ACT No. X of 2018 An Act to provide for the production of cannabis for medicinal and research purposes.

I assent.

(L.S.)

MARIE-LOUISE

COLEIRO PRECA

President

17th April, 2018

ACT No. X of 2018

An Act to provide for the production of cannabis for medicinal and

research purposes.

The short title of this Act is the Production of Cannabis for

Medicinal and Research Purposes Act, 2018.

In this Act, unless the context otherwise requires

"Board" means the Licensing Appeals Board established by article

5;

"cannabis" means

(a)

fresh or dried cannabis;

(b)

cannabis oil;

(c)

cannabis plant or seeds;

(d) derivatives

of

cannabis

excluding

synthetic

derivatives; and, or

(e) any substance and, or product set out in guidelines

issued by the regulatory authority,

all of the foregoing to be used exclusively for manufacturing of

products for medicinal and, or research purposes;

"drugs laws" means the Medical and Kindred Professions Cap. 31

Ordinance, the Dangerous Drugs Ordinance and the Drug Dependence Cap.

101. (Treatment not Imprisonment) Act;

"letter of intent" means a letter issued by Malta Enterprise which

shall constitute a preliminary approval and may include inter alia the

regulating of assistance under the Malta Enterprise laws, and a letter of

intent that includes assistance under the Malta Enterprise laws shall be

subject to the provisions of the Malta Enterprise laws, which shall,

mutatis mutandis, apply;

"licence" means the approval given by the regulatory authority or

any other authority as may from time to time be prescribed;

"Malta Enterprise laws" means the Business Promotion Act and the Cap. 325.

Malta Enterprise Act;

"Minister" means the Minister responsible for the Medicines

Authority save for the purposes of article 3 and article 5(2) where it

shall mean the Minister responsible for industry;

"premises" means the industrial premises where the production of

products derived from cannabis, for medicinal and, or research purposes,

is to be carried out;

"prescribed" means prescribed by regulations made under the

powers conferred by this Act;

"prescribed form" means a form as from time to time published by

Malta Enterprise;

"public health" has the same meaning as is assigned to it by article 2

of the Public Health Act;

"public health emergency" has the same meaning as is assigned to it

by article 2 of the Public Health Act;

"public health risk" has the same meaning as is assigned to it by

article 2 of the Public Health Act;

"regulatory authority" means the authority as established by article

4 of the Medicines Act;

"research" means research for pharmaceutical, pharmacological

and, or clinical purposes; and

"superintendent" means the Superintendent of Public Health as

established by article 3 of the Public Health Act.

Part II - Administration

(1) The administration of this Act shall be vested in the

Minister or such other person, agency or authority designated by the

Minister for any of the purposes of this Act

Provided that the Superintendent shall have the functions and

powers vested in him by virtue of

(a) the Public Health Act, in relation to matters of public

health, public health emergency and public health risk;

(b)

the Medicines Act.

(2) Unless otherwise explicitly provided by or under this Act, the

provisions of this Act shall apply only to the production of cannabis for

medicinal and, or research purposes.

Part III – General Provisions

(1) No cultivation, importation or processing of cannabis and

no production of any products intended for medicinal and, or research

purposes deriving from or resulting from the use of cannabis as defined

in this Act and no trade in cannabis and, or any preparations intended for

medicinal and, or research purposes as deriving from cannabis shall be

carried out in Malta prior to obtaining all necessary approvals,

authorisations, licences and, or permits as required by or under all

applicable laws including this Act and any regulations subsidiary to it

Provided that an approval, authorisation, licence and, or

permit may only be granted where the intended use of cannabis and, or

products deriving therefrom is for medicinal and, or research purposes

Provided further that cultivation that does not form an integral

part of a production process intended for production of products for

medicinal and, or research purposes is expressly prohibited.

(2)

All persons intending to carry out any of the activities

identified in sub-article (1) shall:-

(a)

comply with the provisions of this Act;

(b) obtain a letter of intent from Malta Enterprise after

making an application on the prescribed form. Malta Enterprise

shall ensure that the proposed activity is solely a production

process;

(c) comply with all regulations, including international

obligations resulting from a treaty to which Malta may from time

to time be a party, as may be applicable;

(d) comply with all regulations relating to the production

and quality standards of products for medicinal and, or research

purposes, as the case may be, as applicable under the Medicines Cap. 458.

Act and with any other relevant regulations;

(e)

obtain a licence from the regulatory authority;

(f) comply with any other relevant regulations as shall,

from time to time, be promulgated under this Act or any other

applicable law.

Part IV – Operational Requirements

(1) The issuing of a licence by the regulatory authority shall Operational

requirements.

be subject to

(a) the submission by the applicant and the evaluation of

documents, including due diligence documentation, and other

prescribed information as may be deemed necessary in order to

ensure fulfilment of licence requirements;

(b) the attainment by the applicant of authorizations,

permits, approvals and clearances from other entities as may be

prescribed and applicable under this Act and under any other

relevant legislation current at the time;

(c) compliance by the applicant with terms and Cap. 451.

conditions as may be prescribed, including the possession of

relevant qualifications in line with the Mutual Recognition of

Qualifications Act and of any regulations made there under

Provided that the regulatory authority may at its own

discretion request additional information as may be necessary for

the evaluation of the application.

(2)

The issuing of a letter of intent by Malta Enterprise shall be

subject to the applicant submitting an application on the prescribed

form

Provided that Malta Enterprise may at its own discretion

request additional information as may be necessary for the evaluation

of the application.

(3) Notwithstanding any licence, permit or authorisation issued,

the Commissioner of Police may, if a crime is carried out on the

premises where any activity authorised under this Act is taking place,

or is suspected to be carried out or is expected to happen take any

action as reasonably necessary.

(4) The withdrawal, revocation, cancellation or expiry of either

the license or the letter of intent, or both the license and the letter of

intent, issued under this Act shall preclude the holder thereof from

carrying out any activity under this Act.

Part V – Appeals

(1) The Minister shall appoint a Licensing Appeals Board,

consisting of a Chairperson and three members of whom one of the

members shall be a person who has practiced as a qualified scientist

for not less than seven years.

(2) The members of the Board shall be appointed by the Minister

for a period of five years, and may only be removed from office by the

Prime Minister on grounds of proved inability to perform the functions

of their office (whether arising from infirmity of body or mind or any

other cause) or proved misbehaviour.

(3) A member of the Board may be challenged or abstain for any

of the reasons for which a judge may be challenged or abstain in

accordance with article 734 of the Code of Organization and Civil

Procedure. In any such case, the Minister shall appoint a person,

having the qualifications of the member challenged or abstaining, to sit

as a member of the Board in substitution of the said member.

(4) A member of the House of Representatives or of a local

council, a judge or a magistrate shall be disqualified from being

appointed or continuing to be a member of the Board for so long as he

holds that office.

(5) The Minister shall also designate a person to serve as

secretary to the Board

Provided that the Minister may appoint a substitute secretary

in the following cases

(a) in cases of urgency if the designated secretary is in

any way not available to perform his duties; and

(b) in cases where the designated secretary abstains

himself for the same reasons that a member of the Board may

abstain himself as mentioned above.

(1) An appeal shall lie to the Board on any decision taken Right of appeal.

according to the provisions of this Act and any regulations made

thereunder. The right of appeal shall be competent to the applicant and

to any person showing such interest as may be prescribed, who has

duly filed an objection or made representations against the grant of the

licence.

(2) An appeal to the Board may be filed on any of the following

grounds

(a)

that a material error as to the facts has been made;

(b)

that there was a material procedural error;

(c)

that an error of law has been made;

(d) that there was some material illegality, including

unreasonableness or lack of proportionality.

(3) The Board shall, after hearing the appellant, the regulatory

authority and the applicant, if he is not the appellant, decide the appeal

giving reasons for its decisions in open session.

(4)

In determining an appeal under this article the Board may

(a)

dismiss the appeal;

(b) annul the decision, and refer the matter to the

regulatory authority.

(1) The Board shall be competent to hear and decide any Competence of

appeal made to it in accordance with the provisions of this Act and any the Board.

regulations made thereunder.

(2) For the exercise of its functions, the Board may summon any

person to appear before it and give evidence and produce documents

and the chairperson shall have the power to administer the oath. The

Board may also appoint experts to advise it on any technical issue that

may be relevant to its decision.

(3) For the purposes aforesaid, the Board shall have the same

powers as are competent to the First Hall, Civil Court according to

law.

(4) The procedure to be followed before the Board, the time

within which and the manner in which an appeal to the Board is to be

made, shall be such as may be prescribed and subject thereto, and to

any other applicable provision of this Act, the Board may regulate its

own procedure.

(1) Any party to an appeal before the Board who feels

aggrieved by a decision of the Board, or the regulatory authority if it

feels dissatisfied with any such decision, may on a question of law,

appeal to the Court of Appeal as constituted in accordance with article

41(6) of the Code of Organization and Civil Procedure by means of an

application filed in the registry of that court within twenty days from

the date of the Board’s decision.

(2) The provisions of the Code of Organization and Civil

Procedure regulating the hearing and determination of appeals shall

apply to appeals from decisions of the Board.

The effect of a decision to which an appeal relates shall not,

except where the Board or the Court of Appeal, as the case may be, so

orders, be suspended in consequence of the filing of the appeal.

Part VI - Miscellaneous Provisions

The Minister may make regulations for the purpose of

regulating the use of cannabis for the production of products for

medicinal and, or research purposes, but without prejudice to the

generality of this provision, he may make regulations for all or any of

the following purposes

(a) for prescribing the conditions under which the

licence and authorisations may be granted, renewed, suspended,

transferred or cancelled;

(b) for providing the manner in which applications for

the grant, renewal, suspension, transfer or cancellation of the

license and authorisation, or of any one or more categories or

classes thereof are to be made;

(c) for providing the manner in which applications for

such licence, authorisations and approvals as may be prescribed

are to be publicised and for providing the manner in which any

person, who may be prejudiced by such licence, authorisations

and approvals may make an objection or representation thereon;

(d)

for establishing the duration of the validity of the

licence and authorisations or of any one or more categories or

classes thereof;

(e) for establishing the qualifications that certain key

personnel involved in or with the premises may be required to

possess;

(f) for regulating inspections to be carried out at the

premises;

(g) for prescribing the inventory controls, registers,

records or databases that have to be kept by the licence holder at

the premises and any financial guarantees which the licence

holder shall have to give;

(h) for the establishment of quality controls and quality

assurances other than those under the Medicines Act and any Cap. 458.

matter in relation to any activity carried on or any premises or by

any person licensed under this Act;

(i) for establishing the fees leviable in respect of the

letter of intent, licence, authorisations and approvals or of any

one or more categories or classes thereof, either by direct

determination or by reference to the manner in which such fees

are to be reckoned; and to make provision for fees leviable in

respect of broken periods

Provided that regulations made under this paragraph

may establish the minimum and the maximum of any fee leviable

in respect of the letter of intent, licence, authorisations and

approvals or of any one or more categories or classes thereof;

(j) for establishing the penalties or administrative

sanctions to which any offender against the provisions of this

Act or any regulations made thereunder shall be liable, except

where anything done constitutes an offence under the drugs laws,

which administrative penalties shall not exceed one hundred

thousand euro (€100,000) and one thousand euro (€1,000) for

every day during which an offence or a default subsists.

Malta Enterprise and the regulatory authority may issue Power to issue

guidelines and, or directives for prescribing any matter, including high guidelines.

level of security considered necessary or expedient for the better

carrying out of any of the provisions of this Act.

(1) The regulatory authority shall monitor and review Monitoring.

relevant operations within premises to ensure that any operation within

the ambit of this Act is carried out only in accordance with the

provisions of this Act and in compliance with the decisions lawfully

taken under this Act as well as other relevant and applicable

legislation.

(2) For the purposes of such monitoring and review the regulatory

authority or any person authorised thereby to that effect shall have the

right at all reasonable times to enter and inspect any premises.

(1) Any person acting in accordance with the provisions of

this Act or of any regulations or licence issued thereunder shall, for the

purposes of the implementation of the provisions of this Act, be

exempt from the provisions of the drugs laws insofar as those laws

relate to cannabis.

(2) Where a person fails to abide by the provisions of this Act or

by any regulations issued thereunder or by the conditions of a licence

issued under this Act and the act done by such person constitutes an

offence under the drugs laws, the provisions of the drugs laws shall

apply.

Passed by the House of Representatives at Sitting No. 100 of the

16th April 2018.

CLAUDETTE BUTTIGIEG

Deputy Speaker

RAYMOND SCICLUNA

Clerk of the House of Representatives

€0.90