Do the laws relating to design-a-baby
differ throughout Europe - or do all countries think alike?
Find out about the following
issues.
Is sex selection
legal?
Is selecting an embryo for
its genes legal?
Is it legal to select a
particular embryo to provide tissue for another person?
Is it legal to genetically
engineer animals?
Who makes and enforces these
laws?
Click on an issue to find
out more. Click
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Is sex
selection legal?
United Kingdom
British law says that parents are only
able to select the sex of their child if there is a substantial
risk that a gender-related genetic disease could be passed
on. 'Family balancing', where the reasons for sex selection
are social rather than medical, is not allowed at licensed
clinics in the UK. However, private, unlicensed clinics are
not breaking the law by offering sperm sorting.
Denmark
The national Danish law on sex selection
came into force in June 1997. The law says, that the sex of
the child cannot be chosen, unless it is done to prevent a
serious gender-related hereditary disease.
Finland
At present, there are no specific regulations
concerning the selection of sex. A fertility treatment law
is being discussed in Parliament in 2002. The law will include
regulations about sex selection for gender-related hereditary
diseases or other medical factors.
France
In France, there are no explicit regulations
concerning the selection of sex.
However, the law does permit a therapeutic
abortion if a couple has a high risk of having a child with
a gender-linked genetic disorder. This would apply to gender-linked
disorders such as haemophilia. Although the gene is carried
by females, the disease only shows in males.
Germany
In Germany, selecting an already existing
embryo for its gender is prohibited by the 'Embryonenschutzgesetz'
('Law Protecting the Embryo'). This law applies even if the
intention is to prevent a life-threatening disease.
Selecting the sex of your child by selecting
particular sperm with which to fertilise an egg is also illegal,
except to prevent a few special, very serious gender-related
genetic diseases (e.g. Muscular Dystrophy). This applies whether
sperm are used for IVF or artificial insemination.
Italy
To avoid a disequilibrium in the number
of babies of a specific gender, sex selection of embryos is
not legal. However, it is allowed if the embryo is at risk
of sex-linked pathologies.
In fact, if the father suffers from a
hereditary pathology linked to his sex, that is linked to
his chromosome Y, the physician has to select healthy spermatozoa
containing only the chromosome X, avoiding those that contain
the chromosome Y.
Portugal
In Portugal, the Convention on Human Rights
and Biomedicine (Oviedo Convention) came into force in December
2001. Article 14 of the Convention explicitly prohibits the
use of medically assisted procreation techniques for the purpose
of choosing a future child's sex, except where serious hereditary
sex-related diseases are to be avoided.
Spain
In Spain, sex selection is only allowed
for therapeutic reasons to avoid a gender-related disease.
The 'Sentencia de Mataró' court case denied a mother
with four sons the legal right to choose to have a baby daughter.
This was one of a few judicial cases that applied to Law 35/
1988 regarding human assisted reproduction techniques. At
its time (1988), this law was innovative on a world scale
and still enjoys wide social consensus. However, 14 years
after its publication, some aspects of the law need revising.
European Union
There is no such thing as a European law
on designing babies. The closest we can get to a general consensus
is the Convention on Human Rights and Biomedicine of 1997,
which forbids sex selection except for therapeutic reasons
(article 14). The same recommendation is also given by several
Ethics Committees at a European level. However, the Convention
must be ratified by national Parliaments before it has the
force of law in member states and this did not happen. Germany,
Ireland and the UK did not sign or ratify it. Italy signed
but did not ratify the Convention.
There are no EU directives concerning
designing babies. However, the directive concerning the legal
protection of biotechnological inventions (directive 98/44/EC,
6 July 1998) is sometimes used as an argument against any
genetic modification.
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Is selecting an embryo
for its genes legal?
United Kingdom
At the moment in the UK, it is legal to
select an embryo for its genes. A technique called Pre-implantation
Genetic Diagnosis is used to screen for a handful of genetic
diseases. Doctors select only healthy embryos and implant
these into the mother's womb.
Denmark
The Danish law about artificial fertilisation
says that genetic investigation (screening) of a fertilized
egg can only be done in those cases where there is a known
and substantial risk that the child will get a serious hereditary
disease (Law of Artificial Fertilisation, 1997).
Furthermore, this law says that genetic
investigation of a fertilized egg can only be done in cases
of IVF treatment of couples unable to have children on their
own. As the egg in those cases is outside the body, it is
legal to screen for a chromosome abnormality.
Finland
At present, there are no specific regulations
governing this issue and no such cases are known where embryos
have been selected on the basis of their genes. However, the
issue is continuously under debate due to its controversial
ethical aspects. Generally speaking, Pre-implantation Genetic
Diagnosis (PGD) is used very little in Finland.
France
If a couple has a high risk of having a
child with a genetic disorder, they may choose to use the
In Vitro Fertilisation process (IVF). The embryos can be screened
and only healthy embryos are implanted into the mother. This
is legal in France.
However, you cannot lawfully choose to
have a blue-eyed child - for example.
Germany
Generally in Germany, the 'Embryonenschutzgesetz'
('Law Protecting the Embryo', which came into force in December
1990) only allows diagnosis or any analysis of an embryo if
the aim is to implant the individual embryo with the intention
of enabling pregnancy and birth.
But, there is a certain disagreement over
how to interpret the 'Law Protecting the Embryo' regarding
Pre-implantation Genetic Diagnosis (PGD). German law definitely
does not allow PGD just a few days after fertilisation. This
is because, at this stage of the fertilisation process, every
cell of the embryo still has the ability to become a complete
embryo again. Several experts think that this law might allow
PGD later in the development of the embryo, yet still early
enough to allow the embryo to be implanted into the womb.
Italy
Gene therapy and embryo selection procedures
are allowed only to avoid the transmission of hereditary pathologies.
The article 13 specifically forbids every
form of eugenetic selection of embryos and gametes. In particular,
it forbids the selection, manipulation or artificial change
of embryo or gamete genome, aimed at predetermining their
genetic characteristics. However, it is allowed in diagnosis
and therapy.
Portugal
There is no applicable law in Portugal.
The status of the embryo and its consequent use in research
have been discussed intensely several times. Several proposals
of law have been presented but none of them have been successfull
so far. It should be noted that
this particular topic is very controversial in Portugal, because
every time the use of embryos is discussed the topic of abortion
comes up too and the debate instantly becomes very emotional.
Spain
In Spain, Pre-implantation Genetic Diagnosis
to detect genetic diseases and abnormalities is a common and
legal practice. The selection of embryos helps parents to
have healthy children, which is one of the objectives behind
using human assisted reproduction techniques.
European Union
There is no applicable EU law. The Convention
on Human Rights and Biomedicine (1997) states that designing
babies for anything other than therapeutic reasons is forbidden
(article 14). This is also recommended by several Ethics Committees
at European level. However, the Convention must be ratified
by national Parliaments before it has the force of law in
member states and this did not happen. Germany, Ireland and
the UK did not sign or ratify it. Italy signed but did not
ratify the Convention.
[Return to list of Issues]
Is it legal to select
a particular embryo to provide tissue for another person?
United Kingdom
In the UK, the human fertilisation and
embryology authority (HFEA) announced it was prepared to allow
a couple to select their future child's genes to save the
life of their existing sick child. Pre-implantation Genetic
Diagnosis was used to ensure their new baby was not only free
from the genetic disease that affected his sister, but also
a tissue match. This enabled doctors to provide tissue from
the placenta to cure his sister. In the future, the HFEA will
review the merits of each case.
Denmark
There is no specific law about this in
Denmark. But the law on artificial fertilisation states that
it is only legal to select an egg if there is a risk of a
known hereditary disease. Consequently, it is illegal to select
a particular embryo to provide tissue for another person (Law
of Artificial Fertilisation, 1997).
Finland
For now, there have been no cases in Finland
in which embryos have been selected on the basis of their
genes in order to produce a perfect match to cure an existing
disease. However, this issue is continuously under debate
due to its controversial ethical aspects. Generally speaking,
pre-implantation genetic diagnosis (PGD) is used very little
in Finland.
France
So far, French law has not made it illegal
to use stem cells an embryo to cure another person's disease.
French Parliament debate over all types of stem cell research
is ongoing and strong.
As yet, there have been no cases in France
where an embryo has been selected for its genes, in order
to produce a perfect match to cure a relative's disease.
Germany
In Germany, it is illegal to investigate
an embryo for any reason except for its own benefit. Therefore,
a case like the one in the UK, where an embryo with particular
genes was chosen to save the life of a sick sibling would
definitely be illegal in Germany.
Italy
No. In Italy, assisted procreation
has the only aim to solve reproductive problems deriving from
human sterility or infertility.
In fact, assisted procreation aims at ensuring
equal rights to Italian population and, in particular, to
the newborn.
Furthermore, law punishes every kind of
marketing, importing and exporting, of gametes and embryos.
Portugal
There is no applicable law in Portugal.
Spain
There is no specific, applicable law nor
have there been test cases on this matter in Spain. However,
it is generally accepted that it is not illegal to select
a particular embryo to provide tissue so long as the rights
of the newborn child are always guaranteed. Like any individual
the newborn would of course have his or her fundamental rights
protected by the state.
European Union
There is no applicable EU directive.
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Is it legal to genetically
engineer animals?
United Kingdom
In the UK, it is legal
to genetically engineer mice, cows, pigs, sheep and goats.
The Medical
Research Council, which funds most animal experimentation
in British labs, stated that "UK law and animal ethical
codes require researchers to use the least 'advanced' animals
and the minimum number wherever possible. We expect genetically
modified mice will remain the most important species where
animals have to be used to help us understand disease and
improve health." Genetically engineered monkeys such
as ANDI would therefore not find much favour in UK labs.
Denmark
The national Danish law about protection
of animals came into force in 1991 (Law of Animal Protection,
1991). It does not include any specific rules about genetic
modification of animals but states that animals should be
treated properly and be as well-protected as possible against
pain, suffering, fear, permanent injury and 'essential disadvantage'
(meaning anything that is bad or inconvenient for the animal).
The Danish Minister of Justice can lay down more specific
rules or even ban the use of biotechnology, gene technology
and the like on farming animals. But this has not yet been
the case (Law of Animal Protection, 1991).
Finland
Genetically engineering animals is legal
in Finland. However, any such action is strictly regulated
and controlled by the Board for Gene Technology.
France
Genetically engineering animals is legal
and practiced in France, both for agriculture and research
purposes.
Germany
Genetically engineering animals is legal
and practised in Germany for research purposes. Particularly
in medical research large numbers of genetically engineered
animals are used, mainly mice and rats. So far, there are
no cases of genetically modified animals being used in agriculture.
Italy
Besides what is stated into the European
Union set of rules for this subject, genetically modified
plants and animals, excluding microorganisms, can be introduced
in the outer environment only if they cannot spontaneously
reproduce and if they pass all the tests described in the
article 2. These precautions are needed to evaluate possible
future risks.
However, it is considered necessary that plants
and animals be evaluated in specific test fields, be registered
in apposite genealogic records and be permanently certified
for their transgenic origin.
Furthermore, Italian law establishes that
animals that are or were subject to genetic engineering must
not be treated cruelly. Also, transgenic animals cannot be
generated to have diseases generate spontaneously.
Portugal
There is no law specifically regarding
genetic engineering of animals. However, mice, pigs, dogs,
cats, horses, sheep, cows, goats and (non human) primates
are used extensively for research under EU Directive nº
86/609/CEE. However, the directive does not refer to genetic
engineering and there is no other law.
Spain
In Spain, genetic selection of plants and
animals is not only authorised, but commonly used to improve
animal and plants characteristics. However, limits are imposed
by Law 15/1994, which aims to protect biodiversity and consumer
rights.
Nowadays however the well-being of animals
is increasingly considered, and both the central government
and the autonomic (regional) governments are issuing more
restrictive laws on animal research. Ethics Committees for
Animal Experimentation were created at both National and Autonomic
levels.
European Union
There is no applicable EU directive specifically
related to genetic engineering. Mice, pigs, dogs, cats, horses,
sheep, cows, goats and (non human) primates are used for research
in universities and laboratories.
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Who makes and enforces
these laws?
United Kingdom
The Human Fertilisation and Embryology
Authority (HFEA), which was set up in the UK in 1991, ensures
that all UK treatment clinics offering In Vitro Fertilisation
(IVF) or Donor Insemination (DI), or storing eggs, sperm or
embryos, conform to high medical and professional standards
and are inspected regularly. They collect comprehensive data
about such treatments, and provide detailed advice and information
to the public.
The HFEA also licenses and monitors
all human embryo research, supervising controlled research
for the benefit of humankind. They also consider the ethical
implications of a number of key issues.
As fertility and genetic manipulation
techniques develop, the law needs to review their application
for each new case. The law needs to catch up with the science.
Denmark
National
Danish laws are written by the relevant ministries. In cases
of artificial fertilisation, the law is in the hands of the
Ministry of Health. In animal welfare cases the Ministry of
Justice enforces the law.
In Denmark, biomedical research on living human
beings, human eggs and sperm, human fertilized eggs, embryos
and foetuses requires the permission of a 'Science-ethical
committee'. There are eight regional cpommittes and one central
committee. The task of the science-ethical committees is to
ensure the protection of the subjects taking part in research
projects whilst making possible the development of new and
valuable knowledge. The national Danish law for a science-ethical
committee system and their trial of biomedical research projects
came into force in 1992 (Law of Biomedical Research, 1992).
The Ethical Council advises the Minister
of Health, the authorities of health etc about general ethical
aspects of new biomedical technology. The ethical council
was established in 1987.
Finland
Medical research is governed by the Medical
Research Act, which came into force in 1999. The Act states
that in medical research the interest and well-being of the
research subject shall always be put before any benefits to
science or society. Under the law, medical research involving
human subjects, which also covers research involving embryos
and foetuses, always requires authorisation from the ethics
committee of the hospital district.
The Board for Gene Technology is constituted
by the Gene Technology Decree. The Board aims to ensure safe
and ethically acceptable use of gene technology. It issues
instructions and regulations, acts as a registration authority
and monitors the use of gene technology. The Board is appointed
by the Council of State.
The National Advisory Board on Health Care Ethics
(ETENE) is an expert committee concerning ethical issues related
to health care and relevant legislation.
France
A National Consultative Ethics Committee
for Health and Life Sciences (CNCE) was created by law in
July, 1994. This committee looks at the donation and use of
components and products from the human body, medically assisted
reproduction, and prenatal diagnosis issues.
The mission of CNCE is to 'give opinions on
ethical problems raised by progress of knowledge in the fields
of biology, medicine and health, and to publish recommendations
on these proposed topics'.
Since 1994, new laws in this area have been
prepared and proposed by the Ethics Committee (CNCE) and made
law by the French Parliament.
Local Ethics Committees have also been
created by a number of hospitals.
Germany
In Germany, the legal authority is the
Deutsche Bundestag, the German Parliament. Two boards of experts,
the 'Inquiry committee of the Deutsche Bundestag for Law and
Ethics in Modern Medicine' and the 'National Ethics Committee'
situated at the chancellor's office, give scientific advice.
There is no special commission to control
these laws, but there is discussion on whether such a commission
should be founded within the scope of a revised form of the
'Embryonenschutzgesetz' ('Law Protecting the Embryo').
Italy
In Italy, a committee, led by the Noble
Prize Renato Dulbecco, evaluates and defines the ethical implications
of any issue in this subject, being as objective as possible.
Furthermore, a ministerial committee,
led by the Minister of Health, is in charge of proposing and
reviewing laws, so that these can catch up with population
needs and European guidelines. Besides, the committeee establishes
the range of applicability of the different techniques, and
licenses and monitors Italian centers where these can be used.
Portugal
The law is made by the Portuguese Parliament
and enforced by specific committees established ad hoc and
on a case-by-case basis. On general health issues, each hospital
has a specific ethics committee (created by the Decree-Law
nº 97/95). However, the decisions of these committees
only have to be strictly followed in the case of human medical
experiments (e.g. testing new treatments, new pharmaceutical
products, etc.). For all other cases, the committees issue
recommendations and the professional codes of doctors and
researchers apply.
For research on animals, the General-Directorate
of Veterinary Medicine (Ministry of Agriculture) supervises
all procedures, on a case-by-case project evaluation.
Spain
In Spain, legislation regarding medically
assisted procreation dates from 1988 and its basic regulations
are: a) Law 35/1988, concerning human assisted reproduction
techniques and b) Law 42/1988, regulating the donation and
use of human embryos and foetuses. Both are approved by the
State Parliament. Moreover, the Convention on Human Rights
and Biomedicine (Council of Europe) has had the force of law
in Spain since 1 January 2000, and its directives are in accordance
with the legislation already in existance.
Since 1998 Spain has had a National Commission
on Assisted Human Reproduction, which is in charge of issuing
reports and evaluating research projects and improving techniques.
Catalonia also has a Commission for Assisted
Human Reproduction Techniques - which is older than its National
counterpart. They have produced many reports concerning complex
issues, including research on embryos, oocyte donation, and
storing eggs and sperm.
European Union
The EU decision-making process is complex
and there is more than one decision procedure. For matters
of scientific and technological research, the 'co-decision'
process applies. To begin with, the technical work is the
responsibility of the European Commission (the Director Generals
and Services), which then makes one proposal. This proposal
is then subject to discussion between the Council of the European
Union (Ministers from the 15 member-states) and the European
Parliament, until an agreement is reached. Advice can always
be asked from advisory groups (for example the European Group
for Ethics in Science and New Technologies. For more information
see http://europa.eu.int/comm/european_group_ethics/index_en.htm.
The final responsibility for approval belongs
both to Council and the Parliament (which is why it's called
a co-decision).
Once the legislation is approved, the member-states
are responsible for its enforcement. A law in the EU can be
called a regulation, directive, decision or recommendation
- for the differences see http://europa.eu.int/eur-lex/en/about/pap/process_and_players2.html#1.
If the law is not followed or wrongly followed, the Commission
can present a complaint to the Court of Justice of the European
Communities. European citizens or persons residing or having
their legal domicile in a Member State can also present a
complaint to the European Ombudsman (http://europa.eu.int/institutions/ombudsman/index_en.htm).
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