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At BTG we are committed to achieving high standards of corporate governance which we believe are fundamental to the success of our business. The Board is ultimately responsible for this and looks to improve standards as part of building a successful company. We have a strong governance framework embedded within the culture of our organisation which goes beyond compliance to the integrity with which we operate. We support the principles of the UK Corporate Governance Code as published by the Financial Reporting Council (FRC).
The roles of the Chairman and Chief Executive are separate and distinct and the division of their responsibilities is clear. Twenty-two percent of the members of the Board are women and this is a percentage which BTG seeks to improve in the future.
The Governance section of the Annual Report contains a detailed description of our Board and governance including Board structure, roles and responsibilities, committee activities, selection criteria for new Board members, conflicts of interest, audit procedures, performance evaluation, and remuneration.
Available on this website are links to the BTG articles of Association as well as those matters reserved for the Board and the Terms of Reference for the Remuneration Committee, Nomination Committee, and Audit Committee. Biographies of the Board members are available in the About Us section here.
We build trust in all interactions by consistently displaying high standards of ethical and professional business practice. These standards are more than a slogan or a catch phrase – they underpin everything we do and are reflected in the way we do business.
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. That means embedding our values and committing to abide by the letter and spirit of our Code in everything we do.
BTG’s 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.
To deliver our vision of being a trusted and valued partner, it is everyone’s responsibility to know, understand and conduct their activities in accordance with this Code, all supporting policies, procedures and applicable industry codes of practice (e.g. ABHI, AdvaMed, EFPIA, IFPMA, JPMA, MedTech Europe, PhRMA), and the specific laws and regulations of the countries in which we do business.
This Code applies to all BTG employees worldwide, within all sectors, regions, areas, functions, and subsidiaries. All employees must ensure this Code (and the associated standards and procedures) is followed by any contractors or other third parties whom they engage. Every manager is responsible for providing the necessary support to their teams to ensure they understand the requirements of this Code and the relevant policies and how they should be applied in practice. Managers are expected to provide assurance on these matters to the BTG Leadership Team and ultimately the Board of Directors of BTG plc.
BTG is 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, BTG has 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 establishes that BTG conduct 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.
Bribery is considered illegal in all countries in which BTG conducts business. In addition to exposing BTG to severe sanctions, any employee, officer, director or other person acting on behalf of BTG who engages in such conduct can also face substantial fines and/or imprisonment.
BTG’s 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 BTG’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 employees are expected to report potentially corrupt behaviour.
BTG management is dedicated to ensuring that the standards of legal and ethical behaviour 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.
The Board Audit Committee ensures that these procedures are operating effectively and that appropriate follow-up action takes place.
BTG is committed to quality in all of its operations throughout the world. At BTG, 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 policy is to develop, manufacture, distribute, market, sell and out-license medicinal and healthcare products which are fit for their intended use, comply with applicable regulatory requirements, and never place patients at risk due to inadequate safety, quality or efficacy.
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.
We rely on third-party contractors for the supply of many key materials and services.
BTG’s key priorities for supply chain management relate to security of supply, supplier compliance with the required quality standards, reduction of lead times and cost control. BTG is also developing formal supplier relationship management strategies with key vendors, involving effective governance to underpin operational performance and implementation of continuous improvement initiatives to drive value. BTG undertakes specific sourcing projects in accordance with business need, and supplier selection is based upon a number of criteria, including the quality of responses to questions about environmental, social and governance included in the Requests for Proposals or Quotations (RFP/RFQ).
Procurement staff are incentivised based on delivery against performance management objectives. These objectives include execution of category management plans that result in robust supply chains with reputable suppliers who can meet the required standards and create genuine value for BTG.
BTG performs a spend analysis of its supply chain for each of its divisions, assessing current and historical spend by supplier and using a combination of forecast and budget data to determine future spend. This information is referenced in price negotiations with suppliers. A Pareto analysis of spend is also applied to inform and support prioritisation of category management activity.
BTG has defined a mechanism for grading critical suppliers based on a number of criteria including source flexibility, lead time for products, supplier location and quality of products.
Formal, longer-term contracts are implemented with the most critical suppliers in order to secure continuity of supply. Our risk matrix also provides guidance on the recommended level of stock to be held by BTG. However, availability of storage space, shelf life of suppliers’ products and the level of BTG’s working capital invested in raw materials inventory is also considered in determining the volume of contingency stock to hold.
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. BTG continues to focus on this area to ensure market demand for products can continue to be met.
BTG expects its 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. They are expected to comply with all policies that relate to work conducted on BTG’s behalf. BTG enforces required standards through its contract terms and obliges suppliers to ensure relevant standards are met by sub-contractors.
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.
BTG is pursuing several opportunities to leverage its supply chain. For example, we work to rationalise our supplier base and use the same suppliers across multiple sites. This reduces management time, ensures greater consistency of standards or service, improves reliability, and can shorten lead times and lower costs. We’re also eager to access supplier innovations that can improve the efficiency of our manufacturing process or reduce or eliminate the cost of new materials.
BTG uses many communication channels when delivering information about our products. Examples of these include: direct contact by sales representatives, scientific interactions by medical science liaisons, the internet and websites, conferences and congresses, patient advocacy, journal advertisements, and industry meetings. Regardless of the communication channel, it is BTG’s policy that all promotional materials, communications, and scientific exchange be accurate and not misleading; balanced, substantiated, and scientifically rigorous; compliant with local medical, legal and regulatory standards; and a reflection of BTG’s deeply held corporate values of openness and integrity.
BTG’s employees are expected to understand and adhere to communication and promotional policy guidelines, and our business practices worldwide are expected to meet or exceed the minimum standards set by applicable laws, regulations, guidelines and industry codes of practice.
Our global sales and marketing policies reflect international, regional and country-specific regulations for biologics, pharmaceuticals and medical devices, which act on the human body. These policies are consistent with industry code of ethics and are compliant with applicable laws, regulations and government guidance, and cover marketing activities involving healthcare professionals, patients, payers, and direct-to-consumer activities.
The company employs a compliance programme 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.
There is a growing need for improved healthcare treatments that add value for patients, physicians, and healthcare systems. We aim to develop new treatment options that are backed by level 1 clinical data and offer patients improvements in efficacy, safety, and/or quality of life, and to give physicians access to new products and procedures that they can be confident address their patient’s needs.
BTG operates in areas of medicine where there are underserved patient populations and specialist physician groups. For example, our interventional oncology products are used to treat patients with liver tumours, a significant unmet need with limited treatment options. Our specialty pharmaceuticals rescue medications can be life-saving for those exposed to toxic levels of certain medicines. In such areas of medicine, the impact on patients can be dramatic, and innovation is rewarded through appropriate product pricing and reimbursement.
We believe that in today’s healthcare environment, it is important to demonstrate the value of products to payers as well as physicians. Several of our products have been reviewed by well-known health technology assessment agencies.
After a number of acquisitions BTG has assembled a considerable portfolio of R&D programmes and technology platforms that can potentially generate new product opportunities. The R&D portfolio is broad and diverse, spanning drugs, devices, drug-device combinations, and early and late-stage R&D and across all of our business areas. The pipeline includes investment in life cycle management programmes for currently marketed products, Phase III programmes of large market potential, and a number of exploratory programmes to replenish our pipeline.
A Portfolio Review Board serves to oversee the execution of the Company’s R&D strategy, steering R&D project prioritisation while providing the flexibility to reassign financial and human resources throughout the budget year.
We set targets around delivery and execution through trial planning and streamlined reporting that supports management decision making and control. We measure and continually look to improve performance over a range of indicators, with an emphasis on informative lead measures to monitor progress.
Our R&D group includes a dedicated Innovation organisation focused on new product development and life cycle management of existing products.
Our Innovation team specifically engages with customers and the wider scientific and medical community to gain insights into treatment practice and trends and to identify unmet medical needs where we may focus our development efforts.
For example, Clinicians who use our embolising beads identified situations where a smaller average bead size than was available could be beneficial in the treatment of certain liver tumours. In response, our Innovation team expanded our product offering to include a unique size range and distribution that may allow the doctor to be more selective and penetrate deeper into the tumour, while protecting the healthy liver and reducing stress to cirrhotic livers.
Our newest innovation in the beads business is an imageable bead product that would enable physicians to visualise where beads are placed in the tumour vasculature.
The Innovation team continues to build our pipeline of products in early development, including a bioresorbable bead product for use in non-malignant tumours.
Our quality systems and regulatory processes and documentation (including those relating to Good Laboratory Practice and Good Clinical Practice) are regularly audited by regulators such as the US FDA. Our processes continue to be improved in light of the results of such audits.
BTG has established a framework for process excellence by mapping all R&D processes end-to-end with clearly defined key deliverables and accountabilities. Following a gap analysis we are working to ensure key processes are fit for purpose for the current and growing BTG organisation. A core team has been trained to the “green belt” standard, as defined in the Six Sigma approach to process improvement, in order to drive such continuous improvement.
The overriding policy of BTG is to pay the taxes which are legally due in the territories in which it operates and to make filings and tax payments on a timely basis.
Tax strategy does not drive our actions, but rather supports BTG’s business decisions and business strategy.
Tax decisions take account of the views and interests of all of our stakeholders and are in accordance with the BTG Code of Conduct and core values. BTG operates policies, procedures and governance to ensure compliance with tax laws in the territories in which we do business.
BTG is committed to transparent relationships with all tax authorities. BTG discloses tax information in our annual report and half-year statement in a clear and open manner, to provide appropriate detail on the effective tax rate of the group and the amount of tax paid.
Our Global Tax Strategy page provides additional information on how we manage tax risk, our approach to tax planning and tax risk, and how we interact with tax authorities. This page fulfills our responsibilities under Paragraph 16(2), Schedule 19 of the Finance Act 2016.
As risk is inherent in our business strategy, BTG has adopted a risk management programme intended to ensure that internal processes are in place to identify, assess, monitor, manage and mitigate key risks effectively. Risk management is embedded throughout the company’s operations and functions. 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.
Risks are identified and assessed by operational staff and managers and are collated into a composite Risk Register for review at least twice per year by a Risk Committee, which comprises senior members of staff representing relevant parts of the business and key functions, as well as members of the Leadership Team. The materiality of each risk is assessed in relation to its impact on achieving key measures of success. In the intervening periods the status of key risks are tracked and reported to the Leadership Team and the Board. The Board performs a risk review at least twice a year, as well as “deep dive” assessments of key risks from time to time. The risk assessment is integrated in the strategic discussion at Board level.
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.
A detailed discussion of what we believe are the principal risks that could materially affect BTG are detailed in our Annual Report.
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