Bioethics

BTG is committed to maintaining high ethical standards in the conduct of our research and development studies. The safety and well-being of the patients participating in our clinical trials is our utmost concern. We ensure that the individuals participating in our clinical studies understand the risks involved and why they qualify to take part in a trial, as well as the protection of their personal information and privacy. The provision of written informed consent is of paramount importance. All clinical trial proposals are reviewed and evaluated for scientific merit, both internally, but also with experts in the medical field and external bodies, such as independent review boards (IRBs) or Ethics Committees.

Our people

We believe every employee plays an important role in bringing products to market and delivering meaningful benefit to patients. We value the skills, experience, and expertise that individuals bring to our business, as well as their personality. We’re committed to providing employees with development opportunities, and investing to help each individual realize their full potential.  Managers ensure that every employee has a training and development plan.

Our employees come from all walks of life and represent a diverse range of age, race, religion, gender, gender expression and sexual orientation. More importantly, our employees offer a diversity of opinions and perspective. We foster an open and inclusive culture that allows employees to understand and trust each other, and to listen and learn from each other’s experiences. We believe this leads us to better business decisions and more innovative solutions to problems. 

We expect that all people decisions, including recruitment, development, promotion and compensation, will be based solely upon a person’s ability, experience, behavior, work performance and demonstrated potential in relation to the needs of the role without regard to unrelated personal characteristics such as race, color, religion, gender, sexual orientation, age, gender identity, or gender expression, national origin, marital status, disability, veteran status, or other characteristics protected by applicable laws.

We do not tolerate discriminatory behavior, harassment or retaliation against those reporting or involved in the investigation of claims alleging such behaviors.

Occupational health and safety

We understand our responsibility to protect the health and safety of our employees and conduct regular risk assessments, audits and training. BTG complies with all requirements of local legislation and provide a minimum standard by which all sites will operate in the absence of local legislation. The company maintains strong local relationships with government health and safety bodies.

Our Leadership Team receives a monthly report covering a range of environment, health, and safety metrics, and we regularly remind employees of their obligation to report any incidents to ensure that measures can be taken for improvement. We aim to record all accidents and incidents resulting from work-related activities for anyone engaged by BTG either in full-time employment or as a contractor. This includes activities such as driving on company business and incidents that occur on supplier or customer sites.  We publish Health and Safety incidence rates for our manufacturing sites in our annual report and on this website.

Human rights and labour practices

BTG takes its responsibility to protect human rights very seriously. BTG respects numerous international standards including the United Nations Universal Declaration of Human Rights.

We have a Modern Slavery Statement describing the activities that we undertake and defining the companywide standards that we adhere to. This document also summarizes our activities to ensure slavery and human trafficking is not taking place in our business or our supply chain.  We believe this statement aligns with the requirements of the US California Transparency in Supply Chains Act which came into effect at the beginning of 2012, and the UK Modern Slavery Act which came into effect on 1 October 2015.

Our values

Our values and the behaviors that support them are reflected in the way we do business and are an important differentiator for BTG. They are at the core of our hiring, employee development, and our performance review processes. We invest time and effort to deliberately preserve our values and culture. We incentivise and reward values-based behavior by including a values-based assessment as part of our appraisal process. 
 

You can read more about our values here.

We hold our people and communities in the highest regard and believe that treating people well helps ensure the sustainability of our business.

Environment health and safety management system

In addition to compliance with all requirements of local legislation, we have also developed 20 Environment Health and Safety (EHS) standards that we monitor and manage on a continual basis using our EHS management system. These are:
 

• Responsibilities and Organisation
• Assessment and Control
• Emergency Preparedness
• Pressure Systems
• Electrical Systems
• Permit to Work
• Work Equipment
• Waste Management and Transport of Chemicals
• Hazardous Substance Exposure Monitoring & Control
• Competency, Information & Training
• Contractors & Supplier Management
• EHS Checking & Monitoring
• Noise Exposure Monitoring & Control
• Ergonomics
• Plant & Process Safety
• Emissions to Air, Water & Ground
• Storage & Handling Hazardous Substances
• Contamination of Land & Groundwater
• Raw Material & Energy Conservation
• Animal Welfare

Our EHS/Risk team audits our performance against standards in these areas every three years with improvement plans put in place wherever necessary, and more frequent auditing where standards are not met.

Environmental Responsibility

Managing our resources and protecting the environment are essential parts of our commitment to becoming a more sustainable business. We continue to refine our environmental reporting with the intention to continuously monitor and improve our sustainability and impact on the environment. 

Operational Eco-efficiency

We regularly assess the environmental impact of our business to ensure that we take advantage of opportunities to improve our performance and efficiency and to help manage finite resources. All facilities exclusively occupied by BTG with more than 20 employees are committed to implementing two eco-efficiency projects per year.

We recycle paper, cardboard, plastic and metal at each of our sites and encourage the use of local materials, suppliers and contractors wherever possible and cost effective. We measure waste produced from all of our production sites.

We operate an international supply chain for the manufacture of our products and where possible we transport in bulk using the most efficient transportation in order to save money and reduce our carbon emissions.
We monitor electricity and gas consumption at manufacturing sites and offices, and we try to reduce our carbon emissions and increase energy efficiency wherever possible.

Anti-bribery and corruption

Bribery is considered illegal in all countries in which BTG Specialty Pharmaceuticals conducts business. BTG Specialty Pharmaceuticals employees are advised not to offer or accept money, gifts or anything else of value as a bribe or inducement to make, or as a reward for making (or not making) any decision that favours the company’s interests or to otherwise seek to gain an unfair business advantage or enhanced product sales. This includes providing benefits to government officials (including those in local and national governments and those serving public interests) and other organisations, healthcare professionals, patients, suppliers, charities or advocacy groups. BTG Specialty Pharmaceutical employees are expected to report potentially corrupt behavior.

Code of Conduct

Our Code of Conduct  describes the principles, policies and procedures that we have developed to promote understanding of, and adherence to, the ethical behaviours that we expect of all employees. The core principle is that every one of us has to take individual responsibility for behaving ethically and compliantly. This Code applies to all BTG employees worldwide and employees must ensure this Code (and associated standards and procedures) is followed by any contractors or other third parties whom they engage.

The Code of Conduct covers issues relating to our marketplace, our assets, our stakeholders, and our employees. Among the topics included are: interactions with healthcare professionals and purchasers, bribery and corruption, confidentiality and privacy of personal information, competition and anti-trust laws, handling of price sensitive information and share ownership, discrimination, health, safety and the environment. The Code also details a process for raising concerns about a possible compliance breach without fear of retaliation.

Compliance Programme

We are committed to complying with laws and regulations related to healthcare fraud and abuse, generally accepted as relating to improper product promotion, bribery and corruption such as providing kickbacks to generate business, and making or causing the submission of false claims to the government. To help meet its commitment, we have implemented a comprehensive compliance programme which establishes the framework within which employees are permitted to operate. This framework includes documented policies and procedures, the provision of regular and effective training and opens lines of communication so that employees may raise concerns related to fraud and abuse matters. Our compliance programme includes internal monitoring and auditing to validate the effective operation of these processes.
 

As a part of the compliance programme, BTG has made a Declaration of Compliance to the State of California.

Governance

We build trust in all interactions by consistently displaying high standards of ethical and professional business practice.

Tax Strategy Disclosure

The relevant UK entities within BTG Speciality Pharmaceuticals (“BTGSP”), which incorporate BTG International Healthcare Ltd, Protherics Medicines Development Limited and Protherics UK Limited, recognise their obligations to comply with all relevant tax requirements and filing obligations, including corporate income tax, payroll taxes, VAT and other taxes^*.

BTGSP aim to be open and transparent in dealing with the tax authorities. The BTGSP finance teams will, on behalf of the Board of Directors of the entities within BTGSP, engage with local tax advisors to obtain advice and assistance in the preparation of their tax returns and in considering their tax positions. An external auditor audits the accounts of the entities within BTGSP on an annual basis. Where appropriate, accruals are made for uncertain tax items in line with local GAAP requirements.

BTGSP believes that it should pay the amounts of tax legally due. There will, however, be circumstances where this amount may not be clearly defined, or where alternative approaches may result in differing tax outcomes. The Board of Directors of BTGSP entities will use their best judgement in determining the appropriate course of action, using available reliefs and incentives where possible.

The Board of Directors of the relevant entities of BTGSP are updated on significant tax matters including the tax implications of commercial activities. The relevant entities within BTGSP seek to interpret the relevant tax laws in a reasonable way and external professional tax advice is taken where necessary.
 
^*Last reviewed in September 2022 and relates to the financial year ended 31 December 2021
 
Under UK law, the relevant UK entities of BTGSP as listed above are required to publish their tax strategy. BTGSP entities consider that through this communication, they are complying with the duty under paragraph 22(2) schedule 19 of the UK Finance Act 2016.

Animal Welfare

Animal welfare is a key consideration in the decisions that we make. Our animal welfare policies and standard ensure that animals are treated as humanely as possible and any pain or suffering is minimised.

Our Animal Ethics and Welfare Standard applies to all BTG sites and any facilities of a contractor directly contracted to BTG where animals are used for research or production purposes. The standard also applies to any research protocols which involve animals.  The standard is based on OECD guidelines relating to the humane use of animals in experimentation for purposes of ensuring medicinal product safety.
Our sites are audited regularly to ensure they are applying the standard. All sites which have animals produce animal safety reports on a monthly basis.

Research involving animals is carefully considered, justified and monitored. Our policy requires that the use of animals in research will be performed to the highest standard of ethics, adhering to the three guiding principles of reduction, refinement and replacement. All animal studies are performed at external Contract Research Organisations and academic units, and we will only work with external parties that evaluate animal studies using a local ethical review process. In addition, we will only perform animal studies in territories where they are strictly regulated.

Marketing practices

Our policy is for all promotional materials, communications, and scientific exchange to be accurate and not misleading; balanced, substantiated, and scientifically rigorous.

The company employs a compliance program to monitor, audit and correct internal or external notifications or suspicions of sales and marketing practices which may be inconsistent with BTG policies and values. All sales and marketing materials are systematically and thoroughly reviewed through BTG’s Promotional Review Committee and are appropriately submitted to regulatory bodies (e.g., The Office of Prescription Drug Promotion, (OPDP), a division of the US Food and Drug Administration) as required by law.

Open door and incident reporting

Management is dedicated to ensuring that the standards of legal and ethical behavior are upheld. Concerns about a possible compliance breach raised in good faith will have the support of management. Those raising concerns will not be subject to retaliation. In fact, any act or threat of retaliation would in itself be considered a serious violation of the Code. The Code details the process for raising such concerns, including an independent telephone line should staff wish to use it.

Product quality and safety

Quality is not just the name of a department; it is a companywide priority and every employee’s responsibility. It is all about aiming high and aspiring to attain the very highest standards in everything that we do.

Our quality systems, policies, processes and procedures are in place to ensure we meet our legal and compliance obligations; and that we put patient safety first in meeting and exceeding the expectations of our customers and regulatory authorities.

Risk management

We have a risk management program in place intended to ensure that we identify, assess, monitor, manage and mitigate key risks effectively. This process utilises both risk maps and a timeline that plot risks with respect to our strategic goals. The risk timeline enables a discussion of potential concurrent risks and the mitigations required.

While we aim to identify and manage potential risks, no risk management strategy can provide absolute assurance against loss or unforeseen events occurring, or mitigations proving ineffective.

Supply chain management

We rely on third-party contractors for the supply of many key materials and services.  Risks, such as problems at contractors’ facilities or materials and services available from very few sources, are mitigated through rigorous monitoring of suppliers; maintenance of adequate product and component inventories; and employing dual sourcing where practicable. Quality agreements and/or service level agreements with associated key performance metrics are used with the most significant providers.

We expect our vendors and contractors to operate to high standards as defined by our Code of Conduct. Where appropriate, quality surveillance audits are conducted and each supplier is monitored via the BTG Quality system which captures the required quality information.

Specific questions are included in requests for proposal to assess how suppliers safeguard human rights, anti-bribery measures, corporate social responsibility, and environment health and safety policies.