JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

22.1: Introduction

Cellular therapy is now covered by a variety of legislation. The EU Directive on Tissues and Cells (2004/23/EC) and its associated Commission Directives (2006/17/EC and 2006/86/EC) have been transposed into UK law as the Human Tissue (Quality and Safety for Human Application) Regulations 2007. For advanced therapy medicinal products there is EU Directive 2001/83/EC with its subsequent amendments and Regulation (EC) No. 1394/2007 on advanced therapy medicinal products. The Human Tissue Act 2004, Human Tissue (Scotland) Act 2006 and Directions or Codes of Practice issued by the Human Tissue Authority also apply. In addition, there are a number of key international standards for haemopoietic stem cells, notably the FACT-JACIE and the NetCord-FACT Standards. The lists of publications in sections 22.1.1 to 22.1.5 have been grouped according to their origins.

The guidelines in this chapter apply to the donation, collection, testing, processing, cryopreservation, storage and distribution of haemopoietic progenitor cells (HPC) and therapeutic cells (TC) within the UK Blood Transfusion Services (UKBTS). HPCs include bone marrow, peripheral blood and cord blood progenitor cells. The guidelines must be read in conjunction with the other sections of the book including those that apply to quality systems, quality assurance and testing of donors. These guidelines are applicable to stem cell donor registries and to bone marrow, peripheral blood and cord blood collection and processing facilities.

22.1.1: European Union Directives/guidelines

1. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. OJ, L 102, 07.04.2004, p48. Available at
www.transfusionguidelines.org.uk.

2. Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. OJ, L 038, 09.02.2006, p40. Available at
www.transfusionguidelines.org.uk.

3. Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. OJ, L 294, 25.10.2006, p32. Available at www.transfusionguidelines.org.uk.

(Note: The EU Directive on Tissues and Cells and its associated Commission Directives are referred to collectively as the EU Directives on Tissues and Cells in this chapter.)

4. Regulation (EC) No. 1394/2007 of the European Parliament and Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No. 726/2004. Available at

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:EN:PDF.

5. Directive 2001/83/EC of the European Parliament and Council on the Community code relating to medicinal products for human use. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:EN:PDF.

6. Commission Directive 2003/63/EC amending Directive 2001/83 on the Community code relating to medicinal products for human use. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:159:0046:0094:EN:PDF.

7. Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:EN:PDF.

8. EC Guidelines to Good Manufacturing Practice Volume 4, Annex 1 (2008 revision): Manufacture of Sterile Medicinal Products. Available at http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.

9. Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Available at
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF.

10. Commission Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2005:091:0013:0019:EN:PDF.

11. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) prepares scientific guidelines, in consultation with the Competent Authorities of the EU member states, to help applicants prepare marketing-authorisation applications for medicinal products for human use. Guidelines are intended to provide a basis for practical harmonisation of the manner in which the EU member states and the Agency interpret and apply the detailed requirements for the demonstration of quality, safety and efficacy contained in the EU Directives. Available at www.ema.europa.eu/ema/index.jsp.

22.1.2: International Standards

12. International Standards for Cellular Therapy Product Collection, Processing, and Administration. Fifth edition (2012) from the Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-Europe and EBMT (JACIE). Available at www.jacie.org.

13. International Standards for Cellular Therapy Product Collection, Processing, and Administration Accreditation Manual. Fifth edition (2012). Available at www.jacie.org.

14. NetCord-FACT International Standards for Cord Blood Collection, Processing and Release for Administration. Fourth edition (2010). Available at www.factwebsite.org.

15. NetCord-FACT Cord Blood Accreditation Manual. Fourth edition (2012). Available at
www.factwebsite.org.

16. World Marrow Donor Association (WMDA) promotes a range of standards, guidelines and recommendations to facilitate the exchange of haemopoietic stem cells across international borders. Available at www.worldmarrow.org.

22.1.3: Human Tissue Authority

17. Human Tissue Act 2004 (except Scotland). Available at www.legislation.gov.uk. The Human Tissue Act 2006 (Scotland). Available at www.show.scot.nhs.uk.

18. Statutory Instrument 2007 No. 1523 The Human Tissue (Quality and Safety for Human Application) Regulations 2007, implementing the EU Directives on Tissues and Cells. Available at www.legislation.gov.uk/uksi/2007/1523/made.

19. Human Tissue Authority Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment (implemented by HTA Directions: 003/2010), explains the requirements under the EU Tissues and Cells Directives. Available at www.hta.gov.uk.

20. Human Tissue Authority (HTA). Codes of Practice for: Consent (Code 1); for Disposal of Human Tissue (Code 5); for Donation of Allogeneic Bone Marrow and Peripheral Blood Stem Cells for Transplantation (Code 6). Available at www.hta.gov.uk.

22.1.4: Histocompatibility, donor selection and microbiology documents

21. Hurley CK (1999). Histocompatibility testing guidelines for haematopoietic stem cell transplantation using volunteer donors: report from the World Marrow Donor Association. Quality Assurance and Donor Registries Working Groups of the World Marrow Donor Association. Bone Marrow Transplant, 24(2), 119–121.

22. European Federation for Immunogenetics (EFI) ‘Standards for histocompatibility testing’ version 5.6.1 (2010). Available at www.efiweb.org.

23. National Marrow Donor Program (USA) Standards, 20th edition, March 2009. Available at www.marrow.org

24. Joint UKBTS/NIBSC Professional Advisory Committee’s (JPAC) Donor Selection Guidelines for either cord blood donors or bone marrow/peripheral blood stem cell donors are available at www.transfusionguidelines.org.uk.

25. SaBTO (2011). Guidance on the microbiological safety of human organs, tissues and cells used in transplantation. Advisory Committee on the Safety of Blood Tissues and Organs. Available at https://www.gov.uk/government/publications/guidance-on-the-microbiological-safety-of-human-organs-tissues-and-cells-used-in-transplantation

22.1.5: UK legislation

26. Caldicott Report (1997). Available at http://webarchive.nationalarchives.gov.uk/20130107105354/ http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4068404.pdf.

27. Data Protection Act 1998. Available at www.legislation.gov.uk/ukpga/1998/29/contents.