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New
europe-wide law to regulate tissue implants
A
EUROPE-wide law may soon regulate the harvesting, testing and transplant
of tissue, including eye tissue.
Under a new proposal by the European Commission, the European Union's
executive body, the EU's 15 member states would introduce comprehensive
standards to ensure the safety of tissue donations, the quality
of tissue banks and the traceability of tissue.
Quality and Safety
"In order to increase public confidence in the use of human
tissues and cells for application in the human body, it is essential,
therefore, that EU provisions should ensure their quality and safety,"
the Commission proposal, published this summer, outlined.
It added: "Increased therapeutic use of substances of human
origin and the recognition that they can transmit diseases have
led to extensive discussion not only on the need for increased safety
measures but also on the associated ethical issues."
To become law, the directive will require the approval of the European
Parliament, which represents EU citizens directly, and the European
Council of Ministers, which represents the governments of the 15
EU countries. Debate on the provisions of the proposed tissue directive
will occur over the coming months.
Regulate every step
Under the proposal, formally entitled "Directive on Setting
Standards of Quality and Safety for the Donation, Procurement, Testing,
Processing, Storage and Distribution of Human Tissues and Cells",
each EU country will be required to establish a national authority
to oversee and regulate every step of the tissue donation process.
The tissue directive, which the Commission wrote after consulting
with such groups as the European Eye Bank Association and European
Association of Tissue Banks, would assign to each national authority
the responsibility to inspect, supervise and even accredit tissue
banks. Unaccredited tissue banks would be prohibited. Tissue banks
will play a central role in co-ordinating donations from within
and outside the EU according to the new directive.
In particular, it would appear from the wording of the proposed
directive that ophthalmologists will be prohibited from importing
eye tissue directly from outside the EU; instead, they will have
to import the tissue through an accredited EU eye bank from a country
whose tissue donation standards conform to those of the European
Union.
Although the directive represents the most comprehensive tissue
law of its kind, it will not affect human organs or tissues, or
organs or cells of animal origin.
According to the European Commission, the transplantation of human
organs "requires a different policy approach due to their specific
nature and the severe shortages that result in many patients going
untreated".
Regulatory problems
Also organs, tissues and cells of animal origin for human therapy
"pose different regulatory problems that will need to be addressed
in due course", according to the Commission.
The directive will also not affect the donation or transfusion of
blood and blood products; they are already regulated under EU law.
Although the proposed tissue directive will apply to tissue transplants
performed as part of a clinical trial, the directive will not affect
"research using human tissues and cells when used for purposes
other than application to the human body", including in vitro
research and research involving animal models.
According to the Commission, the directive will also apply to germ
cells, foetal cells and tissues and embryonic stem cells.
Although the use of such tissues poses particular ethical concerns
in a number of EU countries, the actual use of such cells in transplantation
will ultimately be determined by individual EU countries and not
the EU as a whole.
In other words, if a country approves of the use of such cells and
tissues, the provision of the directive will apply. If a country
prohibits the use of such cells, the directive will not legalise
their use.
Promote - not pay
The directive calls upon every EU country to "encourage voluntary
and unpaid donations of tissues and cells with a view to ensuring
they are in so far as possible provided from such donations".
Although the directive does not appear to prohibit the sale of human
tissue, it does prohibit any advertising of such sale of tissue
"Advertising the need for, or availability of, human tissues
and cells, with a view to offering or seeking financial gain or
comparable advantage shall be prohibited," the directive reads.
In addition, it calls upon EU countries to undertake any necessary
steps to "encourage that the procurement of tissues and cells
is carried out on a non-profit basis".
The provisions of the tissue directive forbid the harvesting of
tissue until the harvesting physicians comply with their own national
laws in obtaining the consent of the relatives of the deceased.
In addition, the directive requires that tissue harvesters explain
to the relatives of the deceased any results from tissue evaluation
"when these results have relevance for their health or for
public health".
The directive specifically prohibits cadaver donations in a number
of situations where the cause of death is unknown or where there
is a risk of the spread of infection or disease.
It also mandates a physical examination of the body before donation
to exclude donors with vessel punctures, tattoos or body piercing.
Traceability required
Under the directive, EU countries will be required to ensure that
"all tissues and cells procured, processed, stored and distributed
on their territory can be traced from the donor to recipient and
vice versa".
As part of the traceability programme, each donation and its products
will receive a unique identification code which will be written
on any packaging containing the tissue.
Also, the physicians who harvest the tissue will create a dossier
to accompany each piece of tissue and product to its recipient.
In addition to the dossier for each piece of tissue, the directive
will require tissue banks to maintain a detailed register of all
donations it processes.
Donation excluded when cause of death is unknown
Under
the tissue directive, donations will be excluded whenever a donor
dies of an unknown cause or in circumstances that could place the
tissue recipient at risk from disease or infection.
Such circumstances include:
When deceased ingested or was exposed to a toxic substance that
may be transmitted in a toxic dose to the tissue recipients.
When the donor has died with most cancers. However, the directive
makes a special exception for cornea donations: " with malignant
diseases could be evaluated and considered for cornea donation,
except those with retinoblastoma, melanoma of the anterior pole,
haematological neoplasm, and malignant tumours that could affect
the anterior pole of the eye."
When the donor may have contracted a prion-caused disease, including
confirmed and suspected cases of Creutzfeldt-Jakob Disease (CJD),
and non-variant CJD, the human form of bovine spongiform encephalopathy
or so-called "mad cow disease".
When the donor had a history of rapid progressive dementia or degenerative
neurological diseases of unknown origin.
When the donor had received pituitary gland-derived human growth
hormones or dura matter.
When the donor died with an uncontrolled infection.
When the donor had a history, clinical evidence, or confirmed positive
laboratory tests of HIV infection, acute or chronic hepatitis B
or hepatitis C infection.
When the donor had a history of chronic haemodialysis.
Dossier for all tissue
Under
the proposed human tissue directive any doctor who harvests tissue
will be required to create a dossier to accompany the tissue.
The dossier will contain:
Donor identification
The consent form from the relatives of the deceased
Clinical data of donor
Date and starting and ending time of procurement of tissue
Laboratory test results
Autopsy results, if any
Also under the directive, such dossiers must be "legible and
permanent and shall be in compliance with data protection legislation".
In addition, the clinical records of the donor must be kept for
at least 30 years.
Tissue banks will maintain tissue registers
Under
the proposed human tissue directive, every tissue bank will be required
to keep a register to which it will enter information about any
tissue it has processed.
The register will record:
Details of the consent to the donation
Donor identification and characteristics: type of donor, age, sex,
cause of death and presence of risk factors
Review of clinical data against donor selection criteria
Results of physical examination, laboratory tests and other tests
(autopsy report where one was conducted)
Date and time of the death
Date and time of the procurement and health care establishment where
the procurement is carried out
Conditions under which the cadaver is kept: refrigerated (or not),
time of start of refrigeration and time of transfer to procurement
site
Place of procurement, procurement team and person in charge of procurement
Degree of asepsis
Details of the preservation solutions used during procurement, including
composition, lot, date of expiry, temperature, amount, concentration
and preparation method
Grafts obtained and relevant characteristics
Relevant incidents that have occurred before, during, and after
procurement
Destination of the cells/tissues procured
Method of preservation until arrival of tissues or cells at the
bank
In
the case of cellular cultures, it will also be necessary to document:
Characteristics of the lesion to be treated
Medicinal allergies of the recipient
If you have any suggestions for future Regulatory Matters columns,
please contact Paul McGinn at +353 1 628 9747 or email paulrmcginn@eircom.net.
If you would like to read previous "Regulatory
Matters" columns, check
out the archive.
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