Row over Massachusetts stem cell regulations

New regulations on the use of human embryonic stem cells (ES cells) have been adopted in the US state of Massachusetts. However, Harvard University, as well as other research centres and hospitals, say that the regulations could criminalise certain research activities and leave researchers open to prosecution.

In May, the state legislature overruled a veto of legislation that was passed to regulate ES cell research in the state. The legislation, which was sponsored by Senate President Robert Travaglini, would have allowed embryos to be cloned for medical research purposes, but prohibited human reproductive cloning. The Massachusetts House of Representatives had passed the bill by 119 votes to 38, it having previously passed through the state Senate by 34 votes to two. Later, both the House and Senate rejected four amendments proposed by State Governor Mitt Romney, and sent it back to him for his signature. In late May he vetoed the bill, but the margin of both votes - above a two-thirds majority - meant that the legislature had the chance to overrule that veto. The House voted 112-42 to do so, with the Senate voting 35-2.

The law also set up a stem cell advisory committee to oversee ES cell research in the state and establish safeguards, although it did not provide state funds for researchers. The advisory committee would also advise lawmakers on the implications of ES cell research and, for example, look into issues such as whether women who donate their eggs for ES cell research should be compensated.

In a written submission to the Massachusetts Department of Public Health (MDPH) in May, Harvard, alongside Partners Healthcare, the Dana-Farber Cancer Institute and six other research centres and hospitals said that the regulations may prevent researchers in the state from carrying out some experiments that would be allowed in some other states. Their submission called for some of the language in the regulations to be changed - such as that which says that a fertilised embryo cannot be created with the sole purpose of 'using' it for research. The text of the law says that fertilised embryos cannot be created for the sole purpose of 'donation' - which the signatories to the letter say is different - as they argue that the wording of the regulations would apply to scientists doing research, which was not intended by the lawmakers.

Melissa Lopes, Deputy General Counsel for the MDPH, said last week that the law gives the council the power to write regulations and that it does in fact prohibit the creation of embryos solely for use in research. Some state legislators have since joined the debate, saying that health regulators in Romney's administration have overstepped their authority and are 'endangering the state's position as a leader in science'. Salvatore diMasi, Speaker of the House, said that the new rules 'clearly fly in the face of both the law as passed and legislative intent' and called for a hearing on the new regulations. Representative Daniel Bosely said that the council had not notified lawmakers of the change to the wording. Kerry Healey, who is running for Governor, said the regulations would deter scientists from conducting ES cell research in the state, therefore she opposes them. But Paul Cote, the public health commissioner, said the new rules came from 'an active dialogue' with Romney's office and said the MDPH was tasked with 'eliminating loopholes' in the law and providing a 'bright line to guide the researchers in the future as to what they can do and what they can't'.

Mitt Romney has reiterated his support for the regulations and says that they are intended to prevent 'an Orwellian future'. But a spokesperson for Harvard University said that Romney appear to be using these regulations 'to accomplish what he was unable to accomplish through the legislative process'.