SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis

Sundheds- og Ældreudvalget 2017-18
SUU Alm.del Bilag 444
Offentligt

MINISTRY

OF HEALTH

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

Prof. Itamar Grotto

Associate Director General, Israeli Ministry of Health

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Medical use of Cannabis in ancient times

•

5000 years ago in Egyptian tombs

2700 years ago in India

2000 years ago in China for the treatment of pain

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

International - Single Convention on

Narcotic Drugs 1961

The Cannabis plant is subject to additional

measures of control

Israel - The Dangerous Drug

Ordinance [New Version] - 1973

The Cannabis plant and its products are

defined as narcotic substances

They are not registered as medicinal

products

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The Government of Israel Resolutions

Government Resolution 3609 (7.8.

2011

)

•

Establishes the obligation of the Ministry of Health to serve as “Government

Agency” for Cannabis

•

The multi-ministerial Stirring Committee

•

The Israeli Medical Cannabis Agency (IMCA) is established

Government Resolution

1050

(15.12.

2013

)

•

Improving efficiency of prescription, indication inspection, appointing of

Physicians and accessibility to service.

•

Search for feasibility of export

•

Regulating research.

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Government Resolution 1587 (26.6.2016) -

Cannabis for medical purpose and research

The “Medicalization” of Cannabis

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The Vision of

The Israeli Medical Cannabis Agency (IMCA)

To support the use of Cannabis

for medical purposes exclusively,

while preventing misuse

and keeping public safety.

Government Resolution 1587

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Professional infrastructure

Inter-ministerial Board of Directors of the IMCA

MOH (Chair), MOF, MOA, MOJ, MOHLS, Police, Customs

•

Medical Indications Committee

•

Security Measures Committee

•

Quality Control Committee

•

Research and Development Committee

•

Appeal Committee

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The main challenges regarding the medical use of Cannabis

•

EBM & Research are missing

Plant containing multiple substances

“Entourage” effect (cannabinoids, flavonoids, trephines)

Recreational use

Smoking (decarboxylation)

An emotional issue:

Disagreements and fears among medical

community

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The principles of the Policy on Cannabis for medical use

1. Medicalization – The use of Cannabis for medical purposes

not legalization nor decriminalization.

2. Standardization of Medicinal Cannabis products

–

Medical Grade Cannabis (MGC) products, constant & controlled

concentrations, practitioners safely prescription, sold in pharmacies.

3. Medical indications for prescribing Cannabis

–

professional teams, IMA experts, supervision & learning from

medical practice

4. Training of medical practitioners

– Physicians, pharmacists to

treat with MGC using a systematic method of medical practice

IMC-GCP (the "green book").

5. Regulation of Research and Development

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The principles of the Policy on Cannabis for medical use

1. Medicalization – The use of Cannabis for medical purposes

not legalization nor decriminalization.

2. Standardization of Medicinal Cannabis products

–

Medical Grade Cannabis (MGC) products, constant & controlled

concentrations, practitioners safely prescription, sold in pharmacies.

3. Medical indications for prescribing Cannabis

–

professional teams, IMA experts, supervision & learning from

medical practice

4. Training of medical practitioners

– Physicians, pharmacists to

treat with MGC using a systematic method of medical practice

IMC-GCP (the "green book").

5. Regulation of Research and Development

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Procedures for Good Quality Practices

•

IMC-GAP -

Quality guideline for cultivation and multiplication of

Cannabis strains, genetically defined.

Supervised range of concentrations of several active ingredients.

IMC-GMP -

Quality guideline for production of generic and uniform

Medical Grade Cannabis (MGC) products.

IMC-GDP -

Quality guideline for distribution of MGC products.

IMC-GSP -

Guideline for ensuring the safety , security, prevention of

diversion and supervision of adequacy of medical practice.

IMC-GCP

•

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Sta dardizatio of

suggested a

C D

( 2% 2%

8 - 0)

( 2% 1%

4 - 6)

( 1% 1%

9 - 1 )

( 1% 6 )

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8 - . )

(3% 0%

8 - . )

(5% 0%

5 - . )

(5% 0%

5 - . )

(7 -1 )

% %

(7 -1 )

% %

a is produ ts

T /C

S ti a

I d a

S ti a

I d a

S ti a

I d a

C D

פ /

T C

R h

E p

C N

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T C

(0% 0%

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(5% 0%

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(7% 2%

5 - . )

( 1% 6 )

4 - %

1% "

( 1% 6 )

4 - %

1% "

( 1% 6 )

4 - %

1% "

( 1% 1%

9 - 1 )

1% "

( 1% 1%

9 - 1 )

2% "

( 2% 1%

4 - 6 )

2% "

( 2% 1%

4 - 6 )

C D

R h

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Cultivation

Cultivation farm for Medical Cannabis by

IMC-GAP

and

complying with security standards

IMC-GSP

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Manufacturing

Produce generic and uniform Medicinal Cannabis products

IMC-GMP

grade and complying with security standards

IMC-GSP

GMP approved plants – BOL, Panaxia

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Storage and distribution

Storage and distribution by certified Cannabis wholesalers under

IMC-GDP

conditions and according to

IMC-GSP

security standards

BOL

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The principles of the Policy on Cannabis for medical use

1. Medicalization – The use of Cannabis for medical purposes

not legalization nor decriminalization.

2. Standardization of Medicinal Cannabis products

–

Medical Grade Cannabis (MGC) products, constant & controlled

concentrations, practitioners safely prescription, sold in pharmacies.

3. Medical indications for prescribing Cannabis

–

professional teams, IMA experts, supervision & learning from

medical practice

4. Training of medical practitioners

– Physicians, pharmacists to

treat with MGC using a systematic method of medical practice

IMC-GCP (the "green book").

5. Regulation of Research and Development

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Administration of Medical Grade Cannabis Products

a is ookies for hildre o l

a is oil e tra ts

a is Flosses a d Rolli gs

INH

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The principles of the Policy on Cannabis for medical use

1. Medicalization – The use of Cannabis for medical purposes

not legalization nor decriminalization.

2. Standardization of Medicinal Cannabis products

–

Medical Grade Cannabis (MGC) products, constant & controlled

concentrations, practitioners safely prescription, sold in pharmacies.

3. Medical indications for prescribing Cannabis –

professional teams, IMA experts, supervision & learning from

medical practice

4. Training of medical practitioners

– Physicians, pharmacists to

treat with MGC using a systematic method of medical practice

IMC-GCP (the "green book").

5. Regulation of Research and Development

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Prescription of Cannabis

Prescription of

Medical Grade Cannabis Products

and a License issued by Trained Physician

according to the

Green Book – GCP standards

”

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Dispensation of Cannabis products to patients in pharmacies,

country-wide distribution.

According to the Narcotic Drug Ordinance and guidelines.

Pharmaceutical instruction of patients.

Dispe satio i Phar a ies

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The old chain of supply of Cannabis

Cultivation in old farms according to

“traditional” methods

Production of different “strains” of

products by the cultivators themselves

Transport to a distribution center (in

hospitals) or to patient’s home

Selling of Cannabis & training the patient

by the cultivator.

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Implemented chain of supply of Cannabis

Cultivation in special cultivation farms

IMC-GAP grade.

Production of generic and uniform

Medicinal Cannabis products

IMC-GMP grade.

Distribution and storage of Cannabis

products

IMC-GDP grade

Drug Dispensation at pharmacies

according to narcotic products

regulation and training by registered

pharmacists.

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

Summary

- From concept to implementation

of the Medicalization of Cannabis

Multiplication

farms

Trained

practitioner

Patient

pharmacy

LAB

Cultivation

farms

Distribution

Manufacturing

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The principles of the Policy on Cannabis for medical use

1. Medicalization – The use of Cannabis for medical purposes

not legalization nor decriminalization.

2. Standardization of Medicinal Cannabis products

–

Medical Grade Cannabis (MGC) products, constant & controlled

concentrations, practitioners safely prescription, sold in pharmacies.

3. Medical indications for prescribing Cannabis –

professional teams, IMA experts, supervision & learning from

medical practice

4. Training of medical practitioners –

Physicians, pharmacists to

treat with MGC using a systematic method of medical practice

IMC-GCP (the "green book").

5. Regulation of Research and Development

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Medical Grade Cannabis -

The Israeli Roadmap to Medicalization

MINISTRY

OF HEALTH

The regulation of Research and Development

•

Agricultural research

Agronomic, agro technic, biochemical,

physiologic and molecular aspects

of the Cannabis plant.

•

Technological and medical device research

Development

of cannabis-based

medical devices, smoking alternatives, etc.

•

Clinical research field - EBM

Clinical, pre-clinical, pharmacologic, and molecular research on

cannabis, cannabinoids and cannabis products

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Cannabis Research &

Development Categories (n=246)

Ag o.

Resea h

Te h. Resea h

MINISTRY

OF HEALTH

Med. Resea h

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

MINISTRY

OF HEALTH

Data on Usage of Medical Cannabis in Israel

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Nu er of Patie ts with a Li e ses

to use Medi al Ca a is

5‐ 8

‐

MINISTRY

OF HEALTH

Ce tral o puterized s ste

O ologi al patie ts esti ate

Total

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

Upward tre d of u

er of li e ses

MINISTRY

OF HEALTH

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

MINISTRY

OF HEALTH

Chro i Pai

er of Patie ts y Cli i al Category

‐

PTSD

O olog

Neurolog *

IBD

Paliative

HIV

Other

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

MINISTRY

OF HEALTH

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

MINISTRY

OF HEALTH

Opiates Use y Cou try OECD –

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

MINISTRY

OF HEALTH

De ographi s of Patie ts with Li e se

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

MINISTRY

OF HEALTH

Geographi Distri utio of Patie ts with Li e se

SUU, Alm.del - 2017-18 - Bilag 444: Præsentationer fra Sundheds- og Ældreudvalgets høring den 4. september 2018 om viden om og brug af medicinsk cannabis - erfaringer fra andre lande

MINISTRY

OF HEALTH

Fu di g a d fi a i g

•

F ee a ket, ut:

–

P es i i g physi ia s i the pu li se i e o

e ui ale t , li ited isit’s fee



–

A ility to o t ol the p i e



$ pe g

•

Pu li esou es:

–

Ad i ist atio ill ha ge ith i ple e tatio

of the e syste

–

Regulatio a d Co t ol MoH, Poli e

–

Resea h a d De elop e t