藥業行銷遵循IRPMA法令之審計個案研究

本論文為跨領域的議題：對醫學領域而言是個倫理問題，係為避免健康照護專業人員與藥廠醫藥代表走得太近，以防止健康照護專業人員用藥不客觀；對審計領域而言是個審計運用的命題，用以健全與彌補醫學倫理上的不足。蓋倫理是一種自律卻沒有法條強制性的規定，透過健全審計制度即可杜絕健康照護專業人員與藥廠醫藥代表不當勾結所造成的弊病，此正是審計制度能為民眾用藥權益與用藥安全健康的具體功能。本論文著重於如何運用審計制度以健全健康照護專業人員與藥廠醫藥代表應遵循的規定，促使健康照護專業人員與藥廠醫藥代表的互動關係回到增進病患福祉與提升病患照護品質為目標，而不僅僅依賴倫理方式的道德勸說。基此，本論文透過質化研究方法的個案研究法，以某藥廠公司實際運作為例，歸納出如何透過審計制度的運作，對藥廠執行行銷活動時予以適當的管理（包括活動規劃時的核准程序、活動前必要文件取得的管理、活動後文件的追蹤等），研究結果發現，透過審計制度的運作，藥廠在上述行銷活動的作業流程效率提高；同時因為行銷活動所產生的問題亦下降，且審計制度更能讓倫理無法具體完成的模糊地帶，透過遵守IRPMA規定的作為，促使公司內部規範更為健全。因此，本論文建議，未來應規範製藥業遵守審計制度替代較為模糊的倫理作為，以達到藥廠、政府與民眾多贏的狀態。

關鍵字

製藥業；審計研究；藥業行銷；法令遵循審計；個案研究法

並列摘要

This thesis is an interdisciplinary topic. As far as medical field is concerned, it’s an ethical question about how to prevent the collusion between healthcare provider and pharmaceutical medical representatives which may result in less objective judgement of medication. As far as audit field is concerned, this is about how to use audit to strengthen and improve the defects of ethic. Ethic is a self-regulation and no mandatory requirement. Through audit process, the collusion between healthcare provider and pharmaceutical medical representatives can be discovered. That is a specific function that audit can contribute in the public’s right in drug usage and safe medication. This study focused on how audit system can enhance the compliance of regulation, further support high-quality patient care, and eventually benefit the public. Based on the mentioned above, the method of our research is by means of case study of qualitative research. We take a pharmaceutical company as a case study target to illustrate that audit system can help manage the process of marketing activities in pharmaceutical industry, including the pre-approval process of marketing activities, the required documents before the activities, and the follow-up documents after the activities. The study has shown that the audit system does enhance the operation efficiency and at the same time lower the incident ratio. It also has shown that audit system can clearly regulate/define the grey area which ethic cannot. By following the regulation of IRPMA, internal control in a company can become strong and robust. This paper suggests that pharmaceutical industry should enforce audit system to replace the ethic as code of conduct, which leads to a three-way win for the pharmaceutical industry, the government, and the public.

並列關鍵字

Pharmaceutical industry ； Audit research ； Marketing activities of pharmaceutical industry ； Compliance audits ； Case study method

參考文獻

一、中文部分(Chinese Section)

Google Scholar

中華民國開發性製藥研究協會市場行銷規範(2018年版)International Research-based Pharmaceutical Manufacturers Association(IRPMA) Code of Practice，2018年5月25日，取具http://www.irpma.org.tw/zh_TW/marketing2