The Ministry of Food and Drug Safety (MFDS) refused the request from the pharmaceutical industry to allow the indirect export of botulinum toxin (BTX) products through agencies.
On Tuesday, Jeong Hyeon-cheol, director of the Biopharmaceutical Policy Division at the MFDS, said in a meeting with reporters that the government did not take issues with indirect export. “Rather, it is deemed illegal to sell BTX to agencies not qualified to handle pharmaceutical products,” he said.
According to the MFDS, the Pharmaceutical Affairs Act stipulates entities qualified for the sale of drugs, such as manufacturers, importers, wholesalers, and pharmacies.
However, the law recognizes an exception when drugs are conferred to “a person (an agent) who wants to handle export procedures for drug export.” In this case, the medicines should be conferred for free.
Specifically, when a drugmaker directly exports a product or confers the product to an agent to export the item, the company does not have to get state approval for shipments.
However, the act is deemed illegal when a pharmaceutical company exports an item through a wholesaler without government approval or sells an item to an agent to export it.
Earlier, the MFDS revoked the license of Hugel and other companies’ BTX products. However, the companies claimed they did not have to get government approval because the products were manufactured and sold for export purposes.
The MFDS presented its interpretation of the Pharmaceutical Affairs Act but did not offer an alternative to pharmaceutical companies.
“The pharmaceutical industry may submit their opinions that they want to sell products to agents and let them export,” Jeong said. “To do so, we have to change the Pharmaceutical Affairs Act because agents are not qualified to handle pharmaceutical products.”
For BTX makers such as Hugel to make their export practice legal, the nation needs to insert “exporters” in the list of eligible entities who can handle drugs in the law, Jeong explained.
Regarding BTX exports, the MFDS will not take any further measures, he said.
The MFDS will have to decide on a follow-up measure on BTX makers after the lawsuit results between the companies and the government come out, Jeong went on to say.
“The content of the court’s decision is important rather than who wins and who loses. For example, if the court says the MFDS abused its discretionary right, we can supplement the system as ordered by the court,” he said.
If the MFDS wins, the government can maintain the current system but reduce the period of administrative punishment to reflect the industry’s reality, he added.
Hugel filed a lawsuit against the MFDS to nullify the government’s decision to revoke the license of Botulax. Jeong also mentioned the Supreme Court’s recent order to stop the MFDS’ administrative appraisal.
The MFDS argued that the court’s decision on whether to stop the administrative punishment is based on a judgment of whether a reversal of the administrative decision would cause irreparable damage to the company. Thus, the decision is irrelevant to the adequacy of administrative measures, the MFDS said.
Jeong said the Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) sent an opinion about the indirect export of BTX products.
“We plan to reply because the pharmaceutical industry has some misunderstanding about the Pharmaceutical Affairs Act,” he said.
