Blood & Organs Policy Unit

Objectives

  1. Support and monitor the standards and delivery of services relating to the use of blood, tissues and organs in Ireland in order that they comply with high international standards for quality and safety.
  2. Oversee the provision of services under the Health Amendment Act provided by the HSE.
  3. Management of High Court and Supreme Court appeals on behalf of the Minister relating to Hepatitis C and HIV.

Functions and Responsibilities

  • Monitoring of appropriate health and personal social services (including compensation schemes) for persons infected with Hepatitis C and HIV through the administration within the State of blood or blood products.
  • Management of legal matters, including litigation relating to State-acquired Hepatitis C and HIV
  • Governance of the Irish Blood Transfusion Service , including evaluation of performance objectives, sales and financial targets.
  • Oversee establishment of quality and safety standards in organ donation and transplantation in line with Directive 2010/53/EU and support initiatives aimed at increasing the number of organs available for transplantation.
  • Liaise with HSE on development of best transfusion service.
  • Oversee compliance of hospitals with blood and tissue safety regulations as reported by the IMB.
  • Link with colleagues in the Department on the development of the Human Tissue Bill.

Contacts

Principal Officer Mary Jackson (01) 6354337 mary_jackson@health.gov.ie
Assistant Principal Officer Maeve O'Brien (01) 6354732 maeve_o'brien@health.gov.ie

Agenices

Irish Blood Transfusion Service (IBTS)

The Blood Transfusion Service Board (BTSB) was established by Statutory Instrument No. 78 of 1965 under the Corporate Bodies Act 1961. In 1975 and 1991 respectively the Cork and Limerick Blood Transfusion Services were absorbed by the BTSB. Amendment Order SI. 22 of 2000 changed the name of the organisation to the Irish Blood Transfusion Service (IBTS).

The IBTS remit is to provide a safe, reliable, robust blood service to the Irish health system. Blood, and the products derived from it, are an integral facet of healthcare delivery. A major objective of the organisation is to ensure that it always has the necessary programmes and procedures in place to protect both the donors of blood and recipients of blood and blood products. www.ibts.ie

National Haemophilia Council

The establishment of a National Haemophilia Council was approved by Government following the recommendations of the Lindsay Tribunal in 2001. The Regulations placing the Council on a statutory footing were signed by the Minister for Health and Children on 22 July, 2004. (S.I. No. 451 of 2004.)

The principal function of the Council is to advise the Minister, health service agencies and other persons on any matter relating to haemophilia, on its own initiative or at the request of the Minister, or a health agency. www.nationalhaemophiliacouncil.ie

Consultative Council on Hepatitis C

The Consultative Council on Hepatitis C was established by the Minister for Health and Children on the 26th of November 1996 by Statutory Instrument (SI No 339 of 1996), to advise on all matters relating to Hepatitis C. www.consultativecouncilonhepc.ie

Hepatitis C and HIV Compensation Tribunal

The Tribunal was set up by Government in 1995 to compensate, inter alia, persons infected with Hepatitis C as a result of the use of Human Immunoglobulin Anti-D or as a result of the receipt of a blood transfusion or blood product within the Republic of Ireland.

The Tribunal became a Statutory Body with the enactment of the Hepatitis C Compensation Tribunal Act, 1997 (No 34 of 1997). In addition, the Hepatitis C Compensation Tribunal Amendment Act, 2002 makes provision to compensate, inter alia, persons infected with HIV as a result of the receipt of a relevant blood product within the Republic of Ireland. The Hepatitis C & HIV Compensation Tribunal Amendment Act 2006 allowed for the establishment of an insurance support scheme for persons who have been infected with Hepatitis C and HIV through the administration within the State of infected blood and blood products. www.hepccomptrib.com

Fact Sheet

1. Organ Donation & Organ Transplantation in Ireland

  • Ireland has a relatively high rate of organ donation, i.e. a rate of 20.3 per million in 2011. Comparatively in the UK the figure is 16 per million, while Spain has a figure of 37 per million. There is wide recognition of the necessity to maximise organ procurement and utilisation opportunities to save and enhance lives.
  • While 2010 was a poor year for organ procurement, there was a considerable increase in donor rates in 2011.
  • 2003 2004 2005 2006 2007 2008 2009 2010 2011
    Total Donors 86 89 76 91 88 81 90 58 93
    Total Transplants 187 206 205 234 223 224 261 151 *276

    * Includes 27 kidney transplants from live donors in 2011

  • The HSE has established a National Office for Organ Donation and Transplantation, which will endeavour to enhance organ donation in Ireland and underpin the quality of outcomes for patients following organ donation in line with the European Directive on Organ Transplantation.
  • EU Directive 2010/53/EU sets down common quality and safety standards for the procurement, transport and use of organs and must be transposed into national law by 27th August 2012. It applies to the donation, testing, characterisation, procurement, preservation, transport and transplantation of organs. It provides for the establishment of a competent authority, the authorisation of transplant centres, the establishment of conditions of procurement and systems of traceability. The Directive also sets out minimum information required to make an assessment as to whether a particular organ is suitable for transplantation.
  • This Directive was transposed into Irish law by the European Union (Quality and Safety of Human Organs intended for Transplantation) Regulations 2012 (S.I. No. 325 of 2010) which came into effect on 27 August 2012.

2. Services for Persons Infected with Hepatitis C

  • Services under the Health (Amendment) Act 1996 (No 15 of 2006) are demand led and will continue to be provided to meet the needs of around 1,500 Health Amendment Act card holders, as the cohort of infected persons ages. Approximately €14m was allocated in 2011 - Hospital Services (approx. €8m approx), Primary Care Services (€4.15m), Patient Support Group funding (approx. €1.57m) and the National Hepatitis C Database (€150k). Additional expenditure of €8m was incurred under Primary Care Services in 2011.
  • Services continue to be provided to eligible persons in hospital and primary care settings under the terms of the Health (Amendment) Act 1996.
  • The National Hepatitis C Database Report profiles the health status of persons infected with Hepatitis C.
  • The Consultative Council on Hepatitis C advises the Minister and others on all aspects of Hepatitis C. It also organises an annual Information Day for persons with Hepatitis C. A number of International Conferences have also been organised.
  • A set of guidelines have been developed by the HSE to allow for the introduction of standardised health and social care needs assessments for all HAA cardholders, on a continuum from home support, to home care and eventually home nursing. This will allow the HSE to provide appropriate support to clients and plan for service needs in the future. The HSE and the Department are awaiting agreement for the guidelines from two of the four patient support groups.

3. Insurance Support Scheme for Persons with Hepatitis C and HIV

  • Primary legislation was enacted in 2006 (No 22 of 2006) to allow for the establishment of an insurance support scheme for persons who have been infected with Hepatitis C and HIV through the administration within the State of infected blood and blood products.

4. Hepatitis C and HIV Compensation Tribunal

  • The total cost of the Hepatitis C and HIV Compensation Tribunal from 1996 to 31st December 2011, including payments to 3,076 claimants, legal fees, and administrative costs, is €1.033 billion.

5. Blood Safety and Quality

  • Standards of quality and safety relating to blood and blood components are set out in European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005 (SI 360 of 2005). These Regulations apply to the collection, testing, processing, storage and distribution of human blood and blood component. Under the Regulations, all blood establishments and hospital blood banks are authorised by the Irish Medicines Board, which has been designated as the Competent Authority. Hospital blood banks must meet ISO 15189 accreditation standard and are audited by the Irish National Accreditation Board (INAB), which has been contracted by the IMB to perform the audits.
  • All blood banks are compliant with ISO 15189 standards.
  • The IBTS continues to make incremental progress in conjunction with the HSE in realising efficiencies, while at the same time having a safe effective service.
  • A blood stock management system has been put in place to manage blood stocks.
  • European Communities (Quality & Safety of Human Blood & Blood Components) (Amendment) Regulations 2011 were transposed into Irish law on by S.I. No. 329 of 2011. This S.I. amends Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of shelf life and also provide that blood establishments should encourage voluntary and unpaid donation of blood and blood components.
  • There is continued monitoring and evaluation of progress on compliance with the regulations which transposed the Directive by the IMB.

6. Quality and Safety of Tissues and Cells

  • Standards of quality and safety relating to human tissues and cells intended for human application are set out in the European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006 (SI No 158 of 2006). These Regulations apply to the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells when intended for human applications. They also apply to manufactured products derived from human tissues and cells intended for human applications. The Irish Medicines Board is the competent authority under the Regulations. All tissue establishments require authorisation by the IMB to carry out their activities and are subject to regular inspections.

The Human Tissue Bill

The Department is working on the Human Tissue Bill which will:

  • provide for the implementation of key recommendations in the Madden Report on Post Mortem Practice and Procedures that no hospital post-mortem may be carried out and no tissue retained without consent
  • put in place a legal framework in relation to the donation of organs and tissue for transplantation or research purposes by living and deceased persons and
  • put in place enhanced arrangements in relation to the donation of bodies to anatomy schools and provisions for the setting of guidelines and standards to be met in the practice of anatomy.

Primary Legislation

  • Health (Amendment) Act 1996
  • Hepatitis C Compensation Tribunal Act 1997
  • Hepatitis C Compensation Tribunal (Amendment) Act 2002
  • Hepatitis C Compensation Tribunal (Amendment) Act 2006

Section 15 FOI

Record Classes: Files on Policy Issues, Correspondence, Representations and PQs

Working Groups: None

Significant Systems: N/A

Personal Information Holdings: Personal records related to High Court Appeals of Compensation Tribunal Awards

Disclosees: N/A

Notes: including information on admin access practice, Ebriefs etc: Standard policy and briefing documentation