Blood, Tissue and Cells Centre Regulations, 2024

L.N. 300 of 2024

HEALTH ACT

(CAP. 528)

Functions and Responsibilities of the Department operating the

Blood, Tissue and Cells Centre Regulations, 2024

IN EXERCISE of the powers conferred by article 30 of the

Health Act, the Minister responsible for health, has made the following

regulations:-

The title of these regulations is the Functions and Citation.

Responsibilities of the Department operating the Blood, Tissue and

Cells Centre Regulations, 2024.

(1)

In these regulations, unless the context otherwise Interpretation.

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 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

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 Data protection.

applicability of Regulation 2016/679/EC and the Data Protection Act, Cap. 586.

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 National Health

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

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

healthcare obligations.

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