GSK Korea, Janssen Korea and Astellas Pharma Korea refused to adopt ISO 37001, an international anti-corruption management system to be introduced by Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) in multiple phases.

In October 2016, the International Organization for Standardization with 162 member countries established ISO 37001 to prevent illegal rebates and organizational corruption.

However, the three pharmaceuticals notified the KPBMA of their refusal to adopt the system, saying they have already established their own ethics management systems.

“We agree with the intention and purpose of introducing ISO 37001. However, we are operating a unified compliance program under the headquarters. Also, we are building a separate, company-wide management and supervision system for anti-corruption policy,” Astellas Pharma Korea said to the KPBMA.

Janssen Korea said the company was already running an anti-corruption and anti-bribery management system complying with ISO 37001. Thus, it had no plan to introduce another, the company said.

GSK Korea also said the Korean unit was strictly enforcing the headquarters' ethics management guidelines, making it clear that it did not plan to introduce ISO 37001.

In contrast, Korea Otsuka Pharmaceutical advanced the schedule for adopting ISO 37001. The drugmaker recently requested KPBMA to change its participation time from the fourth to the third phase.

Pharmaceutical companies planning to adopt ISO 37001 are categorized in five phases – the first from December 2017 to May 2018, the second from May 2018 to October 2018, the third from October 2018 to March 2019, the fourth from March 2019 to August 2019, and the fifth from July 2019 to December 2019.

“We decided to adopt the system in the third phase because we thought that introducing it as soon as possible would help enhance corporate management,” said an official at Korea Otsuka Pharmaceutical.

To date, no multinational drug company has obtained the ISO 37001 certification. Local firms that adopted the system in the first phase include GC, Daewon Pharm, Dong-A ST, Yuhan Corp., Ildong Pharmaceutical, JW Pharmaceutical, Hanmi Pharmaceutical, and Kolon Pharm. Daewoong Pharmaceutical is undergoing processes for the certification.

Companies in the second phase certification have completed receiving training from the Korean Standards Association. They include Dongkoo Bio & Pharma, Myung In Pharm, Boryung Pharmaceutical, Samjin Pharm, Ahn-Gook Pharm, Chong Kun Dang, and Huons.

GSK Korea, Janssen Korea, and Astellas Pharma Korea had been included in the third-phase companies.

The KPBMA said the ISO 37001 audit process could regard a particular company “significantly unsuitable” for the certification, if “there is a good reason to doubt the effectiveness of process management or there is a good reason to suspect that the product or specified requirements will not be met.”

Also, multiple decisions on a company as “lightly unsuitable” due to repeated failures on the same requirements may also lead to the company getting “significantly unsuitable” status.

A “significantly unsuitable” company needs three more months to correct the system, and a “lightly unsuitable” one, one additional month.

Copyright © KBR Unauthorized reproduction, redistribution prohibited