CODE OF ETHICS AND CONDUCT

Transcription

1 CODE OF ETHICS AND CONDUCT BSN medical S.r.l. Capital 10,000.00, fully paid-in Single-Member Company - Monza and Brianza Economic Administrative Repertoire Monza and Brianza Register of Companies, Tax Code and VAT no Company subject to management and coordination, pursuant to art of the Italian Civil Code, by BSN medical Netherlands Holding BV Rev. 05/

2 BSN medical S.r.l. CODE OF ETHICS AND CONDUCT 1 PRINCIPLES 1.1 ETHICS IN CONDUCTING BUSINESS AND COMPANY AND ASSOCIATION OPERATIONS 1.2 WORK ETHICS, PROTECTION AND USE AND DEVELOPMENT OF CONTRACTORS 1.3 ETHICS OF INFORMATION 2 CONDUCT GUIDELINES: ETHICS IN CONDUCTING BUSINESS AND COMPANY OPERATIONS 2.1 COMPETITION 2.2 CONTROLS AND PENALTIES CONCERNING EXPORTS 2.3 ILLEGAL PAYMENTS AND PRACTICES 2.4 CONFIDENTIALITY OF INFORMATION 2.5 COMPANY IMAGE 2.6 SUSTAINABLE DEVELOPMENT AND RESPONSIBILITY TO THE COMMUNITY 2.7 RELATIONS WITH HEALTHCARE PROFESSIONALS AND WITH THE PUBLIC ADMINISTRATION TRAINING AND EDUCATION ON PRODUCTS SPONSORED BY BSN SUPPORT FOR TRAINING CONFERENCES HELD BY THIRD PARTIES MEETINGS FOR INFORMATION AND/OR PROMOTIONAL PURPOSES 2.8 DONATIONS TO THE PUBLIC ADMINISTRATION FOR CHARITY OR PHILANTHROPY 2.9 SCHOLARSHIPS 2.10 ASSIGNMENTS, CONSULTING SERVICES, STUDIES ENTRUSTED TO EMPLOYEES OF THE PUBLIC ADMINISTRATION 2.11 DONATIONS TO EMPLOYEES OF THE PUBLIC ADMINISTRATION 2.12 QUALITY GUARANTEE 3 BSN S COMMITMENT (as a member of the ASSOBIOMEDICA Association) 4 CODE OF ETHICS CONTROL BODY 5 REPORTING PROCEDURES Rev. 05/

3 1 PRINCIPLES 1.1 ETHICS IN CONDUCTING BUSINESS AND COMPANY AND ASSOCIATION OPERATIONS BSN medical S.r.l., hereinafter referred to as BSN, belongs to an international group whose goods/products offer solutions for human health. BSN undertakes to comply with all laws and regulations, as well as with the Association By-Laws of Assobiomedica. The ethical nature of conduct is not only based on the strict compliance with the above, but goes beyond this and lies in the intention to adopt the highest standards of conduct in various situations. Compliance with applicable laws and the observance of ethical standards are important due to the need for close cooperation between the medical devices/technologies sector and healthcare professionals. This cooperation may take the following forms: a) Development of medical technologies; b) Provision of training, education, services and support to ensure the effective, safe use of medical technologies; c) Support to medical research and education and development of professional skills. These activities are required for the progress of medical science and improvement in patient care, but must occur by means of interactions based on maximum transparency, correctness and ethics. Thus, BSN s actions must be marked by correctness and transparency, avoiding misleading information and conduct which results in obtaining an undue advantage from other s position of weakness or unawareness. Respecting the freedom of initiative and of private property, the function of the company operating in a free market, companies maximise their economic and financial results through correct business relations with customers and suppliers and adequate recognition of the contribution of their contractors. Specifically, when business relations are established with the Public Administration, it is deemed suitable to adopt specific precautions, as illustrated below. 1.2 WORK ETHICS, PROTECTION AND USE AND DEVELOPMENT OF CONTRACTORS Internal and external contractors of BSN are a fundamental resource for the company s development. The knowledge base, experience, intelligence and culture of Contractors must be used and developed, thereby contributing to their professional growth and wellbeing. Rev. 05/

4 Professional development and growth is implemented through specific, institutional training initiatives. Contractors ensure that each business decision is taken in the interests of the structure to which they belong and must avoid any situations involving conflicts of interest between personal or family economic activities and duties carried out which could compromise their independence of judgment and opinion. The professional development and management of contractors are based on the principle of equal opportunities: recognition of results achieved, professional potential and skills demonstrated by individuals constitute the essential criteria for assessing Contractors. External Contractors (consultants, agents, resellers, distribution partners, partners, etc.) are required to comply with the principles set forth in this Code, also through an express commitment included in the related contracts. 1.3 ETHICS OF INFORMATION BSN s communications mainly take the form of scientific information, which must be accurate, balanced, correct, objective, unambiguous and not misleading in any way, documented and documentable. Information must be developed and disclosed in compliance with the provisions governing the matter. 2 CONDUCT GUIDELINES: ETHICS IN CONDUCTING BUSINESS AND COMPANY AND ASSOCIATION OPERATIONS The practical implementation of ethical principles must be translated into guidelines that must act as a specific reference for the conduct to be adopted, and must be applied to employees, agents or representatives in general. BSN must adopt fulfilment plans by publishing written policies and procedures and activating training programs and implementing clear procedures, checks and application mechanisms. BSN acknowledges that, through its bodies, Assobiomedica reserves the right, in the final instance, to expel any member which does not comply with the guidelines in its Code of Ethics. Rev. 05/

5 2.1 COMPETITION The free market assumes the autonomy of its players in determining and pursuing their company purposes. BSN strongly believes in competition and in the free market, assets which are to be defended from any undue pressures, both internal, deriving from the interested market players, and external, from third parties in any role whatsoever. BSN undertakes to conduct its business in compliance with the requirements of law on competition and on supply tenders. The regulations protecting competition (Antitrust regulations) establish precise rules and, specifically, seriously penalises those who implement agreements that restrict competition or who abuse their dominant position. BSN condemns conduct contrary to the principles of competition and undertakes to comply with such principles, adopting necessary measures to prevent anticompetitive conduct. BSN undertakes to avoid contact between competitors (by way of example, discussions of prices or quantities, market sharing, limitations of production or sales, customer sharing agreements, exchanges of information regarding prices) which may appear to be violations of the regulations protection market competition. 2.2 CONTROLS AND PENALTIES CONCERNING EXPORTS BSN undertakes to comply with applicable laws on the control of exports and trade with other countries. 2.3 ILLEGAL PAYMENTS AND PRACTICES BSN shall not offer, make or authorise, directly or indirectly, the payment of amounts of money or any other item of significant value for the illegal purpose of: a) influencing the judgment or conduct of any party, customer or company; b) obtaining or maintaining business activities; c) influencing any action or decision by any public official; d) obtaining benefits in any event. This requirement not only applies to direct incentives, but also to indirect incentives in any form, also those provided through agents, consultants or other third parties. BSN must pay particular attention to the laws and regulations which prohibit or restrict incentives aimed at influencing medical personnel or customers. 2.4 CONFIDENTIALITY OF INFORMATION BSN must guarantee that information regarding customers and other types of confidential or personal information is kept and used in compliance with the requirements of applicable law. Rev. 05/

6 2.5 COMPANY IMAGE BSN s conduct in the market and in relation to competitors shall be based on the utmost correctness. Specifically, BSN shall abstain from any incorrect conduct which damages the image of competitors. 2.6 SUSTAINABLE DEVELOPMENT AND RESPONSIBILITY TO THE COMMUNITY BSN undertakes to take into consideration the needs of the community in the geographical areas where the company is located in its development plans, with the objective of contributing to its economic, social and civil development. BSN must exercise its activities using the best technologies available, promoting and developing activities aimed at making good use of natural resources and preserving the environment in compliance with the laws and regulations concerning environmental protection. 2.7 RELATIONS WITH HEALTHCARE PROFESSIONALS AND WITH THE PUBLIC ADMINISTRATION BSN recognises that compliance with ethical standards and observance of applicable laws are essential for medical technology sectors to develop and sustain cooperative relations with Healthcare Professionals. BSN undertakes to put business ethics into practice and maintain socially responsible conduct in interactions with Healthcare Professionals. BSN must also respect the obligation of Healthcare Professionals to take independent decisions concerning treatments to be prescribed. These Guidelines establish appropriate standards for the various types of relations with Healthcare Professionals, but do not attempt to replace or supersede applicable national and EU laws and regulations or professional codes (including company codes) which impose specific conditions on Members or Healthcare Professionals in carrying out their activities. BSN must independently guarantee that the respective interactions with Healthcare Professionals comply with national, EU and local regulations in force and professional regulations and codes. In general, when any business negotiations, requests or relationship with the Public Administration are pending, BSN may not attempt to unduly influence the counterparty s decisions, including those of officials who negotiate or who have the power to make decision on behalf of the Public Administration. In the specific case of execution of a call for tender with the Public Administration, BSN must act in compliance with law and correct business practices. Relations which BSN establishes, at all levels - internationally, nationally, regionally and locally - with employees of the Public Administration, including operators of the Public Healthcare Service, must be characterised by the utmost transparency and Rev. 05/

7 correctness. Contractors of BSN may not promise or pay amounts of money, promise or provide goods in kind or other benefits to government employees for personal reasons, in order to promote or favour the interests of BSN, even following of illegal pressure. During business negotiations, requests or business relations with the Public Administration, BSN shall refrain from (directly or indirectly) undertaking the following actions: a) considering or proposing job opportunities and/or business opportunities which could be to the personal advantage of employees of the Public Administration; hiring former employees of the Public Administration (or their close relatives) who have personally and actively participated in business negotiations, tenders or the endorsement of applications made by the company to the Public Administration during the year following their conclusion or completion; b) offer or in any way provide free gifts other than those of little value. BSN shall guarantee that such gifts may be traced via specific documentation (ex. transport document); c) solicit or obtain confidential information beyond that permitted by law. There are many forms of interaction between companies and businesses which are Assobiomedica members and healthcare professionals which contribute to the progress of medical science or improve patient diagnosis and care, including: a) the progress of medical technology: research and development of innovative medical technologies and the improvement of existing products are often the result of the cooperation between Assobiomedica members and Healthcare Professionals. Innovation and creativity are essential for the development and evolution of medical technologies and often occur working with entities, institutions and individuals outside the structure of the manufacturing companies; b) The effective, safe use of medical technology: this very often requires that BSN offer Healthcare Professionals adequate education, training, services and technical support. Regulatory bodies may also require this type of training as a condition for the approval of products c) Research and education: BSN s support to medical research performed in good faith, education for the best, most appropriate use of the technologies supplied and, more generally, to increase professional skills, are several of the elements that contribute to patient safety and increase access to new technology and, thus, to the most advanced, effective treatments. BSN has set up a specific procedure in line with regulations in force and shall follow such procedure in demonstrating its willingness to incur costs relating to the registration and/or participation of a healthcare worker employed by the Public Administration in a specific event. BSN draws up and sends an informational notice to the Public Administration (National Healthcare Service, Hospitals, etc.) demonstrating its willingness to incur Rev. 05/

8 costs relating to the registration and/or participation of a healthcare worker in a specific conference event. BSN has the right to propose the names of one or more healthcare workers in the sector of interest of the conference event, whose participation the Administration has full and complete autonomy to decide on. If the healthcare workers participation in the conference event is a paid assignment, it shall be permitted only on the written authorisation issued to BSN by the Administration and, in any event, always in accordance with correct, verifiable procedures. For events organised exclusively by BSN, the information concerning the invitation and coverage of the expenditure may include the name of the healthcare worker, not just a simple invitation. BSN undertakes, also being responsible in this regard for any actions by the parent company and its agents and distribution partners, not to directly or indirectly organise or participate in any way in conferences, conventions, workshops and similar events where: a) Tourism and recreational aspects prevail over technical and scientific matters; b) Travel and accommodation expenses are covered for parties accompanying invited parties; c) Travel and accommodation expenses extend over a period of time exceeding 24 hours prior to the beginning and/or following the end of the event TRAINING AND EDUCATION ON PRODUCTS SPONSORED BY BSN Where needed, BSN shall provide education and training to Healthcare Professionals relating to products and technical administrative activities and operational management in order to facilitate the safe, effective and efficient use of medical and diagnostic technology. These education and training programs must take be held in suitable locations, taking into consideration the comfort of participants and the type of training. Specifically: - Programs and events must be conducted at premises which are equipped for clinical, laboratory, training or conference use or other suitable premises including those owned by BSN or business meeting facilities which are suitable for the effective transmission of knowledge and any type of practical training. Events must be held in locations and offices chosen based on logistical, scientific and organisational purposes. Locations of a primarily touristic nature are excluded in the period 15 June - 30 September for seaside locations and 15 December 30 March, as well as 15 June 15 September for locations in mountain areas. The personnel in charge of training must have suitable qualifications and experience. - BSN may provide low cost meals to participants in these programs and other hotel accommodations may be necessary for training programmes which require overnight stays. Any hotel accommodations must be low cost and, in any Rev. 05/

9 event, must not be a structure with more than 4 stars, be appropriate to the duration and useful for the educational purpose of the training course as well as compliant with all applicable regulations. - BSN may pay reasonable travel and accommodation costs incurred by Healthcare Professionals participating in the event, in compliance with all applicable regulations. Air travel must be exclusively economy class, excluding intercontinental flights. - BSN shall not have to pay travel expenses or other expenses for the spouses, guests of Healthcare Professionals, or any other party who does not, in good faith, have a legitimate professional interest in the issues that will be covered during the meeting. Spouses and guests may use the hotel accommodations of the group provided that they pay for their additional share. - BSN may not participate or fully or partially pay any expenses to cover activities which are not strictly training activities during the event itself (purely by way of example: concerts, shows, social programmes) SUPPORT FOR TRAINING CONFERENCES HELD BY THIRD PARTIES BSN may support independent, training or scientific conferences or conferences which support policies promoting scientific knowledge, medical progress and effective healthcare services. These generally include conferences organised by international, national, local or specialised medical associations or by accredited bodies providing ongoing medical training. BSN may support such conferences when the events are held in locations and offices chosen based on logistical, scientific and organisational purposes, excluding locations of a primarily touristic nature in the period 15 June - 30 September for seaside locations and 15 December 30 March, as well as 15 June 15 September for locations in mountain areas, according to the following methods: - conference support. BSN may provide financial contributions to cover the costs of conferences and reasonable travel and accommodation expenses incurred by the Healthcare Professionals (and by medical students, honorary members and other parties studying to become Healthcare Professionals), in the case such conferences are focused on promoting objective scientific and training activities. This support must be compliant with applicable regulations. The conference organisers shall be responsible for the conference, and shall check the choice of content, the instructors, methods and training materials. BSN s sponsorship of the conference must be clearly stated in advance and during the meetings. - Low cost hotel accommodation and meals. BSN may provide financial support to the conference organisers and to the instructors in the form of low cost meals and hotel accommodation for participating parties. Reasonable contributions may be provided to the instructors as fees. Any meals and hotel accommodation must be appropriate to the duration and useful for purposes of the conference. Hotel accommodation must be provided in hotels with a maximum of 4 stars, and any air travel must be exclusively economy class, excluding intercontinental flights. Rev. 05/

10 - Advertising and demonstrations. BSN may purchase advertising and rent spaces for exhibition stands for its products and/or services during the conferences MEETINGS FOR INFORMATION AND/OR PROMOTIONAL PURPOSES When BSN meets with Healthcare Professionals in order to illustrate the characteristics of its products it must, as a general rule, hold these meetings near the place of work of the Healthcare Professionals. Events must be held in locations and offices chosen based on logistical, scientific and organisational purposes. Locations of a primarily touristic nature are excluded in the period 15 June - 30 September for seaside locations and 15 December 30 March, as well as 15 June 15 September for locations in mountain areas. In relation to these meetings, BSN may offer meals and hotel accommodation to the participating Healthcare Professionals. Hotel accommodation must be provided in hotels with a maximum of 4 stars. BSN may also pay reasonable travel expenses incurred by participants where necessary (e.g. for visits to specific plants or Centres). Any air travel must be exclusively economy class, excluding intercontinental flights. It is prohibited to offer any form of accommodation, payment for meals, travel and other hotel services on behalf of the guests of Professionals or any other individual who does not in good faith, have a legitimate professional interest in the issues that will be covered in the meeting. Spouses and guests of the Professionals may use the hotel accommodations of the group provided that they pay for their additional share. BSN may organise any activities related to the informative and/or promotional event provided that such activities do not, due to their very nature, costs or visibility, distort the informative and/or scientific purpose of the event. 2.8 DONATIONS TO THE PUBLIC ADMINISTRATION FOR CHARITY OR PHILANTHROPY BSN may make donations (including financial contributions, for charity or other philanthropic purposes such as support to effectively independent medical research for the progress of science or medical education, care of destitute persons, patient education, public education or sponsorship of events whose proceeds will be donated to charity. Donations must be made solely to organisations and entities which have the right to receive them in accordance with applicable laws and regulations. All donations must be adequately documented. The following are examples of appropriate donations and related contributions: - Progress in medical education. BSN may provide financial contributions to support effective medical education for medical students, members participating in programs of associations which have charitable purposes or academic affiliations or, where this is in line with point 2.7, above, for other medical personnel. - Support for scientific research. BSN may provide financial contributions to support medical research. The purpose of the contribution must be clearly documented. - Education of the Public. BSN may provide financial contributions to support Rev. 05/

11 patient education or education of the public on important healthcare issues. Donations of cash, goods, equipment etc. to the Public Administration must be made in compliance with regulations in force. In terms of relations with Public Administrations it is important to formally establish a specific procedure, with the following fundamental aspects: The donor, BSN, must draw up and send the Public Administration (National Healthcare Service, Hospital, etc.) a notice in which it expresses its intention to donate an amount of money or specific equipment. Conversely, the public institution concerned shall sent the donor BSN a request for donations. The beneficiary Public Administration (National Healthcare Service, Hospital, etc.) shall comply with the regulations in force for the purposes of implementing the donation. The donor, BSN, specifically acknowledging the acceptance, shall provide all details of the donation and shall ensure fulfilment of all the obligations pursuant to law. 2.9 SCHOLARSHIPS Scholarships must be granted, in compliance with provisions in force on the matter, based on transparent, objective procedures for assessing candidates according to recognised scientific criteria ASSIGNMENTS, CONSULTING SERVICES, STUDIES ENTRUSTED TO EMPLOYEES OF THE PUBLIC ADMINISTRATION In good faith and in compliance with the regulations in force, Healthcare Professionals may provide consulting services and significant services, presentations at training courses or presentations sponsored by BSN and collaboration in the development and application of its products. It is deemed suitable to pay the Healthcare Professionals reasonable remuneration for providing these services. A consulting agreement between BSN and the Healthcare Professionals may be finalised in good faith, if supported by the following elements: - Consulting agreements with Healthcare Professionals must be in written form, signed by the parties, specifying all the services which are to be provided. These agreements must comply with the laws and regulations of the country where the Healthcare Professional carries out his/her profession; - The remuneration of the Healthcare Professionals that provide consulting services must be reasonable based on the nature and proportionate to the services actually provided, in compliance with tax requirements and other applicable legal requirements. BSN may reimburse reasonable expenses incurred by consultants in performing that set out in the consulting agreement. - The consulting agreements must be entered into solely where a legitimate purpose for these services is identified in advance. Rev. 05/

12 - The choice of consultants must be based on their qualifications and experience, in order to achieve the identified purpose. - The location and circumstances of the meetings between BSN and consultants must be suitable to the subject of the consultation. Hotel accommodations, which shall never exceed 4-star hotels, financed by BSN and provided in relation to a meeting with consultants must be low cost and appropriate to the duration and useful for the main purpose of the meeting. - Where BSN enters into a contract with Healthcare Professionals who work as consultants for research services, a research protocol must be drawn up, the necessary permits and authorisations obtained and, in any case, the relationship must be characterised by the principle of utmost transparency with regard to the Administration the Professional works for. - The P.A. must provide BSN with authorisation of the assignments granted to employees of the P.A. - The P.A. must be notified of the provision of remuneration to Healthcare Professionals. - It is not possible to enter into contracts and/or grant assignments with parties who have exercised authority or negotiation powers on behalf of the Public Administration in the last three years DONATIONS TO EMPLOYEES OF THE PUBLIC ADMINISTRATION BSN may occasionally make modest donations to Healthcare Professionals but these shall be modest amounts and comply with the laws and regulations in force. As a general rule, donations must made for the benefit of patients or have an essentially educational purpose. Note that the current code of conduct for government employees identifies the threshold considered low at a limit of (limit which thus must be considered binding for BSN). BSN may also occasionally provide products with a low value, related to the work of the Healthcare Professional, for promotional purposes or for the benefit of patients. Donations shall never be in cash or cash equivalents. This section does not refer to the legitimate practice of providing appropriate product samples and opportunities to test products QUALITY GUARANTEE BSN bases its reputation on the highest quality of its products, in general medical devices, services and treatments, so that healthcare workers can provide patients with the best possible outcome. BSN s commitment is not limited to compliance with quality and safety standards set out by law but, whenever possible, goes beyond this to guarantee increasingly effective products, services and treatments. Rev. 05/

13 3 BSN S COMMITMENT (as a member of the ASSOBIOMEDICA Association) BSN has drawn up this Code of Ethics based on the code prepared by Assobiomedica. As a member of the Association, BSN undertakes to comply with and promote the principles and rules set forth in said Code. BSN undertakes to comply with and ensure that its parent company and its agents and distribution partners comply with this Code, including the agreements and guidelines that Assobiomedica shall implement with various scientific companies regarding procedures for participating in conferences organised by these companies. BSN undertakes to include clauses requiring compliance with the principles in the Code of Ethics in the agreements entered into with its Consultants, External Contractors and Partners. 4 CODE OF ETHICS CONTROL BODY The Supervisory Body is in charge of implementing and monitoring the Code of Ethics, and shall: o o o o Communicate the operating procedures of its function; Promote the issue of guidelines and operating procedures; Set up communication and training programs for employees, to improve their knowledge of the Code; Verify the knowledge of the Code inside and outside BSN, and implementation thereof. 5 REPORTING PROCEDURES In order to ensure that the Code is actually implemented for employees, agents, distribution partners, consultants, external consultants and partners, the communication channels described in detail in the Control Model shall be used, which may be used to report conduct which violates the Code and any other instructions on behaviour contained therein. For all matters not expressly covered in this Code of Ethics, refer to the Code of Ethics of Assobiomedica, which can be downloaded from the internet: Rev. 05/