Stem-cell therapies for diseases such as Parkinson’s and diabetes could become illegal under embryo research laws planned by the Government, The Times has learnt.

The Human Fertilisation and Embryology Bill currently passing through Parliament could prevent patients from receiving potentially life-saving treatments based on embryonic stem cells, because it does not permit regulators to license them for therapeutic use.

Embryonic stem cells are powerful master cells found in human embryos, which can grow into any type of tissue. They hold great promise for treating conditions such as diabetes, Parkinson’s and spinal paralysis.

While the Bill allows scientists to obtain licences to use these cells for medical experiments, it contains no mechanism for approving treatments should this research prove successful.

Leading scientists, lawyers and MPs have warned ministers that unless the legislation is amended when it reaches the House of Commons in late spring, it could stop patients from benefiting from the very medical research the Government is encouraging.

The problem has arisen because the Bill allows the Human Fertilisation and Embryology Authority to license the use of human embryos only for medical research or treatment of infertility. This does not matter at present, as no embryonic stem-cell therapies are ready to be given to patients, and it would not affect clinical trials because these would be classified as research.

Once techniques move beyond an experimental stage, however, doctors would not be allowed to give them to patients without fresh primary legislation, scientists and lawyers say.

This would significantly delay patients’ access to therapies that are the goal of stem-cell research, and would make it harder for scientists to raise funds from the biotechnology industry.

Professor Robin Lovell-Badge, a stem-cell scientist at the National Institute for Medical Research in London, said: “They have not thought the whole picture through properly. Once you get the protocol right, and you want to grow embryonic stem cells to treat patients, that is no longer research.”

James Lawford Davies, a solicitor with Clifford Chance who specialises in embryology law, said: “There is at the very least a grey area here. Without proper provisions you can guarantee that people who object to embryo research are going to try a legal challenge.”

Evan Harris, the Liberal Democrat science spokesman, said: “One of the goals of embryonic stem-cell research is to provide therapies, but as the Bill stands it may not be possible to license these.”

The Government rejected amendments tabled in the House of Lords that would have allowed the HFEA to include treatment in the terms of its licences, saying that the definition of research would be sufficiently broad.

A spokeswoman for the Department of Health said: “On the basis of [legal] advice, the Government is of the view that the currently anticipated licensing framework would in fact allow the derivation of embryonic stem cells, and the development of those cells into a therapeutic product without the need for amendment of the Bill.”

The Times understands, however, that the Government is now reconsidering its position, and may table an amendment in the Commons to address scientists’ concerns.

The Government also came under pressure yesterday to allow Labour MPs a free vote on the entire Bill, after MPs who support more liberal legislation said their opponents should be free to vote with their consciences.

An early day motion calling for a free vote, tabled by David Burrowes, a Conservative MP, has been signed by 70 MPs. They include advocates of embryo research such as Dr Harris, Robert Key, a former Tory science spokesman, and Phil Willis, who chairs the Innovation, Skills, Science and Universities Select Committee, as well as opponents such as Mr Burrowes and Ann Widdecombe.

Last week more than 100 academics with different opinions on the legislation wrote to The Times to demand a fully free vote, as was granted when the present laws were passed in 1990.

Dr Harris said: “Individual MPs should be entitled to vote with their conscience on clear conscience issues such as these.”

The big issues

Three issues on which the Government has backed down

Merged regulators
Original Human Tissue and Embryos Bill proposed merger between embryo research and IVF watchdog and human tissue regulator. Plan dropped and Bill renamed after criticism from scientists, MPs and peers

Hybrid embryos
Draft Bill would have banned research on embryos created by combining human and animal tissue, which scientists want to use to make laboratory models of disease. These will now be permitted

Consent
Legislation would have banned scientists using tissue for cloning when donors had not given explicit consent. This will now not be applied retrospectively, after researchers said this would deny them access to important cell libraries that were donated for general medical research

And three more on which it might

Treatment licences
Bill does not provide for licences to be issued for therapies based on embryonic stem cells. Ministers considering revising it to permit this

Artificial sperm and eggs
Present Bill bans the use of sperm or eggs made from stem cells in fertility treatment. MPs will table an amendment that would give Parliament the right to approve this at a later date without primary legislation

Children
Existing wording means parents cannot consent to use of their children’s cells in cloning experiments, even when they would die before reaching the age of majority. Government has accepted the case for revising this, and lawyers are drafting a clause that would be compatible with the Human Rights Act

Source: Times database

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