The government should help doctors and pharmacists resolve disputes over regenerative medicine, lawmakers and medical groups said yesterday, a day before the legislature was expected to begin reviewing two bills concerning the emerging medical field.
The Social Welfare and Environmental Hygiene Committee is to discuss the proposed laws — the regenerative medicine and the regenerative medicine pharmaceutical manufacturing bills — starting today.
The field seeks to regenerate or replace cells, organs and tissue to restore function using artificial organs made of biological materials.
Photo: Tu Chien-jung, Taipei Times
A panel of experts in medicine, drugs, ethics and law should be convened to help forge a consensus between the Taiwan Medical Association and the Federation of Taiwan Pharmacists’ Associations, Chinese Nationalist Party (KMT) Legislator Lin Wei-chou (林為洲), a member of the committee, told a news conference at the legislature in Taipei.
The federation believes that the Food and Drug Administration (FDA) should retain authority to approve regenerative medicine products, as it does for any other pharmaceutical product, Lin said.
The association says that as the products are sufficiently different from conventional medications, use authorization should be controlled by a proposed regenerative medicine evaluation board, he said.
Regenerative medicine is an important rising field and lawmakers would like to pass the bills as soon as possible, but the government must end the dispute to avoid public confusion that could arise from the disagreement between the medical groups, he said.
The Ministry of Health and Welfare and the Ministry of Education should create a platform to oversee the education, training and certification of professionals involved in regenerative medicine, Lin said.
The measures, which would ensure proper division of labor and patient safety, could be implemented administratively after passage of the legislation, he said.
The products fit Taiwan’s legal definition of drugs and most regulators around the world agree that they should be regulated as such, federation president Huang Jin-shun (黃金舜) said.
Keeping expertise in technological development and manufacturing separate would facilitate efficiency in the division of labor and certifications to manage a lack of certainty and consistency in effects of regenerative medicine, Huang said.
Most overseas regulators have defined the products as drugs, as the classification allows for more rigorous standards to be enforced in their manufacture, association spokeswoman Chang Wen-ching (張文靜) said.
As the cultivation of live cells in regenerative medicine is more complex than making conventional drugs, the regulatory standards must be at least equal to those of drugs, Chang said.
Additional reporting by CNA
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