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MANILA, Philippines – Rep Paulino Salvador “Doy” Leachon of Oriental Mindoro’s 1st district filed on Thusday, August 15, a house resolution calling for a congressional inquiry in aid of legislation on the conduct of stem cell therapy in the country.
House Resolution 215 was filed a day after Leachon’s scheduled privilege speech, calling for the resignation of Health Secretary Enrique Ona over the cabinet official’s stand on stem cell therapy.
The 40-year-old lawmaker also urged concerned government agencies to step up their regulatory oversight. These agencies include the Department of Health (DOH), the Food and Drug Administration (FDA), and the Professional Regulation Commission (PRC).
First attempt to regulate
Government regulation of stem cell treatment is still in its infancy stage, with the guidelines for accreditation of facilities released only in March.
It is DOH’s first attempt at regulating the practice, despite the therapy having been administered by Filipino physicians for years now.
The types of stem cell treatment that are allowed, prohibited, and restricted (i.e. allowed but with limitations) in the facilities to be accredited by August 31 are listed in the released guidelines.
A stem cell transplant physician from The Medical City, Dr Samuel Bernal, said the guidelines are “one of the strictest in the world.”
Need for clinical trials
The medical community is, however, divided on the ethics and the sufficiency of the regulation provided by the DOH thus far.
21 medical groups have reiterated their call on the health department and the FDA for stricter regulations, following a pronouncement from the health secretary that stem cell and stem cell-based products can be administered even without undergoing clinical trials approved by the FDA. This, he said, was for the sake of innovation.
Categorizing stem cell therapy as part of “innovative therapy,” Ona acknowledged that “predetermined adherence to a protocol might be a fatal rigidity.”
He said practitioners can continue offering stem cell treatments in the meantime, even if their stem cell products have not yet been registered with the FDA.
As of Wednesday, August 14, not a single product has been registered. – Rappler.com
(Read the resolution below.)