Stem cell rules due in days, says Harney

New regulations governing the use of stem cells will be signed into law within days, Minister for Health Mary Harney said yesterday…

New regulations governing the use of stem cells will be signed into law within days, Minister for Health Mary Harney said yesterday.

The Minister was commenting after a disclosure that the Irish Medicines Board (IMB) is investigating the provision of controversial unlicensed stem cell therapy being conducted in the Cork region.

"We will have new legislation and I will be signing new regulations into law within a matter of days," she said.

The regulations have to be transposed under an EU tissues directive by next Thursday, April 6th, she said.

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"Work is very advanced in the department in relation to those regulations so we will have legislation in this area where stem cells are used in relation to humans," the Minister added.

On the situation in Cork, Ms Harney said the regulatory body in this area was the IMB and the Department of Health had been in touch with the board. Her understanding was that the IMB was involved in the situation.

"Until I know the outcome of the medicines board investigation into the Cork issue I don't want to really discuss it. I'm not familiar with all the facts to be fair," she said.

"But we have strong regulations and the medicines board is the proper regulatory body."

The EU directive sets out guidelines for the donation, procurement, testing, storage and distribution of human cells and tissues within the EU.

The IMB will be empowered to visit any premises and inspect any process where stem cells are stored or distributed.

In Cork, it was reported that the stem cell treatment, unlicensed in Ireland, was being provided by a Cork GP.

Reports also indicated that the stem cell material was being delivered from Switzerland and that patients from Ireland and the UK were being charged up to €30,000 for the treatment.