本期專遞中「美國第114-89號公共法」一文為美國富理達律師事務所貢獻。
In this issue, the article on U.S. Public Law No. 114-89 has been contributed by Foley & Lardner LLP (U.S.).
深度觀察︱Han Kun Insights [1]
1. 原研藥定價改革及破除壟斷利潤
Branded Drug Pricing Reform and Elimination of Monopoly Profits
閱讀中文 / Full text
立法動態︱Legislative Developments [1]
2. 美國新法案解決含受控物質藥物的「批准日」排他權問題
富理達點評：美國近期發布第114-89號公共法《提高新藥物療法監管透明度法案》（「法案」）。新法解決了含有受控物質的藥物製品雖經FDA批准，但只有在獲得美國緝毒署出具的受控物質核定的最終決定後方可上市銷售的困境。這個問題通常會導致在FDA作出批准的時候新化學實體（NEC）排他權的部分喪失。上述回歸常識的立法變化則很好地解決了這個問題。
New U.S. law resolves 「date of approval」 exclusivity issues for controlled substance drugs
Foley Comments: The U.S recently passed Public Law No. 114-89, the 「Improving Regulatory Transparency for New Medical Therapies Act」 This legislation addresses a problem that existed for drug products containing controlled substances that could be approved by the FDA, but that could not be marketed until the DEA issued a final determination scheduling the controlled substance under the CSA. This often resulted in a partial loss of New Chemical Entity exclusivity which was triggered on the date of FDA approval. This common-sense change to the law now addresses this problem.
監管實踐︱Regulatory Practice [1]
3. CFDA暫停執行藥品電子監管碼，影響深遠
漢坤點評：2016年2月20日，國家食藥監總局發布公告，決定暫停執行2015年第1號公告中藥品電子監管的有關規定，並於同日就2015年6月新頒布的藥品經營質量管理規範的修訂公開徵求意見。聯想到2008年國家質檢總局因推行產品質量電子監管碼被企業起訴，案件雖然未被受理但產品質量電子監管碼計劃最終擱淺，藥品電子監管碼的這一結局並不讓人意外。但這一事件的後續影響應該遠未結束。已實施藥品電子監管碼系統的企業如何善後？總局最終會推行何種藥品可追溯體系？更深遠者是否會對呼之欲出的網售處方藥政策以及醫藥分家層面的醫療改革造成延宕效果？都有待進一步觀察。
CFDA’s suspension of electronic drug monitoring system expected to have a far-reaching impact
Han Kun Comments: On February 20, 2016, the CFDA announced that it would suspend the electronic drug monitoring system initiated in Announcement [2015] No. 1 and, on the same day, released a revised Good Supply Practices for Pharmaceutical Products, dated June 2015, for public comment. Suspension of electronic drug monitoring was not surprising if we connect it to a similar event in 2008 in which the AQSIQ had to abandon the electronic product quality monitoring system after it was sued by boycotting companies. However, following this announcement, there remain a number of questions that must be answered. How will companies that have already adopted the system deal with the suspension? What alternative system may CFDA introduce to track the distribution of drugs? And will the suspension have any far-reaching impact on online prescription drug sales policy or in effecting the healthcare reforms in terms of separation of pharmaceutical and medical services? Further observation will be required to determine the answers to these questions.
4. 湖北試點網售處方藥，釋放積極信號
漢坤點評：2016年2月4日，九州通發布公告稱旗下好藥師大藥房試點開展醫院門診藥房部分藥品遠程配送。好藥師與武漢中心醫院合作憑藉後者處方配藥，聯合阿里健康打通村一級藥品配送。不同於現有的線上下單線下配送並付款的打擦邊球式的處方藥網售模式，湖北省食藥監督局準予好藥師在網際網路上結算相關費用，於線上完成處方審核及支付，並以此「探索處方藥電子商務銷售和監管模式」。本案例中，武漢中心醫院本身有很強的「網際網路＋」模式訴求，並主動尋求與醫藥流通企業合作。因此，特殊個案雖不具有普遍意義，但仍代表了一個重要和積極的信號，值得醫藥電商和醫療機構的重視。
Hubei’s online prescription drug sales pilot program signaling positive progress
Han Kun Comment: On February 4, 2016, pharmaceutical distributor Jointown announced that one of its subsidiaries, ehaoyao.com, will launch a pilot program by which certain hospital outpatient drugs will be express shipped to remote areas. The program will operate jointly with Wuhan Central Hospital, ehaoyao.com and alijk.com. Wuhan Central Hospital will provide the prescriptions and ehaoyao.com will work with alijk.com to deliver the drugs to as far as remote villages. Unlike the existing online prescription drug sales model by which drug purchase orders are submitted online and the delivery and payment is processed off-line, the prescription review and fee settlement will be completed online on the ehaoyao.com platform as approved by Hubei drug administration. This program is regarded as an attempt by Hubei to explore the online sale and regulation of prescription drugs. In this case, Wuhan Central Hospital has exhibited its strong intent to develop the "Internet +" business model by taking the initiative to join with pharmaceutical distributors. Although this particular case does not represent the industry norm, it still delivers a positive sign which both the e-commerce pharmaceutical suppliers and medical institutions cannot ignore.
5. 葛蘭素史克被重罰，「反向支付」問題引重視
漢坤點評：2016年2月12日，英國競爭和市場管理局對葛蘭素史克公司判處3760萬英鎊罰款。該局認為葛蘭素史克與仿製藥廠GUK和Alpharma達成限制競爭協議，並濫用市場支配地位，通過向GUK和Alpharma付款以推遲Paroxetine仿製藥的上市。GUK和Alpharma也分別被處以罰款。近幾年仿製藥產業迅猛發展，原研藥廠為了維護並延長自己的專利壟斷利益，通過反向支付的方式延遲仿製藥進入市場的時間的行為多有發生。反向支付的行為有可能因觸犯反壟斷法而被處以巨額罰款。隨著我國在醫藥領域反壟斷執法力度的增強，無論是原研藥廠還是仿製藥廠，都應當對這一問題引起重視。
GSK hit with large fines, highlighting the issue of "reverse payments"
Han Kun Comments: On February 12, 2016, the UK Competition and Markets Authority (「CMAC」) imposed a fine of 37.6 million pounds on GSK, because CMAC found that GSK had entered into competition-restricting agreements with generic drug manufacturers GUK and Alpharma, and abused its dominant market position by making payments to GUK and Alpharma in order to delay the pace bringing Paroxetine to market. GUK and Alpharma were also fined in this case. In recent years, threatened by the rapid development of the generic drug industry, certain patent drug companies make so-called 「reverse payments」 to delay the entry of generic drugs into the market, which may result in substantial fines due to a breach of anti-monopoly laws. Both patent and generic drug manufacturers should pay close attention to this issue considering that the Chinese authorities have enhanced their efforts to fight anti-competitive activity in the healthcare industry.
6. 賽生製藥FCPA調查案再次明確國有醫院工作人員為「外國官員」
漢坤點評：2016年2月4日，賽生製藥公司同意支付1208萬美元和解美國證券交易委員會提起的關於其違反美國海外反腐敗法（FCPA）的指控。根據該指控，賽生製藥通過其中國子公司向中國公立醫院的醫藥衛生人員提供現金支付和其他好處，換取醫藥銷售收入。和解延續了美國政府在其他案件中認定公立醫院僱傭的醫藥衛生人員屬於FCPA定義的 「外國官員」的判斷標準。
FCPA investigation of SciClone Pharmaceuticals reaffirms state-owned hospital employees as 「foreign officials"
Han Kun Comments: On February 4, 2016, SciClone Pharmaceuticals, Inc. agreed to pay $12.8 million to settle SEC charges that it violated the Foreign Corrupt Practices Act of 1977 (「FCPA」). According to the charges, SciClone Pharmaceuticals gave money and other items of value to healthcare professionals employed by state-owned hospitals in China through its PRC subsidiary in exchange for pharmaceutical product sales. This settlement follows the judgment criteria found in other U.S. government cases in which healthcare professionals employed by state-owned hospitals were determined to be 「foreign officials」 as defined in the FCPA.
7. 工商局與發改委就同一案件分別處罰重慶青陽
漢坤點評：2016年1月15日，國家發改委對重慶青陽藥業有限公司達成並實施別嘌醇片壟斷協議案作出行政處罰。此前，2015年10月28日，青陽藥業亦因其濫用別嘌醇片市場支配地位的行為已受到重慶市工商局的行政處罰。重慶工商局的處罰決定指向的青陽藥業實施違法行為的期間為2013年10月至2014年3月。而國家發改委的處罰決定則針對2014年4月至2015年9月。建議藥企注意，一家反壟斷監管機構對案件結案並不一定能避免其他監管機構的調查。在我國，不同監管機構可能分別調查與處罰同一企業相同事由的涉嫌壟斷違法行為。
AIC and NDRC separately punish Chongqing Qingyang for the same anti-monopoly violations
Han Kun Comments: On January 15, 2016, the NDRC imposed an administrative penalty on Chongqing Qingyang Pharmaceutical Co., Ltd. for concluding and implementing monopoly agreements involving allopurinol tablets. However, Chongqing AIC had already punished Qingyang on October 28, 2015 for its abuse of dominant position in the allopurinol tablet market. The period of violation referred to in the Chongqing AIC decision was from October 2013 to March 2014, while the period for the NDRC decision was from April 2014 to September 2015. It is worth noting that, in China, the authority of one anti-monopoly agency in a case does not necessarily preclude the authority of another agency. This means that different authorities may investigate and punish a company in the same case involving illegal monopolistic activity.
✦ 如需諮詢任何相關問題或針對本刊物發表任何意見，請發送郵件至research@hankunlaw.com。
China Practice Global Vision