the dutch medicinal cannabis program - ministrstvo … · the dutch medicinal cannabis program...
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The Dutch Medicinal Cannabis Program
Marco van de Velde, PhD, MBA Office of Medicinal Cannabis (OMC) Ministry of Health, Welfare & Sport The Netherlands April 2017
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2 CIBG
Overview
• Policy and legislation
• Responsibilities
• Production and distribution
• Quality control
• Reimbursement
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Dutch cannabis policy
3 CIBG
1980 – 2017 (illegal; tolerated) 2003 – 2017 (legal)
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4
Why medicinal cannabis legally available (on prescription)?
From 1993 onward:
Increase pressure from society against prohibition of medicinal use;
Health Council advised (1996):
insufficient evidence of efficacy;
trials done with ill-defined products.
Existing practice of illegal medical use
No quality control;
No medical coaching of patients;
Patients at the mercy of illicit trade.
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5 CIBG
Microbiology: recreational cannabis coffee shop (Source: A. Hazekamp et al; University of Leiden, the Netherlands,
Cannabis sample
aerobic bacteria
(cfu/gram) 1)
aerobic fungi
(cfu/gram) 1)
Identified
pathogens
Bedrocan 2)
<10 < 100
Bedrobinol 2)
<10 < 100
A <10 480000
B 4500 900
C <10 1000
D 70 120
E 13000 6500
F 80000 4800
G 180 350
H 27000 1300
I 350 4200
J 23000 91000
K 5900 3600 E. coli
Penicilium
Cladosporium
Aspergillus
1) : CFU = colony forming units
2) : limit: total areobic bacteria and fungi <100 cfu
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6 CIBG
Illegal cannabis coffeeshops
Heavily contaminated with fungi
Up to 600.000 colony forming units/gram
(source: Hazekamp);
50% of samples contaminated with pesticides
(source: Rikilt, The Netherlands);
Heavy metals;
No constant content (st dev: 15%).
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7 CIBG
Foundation of OMC
In 1998 the Dutch government decided to establish an agency as regulator for medicinal cannabis according to art. 28 of Single Convention (UN);
Foundation of the Office of Medicinal Cannabis (OMC) (1 March 2000);
Office of Medicinal Cannabis empowered as national agency (1 January 2001);
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Change of national legislation
Opium Act • With respect to hemp, hashish and hemp oil Our Minister is, to the
exclusion of others, authorized:
to bring it inside or outside the Netherlands; to sell and deliver it; to have it available, with the exception of stocks maintained by those who have a license to cultivate, work up and convert.
Royal Decree Royal Decree on prescribable and dispensable controlled substances. 8 CIBG
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9 CIBG
Main responsibilities of the OMC
Ensure constant quality of medicinal cannabis produced which meets pharmaceutical standards;
Establish an effective procedure for distribution;
Prevent leakage to the criminal circuit (tracking procedure / recordkeeping);
Ensure availability of medicinal cannabis;
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10 CIBG
Organisational aspects
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Policy within the Ministry of Health
Part of pharmaceutical affairs policy
and NOT
Part of addiction care policy because:
1. Patients using cannabis as a medicine should not be stigmatised as drug abusers.
2. Cannabis as a medicine should meet all pharmaceutical requirements.
11 CIBG
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12 CIBG
Production and distribution model
Office of Medicinal Cannabis
(OMC)
growers packager logistics service
provider pharmacy
laboratory
distribution
invoicing
collection
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Contracted third parties:
Cultivation (Bedrocan BV)
Quality control (Eurofins | Proxy)
Packaging and distribution (Fagron BV)
Pharmacy/Research/Product development
13 CIBG
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14 CIBG
Growers - requirements
Growers need:
License to grow cannabis
according to Opium Act
supervised by Health Inspectorate
permitted by OMC
Contract to supply cannabis
with Minister of Health
supervised by OMC
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15 CIBG
Growers - criteria for contracting
Screening procedure;
Directives for cultivation of medicinal cannabis (based on GAP).
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16 CIBG
Growers – points to consider
Standardized product;
Security of the production company / facilities;
Continuation of the company;
Mandatory compliance to GMP / GAP-rules and guidelines;
Standard operating procedures (SOP’s).
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17 CIBG
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Laboratory analysis
Monography available: EU pharmacopeia;
Validated testing methods;
Every batch tested;
Approval by OMC;
Certificate of analysis for pharmacists.
18 CIBG
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19 CIBG
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20 CIBG
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21 CIBG
Logistics – packaging and distribution
External partner with experience in packaging
and labelling of pharmaceutical products;
Quality standards and certification: GMP
certified, FDA audited / approved;
Recordkeeping procedure for tracking medicinal
cannabis to the patient.
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22 CIBG
Clean rooms
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23 CIBG
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PART II
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25 CIBG
Medicinal cannabis complies with pharmaceutical quality guidelines
Standardized product with constant content (dronabinol, cannabidiol and other)
Within ranges of regulatory authorities
Very low concentration of degradation compounds (e.g. CBN)
Free of contamination Micro-organisms
Pesticides
Heavy metals
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26 CIBG
Products
–Cannabis flos, variety Bedrocan: 22% THC, <1% CBD
–Cannabis flos, variety Bedrobinol: 13,5% THC, <1% CBD
–Cannabis flos, variety Bedica granulated: 14% THC, <1% CBD
–Cannabis flos, variety Bediol, granulated: 6,3% THC, 8% CBD
–Cannabis flos, variety Bedrolite granulated: <1% THC, 10% CBD
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Standardization
27 CIBG
0
5
10
15
20
25
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Co
ncen
trati
on
Bedrocan
Bedrobinol
Bedica
Bedrolite
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28 CIBG
Products
–Cannabis flos, variety Bedrocan • Approx. 19% dronabinol, • <1% cannabidiol, • other cannabinoids very low
–Cannabis flos, variety Bedrobinol
• Approx. 12% dronabinol, • <1% cannabidiol, • other cannabinoids very low
–Cannabis flos, variety Bediol, granulated
• Approx. 6% dronabinol and 7,5% cannabidiol, • other cannabinoids very low
Bedrocan dried flowers
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29 CIBG
Bediol granulated
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30
Bediol granulated
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Pharmaceutical characteristics:
- Pharmaceutical raw material;
- Standardised herbal medicinal product;
- Not registered as a medicine;
- Opium Act.
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Patient
Physician
(prescription)
Pharmacy
(dispensing)
32 CIBG
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33 CIBG
Indications
Spasticity: multiple sclerosis, spinal cord injury, etc;
Anti-emetic: chemotherapy, radiotherapy, etc;
Appetite loss: HIV/AIDS, cancer, etc;
Chronic pain / neuropathic pain: multiple sclerosis;
Gilles de la Tourette syndrome;
Glaucoma.
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34 CIBG
Prescription behaviour of physicians
Only if treatment in conformity with guidelines or protocols does not work sufficiently or gives too many side effects.
A Dutch physician is free to prescribe medicinal cannabis for every indication
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35 CIBG
Supply of information in the Netherlands
Leaflets for physicians, pharmacists and patients;
Presentations for organizations involved;
Direct contact with patients, general practitioners and specialists;
Website and call center OMC;
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CIBG
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Patient characteristics N Percentage
Age 53,1 ^ (24-81) ^
Sex
Mail 35 (45,5%)
Female 42 (54,5%)
Variety
Bedrocan 38 (49,4%)
Bedrobinol 19 (24,7%)
Bediol 16 (20,8%)
Bedica 4 (5,2%)
Therapeutic indication
Multiple Sclerose 16 (20,8%)
Chronic pain 51 (66,2%)
Nausea / vomiting 7 (9,1%)
Cancer of AIDS 5 (6,5%)
Mental disorders 10 (13,0%)
Others 18 (23,4%)
Therapeutic use
Decreased spasticity 37 (48,1%)
Pain relieve 63 (81,8%)
Anxiety 8 (10,4%)
Decreased drowsiness 42 (54,5%)
Appetite stimulation 10 (13,0)
Improvement daily functioning 26 (33,8)
Improvement state of mind 15 (20,8%)
Others 7 (9,1%)
37
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Bedrocan Bedrobinol Bediol Bedica
Route of administration Tea Inhalation
Vaporiser Smoking
Others
11 (29,7%) 25 (67,6%) 9* 23* 2 (2,7%)
3 (15,8%) 15 (78,9%) 5* 11* 1 (5,3%)
3 (18,8%) 13 (81,3%) 4* 10* 0 (0%)
1 (25,0%) 3 (75,0%) 2 1 0 (0%)
38 CIBG
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Retrospective study 2003-2010 (Hazekamp et al, 2012)
N= (%)
Average duration of use (days)
Average number of
dispensations Average daily use (grams)
Study population 5,540 (100) 251 6.43 0.68
Age
≤ 20 93 (1.7) 181 5.57 0.82
21-40 846 (15.3) 316 8.73 0.72
41-60 2,551 (46.0) 304 7.44 0.66
61-80 1,722 (31.1) 174 4.51 0.67
> 80 303 (5.5) 99 3.01 0.74 39 CIBG
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Cannabis oil - magistral preparation
Preparation of (cannabis)oil (GMP-conditions);
Standardized production process;
40 CIBG
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Preliminary data: (Bedrolite-)oil and epileptic attacks
41 CIBG
Bron: Transvaal apotheek Den Haag
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42 CIBG
Export of Medicinal Cannabis (or derivatives)
Import permit (original copies in duplo); Contract; Apply for an export permit.
For medical treatment: Canada, Finland, Germany,
Italy, Luxembourg, Poland; Czech Republic For research/product development: Belgium,
Germany, Switserland, UK, USA
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43 CIBG
Policy rules on export
Country of import is member of UN and supports international treaty on narcotics and psychotropic substances;
Cannabis may only be used for patients, scientific research or product development;
Quantity per country / year:
» 0-40 kg: no limitations »>40 kg: maximally 100 kg a year for three consecutive years.
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44 CIBG
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Reimbursement
45 CIBG
Health Insurer Reimbursed Standard - supplement % reimbursement Prescription
Achmea ZK Yes Standard 80 - 100 % Neurologist/oncologist
Azivo No No No No
CZ Only palliative patients Supplement Partial Physician
FBTO Yes Standard Partial General practitioner
De Friesland Coulance Supplement Partial Physician / general practitioner
Menzis No No No No
OHRA Exceptional cases Standard Partial Physician / general practitioner
Salland Yes Supplement Partial Physician / general practitioner
Univé No No No No
VGZ No No No No
DSW Yes Standard Partial Physician / general practitioner
Date: 01-12-2015
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Procedure for reimbursement (not-registered e.g. magistral preparation)
Criteria for reimbursement:
Therapeutic efficacy / effectiveness
Most ‘cost-effective’
Therapeutic value must be evidenced-based / Assesment of scientific data obtained from (peer reviewed) clinical studies”:
• Design of the clinical study
• Used comparitor
• Well described or standardized product
46 CIBG
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Clinical research
•Trials (including placebo) :
LUMC Leiden: chronic pain
Sydney Australia: palliative care / appetite
47 CIBG
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To a registered pharmaceutical product
Echo Pharmaceuticals (www.echo-pharma.com): fase 2 study; oral tablet (indic.: MS, Alzheimer’s disease, chronic pain)
Axim Pharmaceuticals (www.aximbiotech.com): fase 2 study; chewing gum
Spirocan / Bedrocan International (www.bedrocan.com): drug-inhalation device;
48 CIBG
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Learning points
Positive: • When establishing the OMC patients have been involved and
asked for their opinion • The OMC buys every harvest and keeps the stock • Delivered by the pharmacy which has an overview of the
medication use • Expanding number of cannabis varieties and formulation in
conjunction with patient organizations • Standardized medicinal cannabis available: on prescription, for
product development, clinical studies Negative: • No financial participation in clinical studies • No standard reimbursement
49 CIBG
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50 CIBG
Thank you for your attention.
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51 CIBG
Office of Medicinal Cannabis
CIBG / Ministry of Health, Welfare and Sport
PO Box 16114
2500 BC The Hague
The Netherlands
www.cannabisbureau.nl
Phone 0031 70 340 5113
Fax 0031 70 340 7426