European Reference Networks Regulations, 2018

L. N. 304 of 2018

HEALTH ACT

(CAP. 528)

European Reference Networks Regulations, 2018

IN EXERCISE of the powers conferred by article 30 of the

Health Act, the Minister for Health has made the following

Regulations

(1) The title of these regulations is European Reference

Networks Regulations, 2018.

(2) The scope of these regulations is the implementation of

Article 12 of Directive 2011/24/EU of the European Parliament and of

the Council of 9 March 2011 on the application of patients’ rights in

cross-border healthcare.

In these regulations, unless the context otherwise requires -

"Advisory Committee" means the National Advisory Committee;

"Healthcare provider" means any licensed healthcare facility

legally providing healthcare;

"Network" means the European Reference Networks established

by Article 12 of Directive 2011/24/EU of the European Parliament and

of the Council of 9 March 2011 on the application of patients’ rights in

cross-border healthcare;

"Licensing Authority" means the Superintendent of Public

Health as defined by the Public Health Act and the Health Act.

The Licensing Authority is authorised to designate a

healthcare provider to apply to be part of the Network.

There shall be an Advisory Committee to be known as the

National Advisory Committee, to assess and advise the Licensing

Authority on requests presented by health care providers operating in

Malta to enrol in European Reference Networks either as centres of

expertise or as affiliated partners.

(1) The Licensing Authority shall appoint the Advisory

Committee which shall be composed of three (3) members, and one (1)

of these members shall serve as Chairperson.

(2) A secretary to the Committee shall be appointed by the

Licensing Authority. The secretary shall be a member of the public

service.

(3) The Advisory Committee shall provide for any matter or

procedure it may deem necessary for the better implementation of the

functions of the Advisory Committee.

(1) Health care providers may submit an application in Application.

writing to the Licensing Authority in order to apply to be enrolled as

centres of expertise or as affiliated partners.

(2) The applications shall be submitted in writing to the

Licensing Authority, through an application on the form prescribed by

the Licensing Authority.

(3) The Licensing Authority shall refer the application to the

Advisory Committee for its assessment. The Advisory Committee

shall subsequently present its formal recommendations to the

Licensing Authority.

(1) The Advisory Committee shall assess applications Function of

received by the Licensing Authority for enrolment as centres of Advisory

Committee.

expertise or as affiliated partners.

(2) The applications submitted shall be assessed according to

Directive 2011/24/EU of the European Parliament and of the Council

of 9 March 2011 on the application of patients’ rights in cross-border

healthcare and any implementing and delegated decision there under,

and shall fulfil rules established by the Licensing Authority from time

to time. The National Advisory Committee may adapt the assessment

tools as it deems appropriate, following approval by the Licensing

Authority.

(3) After receiving recommendations drawn up by the

Advisory Committee, the Licensing Authority may issue the

designation to the health care provider to the specified level for

enrolment in the Network.

(4) The enrolment in the Network shall be subject to the

conditions as set out by the Licensing Authority.

(5) The Licensing Authority and the Advisory Committee may

request the applicant to present any further documentation or

information in addition to those presented together with the

application, at any stage during the evaluation of the application and

after enrolment in the Network.

(6) The enrolment of a health-care provider as a centre of

expertise or as an affiliated partner in the Network, shall be subject to a

review every five (5) years by the Licensing Authority.

(7) The healthcare provider that joins the Network must fulfil

and abide with the obligations and responsibilities arising from

participation within the Network.

The enrolment of a health-care provider as a centre of

expertise or as affiliated partner in the Network may be withdrawn by

the Licensing Authority when there is a breach of any condition for

enrolment.

The Licensing Authority may at any time make additional

protocols for implementation of these regulations.

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