In UK, the Human Tissue Act applies for Import/Export of human biological samples for research use.

However, it is good practices to apply Codes of Practice which provide most of requirements on this field.

• Human Tissue Act 2004 (HT Act)

The HT Act sets out a legal framework for regulating the storage and use of human organs, tissue and cells from the living, and the removal, storage and use of human organs, tissue and cells from the deceased, for specified health-related purposes including ‘research in connection with disorders or the functioning of the human body'.

The Human Tissue Act is the only binding text (Human Tissue Act (HT Act) 2004).

It notably provides:

“As long as the activities are lawful under the HT Act, consent is not required for:

A body that has been imported (s.1 (5) (a) of the HT Act)

“relevant material” that has been imported whether it comes from a living or dead person: (s.1 (6) (a) of the HT Act)

“relevant material” that has come from a body that has been imported (s.1 (6) (b) of the HT Act)

These exemptions from consent also apply to material or bodies where the person was dead before the Act comes into force or in cases where 100 years have lapsed since the person’s death. (s.1 (5) (b) and s.1 (6) (c) of the HT Act)

• Code of practice on the import and export of human bodies, body parts and tissue, HTA, 2007

The Human Tissue Authority (HTA) produced a Code of Practice on the import and export of human bodies, body parts and tissue. The Code provides guidance and practical steps for establishments (with or without a licence from HTA) that are involved in the import and export of human bodies, body parts or tissue.

Scope

“[...] This Code applies to the import and export of human bodies, body parts and tissue, including:

(i) Human bodies or body parts removed after death and

(ii) Tissue removed at biopsy and during surgery.

From the deceased, this includes material that is fresh, frozen, plastinated, dried, embalmed or preserved in some way.

From living people, this includes tissue for research (including paraffin blocks and slides).[...]”

“[...] The Code does not apply to whole bodies or parts of bodies that:

Fall outside the HT Act e.g. gametes and embryos created outside the human body, and material that does not contain cells;

Come under the jurisdiction of the Coroner in England, Wales and Northern Ireland;

Are being brought into, or removed from, England, Wales and Northern Ireland for lawful disposal here or abroad ;

Are historical human remains, or human remains incorporated into artefacts, which are more than 100 years old, and imported by museums;

Are from the living and only intended for diagnostic use.[...]”

See the “Summary of Import/Export requirements of HT Act 2004, applicable for England, Wales and Northern Ireland” produced by the Regulatory Support Centre of the medical research Council in consultation with the Human Tissue Authority.

• Human tissue and biological samples for use in research, operational and ethical guidelines, MRC, 2001.

Scope

“[...] this guidance applies to the use of samples of human biological material for research purposes. It is not intended to cover the use (or re-use) of human samples for clinical diagnostic purposes, clinical audit, disease surveillance or quality control of existing diagnostic testing procedures.

The principles in these guidelines must be applied to all new samples of human material obtained wholly or partly for use in medical research, whether to be used immediately or to be stored for future use.[...]”

• Nuffield Council on Bioethics, Report "Human bodies: donation for medicine and research", October 2011

Scope

This Report identifies and considers the ethical, legal and social implications of transactions involving human bodies and bodily material (organs, cells) in medical treatment and research. It also considers, with reference to different forms and purposes of donation or volunteering, what limits should be, if any, on the promotion of donation or volunteering, including consideration of:

a the role of payment and any other form of remuneration or exchange;
b the role of consent;
c the question of subsequent use, ownership and control of donated materials;
d the role of those acting as intermediaries between donors and recipients; and
e the cultural and international perspectives, including regulatory differences.

The issues related to the exchanges and "transactions" involving human bodily materials are tackled with regards to the several purposes for which they can be used.

 The English rules to export (updated on 2010-07-06)

DEFINITIONS

According to English Law, the following terms have specific meanings :

Import

Defined as import into England, Wales or Northern Ireland from a place outside England, Wales and Northern Ireland.

Export

Defined as export from England, Wales or Northern Ireland to a place outside England, Wales and Northern Ireland.

Relevant material

Material other than gametes, which consists of or includes human cells (inludes blood and tissue but does not include embryos or hair and nails from the living).Once DNA is isolated and extracted from the blood or tissue, it will be excluded from the definition because it does not “consist of or include human cells".

The actual export of relevant material is not considered a licensable activity.

PROCEDURE

According to the Code of practice on the import and export of human bodies, body parts and tissue, HTA, 2007

For establishments with and without an HTA licence:

Exported tissue should be procured, used, handled, stored, transported and disposed, in accordance with the consent which has been given, and with due regard for safety considerations and the dignity and respect accorded to human bodies, body parts and tissue.

“Human bodies, body parts and tissue to be exported from England, Wales and Northern Ireland should be used in accordance with the consent which has been obtained.” (Point 39 & 71of the HTA’s Code)

The recipient country is responsible for ensuring the material is handled appropriately and that the required standards of that country have been met.

For licensed establishments:

Service Level Agreements should be in place to ensure exported tissue is used in accordance with the consent given.

According to the import & export of human body parts and tissue for non- therapeutic uses, a code of practice, DH, 2003

Download the form for notification to HM Inspector of Anatomy of intention to import or export human body parts (Available at the end of the DH’s code of practice)

The form should be sent to:

HM Inspector of Anatomy,

Room 611, Wellington House,

135-155 Waterloo Road, London SE1 8UG

According to Medical Research Council Regulatory Support: "the HTA expects requirements applying to tissue imported from Scotland will be maintained at the level of the rest of the UK."

The UK Nuffield Council on Bioethics organised a public consultation on the theme "Give and take? Human bodies in medicine and research". This consultation was opened on the 20^th April of 2010 and closed in July 2010. The purpose of this consultation is to identify and define ethical questions raised by recent advances in biological and medical research in order to respond to, and to anticipate, public concern; to make arrangements for examining and reporting on such questions with a view to promoting public understanding and discussion; this may lead, where needed, to the formulation of new guidelines by the appropriate regulatory or other body. You can consult the consultation paper. A workshop has been held on this subject in Bristol on the 26^th of July 2010.

The Workshop’s report and the Council Recommendations based on the results of this public consultation will be published both in autumn 2011.