, MCUA Australia
FURTHER NOTES
Queensland Institute of Medical Research Act 1945
The Preamble to the QIMR Act provides: “Whereas it is considered that a system of research in medical science, particularly in relation to diseases of particular significance to Queensland, is an essential factor in and towards the betterment of the health and the general wellbeing of the people of this State. And whereas for the purpose of providing for a system of such medical research on a sound basis it is desirable that an institute, called ‘The Queensland Institute of Medical Research’, should be established and maintained. And whereas it is desirable that statutory approval should be given to the establishment and maintenance of this Institute, and that the necessary provisions, hereinafter set forth, should be enacted for such purpose.
Section 3 - Establishment of The Queensland Institute of Medical Research provides: (2) The Institute is established for the purpose of research into any branch or branches of medical science. (3) The Institute shall be under the control and management of the Council. (4) The name of the Council shall be ‘The Council of The Queensland Institute of Medical Research’.
Terry Hurst - Founding Member of Q Pharm, Former General Manager of Q Pharm - Zynerba
Terry Hurt’s profile on LinkedIn states: “I was one of the “foundation members of Q-Pharm Pty Ltd in 2002, I was responsible for the establishment of all of the business systems and services for the company, and this included business development and client acquisition & servicing. In my 15 years with the company I was involved with, or personally responsible for, the acquisition of approximately 400 early phase clinical studies from 100 customers.” Full profile at https://au.linkedin.com/in/terry-hurst-4a94164/de
Zynerba US, Management Personnel Profile for Terry Hurst
“Prior to joining Zynerba, he served as Chief Executive Officer of Q-Pharm Pty Limited, an Australian privately held Early Phase Clinical Trial facility in Brisbane, Queensland. At Q-Pharm, he was responsible for the implementation of strategic initiatives of the Board, and specialised in the management of corporate and business development. Mr. Hurst has served as the General Manager of Zynerba Pharmaceuticals Pty Ltd (Australia) since October 2017. He has 16 years of executive management experience in the early phase clinical trial sector of the biopharmaceutical industry. Mr Hurst has extensive experience in General Management in both industry and academia with a focus on clinical research. He has in-depth knowledge of the Australian clinical trial sector having overseen the acquisition and execution of approximately 400 early phase clinical trials. Mr. Hurst holds a Bachelor of Science degree from The University of Queensland, Brisbane, Australia, and has completed the General Managers Program at the Australian Graduate School of Management.” Zynerba website at http://zynerba.com/about-us-2/management/