Misuse Of Drugs (Prescription And Control Of Supply Of Cannabis For Medical Use) Regulations 2019

• Jurisdiction: Ireland
• Citation: IR SI 262/2019
• Year: 2019

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 28th June, 2019.

I, Simon Harris, Minister for Health, in exercise of the powers conferred on me by sections 4 and 5 (as amended by section 15 of the Misuse of Drugs Act 1984 (No. 18 of 1984), and section 3 of the Misuse of Drugs (Amendment) Act 2016 (No. 9 of 2016)) of the Misuse of Drugs Act 1977 (No. 12 of 1977), hereby make the following regulations:

PART 1

PRELIMINARY

Citation

1. These Regulations may be cited as the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019.

Definitions

2. In these Regulations–

“adverse reaction” means a response to a specified controlled drug which is noxious and unintended;

“Authority” means the Health Products Regulatory Authority;

“CMUR number” means the number assigned to a person under Regulation 5(4) on entry of the person’s name in the Cannabis for Medical Use Register;

“Cannabis for Medical Use Register” means the register established and maintained by the Executive pursuant to Regulation 5;

“Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 20011 ;

“Executive” means the Health Service Executive;

“medical consultant” means a registered medical practitioner who—

(a) is registered on the Specialist Division of the register of medical practitioners established and maintained by the Medical Council under section 43 of the Medical Practitioners Act 2007 (No. 25 of 2007), and

(b) by reason of his or her training, skill and experience in a medical specialty recognised by the Medical Council under section 89(1) of that Act related to a specified therapeutic indication, is consulted by other registered medical practitioners and has a continuing clinical and professional responsibility for that aspect of the patient’s care on which he or she has been consulted;

“medicinal product” has the meaning assigned to it by Directive 2001/83/EC, as amended from time to time;

“Member State” means a state which is a contracting party to the Agreement on the European Economic Area signed in Oporto on 2 May 1992, as adjusted by the Protocol to that Agreement done at Brussels on 17 March 19932 ;

“person carrying on a retail pharmacy business” means a person carrying on a retail pharmacy business in accordance with section 26(1) of the Pharmacy Act 2007 (No. 20 of 2007);

“practitioner” means a registered medical practitioner;

“Principal Act” means the Misuse of Drugs Act 1977 (No. 12 of 1977);

“Principal Regulations” means the Misuse of Drugs Regulations 2017 ( S.I. No. 173 of 2017 );

“prescription” means a prescription issued by a practitioner in compliance with Regulation 15 of the Principal Regulations;

“produce”, where the reference is to producing or production of a specified controlled drug, means produce by cultivation, manufacture, synthesis or any other method;

“registration number” has the meaning assigned to it by the Principal Regulations;

“retail pharmacy business” has the meaning assigned to it by the Pharmacy Act 2007 ;

“serious adverse reaction” means an adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect;

“specified controlled drug” means a cannabis product or preparation—

(a) which is produced from dried, ground or powdered flower of Cannabis,

(b) which is not a medicinal product which is the subject of a marketing authorisation within the meaning assigned to that term in Regulation 3(1) of the Medicinal Products (Control of Placing on the Market) Regulations 2007 ( S.I. No. 540 of 2007 ),

(c) which—

(i) Contains not more than 230 milligrams of tetrahydrocannabinol per gram and not more than 5 grams per pack, or

(ii) is presented as an oil-based solution, suspension or capsule, and has a concentration of not more than 30 milligrams of tetrahydrocannabinol per millilitre (3% w/v) per unit dose and a total volume of not more than 60 millilitres,

(d) which is permitted to be sold or supplied for medical purposes by the relevant public or state body of a Member State other than the State,

(e) which is currently supplied to patients in the Member State referred to in sub-paragraph (d),

(f) which is packaged and labelled in the English language and in accordance with guidance on labelling and packaging as published by the Authority, and

(g) which is specified in Schedule 1;

“specified therapeutic indication” means a therapeutic indication specified in Schedule 2.

PART 2

PRESCRIPTION AND SUPPLY UNDER CANNABIS FOR MEDICAL USE REGISTER

Scope of Part 2

3. This Part does not apply to the prescribing of a particular specified controlled drug pursuant to a licence issued by the Minister under section 14 of the Principal Act, or to the importation, possession, supply or administration of such drug pursuant to such licence.

Restrictions on issuing of prescriptions for specified controlled drugs

4. (1) A practitioner shall not issue a prescription for a specified controlled drug other than where—

(a) the practitioner is a medical consultant,

(b) the practitioner’s name and address are included on the prescription, and

(c) treatment with the specified controlled drug remains under the supervision of that practitioner.

(2) A practitioner shall not issue a prescription for a specified controlled drug other than to a person whose name has been entered in the Cannabis for Medical Use Register and who has received a CMUR number from the Executive.

(3) Subject to paragraph (5), a practitioner shall not issue a prescription for a specified controlled drug other than in a format prescribed by the Executive for that purpose.

(4) Subject to paragraph (5), a practitioner shall not issue a prescription for a specified controlled drug without including in the prescription the CMUR number of the person to whom the prescription is to be issued.

(5) Paragraphs (3) and (4) do not apply in the case of supply of a specified controlled drug pursuant to Regulation 6(3)(a).

(6) A practitioner shall not issue a prescription for a specified controlled drug for the first time to a person under his or her care unless—

(a) the specified controlled drug is intended to treat that person for a specified therapeutic indication, and

(b) the practitioner has notified the Executive, in such form as it may require, including electronically, of—

(i) the name, address, date of birth and specified therapeutic indication of the person,

(ii) the name, registration number and medical specialty of the notifying practitioner, and

(iii) such additional information as the Executive may require.

(7) A practitioner issuing a prescription for a specified controlled drug for use by his or her individual patient does so under his or her direct responsibility in order to fulfil the special needs of that patient.

(8) The fact that a product is a specified controlled drug is not an endorsement of the safety, quality or efficacy of the specified controlled drug and the Minister shall have no liability in respect of the use of a specified controlled drug by a person issued with a prescription under this Regulation.

Cannabis for Medical Use Register

5. (1) The Executive shall establish and maintain a register, to be known as the “Cannabis for Medical Use Register”, which shall contain the information notified to it under Regulation 4(6)(b), and such register may be maintained in electronic form.

(2) The Executive may amend an entry in, or delete an entry from, the Cannabis for Medical Use Register.

(3) The Executive may, before inserting, amending or deleting an entry in the Cannabis for Medical Use Register, require the medical consultant supervising the treatment to provide such additional information as is considered necessary.

(4) The Executive shall assign a number (“CMUR number”) to each person whose name is entered in the Cannabis for Medical Use Register under this Regulation.

Supply of specified controlled drugs

6. (1) A person shall not supply a specified controlled drug to a practitioner unless the person supplying is—

(a) a pharmacist acting in his or her capacity as such, or

(b) a person carrying on a retail pharmacy business,

and the supply is made for the purpose of his or her profession or business.

(2) A person shall not supply a specified controlled drug to a person other than a practitioner unless the person supplying is—

(a) a pharmacist...