職業守則(CODE OF ETHICS)

職業守則論「與醫療專業人員的互動」

經台灣先進醫療科技發展協會採用

1. 1. 前言：

    

   台灣先進醫療科技發展協會（簡稱「TAMTA」）代表了發展、生產、製造、行銷醫藥產品、技術、相關服務與治療（以下簡稱「醫療技術」）的會員公司（以下簡稱「公司」），這些相關服務與治療用於診斷、治療、監控、管理、緩和健康狀況與殘疾。TAMTA 除致力於醫療科技的精進、病患照護的提昇之外，更透過高品質與創新的醫療技術，達成這些目標。TAMTA 亦以促進公司與醫療照護個人或組織的互動為己任。這些醫療照護個人或組織，係指在台灣購買、租用、推薦、使用、安排購買或租用、訂購這些公司的醫療技術，為病患提供健康照護服務與項目的個人與組織。

    

   為了達到此目的，TAMTA訂定此「職業守則」（以下稱「守則」）。

   生效日期:

   2015/08/31(第一版)

   2022/09/01 (第二版)

    

   1.1 TAMTA 守則的目的

    

   醫療專業人員的首要任務就是要做出對病患最有利的決策。醫療公司能夠與醫療專業人員合作，為患者提供服務。為確保這樣的合作關係能符合高道德標準，合作必須適當透明化、遵守相關法規與政府規範。公司與醫療專業人員的互動，有義務符合道德標準，以確保能做出對患者最有利的醫療決策。規範雙方互動的道德原則就是本職業守則。

    

   1.2 TAMTA 守則的範疇

    

   醫療技術

    

   不同於使用藥物和生物製品之治療方式，使用醫療技術的治療過程必需仰賴醫療專業人員之操作技術。例如，利用植入術醫學技術以替代或增強身體部位功能。其他還有如非侵入性的診斷試劑、儀器或軟體來協助診斷、監測，以及協助醫事人員做出治療決策。許多醫療技術在使用過程或療法部署後，均需要搭配其他技術的支持或與其他產品配合使用，以達更加安全有效的目的。

    

   與醫療專業人員互動

    

   醫療公司與醫療專業人員的接觸範圍十分廣泛，也是有利的互動。雙方互動能夠：

    

   • 促進醫療技術的進步。醫療公司與醫療專業人員的合作，能夠促進尖端醫療科技的發展與改良。 醫療技術的發展與革新非常需要創新與創造力，如果只待在實驗室裡則無法達成。

    

   • 讓醫療技術的使用更安全有效。醫療技術產品較為複雜，電子、體外診斷、外科或其他醫療技術產品，時常需要公司提供醫療專業人員適當的指示、教育、訓練、服務以及技術支持。

    

   • 鼓勵研究與教育。公司支持立意良好的醫療研究、教育和專業技術增進，能夠提升病患安全，以及提高醫療技術使用率。

    

   2. 職業守則之遵循

    

   我們鼓勵所有公司採用本守則，並有效落實公司所擬定之遵循計畫。TAMTA會員公司應採用本守則之規範。

    

    

   3. 公司主辦的教育與訓練

    

   公司有義務就生產的產品和產品適用之醫療技術，提供醫療專業人員相關教育與培訓活動。「培訓」是指針對產品醫療技術之安全與有效使用的訓練。「教育」是指就與公司產品使用上直接或間接相關的醫療技術有關之資訊，例如提供疾病狀況相關資訊，或對特定患者人群有助益的醫療技術等。培訓與教育課程包括但不限於：「實作」訓練課程、大體練習、或以演講或講座等方式呈現。公司為醫療專業人員提供醫療技術的教育與培訓課程時，必須遵守以下幾點：

    

   • 舉辦課程與活動的場所，應利於資訊的有效溝通，可以是醫療機構、學術場所、研討會，或其他如飯店或租用的會議設施等場所。有時，公司代表也可以在醫療專業人員的工作場所提供教育訓練或培訓。

    

   • 提供醫療技術的「實作」訓練課程時，應在訓練設施、醫療機構、實驗室或其他合適場所舉辦。公司提供的訓練人員，應具備相關資格與專業能力。訓練人員中，也可以包含能夠提供專業技術訓練的合格銷售人員。

    

   • 公司可以為出席課程的醫療專業人員提供適當的餐飲與茶點。提供的餐飲與茶點之價位應合理，不佔用過多時間，教育培訓應為主要目的。

    

   若需至外地參加醫療技術的教育訓練，公司可在合理範圍內提供醫療專業人員交通及住宿費。但公司不應為醫療專業人員的同行人員、或與會議目的無關的人員，負擔餐飲、茶點、旅費或其他費用。

    

    

    

   4. 贊助第三方教育研究會議

    

   “第三方教育研究會議”是為立意良善的獨立、教育、科學和醫療政策制訂所舉辦的相關會議，協助提倡科學知識、醫學發展以及有效率的醫療。此會議通常包括由國家、區域或專業醫療社會團體/機構和協會、醫療信託基金、醫學繼續教育提供者以及醫院和其它醫療機構所組織（統稱為“第三方教育研究會議組織者”）。公司可藉由以下方式贊助這些會議：

    

    

   1. 提供教育經費/捐贈。公司可以向第三方教育研究會議組織者或其他適當的第三方（例如培訓機構、醫院、醫療或其他專業協會、教育基金會或其他支持醫療專業人員培訓和教育的團體）提供經費或捐贈資金，以便降低或償付會議費用（以下簡稱為“教育經費/捐贈”）。公司僅向提倡客觀的科學和教育活動與演講的第三方教育研究會議提供教育經費/捐贈的支持。第三方教育研究會議組織者應完全掌握並為課程內容、參與訓練或會議的醫療專業人員、教育方式與材料的遴選負責。教育經費/捐贈只能用以支持真正的教育活動，並用於與其相關的合法費用。

    

   1. 當第三方教育研究會議組織者或其他適當的第三方（如以上4- I節所述）要求教育經費/捐贈時，只有第三方教育研究會議組織者或教育經費/捐贈受益人（如與第三方教育研究會議組織者不同）可以選擇並邀請將獲得贊助參加第三方教育研究會議的醫療專業人員，公司不得參與或試圖影響選擇。公司提供教育經費/捐贈時，不得以此為交換條件，要求或試圖影響接受參會支持的醫療專業人員購買、訂購、推薦或推銷任何產品或醫療技術的決定，也不得以要求購買、訂購、推薦或推銷任何產品或醫療技術為條件，提供經費/捐贈。公司應確保恰當記錄對第三方教育研究會議的所有支持。第三方教育研究會議結束後，公司應考慮要求第三方教育研究會議組織者提供關於公司教育經費/捐贈使用用途的報告或說明。在提出此類請求時，公司不應要求第三方教育研究會議組織者提供受益於公司教育經費/捐贈的特定醫療專業人員的名單，除非此要求是為進行真正的合規審計、監控活動或調查。

    

   • 會議餐飲與茶點。公司可為第三方教育研究會議組織者提供資金，為與會者提供會議餐飲與茶點。餐飲和茶點的價值應適中、時間適宜，並不得做為持續性教育會議活動(Continuing Medical Education)會議時間之一部分。

    

   1. 教學人員支出。公司可贊助第三方教育研究會議組織者，在合理範圍內提供會議教學人員（在會議中被列為講師，於會議中進行有意義的演講/報告）的演講費、交通費、住宿費及餐費。但公司不可或不適當地影響會議教學人員的選擇，或指示第三方教育研究會議組織者使用教育經費/捐贈來補償特定的教學人員。

    

   1. 廣告與展示。公司可以產品展示為目的，於第三方教育研究會議購置廣告媒介或租用攤位，但仍應遵循當地相關法令規定。

    

   1. 停止直接贊助。“直接贊助”是指 (i) 公司支付特定醫療專業人員參加第三方教育研究會議的費用，(ii) 公司選擇或影響選擇特定醫療專業人士參加第三方教育研究會議，或 (iii) 公司已經事先瞭解將直接受益於公司贊助的特定醫療專業人員的身份。直接贊助通常包括公司直接向醫療專業人員、醫療專業人員所在機構或特定醫療專業人員的第三方服務供應商 (例如旅行社) 支付差旅、住宿、餐飲、其他交通、會議報名費以及其他費用。

    

    

    

   5. 銷售、宣傳或其他商務會議

    

   公司可向醫療專業人員舉辦與公司產品有關的銷售、推廣或其他有關之商務會議。會議舉辦地點應選擇鄰近於與會之醫療專業人員的場所，若有需要，可提供合理的交通費、住宿費，也可在舉辦會議時提供適當的餐飲與茶點。然而，公司不應為醫療專業人員的同行人員、或與會議目的無關的人員，負擔餐飲、茶點、交通費或住宿等任何費用。關於雙方商務互動時之餐飲細節，請見第8節。

    

    

    

   6. 與醫療專業人員之諮詢安排

    

   公司可透過如研究合約、產品研發或智慧財產權研發或轉移合約、行銷及諮詢委員會之參與、或由公司贊助的訓練會議以及其他服務等方式，請醫療專業人員提供諮詢服務。在服務係基於合理業務需求範圍內，且不構成非法誘因之前提下，公司可提供顧問人員符合公允價值的酬金，做為服務提供之報酬。在與醫療專業人員從事有關之諮詢安排時，公司應遵守下列標準：

    

   • 應以書面諮詢協議之方式記錄所有擬提供之服務。若公司請求醫療專業人員提供臨床研究服務，亦應簽具臨床實驗研究計劃之書面協議。

    

   • 唯有經事先確認合法性且記錄完善之諮詢服務得以被執行。

    

   • 選擇諮詢人員時，其資格與專業能力應符合需求。

    

   • 支付顧問人員之報酬，應符合相關服務常規交易的公平市值，不應以該顧問過去、目前或預期的業務量或業務價值作為根據。

    

   • 公司可支付顧問人員執行諮詢服務的必要支出，例如差旅、簡餐與住宿費用，相關費用必須合理、符合事實並附有文件證明。

    

   • 公司與顧問人員舉行會議的場地與狀況，應當合乎諮詢主題。此類會議應在臨床、教育、會議或其他場合中舉行，包括旅館或其他可供使用並促成資訊有效交流的商務場地。

    

   • 公司在諮詢服務有關會議中，得提供適當之餐飲與點心，唯應力求節制，應以會議為主。公司並不得搭配相關會議提供娛樂或招待。

    

   • 公司銷售人員可針對顧問人選的合適性提供意見，但不應控制相關決定或對其發揮不當影響力， 以便安排特定醫療專業人員擔任顧問。公司應當考慮實施適當程序，以便監控本節規定的遵循狀況。

    

    

   7. 招待與娛樂方面的禁令

    

   公司與醫療專業人員之互動應以病患福利及促進醫療為基礎，著重於醫學教育或醫療科學資訊交流，同時應避免造成外界的不當觀感。公司不應向任何醫療專業人員提供任何招待與娛樂活動，或是支付這類活動的費用，包含其同行人員此類之有關費用。

    

    

   8. 公司與醫療專業人員進行業務互動時的用餐

    

   公司與醫療專業人員的業務互動可能涉及科學、教育或商業資訊的解說，包括但不限於本職業守則

   第 3 節至第 6 節提及的各種互動。這類資訊交流若與用餐結合，便應具有成效與效率。因此公司可顧及商業禮儀而提供用餐，並應遵守本節所訂的限制。

    

   目的：用餐應為科學、教育或商業資訊解說活動的附帶項目，並能促成這類資訊溝通之達成。餐點不應成為招待或娛樂活動的一環。

    

   環境與地點：用餐環境應能促成真正的科學、教育或商業討論。用餐場所可以是醫療專業人員的工 作地點。然而在某些情況下，這類工作地點或許是不能或無助於討論科學、教育或商業資訊的病患 照護場所。在其他情況下，在醫療專業人員的工作地點提供餐點可能不切實際或不合適，例如 (1) 醫療科技器材無法輕易運送至醫療專業人員的工作地點，(2) 必須討論產品研發或改良方面的機密資訊，或是  (3) 無法在該處找到私下談話的空間。

    

   與會者：公司僅可為實際上有參與會議的醫療專業人員提供餐點，不得為全部門或處室單位未出席會議的醫療專業人員提供餐點，亦不得在公司代表不在場的情況下提供餐點。醫療專業人員的客人或配偶，若與會議無關，公司不得為其支付餐點費用。

    

   其他原則：本道德守則其他部分的原則可能適用，端視業務互動的類型而定。尤其是：

    

   • 第3節：公司舉行的產品教育訓練活動。
   • 第4節：贊助第三方教育研究會議。
   • 第5節：銷售、促銷與其他業務會議。
   • 第6節：與醫療專業人員之諮詢安排。

    

    

   9. 教育用品及行銷之品牌提示贈品: 不得提供現金或等值現金 (例如: 禮券) 或禮物給醫療專業人員。

    

   公司可於當地法律或當地企業倫理準則允許範圍內，提供專為病人或醫療專業人員使用之教育用品或行銷之品牌提示贈品。此教育用品或行銷之品牌提示贈品應價值適當，不得使其逾越醫療專業人員的責任。行銷之品牌提示贈品應屬價值低廉、具合理教育目的或與病人福祉相關，亦應符合「公務員廉政倫理規範」之精神。

    

    

    

   10. 研究與教育捐助以及慈善捐款

    

   公司可提供研究與教育捐助，以及慈善捐款，但不得以這類捐助與捐款作為非法誘因。因此公

   司應當：(1) 在提供這類捐助與捐款時採取客觀的標準，不應考量收受者過去或預期採購項目的數量或價值；(2) 實施適當的程序，確保這類捐助與捐款並未用作非法誘因；以及  (3) 確保這類

   捐助與捐款已被適當記錄。針對可能獲得捐助或慈善捐款的對象或計劃，公司銷售人員可就其適當性提供意見，但不應針對特定對象是否獲得捐助或捐款或是針對金額，造成決策控制或發揮不當影響力。公司應當考慮實施適當程序，以便監控本節規定的遵循狀況。

    

   研究捐助

    

   研究能提供寶貴的科學與臨床資訊、提升臨床照護的水準、造就極具潛力的新療法、提倡更先進的

   醫療保健服務，以及造福病患。為了達成這些目標，公司可提供研究捐助，支持具有科學價值的

   獨立醫學研究。這類活動應明訂目標與里程碑，不得直接或間接與醫療科技的採購有關。

    

   至於公司針對旗下醫療科技推動或管理的研究（例如臨床研究協議），第 6節已明訂相關規定。

    

   教育捐助

    

   公司可基於合法目的提供教育捐助，包括但不限於下列範例。正如第  4 節所言，公司可向會議主辦者或訓練機構提供教育捐助，但不得向醫療專業人員個別提供教育捐助。

    

   • 進修或醫學教育。公司可提供捐助，以便贊助參加慈善或學術性質進修課程的醫療專業人員。（教育捐助的其他考量事項，請見第 4 節。)

    

   • 大眾教育。針對重要的醫療保健主題，公司可提供支持病患或大眾教育的捐助。

    

   慈善捐獻

    

   公司可提供金錢或醫療技術的捐獻作為慈善之用，例如支持貧民照護、病患教育或大眾衛教，或是贊助各項運用收益行善的活動。這類捐獻應以真正的慈善目的作為動機，對象應以真正的慈善組織

   為限，或是（在極少數個案中）為了支持真正的慈善使命而參與慈善活動的人士。公司應進行實質 審查，確保慈善組織或慈善使命皆名符其實。

    

    

    

   11. 評估與展示產品

    

   免費提供產品給醫療專業人員，作為評估或展示之用，對病患有許多好處，包括提昇病患照護、促

   進產品使用的安全與效用、提高病患的認知、教導醫療專業人員如何使用產品。在下述特定情況下， 公司得免費提供合理數量的產品給醫療專業人員，作為評估與展示之用。

    

   得提供給醫療專業人員作為評估之用的產品包括：單次使用產品（例如消耗性或拋棄式產品）及多 次使用產品（有時稱之為「資本設備」）。這些產品可以免費提供，讓醫療專業人員評估產品使用 的合適性與功能性，決定是否及何時使用、訂購、購買或推薦該項產品。供評估之用的產品一般都 是期望未來可使用在病患照護的產品。

    

   消耗品／拋棄式產品：免費提供的產品數量不得超過評估所需的合理數量。

    

   資本設備／非消耗品／非拋棄式產品：不移轉所有權而提供多次使用產品供評估之用時，應於合理的評估時間之

   後，再提供新的產品，該產品的評估期間應事先以書面明訂之。公司在評估期間保有此產品的所有 權。

    

   展示品通常不應用於病患照護。展示品亦通常在產品主體、產品包裝以及／或者附帶文件中標有「樣 品」、「不適用於人體」或其他合適的字樣，註明這類產品不應用於病患照護。

    

   公司應針對免費的評估與展示用產品，向醫療專業人員提供文件與說明。

    

   本職業守則有中英文版本。如有疑義，以中文版內容為準。

Code of Ethics

Regarding “Interactions with Medical Professionals”

Adopted by the Taiwan Advanced Medical Technology Association

 

 

1. Preface:

The Taiwan Advanced Medical Technology Association (“TAMTA”) represents member companies (hereinafter referred to as “companies”) that develop, produce, manufacture, and market pharmaceutical products, technologies, related services and treatments (hereinafter referred to as “medical technologies”). These services and treatments are used to diagnose, treat, monitor, manage, and alleviate health conditions and disabilities. TAMTA commits to advancing medical technologies, as well as improving patient care, and achieving these goals through high-quality and innovative medical technologies. TAMTA also endeavors to facilitate the interaction between companies and healthcare individuals or organizations. These healthcare individuals or organizations refer to individuals and organizations that purchase, lease, recommend, use, and make arrangements for purchasing or leasing, or order the medical technologies of these companies in Taiwan to provide health care services and programs for patients.

 

To achieve this goal, TAMTA has devised this “Code of Ethics” (hereinafter referred to as “the Code”).

Effective dates:

First edition: 2015-08-31

Second edition: 2022-09-01

 

 

1.1 Purpose

The key task for healthcare professionals is to make decisions that are in the best interests of patients. Medical companies work with medical professionals to service patients. To ensure that such partnerships meet high ethical standards, the collaboration must be appropriately transparent and compliant. Companies have an obligation to meet ethical standards in their interactions with healthcare professionals to ensure that medical decisions are made in the best interests of patients. This Code of Ethics delineates the ethical principles that govern interactions between these parties.

1.2 Scope

Medical Technologies

 Unlike treatment modalities using drugs and biological products, the treatment process using medical technologies must rely on the operational skills of medical professionals, such as the use of implantable medical technology to replace or enhance the function of body parts. Other examples include non-invasive diagnostic reagents, instruments or software to assist in diagnosis, monitoring, and assisting medical staff in making treatment decisions. Many medical technologies need to be supported by other technologies or used in conjunction with other products for safety and efficiency purposes.

Interactions with Medical Professionals

Medical companies have extensive and beneficial interactions with medical professionals:

• Expediting progress in medical technologies. Partnership between medical companies and medical professionals can promote the development and advancement of cutting-edge medical technologies. Development and innovation of medical technologies require originality and creativity, which are not attainable in the laboratory.
• Increasing safety and effectiveness of medical technologies. Medical technological products are complex; electronics, in vitro diagnostics, surgical or other medical technology products often necessitate companies to provide appropriate instructions, education, training, services, and technical support for medical professionals.
• Fostering research and education. Support for well-intentioned medical research, education, and professional technology advancement can improve patient safety and increase the use of medical technology.

 

2. Compliance

We encourage all companies to adopt this Code and follow compliance plans developed by the companies. TAMTA member companies should adopt the regulations of the Code.

 

3. Company-Sponsored Education and Training

Companies have the obligation to provide education and training for medical professionals for their products and the medical technologies applicable to these products. “Training” refers to training in the safe and effective use of a product. “Education” refers to information about medical technology that is directly or indirectly involved in the use of products, such as disease data, or medical technology helpful to specific patient populations. Training and education include, but are not limited to, “hands-on” courses, dissection exercises, or presentations or lectures. Companies that provide education and training courses in medical technology for medical professionals must comply with the following:

• The venue for courses and activities should be conducive to the effective communication of information, which can be medical institutions, academic venues, seminars, or other venues such as restaurants or rented conference facilities. Occasionally, company representatives may also provide education and training at the medical professional’s workplace.
• “Hands-on” training courses in medical technologies should be held in training facilities, medical institutions, laboratories or other suitable venues. The training personnel of companies shall hold relevant qualifications and professional capabilities. Technical training personnel may also be qualified sales members.
• For attending medical professionals, companies may offer appropriate food and refreshments that are reasonably priced and do not take too much time as education and training should be the focus.

If traveling is required for medical technology education and training, companies may provide medical professionals with transportation and accommodation expenses within a reasonable range. However, companies should not cover food, refreshments, travel or other expenses for accompanying individuals, or people unrelated to the purpose of the conference.

 

4. Sponsoring Third-Party Educational Research Conferences

“Third party educational research conferences” are conferences for well-intentioned independent, educational, scientific, and healthcare policy-making that help promote scientific knowledge, medical advancement, and effective healthcare which are typically organized by national, regional or professional medical societies/institutions and associations, medical trusts, continuing medical education providers, and hospitals and other medical institutions (collectively, “third-party educational research conference organizers”). Companies can sponsor these conferences with:

I. Educational funding/donations. Companies may fund or donate to third-party educational research conference organizers or other appropriate third parties (such as training institutions, hospitals, medical or other professional associations, educational foundations, or other groups that support the training and education of medical professionals) to reduce or reimburse conference expenses (hereinafter referred to as “educational funding/donations”). The companies only support educational funding/donations to third-party educational research conferences that promote objective scientific and educational events or presentations. Organizers of third-party educational research conferences shall have full control over, and responsibility for, the content of the course, selection of attending medical professionals, and the educational methods and materials. Educational funding/donations may only be used to support genuine educational events and legitimate expenses associated with them.

II.When a third-party educational research conference organizer or other appropriate third parties (as described in Section 4-I above) request educational funding/donations, only the third-party organizer or beneficiaries of the educational funding/donations other than the organizer may select and invite medical professionals who will receive sponsorship to attend the third-party educational research conference. Companies may not take part in or attempt to influence the selection. Companies shall not provide educational funding/donations in exchange for requesting or attempting to influence the decision to purchase, order, recommend or promote any product or medical technology on medical professionals sponsored the conference. Companies may also not ask for purchases, orders, recommendations, or promotion of any products or medical technologies as a condition for funding/donations. Companies should ensure that all support for third-party educational research conferences is properly documented. Following the conclusion of a third-party educational research conference, companies should consider requesting a report or statement on the use of the companies’ educational funds/donations from the organizer. When making such requests, companies should not demand a list of specific medical professionals who benefited from the companies’ educational funding/donations, unless it is for a genuine compliance audit, inspection, or investigation.

III. Food and refreshments at the conference. Companies may fund organizers of third-party educational research conferences to provide reasonably priced food and refreshments to attendees. Food and refreshments should take a moderate amount of time, and not be part of the scheduled Continuing Medical Education conference.

IV. Teaching staff expenses. Companies may sponsor third-party educational and research conference organizers for lecture fees, transportation, accommodation, and food of the conference teaching staff (listed as lecturers in the conference and giving meaningful speeches/presentations in the conference) within a reasonable range. However, the companies may not inappropriately influence the selection of conference teaching staff, or direct third-party educational research conference organizers to use educational funding/donations to compensate specific teaching staff.

V. Advertisement and display. Companies can purchase advertising media or rent booths at third-party education and research conferences for the purpose of product display in a compliant manner with local laws and regulations.

VI. Cessation of Direct Sponsorship. “Direct sponsorship” means (i) companies’ payment to specific medical professionals to attend a third-party educational research conference, (ii) companies’ selection or influence in the selection of specific medical professionals to participate in third-party educational research conferences, or (iii) companies have prior knowledge of the identities of the specific medical professionals who will directly benefit from such sponsorship. Direct sponsorship typically involves the companies’ direct payment of travel, lodging, food, other transportation, conference registration fees, and other expenses to a medical professional, the medical professional’s institution, or a third-party service provider for the specific medical professional (such as a travel agency).

 

5. Marketing, Promotion, or Other Business Meetings

Companies may hold marketing, promotion, or other business meetings with medical professionals relevant to the companies’ products. Venues for such meetings should be close to the participating medical professionals. If necessary, reasonable transportation and accommodation fees can be reimbursed, and appropriate food and refreshments can be provided at the meeting. However, the companies should not cover any expenses such as food, refreshments, transportation, or lodging for accompanying individuals, or persons unrelated to the purpose of the meeting. Please see Section 8 for details on food during business interactions.

 

6. Consultations with Medical Professionals

Companies may consult medical professionals through, for example, research contracts, product development or intellectual property development or contract transfer, participation in marketing and advisory committees, or company-sponsored training sessions and other services. On the premise that the service is based on reasonable business needs and does not constitute an illegal inducement, companies may remunerate consultants a fair amount for the service. Consultations with medical professionals should abide by the following standards:

• All proposed services should be documented in a written consultation agreement. If the companies request medical professionals to provide clinical research services, they should also sign a written agreement on a clinical trial research plan.
• Only consultative services that have been legally confirmed in advance and well-documented can be performed.
• Selection of consultants should be based on qualifications and professional abilities.
• Remuneration for consultants should be in accordance with the fair market value of the regular transactions for relevant services and should not be based on the consultant’s past, current or expected business volume or value.
• Companies may pay the consultants necessary expenses for the performance of consulting services, such as travel, light meals, and lodging expenses, which must be reasonable, factual, and documented.
• The venue and setting of the meeting between the companies and consultants should be in line with the subject of the consultation. Such meetings should be held in clinical, educational, conference or other settings, including hotels or other business venues that are available and facilitate the effective exchange of information.
• Companies may provide appropriate food and refreshments in meetings related to consulting services. Companies may not provide entertainment in conjunction with these meetings.
• Companies’ sales personnel may advise on the suitability of consultant candidates but should not control decisions or exercise undue influence over them in order to place specific medical professionals as consultants. Companies should consider appropriate procedures to monitor compliance with the provisions of this section.

 

7. Prohibition on Entertainment

Interactions between companies and medical professionals should be based on patient welfare and healthcare promotion, focusing on medical education or dialogue in medical science to avoid inappropriate outside perceptions. The companies shall not provide or pay for any entertainment to any medical professionals, including accompanying personnel.

 

8. Meals During Business Interactions between Companies and Medical Professionals

Business interactions between companies and medical professionals may involve the interpretation of scientific, educational, or business information, including but not limited to those mentioned in Sections 3 to 6 of the Code. This type of information exchange, when combined with meals, can be effective and efficient. Companies may therefore provide meals with due regard to business etiquette and shall comply with the restrictions set forth in this section.

Purpose: Meals should be incidental to scientific, educational, or business information presentation activities and should facilitate such communication. Meals should not be part of hospitality or entertainment.

 Setting and Location: The dining setting should foster a genuine scientific, educational, or business discussion. The venue can be the workplace of a medical professional. In some cases, however, such workplaces may be patient care settings that are not conducive or unhelpful for discussing scientific, educational, or business information. In other situations, it may be impractical or inappropriate to provide meals at the medical professional’s workplace; for example, when (1) medical technology equipment cannot be easily transported to the medical professional’s workplace, (2) confidential information regarding product development or improvement must be discussed, or (3) no space for private conversation is available.

Attendees: Companies can only provide meals to medical professionals who are actually participating in the meeting, and cannot provide meals to medical professionals who are not present at the meeting from the entire department or division, nor in the absence of company representatives. Companies may not pay for meals for guests or spouses of medical professionals irrelevant to the meeting.

Other Principles: The principles of other parts of the Code may apply, depending on the type of business interaction, especially

• Section 3: Product Education and Training Held by Companies
• Section 4: Sponsorship of Third-Party Educational Research Conferences
• Section 5: Sales, Promotions and Other Business Meetings
• Section 6: Consultations with Medical Professionals

 

9. Educational supplies, marketing giveaways and other branded items: No cash, cash equivalent (e.g. gift cards), or gifts to medical professionals is permitted.

Companies may, to the extent permitted by local laws or local corporate ethics guidelines, provide educational supplies or branded items for patients or medical professionals. The supplies or items should be of appropriate value and should not exceed the responsibility of the medical professional. Branded gifts should be of low value, have a reasonable educational purpose or be related to the well-being of patients, and should also comply with the spirit of the “Code of Ethics and Integrity for Civil Servants”.

 

10. Research and Education Contributions and Charitable Donations

Companies may make research and educational donations, as well as charitable donations, but must not use such donations and contributions as an unlawful inducement. Accordingly, companies should: (1) use objective criteria in making such contributions and donations without regard to recipients’ past or anticipated purchases in terms of volume or value; (2) implement appropriate procedures to ensure that such contributions and donations are not used as unlawful inducements; (3) ensure that such contributions and donations are properly recorded. Companies’ sales personnel may advise on the appropriateness of potential recipients of the donations or charitable contributions, but should not exercise control over decisions or exercise undue influence over whether or not a particular person receives donations or contributions and the amount. Companies should consider appropriate procedures to monitor compliance with the provisions of this section.

Research Donations

Research can provide valuable scientific and clinical information, improve the standard of clinical care, lead to promising new treatments, promote more healthcare advancements, and benefit patients. To achieve these goals, companies can make research donations to support independent medical research of scientific merit. Such activities should have clear goals and milestones and should not be directly or indirectly related to the procurement of medical technology.

Section 6 sets out the relevant requirements for research (such as clinical research agreements) that the companies promote or manage with respect to their medical technologies.

Educational Donations

Companies may make educational contributions for legitimate purposes, including but not limited to the examples below. As stated in Section 4, companies may make educational contributions to conference sponsors or training institutions, but may not make individual educational contributions to medical professionals.

• Continuing or medical education. Contributions may be made by companies to sponsor medical professionals attending charitable or academic education programs. (For other considerations for educational donations, see Section 4.)
• Public education. On important healthcare topics, companies can make donations to support patient or public education.

Charitable Donations

Companies may donate money or medical technologies for charitable purposes, such as supporting low-income healthcare, patient education or public health education, or various activities whose proceeds go toward charitable ends. Such donations should be motivated by a genuinely charitable purpose and should be limited to genuinely charitable organizations or (in rare cases) persons engaged in charitable activities in support of a genuinely charitable mission. Companies should conduct a substantive review to ensure that the charitable organization or charitable mission is true to its name.

 

11. Products for Evaluation and Demonstration Purposes

Providing products free of charge to medical professionals for evaluation or demonstration purposes has many benefits to patients, including improving patient care, promoting the safety and efficacy of product use, increasing patient awareness, and teaching medical professionals how to use the product. In the specified circumstances described below, companies may provide a reasonable number of products to medical professionals for free for evaluation and demonstration purposes.

Products that may be provided to medical professionals for evaluation include: single-use products (such as consumable or disposable products) and multiple-use products (sometimes referred to as “capital equipment”). These products may be available free of charge to allow medical professionals to assess the suitability and functionality of the product and to decide whether and when to use, order, purchase or recommend the product. Products for evaluation are generally expected to be used in patient care in the future.

Consumable/Disposable Products: The number of products offered for free shall not exceed a reasonable amount required for evaluation.

Capital Equipment/Non-Consumable/Non-Disposable Products: When multiple-use products are provided for evaluation without transferring ownership, new products shall be provided after a reasonable evaluation period, and the evaluation period of the product shall be specified in writing in advance. Companies retain ownership of the products during the evaluation period.

 

Sample products are generally not intended for patient care and are usually marked “Sample”, “Not for use in humans” or other appropriate words on the body of the product, product packaging and/or accompanying documents, indicating that such products are not intended for patient care.

Companies should provide documentation and instructions to medical professionals for free evaluation and demonstration products.

• This Code of Ethics is available in Chinese and English. In the event of discrepancy, the Chinese version always takes precedence.

台灣先進醫療科技發展協會

職業守則

常見問題

生效日期:
第一版: 2017/3/31
第二版: 2019/6/12
第三版 :2022/9/1

 

本章節係參考其他國家之實施規範、本地現行市場常規所訂定。本章節內容應由 TAMTA E&C 工作
小組定期（每半年）審議及修正，交由理監事會討論決議後執行。

1. 本職業守則適用公司範圍為何？
A1: 本職業守則經 TAMTA 全體會員公司同意採用。各會員公司負有自我管理其經銷商、代理商之
責。

2. TAMTA 職業守則規定公司不應向任何醫療專業人員提供任何招待與娛樂活動，或是支付這類活動的費用。這項規定是否有例外？
A2: 沒有例外。會員公司企劃會議時，可提供附帶的餐飲，但其重要性不得超過會議主旨。會員公司也不得贊助參加音樂會、提供娛樂票券、或支付任何形式的娛樂活動。若會議場地中有背景音樂或
當地演出，只要不是由會員公司支付且不影響會議進行，則可被允許。

3. 可否提供婚喪喜慶及習俗性禮金或禮品？
A3: TAMTA 職業守則已明確規範不得提供現金或等值現金 (例如: 禮券) 或禮物給醫療專業人員 (依
本地法律所規定者，眼鏡行目前不在規定範圍內) 。故不可提供禮金、禮品，包括（但不限於）婚禮時致贈禮金、開業時致贈禮品花籃、習俗性傳統節慶時贈送禮品給醫護人員、喪禮時致贈鮮花輓聯等。

4. “第三方教育訓練會議” 附屬之廠商主辦衛星會 (satellite symposia) 邀請講者之交通、住宿費如何管理？
A4:
•如果醫療專業人員在衛星研討會上擔任教員：會員公司可依實際情況並視公司內部規定自行判斷。
•如果醫療專業人員是衛星研討會的與會人員：TAMTA 職業守則第4節 VI. 停止直接贊助章節已明確相關規範。

5. 會員公司可否為公司舉辦的線上商務會議提供餐飲與茶點？
A5 可以。TAMTA 職業守則第3、5、8節規範說明，會員公司可依實際情況並視公司內部規定於公司舉辦的商務會議提供適當的餐飲與茶點，其中包含線上或實體會議。會員公司可視情況設置相關控制，例如僅可為實際上有參與會議的醫療專業人員提供餐點、不得為全部門或處室單位未出席會議的醫療專業人員提供餐點、不得在公司代表不在場的情況下提供餐點，並建議避免居家送餐或多方考量其合適性。

 

• 本職業守則常見問題有中英文版本。如有疑義，以中文版內容為準。

 

TAIWAN ADVANCED MEDICAL TECHNOLOGY ASSOCIATION 

CODE OF ETHICS

Frequently Asked Questions

 

This chapter has referenced international regulations and current industry practices in Taiwan. The contents of this chapter shall be regularly reviewed and revised by the TAMTA E&C working group, and revisions shall be approved in Board meetings.

 

1.  In what companies is the Code of Ethics applicable?
   Answer: The Code of Ethics has been adopted by all TAMTA member companies. Each member company is responsible for the regulation of its distributors and agents.
2. The TAMTA Code of Ethics prohibits companies from providing or paying for any hospitality and entertainment activities for any medical professionals. Are there any exceptions?
   Answer: There are no exceptions. Conferences and meetings may include food and beverages, but their importance must not exceed the topic of the meeting. Member companies may also not sponsor concerts, provide entertainment tickets, or pay for entertainment of any kind. Background music or local performances in the meeting venue are permitted as long as they are not paid for by member companies and do not interfere with the meeting.
3. Are gifts or money allowed for weddings, funerals, or traditional occasions?
   Answer: The TAMTA Code of Ethics explicitly prohibits giving cash, cash equivalents (e.g., gift cards), or gifts to medical professionals. It includes (but is not limited to) wedding cash gifts, gift baskets at clinic openings, gifts to medical professionals at customary and traditional festivals, and flower or elegiac couplets at funerals.
4. How to manage transportation and accommodation expenses of the invited speakers for satellite symposia hosted by affiliated companies at “third party training conferences”?
   Answer:
   •If a medical professional is an instructor at the satellite symposium: Member companies can make their own judgments based on actual circumstances and internal company regulations.
   •If a medical professional is a participant at the satellite symposium: See TAMTA Code of Ethics for Section 4 VI. Cessation of Direct Sponsorship for the specific provisions.
5. Are meals or refreshments allowed at online business meetings organized by member companies?
   Answer: Yes. TAMTA Code of Ethics Sections 3, 5, and 8 specify that a member company can provide appropriate meals and refreshments at business meetings held by the company, online or physical, according to the actual situation and internal regulations. Member companies may set relevant controls as appropriate, e.g., serving food to medical professionals who are actually present at the meeting, not offering meals to medical professionals who are not present at the meeting from the entire department or division, nor in the absence of company representatives. It is recommended to avoid home delivery or to examine its appropriateness before doing so.

 

• In case of any discrepancy between the English version and the Chinese version, the latter shall prevail.