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Nervous system

The system which coordinates the actions of the body in response to changes in the environment using electrical signals travelling through a system of nerves

Home Office

The UK government department responsible for regulating the use of animals in scientific research.

Patent

Legal protection that gives an inventor the right to be the only one to make and market their invention for the next 20 years.

In vitro fertilisation

In vitro fertilisation is a form of infertility treatment where ova are removed from a woman and fertilised outside of the body by sperm. The resulting zygotes are allowed to develop for a few days before one or at most two embryos are returned to the uterus to implant and develop.

Stem cells and the law

William Burke and William Hare murdered sixteen people in Edinburgh in 1828. They sold the bodies of their victims to a doctor to use as anatomy specimens. Killing someone to provide a body to carry out research on is wrong, as is killing someone for spare body parts or cells. So is there a moral (and legal) difference between killing a person for research purposes, and destroying an embryo to obtain stem cells?

UK law

Research using stem cells is strictly controlled to maximise the benefit gained from the research whilst minimising the areas of it that some people find ethically wrong. In the UK, any scientific establishment using human embryos to create stem cells must hold a licence from the Human Fertilisation and Embryology Authority (HFEA); any establishment storing and using human tissue must hold a licence from the Human Tissue Authority (HTA); any establishment testing the effects of stem cells in animals must hold a licence from the Home Office; and any establishment altering the genetic material of a stem cell must inform the Health and Safety Executive of what they are doing. All these government bodies ensure that research using stem cells is carried out safely and within the law.

In the UK, embryonic stem cells are mostly harvested from embryos donated by couples undergoing fertility treatment. These embryos would otherwise be destroyed without being used – so for many people it is appropriate to use them in work that could prevent or alleviate illness before they are destroyed. If scientists require embryonic stem cells with a specific genetic disease, they must obtain special permission to create them using the same methods as for IVF. The law in the UK states that the embryo must be used within 14 days of its development: this is before it develops a nervous system (so it isn’t conscious and can’t feel pain – similar to a dead organ donor on a life support machine), before it becomes an individual (because it could still split to become twins) and at the stage where it cannot develop further and survive outside the womb. In fact embryonic stem cells are removed from the blastocyst much earlier than this – at about 5-6 days. Most scientists accept that the embryo at this stage is not a human being with human rights, although many understand the opinions of people who oppose this view. Many scientists are keen to develop alternative, less controversial methods of producing stem cells.

Some people feel that the destruction of an embryo is never justified, whatever benefits it might bring to thousands of others in future. They feel that because the embryo has the potential to become a human, it must be afforded its full human rights. Those with religious beliefs may believe that life begins at fertilisation, and so harvesting stem cells from an embryo is as great an evil as killing a grown human being. However, as long as scientists comply diligently with the law, it remains legal in the UK to develop cell lines from human embryos before they are 14 days old. As the UK separates from Europe, UK law-makers will continue to make their own decisions on these emerging technologies.

EU and US law

Other countries in Europe have similar, or stricter, rules relating to stem cell research than the UK: Belgium has similar laws to the UK, whilst Germany and Italy prevent the production of embryonic stem cells from human embryos. Perhaps surprisingly, many European countries including Austria, Bulgaria, Cyprus, Ireland, Lithuania, Luxembourg, Malta, Poland, Romania and Slovakia currently (2017) have no specific legislation at all about the production of ESCs. The European Court of Human Justice has ruled that patents cannot be granted to the inventor of an embryonic stem cell product. A patent is a set of exclusive rights in the market granted to the owner of an invention, meaning the person who holds the patent can set a price for the product. This generally guarantees a profit – so if a person has invested money in researching an embryonic stem cell invention, they know they will make a good return. For years the European Parliament would not allow patents to be granted for any processes using embryos or tissues which can only be obtained by the destruction of embryos for industrial or commercial processes. Although this meant that the price of stem cell therapies cannot be artificially increased which could put them out of the financial reach of some patients in the EU, it also made investment in European stem cell research difficult. However, in 2014 the EU position changed to reflect the ability of scientists to produce iPSCs, effectively embryonic stem cells produced from adult human cells. Any treatment or process which can be carried out using embryonic stem cells which do not have to be derived from a viable human embryo can now be considered for a patent in Europe.

In the United States, there is a double legislative structure, with individual states often making their own decisions on controversial laws. President Barack Obama was a strong advocate of stem cell research. In spite of this, in contrast to the UK, where public money supports stem cell research, some US states banned public funding of embryonic stem cell research. Other states, such as California, have taken a leading role in stem cell developments. It is legal to patent an invention involving embryonic stem cell research in the US, so cautious private investors are possibly more likely to pay to invest there than in Europe. In 2017 Donald Trump became president of the US. So the situation for stem cell research in the US in the foreseeable future is unknown at the moment, but many scientists have serious concerns.