Código de conducta
Biocomposites requires the utmost legal and ethical behaviour on the part of all its employees, directors, suppliers, distributors, vendors and physician consultants. This policy defines our code of conduct regarding business practices, physician payments and off-label use of our products.
- We respect the rights and property of others, including intellectual property.
- We protect and preserve the Company’s assets and intellectual property for the Company’s benefit and not for personal benefit.
- We compete fairly, without collusion or collaboration with competitors to fix prices, restrict production or allocate customers.
- We provide fair opportunities for all those wishing to do business with us.
- We are truthful and accurate in our internal and external reports.
- We respect all employees and interested parties regardless of position or level and reward people based on their performance and contribution.
- We respect and follow codes of conduct, rules, regulations and laws in countries where we do business, including, but not limited to, the US Anti-Kickback Statute, The Bribery Act 2010. ABHI Code of Ethical Business Practice, AdvaMed Code of Ethics on Interactions with Healthcare Practitioners.
- We offer no unlawful payment or benefit in kind to influence others to obtain sales.
- We ensure that expenditure for genuine corporate hospitality and similar business events involving the Company, its employees, clients, customers and other interested parties are reasonable in all circumstances and proportionate to the business venture without seeking to compromise client, customer or interested party impartiality.
- Where appropriate, events involving corporate hospitality are reviewed and cleared in advance by the department head organising the event, the CEO, and Compliance Director.
- We encourage all employees and directors to recognise and report any concern about possible illegal or unethical behaviour. All reports will be investigated responsibly and in good faith without fear of retribution or retaliation.
- Any concern regarding illegal or unethical behaviour, discrimination or harassment shall be reported to the CEO unless the event involves the CEO in which case it shall be reported to any member of the Board of Directors.
- We respect legal and ethical non-competition and non-solicitation agreements.
- The Company prohibits commercial bribes, kickbacks or similar payoff/benefits to any supplier, customer, government official or other interested party.
Physicians provide a key role in understanding and identifying innovative solutions to patients with diseases or conditions that require surgical intervention.
Physicians may provide services relating to:
- Design of devices
- Evaluation of device designs
- Training on the use of the Company’s devices
- Presentations and meetings
- Clinical consultancy/opinion
In providing these services, physicians are entitled to be compensated in a way that eliminates any suggestion that the remuneration is for any purpose other than for the work requested. The following protocol shall apply:
- Interested parties providing consultancy services shall certify in writing that they have received, read and understood their obligations and responsibilities in accordance with this Code of Conduct and will not knowingly pay or receive anything of value to influence the referral of (US federal) healthcare business.
- All proposed contracts and remuneration shall be reviewed by the CEO before any contract is offered and any remuneration made.
- Proposed contracts shall have relevance to a medical or economic benefit.
- Proposed contracts shall be specific to the project or task required and shall comply with compensation guidelines and safe harbors.
- To ensure objectivity and avoid conflict of interest, the majority of cases performed during an approved study should not be performed by those holding any stock or share investment in the Company.
- Requests for donations or support for studies that might be misinterpreted as bribe, kickback or rebate will be rejected.
- Remuneration for presentations and meetings shall be proportional to the time spent in preparing and delivering the presentation, and for reasonable travel time to and from the meeting.
- Expenses shall not be reimbursed for attending a meeting where the physician would have attended anyway had he not been asked to make the presentation.
- Expenses shall not be paid for any guest accompanying the physician to a meeting or presentation.
Product used off-label
Once a medical device has completed the registration process for a particular country or territory, it may be freely marketed for the cleared intended use and applications. National regulations sanction criminal offences regarding manufacturer’s promotion of products for non-cleared uses or to make unsubstantiated claims about the product.
Due to the continual advancement of medical science, it is not uncommon for physicians to adopt new and innovative uses for products that are not contained within the regulatory clearance. Within the bounds of medical ethics (Hippocratic Oath, Convention of Geneva, etc), such practice is permitted on the basis that the physician will do all they can in the best interests of their patient.
The pace of medical development is invariably ahead of the regulatory framework and so creates the ‘off-label’ scenario.
Regulatory authorities, physicians and the medical industry recognise the importance of advancing medical science and treatment albeit within the framework of regulatory constraints. This policy therefore defines a code of conduct regarding off-label use of our products.
- We will not promote the use of a product outside of its regulatory clearance.
- We will not make false or misleading claims that cannot be substantiated by objective evidence.
- We will avoid presence in the operating theatre to support off-label cases.
- We will avoid promotional discussions with physicians regarding off-label use.
- We will avoid attending presentations regarding off-label use at physician meetings.
- We will refer unsolicited enquiries regarding off-label use to the Compliance Department.
Despite the controls imposed by this policy it is recognised that, on occasions during an operating room procedure, a sales representative may receive a request for information or technical support related to the preparation and use of the company’s device from a physician who, solely within their professional judgment, has elected to use the device off-label. The representatives may only answer questions and provide technical support related to the preparation and use according to the labelled Instructions for Use of the device.
This code of conduct was last revised in June 2017.