Modern Slavery Statement

This statement is made pursuant to section 54(1) of the modern slavery act 2015 and constitutes our group’s slavery and human trafficking statement for the financial year ending 30 June 2021.

Our commitment

Clinigen Limited and its subsidiaries (the “Company” / “We” /” Our”/ “Group”) recognises our responsibility to identify, address and mitigate the risk of modern slavery and human trafficking in our operations and supply chains, and we are committed to doing so by operating to the highest ethical standards.

While the risk of modern slavery and human trafficking is relatively lower in the highly regulated pharmaceutical and pharmaceutical services industry, we recognise that this responsibility also extends to our business relationships.

We have established and maintain systems and controls to safeguard against slavery and related human trafficking in our supply chain.

Our business and structure

Clinigen is a global pharmaceutical products and services company with a unique combination of businesses focused on providing access to medicines to improve the quality of people's lives around the world. We are the global leading experts, trusted by both pharmaceutical and biotech companies and healthcare professionals, in providing access to medicines throughout the lifecycle of a medicine, clinical trials, unlicensed and commercial supply.

The Group is headquartered in the United Kingdom. The Company has operating entities incorporated in the UK, mainland Europe, Japan, Hong Kong, Malaysia, Singapore, Australia, New Zealand, South Africa, and the USA.

Our supply chains

Our supply chains include:

Raw material/API suppliers;
Componentry suppliers (packaging, vials, etc);
Contract manufacturers (CMOs);
Pharmaceutical and Biotechnology companies;
Freight forwarders;
Warehouse storage; and,
Distributors.

Our policies on slavery and human trafficking

In keeping with our values, many of our policies assist with the ongoing prevention of modern slavery or trafficking in our business:

Our Human Rights Policy reflects our commitment to acting ethically and with integrity in all our business relationships and to implementing and enforcing effective systems and controls to ensure slavery and human trafficking is not taking place anywhere in our supply chains. The policy has been developed in line with the UN Guiding Principles on Business and Human Rights (Guiding Principles) and our employment policies detail our high standards of employment practices including respecting diversity and complying with national legal requirements regarding wages and working hours.

Our Code of Conduct sets out our values and our behavioural standards. It contains a requirement for our employees to interact with others in an ethical and proper manner and highlights our employment principles and other ethical standards. It specifically prohibits the use of modern slavery or human trafficking in our business. The Code of Conduct applies to all Clinigen employees, whether permanent or on fixed term contracts.

The ‘Freedom to Speak Up’ Policy encourages an environment of accountability and integrity. The Group offers all employees a confidential process through which complaints can be raised within the organisation in the knowledge that they will be taken seriously and dealt with in an appropriate and professional manner.

In addition to our policies, as a signatory of the United Nations (UN) Global Compact we have committed to advance the Ten Principles on human rights, labour, environment and anti-corruption and the UN Sustainable Development Goals (SDG).

Assessing risk in relation to slavery and human trafficking in our business and supply chains

Modern slavery is a complex issue that can manifest at multiple tiers of the supply chain. To assess modern slavery risk, we have considered several globally recognised indices in our risk evaluation process and consulted other sources such as the Global Slavery Index to help determine areas of focus. To identify the business activities with greater exposure to modern slavery risk, we have considered the following factors:

Reliance on low skilled, seasonal, and/or temporary workforce (low risk)
Hazardous or undesirable work (low risk)
Presence of migrant workers across the supply chain (low risk)
High risk sectors we work with (low risk)
Long, complex, or non-transparent supply chains (medium risk)
Presence of child labour (low risk)
Country risks i.e. poverty, conflict, weak enforcement of international human rights standards (using the Global Slavery Index).

Based upon our risk assessment and analysis, we believe that the risk of modern slavery in our directly employed workforce is low. This is due to the highly regulated nature of our industry, our employees being largely educated or skilled, or undertaking work in controlled and validated environments where there are established policies and processes. We have not assessed any high-risk types of work (i.e. seasonal, low-skilled, temporary) or vulnerable groups (migrant workers, refugees, women, or children) within our existing supply chain.

Our exposure to the risk of modern slavery marginally increases when we engage with third parties, particularly in categories such as protective equipment and clothing, manufacturing, and distribution & logistics. In addition, as a global supplier of hard-to-reach medicines we recognise that our supply chain may operate in countries that may be more vulnerable to human rights abuses. For instance, in the last 3 years we have provided access into 127 countries for patients with unmet medical needs, of which 65 were developing countries where access to important medicines can be hugely delayed and, in some cases, would never happen.

Use of materials and commodities within our value chain, is also considered to be low risk, both in the prevalence and vulnerability to modern slavery abuse. We have made this assessment utilising the US Bureau of International Labor Affairs (ILAB) list of goods that are at higher risk of being produced by child labour or forced labour (https://www.dol.gov/agencies/ilab/reports/child-labor/list-of-goods).

To mitigate and help manage our zero-tolerance policy for any such abuses we:

Clearly communicate our expectations to suppliers within our new Supplier Code of Conduct.
Ensure our contracts require our supplier(s) to follow statutory requirements in the country in which they operate, including where appropriate, any applicable laws regarding human trafficking, forced labour and other forms of modern slavery.

Due diligence processes for slavery and human trafficking

As part of our initiative to identify and mitigate risk we have in place systems to:

Identify and assess potential risk areas in our supply chains.
Mitigate the risk of slavery and human trafficking occurring in our supply chains.
Monitor potential risk areas in our supply chains.
Encourage the reporting of illegal or unethical conduct.

During the next financial year (2022), we plan to develop and roll-out a more formalised approach to third party due diligence on our key suppliers, distributors, and other companies whose activities may impact the quality, safety or efficacy of our products. The development of third-party due diligence checks forms part of our continuous improvement programme.

Employee training

To ensure a high level of understanding of the risks of modern slavery and human trafficking in our supply chains and our business, we plan to provide targeted training to our employees in 2021/22. The competency-based training will be ‘role’ based to ensure we specifically train those employees where modern slavery risk is of higher risk prevalence and vulnerability in their day-to-day activities i.e. supply chain and/or country.

In respect of agency workers, Clinigen only engages with reputable employment agencies in relation the engagement of temporary or contract personnel.

Measuring our effectiveness in combating slavery and human trafficking

Clinigen will review the effectiveness of its modern slavery processes and controls through its established enterprise risk management program from FY 2021/22 and will action any issues identified. This will include assessing those systems and controls in place to detect and mitigate modern slavery risk within the supply chain.

Clinigen recognise that as a complex issue, modern slavery requires more effort to uncover, particularly in lower tiers of supply. As such, the company will continue to develop its onboarding and due diligence activities of tier 1 suppliers (i.e. critical suppliers such as Contract Management Organisations / Active Pharmaceutical Ingredient suppliers) in FY22 and will consider the need for additional ways to assess the effectiveness of its actions.