BOSTON (AP) – Academic and medical researchers are concerned that rules adopted by state health regulators may inhibit scientists from participating in stem cell research that will be conducted in other states and could criminalize certain types of scientific activity.

The rules passed this week by the Public Health Council included language that critics said goes against the intent of a stem cell law passed last year whose goal was to create a more hospitable environment in Massachusetts for research on human embryonic stem cells.

“Clearly the thrust of the legislation was to encourage biotech research,” said state Sen. Cynthia Creem, D-Newton, one of the chief sponsors of the bill. “Why then did they take this law and interpret it to make it potentially harder to do research here and potentially criminal?”

More than a dozen Massachusetts hospitals and colleges, including Harvard University, have been certified by the state to conduct human embryonic stem cell research since the law’s passage over a veto by Gov. Mitt Romney, a potential GOP candidate for governor in 2008.

B.D. Colen, a Harvard spokesman, said the council’s action on Tuesday expanding a prohibition on the creation of embryos for research resulted in new meaning in that portion of the law that the Legislature had intentionally left out.

“We worry that this could put scientists at risk,” he said. “It could even potentially raise questions about scientists who do research with stem cell lines that we’re derived in another jurisdiction.”

Several hospitals and universities conducting stem cell research had complained in May in written testimony to the state Department of Public Health that the council was exceeding its authority in proposing some of the rules on stem cell research. They specifically objected to language expanding the prohibitions outlined in the law that make it a crime for donors to create fertilized embryos with the sole intent of “donating” the embryo for research.

The new regulation prohibits the creation of a fertilized embryo for the sole intent of “using” it for research.

“The legislature was asked by the Governor to extend this criminal liability to researchers, but the legislature specifically rejected this view. Despite the clear legislative history … the DPH’s proposed regulations do extend criminal liability to scientists,” Edward Benz, president of the Dana-Farber Cancer Institute, wrote in the letter.

When Romney vetoed the legislation, he said he couldn’t sanction the creation of human embryos by scientists only to see them destroyed for research. The Democratic-controlled Legislature overrode his veto.

Melissa J. Lopes, deputy general counsel for Public Health Department, said in a memo to the council that the law gives the agency authority to write regulations. She also said that nowhere in the law does the Legislature “promote or permit the creation of embryos by the method of fertilization solely for use in research.”

But Creem said that’s not a logical interpretation of the law.

“They wrote a regulation that is different than what we had,” she said. “I don’t think the Public Health Department is supposed to form whole new thoughts. I think this has a very big potential impact.”

Stem cells are important because of their potential to transform into any type of human tissue, perhaps leading to new treatments for several types of diseases.

But critics, including President Bush and the Vatican, have argued that even the earliest stages of human life should not be sacrificed to fulfill that medical potential.


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