FUNCTIONS AND RESPONSIBILITIES OF THE DEPARTMENT OPERATING THE BLOOD, TISSUE AND CELLS CENTRE REGULATIONS

FUNCTIONS AND RESPONSIBILITIES OF THE

DEPARTMENT OPERATING THE BLOOD, TISSUE AND

CELLS CENTRE

SUBSIDIARY LEGISLATION 528.12

FUNCTIONS AND RESPONSIBILITIES OF THE

DEPARTMENT OPERATING THE BLOOD, TISSUE

AND CELLS CENTRE REGULATIONS

15th November, 2024

LEGAL NOTICE 300 of 2024.

The title of these regulations is the Functions and

Responsibilities of the Department operating the Blood, Tissue and

Cells Centre Regulations.

(1)

In these regulations, unless the context otherwise

requires

"Act" means the Health Act;

"blood" means whole blood collected from a donor and

processed either for transfusion or for further manufacturing;

"cells" means individual human cells or a collection of

human cells when not bound by any form of connective tissue;

"Centre" means the Blood, Tissue and Cells Centre, an

establishment for the collection, processing, storage and

distribution of blood, tissues and cells;

"data subject" means any individual whose personal data

is being collected, held or processed;

"Department" means the Department operating the Blood,

Tissue and Cells Centre established by the Act to develop and to

operate the Centre for the reception, collection, processing,

storage and distribution of blood, tissues and cells and to

perform other functions or responsibilities entrusted to it by

law;

"Regulation (EU) 2016/679" means Regulation (EU)

2016/679 of the European Parliament and of the Council of 27

April 2016 on the protection of natural persons with regard to

the processing of personal data and on the free movement of

such data, and repealing Directive 95/46/EC (General Data

Protection Regulation);

"tissue" means all constituent parts of the human body

formed by cells.

(2)

Words and expressions used in these regulations shall

FUNCTIONS AND RESPONSIBILITIES OF THE

DEPARTMENT OPERATING THE BLOOD, TISSUE AND

CELLS CENTRE

have the same meaning as assigned to them in the Act.

(1)

It shall be the function of the Department in

general to develop and to operate the Centre for the reception,

collection, processing, storage and distribution of blood, tissues and

cells.

(2)

In particular, the functions and duties of the Department

shall include

(a)

to provide blood banking services, including labile

blood products, stem cell collection for cellular therapies,

including autologous stem cell transplantation, human leukocyte

antigen typing, bone marrow donor registry, and tissue banking

services including bone, cornea and amnion banking services and

any other tissues and cells for which there is clinical demand;

(b)

to participate in research, innovation, training and

education activities through partnerships with appropriate

bodies;

(c)

to advise the Government on issues related to the

core functions of the Centre;

(d)

to promote research, teaching and training in the

fields relating to its functions and responsibilities;

(e)

to cooperate with local and international

organisations on matters relating to its functions and

responsibilities;

(f)

to advise upon innovative models of service

provision and delivery following consultation, where necessary,

with relevant stakeholders;

(g)

to anticipate the needs of professional staff, and

other human resources, and to collaborate with third parties,

including the University of Malta established in accordance with

article 72 of the Education Act, the Malta College of Arts,

Science and Technology established and incorporated in

accordance with article 86 of the Education Act and any other

institutions, public and private, in order to ensure the training

and development of healthcare professionals and non-healthcare

personnel, according to their needs in matters relating to the

functions and responsibilities of the Department;

(h)

to carry out such other function or functions as the

Minister may from time to time determine and direct; and

(i)

to implement any other matter required for the

FUNCTIONS AND RESPONSIBILITIES OF THE

DEPARTMENT OPERATING THE BLOOD, TISSUE AND

CELLS CENTRE

fulfilment of its mission, and for the execution of duties

pertaining to the State, as established in the Act.

(1)

Nothing in these regulations shall prejudice the

applicability of Regulation 2016/679/EC and the Data Protection Act,

including the regulations made thereunder, and the fundamental rights

and freedoms of the data subjects.

(2)

The Department in its capacity of a controller in terms of

Article 4(7) of Regulation (EU) 2016/679 shall perform the relevant

data processing operations which are limited to the extent necessary

and proportionate to perform its functions and duties.

(3)

Any personal data processed by the Department shall

fully comply with all the principles relating to the processing of

personal data pursuant to Article 5 of Regulation 2016/679/EC.

(4)

The Department, whilst taking into account the nature,

scope, context and purpose of processing, as well as the risks of

varying likelihood and severity for the rights and freedoms of the data

subjects, shall implement appropriate technical and organisational

measures, in an effective manner in order to ensure a level of security

appropriate to the risks.

(5)

For the purpose of ensuring and to be able to prove

compliance with the principles relating to the processing of personal

data, the Department shall implement appropriate data protection

policies, which policies shall be reviewed and updated where

necessary.

(6)

The access to personal data shall be reserved exclusively

to duly designated officers on the basis of a role-based access control

mechanism and subject to confidentiality and, or professional secrecy

obligations, in order to prevent abuse or unlawful access to, or

disclosure of personal data.

(7)

The data protection officer designated by the Department

in terms of Article 37 of Regulation 2016/679/EC shall be involved

and duly consulted and in a timely manner in relation to the protection

of personal data processed for the purpose of these regulations.

The activities and services offered by the Department

and the Centre are an integral part and inseparably connected with the

public healthcare system, and are part of the State’s social and

healthcare obligations.