From September 21st to September 23rd, 2016, BMI SYSTEM attended the sixth Asia Pacific Pharmaceutical and Medical Device Compliance Congress which was held in Singapore.
This congress addressed several topics such as:
- Key risks for the industry and the future of ethics and compliance programs
- Anti-corruption and the new ISO 37001 anti-bribery management systems standard
- AsiaPac regional regulatory and enforcement
- Transparency requirements update in AsiaPac
First of all, it was pointed out that the Pharmaceutical and Medical Device industries are high risk profiles regarding corruption, and especially in this geographical area because of:
- An exposure to multiple enforcement jurisdictions
- Interactions with government
- Engagement with emerging markets
- Increased competition
In this respect, the new ISO 37001 anti-bribery management systems standard is a useful tool to build a trustful anti-corruption system within an organisation. The aim of this standard is to define common international anti-corruption measures which can comply with all the main anti-bribery legislations (read more about the anti-bribery standard).
In China, anti-corruption measures are getting more and more numerous. Since 2012, 8 prohibition rules have been enforced and since 2013, there have been more than 210 investigations involving top leaders at the provincial level or above.
In this country, risk of corruption is due to:
- interaction with government
- interactions with third parties
- interaction with numerous HCPs and HCOs (there are 3 million physicians and 20 000 hospitals)
- HCPs with very low incomes
Investigations are increasing on hospital medical associations and these investigations can lead from medical associations to the manufacturers related to these associations.
Misuse of donations is another key issue since device and products donated are frequently sold to patients.
Events organisation is also at high risk and requires regular checks of event spots. As a consequence, monitoring processes are in place in companies to randomly check events. As an example, a major international pharma company described its own process:
- The event is internally approved
- An auditing firm has access to the events database and selects events to check
- The initiator of the event is notified shortly before the event
- Auditors attend the event and check the conformity of the event; a report is sent to the company
This highlights, if needed, that compliance teams are key in an organisation. But the next compliance challenge is to move from cost to value and to make compliance a strategic activity within the company. To achieve this goal, the compliance team needs to be involved as early as possible in strategic decisions. It requires new skills from compliance managers such as capability to understand the business and the associated risks. It also requires to make a hard choice between being a valid business partner, a controller or an auditor
During this congress, roundtables addressed compliance updates in some AsiaPac countries:
- In Japan, there is no Transparency Law but disclosure is governed by a voluntary code. This code was prepared by JPMA (a voluntary association comprising of 73 research-oriented pharmaceutical companies). From 2011 to 2012, guidelines expended voluntary transparency to all stakeholders (pharma, device and generic). Regarding Data privacy requirements, a comprehensive written consent is needed. The first disclosure took place in 2012. Disclosures are made on company’s websites once a year. Recently JPMA transparency guidelines were revised to shift from a total annual amount disclosure to an individual amount one.
- In South Korea, “The Act on the Prohibition of Improper Solicitation and Provision/Receipt of Money and Valuables” came into effect from 28 September 2016. The new anti-corruption law was designed to close loopholes in existing law that governs and penalises government officials’ improper solicitations or bribery and thereby purports to eradicate corruption and increase transparency. The Act is applicable to journalists, employees and educators in public and private schools, and public officials as well as the officials’ spouse.