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。

    

   單次使用／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。

    

   多次使用／資本設備：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
ON INTERACTIONS WITH HEALTH CARE PROFESSIONALS

ADOPTED BY THE TAIWAN ADVANCED MEDICAL TECHNOLOGY ASSOCIATION

 

1. Preamble:

The Taiwan Advanced Medical Technology Association (“TAMTA”) represents its member companies (collectively “Companies” and  individually “Company”) that develop, produce, manufacture and market medical products, technologies and related services and therapies used to diagnose, treat, monitor, manage and alleviate health conditions and disabilities ( “Medical Technologies”). TAMTA is dedicated to the advancement of medical science, the improvement of patient care, and, in particular, the contributions that high quality, innovative Medical Technologies make toward achieving these goals. TAMTA recognizes the obligation to facilitate ethical interactions between Companies and those individuals or entities involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Companies’ Medical Technologies in Taiwan (“Health Care Professionals”).

To achieve the above goal, TAMTA has established the Code of Ethics (“the Code”), effective August 31, 2015.

 

1.1 The Purpose of the Code of Ethics

Health Care Professionals’ first duty is to act in the best interests of patients. Companies can serve the interests of patients through beneficial collaborations with Health Care Professionals. To ensure that these collaborative relationships meet high ethical standards, they must be conducted with appropriate transparency and in compliance with applicable laws, regulations and government guidance. The obligation to facilitate ethical interactions between Companies and Health Care Professionals in order to ensure that medical decisions are based on the best interests of the patient. The ethical principles that govern these interactions are the subject of the Code.

 

1.2 The Scope of the Code of Ethics

Medical Technologies

Unlike treatment approaches using drugs and biologics, Medical Technologies are highly dependent upon “hands on” Health Care Professionals from beginning to end. For example, implantable Medical Technologies are often placed in the human body to replace or strengthen a body part. In other circumstances, Medical Technologies are noninvasive reagents, instrumentation and/or software to aid in the diagnosis, monitoring and treatment decisions made by Health Care Professionals. Many Medical Technologies work synergistically with other technologies, or are paired with other products that deploy devices in the safest and most effective manner. Many Medical Technologies require technical support during and after deployment.

 

Interactions with Health Care Professionals

The scope of beneficial interactions between Health Care Professionals and Companies is broad and includes interactions intended to:

• Promote the Advancement of Medical Technologies. Developing and improving cutting edge Medical Technologies are collaborative processes between Companies and Health Care Professionals. Innovation and creativity are essential to the development and evolution of Medical Technologies, which often occur outside a Company’s laboratory.

• Enhance the Safe and Effective Use of Medical Technologies. The safe and effective use of sophisticated electronic, in vitro diagnostic, surgical or other Medical Technologies often requires Companies to provide Health Care Professionals appropriate instruction, education, training, service and technical support.

• Encourage Research and Education. Companies’ support of bona fide medical research, education and enhancement of professional skills improves patient safety and increases access to Medical Technologies.

 

2. Code of Ethics Compliance

All Companies are strongly encouraged to adopt this Code and to implement an effective compliance program. All TAMTA member companies should adopt the Code.

 

3. Company-Conducted Product Training and Education

Companies have a responsibility to make training and education on their products and Medical Technologies available to Health Care Professionals. “Training” means training on the safe and effective use of Medical Technologies. “Education” means communicating information directly concerning or associated with the use of Companies’ Medical Technologies, e.g. information about disease states and the benefits of Medical Technologies to certain patient populations. Training and Education programs include, but are not limited to, “hands on” training sessions, cadaver workshops, lectures and presentations, and grand rounds. Companies should adhere to the following principles when conducting training and education programs concerning Medical Technologies for Health Care Professionals:

• Programs and events should be conducted in settings that are conducive to the effective transmission of information. These may include clinical, educational, conference, or other settings, such as hotels or other commercially available meeting facilities. In some cases, it may be appropriate for a Company representative to provide training and education at the Health Care Professional’s location.

• Programs providing “hands on” training on Medical Technologies should be held at training facilities, medical institutions, laboratories or other appropriate facilities. The training staff used by the Company should have the proper qualifications and expertise to conduct such training. Training staff may include qualified field sales employees who have the technical expertise necessary to perform the training.

• Companies may provide Health Care Professional attendees with modest meals and refreshments in connection with these programs. Any such meals and refreshments should be modest in value and subordinate in time and focus to the training and/or educational purpose of the meeting.

• Where there are objective reasons to support the need for out-of-town travel to efficiently deliver Training and Education on Medical Technologies, Companies may pay for reasonable travel and modest lodging costs of the attending Health Care Professionals. It is not appropriate for Companies to pay for the meals, refreshments, travel or other expenses for guests of Health Care Professionals or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.

 

4. Supporting Third-party Educational Conferences

Bona fide independent, educational, scientific and policymaking conferences promote scientific knowledge, medical advancement and the delivery of effective health care. Companies may support these conferences in various ways:

• Sponsorship of Health Care Professionals. Companies may provide limited financial support to individual Healthcare Professionals to attend bona fide third-party educational conferences in the form of conference registration fees or reasonable travel and accommodation costs.  Financial support may not be provided to the Health Care Professional, but may only be provided directly to the relevant conference organizer or vendor, such as a hotel, airline, or travel agency.  Any financial support must be appropriately documented and preserve the independence of medical education.   Financial support must not inappropriately benefit, or be used as a means to inappropriately induce, a Health Care Professional.

• Conference Grants. Companies may provide a grant to the conference sponsor. They may also provide grants to a training institution or the conference sponsor to allow attendance by Health Care Professionals. Companies may provide grants when: (1) the gathering is primarily dedicated to promoting objective scientific and educational activities and discourse; and (2) the training institution or the conference sponsor selects the attending Health Care Professionals who are in training. Such grants should be used to reimburse only the legitimate expenses for bona fide educational activities. The conference sponsor should completely control and be responsible for the selection of program content, faculty, educational methods and materials.

• Conference Meals and Refreshments. Companies may provide funding to the conference sponsor to support the provision of meals and refreshments to conference attendees. Any meals and refreshments should be modest in value, subordinate in time and clearly separate from the continuing medical education portion of the conference.

• Faculty Expenses. Companies may make grants to conference sponsors for reasonable honoraria, travel, lodging and modest meals for conference faculty members.

• Advertisements and Demonstration. Companies may purchase advertisements and lease booth space for Company displays at conferences, but they must still abide by the relevant local laws and regulations.

 

5. Sales, Promotional and Other Business Meetings

Companies may conduct sales, promotional and other business meetings with Health Care Professionals. Often, these meetings occur close to the Health Care Professional’s place of business. It is appropriate to pay for reasonable travel costs of attendees when necessary and/or to provide occasional modest meals and refreshments in connection with such meetings. However, companies may not pay for meals, refreshments, travel or lodging of guests or individuals accompanying Health Care Professionals or any other person who does not have a bona fide professional interest in the information being shared at the meeting. See Section 8 for detail principles related to the provision of meals associated with Health Care Professional business interactions.

 

6. Consulting Arrangements with Health Care Professionals

Companies may engage Health Care Professionals to provide a wide-range of valuable, bona fide consulting services through various types of arrangements, such as contracts for research, product development, development and/or transfer of intellectual property, marketing, participation on advisory boards, presentations at Company-sponsored training and other services. Companies may pay consultants fair market value compensation for performing these types of services, provided that they are intended to fulfill a legitimate business need and do not constitute an unlawful inducement. Companies should comply with the following standards in connection with consulting arrangements with Health Care Professionals:

• Consulting agreements should be written and describe all services to be provided. When a Company contracts with a consultant to conduct clinical research services, there should also be a written research protocol.

• Consulting arrangements should be entered into only where a legitimate need for the services is identified in advance and documented.

• Selection of a consultant should be made on the basis of the consultant’s qualifications and expertise to meet the defined need.

• Compensation paid to a consultant should be consistent with fair market value in an arm’s length transaction for the services provided and should not be based on the volume or value of the consultant’s past, present or anticipated business.

• A Company may pay for documented, reasonable and actual expenses incurred by a consultant that are necessary to carry out the consulting arrangement, such as costs for travel, modest meals and lodging.

• The venue and circumstances for Company meetings with consultants should be appropriate to the subject matter of the consultation. These meetings should be conducted in clinical, educational, conference or other settings, including hotel or other commercially available meeting facilities, conducive to the effective exchange of information.

• Company-sponsored meals and refreshments provided in conjunction with a consultant meeting should be modest in value and should be subordinate in time and focus to the primary purpose of the meeting. Companies should not provide recreation or entertainment in conjunction with these meetings.

• A Company’s sales personnel may provide input about the suitability of a proposed consultant, but sales personnel should not control or unduly influence the decision to engage a particular Health Care Professional as a consultant. Companies should consider implementing appropriate procedures to monitor compliance with this section.

 

7. Prohibition on Entertainment and Recreation

Company interactions with Health Care Professionals should be professional in nature and should facilitate the exchange of medical or scientific information that will benefit patient care, and avoid the appearance of impropriety. A Company should not provide or pay for any entertainment or recreation event or activity for any Health Care Professional, including any companion of the Health Care Professional.

 

8. Modest Meals Associated with Health Care Professional Business Interactions

A Company’s business interactions with Health Care Professionals may involve the presentation of scientific, educational or business information and include, but are not limited to, the different types of interactions described in Sections 3 through 6 of the Code. Such exchanges may be productive and efficient when conducted in conjunction with meals. Accordingly, modest meals may be provided as an occasional business courtesy consistent with the limitations in this section.

Purpose: The meal should be incidental to the bona fide presentation of scientific, educational or business information and provided in a manner conducive to the presentation of such information. The meal should not be part of an entertainment or recreational event.

Setting and Location: Meals should be in a setting that is conducive to bona fide scientific, educational or business discussions. Meals may occur at the Health Care Professional’s place of business. However, in some cases the place of business may be a patient care setting that is not available for, or conducive to, such scientific, educational or business discussions. In other cases, it may be impractical or inappropriate to provide meals at the Health Care Professional’s place of business, for example, (1) where the Medical Technology cannot easily be transported to the Health Care Professional’s location, (2) when it is necessary to discuss confidential product development or improvement information, or (3) where a private space cannot be obtained on-site.

Participants: A Company may provide a meal only to Health Care Professionals who actually attend the meeting. A Company may not provide a meal for an entire office staff where everyone does not attend the meeting. A Company also may not provide a meal where its representative is not present. A Company may not pay for meals for guests or spouse of Health Care Professionals, or any other person who does not have a bona fide professional interest in the information being shared at the meeting.

Other principles: Depending on the type of business interaction or meeting, additional principles may apply, as described in other sections of this Code of Ethics. Specifically:

• Section 3: Company-conducted Product Training and Education.
• Section 4: Supporting Third-party Educational Conferences.
• Section 5: Sales, Promotional and Other Business Meetings.
• Section 6: Consulting Arrangements with Health Care Professionals.

 

9. Educational Items and Branded Promotional Gifts: A Company may not give Health Care Professionals cash or cash equivalents (e.g. gift vouchers), or gifts.

Within limits permissible by local laws or local business ethics, a Company may provide educational items or branded promotional gifts that are capable of use by patients or Health Care Professionals. Such educational items or branded promotional gifts should be of appropriate value and not beyond the responsibility of Health Care Professionals.

 

10. Research and Educational Grants and Charitable Donations

A Company may provide research and educational grants and charitable donations. However, a Company may not provide such grants or donations as an unlawful inducement. Therefore, a Company should: (1) adopt objective criteria for providing such grants and donations that do not take into account the volume or value of purchases made by, or anticipated from, the recipient; (2) implement appropriate procedures to ensure that such grants and donations are not used as an unlawful inducement; and (3) ensure that all such grants and donations are appropriately documented.  A Company’s sales personnel may provide input about the suitability of a proposed grant or charitable donation recipient or program, but sales personnel should not control or unduly influence the decision of whether a particular Health Care Professional or institution will receive a grant or donation or the amount of such grant or donation. Companies should consider implementing procedures to monitor compliance with this section.

Research Grants

Research provides valuable scientific and clinical information, improves clinical care, leads to promising new treatments, promotes improved delivery of health care, and otherwise benefits patients. In furtherance of these objectives, a Company may provide research grants to support independent medical research with scientific merit. Such activities should have well-defined objectives and milestones and may not be linked directly or indirectly to the purchase of Medical Technologies.

Company-initiated or directed research involving a Company’s Medical Technologies (such as clinical study agreements) is addressed separately in Section 6.

 

Educational Grants

Educational grants may be provided for legitimate purposes, including, but not limited to, the examples below. As noted in section 4, a Company may make educational grants to conference sponsors or training institutions. A Company may not make educational grants to individual Health Care Professionals.

• Advancement of Medical Education. A Company may make grants to support the genuine medical education of Health Care Professionals participating in fellowship programs that are charitable or have an academic affiliation. (For additional considerations regarding educational grants, see Section 4.).

• Public education. A Company may make grants for the purpose of supporting education of patients or the public about important health care topics.

 

Charitable Donations

A Company may make monetary or Medical Technology donations for charitable purposes, such as supporting indigent care, patient education, public education or the sponsorship of events where the proceeds are intended for charitable purposes. Donations should be motivated by bona fide charitable purposes and should be made only to bona fide charitable organizations or, in rare instances, to individuals engaged in genuine charitable activities for the support of a bona fide charitable mission. Companies should exercise diligence to ensure the bona fide nature of the charitable organization or charitable mission.

 

11. Evaluation and Demonstration Products

Providing products to Health Care Professionals at no charge for evaluation or demonstration purposes can benefit patients in many ways. These benefits include improving patient care, facilitating the safe and effective use of products, improving patient awareness and educating Health Care professional regarding the use of products. Under certain circumstances described below, a Company may provide reasonable quantities of products to Health Care Professionals at no charge for evaluation and demonstration purposes.

Company products that may be provided to Health Care Professionals for evaluation include single use (e.g. consumable or disposable products) and multiple use products (sometimes referred to as “capital equipment”). These products may be provided at no charge to allow Health Care Professionals to assess the appropriate use and functionality of the product and determine whether and when to use, order, purchase or recommend the product in the future. Company products provided for evaluation are typically expected to be used in patient care.

 

Single Use/ Consumables/ Disposables: The number of single use products provided at no charge should not exceed the amount reasonably necessary for the adequate evaluation of the products under the circumstances.

Multiple Use/ Capital: Multiple use products provided without transfer of title for evaluation purposes should be furnished only for a period of time that is reasonable under the circumstances to allow an adequate evaluation. The terms of an evaluation of such multiple use products should be set in advance in writing. Companies should retain title to such multiple use products during the evaluation period.

Demonstration products typically are not intended to be used in patient care. Demonstration products also are typically identified as not intended for patient use by use of such designations as “Sample”, “Not for Human Use” or other suitable designation on the product, the product packaging and/or documentation that accompanies the product.

A Company should provide Health Care Professionals with documentation and disclosure regarding the no-charge status of evaluation and demonstration products.

 

 

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

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: 2019/6/1

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: 會員公司可依實際情況並視公司內部規定自行判斷。

• 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 (TAMTA)

CODE OF ETHICS

Questions & Answers

 

The Q&A of TAMTA Code of Ethics is set referring to the Code of Practice of other countries and the current local market common rules. This section should be periodically reviewed and revised by the Educational & Compliance (E&C) working group of TAMTA once half a year. The revision will be adopted after being discussed and resolved by the Board of Directors and Supervisors.

 

1. Who should adopt the TAMTA Code of Ethics?

Answer: The Code of Ethics is adopted by all member companies of TAMTA. It applies to all TAMTA member companies and the companies need to monitor their agents/ distributors.

 

2. The TAMTA Code of Ethics prohibits companies from providing entertainment and leisure activities to healthcare professionals or pay for the activities. Are there exceptions to this rule?

Answer: No. When a member company organizes a meeting, refreshments and/or meals incidental to the main purpose of the event can be provided. It would not be appropriate for a company to fund attendance at a concert, purchase of entertainment tickets or pay for entertainment in any form. However, if there is background music or a local performance at the venue where the event is taking place, which is not paid for by a member company and not interfering the main purpose of the meeting or event, this may be permitted.

 

3. Could we offer cash/ cash equivalent or gifts to weddings, funerals and cultural courtesy gifts?

Answer: The payments in cash or cash equivalent (such as gift certificate) must not be offered to healthcare professionals regulated by the TAMTA Code of Ethics. Cash or Gifts must not be provided or offered including but not limited to, grand opening flower basket stand, gifts offered to healthcare professionals on traditional festivals or flowers and funeral scrolls for funeral.

 

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