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

深度觀察︱Han Kun Insights [1]

1. 中國或將建立「藥品專利鏈接制度」，企業該如何應對？

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

閱讀原文/Full Text

行業熱點丨Industry News [1]

2.互聯網診療或面臨更嚴格監管

漢坤點評：近日，坊間流傳一份衛計委辦公廳印發的《關於徵求互聯網診療管理辦法（試行）（徵求意見稿）和關於推進互聯網醫療服務發展的意見》（「《意見》」）。根據《意見》，只有醫療機構間的遠程醫療服務和基層醫療機構提供的慢性病簽約服務兩種情況下，允許開展互聯網診療活動，並實行嚴格准入管理。

此外，《意見》還規定：醫療機構不得對首診患者進行互聯網診療活動；醫療機構開展互聯網診療服務，應當建立互聯網診療活動醫療質量和醫療安全管理制度，建立和保管互聯網診療活動電子病歷；按規定開具互聯網診療活動電子處方；建立互聯網診療信息安全制度；執行信息安全和醫療數據保密制度。此外，《意見》第三十七條規定，本辦法發布前設置審批的互聯網醫院、雲醫院、網路醫院等，應當在本辦法發布後15日內予以撤銷，並按照本辦法規定重新對其互聯網診療活動實施管理。

但截至目前，並未在衛計委網站等官方途徑查詢到《意見》，《意見》內容的準確性還有待考證。眼下，互聯網醫療領域的監管政策相對比較模糊，也因此促成了互聯網醫療在部分地區的集中快速發展，若《意見》按照現有內容出台，必然會對行業造成較大的衝擊。雖然《意見》的部分內容值得商榷，但其所明確的大部分監管和合規紅線，對於保障醫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對行業未必不是一個利好。

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︱Legislative Developments [3]

3. CFDA接連發文鼓勵藥品醫療器械創新

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，促進藥品醫療器械產業結構調整和技術創新，CFDA連續發布了四則「關於鼓勵藥品醫療器械創新」的徵求意見稿，包括加快新葯醫療器械上市審評審批的相關政策（徵求意見稿）（52號文）、改革臨床試驗管理的相關政策（徵求意見稿）（53號文）、實施藥品醫療器械全生命周期管理的相關政策（徵求意見稿）（54號文）和保護創新者權益的相關政策（徵求意見稿）（55號文）。

我們認為，如下內容值得關註：

對於國外已批准上市的罕見病治療藥物和醫療器械，可有條件批准上市後，在規定時間內補做相關研究；

將臨床試驗機構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；

審評機構自受理之日起60個工作日後，沒有給出否定或質疑的審查意見即視為同意；

接受境外臨床試驗數據，包括申請人在境外取得的臨床試驗數據、境外企業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、日本獲准上市仿製葯的生物等效性試驗數據，以及境外獲准上市的醫療器械在上市時提交的臨床試驗數據；

總結MAH試點經驗，將上市許可持有人制度在全國藥品和醫療器械許可（註冊）人中普遍實行；

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

完善藥品試驗數據保護，針對創新葯、改良型新葯、創新的治療用生物製品和境內首仿上市的藥品，分別給予1.5年至10年不等的數據保護期。

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. 《醫療器械監督管理條例》首次重大修訂

漢坤點評：2017年5月19日，國務院公布關於修改《醫療器械監督管理條例》的決定。《決定》除了將醫療器械臨床試驗機構的資質管理由許可改為備案之外，最重大的一項修改在於新增了大型醫用設備配置的行政許可事項，並規定將另行制定並發布大型醫用設備配置管理辦法和大型醫用設備目錄。

早在2005年，原衛生部即發布《大型醫用設備配置與使用管理辦法》，並按照甲類、乙類大型醫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。針對近些年各級醫療機構（尤其是大型公立醫院）競相配置高端機型設備，導致政府財政負擔增加，以及破除「以葯養醫」頑疾之後防止「以械養醫」現象的形成，政府監管部門有意強化大型醫用設備配置許可。這也是新《醫療器械監督管理條例》自2014年6月1日施行後短時間內即面臨重大修訂的主要原因。根據此次修訂，配置許可的相關規定從部門規章上升到國務院行政法規的層級，法律性質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並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. 七部門聯合發文全面推開公立醫院綜合改革

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

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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