Tue, 01 Sep 2015
The Human Tissue Act 2004 (HT Act) replaces the Human Tissue Act (1961), Anatomy Act (1984) and the Human Organ Transplants Act (1989), and came into force on 7 April 2006.
Briefly the collection, removal, storage and use of human tissue (defined as material that has come from a human body and consists of, or includes, human cells) is governed by the provisions of the HTA 2004; the Act creates a range of offences for removing, storing or using human tissue for purposes without appropriate consent. Under the Act the Human Tissue Authority (“HTA”) was set up to regulate activities concerning the removal, storage, use and disposal of human tissue; the HTA has in turn published Codes of Good Practice.
The HTA is also the Competent Authority in the UK for the implementation of the European Union Directive 2010/53/EU on the standards of quality and safety of human organs intended for transplantation (the Directive). The requirements of the Directive are transposed into UK law via the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (Q and S Organs Regulations).
On 1 December 2015 an opt-out system for organ donation after death will become operational in Wales, the legislation on this is the Human Transplantation (Wales) Act 2013. The HTA has drafted a Code of Practice to provide advice and guidance on the Human Transplantation (Wales) Act.
The HT Act and the HTA's codes of practice require that consent is required to: store and use dead bodies; remove, store and use relevant material from a dead body; store and use relevant material from the living.
Anyone removing, storing or using material in circumstances for which the HT Act requires consent must be satisfied that consent is in place.
In the absence of requisite consent, the removal, testing, or storing of human tissue would be a criminal offence (section 5). As the HTA Code of Practice [1] makes clear:
“If there is no-one available in a qualifying relationship to make a decision on consent (and consent had not been indicated by the deceased person or nominated representative), it is not lawful to proceed with removal, storage or use of the deceased person's body or tissue for scheduled purposes”.
The sources of appropriate consent (in relation to the removal, storage or use of relevant human tissue of deceased adults) are set out in Section 3 of the 2004 Act.
Where the person from whom the human tissue or blood is to be removed has died, 'appropriate consent' means:
i) his (or her) consent (if the consent was in force immediately before he/she died);
ii) if (i) does not apply, a person appointed to deal with the issue of consent in relation to the specific activity;
iii) if neither (i) nor (ii) apply, the consent of a person who stood in a qualifying relationship to him/her immediately before he/she died.
The Coroner has power to remove, store, and use human tissue and blood, for any purpose associated with his functions as, or under the authority of, a Coroner (Section 11(1) of the 2004 Act). The HTA Code of Practice provides:
“A PM examination and the removal and storage of relevant material to determine the cause of death do not require consent from the relatives if these activities have been authorised by the coroner. However, following the cessation of the coroner's authority, it is unlawful to use the retained material for a scheduled purpose set out in the HT Act, or to continue to store it with the intention of issuing it for a scheduled purpose, without appropriate consent.”
Before deciding whether to proceed with the removal, storage or use of tissue for scheduled purposes, the following should be considered: 1. Does the activity require consent? For tissue from the deceased, consent is required for all scheduled purposes. Consent is not required under the HT Act for storage and use of tissue from the living in some circumstances 2. Who may give consent? 3. Has sufficient written or verbal information been provided for the person giving consent to make a properly considered decision? 4. How will the consent be given and recorded? 5. When is written consent required? 6. Is consent needed for more than one purpose? 11 7. If a child is involved, are they competent to consent and have they expressed particular wishes or views? 8. If an adult lacks capacity to consent, how should the provisions of the MC Act be applied? 9. What are the exceptions to the consent provisions of the HT Act? 10.Is DNA analysis likely to be involved? 11.What are the consent implications for fetal tissue?
The effect of Section 11 of the 2004 Act and the Code above is that:
i) A Coroner may remove, store and use relevant material for the purpose of the post mortem examination to determine the cause of death without obtaining the consent of relatives;
ii) A Coroner does not have the power to consent to samples being taken for the benefit of a third party;
iii) A Coroner's consent is required before any sample can be removed, stored or used for purposes other than in the exercise of his own functions or authority.
If the organ or part of the body of the deceased is retained for further examination then the Code of Practice should be considered. The Code provides that if a deceased person has been the subject of a post mortem examination, tissue may have been retained. This tissue should be handled in accordance with any reasonable wishes expressed by the deceased person or their relatives, as long as the method of disposal is legal. The police may retain body parts under their general powers set out in PACE 1984 in the furtherance of a criminal investigation.
In Arkestov –v-Russia App No 22089/07 the applicants alleged that the circumstances of identification of their deceased family members had been inhuman and degrading and that the decision not to return the bodies of these persons to their families had been unlawful and disproportionate, in breach of Articles 3, 8 and 9, taken alone and in conjunction with Articles 13 and 14 of the Convention. According to the applicants the bodies, for several days were kept in the town morgue and other locations in wholly unsatisfactory conditions.
The Court held that the suffering applicants or the other applicants who were simply aware of the difficult conditions of storage of the dead bodies of their relatives did not amount to a breach of article 3.
In relation to article 8 the Court found the interference with the applicants’ Article 8 rights was particularly severe in that it completely precluded them from any participation in the relevant funeral ceremonies and involved a ban on the disclosure of the location of the grave, thus permanently cutting the links between the applicants and the location of the deceased’s remains.
From this case it would appear that if the authorities retained body parts unlawfully and failed to return them to the deceased’s relatives diligently or at all then there might be a case for interference with article 8.
The Court did not have to consider article 9 ECHR.
The Code does refer to religious practices:-
Attitudes towards the use of tissue and especially towards post mortems may vary widely among cultures and religions. All healthcare professionals should be sensitive to this. However, each case and decision is an individual and personal one, and should be treated as such. Trusts and other establishments should ensure that their employees are given the necessary training and support to help them identify and meet the widest possible range of needs and wishes.
In the case of CM v EJ's Executor [2013] EWHC 1680 (Fam) [2013] 2 F.L.R. 1410 the applicant doctor applied for declarations that samples could lawfully be taken from the body of a deceased person and tested for communicable diseases. While off duty, the doctor had attempted to save the deceased’s life after she had fallen from a building. In the course of her efforts, her hands were covered in the deceased's blood. She later noticed that she had abrasions to her hands. Anxious about the risk of being infected with a blood-borne disease, the doctor began a course of antiretroviral medication, which had severe side effects. The doctor sought to obtain samples from the deceased’s body to determine whether she had been infected with such a disease. The coroner with custody of the body gave consent subject to the doctor having appropriate authorisation. The police traced a family member, the deceased’s mother's cousin (P), who stated that the deceased’s parents lived abroad and did not yet know of her death. The Court granted the doctor the declaration she sought under its inherent jurisdiction.
Care should be taken regarding the possible disclosure of information, such as genetic information or HIV status, which the deceased person may not have wished to be disclosed, or which may have significant implications for other family members. Healthcare professionals will have to make a decision based on the individual circumstances of each case about whether it is appropriate or not to disclose information about the deceased's medical history, as well as any other sensitive information that the Trust may hold (about the deceased), that the family may not necessarily be aware of. In making decisions, healthcare professionals will have to have regard to their duty of patient confidentiality and may have to consider the provisions of the Data Protection Act 1998.
There is specific guidance given in the Code in relation to DNA:
If consent under the HT Act has been given for material to be used for a scheduled purpose, it is not necessary to seek separate consent where that use involves use of the results of DNA analysis, but it should be made clear to the donor that their bodily material may be used in this way. When discussing consent, the donor should be made aware if the intended DNA analysis may reveal significant results e.g. a family genetic condition. Where this applies, their decision on whether they wish such information to be made known to them should be respected.
Article written by Ramby de Mello.
