Ethics and Legal Compliance

As a business we are focused on doing the right thing. It is important to us and is what our customers, employees, and shareholders find compelling. We ensure we comply with the law throughout our business operations, from the way we source materials, design and manufacture our products, through to selling our products across the world.

Our Code of Conduct reinforces this culture. All employees are trained on this policy, and understand they have a responsibility to work in a legal and ethical manner. The Code covers a range of areas relevant to legal compliance, including competing fairly, health and safety, data protection and privacy, working with customers and suppliers, sanctions compliance, responsible marketing, financial records and reporting, continuous disclosure and insider trading, combating bribery and corruption and interactions with healthcare professionals. 

Our Speak Up (or whistle-blowing/protected disclosures) policy ensures that employees know how to report potentially unethical or illegal behaviour or breaches of our Code of Conduct, without fear of retaliation or harassment. 

We have an in-house legal team that provides advice and assistance to the business globally on how to comply with our various legal obligations, and engage external legal counsel to assist us as and when required.
 

Anti-bribery and corruption

In the course of our business we interact with a wide range of government officials and private sector individuals or businesses, including government regulators, inspection authorities and healthcare professionals. 

We do not tolerate bribery, corruption, kickbacks or other types of improper benefits, whether committed by our own people or by anyone we deal with.

Most of the countries in which we operate have strict anti-bribery and corruption laws that apply to our interactions with public officials. We have processes in place for assessing anti-bribery and corruption risk and implement measures to mitigate these risks. 

Failing to comply with these laws could have serious consequences for us, both as individuals and as an organisation. In some cases, these consequences could include criminal charges. 
 

Our Code of Conduct sets out our expectations for all employees in combatting bribery and corruption. We never offer or accept (or ask a third party to offer or accept) bribes, facilitation payments, secret commissions or kickbacks to or from any person. These rules apply to all our business activities, including any interactions we may have with government officials or with any private person or business, either locally or overseas.

The Code requires that where we suspect bribery or corruption, either by our own people or by any of our suppliers, customers or other business partners, we report it immediately. The Speak Up policy ensures that all employees know how to make such a report, and can be confident that concerns will be taken seriously and investigated and will not result in retaliation or other harassment. 

On 22 March 2017, a former employee, Simon Hall, pleaded guilty to charges laid by the Serious Fraud Office (SFO), in relation to actions taken while an employee of Fisher & Paykel Healthcare. It is understood that Mr Hall received approximately $213,000 in payments. 

When the company became aware in 2014 of issues relating to the management of two Middle East distributors, the company commissioned a third party to conduct an internal investigation. Following the outcome of the investigation, Mr Hall was dismissed for misconduct and the matter was referred to the SFO. The company does not tolerate this type of behaviour and, following an independent review, we are confident in our systems to prevent a recurrence.
 

Interactions with healthcare professionals

As we are a healthcare business, we must comply with laws and regulations on interacting with healthcare professionals in various countries around the world.  It is critical that our activities do not improperly influence the medical decisions of healthcare professionals or the purchasing decisions of entities that buy our products.

Our Policy on Interactions with Healthcare Professionals ensures that we act ethically and legally in our interactions with healthcare professionals, comply with all applicable laws, and do not provide improper benefits or inducements to healthcare professionals. We provide training to employees on this policy.

Animal ethics

Regulatory bodies occasionally require biocompatibility testing of our medical device materials. This testing follows a risk management approach based on ISO 10993-1, Biological Evaluation of Medical Devices. ISO 10993-1 includes requirements for the wellbeing of animals and for minimising the number of animals involved, and tests are conducted in laboratories accredited to international standards (ISO 17025).

We may sometimes participate, observe or otherwise be involved in clinical studies which include animal testing.

We minimise this impact by ensuring these activities are approved by the relevant animal ethics committees and comply with applicable legislation. We support efforts to further reduce animal testing by funding and supporting research in sophisticated physiological computer models.

Market access risk

In order to sell our products around the world, regulatory permission and compliance with established regulatory requirements is required. Without evidence of regulatory compliance or specific product licenses, we are not permitted to market our products in certain countries.

Fisher & Paykel Healthcare has regulatory affairs processes that enable the obtaining and maintaining of product licenses, as well as a Quality Management System that ensures compliance to applicable regulatory requirements.

Processes exist to ensure the obtaining and maintaining of regulatory product licenses, as well as ensuring our Quality Management System complies with current regulatory requirements. Short and longer term programmes are established to continuously improve our approach.

We have monitoring programmes in place to evaluate the effectiveness of our programmes, and our executive management team conducts regular management reviews.