
At present Britain is a world leader in stem cell use, thanks to investment from private and government sectors. Working is underway on treatments for blindness, Alzheimer's, Parkinson's, strokes and spinal injuries as well as an alternative to testing new drugs on animals. Stem cell and regenerative medicine research has the potential to impact on several industry sectors and a global market value is expected to reach nearly $10bn (£6.5bn) by 2013.
Academics say 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 with much of the work moving to China, Asia and US – if the European Court of Justice makes a new directive effectively outlawing the use of human embryos for any commercial purpose.
The Telegraph reports that 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 Britain.
One of one of the 13 letter signatories to Nature outlining their concerns, Prof Coffey said: “There’s an ethical need to treat disease which appears to have been lost in this whole debate.”
Two other clinical trials involving stem cell treatment for spinal injuries and another eye condition are scheduled with stem cell pioneer Stephen Minger is looking at ways to use them for drug screening and toxicology
The court was given the advice by Yves Bot (right) one of its eight
advocate generals responsible for independence guidance to the court. If the court heeds that advice, scientists warn the ban on stem cell treatments would be catastrophic for patients and the biotech industry across Europe.
It would effectively plunge Europe into a dark ages, while other regions such as the US, China, and Asia advanced developments.
Patent grant battle origins
What began as a legal battle over a patent granted in 1999 to Professor Oliver Bruestle, from the University of Bonn in Germany, who wanted to safeguard his method of producing nerve cell precursors from embryonic stem cells. has come before the European Court of Justice.
Prof Bruestle's patent was challenged in German courts by environmental group Greenpeace in 2004. The dispute was referred to the European Court of Justice by the German Federal Patent Court in 2006.
Without the vital contribution of industry that patents made possible, stem cell therapy development could virtually grind to a halt. Stem cell applications were important in the thinking behind the £200m Government Technology and Innovation Centres set up 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 reach their verdict, but typically the process takes several weeks. Once made that ruling will be binding on all member states.
Scottish work at risk
In Scotland, the UK Gene Therapy Advisory Committee (GTAC) gave approval in February 2010 to ReNeuron’s groundbreaking clinical trial with its ReN001 stem cell therapy for stroke patients. The stem cells are made by Angel Biotechnology in Scotland.
Scotland is also home to one of Europe’s largest and most highly regarded stem cell research communities with leading industry endorsement such as California’s Geron and Sweden’s Cellartis choosing to base their R&D operations here in Scotland.
In S
cotland, Dundee's Courier reports Professor Kate Storey, head ofthe Division of Cell and Dev elopmental Biology in the College of Life Sciences at Dundee University, concurring with the UK reaction
Dundee is home to a biotechnology cluster that accounts for 16% of Tayside's economy already, while Dundee University is Scotland's third most research-intensive university.
Prevention of patent right on uses of human embryonic stem cells "will undermine current development of cell-based therapies and drug discovery for important human diseases, such as Parkinson's and Alzheimer's, says Prof Storey, adding, "This is not only counter-productive for human health, but .. European discoveries will simply be translated into applications elsewhere, affecting EU economic growth as well."