Korean drugmakers have announced that they would introduce an international anti-bribery management system, called “ISO 37001,” to enhance ethics management.
The Korea Pharmaceutical and Bio-Pharma Manufacturers Association said it would offer consultations from November for drugmakers planning to adopt ISO 37001. Eight companies among the 15 firms managed by the association’s board members are scheduled to receive advice first.
The pharmaceutical association aims to raise awareness about ISO 37001 while offering consultations in multiple phases through 2019.
ISO 37001 refers to the 162-member International Organization for Standardization (ISO)’s anti-bribery management system, established in October 2016. Thirty-seven countries, including the U.K., are members of the ISO 37001 project, with the Transparency International and the Organization for Economic Cooperation and Development joining it as partners.
ISO 37001 requires an organization to implement and control a series of measures to prevent, screen and handle bribery. The requirements include implementing an anti-bribery policy, performing responsible leadership in management, disciplining employees, assessing risks, conducting due diligence on projects and colleagues for any suspicion of bribery, reporting/monitoring and reviewing of bribery, and correcting and improving sustainability.
ISO standards are widely used for the establishment of an international treaty or national standards. A company certified by ISO 37001 earns credibility in preventing corruption. Such firm can also replace credibility due diligence, often conducted at multinational corporations and conglomerates, with ISO 37001.
KPBMA quoted the Fair Competition Federation as saying that “ISO37001 will be useful for management to earn internal support when managing issues of rebates.”
The most significant difference between the existing Compliance Program (CP) and ISO 37001 is that the former is a top-down type that can be confined to an organization, whereas the latter is a universal type that affects not only an organization but all interested parties, including business partners. ISO 37001 imposes the authority and the duty to all employees.
The certification of ISO 37001 requires an application, consultations -- including education to nurture an internal compliance manager, support for design and operation of ISO 37001 and responses to certification assessment -- and certification assessment.
KPBMA said it would provide consultations in a phased way to minimize companies’ burdens in adopting ISO 37001.
The KPBMA plans to provide its multi-phased consultations for eight companies out of the 15 firms managed by the association’s executive board members from November to April 2018. Then, the rest seven out of 15 will get it from April to September 2018. The next will be 12 out of 35 firms managed by board members from September 2018 to February 2019. An additional 12 out of 35 will get advice from February 2019 to July 2019 and the rest 11, from July 2019 to December 2019.
Those who volunteer to adopt the anti-bribery management system will receive the association's guidance first.
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