Roles of the IMB and HSE with regard to Directive, 24 April 2012

Introduction

Ireland must bring Regulations into law to comply with the provisions of Directive 2010/53/EC by August 27th. These Regulations will translate the EU Directive into an Irish context and will confer responsibility for different parts of the Directive onto the Irish Medicines Board and the HSE.

The EU Directive provides for the appointment of one or more competent authorities. Given the pivotal role for co-ordination of the health service aspects of the legislation, the IMB will be appointed as the competent authority for specific parts of the Directive. Specific responsibilities will also be assigned to the HSE. Within this arrangement, both organisations will work in partnership to ensure the effective regulation of the donation and transplantation of organs for human use.

When these Regulations come into effect, no person may carry out any activity relating to the donation, testing, characterisation, procurement, preservation, transport and transplantation of organs otherwise than in accordance with an authorisation which will be granted by the IMB. Notwithstanding this, it is intended to include a provision in the legislation to enable a procurement organisation or transplantation centre carrying out these activities to continue to carry out such activities without an authorisation for a temporary period provided that it submits an application for authorisation to the IMB by a certain date yet to be specified.

Under the Regulations, the IMB will be authorised to conduct a regular inspection of each site of a procurement organisation or transplantation centre not less than once every 2 years to ascertain compliance with the requirements of the Directive. The IMB may grant, suspend, or withdraw, as appropriate, the authorisations of procurement organisations or transplantation centres or prohibit procurement organisations or transplantation centres from carrying out their activities where control measures demonstrate that such organisations or centres are not complying with the requirements of this Directive;

Under the Regulations, an authorisation holder will have to designate a person who will be responsible for

Outlined below is a summary of the main requirements of the Directive as they pertain to the IMB, the HSE, procurement organisations and transplant centres. These requirements are subject to change as the legislative proposals are developed further. More detail on these requirements and of other requirements not referred to in this document can be found in the EU Directive which can be accessed on the Department of Health’s website at http://www.dohc.ie/publications/directive2010_53_EU.html

Article 4 - Framework for quality and safety

The HSE, in consultation with the IMB, must ensure that a framework for quality and safety is established to cover all stages of the chain from donation to transplantation or disposal, in compliance with the rules laid down in the Directive.

This framework for quality and safety must provide for the adoption and implementation of operating procedures for:

(a) the verification of donor identity;

(b) the verification of the details of the donor's or the donor's family's consent;

(c) the verification of the completion of the organ and donor characterisation in accordance with Article 7 and the Annex;

(d) the procurement, preservation, packaging and labelling of organs in accordance with Articles 5, 6 and 8;

(e) the transportation of organs in accordance with Article 8;

(f) Insuring traceability, in accordance with Article 10, guaranteeing compliance with the Union and national provisions on the protection of personal data and confidentiality;

(g) the accurate, rapid and verifiable reporting of serious adverse events and reactions in accordance with Article 11(1);

(h) the management of serious adverse events and reactions in accordance with Article 11(2).

The operating procedures referred to in points (f), (g) and (h) must specify, inter alia, the responsibilities of procurement organisations, European organ exchange organisations and transplantation centres.

Procurement organisations and transplant centres must ensure that the healthcare personnel involved at all stages of the chain from donation to transplantation or disposal are suitably qualified or trained and competent, and shall develop specific training programmes for such personnel.

Article 5 - Procurement organisations

A procurement organisation must ensure that the procurement that takes place in, or is carried out by it, complies with the rules laid down in the Regulations.

The IMB will indicate in the authorisation which activities the procurement organisation concerned may undertake.

The IMB, as competent authority, must upon the request of the Commission or another Member State, provide information on national requirements for authorisation of procurement organisations.

Article 6 - Organ Procurement

The HSE must ensure that procurement takes place in operating theatres which are designed, constructed, maintained and operated in accordance with adequate standards and best medical practices so as to ensure the quality and safety of the organs procured;

Article 7 - Organ and donor characterisation

The HSE must ensure that where organs are exchanged between Member States the information on organ and donor characterisation, as specified in the Annex, is transmitted to the other Member State with which the organ is exchanged, in conformity with the procedures established by a separate EU Implementing Directive which is currently being drafted at EU level.

Article 8 - Transport of organs

The HSE will include requirements detailed in this Article in the framework for quality and safety as set out at Article 4 above.

Article 9 - Transplantation centres

The IMB must indicate in the authorisation which activities the transplantation centre concerned may undertake.

The IMB must, upon the request of the Commission or another Member State, provide information on the national requirements for the authorisation of transplantation centres.

Article 10 - Traceability

The HSE, procurement organisations and transplantation centres must ensure that all organs procured, allocated and transplanted in Ireland can be traced from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients.

The HSE, procurement organisations and transplantation centres must ensure the implementation of a donor and recipient identification system that can identify each donation and each of the organs and recipients associated with it while ensuring that confidentiality and data security measures are in place.

The HSE, procurement organisations and transplantation centres must:

(a) keep the data needed to ensure traceability at all stages of the chain from donation to transplantation or disposal and the information on organ and donor characterisation as specified in the Schedule, in accordance with the framework for quality and safety;

(b) data required for full traceability is kept for a minimum of 30 years after donation.

Where organs are exchanged between Member States, the HSE must transmit the necessary information to ensure the traceability of organs in conformity with the procedures established by the Commission pursuant to Article 29.

Article 11 - Reporting system and management concerning serious adverse events and management

The IMB, as competent authority, and the HSE will co-operate in this area:

The HSE must ensure that there is an appropriate system in place to collect, collate, report, investigate, register and transmit relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation which may be connected to those activities.

Each procurement organisation through its responsible person and each transplantation centre through its responsible person must ensure implementation of a reporting system to ensure compliance with the requirement and must transmit relevant and necessary information simultaneously to the IMB and to the HSE.

The procurement organisations and transplantation centres must ensure that an operating procedure is in place for the management of serious adverse events and reactions as provided for in the framework for quality and safety.

Where organs are exchanged between Member States, the IMB, following interaction with the HSE, must ensure the reporting of serious adverse events and reactions in conformity with procedures to be developed at EU level.

Article 15 - Quality and safety aspects of living donation

The HSE must ensure that a register or record of the living donors is kept, in accordance with European Union and national provisions on the protection of the personal data and statistical confidentiality.

The HSE must endeavour to carry out the follow-up of living donors and must have a system in place in accordance with national provisions, in order to identify, report and manage any event potentially relating to the quality and safety of the donated organ, and hence of the safety of the recipient, as well as any serious adverse reaction in the living donor that may result from the donation, as part of the reporting system provided for in Article 11.

Article 16 - Protection of personal data, confidentiality and security of processing

The HSE, procurement organisations and transplantation centres must ensure that the fundamental right to protection of personal data is fully and effectively protected in all organ donation and transplantation activities

Article 18 - Records and reports concerning procurement organisations and transplantation centres

The IMB and the HSE must:

(a) keep a record of the activities of procurement organisations and transplantation centres, including aggregated numbers of living and deceased donors, and the types and quantities of organs procured and transplanted, or otherwise disposed of;

(b) draw up and make publicly accessible an annual report on activities referred to in point (a);

(c) establish and maintain an updated record of procurement organisations and transplantation centres.

The IMB and the HSE must, upon the request of the Commission or another Member State, provide information on the record of procurement organisations and transplantation centres.

Article 20 - Organ exchange with third countries

The HSE, with the oversight of the IMB, must supervise organ exchange with third countries. This organ exchange will only be allowed only where the organs:

(a) can be traced from the donor to the recipient and vice versa;

(b) meet quality and safety requirements equivalent to those laid down in this Directive.