October 19, 2011
Europe’s Top Court Bans Stem Cell Patents If Embryo Destroyed
The European Union Court of Justice (ECJ) on Tuesday banned patents on any stem-cell process that includes the destruction of a human embryo, a ruling some fear will have negative repercussions for medical research.
The ECJ became involved in the controversial issue after German scientist Oliver Bruestle was denied a patent on a technique to create nerve cells from human embryonic stem cells.Bruestle filed an appeal with the German Federal Court of Justice, which sought a ruling from Europe´s top court that would provide an interpretation of the meaning of the term human embryo.
The ruling of the ECJ was that existing EU law intended to "exclude any possibility of patentability where respect for human dignity could thereby be affected".
Bruestle expressed disappointment over the ruling, saying there were already clinical applications for his invention that would treat patients with Parkinson's disease.
"This unfortunate ruling wipes out years of transnational research by European researchers in one fell swoop," he told the AFP news agency.
He also warned that work by European researchers would now benefit scientists abroad, who would use advancements made by European scientists to create medical products that would ultimately be imported back into Europe.
The ECJ said the use of human embryos "for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable”.
However, "their use for purposes of scientific research is not patentable".
"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 Luxembourg-based judges said, referring to the later stage of embryonic development roughly five days after fertilization.
"The concept of 'human embryo' must be understood in a wide sense,” the court said.
An egg must be considered a human embryo as soon as a sperm enters it "if that fertilization is such as to commence the process of development of a human being,” the judges said.
Even a non-fertilized egg can be considered a human embryo when the technique used to extract an embryo can prompt "the process of development of a human being.”
The commission of the European bishops' conference (COMECE) praised the ruling "as a milestone in the protection of human life in EU legislation,” saying attention must be given to scientific research on alternative sources such as adult stem cells or those from umbilical cord blood.
"These methods enjoy wide acceptance both on scientific and ethical grounds," said COMECE in a statement.
Advocates for stem cell research were generally disappointed in the ruling, but said it was only one of many potential challenges, such as funding and manufacturing issues, facing stem cell researchers today.
"This decision is important and it creates uncertainty, which is a problem in itself, but it is not as big as the other barriers we are grappling with,” said Chris Mason of the UK National Stem Cell Network during an interview with the Guardian.
“Funding is a major issue and that has to come from central government. Then there is manufacturing, in that we need to make these therapies at a scale and price that works,” he said.
"This is not a bolt from the blue, and I think people will be able to work around it. Does it impact upon potential therapies? The answer has to be no."
In an interview with Time magazine, Alexander Denoon, a British lawyer specializing in life sciences, said patent attorneys would likely find ways to circumvent the ban. For instance, they might try to patent the discoveries that result from the stem cell techniques, rather than the techniques themselves.
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