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 a flag to view the answers for that country. Click here to view by issue.

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United Kingdom

Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
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.

Is it legal to genetically engineer animals?
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.

Who makes and enforces these laws?
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.

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Denmark

Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
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).

Is it legal to genetically engineer animals?
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).

Who makes and enforces these laws?
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.

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Finland

Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
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.

Is it legal to genetically engineer animals?
Genetically engineering animals is legal in Finland. However, any such action is strictly regulated and controlled by the Board for Gene Technology.

Who makes and enforces these laws?
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.

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France

Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
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.

Is it legal to genetically engineer animals?
Genetically engineering animals is legal and practiced in France, both for agriculture and research purposes.

Who makes and enforces these laws?
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.

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Germany

Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
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.

Is it legal to genetically engineer animals?
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.

Who makes and enforces these laws?
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').

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Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
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.

Is it legal to genetically engineer animals?
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.

Who makes and enforces these laws?
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.

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Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
There is no applicable law in Portugal.

Is it legal to genetically engineer animals?
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.

Who makes and enforces these laws?
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.

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Spain

Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide tissue for another person?
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.

Is it legal to genetically engineer animals?
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.

Who makes and enforces these laws?
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.

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European Union

Is sex selection legal?
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.

Is selecting an embryo for its genes legal?
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.

Is it legal to select a particular embryo to provide a source of spare parts for another person?
There is no applicable EU directive.

Is it legal to genetically engineer animals?
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.

Who makes and enforces these laws?
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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