MEMBERS CODE OF ETHICS

Transcription

1 MEMBERS CODE OF ETHICS 1. PURPOSE The purpose of members code of ethics is to systematize and specify the obligations of Association s members regarding the compliance with the rules of good business practice in their interactions with all clients, either of Public or Private sector. Furthermore, to describe the procedures and define Association s bodies which, according to Articles of Association, are competent for monitoring the compliance to the abovementioned rules, and also for imposition of any sanctions on members, when they violate them. This regulation of Code of Ethics constitutes Association s basic normative document along with its Deed of Association. 2. ASSOCIATION S IDENTITY Hellenic Association of Scientific and Medical Equipment Suppliers was established in 1986 by the initial corporate name Panhellenic Association of Scientific Devices and Medical Equipment (PAN.SPESIM). It includes Hellenic and International companies operating in Greece according to Greek Law. Members of Association are manufacturers and mainly agents and distributors of Scientific Equipment for measuring of physicochemical parameters, as well as Medical Equipment and supplies, such as:

2 1. Analytical instruments and supplies for chemical and environmental control laboratories. 2. Equipment, consumables and reagents for Clinical Laboratories (biochemical, hematological, microbiological, immunological, blood collection s etc) 3. Surgical, as well as Clinical and Intensive Care equipment. 4. Pacemakers Defibrillators and other cardiological equipment, as well as orthopedic and acoustic implants 5. Imaging Medical Equipment, Laser and their consumables 6. General Medical Consumables 7. Hospital info structure equipment 8. Any other product belonging to Scientific and Medical equipment categories 3. SOCIAL CONTRIBUTION Activities of Association s members must decisively contribute to better quality of life in our country, given that better quality of life means, among others: Better medical diagnosis and therapy Better quality control of products Better education and research Better and cleaner environment 4. IMPLEMENTATION OF DIRECTIVES AND RULES REGARDING PRODUCT DISTRIBUTION Association s members are obliged to implement the Greek and European Legislation, which determines the distribution of Scientific and Medical products, in their current form, and where it is applicable to their activities. 2

3 Furthermore members must have accreditation by the proper Greek or International notified organization regarding the implementation of the right practice of Scientific and Medical products distribution. Association s member companies, which handle Medical products, must provide the relevant operating instructions in Greek language. In case that the product is destined for self-diagnostic use by a non expert, operating instructions must be enclosed in the product package. In case that the user is a professional, operating instructions do not have to be enclosed in the package, yet they must be at user s disposal in printed or electronic form, on supplier s responsibility. Operating manuals of all equipment categories, Medical and Scientific, must be at users disposal upon the delivery of equipment. Equipment s operating manuals must be translated in Greek language, wherever it is required by the legislation in force. Association s member companies must adhere to traceability rules, wherever it is required for their products, in order to be able to recall batches or make other corrective actions when they receive such instructions from the manufacturer. In addition, they must immediately notify the National Drug Organization or any other competent authority in these cases. They must closely co-operate with the statutory state alert mechanisms. In general, members must adhere to any directive or rule in regard with companies obligations concerning the implementation of their products good production and distribution practice. 5. ENVIRONMENTAL PROTECTION OBLIGATIONS Association s members must prove their high sensitivity regarding issues of environmental protection by adhering to directives and laws issued for this purpose. 3

4 Namely, they must directly adhere to current and any new directive or law, which will aim to the protection of the environment and the quality or Greek citizens life with specific measures. 6. CLIENTS ACCURATE INFORMATION Members and theirs personnel essential obligation is to transfer to clients accurate and complete information. Prior to any agreement, the client must fully and precisely be aware of the terms of agreement, viz the supplier s commitments to him, as well as the technical data of the offered products. For this purpose, member companies sales personnel must be excellently trained in order to posses the required scientific and technical knowledge regarding the full and reliable clients briefing and must have obtained instructions from the company s administration in relation to their obligation to inform its clients fully and reliably. 7. SCIENTIFIC AND MEDICAL EQUIPMENT AFTER SALES SERVICE. Equipment for sale or lease by members of Association must be supported after sales by properly trained technicians of these companies and the below mentioned rules must be followed: A. PROPER FUNCTION GUARANTEE Duration and guarantee s terms are specified by the supplier in cooperation with the equipment s Manufacturer and the client must be notified about them in written. Guarantee must, among others, define which parts of equipment are considered to be consumables and not covered by guarantee, as well as 4

5 the program of their regular replacement. The Supplier is obliged to inform his client respectively, prior to purchase agreement. B. SERVICES OFFERED In addition with proper function guarantee, when required by equipment s type and complexity, supplier is obliged to provide at least the below mentioned services: 1. Installation and proper function test of equipment, based on the relevant installation protocol provided by the manufacturer. The supplier is not responsible for infrastructure in client s site, wherein the equipment will be installed. Namely, for electrical or hydraulic installation, air conditioning, gas supply and other infrastructure elements, responsible for which is the buyer, unless expressly agreed otherwise. 2. Training on the use of equipment, according to the protocol and the predefined number of hours by the manufacturer. Any extension of this training of client s choice for his special needs coverage, such as: a) Technical and scientific assistance on client s applications b) Training of many users simultaneously or repetitively must be specially agreed between the client and the supplier. 3. Operating Manuals The supplier is obliged to supply the buyer with full operating manual in written or electronic form, as specified by the manufacturer, translated in Greek language, where required by legislation in force. 5

6 8. CONFERENCES AND SEMINARS Within the framework of good co-operation of Association s members with the country s scientific community, members can support their clients scientific conferences and informational seminars, following the below mentioned terms, which will allow them to act within the limits of deontology and rules specified by the competent state authorities (National Drug Organization) Member companies can finance scientific conferences, in Greece or abroad, the overall program of which has scientific content. Conferences can be organized by government entities, universities and national hospitals, as well as scientific associations and scientific unions of any kind In addition, member companies can organize scientific information events, in the form of conferences, seminars, workshops and other similar events, for scientific information purposes. These events must be carried out in co-operation with scientific associations, hospital scientific boards and scientific unions in order to ensure any interested scientist s ability to participate Prerequisite provided that member company is established in Greece for legal financing in both of the abovementioned cases, is to have obtained relevant license by the event organizers from National Drug Organization Member companies can organize at their own expenses informational events for their clients for promoting their products in Greece and abroad In the abovementioned cases no. 8.1 (Scientific Conferences) and 8.2 (Scientific Information Seminars) participation of all public sector scientists, including medical doctors of the National Health System and Universities, is open without limitations. 6

7 8.6. Contrariwise, participation of medical doctors of National Health System as well as members of academic community engaged in clinics placed in hospitals of the National Health System is not allowed in the abovementioned events no. 8.4 (Sales Promotion) Along with financing the abovementioned events, company members are also allowed to cover the expenses of hosting the scientists who participate therein, including medical doctors, under reasonable restrictions. Namely, they can cover expenses of registration and participation to the event, of scientist s feeding and lodging during the event, the scientist s travel expenses from his establishment to the event s one, yet these expenses must be reasonable and fully related to the event s aims. 9. PROVISIONS TO MEDICAL DOCTORS KAI OTHER SCIENTISTS 9.1 Subject to article 8 regarding members contribution to their clients scientific briefing, no other provision to medical doctors and other scientists is allowed. 9.2 In particular, pecuniary gifts or promises for any kind of exchange or benefit to individuals authorized to perform purchases in the public and private sector, directly or indirectly, are not allowed. Items of insignificant value related to client s professional activity do not appertain to this forbiddance. 10. CLINICAL TRIALS OF MEDICAL EQUIPMENT 10.1 Association s member companies may finance clinical trials of medical equipment in several occasions such as for: Products not bearing CE indication destined only for research purposes Products bearing CE indication which are to be tested in new uses 7

8 In Vitro products which are to be in contact with the human body Medical equipment s clinical trials of this kind are performed upon agreement with the Administration of the body that will undertake them and must bear the approval of Greek Drug Organization (ΕΟΦ/EOF). 11. RESEARCH FINANCING 11.1 Member companies may finance research programs, in which fees and compensations for the scientific personnel are included, through special accounts In relation to the universities, through Special Account of Research Funds, retained by the universities, by signing a contract with them. These funds are managed by the university bodies of the special account In the case of the bodies of Ministry of Health, financing is made through Special Account of Research and Development managed by a special committee, created for this program in the respective sanitary region. The affined contract is signed with this committee that has full responsibility for the management of the fund. 12. IMPLEMENTATION OF COMPETITION LEGISLATION Association s member companies must not violate the rules of free trade by abstaining from actions like those mentioned indicatively below: 12.1 Not to make agreements with other companies of the branch regarding the determination of common prices or trading conditions. This does not mean that, in case of bad application of the supplies legislation in force and in general whenever is noted violation of the good trading practice 8

9 by the clients, Association s members are not allowed to unite in order to confront jointly these cases and any other institutional issue of the branch whatsoever Not to deliberately constrain the production and disposal to the market of their products 12.3 Not to constrain the disposal of their products to specific client categories or geographical market areas 12.4 It is legitimate for Association s member companies to try to persuade the competent scientists to buy their products with technical and economical arguments, prior to direct sale or through a public tender, yet by highlighting technical characteristics, which give to the products those functional characteristics that cover the client s actual needs. 13. DISCIPLINARY OFFENCES AND PENALTIES According to Articles of Association, article 8, members may be committed to Association s disciplinary body for the following reasons: DISCIPLINARY OFFENCES: Association s members and members of the Board of Directors, when falling into disciplinary offences against the Association or not evidently following the current Code of Ethics, are subject to sanctions of the next paragraphs of the present article. Disciplinary Offence is considered to be: a) Activity incompatible with Association s and Board s membership, wherein is also included the opposition to Association s purposes or interests, as well 9

10 as the substantial and repetitive infringement of Articles of Association or Code of Ethics. b) Any infringement of Articles of Association or Code of Ethics or legislation in force in general by proven culpable action or omission by a member of the Association or the Board of Directors, regardless of any provided criminal proceedings or other legal sanction SANCTIONS Disciplinary sanctions are set to be: a) Written reprimand, b) Temporary up to three months suspension of the member s right, c) Ejection and removal from the Association member s registry COMPETENT BODY DISCIPLINARY AUTHORITY: a. Body competent for the exercise of the disciplinary proceedings and the imposition of the penalty is the Association s Board of Directors, to which any Association s member or natural or legal person outside the Association, who has been offended by a member s unethical behavior, may complain by signed written notice. Furthermore, the Board of Directors can ex officio commit a member to the disciplinary board by simple majority of its members. b. The prosecuted member must be evidently called in written to attend the meeting of Board of Directors, represented by his legal representative. Notice also includes the reasons of his prosecution. 10

11 If the member does not present himself in the day and time of the meeting of Board of Directors, despite his call for this purpose, it is deemed that he accepts all accusations imputed to him. c. The Board of Directors decides in a special meeting justifiably and by the majority of the 5/7 of the total of its members, having heard previously the member, against whom disciplinary proceedings are exercised. d. If the defendant member is also member of the Board of Directors, he does not have the right to vote in Board of Directors special meeting, but only to testify. In this case decision is taken by majority of the 4/6 of the total of the rest of the Board of Directors members DECISION The decision of the Board of Directors regarding the member s ejection and removal, in order to be valid, must necessarily is approved by the Association s General Assembly, which is obliged to pass judgment after hearing the member Member under ejection is called by notice especially to attend the members General Assembly in order to defend his situation. Along with the notice it is also delivered to him a copy of the Minutes of the decision of the Board of Directors in regard to suspension. In case of member s absence from the General Assembly, despite his lawful notice, it is deemed that he accepts the grounds for ejection and the decision of the Board of Directors The Board of Directors decision imposing the disciplinary penalty, as well as the General Assembly s decision of accreditation, regarding the 11

12 ejection of the member, is delivered to him either by registered letter or by bailiff In any case of disciplinary penalty s imposition, the member who sustained the sanctions of par. 2 may appeal, by application, to the first General Assembly following the decision and ask for its withdrawal. 12