ISO 37001 for the life science industry
ISO 37001 for the life science industry. Does ISO 37001 Anti-bribery Management Systems (ABMS) be able to eradicate unethical practices in the life sciences industry? Given the crucial role that healthcare plays in society, the impact of unethical and/or illegal behaviour can be particularly harmful.
CRI Group (parent brand of ABAC) has conducted an empirical review of international laws and conventions; professional association codes; and individual company Anti-Bribery and Anti-Corruption policies, as well as conducting in-depth interviews with ABAC and Life Sciences legal professionals, in order to validate the efficacy of existing measures, and to identify gaps in good practice and enforcement.
The ebook analysed several aspects including:
- ABAC laws and conventions overview including:
- Foreign Corrupt Practices Act, 1977
- 1997 OECD convention on combating bribery of foreign public officials in international business transactions
- 2005 UN convention against corruption
- UK Bribery Act 2010
- Codes of life sciences business practices overview including:
- ABHI Code of Ethical Business Practice 2018
- ABPI Code of Practice for The Pharmaceutical Industry
- MHRA’s The Blue Guide: Advertising and Promotion of Medicines in the UK
- MEDTECH Europe Code of Business Practice
- Life sciences companies case studies overview
- ISO 37001:2016 – Overview including:
- Conducting a bribery risk assessment
- Ensuring top management responsibility
- Employee Awareness and Training
- Third-Party Culpability
- Support for Whistle-blowers
- Internal Accounting Controls
- Continual improvement
- A Legal Perspective: Interviews with ABAC and Life Sciences Lawyers Overview and Individual Profiles
Findings and conclusion:
Our analysis of six pharmaceutical companies (GlaxoSmithKline, Pfizer, Merck/MSD, Novartis AG, AstraZeneca PLC, Johnson & Johnson) and their Anti-Bribery and Anti-Corruption violations found they all exhibited:
- Inadequate bribery risk assessment
- A lack of top management responsibility
- Insufficient employee awareness and training
- No third-party culpability
- Limited support for whistle-blowers
- Inadequate internal accounting controls
- Limited continual improvement
All of these issues would, in theory, have been addressed by adherence to ISO 37001.
Who is CRI® Group?
Based in London, CRI® Group works with companies across the Americas, Europe, Africa, Middle East and Asia-Pacific as a one-stop international Risk Management, Employee Background Screening, Business Intelligence, TPRM, Due Diligence, Compliance Solutions and other professional Investigative Research solutions provider. We have the largest proprietary network of background-screening analysts and investigators across the Middle East and Asia. Our global presence ensures that no matter how international your operations are we have the network needed to provide you with all you need, wherever you happen to be. CRI® Group also holds BS 102000:2013 and BS 7858:2012 Certifications, is an HRO certified provider and partner with Oracle.
In 2016, CRI® Group launched Anti-Bribery Anti-Corruption (ABAC®) Center of Excellence – an independent certification body that provides education and certification services for individuals and organisations on a wide range of disciplines and ISO standards, including ISO 31000:2018 Risk Management- Guidelines; ISO 37000:2021 Governance of Organisations; ISO 37002:2021 Whistleblowing Management System; ISO 37301:2021 (formerly ISO 19600) Compliance Management system (CMS); Anti-Money Laundering (AML); and ISO 37001:2016 Anti-Bribery Management Systems ABMS. ABAC® offers a complete suite of solutions designed to help organisations mitigate the internal and external risks associated with operating in multi-jurisdiction and multi-cultural environments while assisting in developing frameworks for strategic compliance programs. Contact ABAC® for more on ISO Certification and training.