1. PURPOSE & SCOPE
This Policy of IAMEX S.A. concerns all the Company's transactions with Healthcare Professionals (HCPs), applies to all the following activities and transactions for all the Company's staff and partners. These guidelines apply to the dealings of IAMEX SA employees with individuals (clinical or non-clinical) including, but not limited to, physicians, nurses, technicians and research coordinators or legal entities (such as hospitals or supply companies) that directly or indirectly procure, lease, recommend, use, arrange for the purchase or lease of medical technology products.
2. AUTHORITIES
2.1. General Manager 2.2. YSDD
3. DESCRIPTION
There are many forms of transactions between IAMEX employees and Healthcare Professionals that advance medical science or improve patient care, including the following:
Advancement of medical technology.
The development of innovative medical technology products and the improvement of existing products require collaboration between IAMEX SA employees and Healthcare Professionals. Innovation and creativity are essential to the development and evolution of medical technology products, which often occur outside the company's facilities. medical equipment.
Safe and Effective Use of Medical Technology.
The safe and effective use of medical technology requires the employees of IAMEX SA to provide Health Professionals with appropriate instructions, education, training, technical coverage and support. Regulatory authorities may also require this type of training as a condition of product approval.
Research and education
The support by IAMEX SA employees of bona fide medical research, education and strengthening of professional skills contributes, among other things, to patient safety and increasing access to new technologies.
The employees of IAMEX SA recognize that the observance of ethical standards and compliance with the laws are critical factors for the ability of the medical technology industry to continue cooperation with Health Professionals. IAMEX SA employees must encourage ethical business practices and socially responsible behavior related to their contacts with Healthcare Professionals. IAMEX SA employees must continue to respect the obligation of health care professionals to make unfettered decisions regarding treatment.
The guidelines are based on the following key principles:
1. The principle of separation: The transaction between the industry and Healthcare Professionals should not be abused so as to influence, with unjustified or improper advantages the decisions to purchase, nor should this transaction depend on sales transactions or the use or suggesting the use of its employees' products.
2. The principle of transparency: The transaction between industry and Health Professionals must be transparent and comply with laws, regulations or professional codes of conduct.
3. The principle of equivalence: Where Health Professionals perform a service for or for the benefit of a company, or compensation paid on behalf of the company, must be proportionate and represent the fair market value, for the services performed by the Health Professional.
4. The principle of documentation: For transactions between a company and a Healthcare Professional, where services are performed by a Healthcare Professional for a company or on behalf of a company, there must be a written agreement stating, among other things, the purpose of transaction, the services to be performed, the method to cover the expenses, as well as the compensation to be paid by the company. The activities provided for in the agreement must be justified and proven by relevant reports, etc. Adequate documentation, such as the agreement, related reports, invoices, etc., must be maintained by the company to support the need for the services and their implementation, as well as the rationale for the compensation paid.
4. SPONSORED TRAINING AND PRODUCT EDUCATION
Depending on the case, IAMEX SA employees must be able to provide education and training on their products to Healthcare Professionals, to facilitate the safe and effective use of medical technology.
Such education and training programs should be held at an appropriate location, taking into account the convenience of the participants and the nature of the training.
In particular: Programs and events should be conducted in clinics, workshops, training, conferences or other appropriate environments, including company facilities, or commercially available facilities, which favor effective knowledge transfer and practical "hands on" training. The training staff should have the appropriate expertise to conduct the training in question. IAMEX SA may provide participants with meals at a reasonable cost in relation to the program and, if the training programs require overnight stays, additional accommodation may be provided. is covered. Any accommodation must be of reasonable value, shorter than the duration of the program, focus on the educational purpose of the training and be in accordance with the regulations of the country where the health care professional carries out his activity. IAMEX SA may pay, for reasonable travel and accommodation expenses of a health care professional, in accordance with the regulations of the country where the health care professional practices his activity. IAMEX SA does not may facilitate or pay for meals, travel, lodging or other expenses for spouses or guests of Health Professionals, or for any other person who does not have a genuine professional interest in the information distributed at the meeting.
5. SUPPORT OF THIRD PARTY EDUCATIONAL EVENTS
In good faith, independent, educational and scientific events, or events for policy making, promote scientific knowledge, medical progress and help provide effective health care. For these purposes, IAMEX SA may support such events, as long as the content of these educational events promotes scientific knowledge, medical progress and the dissemination of effective health care and is in accordance with relevant guidelines established by professional companies or organizations for these events.
IAMEX SA may support such events by providing financial, scientific, technical, organizational and/or logistical assistance as follows:
Sponsorship of Health Professionals:
If permitted by national and local laws, regulations and codes of professional conduct, IAMEX SA may provide financial support to cover the cost of participation in scientific events of individual Health Professionals that are approved by the EOF and based on the submission and pre-approval procedures by the EOF . Financial support should be limited to registration costs as well as reasonable travel, meal and accommodation expenses related to participation in the event, based on the limits set by the EOF in the relevant circular. IAMEX SA cannot have any participation in the selection of specific persons to cover their participation costs. IAMEX must ensure full compliance with national and local laws, regarding the notification or conditions, which are related to such sponsorships and where these requirements are not foreseen, they will be covered by transparency, such as written notification of the sponsorship to the hospital management, the superiors of the Health Professional or other designated competent authority.
Conference support:
IAMEX SA can provide a financial grant directly to the organizer of the event, in the form of a sponsorship with some type of participation (exhibition space, logo display, participation in covering food, etc.), coverage of participant registration costs, reasonable amounts for fees (honoraria) , travel, meals and accommodation expenses of the Health Professionals, who are committee members at the event, based on the signing of a relevant private sponsorship agreement with the organizer. A written application must be submitted by the conference organizer to IAMEX SA and any sponsorship must be paid directly to the conference organizer or the relevant educational institution. The organizer of the conference is solely responsible for the program as well as the selection of the speakers. IAMEX SA cannot have any partial participation in determining the content of the conference, except for the proposal for speakers, or the commentary on the program, when this is requested.
Scholarships:
IAMEX SA may also provide educational grants to educational institutions, health care institutions or professional companies, for the purpose of developing medical education, by offering financial support in the form of scholarships and similar awards. The selection of scholars is at the discretion of the institution where they are enrolled or the educational institution in which they will be trained. Grants are offered to the educational or professional institution and not to the individual researchers, unless there is a written request from the contracting institution. In no way should the grant be tied to the purchase of the company's products or based on past use or potential future use of the company's products by the institution.
6. SALES AND PROMOTION MEETINGS
Where permitted, IAMEX SA employees meet with Healthcare Professionals to discuss product features, conduct contract negotiations or discuss terms of sale. These meetings should, as a general rule, take place at or near the HCP's headquarters. In connection with these meetings, IAMEX SA employees may pay for meals at reasonable prices, for Health Professionals, in an environment conducive to mutual information. However, IAMEX SA is not allowed to pay for meals, travel, accommodation or other expenses for the spouses or invitees of the Health Professionals, or for any other person who does not have a bona fide professional interest in the information provided at the meeting.
7. AGREEMENTS WITH CONSULTANTS
Health Professionals may serve as consultants to IAMEX SA by providing bona fide services, including research, participation in advisory boards, or by presenting at educational events sponsored by IAMEX SA, or at educational events organized by third parties, as well as by product development. It is reasonable to pay Healthcare Professionals reasonable compensation for performing these services.
The following factors support the existence of a bona fide agreement between IAMEX SA and the Health Professionals: • An agreement for the employment of consultants is understood when a legitimate purpose has been specified in advance. • The selection of consultants should be based on the consultant's qualifications and experience to address the specific legitimate purpose, and should not be based on the volume or value of business generated due to the consultant. • Consultant Agreements with Professionals Health must be described in a written agreement, signed by both parties, which specifies the services provided. These arrangements must be in accordance with the regulations of the country where the Health Professional is licensed to practice. • Compensation paid to Health Professionals, who are employed as consultants, must be the fair market value for the services rendered and not must be linked, in no way, to the value of the medical devices, which they may use for their own practice.• All payments must comply with applicable tax or other legal requirement.
IAMEX SA may pay for reasonable and actual expenses of consultants in carrying out the subject matter of the agreement, including travel, meals and overnight stays, which are a result of their participation in meetings with IAMEX SA, or on behalf of IAMEX SA.
• The written agreement should describe all expenses that may be required of the consultant in connection with the provision of the services. • IAMEX SA, since it employs Health Professionals as consultants, must ensure full compliance with national and local laws regarding the notification or approval of claims related to IAMEX. In the event that no such requirement is foreseen, IAMEX SA maintains appropriate transparency, requiring prior written notification to the hospital administration, to the head of the health care professional, or any other competent authority at the local level, with which to disclose the purpose and scope of the consulting agreement.• All consulting agreements with Health Professionals must be documented in writing even when the Health Professional does not require payment for his services, or where the agreement involves only a one-day event.• The place and circumstances for meetings with consultants should be consistent with the subject matter of the consultations. Meetings should be held in a clinical, educational, conference or other environment suitable for this purpose, including hotels or other locations conducive to effective mutual information. it should be moderate in value and subordinate to the time and purpose of the meeting. • When IAMEX SA contracts with a Health Professional to develop the spiritual property, there must be a written agreement to grant compensation at a fair market value. However, under no circumstances may the Healthcare Professional receive financial compensation in relation to medical devices that he has used in the past or may use in the future, including medical materials, which include the new intellectual property rights. All required consents and approvals must be obtained, including those from the hospital management or the Health Professional's supervisor (or local authority).
8. GIFTS
IAMEX SA may occasionally offer inexpensive items as gifts to Healthcare Professionals in accordance with national and international laws, regulations and industry and professional codes of conduct in the medical technology industry. Gifts should be of small value, provided exceptionally and either related to the Health Professional's practice or given for the benefit of patients or serve a genuine educational function. The value of the gift (purchase/production cost) is limited to €20.00. Gifts must not be given in the form of cash or cash equivalents.
[GIFT ELIGIBILITY CHART – Source: www.medtecheurope.org ]
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9. HOSPITALITY (TRAVEL - ACCOMMODATION)
For any type of event and meeting with Health Professionals where hospitality is provided, which includes Travel and Accommodation of the Health Professional, the regulations and hospitality limits applicable to Scientific Events (Conferences) apply and are described in detail in P.30.3 Grants-Donations-Grants Policy (Section 4. SPONSORS). Also, the Expenditure Approval process is applied through form E.32-1 Expenditure Approval Form.
10. RECREATION
IAMEX SA does not allow the organization or financial coverage of any Entertainment event.
11. SAMPLES/PRODUCTS FOR DEMONSTRATION
IAMEX SA may provide its products as Products for Demonstration and/or as Samples free of charge, in order to enable Health Professionals or Health Organizations to evaluate them and/or become familiar with their safe, effective and correct use as and functionality of the product and determine whether or when to use, order, purchase or recommend the product in the future.
Demonstration and Sample Products may be single or multiple use products. IAMEX may also provide products from another company, in combination with its own Demonstration/Sample Products exceptionally, if the other company's products are required for the proper and effective demonstration, evaluation or use of IAMEX's products.
The provision of Demonstration Products and Samples must not improperly reward, induce or encourage Healthcare Professionals to purchase, lease, recommend, prescribe, use, procure or acquire IAMEX products or services.
IAMEX SA should in all cases keep appropriate records regarding the provision of Demonstration Products and Samples to Healthcare Professionals, for example, proof of delivery of Demonstration Products or Samples and a return document for multi-use products.
IAMEX should clearly record in its records, as well as clearly communicate to Healthcare Professionals the non-charge and the other conditions that apply, for the provision of said Products for Demonstration or Samples, no later than the time of delivery . Notification to Health Professionals and Health Organizations must be in writing.
Samples
IAMEX may provide a reasonable number of Samples free of charge to allow Healthcare Professionals to familiarize themselves with the products and related services, to gain experience using them safely and effectively in clinical use, and to determine if, or when, they will products will be used, ordered, tendered, prescribed or recommended in the future.
For Samples, which are single-use products, the quantity offered for the purpose of familiarization must not exceed the amount reasonably necessary for Healthcare Professionals to gain sufficient experience in their contact with the products.
For Samples, which are multi-use products, the length of time required for Healthcare Professionals to gain sufficient experience with the product will depend on the frequency of anticipated use, the length of training required, and the number of Healthcare Professionals they should gain experience about the products. IAMEX shall in all cases ensure that they retain ownership of the Multi-Purpose Samples and that they have a procedure in place for the timely return of such Samples after the familiarization period has ended.
12. FILES
Records of the above forms are kept by YDP for 5 years.
Related Documents: 1.P.30.3 Grants-Donations-Grants Policy 2.E.32.1 Expenditure Approval Form
External Documents: 1. MedTech Europe Code of Ethical Business Practice MedTech Europe Code of Ethical Business Practice 2. SEIB Code of Ethical Professional Practice
13. HISTORY OF THE DOCUMENT
Ed. Date Description of Change Version From1 15/07/2024 Initial Version YSDD