HEALTH ACT

The short title of this Act is the Health Act.

Amended by

XXXIX.2024.4.

[Article 15(2)]

The Health Policy and Strategy Board shall be composed as follows

(a) the Minister, as Chairman;

(b) the Permanent Secretary in the Ministry, as Deputy Chairman;

(c) the four (4) Directors General established under this Act, ex officio;

(d) the financial controller of the Ministry, and in his absence, the highest

ranking officer responsible for the financial administration of the

Ministry;

(e) a Minister’s consultant;

(f)

any other officer who the Minister may deem, from time to time, fit to

appoint on this Board; and

(g) an officer appointed by the Minister to act as secretary.

In this Act, unless the context otherwise requires -

"Advisory Committee" means the Advisory Committee on

Healthcare Benefits established by article 22;

"Council" means the Council of Health established under article

16;

"insured person" means a person included in the list established

by regulations made under this Act;

"medical records" means all the documents containing data,

assessments and information of any kind on a patient’s situation

and clinical development throughout the care process;

"Member State" means a State party to the Treaty as defined by

the European Union Act;

"Minister" means the Minister responsible for Health, and

"Ministry" shall be construed accordingly;

"patient" means a person who is receiving, or has received,

medical attention, care, or treatment, whether in a healthcare

setting or otherwise;

"relatives" means relatives as defined under article 30 of the

Social Security Act, but also every person who maintains a close

personal relationship with the patient.

[Article 16(2)]

(1)

The Council of Health shall be composed as follows

(a) the Minister, as Chairman;

(b) the Permanent Secretary in the Ministry, as Deputy Chairman;

(c) the legal officer of the Ministry;

(d) the Superintendent of Public Health;

(e) a person representing the healthcare professionals;

(f)

a specialist in public health medicine;

(g) a person representing private healthcare providers;

(h) a person nominated by associations representing the patients;

(i)

trade-unionism expert in health matters;

(j)

a member of the academic staff on Health Sciences of the University of

Malta; and

(k) an officer appointed by the Minister to act as secretary.

(2) The members referred to in paragraph (1)(e), (f), (g), (h), (i) and (j) shall be

appointed by the Minister for such term as the Minister shall, from time to time,

decide.

HEALTH

This Act intends to establish and ensure a health system

based on the principles of equity, accessibility, quality and

sustainability by regulating the entitlement to, and the quality of,

healthcare services in Malta, consolidating and reforming the

Government structures and entities responsible for health and by

providing for the rights of patients.

*see article 1(2) of the Act as originally enacted, and Legal Notice 386 of 2013.

PART II

Department for Policy in Health

Amended by

L.N. 102 of 2018.

[Article 22(3)]

(1) The Advisory Committee on Healthcare Benefits shall be composed as

follows

(a) the Permanent Secretary in the Ministry, as Chairman;

(b) the Chief Medical Officer to Government, as Deputy Chairman;

(c) the Lead Chairperson of the Chairpersons Committee;

(d) a nurse;

(e) a pharmacist;

(f)

an allied healthcare professional;

(g) a person who has the warrant to practice as advocate in Malta

representing the Ministry;

(h) a representative of the Minister responsible for Finance;

(i)

a representative of the Consumer Protection Department;

(j)

a representative of the Central Procurement and Supplies Unit within

the Ministry for Health; and;

(k) an officer appointed by the Minister to act as secretary.

(2) The members referred to in paragraph (1)(d),(e), (f), (g), (h), (i) (j) and (k)

shall be appointed by the Minister for such term as the Minister shall, from time to

time, decide.

(1) There shall be established a Department for Policy in

Health whose mission shall be, in general, to act as the chief

adviser to the Minister on all matters related to the Government’s

health policies and particularly to advise the Minister on the

development of policy and co-ordination of strategic plans, on the

design and implementation of action plans, and on the evaluation of

outcomes in order to contribute to the sustainability of public

health and health care services.

(2) The Head of this Department shall be the Chief Medical

Officer to Government.

The Department for Policy in Health shall in general

exercise those functions and fulfil all the duties and responsibilities

emanating from law, and in particular, those functions and duties

w h i c h t h e M i n i s t e r m a y, f r o m t i m e t o t i m e , e s t a b l i s h b y

regulations.

PART III

Department for Healthcare Services

(1) There shall be established a Department for Healthcare

Services whose mission shall be to ensure the effective and

efficient operation and delivery of healthcare services with an

emphasis on clinical and corporate governance, service delivery

and quality review within an established framework of controlled

decentralization and autonomy involving user participation.

(2)

The Head of this Department shall be a Director General.

The Department for Healthcare Services shall in general

exercise those functions and fulfil all the duties and responsibilities

emanating from law, and in particular, those functions and duties

w h i c h t h e M i n i s t e r m a y, f r o m t i m e t o t i m e , e s t a b l i s h b y

regulations.

PART IV

Department for Health Regulation

(1) There shall be established a Department for Health

Regulation whose mission shall be to safeguard public health,

licence, monitor and inspect the provision of healthcare services in

order to ensure their quality and safety, and to recommend the

standards to be met by healthcare providers and advice the Minister

on matters relating to public health.

(2) The Head of this Department shall be the Superintendant of

Public Health.

The Department for Health Regulation shall in general

exercise those functions and fulfil all the duties and responsibilities

emanating from law, and in particular, those functions and duties

w h i c h t h e M i n i s t e r m a y, f r o m t i m e t o t i m e , e s t a b l i s h b y

regulations.

PART V

Provisions Common for all Departments

The Heads and Director General shall be appointed by the

Prime Minister for a period of three years which may be renewed

for a further period or periods, after a call for applications under

article 92 of the Constitution of Malta, and under such terms,

conditions, functions and responsibilities as may be stated in the

respective letter of appointment.

The legal and juridical representation of the Departments

shall be vested in the respective Heads and Director General, or in

any other person appointed and acting on their behalf.

Without prejudice to the provisions of this Act, the

executive management, the administration and the administrative

control of the officers and employees of the Departments shall be

the responsibility of the Heads and Director General.

(1) Every Department may request, collect and verify any

information, data and statistics, as may be required for the

performance of its functions.

(2) A Department shall have access to all information which

another Department or other entity, established by or under this

Act.

(3) A Department may request all information from patients,

relatives, personnel, and professionals, and from public and private

healthcare providers, and such data shall be given to it in cases of

emergency, for reasons of public health and to safeguard the vital

interest of the patient or a third person. In all other cases the

informed consent of the patient shall be required.

(4) Every Department shall have access to other statistics and

data of an economic and social nature as required in order that it

may perform its functions according to this Act.

(5) The preceding sub-articles of this article shall be without

prejudice to any data protection legislation in force in Malta.

Without prejudice, and subject to, their functions, the

Departments shall respect the diversity of healthcare entities,

services and programmes, and dialogue and collaborate with other

entities, institutions and agencies, both public and private, local

and foreign, about policies, initiatives and projects in order to

ensure that the whole system operates effectively within the

country.

(1) There shall be established a Board to be known as the

Health Policy and Strategy Board, presided by the Minister, to

discuss and evaluate the policy, strategy developments and

direction in the health sector and to monitor and follow the

implementation of the health policy and strategy adopted by the

Government.

(2) The Board shall be composed as provided for in Schedule

A, and the Minister may by regulations amend the said Schedule,

and provide for any other matter or procedure he may deem

necessary for the better implementation of the functions of the

Board.

PART V A

Department operating Blood, Tissue and Cells Centre

(1)

There shall be established a Department operating

Blood, Tissue and Cells Centre, hereinafter referred to as the

Department, whose objective shall be to provide a safe and sustainable

blood supply and a service for tissue and cells in compliance with all

relevant standards, whilst respecting the donor’s voluntary gift for the

benefit of eligible patients.

(2)

The Head of the Department shall be a Director General.

The Department shall in general exercise such functions and

fulfil all the duties and responsibilities provided for in the law, and in

particular, perform such functions and duties which the Minister may,

from time to time, prescribe by means of regulations.

PART VI

Council of Health

(1) There shall be established a Council of Health.

(2) The Council shall be composed as provided for in Schedule

B, and the Minister may by regulations amend the said Schedule,

and provide for any other matter or procedure he may deem

necessary for the better implementation of the functions of the

Council.

(1) It shall be the duty of the Council to, whenever so

requested, advise Government on any matter affecting all matters

related to health in Malta.

(2) Without prejudice to the generality of the above, it shall be

the duty of the Council, in particular, to advise on any matter with

regards to which the law provides that the advice of the Council

shall be sought.

(1) The Council shall have the power to appoint sub-

committees and to co-opt thereon members who are not members of

the said Council when discussing specific items on its agenda.

(2) The Council shall also have the power to recommend any

such measures, enquiries or scientific investigations as, in its

opinion, are useful in the interests of the public health.

It shall not be lawful for the Council to transact any

business unless there are at least five of its members present

Provided that, if the Council is convened to consider any

matter upon which its advice is urgently required by the Minister,

the Council may decide by a majority of the members present.

Without prejudice to the powers of the Minister under

article 31 to make regulations to give effect to any of the provisions

of this Act, the Minister may make, vary or revoke regulations for

the proper conduct of the business of the Council.

PART VII

Healthcare Benefits and Entitlement

The Minister shall establish the healthcare benefits that are

to be provided directly or indirectly by the public healthcare

system, after considering the advice of the Advisory Committee on

Healthcare Benefits established in article 23.

(1) There shall be established an Advisory Committee on

Healthcare Benefits.

(2) The Advisory Committee on Healthcare Benefits may set

up sub-committees to deal with different and specific categories of

benefits as it may deem necessary. Without prejudice to the

generality of the foregoing, the Government Formulary List

Advisory Committee established by the Availability of Medicinal

Products within the Government Health Services Regulations shall

be deemed to be one of the aforementioned sub-committees.

(3) The Advisory Committee shall be composed as provided for

in Schedule C, and the Minister may by regulations amend the said

Schedule, and provide for any other matter or procedure he may

deem necessary for the better implementation of the functions of

the Advisory Committee.

(4) The Advisory Committee shall meet as often as necessary

and shall regulate its own procedures

Provided that in the case of urgent vitally necessary

treatment, the Chief Medical Officer may authorise the provision of

such healthcare benefits and duly report to the Minister and the

Advisory Committee at the first available opportunity.

(5) The Advisory Committee shall retain the right to advise the

Minister to restrict any form of entitlement on the basis of

protocols.

(1) It shall be the duty of the Committee to recommend the

healthcare benefits to be provided directly or indirectly by the

public healthcare system and to maintain a publicly accessible list

of such benefits regularly updated.

(2) In formulating the list, the Committee shall primarily base

its consideration on the impact of such benefits on the patient and

subsequently shall be guided by the following

(a) international evidence;

(b) health technology assessments;

(c) consultation with relevant stakeholders;

(d) capacity within the public health system;

(e) social and epidemiological considerations;

(f)

affordability and sustainability.

(1) Without prejudice to any other provision of any other

law, only an insured person may qualify for free healthcare benefits

provided by, or on behalf of, the public healthcare system.

(2) The Minister shall, from time to time, determine through

regulations made under this Act who shall be deemed to be an

insured person for the purposes of this article.

(1) There shall be established a Register, to be kept by the

Permanent Secretary of the Ministry for Health, which shall include

all the benefits, services, interventions and treatments provided by

the public healthcare system, and the cost and, or fees

corresponding to each such benefit, service, intervention and

treatment. This register shall be updated on an annual basis, or

before, as the Minister may from time to time determine.

(2) All the information referred to in sub-article (1) shall be

made publicly available.

(3) Without prejudice to any other law or regulations, the

established fees and, or costs, shall be construed as the maximum

reimbursement possible should a person opt for any form of cross-

border healthcare under any form of agreement which Malta may

be a party to, irrespective of the actual fees and, or cost incurred in

pursuance of such cross-border healthcare.

(4) Any person, not being an insured person as defined under

this Act, shall be subjected to pay the full fees and, or costs for

benefits, services, interventions or treatments as they result from

the register established in sub-article (1).

(5) Without prejudice to sub-article (4) or to any other law or

regulation, the Minister may approve for the partial, or full, waiver

of fees and, or costs due by any person, not being an insured

person, in exceptional circumstances and, or on humanitarian

grounds.

Without prejudice to any other law or regulations relating

to consumer protection in force at any time, all private healthcare

providers shall be obliged to apply the same scale of fees for the

services offered by them to patients, independently of the Member

State of which these patients are nationals, in so far as these are in

comparable medical situations.

PART VIII

Patients’ Rights and Safety

(1) It shall be the right of every patient

(a) to receive healthcare in accordance with the provisions

of this Act;

(b) to receive information concerning the state of his

health and the health services and treatments

available;

(c) to be provided in advance with clear information on

the treatment options available and to be involved in

discussions and decisions about the treatment to be

given;

(d) to access his medical records in accordance with the

Data Protection Act, provided this is not to the

detriment of his overall well-being;

(e) to have his medical data processed in conformity with

the Data Protection Act;

(f)

to refuse treatment that is offered to him, provided

such refusal is endorsed by his signature;

(g) to be seen and treated without excessive or undue

delay;

(h) to file a complaint about services received and be

informed of the outcome of the investigation of his

complaint in a timely manner;

(i)

to appeal in respect of any decision taken under this

Act to the Administrative Review Tribunal in

accordance with the provisions of the Administrative

Justice Act and any applicable regulations made

thereunder.

(2) Without prejudice to the provisions of sub-article (1) and

notwithstanding the provisions of any other law, a person who has

attained the age of fourteen (14) years shall have the right to consent

to, or refuse, medical attention, care or treatment if the medical

practitioner is of the opinion that such person has sufficient

maturity and understanding to so consent or refuse

Provided that where the medical practitioner is of the

opinion that the said person lacks the maturity and understanding to

consent to or to refuse treatment, the consent of the person having

parental or other legal authority over such person shall be required

Provided further that where the medical practitioner is of

the opinion that the said person has sufficient maturity and

understanding to consent to treatment but refuses such treatment,

the treatment may still be given if the medical practitioner is of the

opinion that the treatment is urgently required in the best interest of

the said person.

(3) For the purposes of sub-article (2), after a medical

practitioner shall have certified that a person as referred to in the

said sub-article has sufficient maturity and understanding to

consent to treatment, other healthcare professionals regulated by

t h e H e a l t h C a r e P r o f e s si o n s A c t s h a l l b e c o n s i d e r e d t o b e

authorised to participate in the medical attention, care or treatment

and in the healthcare plan decided by the medical practitioner by

offering and administering those services, benefits, interventions

and treatments required by the said person without the need for any

further authorisation in that respect.

(4) In this article any reference to treatment shall be deemed to

include a reference to psychiatric treatment, counselling, therapy,

social work and youth work.

Without prejudice to anything provided in this Act and, or

any other law, whilst health care providers are expected to provide

services based on the respect for human dignity, users are expected

to make use of the services available in a responsible manner and to

show respect to professionals, employees and also for the property.

(1) The Minister shall, within two years of the coming into

force of this Part, publish a document to be known as the Charter of

Patient Rights and Responsibilities.

(2) The Charter shall set out a summary of the rights and

responsibilities of patients and other relevant persons as existing at

the time of publication.

(3) The Charter shall be updated on a regular basis to reflect

contemporary trends and issues.

PART IX

Miscellaneous

The Minister may, subject to the provisions of this Act,

make regulations to give effect to any provisions of this Act or to

regulate or otherwise provide about anything in respect of the

f u n c t i o n s a n d t h e a c t i v i t i e s w h i c h a ff e c t t h e p r o v i s i o n o f

healthcare, and may in particular, but without prejudice to the

generality of the aforesaid, make regulations for any of the

following purposes

(a) to regulate any matter connected with, or incidental to,

the implementation of the functions, operation and

administration of all healthcare entities;

(b) to prescribe such data, reports and statements of

accounts which have to be sent to the Minister and to

the Directors General by the Principals and, or the

Chief Executive Officers, and such other officers and

persons relating to healthcare as the Minister may

deem necessary to request, and in such manner, form,

time and on such subjects as he may specify in the

regulations;

(c) to establish any fee and, or payment which may be due

by, or under this Act, or for any service given in

compliance with the provisions of this Act;

(d) to provide about any form or procedure which may be

required or expedient, and about which there would be

no specific procedure in this Act;

(e) to establish rules by means of which the Government

may ratify and give effect to international conventions

relating to health and which have already been ratified

by the Government of Malta; or in order to achieve

compliance with any international obligation

pertaining to the Government of Malta or with

European Union Directives on any matter or area

concerning health;

(f)

to establish the functions and duties of the directorates

and departments established by, or through this Act;

(g) in order to ensure the provision of health services in a

HEALTH

full and continuous process throughout life, to

establish those healthcare entities in such manner as it

may from time to time appear to be necessary in the

Maltese Islands and, unless otherwise provided in this

Act or in any other law, to establish also statutes and

rules to regulate the mission, scope, functions, powers

and duties, financial accountability or otherwise, and

any other procedure which has to be followed,

performed or observed by any entity so established by

or under this Act;

(h) to establish, unless otherwise provided in this Act or in

any other law, statutes and rules to regulate the

mission, scope, functions, powers and duties, financial

accountability or otherwise, and any other procedure

which has to be followed, performed or observed by

any Council, Committee or Board established by or

under this Act;

(i)

to afford, subject also to the provisions of any other

law, to a person aggrieved by the decision of any

entity, body or organisation established by or under

this Act, means and procedures either to lodge his

complaints and aggravation about a decision or to

contest or appeal from such a decision to the

Administrative Review Tribunal in accordance with

the provisions of the Administrative Justice Act and

any applicable regulations made thereunder, and to be

satisfied if that aggravation is upheld;

(j)

to establish anything which is due to be, or may be

established under this Act, and to provide on any other

matter as may be deemed to be appropriate;

(k) to establish the fines for any contravention or breach

of any provision of any regulation made under this

Act, or for non-compliance with any provision or any

requirement imposed under such provision

Provided that any regulations made under this

paragraph may provide differently for different aims or

circumstances, for different classes or types of entities,

and for different classes of patients;

(l)

to establish the framework of the national health

policy for public and private healthcare providers, and

it shall be the duty of all such providers to implement

this policy according to the potential and the various

needs of patients attending thereat;

(m) to establish, in the paramount interest of health in

Malta, any possible exceptions to any provision

contained in any law;

(n) to regulate any matter related to indemnity insurance

in the healthcare sector;

(o) to regulate any matter connected with patients rights

and safety;

(p) to regulate any matter related to the licensing

connected with the provision of healthcare services.

(1) Any regulations or orders made under the provisions

of the Department of Health (Constitution) Ordinance * and still in

force on the commencement of this Act, or the relevant Part or

article, shall, until provision is made by or in virtue of this Act,

continue to remain in force and have effect as if made under this

Act.

(2) Any licence, permission or other authorisation granted

under any provision of the aforesaid Ordinance shall continue to

have effect as if it were a licence, permission or other authorisation

granted under the authority of this Act.

*Repealed by this Act.