EMBRYO PROTECTION AUTHORITY REGULATIONS

SUBSIDIARY LEGISLATION 524.01

EMBRYO PROTECTION AUTHORITY

REGULATIONS

1st June, 2014 *

LEGAL NOTICE 32 of 2015, as amended by Legal Notice 343 of 2020.

The title of these regulations is the Embryo Protection

Authority Regulations.

In these regulations, unless the context otherwise requires -

"Act" means the Embryo Protection Act;

"Authority" means the Embryo Protection Authority established

by article 3 of the Act;

"Chairman" means the Chairman appointed in accordance with

article 3 of the Act;

"Chief Executive Officer" means the Chief Executive Officer

appointed in accordance with regulation 6;

"Minister" means the Minister responsible for Health.

(1) The Authority shall be a body corporate having a

distinct legal personality and shall be capable, subject to the

provisions of the Act, of entering into contracts, of acquiring,

holding and disposing of any kind of property for the purposes of

its functions, of suing and being sued, and of doing all such things

and entering into all such transactions as are incidental or

conducive to the exercise or performance of its functions under the

Act and, or these regulations.

(2) The legal representation of the Authority shall jointly vest in

the Chairman and the Chief Executive Officer;

Provided that, the Authority may appoint any one or more of

its members, or of the officers or employees of the Authority, to appear

in the name and on behalf of the Authority in any judicial proceedings

and on any act, contract, instrument or other document whatsoever.

(3) Any document purporting to be an instrument made, or

issued by, the Authority and signed by the Chairman or by the Chief

Executive Officer shall be received in evidence and shall, until the

contrary is proved, be deemed to be an instrument made, or issued

by, the Authority.

(1) The meetings of the Authority shall be called by the

Chairman as often as may be necessary but at least once a month

either on his own initiative or at the request of any two of the other

members.

*See regulation 1(2) of these Regulations, as originally promulgated.

(2) Half the number of members for the time being constituting

the Authority shall form a quorum. Decisions shall be adopted by a

simple majority of the votes of the members present and voting.

The Chairman, or in his absence the Deputy Chairman or other

person appointed to act as chairman, shall have an initial vote and

in the event of an equality of votes, a casting vote. Without

prejudice to the other requirements of the Act, and, or these

regulations, no decision shall be valid which is not supported by at

least two members of the Authority.

8(3) Subject to the provisions of the Act and, or these

regulations, the Authority may regulate its own procedure.

(4) Subject to the foregoing provisions of this regulation, no

act or proceeding of the Authority shall be invalidated merely by

reason of the existence of any vacancy among the members.

(5) A member of the Authority who is in any way directly or

indirectly, interested in a decision made, or proposed to be made by

the Authority shall, as soon as possible, disclose the nature of his

interest at the first meeting of the Authority, after the relevant facts

have come to his knowledge.

(6) Any disclosure made under sub-regulation (5), shall be

recorded in the minutes of the meeting at which it is made, and the

member making any such disclosure shall

(a) after said disclosure, withdraw from the meeting

during which that decision is proposed to be made; and

(b) if the decision has been made, be disregarded for the

purpose of constituting a quorum for that decision;

(7) Minutes of the proceedings of the Authority and of any

committee thereof shall be kept. For this purpose and for the

keeping of the relevant records, the Minister shall designate a

person to act as secretary of the Authority for such period and on

such terms, as the Minister may deem appropriate. The secretary of

the Authority shall not have a vote.

(8) In the exercise of its functions under the Act, the Authority

may consult with such professionals, or such other persons having

relevant knowledge and experience in the field of infertility

services, as it may deem appropriate. For such purpose, the

Authority may invite such professionals or other persons to attend

meetings of the Authority and to provide such information and

documentation, as it may deem appropriate.

(9) The members of the Authority, the secretary of the

Authority and any person involved in the proceedings of the

Authority, shall be bound by confidentiality and shall not disclose

to any third party any information which may come to their

knowledge during the proceedings.

(10) The Authority shall keep a precise and correct record of all

its proceedings and the Authority shall give to the Minister such

information as he may require.

(11) The Authority shall lay on the table of the House the annual

report of the work of the Authority, by not later than four months after

the end of each financial year.

(1) Without prejudice to the other provisions of the Act,

and, or these regulations, the appointment of officers and other

employees of the Authority shall be made by the Authority. The

terms and conditions of employment shall be established by the

Authority with the concurrence of the Minister.

(2) The Authority shall appoint and employ, at such

remuneration and upon such terms and conditions as it may, in

accordance with the preceding sub-regulation, determine, such

officers and employees of the Authority as may from time to time

be necessary for the due and efficient discharge of its functions.

(3) Where any officer is detailed for duty with the Authority,

such officer shall, during the time in which such direction has

effect in relation to him or her, be under the administrative

authority and control of the Authority but shall for other intents and

purposes remain and be considered and treated as a public officer.

(4) Without prejudice to the generality of the foregoing, a

public officer detailed for duty as aforesaid -

(a) shall not during the time while such officer is so

detailed -

(i)

be precluded from applying for a transfer to a

department of the Government in accordance

with the terms and conditions of service attached

to the appointment held by that public officer at

a date on which he or she was detailed for duty;

or

(ii) be so employed that the remuneration and

conditions of service are less favourable than

those which are attached to the appointment

under the Government held by that public officer

at the date he or she was detailed for duty as

aforesaid or which would have become attached

to such appointment, during the said period, had

such officer not been detailed for duty with the

Authority; and

(b) shall be entitled to have the service with the Authority

considered as service with the Government for the

purpose of any pension, gratuity or benefit, and of any

other right or privilege to which that public officer

would be entitled, and shall be liable to any liability to

which he or she would be liable, but for the fact that he

or she is detailed for duty with the Authority.

(1) Without prejudice to the other provisions of this Act,

the affairs and business of the Authority shall be the responsibility

of the Authority itself but save as aforesaid, the executive conduct,

administration and organisation of the Authority, including the

administrative control of its officers and employees shall be the

responsibility of the Chief Executive Officer of the Authority, who

shall also have such other powers as may be delegated, from time to

time, by the Authority.

(2) The Chief Executive Officer shall be appointed by the

Minister in consultation with the Authority, for a period of three

years and such period may be extended for further periods of three

years each

Provided that where the Chief Executive Officer is absent

from Malta or is otherwise temporarily unable to perform the

functions of that office, the Authority, in consultation with the

Minister, shall appoint an officer of the Authority to assume the

duties of Director for the duration of such period during which the

D irecto r is so absent o r ot herwi se unabl e to p erfo rm tho se

functions.

(3) The Chief Executive Officer shall attend all the meetings of

the Authority but shall not vote at such meetings.

(4) The Chief Executive Officer shall be responsible for the

implementation of the objectives of the Authority in the exercise of

its functions and, without prejudice to the generality of the

foregoing, the Director shall

(a) be responsible for evaluating the implementation and

fulfilment of the Authority’s established goals, for the

efficient use of its resources, and resultant benefits,

and shall report directly to the Authority;

(b) develop

the

necessary

strategies

for

the

implementation of the objectives of the Authority;

(c) advise the Authority on any matter it may refer or on

any matter which is considered necessary or

expedient;

(d) perform such other duties as the Authority may assign

from time to time.

(1) The Prime Minister may, at the request of the Authority

made with the concurrence of the Minister, from time to time,

direct that any public officer be detailed for duty with the Authority

in such capacity and with effect from such date as may be specified

in the direction.

(2) The period during which a direction as aforesaid shall apply

to any officer specified therein shall, unless the officer retires from

the public service, or otherwise ceases to hold office at an earlier

date, or unless a different period is specified in the direction, end

on the happening of the following events

(a) the acceptance by such officer of an offer of permanent

employment with the Authority made in accordance

with the provisions of regulation 8; or

(b) the revocation by the Prime Minister of any direction

made by him under this regulation in relation to such

officers.

(1) The Authority may, with the approval of the Prime

Minister, offer to any officer detailed for duty with the Authority,

under any of the provisions of regulation 7, permanent employment

with the Authority at a remuneration and on terms and conditions

not less favourable than those enjoyed by such officer at the date of

such offer.

(2) The terms and conditions comprised in any offer made as

aforesaid shall not be deemed to be less favourable merely because

they are not in all respects identical with or superior to those

enjoyed by the officer concerned at the date of such offer, if such

terms and conditions, taken as a whole, in the opinion of the Prime

Minister offer substantially equivalent or greater benefits.

(3) Every officer who accepts permanent employment with the

Authority, offered to that officer under the provisions of sub-

regulation (1), shall for all purposes other than those of the

Pensions Ordinance and of the Widows’ and Orphans’ Pensions

Act, be deemed to have ceased to be in service with the

Government and to have entered into service with the Authority on

the date of such acceptance, and for the purposes of the said

Ordinance and of the said Act, so far as applicable to that officer,

service with the Authority shall be deemed to be service with the

Government within the meanings thereof respectively.

(4) Every such officer as aforesaid who, immediately before

accepting permanent employment with the Authority was entitled

to benefit under the Widows’ and Orphans’ Pensions Act, shall

continue to be so entitled to benefit thereunder to all intents as if

service with the Authority, were service with the Government.

(5) The Authority shall pay to the Government such

contributions as may from time to time be determined by the

Minister responsible for finance in respect of the cost of pensions

and gratuities earned by an officer who has accepted permanent

employment with the Authority as aforesaid during the period

commencing on the date of such officer’s acceptance.

(6) For the purpose of the Pensions Ordinance the pensionable

emoluments of such public officer on retirement shall be deemed to

be the pensionable emoluments payable to an officer in

Government service in a grade and at an incremental level

corresponding to the post and incremental level at which the officer

retires from the Authority.

(7)

(a) For the purposes of this regulation posts and salary

grades with the Authority shall be classified in the

most nearly corresponding grades and incremental

levels in the service under the Government by

reference to job description, skills, responsibilities and

other analogous factors.

(b) The classification referred to in paragraph (a) shall be

carried out by a board composed of a chairperson

appointed by the Minister responsible for finance and

two other members, one appointed by the Minister

responsible centrally for personnel policies in the

public service and one appointed by the Authority. The

classification shall be subject to the final approval of

the Minister responsible for finance.

(c) Such classification shall take place within three

months of any adjustment of salaries of employees in

Government service and, or of employees of the

Authority.

(d) Without prejudice to article 113 of the Constitution, no

person may, following a classification as aforesaid, be

entitled to rights under the Pensions Ordinance less

favourable than those to which that person would have

been entitled prior to such classification.

(1) Where any officer is detailed for duty with the

Authority by any direction under any of the provisions of

regulation 7, such officer shall, during the time in which such

direction has effect in relation to him be under the administrative

direction and control of the Authority but shall for other intents and

purposes remain and be considered and treated as a public officer.

(2) Without prejudice to the generality of the foregoing, a

public officer detailed for duty as aforesaid -

(a) shall not during the time while such officer is so

detailed

(i)

be precluded from applying for a transfer to a

department of the Government in accordance

with the terms and conditions of service attached

to the appointment under the Government held

by that public officer at a date on which he was

detailed for duty; or

(ii) be so employed that the remuneration and

conditions of service are less favourable than

those which are attached to the appointment

under the Government held by that public officer

at the date he was detailed for duty as aforesaid

or which would have become attached to such

appointment, during the said period, had such

officer not been detailed for duty with the

Authority;

(b) shall be entitled to have his service with the Authority

considered as service with the Government for the

purpose of any pension, gratuity, or benefit under the

Pensions Ordinance and the Widows’ and Orphans’

Pension Act, and of any other right or privilege to

which that public officer would be entitled, and shall

be liable to any liability to which he would be liable,

but for the fact that he is detailed for duty with the

Authority.

(3) Where an application is made as provided in sub-regulation

(2)(a)(i), the same consideration shall be given thereto as if the

applicant had not been detailed for duty with the Authority.

(4) The Authority shall pay to the Government such

contributions as may from time to time be determined by the

Minister responsible for finance in respect of the cost of pensions

and gratuities earned by an officer detailed for duty with the

Authority as aforesaid during the period in which such officer is so

detailed.

(1) Without prejudice to the following provisions of this

regulation, the Authority shall so conduct its affairs that the

expenditure required for the proper performance of its functions

shall, as far as practicable, be met out of its revenue.

(2) For such purpose the Authority shall levy all fees, rates and

other payments prescribed in its protocols or deemed to be

prescribed by or under the Act and, or these regulations, or any

other law related to the powers and functions of the Authority.

(3) The Authority shall also be paid by Government out of the

Consolidated Fund such sums as Parliament may from time to time

authorise to be appropriated to meet the costs of specified works to

be continued and for the day to day running of the Authority or

otherwise carried out by the Authority

Provided that any subvention received from Government

shall be exempted from any liability for the payment of income tax

and duty on documents under any law for the time being in force.

The Minister responsible for finance may, after

consultation with the Minister, make advances to the Authority of

such sums as he may agree to be required by the Authority for

carrying out any of its functions under the Act, and may make such

a d v a n c e s o n s u c h t e r m s a n d c o n d i t i o n s a s h e m a y, a f t e r

consultation as aforesaid, deem appropriate. Any such advance may

be made by the Minister respon sible for finance out of the

Consolidated Fund, and without further appropriation other than

under these regulations, by warrant under his hand authorising the

Accountant General to make such advance.

(1) The Authority shall cause to be prepared in every

financial year, and shall not later than six weeks after the end of

each such year adopt, estimates of the income and expenditure of

the Authority for the next following financial year.

(2) In the preparation of such estimates the Authority shall take

account of any funds and other moneys that may be due to be paid

to it out of the Consolidated Fund during the relevant financial

year, whether by virtue of these regulations or of an Appropriation

Act or of any other law; and the Authority shall so prepare the said

estimates as to ensure that the total revenues of the Authority are at

least sufficient to meet all sums properly chargeable to its revenue

account, including, but without prejudice to the generality of that

expression, depreciation.

(3) The estimates shall be made out in such form and shall

contain such information and such comparisons with previous years

as the Minister responsible for finance may direct.

(4)

A copy of the estimates shall, upon their adoption by the

Authority, be sent forthwith by the Authority to the Minister and to

the Minister responsible for finance.

(5) The Minister shall, at the earliest opportunity and not later

than six weeks after he has received a copy of the estimates from

the Authority (or if at any time during that period the House is not

in session within six weeks from the beginning of the next

following session), cause such estimates to be laid before the

House together with a motion that the House approves the said

estimates. Not less than one sitting shall be allotted for the debate

in the House on such a motion; and both the motion and the

approval of the estimates by the House may be with or without

amendments to the estimates.

(1) No expenditure shall be made or incurred by the

Authority unless it has been approved by the House as provided in

regulation 11.

(2)

Notwithstanding the provisions of sub-regulation (1) -

(a) until the expiration of six months from the beginning

of a financial year, or until the approval of the

estimates for that year by the House, whichever is the

earlier date, the Authority may make or incur

expenditure for carrying on its functions under the Act

and these provisions not exceeding in the aggregate

one-half of the amount approved by the House for the

preceding financial year;

(b) expenditure approved in respect of a head or sub-head

of the estimates may, with approval of the Minister

given after consultation with the Minister responsible

for finance, be made or incurred in respect of another

head or sub-head of the estimates;

(c) in respect of the first financial year, the Authority may

make or incur expenditure until the approval of the

estimates for that year by the House not exceeding in

the aggregate such amounts as the Minister responsible

for finance may, after consultation with the Minister,

allow;

(d) if in respect of any financial year it is found that the

amount approved by the House is not sufficient or a

need has arisen for expenditure for a purpose not

provided for in the estimates, the Authority may adopt

supplementary estimates for approval by the House

and, pending such approval but subject to its being

given, may, with the approval of the Minister

responsible for finance given after consultation with

the Minister, incur the relative expenditure or such part

thereof as the said Minister may so approve; and in

any such case the provisions of these regulations

applicable to the estimates shall as near as practicable

apply to the supplementary estimates.

All estimates and supplementary estimates of the Authority

approved by the House shall, as soon as practicable, be published in

the Gazette.

(1) The Authority shall cause to be kept proper books of

account and other records in respect of the Authority’s operations

and shall cause to be prepared a statement of accounts in respect of

each financial year.

(2) The accounts of the Authority shall be audited by an auditor

or auditors to be appointed by it and approved by the Minister, after

consultation with the Minister responsible for finance.

(1) All monies accruing to the Authority shall be paid into

a bank or banks appointed as bankers of the Authority by a

resolution of the Authority. Such monies shall, as far as practicable,

be paid into any such banks from day to day, except such sum as the

Authority may authorise to be retained to meet petty disbursements

and immediate cash payments.

(2) All payments out of the funds of the Authority, other than

petty disbursements not exceeding a sum to be fixed by the

Authority, shall be made by the Chief Executive Officer or such

officer or officers of the Authority as it shall appoint or designate

for that purpose.

(3) Cheques against and withdrawals from any bank account of

the Authority shall be signed by the Chief Executive Officer or such

officer of the Authority as may be appointed or designated by the

Authority for that purpose and shall be countersigned by the

Chairman, or such other member or officer of the Authority as may

be authorised by the Authority for that purpose.

(4)

The Authority shall also make provision with respect to

(a) the manner in which, and the officer or officers by

whom, payments are to be authorised or approved;

(b) the title of any account held with the bank or banks

into which the monies of the Authority are to be paid,

and the transfer of funds from one account to the

other;

(c) the method to be adopted in making payments out of

funds of the Authority; and generally with respect to

any matter which is relevant to the proper keeping and

control of the accounts and books, and the control of

the finance, of the Authority.

(1) Any officer or employee of the Authority, duly

authorised by the Authority, in a reasonable time, can enter any

clinic, laboratory or any other property in order to

(a) make the necessary inspections and, or to ensure that

no infringement of the provisions of the Act, or these

regulations, or of the Protocols which the Authority is

entitled to enforce, or of any decision of the Authority,

is being committed;

(b) have access to and collect all the necessary data or

information that the Authority may require.

(2)

Whosoever does not allow, or impedes, any official or

employee of the Authority from duly exercising his duty under the

Act and, or these regulations, and, or the Protocols, shall be guilty

of an offence, and shall on conviction, be liable to an

administrative fine as established in regulation 18(9), or to

imprisonment for a term not exceeding twelve months, or to both

such fine and imprisonment.

(1) Without prejudice to any other provisions under the

Act and, or these regulations, or any other law which the Authority

is entitled to enforce, the Authority may take the following

measures in respect of any person who infringes any provision of

the Act and, or these regulations, of the Protocols issued by the

Authority, or of any other law which the Authority is entitled to

enforce, or who fails to comply with any decision given by the

Authority or with any authorisation condition

(a) the imposition of an administrative fine in accordance

with the provisions of this regulation,

(b) the ordering of the cessation of any act or omission

which is in breach.

(2) In cases where the Authority considers that a person has

seriously and repeatedly infringed the provisions of the Act and, or

these regulations, or of any other law or the Protocol which the

Authority is entitled to enforce, or of any decision of the Authority

or of any authorisation condition, the Authority may withdraw or

suspend any related authorisation granted by or under the Act and,

or these regulations, or any other law which the Authority is

entitled to enforce.

(3) The Authority shall, before proceeding to take any of

measures under this regulation, inform the person concerned in

writing, warning him of the measure that may be taken and the

specific reason why it may be taken, requiring him to cease or

rectify his acts or omissions and, or to make his submissions

thereto within such period not being more than fifteen days, which

period, without prejudice to the provisions of sub-regulation (6),

may be abridged if the Authority considers that the continuance of

the infringement impacts negatively the effective exercise by the

Authority of its regulatory functions and, or warrants the

immediate intervention of the Authority

Provided that where the measure is an administrative fine

the person concerned shall also be informed of the amount of the

fine

Provided further that when issuing a warning under this

sub-regulation, the Authority may impose such conditions as it may

consider reasonable in the circumstances.

(4) If the person concerned remedies the infringement within

the period established by the Authority in accordance with sub-

regulation (3), and agrees in writing to abide with any condition

that the Authority may impose, the Authority may at its discretion

desist from proceeding any further and this without prejudice to

any regulatory measures that may have already been imposed.

(5)

If after the lapse of the period mentioned in sub-regulation

(3), the Authority considers that the person concerned has not given

any valid reasons to demonstrate why no measure should be taken

against him, the Authority shall notify the person concerned in

writing, specifying the nature of the infringement, stating the

measure being taken, and if the measure is an administrative fine,

stating the amount of the fine being imposed.

(6) Notwithstanding the provisions of sub-regulation (3), where

the Authority has prima facie evidence that the infringement

represents an immediate and serious threat to public safety, public

security or public health it may take urgent interim measures to

remedy the situation in advance of reaching a final decision,

including ordering the immediate cessation of the act or omission

giving cause to the infringement, requiring the cessation or delay of

provision of a service or bundle of services, and the imposition of

administrative fines. Administrative fines are to be considered as a

civil debt

Provided that the person against whom such measures are

contemplated shall, thereafter, be given a reasonable opportunity to

state his view of the facts and propose any remedies

Provided further that the interim measures shall be valid for

a maximum period of three months, subject to an extension of a

further period of three months, in circumstances where

enforcement procedures have not been completed.

(7) The Authority shall give its reasons for any decision taken

under this regulation.

(8) Notwithstanding the provisions of any law, no

precautionary warrant or order shall be issued by any court

restraining the Authority from the exercise of any of the powers

conferred upon it under this regulation.

(9) An administrative fine imposed shall not, unless provided

otherwise by or under the Act, exceed three hundred and forty-nine

thousand and four hundred euro (€349,400) for each infringement

or failure to comply and, or eleven thousand and six hundred euro

(€11,600) for each day of infringement or non-compliance as the

case may be

Provided that if the act or omission which constitutes an

infringement is committed by an undertaking and the Authority

considers that such act or omission has especially significant

effects to the detriment of the clients and, or patients, the stated

amount that may be imposed as an administrative fine may be

increased to an amount that is not more than five per cent of the

turnover of the undertaking in the calendar year immediately

preceding the year when the infringement was committed

Provided further that any daily fine imposed may be back-

dated to the date of the commission, or commencement of, the

infringement.

(10) In determining the amount of an administrative fine, regard

shall be had in particular to the nature and extent of the

infringement, its duration and its impact.

(11) The Authority shall establish the administrative fines that

may be imposed by it for breaches of the Protocols issued and any

other regulations made by the Authority

Provided that the amount of the fines that may be so

prescribed shall not exceed the maximum amounts referred to

under sub-regulation (9).

(12) Where an administrative infringement of any provision of

the Act and, or these regulations, or any other law which the

Authority is entitled to enforce is committed by a body corporate

a n d i s p r o v e d t o h a v e b e e n co m m i t t e d w i t h t he c o n s e n t o r

involvement of, or to be attributable to, any gross negligence on the

part of a person being a director, manager, secretary or other officer

however so described of the body corporate or a person who was

purporting to act in any such capacity, that person, as well as the

body corporate, shall be liable to be proceeded against and found

guilty as if he was responsible for the said infringement

Provided that the body corporate as well as the individual

person shall be responsible in solidum for the payment of the

administrative fines.