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漢坤生命科學與健康專遞(第21期)︱Han Kun Life Sciences & Heal...

 abubaba 2017-06-09

深度觀察︱Han Kun Insights [1]

1. 中國或?qū)⒔ⅰ八幤穼@溄又贫取?,企業(yè)該如何應對?

How will enterprises respond to the establishment of a pharmaceutical patent linkage system in China? 

閱讀原文/Full Text


行業(yè)熱點丨Industry News [1]


2. 互聯(lián)網(wǎng)診療或面臨更嚴格監(jiān)管

漢坤點評:近日,,坊間流傳一份衛(wèi)計委辦公廳印發(fā)的《關于征求互聯(lián)網(wǎng)診療管理辦法(試行)(征求意見稿)和關于推進互聯(lián)網(wǎng)醫(yī)療服務發(fā)展的意見》(“《意見》”),。根據(jù)《意見》,只有醫(yī)療機構(gòu)間的遠程醫(yī)療服務和基層醫(yī)療機構(gòu)提供的慢性病簽約服務兩種情況下,,允許開展互聯(lián)網(wǎng)診療活動,,并實行嚴格準入管理。

此外,,《意見》還規(guī)定:醫(yī)療機構(gòu)不得對首診患者進行互聯(lián)網(wǎng)診療活動,;醫(yī)療機構(gòu)開展互聯(lián)網(wǎng)診療服務,應當建立互聯(lián)網(wǎng)診療活動醫(yī)療質(zhì)量和醫(yī)療安全管理制度,,建立和保管互聯(lián)網(wǎng)診療活動電子病歷,;按規(guī)定開具互聯(lián)網(wǎng)診療活動電子處方,;建立互聯(lián)網(wǎng)診療信息安全制度;執(zhí)行信息安全和醫(yī)療數(shù)據(jù)保密制度,。此外,,《意見》第三十七條規(guī)定,本辦法發(fā)布前設置審批的互聯(lián)網(wǎng)醫(yī)院,、云醫(yī)院,、網(wǎng)絡醫(yī)院等,應當在本辦法發(fā)布后15日內(nèi)予以撤銷,,并按照本辦法規(guī)定重新對其互聯(lián)網(wǎng)診療活動實施管理,。

但截至目前,并未在衛(wèi)計委網(wǎng)站等官方途徑查詢到《意見》,,《意見》內(nèi)容的準確性還有待考證。眼下,,互聯(lián)網(wǎng)醫(yī)療領域的監(jiān)管政策相對比較模糊,,也因此促成了互聯(lián)網(wǎng)醫(yī)療在部分地區(qū)的集中快速發(fā)展,若《意見》按照現(xiàn)有內(nèi)容出臺,,必然會對行業(yè)造成較大的沖擊,。雖然《意見》的部分內(nèi)容值得商榷,但其所明確的大部分監(jiān)管和合規(guī)紅線,,對于保障醫(yī)療安全和患者權益保護無疑是具有積極意義的,。從長遠而言,《意見》所確定的政策和導向?qū)π袠I(yè)未必不是一個利好,。


Internet medical diagnoses and treatments to be subject to stricter supervision

Han Kun Comments: The General Office of the NHFPC is believed to have recently issued the Opinions on Invitation for Advice on Developing Administrative Measures for Internet Medical Services (Trial) (Draft for Comment) and on the Promotion of Internet Medical Services Development (the 'Opinions'), which have attracted wide public attention.  According to the Opinions, Internet medical services are to be limited only to inter-medical institution telemedicine services and chronic disease treatment services at primary medical institutions, and the industry will be subject to strict market-entry requirements.  

In addition, the Opinions stipulate that medical institutions cannot provide online medical diagnoses and treatments to first-time patients.  Medical institutions must establish Internet medical diagnosis and treatment quality and safety management systems, establish and preserve electronic medical records and issue electronic prescriptions in accordance with the relevant rules.  The Opinions also require the establishment of Internet medical diagnosis and treatment information security systems and to implement the information security and medical data confidentiality systems.  In addition, Article 37 of the Opinions stipulates that Internet hospitals, cloud hospitals and network hospitals that have been examined and received approval before the promulgation of the Opinions will have those approvals revoked within 15 days following the promulgation of the Opinions, and that they will be managed pursuant to the provisions of the Opinions for their diagnosis and treatment activities.   

However, the validity of the Opinions remains to be seen, as the document cannot currently be traced to either the NHFPC website or through other official channels.  Due to the ambiguity of the regulatory policy in the Internet medical services sector, Internet medical services saw rapid development in some areas.  If the Opinions are promulgated in their current form, they will inevitably have a significant impact on the industry.  Although some content of the Opinions is still subject to debate and requires further discussion, the regulatory and compliance measures found within the document will undoubtedly help to ensure medical safety and protect patients’ rights and interests.  In this sense, we believe that the policy and principles stipulated by the Opinions will assist the healthy development of the industry going forward.  


立法動態(tài)︱Legislative Developments [3]


3. CFDA接連發(fā)文鼓勵藥品醫(yī)療器械創(chuàng)新

漢坤點評:2017年5月11日至12日,,為進一步深化審評審批制度改革,促進藥品醫(yī)療器械產(chǎn)業(yè)結(jié)構(gòu)調(diào)整和技術創(chuàng)新,,CFDA連續(xù)發(fā)布了四則“關于鼓勵藥品醫(yī)療器械創(chuàng)新”的征求意見稿,,包括加快新藥醫(yī)療器械上市審評審批的相關政策(征求意見稿)(52號文)、改革臨床試驗管理的相關政策(征求意見稿)(53號文),、實施藥品醫(yī)療器械全生命周期管理的相關政策(征求意見稿)(54號文)和保護創(chuàng)新者權益的相關政策(征求意見稿)(55號文),。

我們認為,如下內(nèi)容值得關注:

  • 對于國外已批準上市的罕見病治療藥物和醫(yī)療器械,,可有條件批準上市后,,在規(guī)定時間內(nèi)補做相關研究;

  • 將臨床試驗機構(gòu)資格認定改為備案管理,,鼓勵社會資本投資設立臨床試驗機構(gòu),;

  • 審評機構(gòu)自受理之日起60個工作日后,沒有給出否定或質(zhì)疑的審查意見即視為同意,;

  • 接受境外臨床試驗數(shù)據(jù),,包括申請人在境外取得的臨床試驗數(shù)據(jù),、境外企業(yè)在中國進行的國際多中心藥物臨床試驗、申請人在歐洲,、美國,、日本獲準上市仿制藥的生物等效性試驗數(shù)據(jù),以及境外獲準上市的醫(yī)療器械在上市時提交的臨床試驗數(shù)據(jù),; 

  • 總結(jié)MAH試點經(jīng)驗,,將上市許可持有人制度在全國藥品和醫(yī)療器械許可(注冊)人中普遍實行;

  • 建立藥品專利鏈接制度,,藥品審評機構(gòu)收到司法機關專利侵權立案相關證明文件后,,可設置最長不超過24個月的批準等待期,在此期間,,不停止已受理藥品的技術審評工作,,超過批準等待期,司法機關未作出侵權判決的,,藥品審評機構(gòu)可以批準藥品上市,;

  • 完善藥品試驗數(shù)據(jù)保護,針對創(chuàng)新藥,、改良型新藥,、創(chuàng)新的治療用生物制品和境內(nèi)首仿上市的藥品,分別給予1.5年至10年不等的數(shù)據(jù)保護期,。


CFDA successively promulgates documents to encourage drug and medical device innovation

Han Kun Comments: On May 11 and 12, 2017, CFDA successively issued four documents (drafts for comment) with the purpose of encouraging the drug medical equipment innovation, the Relevant Policies on Accelerating New Drug Medical Device Review and Approval Procedures (Draft for Comment) (“Circular No. 52”), Relevant Policies on Clinical Trial Management Reforms (Draft for Comment) (“Circular No. 53”), Relevant Policies on the Implementation of Drug Medical Device Full Life Cycle Management (Draft for Comment) ( “Circular No. 54”) and Relevant Policies on the Protection of Innovators’ Rights and Interests (Draft for Comment) ( “Circular No. 55”), in order to further deepen the reform of drug medical device examination and approval systems and to promote the restructuring of and technological innovation in the drug medical device industry.

We believe that the following points are worthy of special attention:

  • Drugs and medical equipment for the treatment of rare diseases that have already been approved for marketing in other countries may be approved to be sold in the domestic market after certain conditions are satisfied, and the relevant research can be completed within a specified period thereafter;  

  • Clinical trial institutions will need to file with the relevant authority for establishment and no longer need to undergo qualification determinations.  Social capital will be encouraged to participate in the establishment of clinical trial institutions;

  • The review and approval authority will be deemed to have granted a consent for marketing if it fails to reject or dispute the application within 60 business days from the date of the receipt; 

  • Overseas clinical trial data will be accepted, including clinical trial data obtained by applicants from abroad, data obtained by foreign enterprises from international multicenter drug clinical trials conducted in China, bioequivalence test data of the applicant's generic drugs that are approved to be sold in the European, the U.S. and Japanese markets, as well as clinical trial data for medical devices that are approved to be sold in offshore markets that are submitted at the time of marketing;

  • To summarize the experience with the MAH pilot project and to promote the application of the MAH system to all drug and medical device MAHs (registered) nationally;  

  • A pharmaceutical patent linkage system is to be established, and drug review agencies can set an approval waiting period of up to 24 months upon receiving judicial certification of a patent infringement case.  Within the waiting period, drug review agencies may continue the technical review of the applied drug.  Such drugs may be approved to be sold to the public if the judicial authority fails to render an infringement ruling within the waiting period. 

  • Improvements to drug test data protection.  Innovative drugs, improved new drugs, innovative therapies using biological products and drugs first approved to be sold in the domestic market will be subject to a data protection period ranging from 1.5 years to 10 years.



4. 《醫(yī)療器械監(jiān)督管理條例》首次重大修訂

漢坤點評:2017年5月19日,,國務院公布關于修改《醫(yī)療器械監(jiān)督管理條例》的決定?!稕Q定》除了將醫(yī)療器械臨床試驗機構(gòu)的資質(zhì)管理由許可改為備案之外,,最重大的一項修改在于新增了大型醫(yī)用設備配置的行政許可事項,并規(guī)定將另行制定并發(fā)布大型醫(yī)用設備配置管理辦法和大型醫(yī)用設備目錄,。

早在2005年,,原衛(wèi)生部即發(fā)布《大型醫(yī)用設備配置與使用管理辦法》,并按照甲類,、乙類大型醫(yī)用設備進行配置證分類管理,,但明確該配置證為非行政許可審批項目。針對近些年各級醫(yī)療機構(gòu)(尤其是大型公立醫(yī)院)競相配置高端機型設備,,導致政府財政負擔增加,,以及破除“以藥養(yǎng)醫(yī)”頑疾之后防止“以械養(yǎng)醫(yī)”現(xiàn)象的形成,政府監(jiān)管部門有意強化大型醫(yī)用設備配置許可,。這也是新《醫(yī)療器械監(jiān)督管理條例》自2014年6月1日施行后短時間內(nèi)即面臨重大修訂的主要原因,。根據(jù)此次修訂,配置許可的相關規(guī)定從部門規(guī)章上升到國務院行政法規(guī)的層級,,法律性質(zhì)上也從非行政許可審批項目上升到行政許可事項,。這在眼下中央政府力主簡政放權并減少行政審批事項的大背景下,,顯得尤為突兀。

Medical Device Supervision and Management Regulations undergo major revisions for the first time 

Han Kun Comments: On May 19, 2017, the State Council released the Decision on the Revisions of Medical Device Supervision and Management Regulations (the “Decisions”).  The Decisions stipulate that medical device clinical trial institutions may file with the relevant authority for establishment and are no longer required to obtain a qualification determination.  The most significant modification stipulated by the Decisions is to make the purchase of large medical equipment subject to an administrative permitting system.  The Decisions also provide for the subsequent formulation of administrative measures for large medical equipment purchases and a large medical equipment catalogue.

In early 2005, the Ministry of Health (predecessor to the NHFPC) promulgated the Administrative Measures on Purchase and Use of Large Medical Equipment (the “Measures”), which stipulates that large medical equipment is to be categorized into categories A and B and that the purchase of such equipment was subject to obtaining purchase licenses corresponding to each category.  However, the Measures clearly stipulate that large medical equipment purchases themselves are not a matter subject to administrative review and approval.  The regulatory authorities now intend to include large medical equipment purchases as an item subject to administrative approval because medical institutions at all levels (particularly large public hospitals) often seek to purchase high-end medical equipment that results in increased financial burdens on governments, and also in order to prevent the occurrence of the phenomenon of “equipment-supported hospitals” after the elimination of “drug-supported medicine.”  This is the reason for the Medical Device Supervision and Management Regulations to be significantly revised after their promulgation on June 1, 2014.  After the promulgation of the Decisions, obtaining large medical equipment purchase licenses becomes a requirement under the State Council-formulated administrative regulations rather than a requirement under department regulations, and the large medical equipment purchases will also become a matter subject to administrative approval.  This development is worthy of attention in the industry, in particular since it is unexpected in light of the central government proactively advocating to streamline administration and to delegate power to the lower levels of government and generally being committed to reducing matters requiring administrative approval.



5. 七部門聯(lián)合發(fā)文全面推開公立醫(yī)院綜合改革

漢坤點評:2017年4月19日,,國家衛(wèi)計委聯(lián)合財政部,、發(fā)改委等六個部門聯(lián)合發(fā)布《關于全面推開公立醫(yī)院綜合改革工作的通知》,以全面推開公立醫(yī)院改革,,取消藥品加成,。《通知》特別要求:(1)控制2017年全國公立醫(yī)院醫(yī)療費用平均增長幅度至10%以下,;(2)7月31日前各地出臺城市公立醫(yī)院綜合改革實施方案,,9月31日前全面推開公立醫(yī)院綜合改革,取消公立醫(yī)院所有藥品加成,。

Seven departments jointly promulgate policies to commence comprehensive public hospital reforms

Han Kun Comments: On April 19, 2017, NHFPC, together with Ministry of Finance and NDRC and four other departments jointly promulgated the Circular on Fully Commencing Comprehensive Public Hospital Reforms (the “Circular”) in order to launch comprehensive public hospital reforms and to eliminate drug price markups.  In particular, the Circular requires: (1) ensuring that the 2017 average medical expense growth rate for public hospitals across the nation is below 10%; (2) all cities are to promulgate comprehensive urban public hospital reform plans before July 31, commence comprehensive public hospital reforms and eliminate all drug price markups in public hospitals before September 31.


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