Using human embryos for any purpose other than to create
a baby is highly controversial.
For some people, destroying a human embryo to provide a cure
for a disease is wholly unacceptable. For others it is acceptable
if the embryo is young enough and the disease serious enough.
To form a law which either bans or permits the use of embryos
in medical research, law makers must debate all the issues
with scientists, religious leaders, bio-ethicists, pressure
groups and members of the public.
The cultural and historical variety within Europe has led
each country to form slightly different laws on the use of
embryos. In some cases, what is legal in one country is banned
in another.
Find out about the
following issues.
Is it legal to use human embryos in medical
research?
Is it legal to create an embryo purely for medical
research?
Is it legal to use human embryos to produce
stem cells?
Is it legal to clone a human embryo for medical
research (therapeutic cloning)?
Is there a law banning reproductive cloning?
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Is
it legal to use human embryos in medical research?
United Kingdom
Yes,
in Britain this is legal under strict licensing laws.
Since
1990, the Human Fertilisation and Embryology Act has permitted
research on human embryos for a few specific reasons. These
include research into miscarriage, infertility and genetic
disease.
In
2001, this Act was amended to allow the use of embryos for
research into serious diseases and their treatments, and for
research into the development of human embryos.
In
all cases, the embryos must be destroyed within 14 days of
fertilisation.
Denmark
In
Denmark, there are two cases where it is legal to use human
embryos in medical research. That is, when the aim is to improve
the techniques for artificial fertilisation, and the techniques
for genetic investigation of the embryo. Any other experiments
with embryos are not legal. That is stated in the national
Danish law on artificial fertilisation (Lov om kunstig befrugtning)
from 1997.
Finland
Medical
research is governed by the Medical Research Act (1999). According
to this Act, embryos left over from fertilisation treatments
can be used for research, providing that the donors have given
written consent. Embryos must not be moved into a body and
must be destroyed within 14 days of fertilisation. Eggs and
sperm can be stored in liquid nitrogen for 15 years e.g. in
cases in which an early adulthood disease leads to infertility.
After 15 years, the eggs and sperm cannot be used in research
and must be destroyed.
France
No.
In France, the Bioethics law of July 1994 generally prohibits
experimentation on the human embryo. However, there is an
exception to this rule: research is permitted if it is of
use to the embryo and does not damage it, and if the parents
have given their consent.
Since
this law was passed, the situation has changed. France's highest
medical authorities (the National Ethics Consultative Committee
and the Academy of Medicine) and the Council of State have
recommended that research on embryos in vitro should be allowed.
A new bill to amend the previous law was
presented to the Council of Ministers on the 20th June 2001,
then adopted after a first reading at the Assemblée
Nationale (French Parliament) in January 2002. It could become
law in 2003. This new legislation would allow parents to donate
their surplus frozen embryos (not implanted in the uterus)
for medical research. Experimentation will only go ahead if
both parents have given written consent and if the research
protocol has been specifically approved by the Ministries
responsible for Research and Health.
Germany
Generally
in Germany, the 'Embryonenschutzgesetz' ('Law protecting the
embryo'), which came into force in January 1991, allows any
diagnosis or analysis of an embryo only for its own benefit
and with the aim of implanting this individual embryo into
its mother's womb with the intention of pregnancy and birth.
Using an embryo in medical research therefore is illegal in
Germany.
Italy
In
Italy, it is striclty forbidden to use human embryos for research.
Clinical and basic research are allowed
only if alternative methodologies are not available. Furthermore,
they must be aimed at improving therapy and diagnosis, and
protecting health and development of the embryo itself.
Portugal
No. In Portugal,
there was never a consensus on the status of the embryo. This
has prevented all attempts to legislate medically assisted
procreation (more than 10 draft bills have been proposed in
the past 2 decades).
There is a very general Bill (Bill 135/VII
(1997)) issued by the Council of Ministers prohibiting 'the
creation or utilisation of embryos for the purposes of research
or scientific experiment'. It accepts research however 'when
this has the sole purpose of benefiting the embryo'.
Spain
Spain has directly
applicable legislation on assisted reproduction techniques
(laws 35/1988 of November 22) and on the donation and use
of human embryos and foetuses or their cells, tissue and organs
(laws 42/1998 of December 28). Spain has also ratified the
Council of Europe's Convention on Human Rights and Biomedicine.
Moreover, important sentences have been passed down by the
Constitutional Court (STC 212/96 and STC 116/99).
This legislation authorises
research using unviable embryos, so that the main problem
regards the concept of viability. The discussion centres on
whether surplus cryo-preserved embryos which have passed their
legal date for use and have been discarded for any parental
project, should be considered unviable or not, as their chances
of developing in a liquid nitrogen tank are nil. The National
Commission on Assisted Reproduction and the Observatory of
Bioethics and Law, as well as many scientific groups, have
all declared themselves in favour of this option.
European Union
There is no specific
legislation at the EU level.
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Is
it legal to create an embryo purely for medical research?
United Kingdom
Yes,
in Britain this is legal if consent has been given. Before
any eggs and sperm are collected, the donors must sign a consent
form saying what their eggs and sperm could be used for in
a variety of situations, for example if they should die, or
if any eggs are left over.
If
consent has been given, eggs and sperm can be used to create
new embryos which will only ever be used for medical research,
before being destroyed. The Human Fertilisation and Embryology
Act applies equally to all embryos, whether created to implant
into a woman, or purely for medical research.
Denmark
No.
In Denmark it is not allowed to create embryos purely for
medical research. It is only allowed to carry out research
on embryos that are created for artificial fertilisation,
but are not used. This rule is not directly stated in the
national Danish law on artificial fertilisation from 1997,
but it is the interpretation by the Danish Parliament of this
law.
Finland
In
Finland, creating embryos for research purposes only is strictly
prohibited.
France
No.
In France, the current law (passed on 29th July 1994) prohibits
the production of embryos for research. In vitro fertilisation
(IVF) can have only one purpose: to help a couple have a child.
Surplus embryos are stored in a frozen state for five years
for possible further implantation in the mother's uterus.
The parents can also decide to give them to another couple
or have them destroyed. After this five-year period, they
must be destroyed. Today in France, there are around 100,000
surplus embryos with about 1,000 more produced each month.
The new law to be voted on in 2003 would
also prohibit the conception of human embryos for research
purposes (in other words, where there are no direct plans
to have a child). Here, legislators agree with the reservations
of biologist Jacques Testard (producer of the first French
IVF baby): creating human beings in order to destroy them
would be a genuine anthropological revolution.
Germany
According to §
1 of the 'Embryonenschutzgesetz' ('Law protecting the embryo')
from 1991, any person is subject to prosecution who artificially
fertilises an egg cell for any purpose other than to bring
about a pregnancy of the very same woman who donated the egg
cell. Therefore, it is illegal to create an embryo purely
for medical research.
Italy
No, in Italy it
is forbidden to produce human embryos for research or experimentation
purposes.
Portugal
No.
Bill 135/VII (1997) issued by the Council of Ministers prohibits
'the creation or utilisation of embryos for the purposes of
research or scientific experiment'. It accepts research however
'when this has the sole purpose of benefiting the embryo'.
The European Convention for the Protection
of Human Rights and Dignity of the Human Being with regard
to the Application of Biology and Medicine (also called the
Oviedo Convention) came into force in Portugal in December
2001. Article 18 explicitly prohibits the 'creation of human
embryos for research purposes'.
Spain
No. This is specifically
prohibited in Article 18.2 of the Council of Europe's Convention
on Human Rights and Biomedicine, ratified by Spain and in
force since 1 January 2000.
European Union
There is no specific
legislation at the EU level.
On the level of the Council of Europe,
the European Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to the Application
of Biology and Medicine (also called the Oviedo Convention,
1997) explicitly prohibits the 'creation of human embryos
for research purposes' (article 18). However, the Convention
only has force of law once ratified by national Parliaments,
which did not happen in all EU countries.
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Is
it legal to use human embryos to produce stem cells?
United Kingdom
Yes,
in Britain using embryos to produce stem cells is legal. Since
2001, it has been legal to use embryos in this way to find
cures for serious diseases. Research is only permitted under
a licence from the Human Fertilisation and Embryology Authority.
As with all embryo research, embryos can only be grown for
14 days after fertilisation - at the end of the 14th day they
must be destroyed (although in reality embryos do not survive
this long in culture).
Denmark
It
is not legal to use human embryos to produce stem cells. That
is stated in the national Danish law on artificial fertilisation
from 1997. But it is legal to import stem cells for research
from other countries. That was stated by the Minister of Health
in January 2002.
Finland
Research
that aims at altering hereditary qualities or features is
prohibited, unless a serious disease can be cured or prevented
as a result. Stem cell research is controlled by the ethical
boards of hospital districts.
France
No.
At present in France, the removal of stem cells from embryos
falls foul of the bioethics law of 1994 that prohibits research
on embryos. However, there is a lacuna in the law since the
importation of human embryo cells available on the international
market (around sixty lines) is not forbidden.
The new bill scheduled for 2003 will probably
legalise the production of stem cells for therapeutic ends,
but only using surplus frozen embryos produced by IVF and
donated by both parents for research.
Germany
The
German 'Embryonenschutzgesetz' ('Law protecting the embryo')
explicitly prohibits any use of any embryo except for its
implantation into its mother's uterus with the intention of
pregnancy and birth. Consequently, it is illegal to use an
embryo to produce stem cells.
However, under certain, very strictly
regulated circumstances the import of stem cells from other
countries is possible for special research projects of high
importance. These special stem cells must originate from stem
cell lines created and established before 1st January 2002
and they can only be used in research projects with 'high-ranking
research objectives'. Every single case has to be approved
by a special ethics committee.
Italy
In
Italy, both the division and the dissectogenesis of human
embryos are forbidden.
Furthermore, it doesn't matter if they
are finalized to procreate or research: they are both severly
condemned by the law.
Portugal
In Portugal, there
is no legislation concerning stem cells. However, Article
18 of the Oviedo Convention - which has the force of law in
Portugal - explicitly prohibits the 'creation of human embryos
for research purposes'.
Spain
The law stipulates
that specific authorisation is necessary for this. This authorisation
should, in principle, be given by the National Commission
on Assisted Reproduction or by an ad hoc commission. But opinions
vary and the Conservative government is opposed to it.
European Union
There is no specific legislation at the
EU level.
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Is
it legal to clone a human embryo for medical research (therapeutic
cloning)?
United Kingdom
Yes,
in Britain this was made legal in January 2001 by the 2001
amendments to the 1990, Human Fertilisation and Embryology
Act. This type of cloning is called therapeutic cloning and
is used to produce stem cells to cure serious diseases.
In response to the 2001 amendment (which allowed
therapeutic cloning), anti-abortion campaigners from the Pro-Life
Alliance launched a legal battle in an attempt to block therapeutic
cloning. The British High Court ruled that a cloned embryo
was indeed different from an 'ordinary' embryo and so was
not covered under the 1990 Human Fertilisation and Embryology
Act. Therefore, research using cloned embryos should not be
allowed as there was no law to regulate it.
In January 2002, this ruling was overturned
by 3 appeal judges who ruled that a cloned embryo was in fact
covered by the 1990 Act and therapeutic cloning was therefore
legal. The Pro-Life Alliance have successfully petitioned
the House of Lords to review this decision.
Denmark
It
is not legal to clone a human embryo for medical research.
That is stated in the national Danish law on artificial fertilisation
from 1997. There are no laws on using theraputical cloning
for treatment. A doctor in Denmark can do treatment with theraputic
cloning, as long as he follows the rules on responsibility
in the national Danish law on practising doctors' work (Lov
om udøvelse af lægegerning) from 2001. The rules
states that the doctor should be careful and conscientious
in his work. However, therapeutic cloning is still not used
for treatment.
Finland
Therapeutic cloning of fertilisation treatment
left over embryos is legal, but the embryos must be destroyed
within 14 days of fertilisation.
France
No.
At present, the production of embryos by cloning (implantation
of the somatic nucleus into an ovum) is forbidden in France.
The bill that may be passed in 2003 will also forbid this
technique, despite a recommendation from the National Ethics
Consultative Committee. On 7th February 2001, this committee
voted in favour of the legalisation of therapeutic cloning
by 14 votes to 12. But the National Human Rights Consultative
Committee (CNCDH), the Council of State and the President
of the Republic, Jacques Chirac, have expressed their opposition.
They fear that authorising therapeutic cloning would lead
to the appearance of a commercial market for ova and also
facilitate reproductive cloning.
Germany
According
to the interpretation of most legal experts in Germany, the
ban of cloning in § 6 of the 'Embryonenschutzgesetz'
('Law protecting the embryo') includes 'therapeutic cloning'
as well as "reproductive cloning". In addition,
since such a clone is an embryo in itself it is not only illegal
to produce it but also to use it in medical research. This
is because the 'Embryonenschutzgesetz' prohibits any examination
of any embryo except for its benefit).
Italy
In
Italy, it is forbidden to clone even for therapeutic purposes.
However, the law will be valid until December 31st 2003.
Both manipulation and therapeutic cloning
are punished according to the first paragraph of the law.
This provides for imprisonment, ban from holding public offices
and the professional roll.
Portugal
In Portugal, there
is no legislation on therapeutic cloning. However, Article
18 of the Oviedo Convention - which has the force of law in
Portugal - explicitly prohibits the 'creation of human embryos
for research purposes'.
The Portuguese
scientific community however, agrees with this technological
possibility and sees it as a hope for future medicine.
Spain
In principle,
if therapeutic cloning is done using surplus embryos which
have passed their legal date for implantation and with the
authorisation of the genetic material donors, it should be
legal. The problem is that certain religious groups who control
the administration's decision making mechanisms, are opposed
to this.
European Union
There is no specific legislation at the
EU level.
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Is
there a law banning reproductive cloning?
United Kingdom
Yes,
the Human Reproductive Cloning Act was passed in December
2001. This makes it an offence to place a cloned human embryo
in the womb of a woman. A ten year prison sentence awaits
anyone trying this procedure.
Denmark
Yes,
the national Danish law about artificial fertilisation from
1997. The law bans doctors from treating women with reproductive
cloning. Experiments with reproductive cloning are also banned.
Finland
The
Medical Research Act (1999) bans reproductive cloning.
France
The
bill that may become law in 2003 is very tough on this point.
It considers reproductive cloning (cloning with implantation
in a woman's uterus) to be a criminal infringement of the
integrity of the human race and a eugenist practice (article
21). Articles will be added to the French Civil and Penal
Codes to prohibit this practice. Any biologists or medical
teams producing a cloned and implanted embryo will face up
to twenty years in prison.
In addition, France and Germany have made
representations to the UNO with a view to introducing an international
ban on reproductive cloning. This would make it a crime covered
by a restrictive legal framework like the one that punishes
torture.
Germany
Yes,
§ 6 of the 'Embryonenschutzgesetz' ('Law protecting the
embryo') prohibits the artificial creation or even the attempt
at the creation of a human embryo with the same genetic information
as another embryo, foetus, human being or a deceased person.
Likewise, it is punishable to transfer or to try to transfer
such an embryo into a woman's uterus.
Italy
Human
cloning, even for reproduction purposes, is forbidden according
to the article 582bis.
This article states that every person
who obtains through any artificial method human embryos with
the same genetic characteristics of another embryo, phetus,
or human being, either dead or alive, is liable to punishment
with imprisonment from 5 to 10 years, and ban from holding
public offices and the professional roll.
Portugal
Yes. The Law on
Assisted Procreation Techniques passed by the Parliament in
July 1999 banned cloning and criminalised its use.
Spain
Yes, reproductive
cloning has been prohibited since 1988 under the law on assisted
reproduction. Reproductive cloning is considered a criminal
act under the 1995 penal code and is banned by the additional
protocol to the Convention on Human Rights and Biomedicine
which forms part of Spanish domestic law.
European Union
Yes. The first law banning
reproductive cloning was the Resolution of the European Parliament
(16 March 1989) that stated that criminal punishment was the
only possible reaction to human cloning. This was followed
by another Resolution (28 October 1993) that banned the cloning
of human embryos. a further Resolution (11 March 1997) explicitly
banned cloning and requested EU Member States to adopt measures
to criminally punish all violations of the ban.
The Charter of Fundamental Rights of the European
Union (2000) prohibits the reproductive cloning of human beings
(article 3).
At a broader level, Article 1 of the Additional
Protocol to the European Convention for the Protection of
Human Rights and Dignity of the Human Being with regard to
the Application of Biology and Medicine (Oviedo Convention),
bans cloning.
More international texts that forbid cloning
are: the Resolution of the 50th World Health Assembly (14
May 1997) and Article 11 of the Universal Declaration on the
Human Genome and the Rights of Man (11 November 1997).
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