The Ministry of Food and Drug Safety said it will review whether the enforcement of a certain regulation of the Pharmaceutical Affairs Act can become a measure to prevent a collusion between multinational pharmaceutical companies.

Collusions between multinational pharmaceutical firms have gained attention from some lawmakers after the Fair Trade Commission (FTC) last month fined AstraZeneca and Alvogen for reaching an unfair deal to prevent the launch of a generic version of AstraZeneca’s Zoladex (ingredient: Gosereline), a drug for breast and prostate cancer, in Korea.

Notably, Rep. Seo Young-seok of the Democratic Party of Korea had recently made a written inquiry to the MFDS asking about the punishment measures for disruption in the drug market incurred by a collusion between multinational pharmaceutical companies.

“There are no clear regulations prohibiting or restricting collusion between pharmaceutical companies in the current Pharmaceutical Affairs Act,” the MFDS said in reply to Seo’s inquiry. “However, drug suppliers, including importers from the pharmaceutical manufacturing companies, are prohibited from selling drugs through hoarding or adjusting sales volume to obtain undue profits or to interfere with the prescription or medication of patients.”

Accordingly, the ministry plans to review whether the enforcement rules of such a regulation can be applied to collusions between pharmaceutical companies, it added.

The ministry also noted that if it is impossible to take administrative measures according to the regulations, it will consult with the Ministry of Health and Welfare (MOHW) on how to amend the relevant laws and regulations.

Rep. Seo also asked the MOHW for improved measures to prevent a collusion between multinational pharmaceutical companies by giving extra punishment on AstraZeneca and Alovgen, such as reduction of the upper limit of Zoladex.

In response, while the MOHW agreed on the need to prepare additional measures aside from the fine, the ministry noted that there are practical difficulties in recognizing the act of collusion among companies.

“A collusion is an act that increases the burden of drug prices on consumers by preventing potential competitors from entering the market. As pharmaceutical companies secretly conduct such acts, it is hard for authorities to discover them and stop such collusions in advance,” the MOHW said.

“Also, under the current regulations, there are no bases that allow the ministry to lower drug prices regarding an act of collusion.”