Conduct business in a responsible way and to the highest ethical standards

7

Regulatory inspections of Clinigen

0.02

Average critical findings per audit of Clinigen

0

Product recalls of owned products

Product quality and patient safety

Ensuring the quality of the medicines we deliver is of the utmost importance. The supply of our products and services is becoming ever more complex, and, with the significant regulatory changes taking place across the industry, the expectations of a specialist service provider in terms of technical and project management capabilities are increasingly demanding.

We use our Quality Policy and Quality Management System (QMS) to meet the requirements of our clients and customers in conformance with the Company’s Quality Specifications and current legal and regulatory requirements.

Our quality system is underpinned by our holding manufacturer/ wholesaler/distributor licences around the world, including in the EU, UK, US and Asia-Pacific regions. All of our sites are audited regularly, by a combination of regulators and our pharmaceutical company clients – we see this as a core part of doing business and are very proud of our ability to complete them successfully.

In FY2021 there were 114 audits of Clinigen, with an average of 0.02 critical findings per audit. There were also zero product recalls of Clinigen ‘Owned’ products.

Supply chain, quality assurance, ethics

In 2021, we took steps to further strengthen our approach through the introduction of a new Supplier Code of Conduct. This new code will sit alongside the existing Quality Supplier Terms & Conditions (QTC) document which set out in detail our T&Cs in line with our QMS and compliance with key regulators such as the MHRA.

Clinigen works in a highly regulated industry, and the requirements for qualifying suppliers are well defined within legislation.

For example, EU Good Distribution Practice requires Clinigen to obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question and are required to verify that the supplier complies with the principles and guidelines of good distribution practices.

In FY2021 Clinigen performed 49 audits/ inspections of it suppliers and partners.

The Group fully supports the aims of the Modern Slavery Act 2015 to eradicate human slavery and trafficking. We support the UN Guiding Principles on Business and Human Rights and are committed to upholding and respecting human rights both within our business and in that of our third parties.

In FY2021 Clinigen rolled out a new Human Rights Policy which was approved by the Board in April 2021. We also require all of our suppliers to confirm compliance with our Supplier Code of Conduct which equally sets out the Group’s expectations regarding Human Rights.

We also developed a new ‘Speak up’ Policy which provides a formal route for employees to confidentially speak up about any concern they have at work that they feel is important.

Compliance

In FY2021 a new Internal Audit and Risk function was established, with the appointment of a new Group Head of Internal Audit and Risk who is supported by an external firm to provide additional capacity and expertise.

The Internal Audit remit includes monitoring and assessing the robustness of our Ethics and Compliance activities, including the Anti-Bribery and Corruption (‘ABAC’) Policy and program, with periodic reporting to the Audit and Risk Committee.

During FY2022, further work will be completed to strengthen our approach to fraud prevention and detection. This includes conducting a Fraud Risk Assessment and monitoring our Ethics and Compliance programs through the internal control framework and activities of Internal Audit.