The Ministry of Food and Drug Safety (MFDS) and the pharmaceutical industry are wrangling over whether the nation should allow the indirect export of botulinum toxin (BTX) products through agencies.
Industry officials raised concerns that the latest controversy, sparked by the regulator’s detection of BTX shipments through agencies by Medytox and Hugel, could affect sales of chemical drugs.
Hugel and the MFDS are preparing for the first trial on Hugel’s request to nullify the MFDS’ decision to revoke the license of Hugel’s BTX, Botulax Inj., on May 12.
Last year, the MFDS decided to cancel the permit for Botulax because Hugel sold the product to a domestic seller without getting a national lot release.
Under the Pharmaceutical Affairs Act, biological drugs do not need shipment approval for exports, but they must win it for domestic sales.
Hugel delivered the BTX product to an agency that handled the export procedure.
The company argued that this act was “an indirect export,” but the MFDS said it was “a domestic sale.”
Last month, the Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) sent a letter to the MFDS, proposing to allow the industry’s indirect export practice.
Pharmaceutical companies argued that the MFDS was not in a position to regulate drug exports because export regulations were transferred to the Foreign Trade Act following the amendment of the Pharmaceutical Affairs Act in 1999.
Industry officials said that if the government keeps banning indirect export, biologics manufacturers will have to change drug labels frequently. In addition, the MFDS is failing to reflect the opinions of exporters, they said.
“Drugs for export come with different labels. The law allows only manufacturers to change labels. If the direct export is deemed illegal, the drugmaker has to send Korean labeled products to the wholesaler first, get back export items and change the labels,” an industry official said.
Due to the regulation on indirect export of BTX, other BTX makers such as Huons, Pharma Research, Jetema, BNC Korea, and BMI Korea could also be on the list of the government’s investigation.
Industry officials complained that the MFDS did not grant a period for guidance and abruptly caught an indirect export. If the MFDS had notified that it would crack down on indirect export, they said the manufacturers would have complied.
The MFDS, however, said indirect export was deemed as domestic sale regulated under the Pharmaceutical Affairs Act.
The regulator recognizes a drugmaker’s “confer” of drugs to an agency as an export, but delivering the product with export payment was deemed a local sale, the MFDS said.
The government cannot approve indirect export because the product is a biological drug requiring strict hygiene management.
Agencies unqualified to handle pharmaceutical goods cannot guarantee the safety of the drugs, the MFDS explained.
Regarding the industry’s complaint about the short period for guidance regarding the ban on indirect export, the MFDS said it had already provided some guidelines since 2011, allowing drugmakers to “confer” drugs to agencies.
“The rule has existed for nearly a decade. So it’s not right to say that they did not have any period for guidance,” a ministry official said.
Some industry watchers said they worried that the indirect export controversy could negatively affect exports of chemical drugs. However, the MFDS made it clear that it would not recognize the indirect export of chemical drugs.
Asked whether the regulation on indirect export of BTX would expand to biologic drugs or chemical drugs on Wednesday, the MFDS said, “The enforcement ordinance of the Pharmaceutical Affairs Act applies equally to all drugs.”