Risk Management | Laws & Regulations | Internal Controls | Assets & Information | Continuous Disclosure | Trading | Competition | Conflicts of Interest | Bribery | Market Practices | Entertainment & Gifts | Stakeholder Relations | Privacy
Risk management is an integral element of CSL's overall corporate governance framework. We maintain a structured, consistent, enterprise-wide approach to risk management to help enhance the performance of our businesses. We have a collective responsibility to integrate risk management into our culture and into all our processes at every level.
CSL has adopted the Australia/New Zealand Standard ISO31000; 2009 (Risk Management Principles and Standards) as the basis of our co-ordinated global risk management process. CSL's implementation of risk management is detailed in the CSL Group risk framework.
This framework plays an important role in ensuring that we have adequate controls to mitigate the risks that could impact on our ability to meet our business and financial goals.
Compliance with laws & regulations
At CSL, each employee is responsible for complying with the applicable local laws of the countries in which we operate.
In certain aspects of our business, such as the marketing of our products, our relationships with other healthcare professionals and our research and development, we have made further commitments to comply with both local and internationally accepted pharmaceutical industry codes of conduct.
We expect third parties with which we work to comply with the applicable local laws and regulations of the countries in which they operate, and to observe all of the principles set out in this Code.
Q. I am responsible for sales and marketing of certain CSL products across a number of different countries. How do I ensure that I and my teams comply with applicable laws and regulations?
A. Wherever we operate CSL must comply with applicable national and local laws and regulations. These may vary from place to place, as different countries have different legal requirements. CSL Legal may be contacted for advice on local legal requirements for each country.
Should the applicable local legal requirements be less stringent than the Code in any aspect, then you must still follow the principles of the Code. You must also ensure that you comply with any applicable pharmaceutical industry standards and codes of conduct.
Internal controls & reporting
Accurate and complete business records are essential for the effective management of our business and to maintain investor confidence.
At CSL, we are committed to ensuring the integrity and quality of our business record keeping and that all of our business records are created and managed to give a fair, true and accurate account of our business.
We have internal control systems to ensure financial statements comply with the applicable local laws of the countries in which we operate and to prevent fraud and other improper conduct.
Q. I have been requested to undertake a review of all the records and draft documents I am holding. How should I decide what to dispose of and what to retain?
A. The CSL Global records retention schedule establishes how long different types of information need to be retained. In general, you should dispose of records meeting or exceeding their retention periods. Two classes of records which must be retained are those which are the subject of a legal "hold order" or those considered to be "historical records". Further information is available from your site's Records Manager and in the CSL Global records management policy and any specific local records management policy or standard operating procedure.
Protection of assets & information
CSL facilities, equipment and other assets must be well maintained and secured appropriately against theft, misuse and unauthorised disclosure. As a result, each CSL employee is responsible for ensuring the protection of our assets and information.
The management of our information technology ensures that our information assets are protected and held secure from a wide range of threats to ensure business continuity and minimise business risk. CSL's information technology security management is based on ISO 207001 and 207002.
Electronic equipment is primarily provided to employees to support CSL business objectives and employee responsibilities. Only software that is endorsed and supported by CSL may be installed on a CSL provided electronic device that has direct access to our critical business systems. All data and communications that relate to CSL's business and are created and/or stored on a CSL provided electronic device are the property of CSL.
It is the responsibility of each employee to ensure our information is secure. CSL recognises that internet use is widespread and has numerous benefits to both CSL and the employee or those providing services to or on behalf of CSL. All online communications including the use of social media must adhere to the same principles and guidelines that apply to all other employee activities as referenced in CSL's policies.
Online activity must not disclose information that could be considered trade secrets or are otherwise confidential or proprietary to CSL. Personal use of the internet is permitted within the CSL work environment provided that it does not interfere with the performance of the employee's job, it is done in the employee's personal time (breaks, etc.) and it does not access or send any material in violation of any applicable law or which is damaging to a person's or CSL's reputation, or which may be considered offensive or inappropriate by normal community standards.
We apply filters to CSL electronic equipment to prevent access to web sites of inappropriate content. However, as it is impossible to identify and limit access to all inappropriate websites, each employee should be mindful of the sites they access.
We have the ability to monitor internet, application, and internal network use. We reserve the right to use this capability to protect CSL from criminal or inappropriate activity as well as to ensure that employees perform their duties consistent with CSL policies. In all cases we will ensure that data privacy is maintained in compliance with local laws and regulations.
Any equipment or other assets (including laboratory notes and notebooks) owned or leased by CSL shall remain the property of CSL and upon termination of employment, or upon request by CSL management, must be returned to CSL.
Q. I just noticed a colleague who works in the next workstation looking at pornographic material on his computer at lunchtime. I don't find the images offensive, he's a good worker and does his job well. What should I do?
A. Pornographic material is not allowed on CSL systems in any form and is a misuse of CSL property. The fact that your colleague is a good worker and the activity occurs during lunchtime are not relevant. You must report this to your supervisor/manager so that appropriate action can be taken.
As a publicly listed company on the Australian Securities Exchange (ASX), CSL has obligations under Australian law and the ASX Listing Rules.
Subject to limited exceptions, we must continuously disclose to the ASX information about CSL that a reasonable person would expect to have a material effect on the price or value of CSL securities.
We have a policy that sets clear guidelines and describes the actions that the directors and all employees should take when they become aware of information that may require disclosure.
Q. Regarding CSL's use of application and network monitoring – does this mean that CSL is watching everything I do?
A. No. CSL has the capability to recall and review all email and electronic traffic. We use this capability, subject to applicable laws, to detect criminal behaviour and behaviour that is inconsistent with CSL policy, such as the accessing or sending of pornography or other offensive or inappropriate material.
Trading in securities
At CSL, we encourage all of our directors and employees to be long-term holders of CSL shares. However, we must take care over the timing of the sale or purchase of any such shares.
Insider trading laws prohibit directors or employees from buying or selling CSL shares, where they are in possession of price-sensitive information that is not generally available to the market.
Price-sensitive information could include:
- The financial performance of CSL against budgets or forecasts;
- Entry into or termination of a significant contract;
- Actual or proposed mergers, acquisitions or joint ventures; or
- Progress of significant research and development projects against milestones.
We have a policy that helps directors and employees to fully understand their obligations in relation to insider trading, with particular emphasis on trading in CSL securities.
Insider trading is a criminal offence under Australian law.
Q. My parents manage a share portfolio as part of their retirement savings. They have asked my advice on whether they should buy some CSL shares. I am aware that CSL has a number of new products in the pipeline and that research has proceeded well in the last year. Am I able to discuss this with my parents and to encourage them to invest in CSL?
A. CSL employees are prohibited from trading in CSL shares if they are in possession of price sensitive information that is not generally available to the market. This prohibition extends to encouraging others to trade in CSL shares on the basis of such information. Ask yourself the following question: Do you possess information about CSL's research program or other business activities or plans which has not been released publicly through media or securities exchange releases and which, if known, would be likely to influence an investor's decision to buy or sell CSL's shares? If yes, you must not advise your parents on whether or not to trade in CSL shares. If no, you may advise your parents and they are free to trade. In the absence of your advice, your parents are free to trade.
Compliance with trade practices and competition law is fundamental to our integrity and good reputation.
CSL supports the principle of free competition and forbids practices that would in any way:
- Mislead consumers or restrict access to therapies;
- Result in pricing that would be in contravention of applicable trade practices or competition laws;
- Gather competitive intelligence other than in a manner that is ethical and in compliance with all laws and regulations; or
- Constitute other unfair practices.
We have compliance training programs in place to ensure that relevant employees understand their own and CSL's obligations in relation to applicable trade practices and competition laws. We have also created systems for identifying, communicating, reporting, investigating, and resolving any non-compliance with such laws, and regularly reinforce employee awareness of options to raise concerns.
Breach of trade practices and competition laws can result in serious consequences for CSL and employees, including substantial fines and imprisonment, and is regarded by CSL as serious misconduct, which may lead to disciplinary action up to and including termination.
Q. When attending international conferences, I sometimes encounter former colleagues, who work at competitor companies. During a coffee break at one recent meeting, a former colleague began to talk about difficulties his company was having in preparing a tender for the supply of pharmaceuticals to a government agency. She sought my advice knowing that CSL has been successful in this area in the past. Is it permissible for me to provide general advice to my colleague?
A. You must never engage with competitor companies in discussions on tenders as to which CSL has been, is or may be involved. Related issues which could arise, such as pricing policy, manufacturing capacity and strategy, and profit margins, are very sensitive and must always be avoided. If conversation follows this path, you must remove yourself even if you are not a contributor to the discussion. It is important that CSL employees not only comply with trade practices and competition laws but also avoid any perception otherwise.
Conflicts of interest
In carrying out their responsible duties at CSL, all directors and employees are expected to put the interests of CSL ahead of their private interests. A conflict of interest can occur where an employee's personal interests may compromise or put at risk an employee's obligation to faithfully serve the interests of CSL.
Importantly, it is not necessary for such a compromise to have occurred before the situation can be identified as a conflict of interest. The perception of a conflict of interest in a situation can be enough for an employee's professional reputation and decision making ability to be compromised or questioned.
This includes, but is not limited to, situations in which:
- A private interest (financial or otherwise) could conceivably influence an employee's judgment in handling CSL business;
- An employee's allegiance to immediate family or any third party, group or organisation is regarded as competing with the interests and concerns of CSL;
- An employee has an interest in a transaction in which it is known that CSL has or may have an interest;
- An employee receives fees, commissions or other compensation from a supplier, a competitor or customer of CSL; or
- An employee uses their time, equipment, supplies or efforts for something other than CSL-approved activities, programs or purposes.
In these situations, or where there is a doubt as to whether a conflict of interest exists, employees must disclose the apparent or actual details of the potential conflict to their supervisor/manager or to CSL Legal. In all cases, any decision taken to manage the conflict must be endorsed by CSL senior management and documented appropriately.
To avoid any potential or perceived conflict of interest, an employee must seek permission from their supervisor/manager in order to commence or continue any outside employment.
Q. As a CSL site manager I am seeking a contractor to provide training on health and safety procedures to employees and visitors to the site. My husband is a professional health and safety trainer who is widely recognised for his experience and capability in this area and his rates are fair. Is it ethical for me to offer him the work?
A. If you offer the service procurement contract to your husband you, as the nominated decision maker, may put yourself in a position of having to choose between your support to your husband and CSL’s business interests. This is a clear conflict of interest. Even if it were not, the situation may be perceived by others to be a conflict. Should you wish to pursue the matter, you must notify your supervisor/manager declaring the conflict of interest and not proceed with offering your husband the contract unless and until you have documented authorisation for managing the process.
Bribery & corruption
No CSL businesses or employees will directly or indirectly offer, pay, solicit or accept bribes or give or receive personal financial rewards or inducements in exchange for making business decisions. This applies regardless of the size of the reward or inducement. Even where facilitation payments are not prohibited by law, it is CSL's policy that facilitation payments must not be made.
Our employees and directors must not give or accept gifts or entertainment where to do so might influence, or might be perceived to influence, objective business judgment.
We have a policy and compliance training programs in place to ensure that relevant employees understand their own and CSL's obligations in relation to avoiding bribery and corruption. We have created systems for identifying, communicating, reporting, investigating and resolving any non-compliance with CSL's policy and applicable laws, and regularly reinforce employee awareness of options to raise concerns.
Breach of bribery and corruption laws can result in serious consequences for CSL and employees, including substantial fines and imprisonment, and is regarded by CSL as serious misconduct, which may lead to disciplinary action up to and including termination.
Q. I am a member of a team established by CSL to assess possible alternative water filtering technologies for CSL's manufacturing facilities. As part of the assessment I am required to visit sites across Europe where one of the technologies is in operation. The supplier of one particular technology has offered to meet all first class travel expenses for the team and their respective partners. May I accept this offer?
A. Accepting this offer is against CSL's policy on accepting gifts, as it could be perceived as an attempt to influence your impartial assessment of the technology and CSL's subsequent procurement decision. In offering first class travel and including partners the gift is extravagant in value and exceeds normal business practice. If you require further clarification, you should speak with your supervisor/manager, CSL Compliance or CSL Legal.
Marketing to healthcare professionals
The way in which pharmaceutical companies interact with healthcare professionals is an important aspect for the industry. Pharmaceutical industry organisations around the world have established various codes of conduct to regulate these interactions.
Our practices are informed by these codes and their underlying ethical principles.
We are committed to complying with all applicable local laws and regulations in each country where we operate.
Marketing in the pharmaceuticals industry takes many forms and may include:
- Sponsoring conferences and medical seminars;
- Sponsoring healthcare professionals to speak at conferences and medical seminars; and
- Sponsoring trips for healthcare professionals to attend conferences or medical meetings.
We consider each interaction carefully with an emphasis on ensuring that our products and services are represented truthfully, fairly and accurately and in full compliance with all applicable laws and codes of conduct.
We have policies and compliance training programs in place to ensure that relevant employees understand their own and CSL's obligations in relation to marketing to healthcare professionals. Failing to comply with CSL policies in this regard is considered as serious misconduct, which may lead to disciplinary action up to and including termination.
Q. Attending medical association meetings provides a good opportunity to engage with healthcare professionals to exchange information or otherwise benefit CSL's business interests. Is it permissible to buy a meal for a healthcare professional in the course of these discussions?
A. In general, it is permissible to buy a meal for a healthcare professional as part of a legitimate business relationship and provided the meal is neither extravagant considering the circumstances nor likely to be perceived as an attempt to improperly influence a business or prescribing decision. You also should confirm with the other party that by paying for a meal you are not conflicting with their organisation's policies. In addition, there are different laws and codes covering the provision of meals or gifts to healthcare professionals in different countries, and these must be observed (for example, the public disclosure of the value of the meal). Also, some healthcare professionals may also be considered government officials and additional rules may apply as a result. Please consult with CSL Compliance or CSL Legal if you require further guidance.
Labelling and product claims
CSL's reputation and success as a trusted supplier of medicines relies on ensuring our products are accurately represented.
The labelling and advertising of pharmaceutical products are highly regulated. Advertising and promotional materials must always be true, must comply with the terms and conditions of any marketing authorisation (i.e. no "off-label" promotion), must accurately describe the risks and benefits of a product in a balanced manner and must not be misleading.
Advertising and direct-to-consumer advertising of prescription medicines are strictly regulated, and in many cases, direct-to-consumer advertising is prohibited under applicable local laws in the countries where we operate.
Product disclosure statements connected to any product manufactured or distributed by CSL are strictly controlled by applicable local laws in the countries in which we operate.
Such statements are intended to ensure healthcare professionals or patients are protected from unintended misuse of products and are fully informed as to the appropriate indications, benefits and potential risks associated with the use of our products.
We seek to ensure that all important information is included in product disclosure statements and kept up to date. The omission of important information in product disclosure statements or marketing material may be construed as misleading and deceptive.
We have strict policies and processes for the approval of product information (via our medical affairs and regulatory departments).
We have in place extensive internal training programs to ensure that all relevant employees understand and implement these policies and processes.
CSL is committed to compliance with all applicable international trade regulations, including customs controls, export and import controls and sanctions. Violations of these regulations can result in civil and criminal penalties and loss of export privileges. CSL regularly screens suppliers against government lists of sanctioned parties.
The laws regarding import, export and sanctions are complex and frequently changing, and in some regions may conflict. Employees should contact CSL's Global Trade Compliance department or CSL Legal with any questions or concerns related to trade compliance.
Q. I am undertaking a special shipment of CSL product from Europe and North America to a country we've never shipped to before. I recall hearing something about sanctions being imposed on that country. How do I know if these sanctions affect my shipment?
A. Before engaging with new business partners or new locations, employees must ensure that there is no respective entry on any national or international sanctioned party lists. In the event of a positive result, employees must contact CSL Legal. Before processing an export, employees must ensure that:
- The item is not controlled and does not require an export/re-export license from relevant authorities; and
- All export and import requirements are complied with.
Some destinations are subject to comprehensive foreign trade regulations, embargos or sanctions and require additional considerations prior to proceeding. Employees should contact CSL's Global Trade Compliance department or CSL Legal for guidance.
The establishment and protection of intellectual property underpins our investment in research and development.
CSL will comply with all applicable laws governing intellectual property. We will establish and protect patents, trademarks, registered designs, copyright and confidential information. This includes providing the necessary information, tools and processes, to our employees to protect our assets.
CSL establishes strategic partnerships with academic and other organisations globally to complement our in-house expertise and to further the science and prospects for successful product development. These partnerships often result in shared knowledge, intellectual property or products. We will enter into collaboration agreements to address partnership aspects, including the respect and protection of intellectual property.
Q. I am looking to engage a third party to help progress the research my team has been conducting on a new therapeutic target. I need to move quickly as my contact is going overseas. Can I call them to discuss CSL's work and how they can help? \
A. Any information that is not already in the public domain should be treated carefully. Before discussing any confidential material with a third party, you should engage CSL Legal for advice on how best to safeguard CSL's assets and information. Generally, as a starting point, a confidentiality agreement may be required before both parties can commence discussions or collaborating.
CSL is committed to complying with applicable tax laws and regulations in all countries in which we operate. CSL understands that tax risk arises due to the complexity of the law, its constant evolution and the inherent uncertainty of how it applies to particular facts and circumstances.
- Is committed to complying with applicable taxation laws in all operating countries;
- Does not take aggressive tax positions;
- Adopts a global taxation policy; and
- Ensures tax payments, policy and taxrelated risk management are reviewed and considered by the Audit and Risk Management Committee of the Board.
Entertainment and gifts
CSL accepts that, from time to time in the course of conducting business, employees:
- May provide gifts or entertainment to customers, potential customers or others with whom CSL does business; and
- May be offered gifts or entertainment from suppliers, potential suppliers or others with whom CSL does business.
The provision or receipt of gifts or use of entertainment should be selective, appropriate and infrequent, and in line with applicable CSL policies. Gifts of cash or cash equivalent (e.g. monetary vouchers) must not be given or accepted. Entertainment of fellow employees at CSL's expense is discouraged except in specific circumstances, which must be approved by CSL senior management.
When the provision or receipt of a gift or entertainment is deemed appropriate, the type of gift or entertainment selected should reflect professional and community standards of ethics, moderation and good taste, comply with applicable laws and industry codes and be consistent with our stated values and applicable CSL policies. Gifts or entertainment must not be requested, demanded or solicited. The provision of any gift or entertainment must be transparent and properly recorded in CSL's financial records.
The giving and accepting of entertainment or gifts during purchasing and/or other contract negotiations in connection with CSL's business is not permitted (please also refer to section 2.9 Bribery and Corruption).
Some countries have regulations in place that prohibit or constrain the provision of gifts or entertainment to healthcare professionals and government officials. Entertainment (such as sports events, theatre or concerts) of healthcare professionals and government officials is prohibited under applicable CSL policies and must not be provided; and giving of gifts and providing entertainment in the form of meals (hospitality) is subject to strict requirements under these policies.
We train all relevant employees to ensure compliance with such requirements.
We have policies and compliance training programs in place to ensure that relevant employees understand their own and CSL's obligations in relation to the receipt and provision of gifts and entertainment. We have created systems for identifying, communicating, reporting, investigating and resolving any noncompliance with CSL's policies and applicable laws, and regularly reinforce employee awareness of options to raise concerns.
Q. I have recently completed a project involving employees from a partner research organisation and to celebrate I would like to take the researchers and some CSL employees involved in the project to a local finals football event. Is this allowed?
A. You should refer this proposal to senior management for a decision. To gain approval you would need to demonstrate that the entertainment is appropriate and moderate considering the significance and scale of the project and the nature of the business relationship and is otherwise in compliance with CSL's policy and applicable laws.
External stakeholder relations
CSL accepts that companies may need to be involved in the political environment of the country in which they operate to ensure that legitimate business and stakeholder interests are considered in the development of public policy.
We require that any contributions made to support the work of party and political candidates or representatives shall be reasonably balanced among parties and candidates or representatives and must be made in accordance with local laws and regulations and applicable authorisation levels.
We believe transparency of political contributions is important for pharmaceutical companies given the critical role governments play in the regulation, reimbursement and procurement of medicines. CSL will publicly disclose the total value of contributions annually in our Corporate Responsibility Report and on our website.
Participation in public policy
We believe that CSL has an important role to play where public policy is being developed on issues that directly impact our businesses and where we have particular expertise.
We co-operate thoughtfully with the relevant industry associations in the development of industry and economic policy.
Where we feel CSL brings a unique and important perspective to an issue being discussed by governments, we may consider making an independent submission to provide input to and advocate for an informed debate.
Dealing with government
CSL operates in areas that are heavily regulated. Our employees are likely to come into contact with government officials responsible for the licensure of our medical products, negotiation and management of contracts with us, and the development and enforcement of regulations that affect us.
If one of our employees has occasion to do so, they must provide information honestly and avoid falsification or omissions. We must preserve all records relevant to any government negotiation, enquiry or litigation, in accordance with the CSL Global records management policy and procedures and all our interactions with government must be compliant with section 2.9 (Bribery & Corruption) and section 2.11 (Entertainment and Gifts) of this Code.
CSL has authorised appropriate spokespeople to comment on our business issues to media, analysts and government. Only those authorised spokespeople should make such comment.
Q. I work in a CSL Plasma collection centre and recently received a telephone enquiry from a newspaper journalist concerning the safety of one of CSL's plasma-derived therapies. Should I respond based on what I know about this topic or reply "no comment"?
A. Information released publicly via the media can have important and sometimes unforeseen financial or legal impacts and affect CSL's corporate reputation. It is vital that all public comment provided by CSL, including responses to media questions is accurate, timely and consistent. Consequently, only authorised spokespersons should provide any public comment on behalf of CSL. You should politely reply to the telephone enquirer that you will arrange an appropriate spokesperson to respond as soon as possible. You should ascertain the nature of the enquiry and the caller's contact details. You must then immediately refer the inquiry to the CSL Communications representative for your region.
Privacy of information from third parties
CSL respects and is committed to protecting the privacy of all of the individuals we deal with, including patients, plasma donors, healthcare professionals, collaborators, and other third parties. In this regard, it is important that we comply with all applicable local laws in a timely and efficient way, both as a legal obligation and as a matter of good corporate practice.
When we collect, process, store and transfer personal data, we take appropriate precautions, in accordance with all applicable local laws, to ensure that privacy is respected and protected.
We have a policy and compliance training programs in place to ensure that relevant employees understand their own and CSL's obligations in relation to the management of personal information in accordance with applicable local laws.
Privacy of employee information
CSL ensures that the management of employee information balances the individual's right to privacy with our legitimate business needs. We will therefore only collect employee's personal information where it is necessary for our business needs, and we will do so in a manner that is not intrusive and complies with applicable local laws.
We are committed to informing employees of their right to understand the purpose for which we collect information, their right to examine their own records and to correct any errors held on file.
Q. I am a sales representative and I would like to contact patients who use one of CSL's products to participate in a patient support program. Can I request patient details from a healthcare professional who I know has a large number of patients who use this product?
A. In all countries, there are privacy laws that must be complied with in relation to the collection and use of personal information. In most cases, personal information related to a person's health is held to an even higher standard. In order to gain access to any individual's personal information, you must obtain or see evidence of their direct individual informed consent to the collection of that information and the intended use of that information. In addition, there might be other laws regulating the interactions between companies and patients that need to be strictly adhered to. Please contact CSL Compliance or CSL Legal for further information.