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‘Stop consigned bioequivalence tests for generics to enhance drug safety’
  • By Kwak Sung-sun
  • Published 2018.07.27 15:32
  • Updated 2018.07.27 15:39
  • comments 0

An expert urged the government to abolish a rare generic drugs approval system, called “consigned/joint bioequivalence test system,” to remove risky medicines. His comments came after the government banned sales of hypertension drugs using Chinese-made valsartan due to carcinogen threats.

Howard Lee, a professor at the department of clinical pharmacology and therapeutics at Seoul National University Hospital, expressed his opinion at a debate at the National Assembly on Friday. Organized by Rep. Yoon Il-kyu of the ruling Democratic Party and the Korean Doctors’ Weekly, the sister paper of Korea Biomedical Review, the debate aimed at preventing a mishap in screening out harmful substances in generic drugs.

Participants attend a debate at the National Assembly in Seoul, Friday, to discuss ways to prevent a mishap in screening out harmful substances in generic drugs.

Lee attributed the recent valsartan debacle to too low entry barriers for generic medicines, lack of a system to guarantee generic drugs’ quality, and too high pricing for generic copies that led generic drugmakers to become incompetent.

Lee pointed out that the Ministry of Food and Drug Safety had to ban as many as 115 products made by 54 Korean companies, as opposed to a recall of just several medicines in Europe. He said the significant gap in the number of recalled products resulted from the nation’s problematic generic drugs approval system.

In particular, the government’s introduction of consigned/joint bioequivalence test system, to separate drug prescribing and dispensing in the early 2000s, was the culprit behind the carcinogen threat in valsartan. The system allowed incapable drugmakers to “mooch off” another company to sell generic drugs, he said.

After the introduction of such a system, the number of generic drugs that passed bioequivalence tests surged to 2,555 in 2004 from 186 in 2001. The excessively large number of generic drugs led the government to fail to screen out risky valsartan, Lee said.

“It would have been better if the MFDS’ crisis management had been more sophisticated but I can’t blame their quick response,” Lee said, adding that the MFDS was not responsible for the valsartan ban.

The problem was that Korea had too many generic medicines, he said.

“When the government forcefully pushed to implement the separation of drug prescribing and dispensing in 2001, the infrastructure was poor to supply generic drugs that could replace original drugs,” Lee said. “So, the government needed to quickly increase the number of bioequivalence-approved generics and introduced a globally rare consigned/joint bioequivalence test system.”

The abnormal system raised the number of bioequivalence-approved generic products from 186 in 2001 to 5,569 in 2008, he added.

Lee went on to say that generic drugmakers have malpractice that they change the supplier of raw materials after winning approval for generics.

“Many companies initially use ingredients in sound quality but later change them to cheap ones after obtaining approval. Once their raw materials are registered as DMF (Drug Master File), companies can change raw materials only by papers,” Lee said.

To address such issue, the government needs to visit raw material manufacturers overseas for inspection but there is no legal ground to do so now, according to Lee. Related revision bill to the Pharmaceutical Affairs Act has been submitted to the National Assembly in 2016 but is still pending.

Lee criticized the government’s generic drug pricing policy, saying generic drug prices are excessively high.

“This system creates a moral hazard in the government and in generic drugmakers that do not contribute to enhancing the public health through innovative drugs,” he said.

Lee suggested the government amend the law to allow on-site inspections and regular information updates in overseas raw material manufacturers.

In addition, the government should revise the drug pricing system which is wrongly supporting generic drugs to maintain high prices, he said.


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