PRESS RELEASE

State of Israel

Ministry of Health

Jerusalem

Spokeswoman and Public Relation’s Office

November 3, 2010

To: Health Reporters

The Inter -Ministerial Committee for Examining Uses of Medical Cannabis in Israel and its Conclusions

An inter -Ministerial committee was established by the Assistant General Director in order to regulate Medical Cannabis use in Israel. The committee included representatives from the Ministry of Health, the Israeli Anti Drug Authority, and the Ministry of Agriculture, the Israel Police, patients’ representatives and public representatives. The committee was requested to give its recommendations on the following issues:

1. Process of licensing patients for using Cannabis for medical purposes.

4. Guidance and explanations given to patients and caregivers.

These are the committee recommendations:

1. Management:

The committee recommended establishing a high steering committee, shared by government ministries related to the issue. It will be headed by the “Director” (doctor authorized for licensing), following Dangerous Drugs Order, and will deal with management, supervision and control of Medical Cannabis.

The committee will be comprised of representatives from the Ministry of Health, the Israeli Anti- Drug Authority, the Ministry of Agriculture and the Israel Police solely, in order to meet the requirements for a “Government Agency” set by the UN treaty on the subject, dating 1961. Public representatives and patients’ representatives will be able to participate as observers in this committee.

2. Funding:

The committee unanimously holds the opinion that, when the day comes, treatment with Medical Cannabis should be included in the “Health Basket” (a list of medical treatments and medications Israeli citizens are eligible to receive from the government). Having said that, it still remains unclear whether the Basket Committee would approve the required technology for such treatment, if and whenever such treatments will be offered. This uncertainty is enhanced, since it is considered a dangerous drug and not a medication. Therefore, at this stage, the committee is looking at the actual situation, in which this kind of treatment is not included in the basket, and the State of Israel is not required to provide the medication with no cost; in which the State of Israel does not have a source of funding for this matter, and so costs are mostly paid by the patients. According to careful evaluations by committee members and the current data, Medical Cannabis cost per patient should not amount over 400 NIS (for end user, before VAT), including guidance and transportation. The comprehensive cost of Medical Cannabis sales are supposed to fund the entire process of production and provision.

The work of government offices – such as procedures of dealing with the patients’ applications for obtaining Medical Cannabis (administrative expenses etc.) and the supervision and control procedures (mainly regarding growers and suppliers) – should be examined in cooperation with the Ministry of Finance and the Ministry of Justice, which did not take part in the committee’s work.

3. Responsibilities:

The committee recommends that the Israeli Anti Drug Authority will be responsible (on the condition that it concurs) for the process which starts with growing the Cannabis, and ends at the patients’ hands (or pharmacy/ medical storage facility). The Ministry of Health will be in charge of clinical treatment details such as dosage, varieties, ways of taking the medication, medical indications and patients licenses. This includes responsibility for the accessibility of the treatment for patients within the health system.

The Israeli Anti Drug Authority’s responsibility will focus on processes of growing, cultivation, packing, storage and transportation of the Medical Cannabis until it reaches the stage of provision to patients/ pharmacies/ medical storage facility. In order to perform this responsibility the Authority will establish a body which will supervise the growers (without compromising the responsibility held by the Israeli Police and by the Ministry of Health via the county pharmacists or any other supervising body in any other government office). It will also supervise purchasing of the Cannabis from the growers and taking possession of it on behalf of the State of Israel, all in accordance with the international treaty on the subject (see Ministry of Justice interpretation) until its provision to the end user (or to the pharmacy or to a medical storage facility).

The Ministry of Health will be responsible for the clinical procedures involved in Medical Cannabis treatments, including the medical indications issue, in cooperation with the Israeli Medical Association (a separate committee for discussing these indications, that will answer questions that arise, is currently being established) and under the CEO of Ministry of Health’s approval. The Ministry of Health will be also in charge of issuing the licenses, giving recommendations for the medical varieties of Cannabis, the dosages and the forms of its consumption by patients.

The Ministry of agriculture will be responsible for instructing growers about growing conditions, including agricultural standards, and dealing with growers who do not meet these standards, whether maliciously or not.

The Israeli Police will continue to be the professional body in charge of security standards and any other acts required to prevent crimes.

4. Licensing Patients:

The current licensing procedure will be kept, and will take course as follows:

a. The expert doctor in a certain field will send a written request to the doctor authorized for licensing patients, (AKA “the Director”), in accordance to Dangerous Drug Order. The request should include a diagnosis, reasons for requesting Cannabis treatments, criteria for evaluation of the effectiveness of treatment and a commitment for further observations (“follow ups”).

b. When the authorized doctor is convinced that the request is justified, s/he will issue the license for the patient and will determine the appropriate form of provision.

c. We recommend increasing the number of authorized doctors that will be “Directors”, in accordance to Dangerous Drug Order. However, this should be done gradually and carefully, while examining the full effect of each stage.

d. Recently more doctors were authorized, only for oncological patients at this stage. They follow control and reporting regulations.

5. Growing, Provision, Quality Assurance and Supervision Procedures:

Many of the committee members hold the opinion that import is the preferable and appropriate way, in particular the Israeli Police representatives. However, the committee recommends continuing the current situation, in which local growers are approved, under conditions which are more specified than the current conditions.
Local growing: If the Anti Drug Authority agrees, it will obtain legal authority to license growers (by way of delegation of authority by the Ministry of Health, either to a nominated Authority employee or to an Authority official).

Committee recommends that providers, either growers or importers, would be chosen in a tender which would be published soon, so that the names of the winners would be published no later than January 1st, 2011. The tender for local growers will determine the required lab tests and their frequencies, the agricultural requirements, the security requirements and ways to eliminate surplus material, as well as other requirements.

Scale of offered sanctions:

• Warning

• Decreasing the permitted quota (or not permitting an increasing of the quota on a later date)

• An agreed compensation

• Revocation of license, either temporary or permanent.

Beginning of Cannabis provision by winners: July 2011. Until this date the current growers will continue to operate.
During the current interim there will be a “freeze” and no growing which exceeds the current licenses, will be approved (except adjust the quota to an increasing demand). Current licenses for self growing will be reduced, as gradually as possible.
The committee recommends unanimously establishing a separation between grower and patient. Such a separation is also required, in fact, by the international treaty which demands that the State would obtain the Cannabis from the grower. The separation is also in accordance with the existing model in the pharmaceutical industry, in which there is no direct supply from manufacturer to patient.
It is the Israeli Police position that the State should take upon itself the entire growing process, due to strong concerns about “leakage”.

5. Patients’ Guidance

In light of the uniqueness of this subject matter, the committee believes that a guidance system to be built, should work on two levels:
Guiding patients: Focusing on ways of taking the medication, side effects, treatment of light and common side effects, etc.
Guiding caregivers: Focusing on recommended dosages, “matching” varieties to specific diseases, starting treatment, identifying side effects and treating them, knowledge of medical indications in Israel, licensing procedures and training teams for personal guidance.
Doctor guidance will be performed in cooperation with the Israeli Medical Association, which will also be responsible for it. Guidance of nursing care teams will be examined with nursing care managers.

6. Adaption of Conclusions

The Ministry of Health CEO had approved the inter-ministerial committee’s conclusions and is dictating an adamant, conservative and restraining policy regarding the existing medical indications. He asked to avoid broadening of further indications during the interim period, while the conclusions are adapted.
The Ministry of Health asks all the bodies related to the issue to cooperate with the authorities and allow a gradual regulation process, required due to the sensibility and complexity of the subject matter and regarding the patients and the law.

Sincerely,

Einav Shimron-Grinbaum,

Spokeswoman for the Ministry of Health

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