FUJICOM CODE OF ETHICS
1st Edition São Paulo/SP – 2015
Contents 1 – Introduction 2 – Guidelines 3 – Relationship with Government Entities 4 – Relationship with Service Providers 5 – Interaction with Healthcare Professionals 6 – Good promotional practices 7 – Donations 8 – Security in the negotiations by third parties on behalf of Fujicom
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9 – On infringements
1 - Introduction Our corporate principles, set forth herein, guide the company's VISION we strive to be: an innovative, pioneering and transparent company that prides itself of its employees and deserves the full confidence of its customers and partners. Our MISSION is to import, market innovative and high quality products that meet medical and patient’s needs. Our products and services help in the diagnosis and treatment of diseases, thus improving the people's health and quality of life. The Fujicom acts responsibly and ethically, committing to sustainable development and respect for the needs of the individual, society and the environment. Our Code of Ethics is reflected in our values and attitudes; Integrity – Acting ethically We undertake to comply with the highest ethical principles and quality standards, without concessions Respect – Live with differences We recognize and respect the diversity and needs of our employees, patients and partners, ensuring constructive and transparent interactions, based on mutual trust Solidarity - Being socially responsible Together we fully take responsibility for our actions towards our employees, patients welfare and respect for the environment in a sustainable manner.
The FUJICOM Code of Ethics aims to establish the minimum conditions of conduct that will guide the actions of all our employees and shareholders, committed to base their activities in strict compliance with legal provisions and in compliance with the technical, moral and ethical standards recognized by local, national and international society.
2– Guidelines The Fujicom believes that the main goal of health professionals is to offer the best possible treatment to their patients. We also seek to serve the interests of patients through collaboration with these professionals and medical institutions. However, these collaborative relationships between Fujicom and health professionals must be guided by law enforcement of the highest ethical and moral standards and our code of ethics determines the rules for these relationships. Four basic principles guide this Code of Ethics - separation, transparency, equivalence and documentation - forming the basis for the standards set forth herein, which are expected to comply with our employees in commercial practices: Separation: determines that interactions with Health Care Professionals must not be used incorrectly, in order to influence the Health Professionals purchasing decisions or be dependent on the use or sale of medical equipment; Transparency: refers to ensuring that interactions between our employees and the Health Professionals are clear and, where appropriate, notified in writing to the employer of the Health Professionals; Equivalence: provides that any payment made to a Health Professional, depending on the provision of a service or advice, should be commensurate with their service and represent a fair market value; Documentation: provides that whenever a Health Professional provides a service to the Fujicom, a written agreement should be made specifying the services to be performed and the remuneration to be paid.
Compliance with the standards of this Code of Ethics is intended to protect Fujicom, its employees and shareholders subject to different laws, existing laws and regulations in Brazil. To maintain the highest standard of ethical business practices, we always will compete openly in the market, offering quality products, fair prices and efficient services. We commit ourselves to defending free enterprise, never practicing, permitting or omitting acts that may characterize any practice of corruption, coercion, fraud or favoritism to a particular company. All trade and import transactions will comply with all legal requirements and current tax in Brazil. All persons or entities that do business in Fujicom name must obey all the rules set forth and established in this Code of Ethics. The Fujicom require to all its employees to have ethical business practices and socially responsible in all their interactions with Healthcare Professionals and medical institutions, while respecting the obligation of Healthcare Professionals to decide independently what is the best product or therapy for a given patient.
3 - Relationships with Government Entities The Fujicom is committed to respect the Code of Ethics of public bodies. In the resolution and driving regulatory affairs of our interests, and in order to print transparency to our activities, wherever possible, we will work directly with the Sanitary Authorities or be represented by reputable third parties to commit to compliance with the parameters set forth in this Code. The Fujicom will partner of ANVISA, or any other government regulator, regarding the condemnation of bad regulatory practices and quality in the market.
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In interactions with Government Entities for any type of inspection (health issues, quality system, fair trade practice, compliance with competition laws, taxation, environmental impact, etc.) no payment or other incentives may be offered or made to discourage conduct, result or suspension of an inspection. Where third parties engage to interact with some Government Entity on behalf of Fujicom, we will establish a written agreement for compliance with the rules set out in our Code of Ethics. Payments to Regulatory Authorities All payments to be made by Fujicom to the regulatory authorities should be based on clearly defined laws and regulations, published and transparent. In these circumstances, payment shall be documented and can only be done at banks established in Brazil. The same standards apply in the third case that make such payments on behalf of an associated company.
Hospitality The Fujicom, or third parties acting on its behalf may provide gifts, hospitality or entertainment for regulatory agencies as the code of ethics of each entity and laws, especially the Code of Conduct of the High Federal Administration, which limits the value of these to the ceiling of R$100,00.
Meetings and Minutes Meetings with regulatory agencies and inspection organs shall be documented correctly and appropriately, with minutes or reports that identify participants (the government side and the side of the company, including third parties) and the subjects covered.
4 – Relationship with Service Providers In contracts with third parties, Fujicom should establish clear and precise manner the duties and obligations, together with the commercial aspects, regulatory and best practices for compliance with the laws and regulations in force in the country. The following rules should always be followed when Fujicom hire third parties to provide services:
The services paid by Fujicom shall comply with a legitimate business
need;
The contracted service providers should be individuals or companies
that have specific knowledge or ability to perform the services;
These services must be obtained in terms of a written contract;
The Fujicom will pay for services just as it was determined in accordance with the written agreement, and the agreed remuneration should be an appropriate value to market value; The execution of received services must be documented. The following clauses shall be included in the third party service delivery Agreement for compliance with applicable local laws and anticorruption law;
Device allowing termination of the contract by FUJICOM if it has
evidence that there may have been an offer, promise or payment that violates the anti-corruption laws;
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contract:
5 - Interaction with Healthcare Professionals Fujicom is responsible for promoting education and training for Healthcare Professionals , as well as efficient and safe use of its products. However, this should be done together with qualified team with appropriate experience in clinical and educational scenarios in medical institutions, laboratories or other appropriate facilities. Fujicom should make sure that travel and lodging costs incurred by the Healthcare Professionals participating in the trainings are appropriate, not extravagant and compatible with market prices . Payment of transportation , food and lodging expenditures is limited to occasions inherent to the specific event and exclusively related to the invited Healthcare Professionals. It is absolutely prohibited to pay or reimburse any expenditure of family members , companies or persons invited by the Healthcare Professional. Fuji can sponsor flights for Healthcare Professionals , but the transport should be strictly adequate for the proposed event and compatible with the final destination. Additionally, payment or reimbursement of expenditures related to recreational trips and/ or activities during educational events e prohibited. Any entertainment for the Healthcare Professional should be modest and secondary in relation to the main scientific event. Adult entertainment will never be appropriate and Fujicom is not allowed to offer such entertainment to the Healthcare Professionals. When Fujicom choose to enter consultancy agreements with Healthcare Professionals , such agreements should reflect the conditions of interaction in a clear and precise manner and should be well documented regarding the service offered , with fair payment conditions compatible with market practices and duly signed by the parties. Dining with Healthcare Professionals should be consistent with the exchange of scientific, educational or business information. Under no circumstances , Fujicom is permitted to offer cash or any equivalent, directly or indirectly , to Healthcare Professionals.
Fujicom is permitted to ofer gifts and presents to Healthcare Professionals , while respecting the following conditions: Offering gifts 1) They should be objects of visible promotional character, always identified by a trade name determined by Fujicom, 2) they should be items related to medical practice or administrative routine in a doctor's consulting office, clinics, hospitals; and 3) they should be objects which maximum individual value does not exceed US$ 100,00 on the date of purchase Offering presents 1) they should be offered on an occasional basis, such as national or professional commemorative dates and cannot exceed a limit of two (2) times a year; 2) they should be properly register in internal book ( Book of presents ) 3) they should be within the value limit corresponding US$ 180,00 at the date of purchase When the Healthcare Professionals is linked to public authorities or officials, the limits as provided by current federal , state or municipal laws shall apply to this employee and/ or public agency to which he/she is associated. For top federal workers, the limit of the value for presents is US$ 50,00 per year, regardless of the quantity. Above this value , no gift or present can be offered.
A - Product training and new tecniques Fujicom can develop training activities always seeking efficient and safe use of products and aiming to educate and training Healthcare Professionals. Such training can be offered to people and/ or qualified experienced teams appropriate places , such as clinics, laboratories, hospitals including our own company, whenever possible. Fujicom can make payments for travel costs that Healthcare Professionals incur to attend trainings, always observing the principles of this code.
Payment for social activities and entertainment is not allowed. B - Support to Educational Congress Events organized by third parties Fujicom can supply resources for Events and Congresses organized by third parties provided that they are legitimate, independent and have an educational purpose . These Events and Congresses are generally organized by regional or national medical Association and/ or Societies, with specific speciality, seeking to impart knowledge among the Healthcare Professionals. Fujicom can sponsor these Events and Congresses in a number of ways, such as : Sponsoring to Health Professionals Whenever allowed by applicable laws and rules, Fujicom can financially support Healthcare Professionals so that they can attend Events and Congresses organized by third parties as defined by this chapter, but they should ensure that the appropriate travel and accommodation costs are compatible with market prices. Fujicom cannot make payments or assume the costs incurred by persons invited by the Healthcare Professionals. This support should never be linked with the purchase of the products by the institution or based on a past or future use of products by the institution .
Advertisement Whenever permitted by the applicable law and rules ( ANVISA resolutions,etc) Fujicom can purchase floor space and booths at Events and Congresses, seeking to advertise our products and company. This support can never be associated with the purchase of the products by the institution or based on a past or future use of products by the institution. Fellowship Fujicom can offer educational donations to training institutions, healthcare institutions or professional societies for the purpose of medical educational programs. Such donation can be made thorough financial support to partners and fellowships ( accepting to cover travel costs, instruction, accommodation, food, etc) . Selection of the beneficiary should be done by the institution. These donations should be offered to the institution , not to the individuals. This support should
never be associated with the purchase of products by the institution or based on a past or future use of such products by the institution. Payment for social activities and entertainment is not allowed. C- Consultancy Agreements and Research When Fujicom chose to carry out consultancy agreements with Healthcare Professionals , these agreements should clearly and precisely reflect the conditions and be well documented in relation to the services rendered, with fair payment conditions compatible with market practices , and signed by the parties involved. Fujicom can only remunerate Healthcare Professionals for scientific services supported by a written agreement entered by the parties before the services are provided. The services and the remuneration should be proportional, that is, Fuji should obtain something tangible from the payment of fees, and the fees should have a reasonable value as practiced in the market. Selection of Healthcare Professionals for consultancy should be based on qualification and experience, which should be adequate for the consultancy and should not be, in any way, related to the sales volume to the consultant in the past or any future sales expectations . Fujicom should follow and comply with all applicable laws concerning marketing. The consultancy contracts with Healthcare Professionals seeking research should contain the research protocol and the work plan to be followed by the consultant. Whenever prior approval of the protocol or patient consent is necessary, Fujicom is responsible for documentation. Payment for social activities and entertainment is not allowed.
6 - Good promotional practices In all our activities to promote and advertise our products, we commit to: Disseminate accurate and not misleading information containing sufficient data to permit an adequate evaluation of the quality of the product and its use; Ensure that promotional materials are products based on duly published and approved scientific work; Meeting expectations on transparency in relationships between Fujicom and health professionals, patients and clients. The Fujicom should not act with data involving distortion of the market, aiming by promotion competitors jettisoning.
7 – Donations The Fujicom can donate monetary values to social programs supported by us. As a basic principle, donations should not lead the Health Professionals to buy, lease it, or recommend use of associated products. It is permitted three forms of donation: Donation to Charity The Fujicom can make charitable donations character, such as provision of funds for indigent care, patient education, public education, or sponsorship of events whose results are for charitable purposes. Associated should not make a charitable donation if the proposed donation is connected in the past, present or future to the purchase or lease, or use recommendation, of associated products. All donations should be appropriately documented Donations for Research The Fujicom will follow the following standards: 1. Research should be legitimate, with well-defined steps and results contained in a contract made in writing. 2. T h e r e c a n b e n o c o n d i t i o n s l i n k i n g r e s e a r c h f u n d i n g with purchases by Healthcare Professional of products or associated services. Research funding cannot be linked to past, current or future products sales or associate services for the Health Professional . Donation for evaluation, demonstration and product validation The products marketed by Fujicom can be provided to Health Care Professionals at no charge, for the purpose of evaluating or demonstrating and in order to educate the Health Care Professional, with respect to the proper use of the product functionality and determine whether and when to use, ask, buy or recommend the product in the future. Products donated for evaluation should be used in patients.
8- Security in the negotiations by third parties on behalf of Fujicom Fujicom expects from third parties (sub-distributors, sales executives, employees) that do business on our behalf meet the highest ethical standards in their activities and to comply strictly with national laws and anti-corruption regulations. The Fujicom takes responsibility for the training of all third party contractors, so they have the ability to properly display information about its products and are aware of how it should be their business practices and its relationships with the public policy.
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We will make all efforts to adopt appropriate processes for selection of third parties and to monitor the activities of third parties who are engaged in any form, directly or indirectly, to act on our behalf. We will take immediate action to terminate the agreements with third parties that do not meet the ethical and legal principles applicable to the business, making the necessary communications business practices in violation of this Code or the law.
9 – On Infringements Employees, directors or third parties acting on behalf of Fujicom who break any rule of this Code and / or legal provisions, shall be reported to the Ethics Commission to be within sixty (60) days analyzed, discussed and judged These penalties, in addition to appropriate judicial action and inform the competent supervisory bodies and repression may be, in the opinion of the Ethics Committee: a) Determination that the offender immediately cease the condemned practice; b) Formal warning to the offender; c) Termination for cause or elimination of social picture in the event of noncompliance with the decisions laid down by the Ethics Committee, or recur in the impugned practice; e) Legal action against the offender, based on material evidence, without prejudice to the notification to the competent bodies by operation of law.
Reference Sources
Código de Ética ADVAMED USA Código de Ética da ANVISA FCPA- Lei e Práticas de Corrupção no Exterior. Nova lei do Reino Unido (UK Bribery Act of 2010) Lei Brasileira Anticorrupção No 12843 de 1o de Agosto de 2013