Embryo Protection Authority Regulations, 2015

L.N. 32 of 2015

EMBRYO PROTECTION ACT

(CAP. 524)

Embryo Protection Authority Regulations, 2015

IN EXERCISE of the powers conferred by article 23 of the

Embryo Protection Act, the Parliamentary Secretary for Health has

made the following regulations:-

(1) The title of these regulations is the Embryo

Protection Authority Regulations, 2015.

(2) These regulations shall be deemed to have come into force

on the 1st June, 2014.

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;

"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 be vested in

the Chairman and the Deputy Chairman

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 Deputy

Chairman 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 Meetings of

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

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

members.

(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.

(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.

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

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

the Authority.

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 Director of the Authority, who shall also have

such other powers as may be delegated, from time to time, by the

Authority.

(2) The Director 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 Director 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 Director is so absent or

otherwise unable to perform those functions.

(3) The Director shall attend all the meetings of the Authority

but shall not vote at such meetings.

(4) The Director 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 Detailing of

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

for duty with the

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

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 Offer of

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

employment

under any of the provisions of regulation 7, permanent employment with

Authority to

with the Authority at a remuneration and on terms and conditions not public officers

less favourable than those enjoyed by such officer at the date of such detailed

with the

offer.

Authority.

(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) No post shall be classified in a grade higher than that

of Grade 3 in the service of the Government or such other grade as the

Minister responsible for finance may, from time to time, determine by

notice in the Gazette.

(e)

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 Cap. 93.

which that person would have been entitled prior to such

classification.

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

Authority by any direction under any of the provisions of regulation officers

for duty with the

7, such officer shall, during the time in which such direction has Authority.

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 Cap. 93.

Ordinance and the Widows’ and Orphans’ Pension Act, and of Cap. 58.

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

advances on such terms and conditions as he may, after consultation

as aforesaid, deem appropriate. Any such advance may be made by

the Minister responsible 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 Expenditure to

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

approved

regulation 11.

estimates.

(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 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 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 Enforcement

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

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 Measures which

Act and, or these regulations, or any other law which the Authority is may be taken.

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 and

is proved to have been committed with the consent or 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.

€1.17