醫藥生技產業利益衝突之揭露管制模式-美國醫師陽光法制研究

Abstract

一直以來，醫師與廠商間的利益糾葛就備受爭議，二十世紀末，更發生了許多重大事件，例如：2004年，美國的阿斯特捷利康（AstraZeneca）事件，有病患參加臨床試驗因為忍受不住痛苦而自殺，嗣後發現醫師與藥廠訂立的招募受試者的契約有多處爭議，醫師亦有收受藥廠所給的演講、諮詢、研究等補助的狀況，引起社會大眾的質疑；而在2007年有四家整形醫療廠商巧立名目給予醫師回扣，影響醫師開立醫療產品處方。民眾對於醫師與醫藥生技產業間緊密的財務往來產生擔憂，政府則被迫做出回應。 首先出現的是1972年的反回扣法，以刑法規範醫師與廠商間不當財務關係，處理那些有對價關係，利益衝突明顯並且可責性高的行為。但因為適用範圍過於限縮，因此問題並未得到妥善的解決。接著在1980年代，出現醫藥生技產業界以及醫師社群的自律規範，專業社群希望透過制定同業間必須遵循的指引，來規範社群內大多數的團體與人，達到自我規範的效果。 1990年代以後，美國五州相繼訂立揭露法制，要求醫藥生技廠商每年須定時向州主管單位，揭露前一個年度給予醫師的報酬款項資訊。但州揭露法對於公開資料的資訊可利用性要求不足，並且廠商可主張營業秘密法而不揭露特定報酬，使得大眾無法獲得完整資訊，無法達成陽光揭露法制立法目的。另外，從2008年開始，許多醫藥生技大廠因為違反聯邦法與司法部達成和解並且簽訂企業誠信協定，內容要求廠商必須向大眾揭露與醫師間的財務關係，可稱為廠商的半自願性揭露。然而，廠商在官方網站上的半自願性揭露的揭露報告受到許多質疑，有學者指出，藥廠所為市場行銷總額，與揭露之總額不成比例。 以州揭露法、廠商的半自願性揭露以及國家醫學研究院建議為參考，美國於2010年訂定醫師報酬陽光法。美國的醫師報酬陽光法規定，受規範廠商必須揭露給予醫師、教學醫院的報酬，並且受規範廠商和團體購買組織必須揭露醫師對其投資或所有權價值。主管機關，醫療保險與補助服務中心，依法每年將醫師報酬揭露於醫師報酬資訊公開網站上。希望藉由生技醫療廠商與醫師間財務關係透明化，能增進醫療品質、降低照護成本，並且讓揭露資訊成為病患對於自己的醫療照護決定的參考依據。然而，並非只有美國有類似的問題，世界各國幾乎同時面臨了同樣的問題。繼美國之後，日本、法國、澳洲皆有類似的揭露立法規範出現。 本研究的主軸為美國醫師報酬陽光法立法，從基本的，醫師與醫藥生技產業無可避免的財務關係以及利益衝突問題開始討論，延伸到以美國為主處理醫師與醫藥生技產業關係問題的法規範模式介紹，包括了非揭露模式規範以及揭露模式規範，得以一窺立法規範的進程。本研究在比較了各個揭露法規範模式後，以台灣的現況為反思，給予台灣立法建議。

The financial relationship between physicians and industries has been debated for decades. There were many critical events related to physicians and pharmaceutical companies since 20th century. A patient once committed suicide during clinical trials, while the physician was found receiving financial support from pharmaceutical companies afterwards. Companies could give remuneration disguised as consulting payment or education payment to physicians, in order to change the prescribing habits of physicians. This kind of cases urged the public to aware of the financial relationship between physicians and pharmaceutical companies, and the government was forced to respond to the issue. The United States passed the Anti-kickback law in 1972, dealing with unlawful manners leading to high conflict of interests. Violating Anti-kickback law would result in criminal penalty. However, Anti-kickback law only applies in limited circumstances, leaving the problem of paying and receiveing kickbacks unsolved. In 1980s, pharmaceutical companies and professional societies started to adopt guidelines to regulate members’ manners, hoping to solve the problem by self-regulation. However, self-regulation turned out to be useless without establishing independent investigative units and actual supervision. In 1990s, five states in United States passed disclosure laws, requiring pharmaceutical companies to submit annual reports regarding payments to health care professionals to state government. State disclosure laws didn’t run well because the public accessibility was not as ideal as expected. Besides, pharmaceutical companies were allowed to claim that the information about those payments involved their trade secrets. The Department of Justice has also negotiated settlement with several pharmaceutical companies since 2008, requiring pharmaceuticals to publish payment disclosure data on their website. This is called quasi-voluntary disclosure by pharmaceutical companies. However, some studies show that quasi-voluntary disclosure data is doubtful because the disclosed data couldn’t even match the marketing expenses annually. Having learning lessons from state disclosure laws and quasi-voluntary disclosure by pharmaceutical companies, Federal government passed Physician Payment Sunshine Act (PPSA) in 2010. PPSA requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program to report annually to the Secretary certain payments or transfers of value provided to physicians or teaching hospitals. In addition, applicable manufacturers and applicable group purchasing organizations are required to report certain physician ownership or investment interests annually. Then, the Secretary is required to publish applicable manufacturers’ and applicable GPOs’ submitted payments and ownership information on a public website. By revealing the relevant information, the government hopes to improve health care quality, lower health care costs, and engage consumers in their health care decision making. This problem is worldwide. Following the United States, Japan, French, and Australia passed their own disclosure regulation after Physician Payment Sunshine Act is paseed in 2010. The primary goal of this essay is to introduce Physician Payment Sunshine Act, starting from the unavoidable financial relationships between physicians and pharmaceutical companies, the potential conflict of interests, and conflict of interest policy, to relevant laws in the United States. Finally, the essay introduces the current disclosure regulations on relationship between physicians and pharmaceutical companies all over the world, and then tries to give some suggestions after comparing the different kinds of regulations.