Updated 16.39
THE EUROPEAN COURT of Justice has banned the patenting of stem cells when the process involves the destruction of human embryos at any stage.
The ruling has been described as “the worst possible outcome” and “a disaster for Europe” by Oliver Brüstle, director of the Institute of Reconstructive Neurobiology at the University of Bonn in Germany.
Brüstle had been pursuing a patent on a method for generating neurons from human embryonic stem cells for a number of years, which was rejected by the court, Nature reports.
Chief Scientific Officer of the Irish Stem Cell Foundation, Dr Stephen Sullivan, also expressed disappointment over the ruling, telling TheJournal.ie that there was a “huge need to alleviate the suffering” of patients living with conditions like multiple sclerosis, Parkinson’s, Alzheimer’s and other neurodegenerative diseases – and that stem cell research offered a way to help them.
“It’s heart-wrenching to have to watch them suffer,” Sullivan said, adding that the ECJ ruling meant “greater uncertainty about what stem cell researchers can do in Europe”.
“Stem cell research is very tough; it takes a lot of money and a lot of time. Research rapidly moves from labs to clinical trials – which can take six years or more,” he said.
To underline the importance of clinical trials, Sullivan cited the thalidomide tragedy – which saw pregnant women in the 1950s and 1960s being given the drug to avoid morning sickness that ultimately caused severe birth defects in their children.
Sullivan said that clinical trials were “even more important” when examining cells, as the range of possible outcomes was multiplied when working on such small scales.
Sullivan criticised the lack of clear leadership and long-term thinking by the Irish government on the issue, saying that “short-term gains in the local interest trump long-gains in the national interest”.
As a ruling by the ECJ cannot be appealed, patent lawyers are now examining the ruling in detail. Sullivan said: “Some think its game over – others say that we might not be able to patent cells but perhaps we can patent the procedure“.
However, he added that “the perception alone is that EU is less favourable for stem cell research than other countries is probably enough to deter investment”.
Sullivan made a “conservative” estimate that thousands of related jobs could be lost in Europe as a result of the ruling, as investors will simply move funds to countries like the US and China.
“It will decimate the good work that people have put into stem cell research in EU – and the ruling itself has no reference to patients,” he said.
Trying to conduct research without proper funding was like “asking Seamus Heaney to write a Nobel Prize-winning poem without using consonants,” he added.
Sullivan said that there was a “vocal minority” who were opposed to stem cell research because they were concerned with “commodification” of human cells – however, he said, such an approach ultimately led to a reduction in human dignity because patients living with serious diseases were suffering intensely.
“Patients are effectively being ignored,” he said, warning that Europe could be going “back into Dark Ages”.
The ECJ’s ruling, which cannot be appealed, applies to all 27 member states of the EU and includes both procedures in which embryonic-stem-cell lines are created and those that use previously derived cell lines, Reuters reports.
The ruling stated that “a process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented”. The blastocyst stage follows fertilisation, when an embryo consists of about 80 to 100 cells.
The ruling also stated that it was “intended to exclude any possibility of patentability where respect for human dignity could thereby be affected”.
Christian groups have welcomed the ruling, with COMECE, the commission of Catholic bishops conferences in the European Union, saying: “Fertilisation marks the beginning of the biological existence of a human being that undergoes a process of development. Therefore the human embryo, at every stage of development, must be considered a human being with potential, and not just a “potential human being”.
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