當醫師走法律鋼索 Doctor in trouble for online sales of birth control pills

中國時報 2008.01.21　
當醫師走法律鋼索
李伯璋 　

昨日中國時報頭版報導「世界第一 每三個月 一醫師定罪」，相信很多醫界同仁，法界人士與社會大眾又再度陷入醫療與法律的迷失。 　

根據高雄地方法院廖建瑜法官指出，由法務部起訴書查詢系統，自民國八十六年至九十六年醫療糾紛起訴件數中，判決有罪、無罪確定所需的時間最長十年三個月、最短一年、平均四年六個月。這顯示醫療爭議事件有許多認定的困難，在法律漫長處理過程中，要維持符合真正社會公平正義，對於醫療人員與病人及家屬是相當煎熬的心路歷程。 　


筆者曾針對某醫學中心病人的醫療爭議個案與醫療行為加以分析，很明顯地百分之七十應該有醫療行為與醫療損害的相關性。大家都明白醫療有其風險，不可能百分之百成功，然而爭議事件中，有將近七十％病人或家屬感覺沒有被給予充份告知說明病情，無法充份瞭解醫療行為的發展，以致於當有損害發生時，無可避免地無法接受醫療結果而有爭議。 　

而爭議事件內容以手術合併症為最明顯，至於術後心臟突然發作、腦中風突然發作也都有相當比例，這些都是不可預期地、發作的時機也不是時候，家人當然不可能會接受，常會堅持是因為手術而引起的。因此，術前評估病人病史（如高血壓、糖尿病、尿毒症…），而預先說明心臟病、腦中風發病的好發因子是否存在病人的體質內，對於爭議事件產生時的溝通頗有幫助。 　

筆者也發現有三十％病人即使醫療爭議無因果關係、客觀歸責或告知義務的相關因素，家屬仍然無法接受醫療結果，而堅持尋求慰問金。但假如醫護人員能及時將病情給予家屬或病人充分的告知說明，即使病情有所變化，大多數家屬則依然會充分諒解，而且醫師在醫療訴訟中不必承受不必要的非理性因素。醫療過程中的決策與醫療結果存在著相當因果關係與客觀歸責的因素，過程中的變化是否能善盡注意義務也是家屬最在乎的。對於國內的醫療過失，筆者有以下建議。

　一、多數歐美先進國家均有飛行調查法，作為失事調查的法律規範，一般而言，只要飛機駕駛人員本身沒有犯罪意圖，司法單位並不會因為發生空難就起訴機師。我們希望失事的飛行員要誠實的面對失事的問題，避免相似災難再發生。醫療行為去刑化應該有助於醫師更「誠實」面對疏失，減少醫療錯誤的有效方法是建立「通報制度」，讓醫事人員自發性的報告過錯，進而公開討論，使其他人員從中學習，而不再犯同樣的錯誤。 　

因此，筆者建議有關單位參照民用航空法第八十四條、一一二條之一之規定修法，規定通報的資料不得作為檢察官起訴或法官論罪之證據，對於主動向衛生機關通報醫療錯誤者，得視其情節輕重，減輕或免除其刑罰。 　

二、我國過去有關醫療糾紛之訴訟，係按一般民、刑事訴訟的方式審理，並無特別之專庭。惟為考量醫療糾紛之判決涉及專業性醫療知識與技術，將來司法「參審制」實施之後，由醫療專家實際參與醫療案件之審判，期能迅速審結醫療案件，並有效提升醫療案件之裁判品質。 　

三、避免醫療糾紛鑑定淪為寡佔壟斷，由行政院衛生署審定之各大學醫學院、醫學中心及大型醫院均可接受委託鑑定，惟鑑定結果應具體說明所憑之依據係醫學文獻或醫學理論，以證明其意見的公平性及可靠性。並且應採取兩造聽審制度，由當事人陳述對鑑定內容之意見，避免黑箱作業之批評，惟有如此，鑑定結果始能獲得民眾信賴。 　

照顧國民的健康是政府應負之義務，應考慮由政府開辦社會保險，例如：醫師責任險、醫療機構責任險等的方式來替代無過失補償制度；對當事人而言，可以鼓勵醫師發揮其醫療專業，不至有後顧之憂，病人亦可獲較佳之醫療事後之保障。此外，醫師必須隨時檢視自己的極限，更努力學習面對所謂因難的疾病；而不管醫學倫理觀有多少原則其實只有一個原則，那就是「愛」。 　（作者為成大醫院外科主任，成功大學醫學院、科技法律研究所教授）



しんぶん赤旗
全日本民主医療機関連合会（肥田泰会長）は十九日、東 京都千代田区で、「医療事故を取り扱う第三者機 関の設立をめざす１・１９シンポジウム」を開き、医師 四十四人を ...

Doctor in trouble for online sales of birth control pills

01/21/2008

THE ASAHI SHIMBUN

NAGOYA--The health ministry will investigate a doctor suspected of conducting unauthorized sales of birth control pills over the Internet and issuing prescriptions without even seeing the patients, The Asahi Shimbun has learned.

The 49-year-old doctor, who operates a gynecology and urology clinic in northern Aichi Prefecture, is believed to have violated laws governing medical practitioners and pharmaceutical affairs.

He sold low-dose oral contraceptives to users nationwide after taking orders and providing consultations by e-mail although his clinic is not authorized to sell prescription drugs and physical exams are required to prescribe the pills, regional public health officials said.

The contraceptives were bought through the clinic's Web site for 2,500 yen ($23) per cycle, or one sheet, significantly cheaper than the going price of 3,150 yen.

The site also offers a 2,000-yen discount, or 20 percent, for one cycle of a particular brand.

In addition, the site says the doctor provides "free consultations in deciding which low-dose pill is best suited for the user."

The site asks would-be users to send their vital statistics, such as age, height and weight, overall health condition and medication taken, as well as experience in taking birth control pills.

The doctor told The Asahi Shimbun the Web site receives about 60,000 hits and between 60 and 100 e-mail inquiries for orders or advice a day.

One woman in Tokyo said she obtained the prescription drugs through the site in autumn last year after lying that she had experience in using the contraceptives.

She said she received an e-mail soon after placing her order that said the clinic deemed her "OK" to use the low-dose pills because she had experience and appeared to have undergone a checkup at a gynecology clinic.

The woman, who had never taken the pills before, said she was charged 5,000 yen for two sheets, including taxes.

She received an immediate confirmation of payment after she made a deposit into a designated account. Her pills arrived the following day.

Under the Medical Practitioners Law, doctors cannot issue statements on diagnoses or prescriptions without having actually conducted physical examinations, according to the Ministry of Health, Labor and Welfare.

Also, medication can only be sold by people who have obtained permits to sell drugs or open a pharmacy, except when a doctor prescribes medication immediately after diagnosis.

Online sales of pharmaceuticals are limited to over-the-counter drugs, such as vitamins and certain remedies for intestinal disorders, that do not require a pharmacist, the ministry said.

The doctor's clinic in Aichi Prefecture has not been given a permit to sell drugs or operate a pharmacy, public health officials said.

Medical experts have warned that without proper clinical follow-ups, the long-term use of birth control pills could trigger health problems, including breast cancer and liver disorders.

The doctor, however, said, "It is possible to sufficiently monitor a patient's health condition through e-mail."

Incidents of illegal sales of medical products over the Internet are rising.

Last year, Aichi prefectural police arrested at least three people on suspicion of selling ersatz Viagra made in China over the Internet.

The same year, police in Tochigi and Hiroshima prefectures arrested three people in separate incidents involving online sales of drugs not authorized for production in Japan.(IHT/Asahi: January 21,2008)