141 tal-2014 - Regolamenti tal-2014 dwar Proceduri ta’ Informazzjoni għall-Iskambju bejn Stati Membri ta’ Organi Umani maħsuba għat-Trapjant

L.N. 141 of 2014

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Information Procedures for the Exchange, between Member

States, of Human Organs intended for Transplantation

Regulations, 2014

BY VIRTUE of article 16 of the Human Blood and Transplants

Act, the Minister for Energy and Health, after consultation with the

Licensing Authority, has made the following regulations:-

(1) The title of these regulations is the Information

Procedures for the Exchange, between Member States, of Human

Organs intended for Transplantation Regulations, 2014.

(2) The scope of these regulations is to transpose Commission

Implementing Directive 2012/25/EU of 9 October 2012 laying down

information procedures for the exchange, between Member States, of

human organs intended for transplantation.

Initial Report for suspected serious adverse events or reactions

1. Reporting Member State

2. Report identification number: country (ISO)/national

number

3. Contact details of the reporter (competent authority or

delegated body in the reporting Member State): telephone, e-mail

and, when available, fax

4. Reporting centre/organisation

5. Contact details of coordinator/contact person (transplant/

procurement centre in the reporting Member State): telephone, e-mail

and, when available, fax

6. Reporting date and time (yyyy/mm/dd/hh/mm)

7. Member State of origin

8. National donor identification number, as communicated

under regulation 7

9. All Member States of destination (if known)

10. National

recipient

identification

number(s),

as

communicated under regulation 7

These regulations shall apply to the cross-border exchange

of human organs intended for transplantation within the European

Union.

Final Report of serious adverse events or reactions

1. Reporting Member State

2. Report identification number: country (ISO)/national

number

3. Contact details of the reporter: telephone, e-mail and,

when available, fax

4. Reporting date and time (yyyy/mm/dd/hh/mm)

5. Identification number(s) of initial report(s) (Schedule I)

6. Description of case

7. Involved Member States

8. Outcome of the investigation and final conclusion

9. Preventive and corrective actions taken

10. Conclusion/Follow-up, if required

€0.63

These regulations set out

(a)

procedures for the transmission of information on

organ and donor characterisation;

(b) procedures for the transmission of the necessary

information to ensure the traceability of organs;

(c)

procedures for ensuring the reporting of serious

adverse events and reactions.

In these regulations unless the context otherwise requires

"delegated body" means a body to which tasks have been

delegated in accordance with regulation 3(3) of the Organ Transplants

(Quality and Safety) Regulations or a European organ exchange

organisation to which tasks have been delegated in accordance with

regulation 19 of the Organ Transplants (Quality and Safety)

Regulations;

"Member State of destination" means the Member State to

which the organ is sent for the purpose of transplantation;

"Member State of origin" means the Member State where the

organ is procured with the purpose of transplantation;

"national donor/recipient identification number" means the

identification code attributed to a donor or a recipient in accordance

with the identification system established at national level pursuant to

regulation 10(1)(b) of the Organ Transplants (Quality and Safety) S.L. 483.06

Regulations;

"specification of the organ" means -

(a)

the anatomical description of an organ including its

type (e.g. heart, liver);

(b) where applicable, its position (left or right) in the

body; and

(c)

whether it is a whole organ or a part of an organ,

mentioning the lobe or segment of the organ.

(1) The Superintendent of Public Health shall be the Licensing

Authority.

Licensing Authority for the purposes of these regulations.

(2) The Licensing Authority may delegate any of its functions

to any other body it deems competent.

(1) Information transmitted between the Licensing Common

Authority, or the delegated bodies, procurement organisations and, or procedural

rules.

transplantation centres shall

(a)

be transmitted in writing either electronically or by

fax;

(b) be written in a language mutually understood by the

sender and the addressee or, in absence thereof, in a mutually

agreed language, or, in absence thereof, in English;

(c)

be transmitted without undue delay;

(d)

be recorded and can be made available upon request;

(e)

indicate the date and time of the transmission;

(f)

include the contact details of the person responsible

for the transmission;

(g)

contain the following reminder

‘Contains personal data. To be protected against

unauthorised disclosure or access’.

(2) In case of urgency, the information may be exchanged in a

verbal form, in particular for exchanges pursuant to regulation 7 of

the Organ Transplants (Quality and Safety) Regulations. These verbal

contacts must be followed by a transmission in writing in accordance

with those regulations.

(3) The receipt of the information transmitted in accordance

with these regulations shall be confirmed to the sender, in accordance

with the requirements set out in sub-regulation (1).

(4) Organ procurement centres and transplant centres shall

ensure that designated personnel -

(a)

are available 24 hours a day and 7 days a week, for

urgent situations;

(b) are able to receive and transmit information

pursuant to these regulations without undue delay.

(1) Where organs are envisaged for exchange between

Member States, prior to exchanging the organ, the transplant centre of

origin shall transmit the information collected to characterise the

procured organs and the donor, as specified in regulation 7 of, and in

the Schedule to, the Organ Transplants (Quality and Safety)

Regulations, to the competent authorities or delegated bodies of the

potential Member States of destination.

(2) Where some of the information to be transmitted in

accordance with sub-regulation (1) is not available at the time of the

initial transmission and becomes available later, the transplant centre

of origin must ensure that it is transmitted in due time to allow for

medical decisions

(a)

by the Licensing Authority or its delegated body

when Malta is Member State of origin to the competent

authority or delegated body of the Member State of destination;

or

(b) directly by the procurement organisation to the

transplantation centre.

(3) Procurement organisations and transplantation centres

shall transmit to the Licensing Authority a copy of the information

pursuant to sub-regulation (2)(b).

(1) When Malta is the Member State of origin, the Information to

Licensing Authority or its delegated body shall inform the competent ensure

traceability of

authority or delegated body of the Member State of destination of

organs.

(a)

the specification of the organ;

(b)

the national donor identification number;

(c)

the date of procurement;

(d)

name and contact details of the procurement centre.

(2) When Malta is the Member State of origin, the competent

authority or delegated body of the Member State of destination shall

inform the Licensing Authority or delegated body of

(a)

the national recipient identification number or, if the

organ was not transplanted, of its final use;

(b)

the date of transplantation, if applicable;

(c)

name and contact details of the transplantation

centre.

The Licensing Authority shall ensure that

Reporting of

serious adverse

events and

(a)

whenever as a Member State of destination, the

reactions.

Licensing Authority or its delegated body is notified of a serious

adverse event or reaction that it suspects to relate to an organ

that was received from another Member State, it shall

immediately inform the competent authority or delegated body

of the Member State of origin and transmit without undue delay

to that competent authority or delegated body an initial report

containing the information set out in Schedule I, in so far as this

information is available;

(b) whenever as a Member State of origin, the Licensing

Authority or its delegated body it is notified of a serious adverse

event or reaction that it suspects to be related to a donor whose

organs were also sent to other Member States, the Licensing

Authority or its delegated body, shall immediately inform the

competent authorities or delegated bodies of each concerned

Member State of destination and transmit them each an initial

report containing the information set out in Schedule I;

(c)

when additional information becomes available

following the initial report, it shall be transmitted without undue

delay;

(d) whenever Malta is the Member State of origin, the

Licensing Authority or its delegated body shall, as a rule within

three months of the initial report transmitted pursuant to

paragraph (a) or (b), transmit to the competent authorities or

delegated bodies of all Member States of destination, a common

final report containing the information set out in Schedule II.

The competent authorities or delegated bodies of the Member

States of destination shall provide relevant information in a

timely manner to the Licensing Authority or its delegated body.

The final report shall be drawn up after collecting relevant

information from all Member States involved.

(1) The Licensing Authority shall communicate to the

Commission its contact details or those of the delegated bodies to

which the relevant information shall be transmitted for the purpose of,

on the one hand, regulation 6, and, on the other hand, regulations 7

and 8. These contact details shall include at least the following data

the organisation’s name, telephone number, e-mail address, fax

number and postal address.

(2) The Licensing Authority or the delegated bodies shall

ensure that the information received by one of them pursuant to

regulations 6, 7 or 8 is forwarded to the Licensing Authority or

delegated body at national level, in accordance with the repartition of

competences.

(3) The Licensing Authority shall be responsible for updating

the information related to the competent authorities and delegated

bodies designated by it in the list made available by the Commission

or any third party entrusted by it to establish and maintain the list

updated.

Onset date and time of serious adverse event or reaction

(yyyy/mm/dd/hh/mm)

Detection date and time of serious adverse event or

reaction (yyyy/mm/dd/hh/mm)

Description of serious adverse event or reaction

Immediate measures taken/proposed