Applicable
regulatory provisions in France
Allograft
regulations
(updated March 1999)
Important texts pertaining to
tissue grafts, dominated by bio-ethical acts, have
emerged since 1994. They include general
principles, step monitoring and import product
supervision.
A. General principles
regarding human body products and elements used in
humans for therapeutic purposes.
1)Respect for the human
body :
Consent and free donation,
donor-recipient anonymity, no publicity around one
specific person.
2) Health safety rules
:
a) The health safety rules
(order dated October 9, 1997) are applicable to any
organ, bone marrow, tissue and cell removal, any
sampling of products with a view to using them or
their by-products for therapeutic purposes for
other people, including as part of biomedical
research, including in the event medical appliances
are used or for the purpose of preparing
pharmaceutical specialties (excluding gametes,
blood and its by-products, reactants).
These rule include
:
- mandatory donor personal
and family history investigation (including
spongiform sub-acute encephalopathy
- the performance of medical
biology analyses to search for HIV 1 and 2, HTLV 1
hepatitis B and C and syphilis infections. No
therapeutic use is allowed in the event of
transmission (exceptions are possible in vital
emergency cases, in the absence of any therapeutic
alternative, and subject to informing the recipient
for heart, liver, lung, marrow transplants) (order
dated October 9, 1997).
- further analysis are
mandatory only in the event of organ, bone marrow
or cell samples with a view to looking for
cytomegalovirus, Epstein-Barr virus or
toxoplasmosis infections (if positive, the doctor
appreciates the benefit/risk ratio for each
patient) ;
b) The order dated July 24,
1996 specified the tests to be carried out for
biologic marker detection.
c) The transmission methods
for required data for human body product and
element monitoring and traceability (order dated
October 9, 1997 and order dated October 9, 1995)
provide for obligations relating to transplant
documentation and labeling.
d)The use of some human
tissues is prohibited : dura mater, tympanum and
petrosal bone, ossicles except if taken through the
external auditory canal.
3) Etablissement
français des Greffes, established in 1994
(EFG)
National public institution,
reporting to the Health Ministry.
B. Tissue sampling
:
1) Sampling on a living
person for the purpose of donations
:
These can be carried out with
a scientific or therapeutic purpose, provided the
donor is an adult and legally responsible, and in
previously mentioned ethics and safety conditions.
Practically, this type of sampling mainly involves
organ and cell samplings..
2) Tissue sampling on dead
bodies :
- This can be done provided
the person did not express its refusal of such a
sampling in its lifetime. Such refusal can be
expressed by specifying its will in a national
automated register (order dated May 30, 1997). If
the doctor is not directly aware of the deceased's
will, he should attempt to find out from the
family.
- Tissue cannot be sampled if
the donor is under mechanical ventilation
assistance and retains an hemodynamic function
(order dated February 25, 1992, amended by the
order dated May 24, 1994). Only the cornea,
cortical bone and skin can be sampled if those
conditions are not fulfill.
- Order n° 96-1041 dated
December 2, 1996, provides form death recording
methods prior to sampling.
- Institutions and
organizations carrying out samplings should be
authorized to do so, under the conditions specified
in the order dated April 1, 1997, depending on
technical, sanitary and medical
conditions.
- Good practice rules
relating to the sampling of human body tissue used
for therapeutic purposes were prepared by the
Etablissement Français des Greffes and
approved in an order of the Health Ministry dated
April 1, 1997. These rules cover personnel,
premises and equipment condition, donor selection
procedure, sampling procedures, packaging and
transport to tissue banks and
documentation.
3) Specific case of tissue
sampled during a medical operation, and kept for
later use :
The only applicable rules are
the general ethics rules regarding donation
gratuity, donor-recipient anonymity, absence of
publicity for one specific person, health safety
rules, and rules relating to conservation and
distribution.
The good sampling practice
rules (order dated April 1, 1997) also cover the
sampling of operation residues.
C. Tissue processing,
storage, distribution and transfer :
1) Bank authorization
system :
This activity may only be
carried out by public health institutions and
non-profit organizations authorized to such effect.
However, the permit can be granted to other
organizations, for activities requiring high
technology, as listed in an order.
Permits are issued subject to
technical, sanitary or medical conditions, and as
needed, financial conditions as well as conditions
ensuring an operation in accordance with the
general principles contained in an order issued by
the State Council.
2) Good practice rules
:
Good practice rules relating
to the storage, processing and transport of human
tissue used for therapeutic purposes were prepared
by the Etablissement Français des Greffes
and approved in an order issued by the Health
ministry on December 29, 1998. They include general
provisions regarding tissue banks (bank structure,
personnel, premises, equipment, products and
ingredients, documentation and information system,
activity safety) and technical rues regarding the
various storage, processing and transport
steps).
3) process permit system
(July 1, 1998 Act) :
Tissue and cell preparation,
storage and processing processes that are not
intended for cell or gene therapies used for a
therapeutic use of such tissues or cells by
approved institutions or organizations are subject
to prior authorization by the AFSSAPS under terms
defined in a Sate Council order.
The list of tissues and
cells, and as needed of respective processes, is
set in an order of the Health Minister.
4) Inspection
:
Approved civil servants (Act
n° 95 116 dated 4/2/95) inspect the compliance
of the organization, and have access to the
professional premises.
D. Specific importation
cases :
Authorized tissue banks may
also be allowed to import or export human tissue
used for a therapeutic purpose (order n° 96
327 dated April 16, 1996) ; pending the order
setting bank authorization conditions, the
importation or exportation business can be
continued, subject to a statement to the ministry.
From now on, authorizations are issued by AFSSAPS
(Act dated July 1, 1998 amending article 18 of the
law dated December 31, 1992). The grafts should
meet the above-described ethical and sanitary
requirements.
E. Use of tissues
:
1) Tissue grafting can
only be carried out in health
institutions.
2) Interministerial health
service prices (TIPS) (applicable to private
health institutions).
Only human body by-product
grafts or human body tissue grafts, in accordance
with applicable laws and regulations, with an
approval number issued by the expert group on
microbiology safety and listed in the nomenclature
should be taken (order dated 16/1/96).
Bibliography :
Article 56 of law 94-43 dated
18/1/94 establishing the Etablissement
Français des Greffes.
-Order dated May 24, 1994,
relating to the prevention of the transmission of
some infectious diseases, amending the order dated
February 25, 1992.
- Bioethical Acts dated July
29, 1994, including two texts
- Act n° 94 -653 dated
July 29, 1994, relating to respect for the human
body
- Act n° 94 - 654 dated
July 29, 1994, relating to the donations and use of
human body elements and products, medical
procreation assistance and pre-natal
diagnosis.
- Order n° 94 - 870
dated October 10, 1994, relating to the
Etablissement Français des
Greffes
- Order dated October 7,
1994, relating to the temporary human dura mater
suspension procedure considering the potential
Creutzfeldt Jakob Disease risk, renewed by the
order dated October 25, 1995, and renewed in a
final manner by the order dated October 16,
1996.
- Act n° 95 116 dated
February 4, 1995, article 30 relating to allograft
bank inspection conditions.
- Order dated October 9,
1995, setting terms for the transmission of
required data for the monitoring and tracability of
human body elements and products used for
therapeutic purposes.
- Order dated 26/1/1996
amending title III of the TIPS relating to
transplant medical appliances, transplants based on
or including human by-products and human tissue
grafts.
- Order n° 96 327 dated
April 16, 1996, relating to the importation and
exportation of human organs, tissue and
cells.
- Order dated July 24, 1996,
relating to the nature of tests to be carried out
for biologic infection marker detection by the HIV
1 and 2 virus and the hepatitis C virus.
- Order n° 96 1041 dated
December 2, 1996 elating to the recording of death
prior to the sampling of organs, tissue and cells
for therapeutic or scientific purposes.
- Order dated January 24,
1997, prohibiting the processing, importation,
exportation, distribution, transfer and use for
therapeutic ends, ordering the removal of human
hypophyses, tympana and petrosal bones, and
prohibiting the use for therapeutic ends of human
ossicles.
- Order 97 306 dated April 1,
1997, relating to the authorization of health
institutions carrying out organ and tissue
samplings for therapeutic purposes, amending the
public health code.
- Order dated April 1, 1997
approving the good practice rules relating to the
sampling of human tissue and collection of
operation residues from human bodies used for
therapeutic ends.
- Order 97 104 dated May 30,
1997, relating to the national automated refusal
register for organ, tissue and cell samplings from
deceased people.
- order n° 97 928 dated
October 9, 1997, relating to the sanitary safety
rules applicable to any sampling of elements or
collection of products from the human body and the
use thereof for therapeutic ends, except for
gametes, blood and its components and by-products,
as well as reactants, in pursuance of articles L
665 10 and L 665 15 of the public health code and
amending the same.
- Order dated July 2, 1998,
relating to the implementation date of the national
automated refusal register for organ, tissue and
cell samplings from deceased people.
- Order dated December 29,
1998, approving good practice rules relating to the
storage, processing and transport of human tissue
used for therapeutic purposes.
- Act n° 98 535 dated
July 1, 1998, relating to the reinforcement of the
sanitary watch and of the sanitary safety control
for products intended for humans.
- Article 18 of Act n°
92 1477 dated December 31, 1992, relating to
products subjected to some transport restrictions,
amended by article 19 of Act 98 535 dated July 1,
1998 relating to the reinforcement of sanitary
safety.
Legal
provisions
Regulatory context of bone
substitutes …
History
Since 1993, our health system
has increased its watch, including under an order
dated 28 April 1994 creating a group of medical
device, product and processes microbiology safety
experts : that group was in charge of providing its
opinion on microbiology hazards &endash; and
reported to the General Health Department. In
addition, an order specified that, to be listed on
the reimbursable service and product list as
mentioned in article L 165-1 of the Social Security
Code, medical devices were to be issued a
time-limited approval that was to be published in
the Journal Officiel de la République
Française.
Now,
The group of microbiology
safety experts has been replaced with the Viral
safety Committee, headquartered at the Afssaps ,
with the same functions,
.The medical device listing
procedure has changed and involves two
organisations :
- the CEPS : Comité
Economique des Produits de Santé &endash;
Medical Device Department at the Ministry of
Employment and Solidarity,
- the AFSSAPS : Agence
Française de Sécurité
Sanitaire des Dispositifs
Médicaux
Under the above regulatory
provisions,
The EUROCER range has the EC
marking issued by the Organisme Notifié
français G MED.
Index
- Eurocer
400
- Eurocer
200 +
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