Overview

Our mission of ‘the right medicine, to the right patient, at the right time’ is at the heart of everything we do. We will achieve our mission by being a safe, responsible, ethical, and transparent business. This pillar is made up of the following components which are driven by the principle of acting as a responsible and ethical business:

  • Product Quality and Patient Safety
  • Ethical Business
  • Data Privacy
  • Our Communities

We have set out below further detail on the key aspects of our Responsible Business pillar, including our commitments, targets and activities, and a summary of some of the core activities we undertake to ensure we act responsibly and ethically across our value chain.

Our commitments

We believe that doing business responsibly matters, whatever sector you are in. But it is particularly important in the pharmaceutical industry because of the high stakes for the ultimate beneficiaries, the patients, for whom safe access to the right medicine can be the difference between life and death. We are committed to ensuring safe access to the right medicines whilst operating ethically and transparently. Our commitment to being a safe and responsible business include:

Safe production and supply of our products/services

We are committed to ensuring the safe production and supply of our products and services through adoption of rigorous quality assurance processes throughout the manufacturing and distribution supply chain.  This includes mitigating the risk of falsified product in the supply chain through the adoption of robust quality assurance and regulatory compliance throughout the product lifecycle.

As a business we are committed to working to Good Pharmacovigilance Practices (GVP), Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). We aim to implement and adhere to the rules and guidance from regulatory bodies.

Ethical supply chain

We will do our utmost to ensure our supply chain and production of medicines is ethical through the inclusion of appropriate warranties and deliverables in our contracts and the requirements of our Supplier Code of Conduct.

Zero tolerance towards bribery, corruption and fraud

We adopt a zero-policy approach towards bribery, corruption and fraud throughout our business activities. This will include continued implementation of an anti-bribery & corruption programme which aligns to recognised best practice.

Robust data governance and compliance

We are committed to embedding effective data governance to ensure the safe handling and processing of data. This includes adoption of internal controls and frameworks to ensure we comply with global data privacy laws in all of the countries we operate within.

Upholding external standards to protect human rights

We believe governments are responsible for defining and enforcing a legal human rights framework that accords with international laws and agreements, such as the Universal Declaration of Human Rights. However, as a global business, we recognise that we have a role to play in upholding human rights and in addressing adverse human rights impacts where we are in a position to influence. We support the UN Guiding Principles on Business and Human Rights.

We are committed to upholding and respecting human rights both within our business and in that of our suppliers. In line with the UN Guiding Principles on Business and Human Rights (Guiding Principles), we base our human rights policy commitment on the International Bill of Human Rights and the principles concerning fundamental rights set out in the International Labour Organization’s Declaration on Fundamental Principles and Rights at Work. We are committed to respecting internationally recognised human rights relevant to our operations.

How we will measure our progress against our commitments

We will measure our progress against our stated commitments through by monitoring and reporting against a number of data points highlighted below. We have also highlighted recent initiatives with contribute towards making an impact against our commitments:

Contributing to the UN SDGs

Goal 3: Good Health and Wellbeing

Goal 3: Ensure healthy lives and promote well-being for all at all ages

Our mission and purpose is to enable people to live healthier lives around the world through enabling great and quicker access to new and important medicines. In doing so, we must ensure that we operate in a responsible and ethical manner.  Being a responsible business applies across across our entire value chain, through ethical and safe sourcing and supply, to operating to the highest standards of governance and quality assurance.   By doing so, we will ensure that we can continue to contribute safely to Goal 3.

Goal 16: Peace, Justice and Strong Institutions

Goal 16: Promote just, peaceful and inclusive societies

Goal 16: Promote just, peaceful and inclusive societies: We support the UN Guiding Principles on Business and Human Rights. We are committed to upholding and respecting human rights both within our business and in that of our suppliers through the policies we set, our governance and our actions. As an employer we contribute to a peaceful society with equality and justice are at the heart of how we operate. We do this by:

  • Providing a fair salary and good conditions of employment.
  • Providing a healthy, safe, and secure workplace for all employees and contractors.
  • Opposing discrimination at work and promoting inclusion and diversity.
  • Promoting the personal development and dignity of every individual employee.
  • Being respectful of the right of employees to join an independent trade union, the right to collectively bargain, and of freedom of association.
    Opposing all forms of slavery and exploitative child labour.

Our ethical and compliance policies at a glance

The Group has developed a number of core policies which help govern and ensure we operate ethically, transparently and in line with international legislative and regulatory frameworks. We apply our policies across all of our operations, and also require all of our suppliers to commit to apply the same or equivalent policies. The core Group policies supporting our business to meet the highest standards of governance, ethics and compliance include:

Key policies

Group Quality Policy

This policy is owned by our Group Quality function and acts as the governing policy for quality. It sets out our commitment to adopting the highest standards of quality across our value chain, a requirement for continual improvement, and a basis for establishing quality objectives group-wide.

Supplier Code of Conduct

In 2021, to further strengthen our approach to ensuring an ethical and safe supply chain we introduced a new Supplier Code of Conduct. This new code sits alongside the existing Quality Supplier Terms & Conditions (QTC) document which set out in detail our terms and conditions in line with our QMS and compliance with key medical regulators.

Anti-Bribery & Corruption Policy

It is our policy to conduct all business in an honest and ethical manner. We take a zero-tolerance approach to bribery and corruption and are committed to acting professionally, fairly and with integrity in all our business dealings and relationships wherever we operate, and to implement and enforce effective systems to counter bribery and corruption. Our Anti-Bribery & Corruption Policy (ABAC), which applies group-wide, sets out the core requirements placed upon the business and our employees. The policy is supported by an annual programme of mandatory training.

Whistleblowing Policy

In support of our commitment, Clinigen has implemented a Whistleblowing Policy aligned to best practice. The policy sets out in detail our approach and commitment, including Protection of Whisleblowers and issues can be raised anonymously.

Human Rights Policy

In line with the UN Guiding Principles on Business and Human Rights (Guiding Principles), we base our Human Rights Policy commitment on the International Bill of Human Rights and the principles concerning fundamental rights set out in the International Labour Organization’s Declaration on Fundamental Principles and Rights at Work.

Tax Strategy

Clinigen is committed to full compliance with all statutory obligations and full disclosure to Tax Authorities. Our policy is to manage our tax affairs in a responsible and transparent manner, to comply with relevant legislation and to have due regard to our reputation. Through this we seek to promote the long-term success of the Group and deliver sustainable shareholder value.

Full details on the above policies can be found here.

Our progress and actions

We have set out below a summary of our progress and performance with regard to developing a framework which enables Clinigen as a Group to act responsibly, ethically and in compliance with key legislative and regulatory requirements:

Product quality & patient safety

Overview

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 expertise and resources as a specialty pharmaceutical company (with our own portfolio of medicines) to ethically source the vital commercial and unlicensed medicines we handle on behalf of our clients. We ensure that products are properly looked after throughout their life in terms of storage and transportation conditions, but also that we guard against the risk of falsified product entering the supply chain.

Quality Policy and Quality Management System (QMS)

Clinigen is committed to meeting the requirements of our clients providing our customers with products and services they require, in conformance with the Company’s Quality Specifications and current legal and regulatory requirements.

We aim to achieve the above by implementing a management system that complies with the international standard of good practice. It also includes a continual development of the system and helping to ensure it remains effective. We also aim to provide the best possible service to Physicians, Pharmacists, Pharmaceutical and Biotech Companies and others who use our products and services.

The Group's overall quality and pharmacovigilance objectives are:

  • Complying with the legal requirements for pharmacovigilance tasks and responsibilities;
  • Preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure;
  • Promoting the safe and effective use of medicinal products, through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public;
  • Contributing to the protection of patients’ and public health.

Our quality system is underpinned by our holding manufacturer / wholesaler / distributor licenses 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.

The system for managing quality encompass the organisational structure, accountabilities and responsibilities, procedures, processes and resources, as well as activities necessary to ensure confidence that the services delivered maintains its quality and integrity.

The QMS has been established in order to improve overall quality performance and provide a basis for sustainable development initiatives. The purpose of the system is to ensure the Group:

  • Consistently provide products and services that meet customer and applicable;
  • Meets its statutory and regulatory requirements;
  • Addresses risks and opportunities on a timely basis;
  • Demonstrate conformity to specified PQS requirements; and
  • Comply with the requirements of GxP.

Management has the ultimate responsibility to ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles, responsibilities and authorities are defined, communicated and implemented throughout the company.

Our quality system ensures that:

  • Medicinal products are manufactured (in case of in-house secondary packaging activities or external Contract Manufacturing Organisation (CMO) activities) held, supplied or exported in a way that is compliant with the requirements of GMP & GDP;
  • Safety information is collected and processed within stipulated timelines and communicated to customers and Regulatory Authorities according to regulatory requirements;
  • Employee and management responsibilities are clearly specified;
  • Products are delivered to the right recipients within a satisfactory time period;
  • Records are made according to MHRA and FDA guidelines for data integrity which refers to ALCOA being Attributable, Legible, Contemporaneous, Original, and Accurate; Deviations from established procedures are documented and investigated;
  • Appropriate Corrective Actions and Preventive Actions (CAPAs) are taken to correct non-conformances/deviations and prevent them in line with the principles of quality risk management.
  • Self-inspections (internal audits) are conducted in order to monitor the implementation and compliance with GMP & GxP principles and to propose necessary corrective measures. Reports contain all the observations made during the inspections and, where applicable, proposals for corrective measures. Statements on the actions subsequently taken are also documented.

Supply chain

The Group has effective supply chain management only working with trusted manufacturing and global distribution partners which the Group assesses regularly. The Group also seeks to maintain appropriate stock levels of its own products and related API to minimise the risk of shortage of supply. To the extent possible, the Group supplies its own products directly to hospitals and HCPs. The Group also has industry-leading quality management systems and audits supply partners where appropriate.

The mandatory global serialisation of licensed pharmaceutical products is expected to reduce the trade of counterfeit medicines. As a pharmaceutical company with its own specialty product portfolio in its Products operation and a supplier of licensed comparator products in its Services operation, Clinigen is fully compliant with serialisation regulation.

We aim to build strong, mutually beneficial relationships with the suppliers, distributors and partners who we rely on to meet the needs of our clients and customers. We require that those suppliers, distributors and partners to behave ethically and responsibly, and to demonstrate a culture of compliance. We expect our suppliers, distributors and partners to ensure all aspects of their businesses comply with applicable laws and regulations, and we include obligations to this effect in our standard contract templates.

The Group, through its Quality management team, audits our suppliers and manufacturers regularly. Quality compliance is a key part of the Group’s Quality audit.

Our Quality team have been working this year to strengthen and improve the Quality questionnaires which we ask our suppliers to complete. They have also been reviewing certain other elements of the terms and conditions on which we engage suppliers. We expect these changes to enhance the quality standards of our suppliers, to the benefit of our clients and customers.

Supplier Code of Conduct

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. Similar rules apply for manufacturing practices.

Clinigen may perform on-site assessments of a supplier’s quality management system, on a risk-based approach. All vendors are scored based upon the geographical location, size of business, and the complexity of the product/service being provided. High risk vendors are subject to periodic on-site audits/inspections.

In addition, Clinigen defines the quality assurance responsibilities of the Contract Giver and Contract Acceptor in a Quality/Technical Agreement, where required and where applicable. Quality agreements are reviewed on a periodic basis.

Clinigen qualifies API suppliers with the procurement of API audit reports in cooperation with auditing companies. CMOs are audited with the support of Clinigen's Quality Assurance team (certified auditors) and for the service providers that we are currently working with auditing is performed from our QA Manager and Head of Supply Chain and Analytical Department.

Manufacturing & Handling - Extent of certification to a widely accepted product safety / quality standard (e.g. HACCP, ISO 9001, or equivalent)

Clinigen obtains 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 Practice. Products must be distributed in compliance with Good Distribution practice, including the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013/C 343/01), and products manufactured must be manufactured and released to an appropriate standard of Good Manufacturing Practice.

Clinigen holds API, manufacturing and distribution authorisations in several territories, and is certified to GMP and GDP (where applicable).

Ethical business

Anti-Bribery, Corruption, and Fraud

Failure to comply with anti-corruption and anti-bribery laws/regulations, policies and standards governing the manufacturing, sales, and marketing of our products, could negatively impact Clinigen Group plc and its group (the Group) and/or its officers, Directors and employees, resulting in enforcement activity, civil and/ or criminal liability, fines, penalties, imprisonment, business restrictions, or damage to our reputation.

We operate in numerous countries around the world and our industry is also highly regulated. These circumstances increase our exposure to potential bribery or corruption risks. The Group has a business and Group-wide compliance structure which is continually assessed. Employees are regularly trained in key areas including on Clinigen’s approach to Good Distribution Practice and Good Manufacturing Practice activities, as well as pharmacovigilance and our Group wide Policies including whistleblowing, and anti-bribery and corruption. In addition, the employee code of conduct reinforces the Group’s values of ethics, trust and quality.

The Group is also regularly audited by customers and regulatory authorities to ensure compliance with relevant legislation and acts to address any recommendations. Senior management at Clinigen has full responsibility for the quality management system undertaking periodic management reviews and maintains a close working relationship with the competent authorities to ensure compliance.

It is our policy to conduct all business in an honest and ethical manner. We take a zero-tolerance approach to bribery and corruption and are committed to acting professionally, fairly and with integrity in all our business dealings and relationships wherever we operate, and to implement and enforce effective systems to counter bribery and corruption.

On an annual basis we roll out mandatory Anti-Bribery & Corruption training. All employees are required to confirm they have read, understood and will comply with our Anti-Bribery & Corruption (ABAC) Policy. In addition, employees must complete an online test to demonstrate they have fully understood our policies.

The Group’s ABAC Policy is reviewed and approved annually by the Executive Management Team.  The policy applies to all persons working for Clinigen or on our behalf in any capacity, including all employees, directors, officers, contractors, intermediaries, consultants, third party suppliers and distributors.

Tax evasion is covered under the Group’s Tax Strategy.

Code of Conduct

Due to the scale of operations of Clinigen Group plc, we have a high level of responsibility to shareholders, employees, partners and society at large. We have developed a number of fundamental business principles (Code of Conduct) requiring our suppliers to conduct business activities in accordance with the highest ethical and legal standards.

Ensuring fair, transparent and honest business practices is one of our core values.

Third Party Facilitation Payments

The Group prohibits the making of Facilitation Payments, even in countries where the local law permits such payments. Such payments are prohibited by law in many jurisdictions, including in the United Kingdom.

Annually, we are required to make a disclosure on Facilitation Payment values.  In FY2020, we can confirm the value was nil.

Gifts, Hospitality and Conflicts of Interest

Formal procedures have been implemented for signing off and logging gifts and hospitality accepted by employees.  In addition, the Executive Management Team, all members of the Commercial team and any individuals with authority to place significant contract orders have received anti-bribery training and complete an annual refresher.

All senior employees must sign a declaration of compliance and conflicts of interest statement annually.

Whistleblowing and protection

We value our reputation and we are committed to conducting our business in an honest and ethical manner. We expect all of our employees and other works undertaking activity on our behalf whether full-time or part-time, self-employed or employed through an agency to conduct themselves in accordance with these high standards. By encouraging a “speak up” culture of openness, we encourage employees and contractors to raise issues which concern them at work.

In support of our commitment, Clinigen has implemented a Whistleblowing Policy aligned to best practice. The policy sets out in detail our approach and commitment, including Protection of Whisleblowers and issues can be raised anonymously.

Compliance

In 2020 a new Internal Audit & Risk function was established, with the appointment of a new Group Head of Internal Audit & 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 & Corruption (ABAC) Policy and programme , with periodic reporting to the Audit & Risk Committee.

The Internal Audit team plan to utilise Transparency International's Business Principles for Countering Bribery to provide assurance over the ABAC programmes.

In addition, the Group’s Internal Control Framework (ICF) is designed to prevent and detect non-compliance with key legal and regulatory requirements placed on the Group. This includes Anti-Bribery & Corruption, Fraud, Modern Slavery and Human Rights.

During FY22, 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 programmes through the internal control framework and activities of Internal Audit.
Annually, PwC, as the Group’s External Auditors consider fraud risk as part of their annual audit, the results of which are reported and considered by the Board of Directors.

Modern Slavery

The Group fully supports the aims of the Modern Slavery Act 2015 to eradicate human slavery and trafficking. Further details of these steps can be seen in our Modern Slavery Statement, which is available on our website.

Human Rights

We believe governments are responsible for defining and enforcing a legal human rights framework that accords with international laws and agreements, such as the Universal Declaration of Human Rights. However, as a global business, we recognise that we have a role to play in upholding human rights and in addressing adverse human rights impacts where we are in a position to influence.

We support the UN Guiding Principles on Business and Human Rights. We are committed to upholding and respecting human rights both within our business and in that of our third parties. In line with the UN Guiding Principles on Business and Human Rights (Guiding Principles), we base our human rights policy commitment on the International Bill of Human Rights and the principles concerning fundamental rights set out in the International Labour Organization’s Declaration on Fundamental Principles and Rights at Work. We are committed to respecting internationally recognised human rights relevant to our operations.

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.

Tax Evasion

Clinigen is committed to full compliance with all statutory obligations and full disclosure to Tax Authorities. Our policy is to manage our tax affairs in a responsible and transparent manner, to comply with relevant legislation and to have due regard to our reputation. Through this we seek to promote the long-term success of the Group and deliver sustainable shareholder value.

Our Tax Strategy is made in pursuant to part 2 of Schedule 19, Paragraph 16 of the Finance Act 2016 and sets out the steps taken by Clinigen Group plc (“the company”) has taken to ensure that the Group’s tax affairs are managed in a way which is consistent with the Group’s commitment to high standards of governance.

A copy of our Tax Strategy can be found here.

Share dealing code and insider trading compliance

The Company's shares are admitted and trade on AIM, a market operated by the London Stock Exchange plc ("LSE"). As such, the Company must comply with the:

  • EU Market Abuse Regulation (596/2014) ("MAR"), regulated by the Financial Conduct Authority ("FCA") as the UK’s competent authority; and,
  • The AIM Rules for Companies ("AIM Rules"), regulated by AIM Regulation of the LSE; and
  • Rules 1 to 3 and Rule 5 of the Disclosure Guidance and Transparency Rules sourcebook of the Financial Conduct Authority ("Disclosure Guidance") (which provides guidance on the disclosure requirements under MAR and which applies to both AIM and Main Market companies).

To ensure we fully comply with these requirements, the Group has adopted an Inside Information Policy, including a set of internal procedures, systems and controls to designed to ensure that the Group complies with its obligations relating to inside information under the Market Abuse Regulation (MAR) and the AIM Rules and the Disclosure Guidance and Transparency Rules. We have also adopted a Securities Dealing Code, which applies to the Directors and other relevant employees of the Group and is designed to ensure such persons do not abuse, and do not place themselves under suspicion of having abused, inside information. All the Directors of the Group understand the importance of compliance with the Code.

Data privacy

Clinigen Group respects your right to privacy and is committed to complying with international data privacy laws. Our privacy policy explains who we are, how we collect, share, and use personal information about you when you use our websites, and how you can exercise your privacy rights. You can access full details of our data privacy policy here.

In order to ensure we are able to meet international data privacy requirements we provide regular targeted training to employees.

Our communities

Clinigen has always recognised the role it can play within the communities we serve. As a business with a global reach we know how important it is to work closely with our communities and society as a whole.

The group and our employees are actively involved annual in a number of fundraising activities. During FY20/21, there were various local fundraising activities across the different regions, supporting a number of important cancer charities. including Macmillan Cancer Support and Teenage Cancer Trust in the UK and Kick Cancer in Belgium. Colleagues from our US office volunteered at food banks and supported families in need with food parcels and Christmas gift initiatives.

From an environmental perspective, Clinigen colleagues raised money and donated to the Australian Wildfire Relief Fund. Our South African office, recognising the devastating effect of plastic, made sure that each employee received a wheat straw bottle, which is durable, reusable, and offers an alternative to single-use plastics.

We are proud to support different charitable and environmental projects and will continue to make a positive impact in the regions in which we serve HCPs and patients.