ACT No. XI of 2013 AN ACT to regulate the entitlement to, and the quality of, healthcare services in Malta, to consolidate and reform the Government structures and entities responsible for Health and to provide for the rights of patients.

I assent.

G EORGE A BELA

(L.S.)

President

25th October, 2013

ACT No. XI of 2013

AN ACT to regulate the entitlement to, and the quality of,

healthcare services in Malta, to consolidate and reform the

Government structures and entities responsible for Health and to

provide for the rights of patients.

BE IT ENACTED by the President, by and with the advice and

consent of the House of Representatives, in this present Parliament

assembled, and by the authority of the same, as follows:-

(1)

The short title of this Act is the Health Act, 2013.

Short title and

commencement.

(2) The provisions of this Act shall come into force on such

date as the Minister may establish by notice in the Gazette, and

different dates may be established for different provisions of this Act.

[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 three 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

(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 -

Interpretation.

"Advisory Committee" means the Advisory Committee on

Healthcare Benefits established by article 22;

"Council" means the Council of Health established under article

"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 Cap. 318.

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,

This Act intends to establish and ensure a health system Scope.

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.

PART II

Department for Policy in Health

[Article 22(3)]

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

(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; and

(j)

an officer appointed by the Minister to act as secretary.

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

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

Passed by the House of Representatives at Sitting No. 66 of the 23rd October,

2013. A NĀLU F ARRUGIA

Speaker

R AYMOND S CICLUNA

Clerk to the House of Representatives

(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

which the Minister may, from time to time, establish by 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

which the Minister may, from time to time, establish by 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 Functions of the

exercise those functions and fulfil all the duties and responsibilities Department.

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

which the Minister may, from time to time, establish by regulations.

PART V

Provisions Common for all Departments

The Heads and Director General shall be appointed by the Appointment of

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

Director

a further period or periods, after a call for applications under article General.

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 Juridical

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

any other person appointed and acting on their behalf.

Without prejudice to the provisions of this Act, the Heads and

executive management, the administration and the administrative Director

General to be

control of the officers and employees of the Departments shall be the responsible

officers, etc.

responsibility of the Heads and Director General.

(1) Every Department may request, collect and verify Exchange of

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

between the

Departments.

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 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 Power of the

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

make

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

proper conduct of the business of the Council.

PART VII

Healthcare Benefits and Entitlement

The Minister shall establish the healthcare benefits that are Healthcare

to be provided directly or indirectly by the public healthcare system, benefits.

after considering the advice of the Advisory Committee on

Healthcare Benefits established in article 23.

(1) There shall be established an Advisory Committee Advisory

Committee on

on Healthcare Benefits.

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 S.L. 458.31

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 Powers of the

Committee.

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 Healthcare fees

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

private

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

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

It shall be the right of every patient

Patients rights.

(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 Cap. 440.

overall wellbeing;

(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.

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

functions and the activities which affect the provision of 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 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 Cap. 490.

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) With effect from the coming into force of this Act,

the provisions of the Department of Health (Constitution) Ordinance

shall be repealed. For the avoidance of doubt, parts of that Ordinance

may be repealed at different dates on the coming into force of a

corresponding Part or Article of this Act.

(2) Any regulations or orders made under the provisions of the

said 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.

(3) 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.