Stem cell cures under threat from EU court

Stem cell cures under threat from EU court

Potential cures for dozens of debilitating conditions are under threat from a European ruling that claims making money from embryonic stem cell research is immoral, leading scientists have warned.

Potential cures for dozens of debilitating conditions are under threat from a European ruling that claims making money from embryonic stem cell research is immoral, leading scientists have warned.

Dolly the Sheep with creator Professor Ian Wilmut Photo: JAMES FRASER

 By Richard Alleyne, Science Correspondent 5:00AM BST 28 Apr 2011

The academics said that a change in EU law could “wipe out” much of the biotechnology industry and halt work on revolutionary cures for conditions that affect millions of people.

At present Britain is a world leader in the use of stem cells thanks to investment from the private sector and the government.

Scientists are working on treatments for blindness, Alzheimer’s, Parkinsons, strokes and spinal injuries as well as coming up with an alternative to testing new drugs on animals.

But scientists say all this work could be halted – and much of it moved to China and the US – if the European Court of Justice makes a new directive effectively outlawing the use of human embryos for any commercial purpose.

EU judges are considering a test case that could make it unlawful to patent applications using embryonic stem cells – or anything derived from them – on moral grounds.

The academics are concerned because the judges have been told that patenting any use of cells derived from human embryos breaches ethical principles.

That recommendation was given by French judge Yves Bot, the “advocate general” appointed to provide reasoned, independent guidance to the court.

He has a powerful voice, and although his opinion is not binding, the court follows his advice in eight out of 10 judgments.

A European legal ban on embryonic stem cell patents will have potentially catastrophic consequences for the multi-billion pound European biotech industry, the UK economy, and patients, according to the scientists.

It will lead to a withdrawal of funding and force patients to go abroad to get treatments initially developed in this country.

It could be potentially damaging to the health and wealth of the nation.

Such is the alarm that thirteen leading researchers have written to the journal Nature outlining their concerns.

They include clone pioneer and “Dolly the Sheep” creator Professor Ian Wilmut, chairman of the Scottish Centre for Regenerative Medicine in Edinburgh, and Professor Austin Smith, director of the Wellcome Trust Centre for Stem Cell Research in Cambridge.

Speaking at a press conference in London, Prof Smith said the advocate general’s opinion, issued in a public statement, was “astonishing and shocking”.

He said: “If the European Court of Justice was to follow this opinion then the reality … is that all patents in Europe that involve human embryonic stem cells will be eliminated.

“Other patents will apply in the United States, China and Japan, so this will put Europe at a huge disadvantage. It will effectively wipe out the European biotech industry in this area.”

The ruling could potentially have a massive impact on the provision of new treatments, said the scientists.

Licensing authorities would effectively be prevented from approving therapies based on the “immoral” commercialisation of embryonic stem cells.

More than 100 patents on embryonic stem cell products have already been filed in Europe. But advanced stem cell treatments are only just starting to make the transition from the lab to the clinic.

The first British trial, led by Professor Pete Coffey from University College London, will use cells derived from embryonic stem cells to treat an incurable form of age-related macular degeneration, an eye disease affecting 700,000 people in the UK.

Two other clinical trials involving a stem cell treatment for spinal injuries and another eye condition are in the pipe line and the stem cell pioneer Stephen Minger is looking at ways to use them for drug screening and toxicology

Prof Coffey, one of the letter signatories, said: “There’s an ethical need to treat disease which appears to have been lost in this whole debate.”

He pointed out that obtaining permission for a clinical trial partly depended on the likelihood of ending up with a licensable product.

While “new” embryonic stem cells are extracted from early stage human embryos – usually surplus left overs from IVF treatment – few if any are now used in research.

Instead scientists rely on proliferating cell cultures that have been maintained in laboratories for years.

Such cells can be chemically coaxed into forming different kinds of body tissue for use in treatments. Or they may be used as screening tools to test the toxicity of drugs, providing an alternative to animal models.

But because they originally started out as cells taken from cannibalised embryos, they would still be affected by the European Court patent ruling.

Theoretically so would any technology that can be traced back to a fertilised human egg.

The case before the European Court of Justice began as a legal battle over a patent granted in 1999 to Professor Oliver Bruestle, from the University of Bonn in Germany.

He wanted to safeguard his method of producing nerve cell precursors from embryonic stem cells.

Prof Bruestle’s patent was challenged in the German courts by the environmental group Greenpeace in 2004. Two years later the dispute was referred to the European Court of Justice by the German Federal Patent Court.

Prof Smith said patenting was a “key vehicle” for the successful transfer of stem cell research into applications that can help patients.

Without the vital contribution of industry that patents made possible, the development of stem cell therapies could virtually grind to a halt.

Stem cell applications were an important part of the thinking behind the £200 million Technology and Innovation Centres set up by the Government to produce practical solutions from academic research.

The legal ruling will be made by the European Court of Justice’s “grand chamber” of 13 judges. There is no time limit to how long they take to reach their verdict, but typically the process takes several weeks.

Once a ruling is made it will be binding on all member states.

Any state that disobeys a ruling of the court can be fined.

One Response to Stem cell cures under threat from EU court

  1. graham says:

    The issue here is surely far more complex than be dealt with here in a few words.
    Millions of people in the European Union have deep concerns about the creation, use & destruction of human embryos for research. There is rightly a huge ethical debate around the subject of stem cell research & we must get it right.

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