Keywords: Genetic Testing, Genetic Screening, Newborn-Screening, Newborn-Profiling,
Gene Therapy, DNA-Profiling, Genetic Privacy, Genetic Research
Over the course of 2008, the CNECV drew up and concluded the following opinions:
Opinion on the Draft Bill on the Legal Regime of Quality and Safety relating to the
Donation, Procurement, Testing, Processing, Preservation, Storage, Distribution and
Application of Tissues and Cells of Human Origin - 55/CNECV/2008 (12th February, 2008)
In 2007, the Bureau of the Minister of Health and the Authority for Blood and Transplant
Services (ASST) asked for the opinion of the CNECV on the preliminary draft of a decree law
which transposes to the Portuguese legal system community Directives 2004/23/CE, 2006/17/CE
and 2006/86/CE, which deal, respectively, with the questions relating to “the donation,
procurement, testing, processing, preservation, storage and distribution of tissues and sells of
human origin”, and “the traceability, notification of adverse events and technical requirements for
the coding, processing, preservation, storage and distribution of tissues and cells of human
In Portugal, many of the ethical and juridical principles applicable have already been duly defined
in Law no. 12/2005 of 26th January (Personal genetic information and health information). These
principles are stated in opinion 43/CNECV/2004.
Following Opinion no.54/CNECV/2007 on this subject, the draft bill was reformulated. When the
new document was submitted to the opinion of the CNECV, the comments and recommendations
relating to aspects which had previously been analysed by the CNECV were found to have been
Opinion on Direct Marketing of Genetic Tests to the Public - 56/CNECV/2008 (8th July,
The reflection of the National CNECV on direct selling of genetic tests to the public, by the
Council’s own initiative, was brought about by the growing marketing of this type of tests and,
namely, it’s direct to consumer selling by public and private entities, without medical prescription
and without genetic counselling.
Regarding the direct marketing of genetic tests to the public, the Council considered that those
tests may induce false needs, create undue expectations and bypass the need for medical
indication, and, thus, jeopardises the right to genetic counselling and information for patients and
the general public, and overloads the health system.
When non-medical applications of genetic tests are directly marketed to the public, transparency,
fair advertising and quality assurance should also be required.
Health-related genetic tests for diagnostic or predictive purposes should not be made available for
direct marketing to the public, in respect for the fundamental ethical principles.
Both opinions as well as all the work performed by the Council can be consulted on
UNDERGOING WORK – Bureau of the Minister of Health
Revision of the National Programme for Palliative Care for 2008/2016
Regulation of Law no. 12/2005 of 26th January (Personal genetic information and health
Romania is working on the dissemination of bioethics and introduced bioethics as a mandatory
discipline in all the faculties of medicine. There is also now a two weeks module of bioethics that
is mandatory during the residency training in all the medical specialities. A new centre of studies
in bioethics has been created last year.
The Additional Protocol to the Convention on Human Rights and Biomedicine concerning
Genetic Testing for Health Purposes has been translated and published in the Romanian Journal
of Bioethics to introduce a debate on this subject and hopefully there will be ratification.
A legislative debate on genetic modified organisms is also engaged.
Norwegian regulation related to pre-implantation and prenatal screening, embryonic stem
cells, cloning etc
In the following we update information as requested in the meeting report under chapter V nr 31
and chapter VII nr 50.
These issues are regulated under the Act relating to the application of biotechnology in human
medicine etc (Biotechnology Act). Some of the relevant passages of the Act are cited.
Pre-implantation genetic diagnosis (PGD)
PGD under certain conditions has been allowed since the first Act on Biotechnology was
established in 1994. In practise, however, the former prohibition of research on human embryonic
cells, and the fact that PGD was considered to be experimental, prevented use of the method. A
change in the Act that entered into force January 1st 2004 allowed PGD in individual cases, for
serious hereditary diseases for which no treatment is available. A special board appointed by the
Government had the authority to grant such permission. The Act was changed again in June 2004,
also accepting HLA antigen testing in combination with PGD under certain circumstances, but
not testing for HLA alone.
A change in the Biotechnology Act that entered into force January 1st 2008 has established PGD
as a treatment that can be offered if the mother and/or father carry a genetic predisposition for a
serious monogenic or chromosomal disease, and there is a high risk that the child may be
affected. Under certain circumstances, additional HLA testing in order to both prevent an
inheritable disease and provide a stem cell donor for an already affected sibling can be performed,
but only if stem cell donation has a high probability of curing the sibling.
A new board appointed by the Government has been given the authority to grant permission, but
only after thorough evaluation of each individual case.
Prenatal diagnosis (PND)
The use of PND in Norway is restricted, and can offered in the following situations:
- when the pregnant woman will be 38 years or older at the expected term/time of birth
- if the pregnant woman or the (genetic) father of the child previously has experienced that
their fetus or child had/has a serious disease or anomaly
- if there is a high risk that the fetus/child will be affected by a serious disease, and the
condition can be revealed by PND
- if the pregnant woman use medicines that may harm the fetus
- if ultrasound examination revealed signs of anomaly in the fetus
- in special situations, if the pregnant woman is in a difficult situation and will not be able to
take care of a child with a serious disease or anomaly
Some of the relevant passages of the Act are cited below.
Chapter 4.Prenatal diagnosis
§ 4-1. Definition
For the purpose of this Act, prenatal diagnosis means the examination of fetal cells, a fetus or a
pregnant women to obtain information about the genetic constitution of the fetus or to detect or
exclude a disease or abnormality of the fetus.
Ultrasound examination that forms part of the ordinary health care offered during pregnancy is
not considered to be prenatal diagnosis pursuant to the first paragraph, and therefore does not
come within the scope of this Act, with the exception of section 4-5.
§ 4-3. Consent
Before prenatal diagnosis, cf. section 4-1, is undertaken, written consent shall be obtained from
the person who is to be examined.
§ 4-4. Information and genetic counselling
Before prenatal diagnosis is undertaken, the woman or couple shall be given information on the
procedure, including the fact that it is voluntary, the risk associated with carrying out the
procedure, what the procedure may reveal and the consequences this may have for the child, the
woman, the couple and the family. If there are grounds to suspect a genetic disease, the woman or
couple shall also be given genetic counselling.
If the procedure indicates a disease or abnormality of the fetus, the woman or the couple shall be
given information and genetic counselling on the disease or abnormality in question, and on their
rights and the support that is available.
§ 4-5. Information on the sex of the fetus before the 12th week of pregnancy
Information on the sex of the fetus before the 12th week of pregnancy resulting from prenatal
diagnosis or other examination of the fetus shall only be given if the woman is a carrier of a
serious sex-linked disease.
Use of embryonic stem cells
A change in the Biotechnology Act that entered into force 1st of January 2008 allows research on
surplus human embryos and human embryonic stem cells originating from surplus embryos if the
following conditions are met
- the purpose of the research is to develop and improve methods and techniques used in
relation to medically assisted procreation or PGD, or to provide new knowledge that may
contribute to develop treatment for serious diseases in humans
- the research has been approved by a regional committee for research ethics. In cases where
human embryonic stem cells /cell lines are used in clinical trials or medical treatment, and
additional approval from the Ministry of Health will be required.
- an informed consent has been obtained from the couple donating the embryo. If the embryo
has been created from donor sperm, consent from the donor is also required.
Embryos can be used for research until 14 days after creation, and should then be destroyed. Cell
lines can be grown for a longer period of time.
Reproductive cloning and therapeutic cloning is forbidden.
The relevant passages of the Act are cited below:
§ 3-5 Prohibition against creating human embryos by cloning, etc.
It is prohibited:
a) to create human embryos by cloning,
b) to carry out research on cell lines derived from human embryos by cloning,
c) to create embryos by cloning by the technique of inserting human genetic material into an
Cloning is here understood to mean techniques for creating copies that are genetically identical.
§ 3-6 Prohibition against techniques designed to create genetically identical
The use of techniques designed to create genetically identical individuals is prohibited.
Medically assisted procreation (MAP)
As reported orally, there has been a debate on whether to offer MAP to lesbian couples. This has
now been approved by the parliament, and will enter into force from January 1 st 2009.
The conditions are similar as for heterosexual couples, namely that they are living together in a
stable relationship (or marriage), that the donor identity can be revealed to the child when the
child reach the age of 18, that they both give written consent to the treatment etc.
Some of the relevant passages concerning sperm donation are cited below.
§ 2-7. The child’s right to information on the sperm donor
Any person who is born as a result of medically assisted reproduction using donated sperm has a
right to information on the sperm donor’s identity at the age of 18. A donor register shall assist
the child in this matter.
§ 2-8. Donor register
The Ministry shall establish a register for registration of the identity of sperm donors, so that
children can exercise their rights pursuant to section 2-7.
§ 2-9. Sperm donors
A sperm donor shall have reached the legal age of majority. The donor must give written consent
for the sperm to be used for fertilisation and for his identity to be recorded in the donor register.
Consent may be withdrawn until fertilisation has taken place.
A sperm donor shall not be given information on the couple’s or the child’s identity.
Period October 2006 to November 2007
Preimplantation genetic diagnostic (PGD) for diseases appearing late in life
The Israel National Bioethics Council was asked by the Ministry of Health to give an opinion
about the use of preimplantation (pregestional) test of IVF embryos for the diagnostic of genetic
conditions that cause or predispose to diseases appearing in adult life and late life. Whereas the
use of PGD for diseases that appear in newborns and infants, is permitted under Israeli
regulations, there are ethical questions related to embryo selection by PGD when the disease
appears only after a relatively long period of healthy life, as is for example the case for some
cancer genes (e.g. BRCA genes). Arguments against this use of PGD include the possibility that
a cure may be found before the onset of the disease, that there is no certainty that the disease
will appear or will not be diagnosed in time to be able to cure it, and in general that events in life
are unpredictable (including the possibility of great personal achievements before the onset of the
disease). However, a real suspicion that the offspring will have at midlife, and with high
probability, a severe disease that will cause premature death, causes very high anxiety in
particular for mothers in families prone to grave genetic diseases or familial cancers.. In these
situations, there is no clear difference between PGD for early or late appearing lethal or severe
diseases since the distress to the mother is the basic ethical justification for pregnancy
interruption and for PGD. It was, therefore, decided that after a comprehensive genetic
counseling, the request for PGD should be authorized for known genetic conditions associated
with a high probability of late-appearing disease. A list of late-appearing genetic conditions for
which PGD is authorized was established (the present list includes eight neuromuscular
degenerative dystrophies, eight types of familial cancer predisposition and two types of
cardiomyopathies). The list can be updated periodically. In addition, there will be a case-by-case
review by a local hospital board, to ascertain the genetic, familial and psychological data justifying
the application of PGD in these cases.
UNITED STATES OF AMERICA (2007)
Genetic Information Nondiscrimination
On April 25, 2007, the U.S. House of Representatives passed, by a 420-3 vote, the Genetic
Information Nondiscrimination Act of 2007 (H.R. 493). The bill is now awaiting action in the
Senate, which passed a similar bill in 2005 by a vote of 98-0. The President has stated that he
supports the bill. The bill would prohibit discrimination on the basis of genetic information with
respect to health insurance and employment.
Safety and Quality of Genetic Tests
President Bush signed the Food and Drug Administration Amendments Act of 2007 (Public Law
110-85) into law on September 27, 2007. Among the many components of the law, Section 1103,
on Genetic Test Safety and Quality, requires the U.S. Department of Health and Human Services
(HHS) to enter into a contract with the Institute of Medicine (IOM) to “conduct a study to assess
the overall safety and quality of genetic tests” and prepare a report, including recommendations,
on improving the oversight and regulation of such tests. The requirement is triggered if the HHS
Secretary‟s Advisory Committee on Genetics, Health, and Society (SACGHS) does not complete
and submit its own report and recommendations by July 2008. The SACGHS is currently seeking
public comment on a draft report to the Secretary of HHS on the oversight of genetic testing.
The President’s Council on Bioethics
The President‟s Council on Bioethics (PCBE) is exploring the ethical foundations of health care.
This subject was a focus of its meetings in June, September and November of 2007. (See
http://www.bioethics.gov/meetings/.) The PCBE has also examined controversies in the
determination of death, and undertaken limited inquiries into the ethical implications of
nanotechnologies, the moral basis of medicine and the healing professions, and the role of
conscience in health-care decision-making.
Russian Committee on Bioethics (RCB) under UNESCO Commission of the Russian Federation
was established in April, 2006.
RCB includes more than 30 well known bioethicists from Russian Academy of Science, Russian
Academy of Medical Science, Russian Universities (physicians, biologists, philosophers and
lawyers). RCB is the interdepartmental public expert and advisory body.
Since establishing RCB:
- initiated activities on prolongation of validity of the Federal Law «On temporary ban of human
cloning» from 2002, expiring in June, 2007;
- issued the statement regarding desirability for Russia to join to the Council of Europe‟s
“Convention on human rights and biomedicine” (with reservations regarding Art. 20, 2, ii).
- made decision on support of the initiative of the Secretary of the Department of bioethics of the
Council of Europe about participation of Russia in the tripartite project of the Council of Europe/
the European Union and the Russian Federation under “Program of development and support of
activity of ethical committees network in Russia”;
- proposed an expert assessment of the draft of the Additional Protocol to the Convention on
Human Rights and Biomedicine concerning genetic testing;
- proposed opinion with regard to euthanasia, which was expressed in the corresponding
- supported carrying out of the Round Table discussion on bioethics at the IV International
Congress on Biotechnology in Moscow (March, 2007).
THE NUFFIELD COUNCIL OF BIOETHICS (2007)
The forensic use of bioinformation: ethical issues
The Council published its report The forensic use of bioinformation: ethical issues in September
2007. The report concluded that fingerprinting and DNA profiling are valuable tools in the
detection and prosecution of offenders, but more safeguards are needed to protect the liberty and
privacy of the innocent.
For example, the Council recommended that the police should only be allowed to keep the DNA
of people who are convicted of a crime. Currently, the police can permanently store DNA taken
from people who have been arrested even if they are later found to be innocent. The exception
would be people charged with serious violent or sexual offences, whose DNA could be kept for up
to five years even if they are not convicted. These changes would bring the law in England,
Wales and Northern Ireland into line with that in Scotland.
Further recommendations are made in the following areas:
the storage of bioinformation taken from witnesses, victims and children;
the use of the National DNA Database for familial searching, ethnic
inferencing and research;
the possibility of a population-wide DNA database;
the use of bioinformation in court; and
the governance and ethical oversight of forensic databases.
In each case, the Council weighed up whether the need to protect public safety was sufficient to
justify interfering with innocent people‟s liberty and privacy.
Although it hasn’t been issued any new law in the domain of bioethics there are several
law projects that are under governmental and public discussion at the present moment:
1. the safety, moral and legal acceptability of the use of Genetically Modified
Organisms in Romania
2. the use of genetic testing as a predictive and diagnostic tool in medicine
3. the safety, legal and moral acceptability of stem cell research
UNITED STATES (2006)
Genetic screening: In May 2005, the American College of Medical Genetics recommended that
all 50 states and the District of Columbia mandate the screening of newborns for an expanded,
uniform panel of 29 disorders. The American Academy of Pediatrics applauded the
recommendation, commenting that “more than 1,000 newborns go undetected for conditions that
could have been identified through newborn screening because the administration of newborn
screening is not uniform throughout the United States.” The U.S. Department of Health and
Human Services (HHS) Secretary‟s Advisory Committee on Heritable Disorders and Genetic
Diseases in Newborns and Children also endorsed the recommendation, and many states began
implementing it very quickly.
By their very nature, questions about newborn screening generate questions about genetic
screening and testing at other points in the human life cycle. When is it appropriate to screen, for
what conditions, for what reasons, and should the resulting information be conveyed to patients
and how? With the April 2003 “completion” of the mapping of the human genome, these
questions have taken on a more concrete urgency in the United States. At its November 2006
meeting, the President‟s Council on Bioethics will begin to explore the possibility of a broader
inquiry into these and related issues and questions concerning the ethical significance of genetic
information and knowledge.
More information on the topic of newborn screening is available at the following Internet sites:
UNITED KINGDOM (2006)
Human Genetics Commission (HGC)
On 31 January 2006, HGC launched its report Making Babies: reproductive decisions and genetic
technologies. On publication of the report, Baroness Kennedy QC, the Chair of the Commission
said, “With the accelerating pace of genetic research, the choices open to couples experiencing
fertility problems or families with a history of genetic illnesses are now considerable and
increasing. However these new possibilities bring with them new concerns. We have to balance
the need to assure reproductive autonomy – the rights of parents to make their own decisions –
with the welfare of the child and the wider interests of society. The report provides a framework
for future debate and policy decisions within the UK. Both the report and the results from the
Commission‟s earlier consultation on this issue show that these are issues on which society is
divided and holds deep-rooted views. The report makes it clear that continuing public debate in
this area is needed.”
The report and consultation document is available at
The HGC is currently considering the issue of genetic equity, in parallel to the Government‟s
review of discrimination laws.
“GENOME DATABASE OF THE LATVIAN POPULATION”
The project “Genome database of the population of Latvia” (Latvian Genome Project)
has been submitted to the Latvian government in 1999 and evaluated within the Prime
minister’s order in 2000. National network of research groups in genetics of selected
monogenic diseases and multifactorial diseases is created in 2001. A pilot phase of the
Latvian Genome Project is successfully started in January 2003. An extended version of
the Project is currently under discussion in the government.
The main objective of the project is to create the national system of genetic information
and data processing, to collect representative amount of genetic material for genotyping
of the Latvian population and to compare genomic data with the clinical information and
the information available about specific pedigrees. The direct outcome of the project for
each individual will be seen in the possibility to consider his/her risks to develop certain
diseases due to their genetic features and to eliminate these risks, particularly by
application of the individual therapy based on genetic characteristics of the patient.
AIMS OF THE PROJECT
1. Stepwise collecting and analysis of data about the genome structure of the
Latvian population, building a genome database
2. Identification of pathology causing mutations in medically important genes
3. Analysis of individual genome polymorphism, which could be used in health
care and forensic medicine, person identification and in population genetic
studies in Latvia
4. Comparison of genome analysis results with patient’s clinical data, living
conditions, professional occupancy, infectious diseases and other environmental
factors in Latvia, enabling the development of individual treatment and
5. Analysis of gene expression to discover novel disease controlling genes and
6. Development of proposals for governmental institutions to improve the existing
legislation concerning the protection of human genome data and molecular
testing. A law regarding the Project and genetic testing in Latvia has been
drafted and submitted to the parliament and will be accepted this year.
STRUCTURE OF THE PROJECT
1. Council of the Project will include representatives from the Saeima (Latvian
parliament), governmental, juridical and public institutions, and will guarantee
data safety and interests of state and society in the Project. The Council will also
control the ethical and legal aspects of the Project and inform the society.
2. Biomedical Research and Study centre (BMC), University of Latvia, the
largest institution for molecular and biomedical research in Latvia, will serve as
the Main Processor and store, explore and analyze the genetic material obtained
by institutions of medical service. A State Genome Register will be established
by the Ministry of Health.
3. Clinical hospitals and primary medical care institutions will collect the
sample material and prepare the personal, medical and genealogical information
about the sample donors.
4. Latvian Genome Foundation will be built from donations and voluntary grants
and will support the genome research in Latvia.
INSTITUTIONS CURRENTLY INVOLVED IN THE PROJECT
Biomedical Research and Study Centre, University of Latvia (BMC)
P. Stradiņš Clinical University Hospital
Latvian Centre of Oncology
Riga Stradiņš University
University of Latvia
State Centre of Medical Genetics
State Centre of Haematology
DISEASES, WHICH PRIMARILY COULD BE INCLUDED IN GENETIC STUDIES within the
Project and are caused by genome defects, have been chosen by the following criteria:
High frequency in Latvia and clinical severity
Known causing molecular genetic factors
Possibilities of treatment and disease prevention
Experience in clinical diagnostics and presence of molecular genetic depositions in
Positive experience in other countries.
Oncological diseases Endocrine diseases
Breast and/or ovarian cancer Diabetes mellitus, Type 2
Colorectal cancer Grave’s disease
Prostata cancer Congenital adrenal hyperplasia
Haematological diseases Infectious diseases:
Haemophilia A and B Tuberculosis,
von Willebrand’s disease Tick-born encephalitis
Cardiovascular diseases Others
Coronary heart disease Cystic fibrosis
Familial hypercholesterinemia Primary haemochromatosis
The possible sources of Project financing include:
State budget of the Republic of Latvia (national research and development programs
International sources (EU Structural funds, EC integrated projects etc.)
Private investments (pharmaceutical and biotech companies, banks, insurance
Donations to the Latvian Genome Foundation
The Project is planned for a period of 10 years and will be split into steps:
Step 1 (2001-2003) – preparations for a large-scale analysis of the genome of Latvian
population; analysis of genes responsible for certain diseases and use of the obtained
information to achieve prognostic and diagnostic goals;
Step 2 (2004-2006) – founding of the Genome database of Latvian population and
use of the collected information about genome polymorphisms for specific medical
and prophylactic objectives – evaluation of the state of health and choice of an
Step 3 (2007-2009) – building of a full-scale Genome database of Latvian population
and its wide practical application.
THE PROJECT WILL BE OPEN FOR COLLABORATION WITH OTHER NATIONAL GENOME
RESEARCH PROGRAMS, UNIVERSITIES AND PRIVATE ENTERPRISES.
GENOME RESEARCH IN LATVIA
Research related to human genome is carried out mostly at the Biomedical Research
Centre of the University of Latvia, Riga Stradiņš University and major hospitals. These
research activities are financed from grants issued by the Latvian Council of Science and
are mostly oriented towards the basic research.
The research program “Genomic studies of the Latvian population, their
application for diagnosis and prevention of human pathology” has been approved by
Latvian Council of Science and was launched on January 1, 2001. Scientists from
different universities, hospitals and research institutions are involved in this program and
following projects are currently started (project name, group leaders):
1. Direct and indirect detection of CFTR gene mutations: molecular, clinical, genetic and ethical considerations.
Dr. A.Krūmiņa, Dr. R.Lugovska
2. Factor IX gene mutation analysis of the hemophilia B patients in Latvia. Dr. I.Vasiļjeva, Dr. S.Lejniece
3. Genetic changes in familial melanoma and the possibilities for its early diagnosis. Dr. O.Heisele, Dr.
4. Polymorphism of genes involved in the hypothalamic melanocortin system and its connection to disorders in
regulation of energy homeostasis in Latvian population. Dr. J.Kloviņš, Dr. V.Pīrāgs
5. Development of an efficient procedure for DNA diagnostics of hereditary breast and nonpolyposis colorectal
cancer in Latvian patients. Dr. L.Tihomirova, Dr. J.Gardovskis
6. Genetic markers of coronary heart disease and its different forms. Dr. U.Kalniņš, Dr. N.Līcis
7. Involvement of protein kinase C beta gene (PRKCB1) in the manifestation of type 2 diabetes mellitus or
diabetic complications. Dr. V.Pīrāgs, Dr. M.Lazdiņš
8. POLYMORPHISM OF THE MITOCHONDRIAL DNA IN STUDIES OF LATVIAN ETHNOGENESIS. DR. V.BAUMANIS, DR.
9. Clinical significance of the serologically identified gastric and colon cancer antigens. Dr. A.Linē, Dr.
10. Genetic polymorphism in the genomic domain of the proteasomal protein PROS27 gene and its linkage to
human pathology. Dr. N.Sjakste
11. Study of HLA DR, DQ, DP alleles polymorphism in Latvians. Dr.A.Sočņevs
12. Elaboration of Phenylketonuria prenatal and Fragile X Syndrome prenatal, postnatal DNA-based testing and
quality control system in Latvia. Dr. R.Lugovska
13. The Single Nucleotide Polymorphism (the point mutations) of the HLA -DR, -DQ and other genes susceptible
to Graves’ disease in Latvians. Dr. M.Marga, Dr. V.Pīrāgs
For more information, please contact:
Valdis Pirags M.D. PhD
Associate Professor of Medicine
Head of the Clinic of Internal Medicine
P.Stradins University Hospital
Phone: +371 9237760
Fax: +371 7069955
Elmars Grens PhD
Professor of Molecular Biology and Genetics,
Biomedical Research and Study Centre, University of Latvia,
Member of Latvian Council of Science
UNITED KINGDOM (2005)
Human Genetics Commission (HGC)
On 31 March 2005, HGC launched its report Profiling the Newborn: a prospective gene
technology? This document stems from a request in the Government‟s White Paper on Genetics
for HGC to work with the UK National Screening Committee to look at the case for and against
genetically profiling babies at birth. It concluded that genetic profiling is unlikely to be publicly
affordable within 20 years and that the topic should be kept under review and revisited in five
years. The report is available at www.hgc.gov.uk
The Human Genetics Commission continues to work on its report on genetics and reproductive
decision-making. The results from the discussion document Choosing the future: Genetics and
Reproductive decision making were recently published on the website and HGC intends to report
to Ministers by late 2005.
The Commission is also keen to consider the issue of genetic equity with a view to setting out
some fundamental principles. This could build on the principles already set out in Inside
Information, its report on the use of personal genetic information.
Other Topics Concerned: Reproductive Rights
Act of 5 December 2003 No. 100 relating to the application of biotechnology in human
Please click on the link below:
Other Topics Concerned: Reproductive Rights, Biomedical Research
During 2005, the National Bioethics Council of Israel has reviewed the instructions on the use of
preimplantation genetic diagnostic (PGD) for sex-selection which have been issued by the
Ministry of Health, based on the 2004 recommendations of the Bioethics Committee of the Israel
National Academy of Sciences and Humanities, and the National (Helsinki) Committee on
Medical Experimentation in Human Beings. These regulations stipulate that PGD can be used for
sex-selection only for medical purposes. Among medical purposes, the regulations include the
possibility of a serious and real threat to the mental health of one of the parents but could allow
this only in exceptional cases and subject to a decision case by case by a National Board
established for this purpose by the Ministry of Health.
3. A day of public consultation on " PGD: Diagnostic of diseases or perhaps 'design babies'? The
worthwhile, the desirable and the permissible" will be held by the National Bioethics Council of
Israel in collaboration with the National Committee on Medical Experimentation in Human Beings
under the auspices of the Ministry of Science and Technology and the Ministry of Health. This will
take place on September 25, 2005.
Other Topics Concerned: Reproductive Rights
DENMARK / DANEMARK (2004)
New legislation on PGD
The Danish Parliament changed the Act on medically assisted procreation in connection with medical
treatment, diagnosis, and research, etc. concerning the use of PGD. This Act entered into force 5 April 2004.
The previous legislation specified that PGD only could take place in situations where a known and
considerably increased risk that the child will have a serious hereditary disease is present. This included
also use of PGD in cases where this treatment could ensure a coming child to obtain tissue matching an
elder brother or sister.
The new legislation entitles the use of PGD even if there is not a hereditary disease involved.
The National Board of Health has the power to accept this treatment, which implies that inter alia following
requirements must be met:
The aim of using PGD must be to help the child of the couple concerned
The child in question must suffer from a life-threatening disease
All other treatments must be examined
There are no other equivalent alternatives
The treatment with stem cells must - from a health point of view - be expected to bring considerable
improvement for the child.
Other Topics Concerned: Reproductive Decision Making
OF THE BIOETHICS LAW OF 6 AUGUST 2004
Law No. 2004-800 of 6 August 2004 concerning bioethics is the outcome of a text examined
in a first reading by the Assembly in January 2002 which, after a change in Government, was
taken up again with some adaptations but without modification of its general organisation in the
Senate at the start of 2003. The text was then examined at second reading by the National
Assembly at the end of 2003 and finally by the Senate in July 2004.
The law henceforth establishes the term “bioethics” in its title itself, but does not challenge the
main principles stated by the founding laws of 1994: requirement for free and informed consent,
no property in the human body, free and anonymous donation and the requirement of health
The main points touched on by the law are the following (in the order of the adoption of
articles by the legislator):
1 – To affirm the place of ethical reflection
The National Consultative Bioethics Committee for health and life sciences (CCNE) is confirmed
as an independent authority; fora for ethical reflection are created at regional level.
2 – Creation of a Biomedical Agency
A Biomedical Agency, which will henceforth integrate the tasks of the French Transplant Agency
(FTA) will, besides the tasks formerly allotted to the FTA, have competence in the fields of
reproduction, embryology and human genetics, for which it will deliver the necessary
authorisations and approvals. In all its fields of competence it will contribute to the elaboration of
regulations and recommendations. In particular, it is tasked with authorising research protocols
using embryonic cells (see below). The composition of the advisory council (“conseil
d‟orientation”) gives a place to civil society in this eminently ethical field.
3 – Examination of people’s characteristics
The principal ethical issue of genetic medicine, concerning the problem of discrimination because
of genetic characteristics (in the fields of employment and insurance) was dealt with by the law on
the rights of patients of 4 March 2002. The bioethics law focuses on provisions reinforcing
means of consent and information for the person concerning those examinations and deals
with the question of identification by genetic fingerprinting post-mortem in the framework of a
Moreover, after long debates, a provision was introduced concerning information for the family
in the case of a serious genetic illness detected in a person, if preventative or treatment
measures can be proposed. One part was finally retained, that the person concerned by the
diagnosis shall be informed by the doctor of the risks that the family may incur if not informed; the
liability of the doctor is limited to giving that information in writing and counter-signed (attestée).
On the other hand, the liability of a person who does not implement the provision of information to
the family in this framework is not addressed. Furthermore, the person is offered recourse to the
procedure for medical information of a familial character in which the Biomedical Agency
takes charge of contacting the members of the family concerned.
4 – Donation and use of elements and products of the human body
The bioethical issues in this field concern health and safety on the one hand, and the protection
and respect of the person on the other. Health and safety have been greatly taken into account in
the 1994 law and reinforced by the law of 1/7/1998 concerning reinforcement of health
surveillance and monitoring of the health safety of products destined for humans. The newly
adopted law does not reconsider the main ethical principles of 1994 recalled above. On the other
hand, it brings an administrative organisational change with the creation of a Biomedical
Agency (see above). The other new things mainly bear on two points: the clarification of
consent regimes and an enlarged field of living organ donors, whilst an effort to unify the
regime for collections of biological samples is made in aid of scientific research.
5 – Redefinition of cellular and gene therapies
The bioethics law puts in place a legal framework which is clear, coherent and adapted to the
technological and medical developments of this sector. Cells, which previously came under
different legal regimes (regime for cell therapy products, for cells not destined for cell therapy, for
cells of medullary origin) are regrouped into a single framework: that of cell products for
therapeutic purposes which only contain cells of human origin. Furthermore, the status of a
medicament is conferred on cell products of animal origin and on gene therapy products.
6 – Embryology and reproduction
It is on this subject that the most profound reforms by comparison with the law of 1994
occur and where the most conflictual questions are sited.
From the first reading in the Senate, after the change of Government, the Government requested
the deletion of provisions concerning new techniques of medically assisted procreation as well as
those concerning the post mortem transfer of embryos (provisions provided in the initial draft and
adopted at Ist reading in the National Assembly).
The new things introduced during the Ist reading in the Senate and from then on adopted
a) definition of the prohibition of cloning for the purpose of reproduction (which is
based henceforth on genetic identity and no longer on asexual reproduction) and the creation of
a crime against the human species, a real innovation in French penal law and which in
particular permits prosecution of an infraction committed outside national territory;
b) the prohibition of cloning with therapeutic aims, differentiated from reproductive
cloning, which taking into account the less grave ethical issues however constitutes an
c) a limited opening on embryo research by the adoption of a 5 year positive
In conformity with the principle set in the Oviedo Convention, the plan establishes the prohibition
of the creation of embryos for research purposes. As regards research possibilities, the initial
draft already proposed only a limited and very controlled opening on supernumerary embryos
where there was no parental project (research for medical purposes, no method of comparable
effectiveness, express consent from the two members of the couple, protocols duly authorised by
the Biomedical Agency). The adopted text limits the possibilities still further in enclosing them
within a “positive” five year moratorium at the end of which it was agreed to reconsider the
issue. Research remains strictly controlled.
Moreover, a transitional provision allows the Ministers responsible for health and for research,
after the opinion of an ad hoc committee, from the time of adoption of the law and without waiting
for the creation of the Biomedical Agency, to authorise research on imported embryonic stem
cells in accordance with the principles provided for in the law;
d) extensions of the indications for preimplantation diagnosis (PID) and in
particular its strictly controlled use for the benefit of a sick sibling (a measure called “cell
7 – Patentability of human genes and the partial transposition (Article 5) of Directive 98/44
of 6 July 1998
Ignored in the original draft of the law, the question of the patentability of human genes and the
application of Article 5 of the Directive 98/44 of the legal protection of biotechnological inventions
was the object of a very lively controversy in the National Assembly. The Government then
proposed a transposition of the Directive responding both to Community requirements
(patentability of genes or gene sequences isolated from the human body) and to ethical demands
expressed by the national representatives (very narrow limitation on the scope of patent
protection). This provision was adopted and judged in conformity with the requirements of
Community law by the Constitutional Council.
Furthermore, there is a reform of compulsory licenses (“licences d‟office”) granted by the State in
the interests of public health to perfect the general equilibrium desired by the Government as a
barrier to the situations of quasi-monopoly that an extensive application of a gene patent can
confer (cf Myriad Genetics).
The legislator of 2004, like that of 1994, has includes a revision of the law in five years. The
implementation of the new provisions will now require about 25 implementing regulations
Other Topics Concerned: Biomedical Research, Embryo Research and Cloning, Biopatents
GEORGIA / GEORGIE (2004)
Georgian Legislation Related to Bioethics
Legislation of Georgia related to bioethics comprise texts which regulate various aspects of
medicine/health care: rights of patients and research subjects (including vulnerable groups; such
as minors, persons with mental disorders, patients with HIV/AIDS etc.), duties and responsibilities
of health care professionals, human organ transplantation, assisted reproductive technologies
Below in the table the list of laws (which are on different stages of preparation/adoption)
related to bioethical issues are given. From these laws the Law of Georgia on Health Care is
considered to be the framework law, which determines the priorities and sets out fundamental
principles of the health care legislation of Georgia.
Table 1. Laws on the different stages of preparation/adoption (1995-2004)
GOVERNMEN ADOPTED LAST UPDATE
The Law on Medical Activity 2001 (08.06) 2001 (26.10)
The Law on the Rights of Patient 2000 (05.05)
The Law on Human Organ
2000 (23.02) 2002 (21.11)
The Law on Protection and
Promotion of Infant Natural 1999 (09.09) 2000 (09.06)
The Law on Health Care 1997 (10.12) 2003 (18.07)
The Law on Drug and
1996 (25.12) 2003 (8.05)
The Law on Psychiatric Care (New 1995 (21.03) 1999 (24.12)
The law on HIV/AIDS Prevention 1995 (21.03) 2000 (08.11)
The Law on Abortion Since 2000
The Law on Biomedical Research
Involving Human Subjects
The Law on Reproductive Health
and Reproductive Rights
Legislation Concerning Human Genetics
The laws that include provisions on human genetics are the Law on Health Care and Law on
Patient‟s Rights. Also, respective articles of the Convention on Human Rights and Biomedicine
apply to this subject.
The above legislation cover the issues related to genetics and healthcare in general terms.
Particularly it concerns the following issues:
- general conditions to perform gene therapy;
- general conditions to perform genetic testing;
- restrictions for the interventions seeking to modify the human genome;
- prohibition of sex selection.
Below is given respective articles from the Law on Health Care and Law on the Rights of
The Law on Health Care:
Genetic Therapy is admissible only in the following cases:
a) if its purpose is the prevention, diagnose and treatment of fatal diseases;
b) the absence of other easier and less dangerous methods of treatment;
c) there is a written informed consent of the patient, and/or patient‟s relative, legal
representative in case of patient‟s incapacity;
d) the modern level of development of science allows to determine that the treatment will not
cause undesirable change of the genome of descendants.
The Law on the Rights of Patients:
Discrimination against a person on grounds of his/her genetic heritage is prohibited.
Tests, which serve to identify a gene responsible for a disease or to detect a genetic
predisposition to a disease, shall be carried out only for:
a) patient‟s healthcare purposes;
b) scientific research linked to health purposes.
Any intervention seeking to modify the human genome shall only be carried out for
diagnostic, therapeutic or preventive purposes and only if its aim is not to modify the genome of
The use of methods of medically assisted procreation for the purpose of sex selection shall
be prohibited, with the exception of the cases when hereditary sex-related disease is to be
Other Topics Concerned: Biomedical Research, Ethics Commission / Competent Bodies /
Advisory Organization, Organ Transplantation, Patients‟ Rights, Reproductive Decision-Making
NORWAY / NORVEGE (2004)
New Norwegian Act relating to the Application of Biotechnology in Human Medicine
Last year the Norwegian Parliament passed a new Act relating to the Application of
Biotechnology in Human Medicine. With the exception of the provisions on the right of children to
know the identity of sperm donors and the provisions on prenatal diagnosis the Act entered into
force 1 January 2004.
The Act contains provisions on the prohibition against research on embryos and on the
prohibition against all forms of human cloning. It also contains provisions on genetic testing and
For the most part the new Act is based on the same restrictive principles as the old Act from 1994
as amended until last year.
The core values enshrined in the Act is the respect for human dignity and the fundamental ethical
principles of our western cultural heritage.
Other Topics Concerned: Embryo Research and Cloning
SWITZERLAND / SUISSE (2004)
Récents développements juridiques en Suisse, février 2004
Loi fédérale sur l’analyse génétique humaine
[pas de changements]
Other Topics Concerned: Organ Transplantion, Embryo Research and Cloning
BELGIUM / BELGIQUE (2003)
Au cours des premiers mois de l‟année 2003, le Parlement belge a adopté trois lois concernant la
bioéthique. Elles peuvent être consultées sur le site : www.just.fgov.be (rubrique Moniteur
1. Loi du 28 janvier 2003 relative aux examens médicaux dans le cadre des relations de travail
(Moniteur belge du 9 avril 2003).
Celle loi interdit notamment le recours à des examens génétiques prévisionnels en vue d‟obtenir
des informations relatives à la santé d‟un travailleur ou d‟un candidat travailleur, tant dans le
secteur public que privé.
2. Loi du 25 février 2003 tendant à lutter contre la discrimination et modifiant la loi du 15 février
1993 créant un Centre pour l‟égalité des chances et la lutte contre le racisme (Moniteur belge du
Cette loi crée un nouveau cadre légal d‟incrimination des comportements discriminatoires, sur le
plan pénal ainsi que sur le plan civil.
Sont notamment visées par cette loi, les discriminations fondées sur l‟état de santé actuel ou
futur (détecté par un test génétique prévisionnel) d‟une personne.
3. Loi du 11 mai 2003 reltive à la recherche sur les embryons in vitro (Moniteur belge du
Cette loi définit les modalités (conditions, lieu et contrôle) devant être respectées dans le cadre
de la recherche sur les embryons in vitro.
La constitution d‟embryons in vitro à des fins de recherche est interdite, sauf si l‟objectif de la
recherche ne peut être atteint par la recherche sur les embryons surnuméraires.
La loi prohibe l‟accomplissement de recherches à caractère eugénique ou axées sur la sélection
du sexe (à l‟exception de la sélection qui permet d‟écarter les embryons atteints de maladies
liées au sexe).
Le clonage reproductif humain est interdit.
La loi institue une Commission fédérale pour la recherche médicale et scientifique sur les
embryons in vitro, chargée, entre autres, de veiller au respect de la loi.
UNITED STATES OF AMERICA / ETATS-UNIS D’AMERIQUE (2003)
On October 14 , the United States Senate passed by a vote of 95-0 a bill, the Genetic
Information Nondiscrimination Act of 2003, providing protection of privacy of genetic information
and prohibition of denial of health insurance due to a pre-existing (genetic) condition. The
legislation now goes to the House for action.
The President signed into law on November 5 legislation prohibiting the performance of a
procedure called “partial birth abortion.” Within hours, three different federal judges issued
temporary restraining orders, blocking the new law‟s enforcement for most of the doctors
nationwide who perform the procedure, with the expectation that it will eventually go to the
Supreme Court for review.
The President‟s Council on Bioethics in October 2003 released a report entitled “Beyond
Therapy: Biotechnology and the Pursuit of Happiness.” The report deals with distinctions
between therapy and enhancement in a variety of contexts: genetics, behavior, athletics, and
aging, for example. The report is available at
http://www.bioethics.gov/reports/beyondtherapy/index.html. The Council is currently working on a
report on biotechnologies touching the beginnings of human life.
EUROPEAN COMMISSION / COMMISSION EUROPÉENNE (2003)
On December 2002, the European Commission, Directorate General Research has established a
ETAN-STRATA experts group dealing with ethical implications of genetic tests.
The initiative is considered as an activity under Action 30 of the Science and Society Action
Plan, namely to 'Establish public dialogue on ethics in science'. It is of course also relevant in
the context of the EC Communication on “Life Sciences and biotechnology”.
The aim of the STRATA-Group of 15 persons is to create a stakeholders/industry dialogue on
genetic tests, resulting finally in a report that should be widely disseminated and which in itself will
provide a basis for further discussion with the public in Europe, in different languages and
The initiative seeks to create a consensus between diverse parties on how to progress with
genetic testing in research and applications, in the absence of clear regulations established
across the European countries co-operating in research. The initiative, therefore, should facilitate
the use of these technologies in research and its application, but should in particular provide
answers to questions by the public on this sensitive matter.
The Group consists of relevant industrial stakeholders (5 out of 15), representatives of civil
society (consumers, patients and medical groups) and scientific experts in the fields of biology,
philosophy and law (see Annex). Mrs McNally from the EP and Prof Rodotà, EGE and Chairman
of the “EC Commission on data protection” will co-chair the Group. The Group has organised
hearings in order to acquire an expertise that is not present in the group and will present the draft
report to a wider public.
The members of the Strata-Group are key experts in their fields, responsible representatives of
companies, and leaders of patients groups. The group respects a balanced geographical
distribution (12 countries out of 15 members) and gender participation (30%).
The initiative proposed will contribute an ethical element to ongoing activities of the European
Commission services (IPTS, EMEA) and of other International organisations (the Council of
Europe, OECD, UNESCO, WHO). The above mentioned Organisations have been invited at the
public hearings organised by the STRATA group.
The initiative to establish such a small “ad hoc dialogue platform on a specific topic” in ethics is
new and could be considered as a pilot model for other subjects if successful.
The STRATA Group has already met four times and the final report will be finalised by December
The European Group on Ethics in Science and New Technologies to the European
The EGE is an independent, multidisciplinary and pluralist instance, composed of twelve
members. Its role is to advise the Commission on how the ethical values of the European society
can be taken into consideration in the scientific and technological development promoted by
- ACTIVITIES 2003 -
Opinion nr. 17: "The Ethical aspects of clinical research in developing countries" -
February 4 , 2003
This Opinion aims at providing advise to the Commission on the ethical aspects of implementing
EU-funded research activities in countries which culturally or economically differ from the West
Clinical trials in developing countries (DCs) give rise to ethical questions linked to socio-economic
inequalities, poverty and cultural diversity. The EGE stresses that:
the huge economic inequalities are the cause of most of the problems raised in this
Opinion and that the private or public investigators who do their research in DCs have a
moral duty to make a concrete contribution to overcome inequalities;
the implementation of EU research programmes in DCs should be based on
solidarity, in line with the Charter of Fundamental Rights. Research activities involving
human subjects cannot exclusively be assimilated to an economic activity subject to market
rules. Health should be regarded as a public good rather than a commodity.
The general approach chosen in this Opinion is that the fundamental ethical rules applied to
clinical trials in industrialised countries are to be applicable everywhere, namely :
- the principle of respect for human dignity and the principles of non-exploitation, non-
discrimination and non-instrumentalisation,
- the principle of individual autonomy, entailing the giving of free and informed consent by each
individual involved in a trial,
- the principle of justice and the principle of beneficence and non-maleficence, namely with regard
to the improvement and protection of health,
- the principle of proportionality, between methods and aims of research.
The Group stresses that clinical research must have a specific interest for the host country
and complies with its health priorities.
The Group underlined the importance of partnership stating that the involvement of local
scientists from the host country at the very early stage of the planning and implementation
of the research activities is crucial to develop a culture of collaboration which is different
from charity help.
The evaluation both scientific and ethical of research protocol should involve local committees, or
local independent experts. Where it is not possible to involve such an independent local
representative in the evaluation, then no clinical trial should be implemented in the
More information: http://europa.eu.int/comm/european_group_ethics
Concerning the use of placebo in clinical trials, the use of placebos should be regulated in DCs in
principle by the same rules as in European countries. Any exception must be justified and
the justification clearly demonstrated in the research protocol submitted to the ethical
committees and especially approved by the local committee.
In the context of cultural diversity, the Group emphasized that both the values and ethical
principles of the funding agencies and of the host country have to be considered and in
the case of conflicting views between parties, every effort should be made to negotiate
solutions but without compromising the respect of fundamental ethical principles.
Opinion nr. 18: "The Ethical aspects of Genetic testing in the work place"
The Group is preparing this opinion, to be presented during the summer 2003.
Opinion nr. 19 : "The Ethical aspects of Cord Blood Banks"
The Group works on this opinion, to be finalised during the 1 semester 2004
European Group on Ethics in Science and New Technologies (EGE):
Publication on 28 July 2003 of Opinion no. 18 on ethical aspects of genetic testing in the
Groupe Européen d'Ethique des Sciences et des Nouvelles Technologies (GEE)
Publication le 28 juillet 2003 de son Opinion 18 sur les aspects éthiques des tests génétiques
dans le cadre du travail
ORGANISATION FOR ECONOMIC COOPERATION AND DEVELOPMENT /
ORGANISATION DE COOPÉRATION ET DE DÉVELOPPMENT
ÉCONOMIQUES (OECD) (2003)
10 April 2003
BIO-ETHICS RELATED ACTIVITIES AT THE OECD
The OECD does not have a group specialised in either ethics or bioethics. However, the OECD
has a large number of projects which address the social and economic impacts of advances in
biotechnology, which inevitably have a bioethical component. For example, issues such as equity
and access to health care, intellectual property protection, privacy and security of health data,
figure prominently in the 2003 work programme.
This note describes the bio-ethics related activities of the OECD Biotechnology Unit. For more
complete coverage of all biotechnology work, including activities related to agriculture and the
environment, see the OECD Biotechnology Update on our external website
OECD Structure and Working Method:
The Directorate for Science, Technology and Industry (STI) has covered the biotechnology sector
since 1980. Within DSTI the principle body charged with following how scientific advances in
biotechnology affect society and the economy is the Working Party on Biotechnology (WPB). Its
mission is to advise upon emerging policy-relevant issues of science, technology and innovation
related to biotechnology.
The policy challenges of biotechnology arise faster than governments and societies can respond.
The Working Party on Biotechnology, its subsidiary Working Group on Human Health-Related
Biotechnologies (WGHHRB) and its various task forces, bring together Member country experts
for projects requiring international co-operation. Work focuses on three broad fields: applications
of biotechnology to human health; applications to sustainable development; applications to the
knowledge-based economy. The OECD seeks to help countries to respond by providing a
platform for international discussion and co-operation. Countries share information, discuss new
policy approaches when traditional policies do not suffice and jointly develop collaborative
policies when necessary.
Delegates to the WPB, WGHHRB and the task forces are appointed by member countries. There
are 30 OECD member countries. The European Community is also a member. In addition,
China, Israel, the Russian Federation and South Africa have observer status at the WPB. At the
invitation of the Secretariat, other international organisations can be invited to individual
meetings. Delegates to the WPB and its subsidiary bodies most frequently come from research
or science and technology ministries. However, many projects require more narrow expertise
and appointed delegates can come from other parts of national governments, the research or
medical communities, academia, and industry.
The role of the OECD Secretariat is to facilitate the work of its member countries. It organises
meetings and events, helps to prepare documentation, and promotes project findings and
publications to the global community.
Below are some examples of recent or ongoing projects which may be of relevance to the UN
Interagency Committee on Bioethics.
THE IMPACT OF NEW AND EMERGING HEALTH-RELATED TECHNOLOGIES PROJECT
The project on the new and emerging technologies aims to assess ways in which Member
countries can manage health-related technological change. It is guided by Member country
experts and is part of the wider OECD Health Project.
The project consists of three parts:
A) Conduct a survey on how decisions on health technology are made, the role of health
technology assessment (HTA) and how decisions are translated into practice. This part of the
project aims to assess the impact of decision and implementation processes using common
B) Consider how member countries could address some of the broader policy challenges in
health-technology decision-making and assessment. The broader policy challenges considered in
this part of the project include (1) dealing with uncertainty, (2) how results can be transferred
between settings and countries, (3) how implementation of HTA can be improved, (4) the impact
on R&D, and (5) how decision-makers could deal with bio-medicines, including genetic tests and
C) On the basis of information gathered during the first two parts of the project, draw up principles
of good practice. This will be achieved through an international experts‟ workshop to be held in
the second half of 2003.
The survey is intended to capture the decision-making and implementation experiences for a
number of case study technologies in a wide range of Member countries. Experts, together with
the Secretariat, are in the process of finalising the survey instrument and selecting case studies
technologies for analysis. The project is due for completion early 2004.
Expert Group on Impact of New and Emerging Health-Related Technologies, OECD, Paris,
17-18 March 2003.
Web site: http://www.oecd.org/biotechnology/
under the theme “Scientific, Industrial and Health Applications of Biotechnology”
GENETIC TESTING - SURVEY ON MOLECULAR GENETIC TESTING LABORATORY
The OECD completed in May 2002 a pilot phase for a survey on molecular genetic testing
laboratory practices, with the support and co-operation of its Member countries, the European
Commission and the European Molecular Quality Genetics Network. The pilot of the survey
included over 350 laboratories from nine countries (Italy, Portugal, USA, Canada, UK, Austria,
Finland, Switzerland and Japan).
The objectives of the survey were to get an overview of: a) the settings in which genetic testing is
being offered as a clinical service; b) what types of tests and how many are being performed; c)
the qualifications of the Directors of the laboratories performing genetic testing; d) what quality
assurance methods are being utilised; and e) what measures are taken when deficiencies are
The results of this pilot survey have provided important insights on a number of issues. These
include the first documentation of the practice of referring genetic testing specimens across
national boundaries and of differences in the practices of laboratories with regard to the
requirements for reporting results, written informed consent and confidentiality policies. These
results will need further investigation and discussion in order to provide guidance to policy makers
and others responsible for the practice of molecular genetic testing. A large-scale survey of 18
OECD countries is planned for 2003.
4 Steering Group meeting on Quality Assurance and Proficiency Testing Schemes for
Molecular Genetic Testing in OECD countries to be held in Brussels in November 2003
(date to be confirmed)
GENOMICS AND INFORMATICS: PRIVACY AND SECURITY ISSUES
The Working Party on Biotechnology has agreed to hold a Workshop on Human Genetic
Research Databases – Issues of Privacy and Security in Tokyo, Japan in early 2004. The
workshop focus is on privacy and security issues associated with human genetic research
databases. The aim is to help member countries:
i. Gain an understanding of current practices across OECD member countries for
the acquisition and maintenance of genetic data/information, as well as for the source
samples or specimens the genetic data is derived from.
ii. Identify any challenges in the management of genetic databases (including
issues about their storage, use, transfer, disposal, and abolition) that need to be
iii. Identify good management practices for human genetic research database
management, where such good practices already exist.
A steering group has been established to plan the workshop. It will decide the scope of
databases to be considered and how the workshop will address the following topics: (A) the
acquisition of genetic data; (B) the maintenance of samples and data; (C) the dissemination of
genetic data; and (D) the education and training of database personnel.
A publication identifying the challenges and good practices for dealing with problems as well as a
short policy-oriented summary paper will be produced by a Rapporteur by the summer of 2004.
Workshop on Human Genetic Research Databases: Privacy and Security Issues, Tokyo
Japan, February or March 2004.
Other Topics Concerned: Patients‟ Rights, Biopatents
Activités de l’UNESCO depuis mai 2003
A sa 32e session (30 septembre – 17 octobre 2003), la Conférence générale a décidé de
reconduire l‟éthique des sciences et des technologies, en particulier la bioéthique, comme l‟une
des priorités de l‟Organisation pour 2004-2005.
Aussi, pendant ces deux prochaines années, l‟UNESCO poursuivra-t-elle au plan international sa
mission intellectuelle et normative – marquée notamment par la nouvelle Déclaration
internationale sur les données génétiques humaines et par l‟élaboration d‟une déclaration sur des
normes universelles relatives à la bioéthique –, ainsi que son engagement dans la coordination
entre les différentes organisations par le Comité interinstitutions sur la bioéthique. De plus,
l‟Organisation compte s‟engager davantage dans une approche régionale et nationale,
concentrant dans un premier temps ses efforts dans la région Amérique latine et Caraïbes et en
Europe centrale et orientale, afin de fournir aux États des éléments de réflexion et des moyens
appropriés pour faire face aux nouveaux défis bioéthiques grâce notamment à des activités en
matière d‟éducation, à la création de réseaux des comités nationaux d‟éthique et à la mise en
place de centre de documentation et d‟information sur la bioéthique.
Déclaration internationale sur les données génétiques humaines
Lors de sa 32e session, la Conférence générale de l‟UNESCO a adopté à l‟unanimité et par
acclamation la Déclaration internationale sur les données génétiques humaines le 16 octobre
2003. L‟UNESCO – qui a déjà élaboré la Déclaration universelle sur le génome humain et les
droits de l‟homme adoptée en 1997 – a développé à travers son Comité international de
bioéthique (CIB) une réflexion sur les données génétiques humaines. Le texte adopté aujourd‟hui
est le fruit de cette réflexion, mais aussi d‟une large consultation internationale qui s‟est
notamment traduite par la tenue en juin dernier d‟une réunion d‟experts gouvernementaux.
L‟objectif de la Déclaration, qui constitue une suite logique à la Déclaration universelle sur le
génome humain et les droits de l‟homme et l‟une des modalités de sa mise en œuvre, est
d‟assurer le respect de la dignité humaine et la protection des droits de l‟homme et des libertés
fondamentales en matière de collecte, traitement, utilisation et conservation des données
génétiques humaines, conformément aux impératifs d‟égalité, de justice et de solidarité, et
compte tenu de la liberté de pensée et d‟expression, y compris la liberté de la recherche. Elle
entend proposer les principes qui devraient guider les Etats dans la formulation de leurs
législations et de leurs politiques sur ces questions.
Possibilité d‟élaborer des normes universelles relatives à la bioéthique
Conformément au mandat qui lui avait été confié par la Conférence générale à sa 31e session
(31 C/Rés. 22) et sur la base des travaux du CIB (Rapport du CIB sur la possibilité d‟élaborer un
instrument universel sur la bioéthique, 13 juin 2003) et des Recommandations du CIGB à sa
deuxième session (Paris, 23-24 juin 2003), le Directeur général a présenté à la 32e session de la
Conférence générale (Paris, 30 septembre – 17 octobre 2003) les études techniques et juridiques
réalisées concernant la possibilité d'élaborer des normes universelles sur la bioéthique
(document 32 C/59 disponible sur Internet). La Conférence générale, après examen dudit
rapport, a adopté une résolution par laquelle elle invite le Directeur général à poursuivre la
préparation d'une déclaration sur de normes universelles relatives à la bioéthique et à lui
présenter un projet de déclaration à sa 33e session en 2005. Par ailleurs, elle invite également le
Directeur général a mené des consultations dès le début de l‟élaboration afin d‟associer les Etats
membres, les autres organisations internationales concernées et les organes nationaux
Pour toute information complémentaire :
Division de l‟éthique des sciences et des technologies, Section de bioéthique
1, rue Miollis
75732 PARIS Cedex 15
Tel. : +33 1 45 68 39 39 Fax. : +33 1 45 68 55 15
E-mail : firstname.lastname@example.org Internet : www.unesco.org/bioethics
DENMARK / DANEMARK (2002)
(contribution November 2002)
Summary and conclusions
The ad hoc Committee on Gene Technology was set up in consequence of a debate in the
Danish Parliament in January 2001. The committee was given the task of describing potential
benefits and risks related to the cloning of stem cells, xenotransplantation, gene therapy and
genetic testing of healthy individuals. The committee was not asked to prepare legislation.
Jointly with the Minister for the Interior and Health and the Minister for Justice, the Minister for
Science, Technology and Innovation was given the task of appointing the committee.
The committee has covered the following questions:
> What are the potential benefits and risks of using stem cell therapy, xenotransplantation,
gene therapy and genetic testing of healthy individuals?
> Considering the future application of these emerging technologies, which problems are
important to consider? How could these problems be solved and who should contribute
to the task of problem solving?
Based on the current leading-edge science within the four areas, as well as the ethical aspects
and the legislative matters, the committee points to a number of problems that should be
addressed as a prerequisite for future application of the new technologies.
Stem cell therapy:
Stem cells are the „primordial cells“ of human beings and they have the ability to differentiate
into all the other types of cells. Thus, the vision is that the use of stem cells will make it
possible to repair for instance nerve cells that have been destroyed in patients suffering from
Parkinson‟s disease or repair liver cells in a malfunctioning liver.
Today, it is assumed that stem cells obtained from the human embryo have the greatest
potential. However, there is increasing evidence that adult stem cells e.g . from cord blood and
fully developed tissue might, if properly treated, exhibit a potential similar to the potential of
embryonic stem cells. Both nationally as well as internationally, attention is focused on
embryonic stem cells. The major concern is whether the possibility of developing new medical
treatments can justity the ethical doubts related to the isolation of stem cells from the embryo.
The isolation of stem cells is permitted in, for instance, Sweden and the United Kingdom.
Whereas in Germany, for instance, and in the United States as far as federally financed
research is concerned, only research on already existing stem cell lines is permitted.
In Denmark the situation is not clarified. The field is regulated by the Act on Medically Assisted
Procreation. Stem cells are not mentioned directly in the Act. However, it regulates the
utilisation of the human embryo in a research context. Only research which aims at improving
the IVF treatment and pre-implantation diagnosis is permitted, and only when using embryos
left over from the IVF treatment. According to government interpretation the act does not
restrict research performed on imported stem cell lines. This matter has not been taken to
Independent of Parliament‟s wish either to widen the possibilities of carrying out research on
embryonic stem cells, or to maintain or to further limit the current possibilities for such research,
the committee finds that there is a need to clarify existing regulation trough a legislative
It is recommended
> that parallel with a public debate, political clarity concerning the use of embryonic stem
cells be established as soon as possible. On this basis and if needed, a legislative
preparatory work should be initiated, also with a view to a revision of the Act on Medically
Seven key questions require political resolution:
1) Should it be permitted to derive stem cells from fertilised eggs/embryos left over from
an IVF treatment with the aim to perform basic research on stem cells and to explore the
possibilities of new treatments?
Today, the Act on Medically Assisted Procreation does not allow the utilisation of human
embryos for research purposes unless the purpose is to improve the IVF treatment or methods
for pre-implantation diagnosis.
Should there be a political wish for establishing the possibility of employing embryonic stem
cells, it would require an amendment to the Act on Medically Assisted Procreation.
If such an amendment is adopted, Parliament should also decide whether there is a need for
special approval schemes.
2) Should the fertilisation of eggs by means of IVF technique be permitted even though it
is not part of a fertilisation treatment?
Fertilisation of an egg solely for the purpose of the formation of embryos for research purposes
is, as mentioned above, not permitted at present. Should there be a political wish to allow this
procedure, it would require an amendment to the Act on Medically Assisted Procreation and an
amendment to Denmark‟s ratification of the Convention on Human Rights and Biomedicine of
the Council of Europe.
If such amendments are adopted, Parliament should also decide whether there is a need for
special approval schemes.
3) Should the formation of embryos through nuclear transfer from somatic cells be
Today, the formation of embryos through nuclear transfer from a somatic cell to an unfertilised
egg is not permitted for research purposes.
Should there be a political wish for allowing nuclear transfer, it will requir e an amendment to the
Act on Medically Assisted Procreation and an amendment to Denmark‟s ratification of the
Convention on Human Rights and Biomedicine of the Council of Europe.
If such amendments are adopted, Parliament should also decide whether there is a need for
special approval schemes.
4) Should there be specific rules for the use of embryonic stem cell lines?
If the derivation of stem cells from the embryo is permitted through an amendment to the Act on
Medically Assisted Procreation, self-renewing stocks of these cells (stem cell lines) may be
If these stem cell lines are regarded as being equal to cells isolated from other tissues, the
utilisation in research and in industry will be covered by general acts and rules. However, if
these cell lines are regarded as being different from other cell lines, there will be a need for
setting up specific rules concerning the use of the cells.
5) Should specific rules apply with regard to information and consent from the
couples/the women who might donate fertilised and non-fertilised eggs?
The limited research relating to the IVF treatment and pre-implantation diagnosis that is
currently permitted on embryos must be approved according to the rules of the scientific ethical
Provided that possibilities for research employing embryos are extended, it should be
considered whether there is a need for specific rules concerning information and consent.
6) Should research on imported embryonic stem cell lines be regulated?
According to the Ministry of the Interior and Health, the Act on Medically Assisted Procreation
cannot be extended to apply to research on imported embryonic stem cell lines. A possible
need for regulation concerning the use of imported embryonic stem cell lines sh ould be part of
a comprehensive resolution in this field.
7) Should the use of adult stem cells be regulated further?
At present, adult stem cells may be used for research in accordance with the rules of the
scientific ethical committee system.
It is possible that in time there will be a sliding transition between cell lines produced from adult
stem cells and from embryonic stem cells. Provided that regulation on the use of embryonic
stem cell lines is established, it will therefore be relevant to ensure that regulation in this area is
in accordance with regulation applicable to adult stem cell lines.
Xenotransplantation comprises methods of treatment where cells, tissue or organs are
transplanted from animals to humans. The vision for xenotransplantation is that tissues or
organs from animals - in particular from genetically modified pigs - replace malfunctioning
tissues/organs in humans. At present, xenotransplantation is not offered as a treatment in
Denmark and the future importance of applying xenotransplantation in clinical medicine is
From a public health point of view, one of the main concerns is the risk of new and unknown
epidemics based on disease transmission from animals to man (zoonosis) and from man to
animals. Thus, the most important question will be to balance the advantages that this
treatment will offer the individual patient with the societal risks of major epidemics among
human beings and animals. In spite of extreme care, screening of donors and isol ation of
recipients, it will never be possible to guarantee the elimination of all risks of transferring an
In Denmark there are at present no clinical trials related to xenotransplantation, but in the event
of an international breakthrough in this field, it may be desirable for Denmark to participate in
Statements from The National Board of Health and the Central Scientific Ethical Committee
ensure that no treatment involving xenotransplantation is permitted and that
xenotransplantation should be performed solely as part of a research project and only after a
permission has been granted by the Danish Central Scientific Ethical Committee.
The ad hoc Committee on Gene Technology finds that this field is at present sufficiently
It is recommended
> that the present restrictions are maintained. However, in the event of an international
breakthrough this should be reassessed.
Gene therapy is based on the introduction of genes into the cells of a patien t - either to replace
diseased genes or to adjust the production of cellular proteins.
Early high hopes of applying this technology or treatment have been replaced by more cautious
assessments, but gene therapy is none the less seen as holding important promises for
treatment of conditions such as inherited disorders as well as cancer and cardiovascular
The most essential problems relate to engineered viruses that are often employed to introduce
the genetic material. One concern is that the use of virus may involve a risk of inducing or
transmitting infections. Gene therapy is covered by the existing legislation. The committee finds
that at present there is no need for any further regulation.
It is recommended
> that gene therapy as a field of research and treatment should be monitored with a view to
its possible future introduction in clinical medicine. This applies to both possible new
breakthroughs, questions of side effects and possible future needs for regulation.
Genetic testing of healthy individuals:
Genetic testing is used in the Danish health services today, and it is expected that its use will
increase in the years to come. The committee has in particular been concerned with tests
involving analyses of DNA or the related RNA.
Analyses of DNA/RNA will increase the knowledge concerning genetic predisposition for
development of diseases later in life. At the same time such analyses are likely to establish a
new paradigm, allowing for genetic counselling, prevention and treatment of diseases that are
far more individualised than we know today.
However, a number of challenges and problems are related to genetic testing of healthy
individuals. Firstly, it is important to secure the right of citizens who prefer „not to know“.
Secondly, it is anticipated that the increasing number of genetic tests will result in an increased
need for counselling. Thirdly, commercial aspects of offering these tests outside the authorised
or established medical laboratories or clinics might in some cases outweigh the regards for
proper counselling as a prerequisite for testing.
The introduction and use of genetic tests are regulated just as any other kind of diagnostic test
used within the health services or offered on the market. The Danish acts regulati ng this field
are the Act on Hospital Services, the Act on the Practice of Medicine, the Act on the Rights of
Patients and finally the Act on medical utensils implementing the „in vitro directive“ that covers
approval, including approval of genetic tests to be marketed in the European Union. The
committee finds that the major problem within this field relates to the counselling of the
individuals both before as well as after genetic testing has been performed.
It is recommended
> that the need for counselling of the person to be tested should be assessed in the light of
future developments in this area. The capacity for genetic counselling should be matched
to meet future demands.
Other Topics Concerned: Embryo Research and Cloning, Organ Transplantation,
Reproductive Decision – Making
GERMANY / ALLEMAGNE (2002)
(contribution November 2002)
Voluntary undertaking by the member companies of the Confederation of the German Insurance Industry
(Gesamtverband der Deutschen Versicherungswirtschaft e.V.) (GDV) (7 November 2001)
In their voluntary undertaking of 7 November 2001 the member companies of GDV (Gesamtverband der
Deutschen Versicherungswirtschaft) committed not to make the conducting of genetic tests the precondition
for an insurance contract nor to require their clients to submit voluntarily conducted predictive genetic tests
to an insurance company prior to the conclusion of a contract. One exception is to apply in the case of life
insurance involving very high sums insured (more than EUR 250,000 or annual pensions of more than EUR
30,000 in disability pensions, incapacity to work pensions and care pensions). It applies initially until 31
Coalition Agreement of SPD and Bündnis 90/DIE GRÜNEN(16 October 2002)
According to the Coalition Agreement of SPD and Bündnis 90/DIE GRÜNEN (16 October 2002) the handling
of genetic tests is to be regulated in a Genetic Test Act in order to protect the personal rights of the citizens.
In this context, the right not to know is to be guaranteed in order to protect those concerned from genetic
discrimination and to establish clear boundaries to the passing on of genetic data to third parties (e.g.
employers and insurance companies).
1. Confederation of the German Insurance Industry (GDV)
Voluntary undertaking by the member companies of the Confederation of the German Insurance Industry
(GDV) (Freiwillige Selbstverpflichtungserklärung der Mitgliedsunternehmen des Gesamtverbandes der
Deutschen Versicherungswirtschaft e.V.Gesamtverband der Deutschen Versicherungswirtschaft e.V., GDV)
(GDV) (7 November 2001)
Online version: http://www.gdv.de/fachservice/15807.htm
2. Coalition Agreement of SPD and Bündnis 90/DIE GRÜNEN
Coalition Agreement of SPD and Bündnis 90/DIE GRÜNEN (16 October 2002)
SWITZERLAND / SUISSE (2002)
(contribution November 2002)
Récents développements juridiques en Suisse
Loi fédérale sur l'analyse génétique humaine
Le 11 septembre 2002 le Conseil fédéral a adopté le message relatif à la loi fédérale sur l'analyse
génétique humaine qui par la suite sera discuté au parlement. Le projet de loi règle les conditions
auxquelles des analyses génétiques humaines peuvent être exécutées dans les domaines de la
médecine, du travail, de l'assurance et de la responsabilité civile. Il règle en outre l'établissement
de profils d'ADN visant à déterminer la filiation ou l'identité d'une personne. L'utilisation de profils
d'ADN dans le cadre d'une procédure pénale et pour l'identification de personnes inconnues ou
disparues est régie par la loi sur les profils d'ADN, qui est actuellement discuté au parlement. Le
message relatif à la loi fédérale sur l'analyse génétique humaine se trouve sur le site internet du
l'Office fédéral de justice sous: www.ofj.admin.ch, individu et société, analyse génétique.
Etat actuel de la loi fédérale relative à la recherche sur les embryons surnuméraires et sur
les cellules souches embryonnaires (loi relative à la recherche sur les embryons, LRE)
Le 22 mai 2002, le Conseil fédéral a lancé la procédure de consultation sur le projet de loi relative
à la recherche sur les embryons. 121 prises de position ont été reçues dans le cadre de cette
procédure, qui s'est terminée le 30 août 2002. Le Département fédéral de l'intérieur a évalué ces
prises de position et rédigé un rapport de consultation ainsi que le message relatif au projet de
loi. Le Conseil fédéral devrait prendre connaissance de la loi et du message en novembre 2002
et les transmettre au parlement.
La loi autorise la recherche sur les embryons surnuméraires, la production de cellules souches
embryonnaires à partir de tels embryons et la recherche sur les cellules souches embryonnaires
sous des conditions strictes.
UNITED KINGDOM / ROYAUME – UNI (2002)
(contribution November 2002)
BIOETHICS UPDATE – CONTRIBUTION FROM THE UK
In May 2002, The Human Genetics Commission (HGC) published 'Inside Information: Balancing
interests in the use of personal genetic data', its report on the storage, protection and use of
personal genetic information. Its main recommendations included: making a criminal offence of
testing a person's DNA for non-medical purposes without their knowledge or consent; introducing
measures to protect individuals from unfair genetic discrimination; and implementation of robust
and transparent arrangements to balance the interests of individuals against those of medical
research or forensic science.
The primary focus of HGC's current work is a review of the regulation of genetic testing services
supplied direct to the public, recommendations on which was requested by Ministers for the end
of the year. The deadline for responses to the associated consultation was 4 October, and
evidence is still being gathered from a range of sources, including meetings with relevant/
interested organisations, focus groups and innovative Internet technologies. Issues being
considered include: whether genetic test results should be treated differently from other health-
related information a person might have direct access to; the possible control of genetic testing
services available via the Internet; and the possible right of people to obtain whatever information
they want about themselves. More information can be obtained from the HGC website at
In July 2002, the Government issued a consultation document concerning the reform of the law
governing the taking, storage and use for any purpose of human organs and tissue, from the
living and the dead (including stillbirths and fetuses). The report Human Bodies, Human Choices
is available at www.doh.gov.uk/tissue. Consultation closed on 14 October 2002. The Government
is also developing a Code of Practice on the import and export of human body parts, and consent
forms and a Code of Practice concerning post-mortem examinations; information about this work
is also available on the tissue website.
Other Topics Concerned: Organ Transplantation
EUROPEAN PARLIAMENT / PARLAMENT EUROPEÉN (2002)
Elisa Maria DAMIÃO (PES, P)
Report on the Commission communication on Life sciences and biotechnology - A
Strategy for Europe
(COM(2002) 27 - C5-0260/2002 - 2002/2123(COS))
Procedure : Consultation paper
Debate : 20.11.2002
Parliament adopted a resolution on the Commission communication on life sciences and
biotechnology. The House adopted a very biotechnology friendly view on how to develop this
science in future. It rejected most of the amendments proposed mainly by the Green group.
The Parliament emphasises the urgency to complete a harmonised, knowledge-based,
predictable and ethical legal framework for biotechnology companies and farmers, which aims to
secure consumer safety, competitiveness, the prevention of both a 'brain-drain' in this field and a
future dependency on the import of biotech products. The House considers that users of
biotechnological developments should bear no risk of liability under the relevant EU legislation.
The MEPs say it is important to inform the public that biotechnology offers opportunities in various
fields from health to agriculture and from industry to alternative energy resources. They call on
the Commission to launch a „B-Europe‟ policy in the field of biotechnology. The Parliament
supports the Commission's idea to play a leading role in developing international guidelines but
regrets that this action is focused mainly on the food sector; points out that the establishment of
international guidelines is also necessary regarding the protection of human dignity in the field of
On the issue of food the Parliament strongly supports the view that the existing de-facto
moratorium on GM foods in force since 1998 should cease, in order to promote innovation. The
Parliament states that biotechnology alone will not help to overcome hunger in the world but
underlines that it might also be necessary to use genetically modified crops to produce enough
food. The Parliament states that biotechnology can contribute towards finding genuine solutions
to environmental problems, sustainable development and food sufficiency. MEPs stress the need
to ensure that consumers receive reliable information about GMOs so that they can choose a
product on the basis of prior information and can acquire confidence in GMO products and
On reproductive medicine the MEPs state that genetic testing and analysis must be conducted
under clear rules within the frame of competent, independent and personal counselling which
must cover medical, ethical, social, psychological and legal aspects. They reaffirm that the life
and dignity of all human beings, whatever their stage of development and state of health, must be
respected and is opposed to any form of research or use of life sciences and biotechnology that
runs counter to this fundamental principle. The Parliament considers it important to ensure that no
woman is compelled to have a pre-natal diagnosis carried out. It says that determination of sex in
connection with prenatal diagnosis should be permitted only - if at all - if there is a risk of serious
gender specific hereditary diseases. It also repeats its insistence that there should be a universal
and specific ban at the level of the United Nations on the cloning of human beings at all stages of
formation and development.
The Parliament also calls the Member States to improve education in the field of biology with a
particular focus on genomes and microbiology. MEPs call for a transparent information policy
based on scientific data and the media to cover the issue impartially.
Leena Maria Linnus
(Strasbourg) tel.(33) 3 881 72421
(Brussels) tel.(32-2) 28 42825
e-mail : email@example.com mailto:firstname.lastname@example.org
The above information comes from the following website:
Link: Genetic Engineering, Human Genetics
ESTONIA / ESTONIE (2001)
(Contribution : Januray 2001)
Estonian Parliament adopted the Estonian Human Genes Research Act in December 13, 2000
(The text of this Act is relayed in attachment. It is also available in English
Summary of the Human Genes Research Act
The Human Genes Research Act, passed by the Riigikogu on 13 December 2000, allows to
implement the project of the Estonian Gene Bank. The Act regulates the establishment and
maintenance of the Gene Bank, the collection of data thereinto and the issuing of data therefrom.
The Act shall not apply to genetic testing performed for example for the purpose of identifying a
person or diagnosing an illness. Tissue samples taken in the course of genetic testing shall not
be added to the Gene Bank and it shall not be possible to use the Gene Bank for performing
genetic testing at the request, for example, of a court or of an investigative body.
The Gene Bank shall be established by a non-profit foundation founded by the Republic of
Estonia. Therefore the Republic of Estonia shall have the highest decision-making powers in the
Gene Bank and upon termination of the foundation all rights and assets of the Gene Bank shall
be transferred to the Republic of Estonia. The foundation shall be founded in the capacity of a
chief processor. The management bodies of the foundation shall be the Board and the
Supervisory Board. The Riigikogu (the Parliament), the government of the Republic and the
Estonian Academy of Sciences shall appoint the members of the Supervisory Board. A separate
Ethics Committee shall also supervise the activities of the Gene Bank.
Only the gene donors themselves, doctors treating them and an authorised processor, the
requirements for which shall be established by the Government of the Republic, on the basis of a
respective contract, shall receive information from the Gene Bank. Research institutions of the
Republic of Estonia who are legal persons in public law and gene donors shall be entitled to
receive information from the Gene Bank without charge. The costs of founding the Gene Bank
shall be met to a great extent by the income received from the payments by persons in private
law for obtaining information. Irrespective of the fact whether the gene researcher comes from
Estonia or a foreign country, and irrespective of the amount they have to pay for receiving
information, it is permitted to use the Gene Bank only for research, for the study and treatment of
illnesses, for the improvement of public health and for statistical purposes.
The Gene Bank shall be the owner of a tissue sample, description of health status, genetic data
and personal data and gene donors shall not be entitled to request any fee for the processing of
their data nor a share of the profit created. At the same time the law prohibits any transfer of data
that is not coded or any tissue samples. It is not permitted to take the database out of the territory
of the Republic of Estonia.
Upon drafting the act, the principle of a person‟s free self-realisation has been followed. A person
is granted the possibility to participate in the project of the Gene Bank and no one is obliged. In
order to be really free in his or her self-realisation, a person has to be aware of his or her rights
and obligations as a gene donor. The Act, therefore, prescribes the facts that the gene donor has
to be informed of prior to the taking of a tissue sample (e.g. how the tissue sample will be taken,
what will be done with the tissue sample, what kind of data can be obtained on the basis of his or
her tissue sample, etc.) and the right to genetic counselling. It is only thereafter that a person will
be able to grant a valid consent to become a gene donor. For ensuring the principle of free self-
realisation, it shall be up to gene donors whether they want to know their genetic data or not.
Discrimination against a person on the basis of genetic information is prohibited, in particular in
insurance and employment relationships. It is prohibited both to induce or force a person to
participate in the project and to provide benefits or make restrictions on the basis of the fact of
Another principle underlying the Act is confidentiality of the identity of a gene donor. In the
database of the Gene Bank the personal data of a gene donor shall be separated from genetic
data and each tissue sample and set of health data shall be given a unique code consisting of
sixteen characters. At the present level of technology it is unreal to unlock such a code. If a gene
donor no longer wishes to participate in the project of the Gene Bank, the person has the right to
apply for the destruction of data which allows identification, or in certain cases the destruction of
all information relating to the person stored in the Gene Bank. After the above data has been
destroyed, it is no longer possible to associate a certain tissue sample and a gene donor. The
identity of a gene donor shall remain classified, even in court proceedings. In order to ensure
compliance with the highest standard of data protection, the connection of the Gene Bank to the
Internet, for example, shall be prohibited.
Criminal punishment for inducing persons to become gene donors, for conducting illegal human
research, for disclosure of confidential data and for discrimination is prescribed by law.
Other Topics Concerned: Ethics Commission / Competent Body / Advisory Organization
EUROPEAN COMMISSION / COMMISSION EUROPÉENNE (2000)
(Contribution : December 2000)
“Article 29” Data Protection Working Party
of the European Commission
on the Genome Issue
Adopted on 13th July 2000
THE WORKING PARTY ON THE PROTECTION OF INDIVIDUALS WITH REGARD TO THE
PROCESSING OF PERSONAL DATA
set up by Directive 95/46/EC of the European Parliament and of the Council of 24 October
having regard to Articles 29 and 30 paragraphs 1 (a) and 3 of that Directive,
having regard to its Rules of Procedure and in particular to articles 12 and 14 thereof, has
adopted the present opinion:
Opinion 6/2000 on the Human Genome and Privacy
The completion of a first draft of the DNA blueprint has been recently announced by those
involved in the Human Genome Project.
The Working Party recognises that this achievement of long lasting significance may permit the
diagnosis and treatment of diseases in a manner previously unimaginable.
At the public presentation on 26 June it was recognised that the risks of abuse of genetic
knowledge race legitimate concerns about the privacy of individuals. The Working Party shares
these concerns. The decoding of the DNA blueprint paves the way to new discoveries and uses
in the field of genetic testing. On the other hand, the information can identify individuals, link them
to others, and reveal complex data about the future health and development of those individuals
and other people to whom they are genetically related.
The Working Party wishes to emphasise the importance of privacy as a fundamental right and the
consequent necessity of deploying new genetic technologies with safeguards adequate to protect
Done at Brussels, 13th July 2000
Official Journal no. L 281 of 23/11/1995, p. 31, available at:
BELGIUM / BELGIQUE (2001)
(Contributions : December 1999)
The recently adopted texts on bioethics field are2 :
Law of 22 March 1999 relating to the procedure of identification by DNA
analysis within the framework of criminal justice.
These laws and decrees are available to the Secretariat of the Bioethics Section
This law, not published yet, regulates methods of removal, conservation, use, and destruction of
biological samples used to carry out DNA profiles, as well as the use, conservation and deletion
of DNA profiles and related data.
Moreover, this law provides for the creation of a “criminalistic” DNA database containing DNA
profiles of traces, and the creation of a “convicted offenders” DNA database.
1. Royal decree of 15 February 1999 establishing programming criteria to be applied
to the care programme in the field of “reproductive medicine”.
2. Royal decree of 15 February 1999 establishing standards to be met by care
programmes in the field of “reproductive medicine”, before agreement.
3. There is as yet no adopted law on xenotransplantation in Belgium.
Other Topics Concerned: Reproductive Decision Making
ISRAEL / ISRAËL (1999)
(Contribution : December 1999)
Prohibition of Genetic International Law (Cloning Human Being and Genetic Modifications of
Reproductive Cells), 5759- 1998
1. The purpose of the Law
The purpose of this law is to provide for a limited period of five years, during which certain types
of genetic intervention will not be performed on human beings, in order to examine the moral,
legal, social and scientific aspects of such types of intervention and their implication on human
In this law :
Advisory Committee - the supreme Helsinki Committee, appointed in accordance with the
Public Health Regulations (medical experimentation‟s on human beings), 5740- 1980.
Cloning a human being - the creation of an entire human being who is genetically and
chromosomally absolutely identical to another, person or foetus, alive or dead.
Reproductive cell – human sperm cell or ovule
The Minister – The Minister of Health
3. Prohibited Genetic Intervention
During the period in which this law is in force, no act of intervention in human cells will be
carried out, if the purpose of such act is one of the following:
(1) Cloning a human being.
(2) To bring about the creation of a human being through the use of reproductive cells
which have undergone a permanent intentional genetic modification (Germ-Line
4. Advisory Committee
The advisory Committee will follow developments in medicine, science and biotechnology in the
sphere of genetic experimentation on human beings, will report thereon annually to the Minister,
advise the Minister on these matters, and make recommendations to the Minister regarding the
validity of the prohibitions provided for in section 3 above.
5. Permitted Genetic Interventions
(a) Notwithstanding the provisions of section 3 above, if the Minister finds that no
harm will be caused to human dignity, he may permit, upon the recommendation of the Advisory
Committee, and under conditions which he shall determine by regulations, the performance of
certain types of genetic intervention, which are prohibited according to section 3 (2).
(b) Before performing an act of genetic intervention, which is permitted according to
subsection (a), advance permission is required, in accordance with conditions as will be provided
(c) In regulations according to this section, the Minister will determine the conditions
and procedures for the provision of a permit, the methods of supervision of performance of the
permitted genetic intervention and requirement of reporting.
Whoever carries out one of the following, is liable to a prison sentence of two years:
(1) performs an act forbidden in section 3 (1)
(2) performs an act forbidden in section 3(2), unless he acted lawfully in accordance with
a permit granted under section5.
7. Preservation of laws
The provisions of this law shall add to, and not derogate from, the provisions of any other law.
This law will be in force for five years from the date of its publication.
9. The Minister is responsible for the implementation of this law.
Other Topics Concerned: Embryo Research and Cloning