1. Debby Gibson Human Tissue Act Manager LTHT and UoL
The Human Tissue Act 2004
HTA key facts presentation January 2018
Debby Gibson
Human Tissue Act Manager
LTHT and UoL

2. Introduction The Human Tissue Act 2004 (HT Act)
Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q+S Regs 2007) - EUTCD
Quality and Safety of Organs Intended for Transplantation Regulations EUODD
The Human Tissue Authority (HTA) and how it regulates
(Includes recent initiatives)
5) What licences do we have within LTHT / UoL?
6) Questions and relevant links

3. Consent is the fundamental principle of the HT Act
1) The Human Tissue Act 2004
What is it?
Key points of the HT Act are:
The HT Act, came into force on 1st September 2006 and is a legal framework for regulating:
the storage and use of human organs and tissue from the living;
the removal, storage and use of tissue and organs from the deceased;
for scheduled purposes in England, Wales and Northern Ireland
Provisions relating to the use of DNA cover England, Wales Northern Ireland and Scotland (DNA analysis is a UK wide offence if held without appropriate consent)
Removal of such material from the living is dealt with under common law
Consent is the fundamental principle of the HT Act

4. Why was it implemented?
Followed the discovery of establishments, such as Liverpool's Alder Hey Hospital, removing and retaining human organs and tissue without consent.
The HT Act addressed this issue and brought together other existing laws related to human tissue and organs

5. 2) Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q + S Regs 2007)
The EU Tissue and Cells Directive (EUTCD)
a European law which covers the whole of the UK, including Scotland
Implemented in the UK via the Q&S Regs 2007 on 5th July 2007
Establishments must be regulated in order to conduct the following activities:
Import / export
Procurement
Testing (donors)
Storage
Processing
Distribution of tissue for human application (patient treatment)
Set standards across Europe for activities using human tissues and cells for human application to make sure that tissue is:
Safe and of high quality
Can be traced from donor to recipient
Can be moved more easily between European countries
New coding and Import Directives will come into force in the UK in 2018

6. 3) Quality and Safety of Organs Intended for Transplantation Regulations 2012
Standards are in force for the quality and safety of transplant organs across the UK under the EU Organ Donation Directive (EUODD)
The EUODD is a European requirement that aims to bring all EU countries up to the same high quality and safety standards
The EUODD applies to the :
donation
testing
Characterisation
Procurement
Preservation
transport
transplantation
of organs intended for transplantation (deceased and living organ donation)
Licensable activities must be under the authority of a Licence issued by the HTA (although its governance differs from other HTA licences)

7. 4)The Human Tissue Authority (HTA)
are the Competent Authority for human organs, tissues and cells;
whose powers come from these 3 pieces of legislation
HT Act 2004
Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q+S Regs 2007) - (EUTCD)
Quality and Safety of Organs Intended for Transplantation Regulations 2012 – (EUODD)
The HTA regulate and inspect across the following sectors:
Licence issuing (7 in total) Living Donor Transplants
Tissue for Human Application Approving solid organ donations
Research Approving bone marrow donations
Post Mortem
Anatomy
Public Display
Removal
Transplantation

8. How do the HTA regulate? They have 3 principle statutory functions:
Issue Codes of Practice (and standards)
Issue Licences and Inspect (audit for ODT) establishments
Approve solid organ and bone marrow donations from living donors
The HTA:
regulate activities (scheduled purposes) concerning the removal, storage and use of human tissue (relevant material)
The HTA work to 4 guiding principles:
Consent Emphasising that human tissue and organs will only be used in accordance with a person’s wishes
Dignity Making sure that human tissue and organs are treated with respect and that a person’s privacy is always maintained
Quality Guaranteeing that anyone working with human tissue and organs is doing so in a safe and well managed way
Honesty and openness Maintaining transparency and confidence in our regulation and between the public and our licensed establishments

9. HTA governance requirements for each licence:
Designated Individual (DI)
The person who is responsible for ensuring robust systems and processes are in place to ensure compliance with the relevant licence
Under whose supervision the licensed activity is conducted
There is one DI per licence
Licence Holder (LH)
Must have the consent of the DI for the application
Should preferably be a corporate body
The named representative must have direct contact to corporate body
Person (s) Designated (PD)
A person to whom the licence applies who must be named on the licence
Assists the DI in ensuring HTA compliance by directing others in their area of responsibility
They may have a ‘supervisory’ role at satellite sites
Named Contact (Organ Donation sector only)
A named contact for each clinical area of speciality

10. (PDs) Persons Designated
LTHT / UoL local governance arrangements
Other people working on licensed premises and carrying out licensed activities do so under the direction of the Designated Individual or a Person
Designated by the DI
Complete governance tables for all licenses are available on both the LTHT intranet and UoL website DI
Holds primary legal responsibility
There is one DI per license
(PDs) Persons Designated
Based in their own area and support the DI
Human Tissue Act Manager
Supports the DIs, PDs and other relevant staff

11. LTHT / UoL local communication arrangements
There are clear governance arrangements in place for staff to
ask questions / seek clarity on any HTA issues they may have. Staff should:
In the first instance, contact the Person(s) Designated (PD) for the relevant licence / area referred to (or the HTA Manager if you are unsure)
If the PD is unable to answer the query he/she will pass it on to either:
The Designated Individual (DI) for that licence OR
The HTA Manager (as appropriate)
If an answer can not be found internally, the DI (or HTA Manager) will contact the HTA via e mail and seek clarity
For further guidance please see the LTHT HTA intranet site or UoL R+I HTA internet pages

12. Codes Of Practice
These give guidance and lay down expected standards. There are 7 codes: (and an additional Code of Practice on the Human Transplantation (Wales) Act 2013)
Code A: Guiding principles and the fundamental
principle of consent  
Code B: Post-mortem examination
Code C: Anatomical examination
Code D: Public Display
Code E: Research
Code F: Donation of solid organs and tissue for transplantation
Code G: Donation of allogeneic bone marrow and peripheral blood
stem cells for transplantation
Other relevant HTA guidance documents for:
EUTCD – ‘Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment’ (12 November 2010 – revised June 2017)
EUODD - ‘The Quality and Safety of Organs Intended for Transplantation:
a documentary framework’ (July updated November 2016 )

13. Relevant Material
Defined as material that has come from a human body and consists of, or includes, human cells.
4 categories of relevant material:
Specifically identified relevant material
eg bone, skin, stem cells created inside the human body
ii. Processed material
eg Plastinated tissue and body parts (where the cellular structure is
retained by the plastination process)
iii. Bodily waste products
including excretions and secretions
Iv Cell deposits and tissue sections on microscope slides
as they will probably contain whole cells

14. Relevant Material There are some exclusions; eg:
hair and nail from living people
Live gametes and embryos
Extracted DNA
Cultured cells which have derived outside the human body
Note:
Some materials are not relevant under the HT Act but are under
the Q+S Regs, such as embryonic stem cells.
The HTA website provides a comprehensive list of relevant
material both under the HT Act and the Q+S Regs

15. Scheduled Purposes
The purposes for which consent are required are referred to as 'scheduled purposes‘
The consent required under the HT Act is called 'appropriate consent’ - consent from the appropriate person, as identified in the Act
Penalties of up to three years' imprisonment or a fine, or both, are provided in the Act as a deterrent to failing to obtain or to misusing consent.
The giving of consent is a positive, voluntary act. It should be a process and not a single action

16. Consent considerations
The following are amongst the issues integral to the consideration of consent. They will be explored further in later slides
Is consent required?
Is it appropriate consent?
Is it valid consent?
What is the Scope of the consent?
What is the duration of the consent?
Are processes in place for the possible withdrawal of consent?

17. Is consent required? Scheduled Purposes
Part 1: purposes generally requiring consent where the tissue is from the living or the deceased
Anatomical examination – requires witnessed consent in writing before death
Determining the cause of death – except where a post-mortem is ordered by a coroner
Establishing after a persons’ death the efficacy of any drug or other treatment administered to him – e.g. hospital post-mortem
Public display – requires witnessed consent in writing before death
Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person) – e.g. genetic information
Research in connection with disorders or the functioning of the human body
Transplantation - includes all bodily material such as blood, bone marrow, skin, tissue and organs

18. Is consent required? Scheduled Purposes
Part 2: purpose requiring consent where the tissue is from deceased persons
Clinical audit
Education or training relating to human health – including training in research techniques
Performance assessment – e.g. testing medical devices
Public health monitoring
Quality assurance

19. Appropriate Consent (the person who may give consent):
The person themselves (where possible)
Nominated Representative (if appointed)
Qualifying relationship
Spouse or partner (including civil or same sex partner)
Parent or child (a child, in this context can be any age)
Brother or sister
Grandparent or grandchild
Niece or nephew
Stepfather or stepmother
Half-brother or half-sister
Friend of long standing
Consent for children (under 18 for HTA purposes) or adults lacking the capacity to consent are not covered in detail here (refer to the HTA Code of Practice for Consent)

20. Valid Consent Scope of consent Duration of consent
Consent which is given voluntarily by an appropriately informed person, who has the capacity to agree to the activity in question.
Consent can be given in different ways and does not always need to be in writing
Scope of consent
Consent may differ in its scope as it may be generic (typically only applies to research) or specific.
For research purposes, it is good practice to obtain generic consent to avoid the need for further consent. It must still however be valid consent
Duration of consent
This may be enduring or time limiting
Withdrawal of consent
A person can also withdraw their consent at any time, whether generic or specific. Withdrawal should be discussed during the initial consenting process

21. Consent exceptions The Act provides a number of consent exceptions in order to store or use human tissue for scheduled purposes
Note: Although exempt from consent provisions in the HT Act, the licensing requirements may still apply where material is used / stored for a scheduled purpose
Existing holdings
Consent requirements of the HT Act are not retrospective.
Consent is not necessary for material that was held in storage for a scheduled purpose prior to the HT Act on 1st September 2006.
This, however, does not mean such tissues can be used freely without regard for consent or ethical considerations
The consent provisions of the HT Act do not apply to imported material. The HTA do consider it good practice however, to obtain assurance that valid consent has been sought

22. Consent exceptions Tissue from the living
Consent is not needed for the use of surplus or 'residual' tissue, from the living, left over from diagnostic or surgical procedures for the purposes set out in Part 2 of the scheduled purposes slide (eg public health monitoring)
Consent is not needed for the use of 'residual' tissue in research, provided that:
the research project has recognised* research ethics approval
the researcher cannot identify the tissue donor and is not likely to be able to do so in the future. (allows linking with medical records, provided patient-identifying information is not obtained)
* A University REC is not, for consent exemption purposes, a recognised REC.
A REC established and working by UK Health Depts. OR UKECA is a recognised committee

23. Consent exceptions Licensing exemptions
Tissue from the deceased
Consent is not required for a Coroner’s post mortem.
However, it is required for the continued use / storage of tissue, for a scheduled purpose, once the coroner’s purposes are completed
Licensing exemptions
Storage of material from the body of a deceased person: if at least 100 years has passed since the date of death
The licensing requirements for storage do not include storage which is incidental to transportation (no longer than one week)

24. recent HTA initiatives / advances
Review of Codes of Practice and Standards
The substantially updated Codes of Practice and Standards went live on 4th April 2017
This was the first major review which resulted in the removal from use of 2 codes altogether:
Import / Export of human bodies/body parts and tissue
Disposal of human tissue
Information from these codes has been subsumed into the remaining 7 new codes and standards
Further work is required for the Human Application standards review.
New public information
2017 saw the introduction of public guides to the HTA Codes of Practice

25. We do not hold a Public Display or Removal Licence
5) What licences do we have within LTHT / UoL
To comply with the HT Act and associated legislation, the LTHT and UoL chose
to work collaboratively and between them hold five of the seven HTA licences:
Anatomy covering specific premises at UoL for anatomical examination
Research covering specific premises at LTHT and UoL (mainly faculty of Medicine and Health but not exhaustive)
Human Application covering specific premises at LTHT
Post Mortem covering specific premises at LTHT for post
mortem activities
Note: licensed activities can only take place in the identified locations designated on
each licence and under the knowledge and approval of the DI. Any proposal to change
the location must be submitted in writing, by the DI, to the HTA and is subject to HTA
approval.
Transplant covering specific licensable activities within LTHT
We do not hold a Public Display or Removal Licence

26. This presentation is only a generic overview.
For further, licence specific info you should contact:
The PD for the relevant licence
The DI for the relevant licence
Debby Gibson
HTA Manager
LTHT / UoL
Tel: Mob:
E mail:

27. 6) Questions Thank you Useful websites:
Human Tissue Act
Human Tissue Authority
NHS Blood and Transplant
Department of Health
Health Research Authority
LTHT intranet A – Z index, H for Human Tissue Act
Research and Innovation (UoL)
Overall comments / suggestions: