China: 热议新版《药品管理法》:积极响应监管,把握行业机遇

Last Updated: 6 September 2019
Article by DeHeng Law Offices
Most Read Contributor in China, October 2019

法律的调整步伐难免滞后于现实生活。新版《药品管理法》(以下简称"新药法")于8月26日人大审议通过,将在今年12月1日起正式施行。我们惊喜地看到,新药法及时响应了时代和业态变迁带来的新需求,落实了之前通过零散的规范性文件陆续推出的改革措施,同时也体现了立法者对于相关方利益的审慎权衡,监管日趋成熟,并与国际接轨。

以下谨对新药法的重大变化、对行业可能带来的影响做力求贴近实操的选择性分析,对之前草案中已经涉及的、实践中已提早落地的举措不予赘述。

一、药品生命周期全程监管的新思路

1984年首部《药品管理法》颁布,2001年2月首次修订迄今已经过18年,这期间中国医药行业出现了根本性的变化。80年代中国市场以原料药和仿制药生产为主,现今出现越来越多以创新药研发为主的企业,他们的市场触角开始向海外延伸,更多跨国药企也将中国列入最具战略意义的市场。随着行业结构的变化,药法的思路也需要与时俱进,一方面加大对创新的支持,创造有利于临床急需新药和特殊人群用药上市的制度,同时引进动态监管和风险管理的理念,落实行业参与者和监管部门各自应担负的义务和责任,以确保群众用药安全。新药法一改现行法分块监管的规范框架,引进以药品生命周期为主轴、全程监管的新思路,值得肯定。

二、落实政策红利,鼓励创新

在一系列鼓励药品创新的改革措施当中,值得业界重点关注、可把握的政策机遇有:

1.基于之前的十省试点,上市许可持有人制度(MAH)正式入法。虽然具体如何落实还要看待出台的实施细则,但可以期盼的是,将普遍允许上市许可持有者与生产企业的分离,外包生产行业将迎来春天,上市许可持有人之间转让药品资产、切换生产场地将有更为简便易行的路径。

特别值得注意的是第四十条规定:"经药监部门批准,药品上市许可持有人可以转让药品上市许可",这是史上第一次承认药证得单独作为交易标的,将大幅便利企业盘活现有资产。这意味着一是药证的转让不见得伴随着生产的转让,受托生产厂(CMO)可保持不变;即使是伴随着生产变更的上市许可转让的情况,也不必按照原先冗长的药品技术转让程序,其审批会更近似于对药品生产场地变更的考察,可按照风险管理原则评估场地变更的影响,前后进行足够的对比研究和工艺验证即可批准转让,具体如何操作有待下位法的制度设计。增强灵活性的同时,新法也明显强化了上市许可持有人的资质要求,要求是建立起质量保证体系的企业或研发机构,需要对全生命周期承担起相应责任,言下之意不是什么壳公司都可以成功担当药品上市许可持有人之职。

之前的MAH试点不仅有地理和时间上的局限性,而且适用品种只包括2016年6月后批准上市的新药、通过一致性评价(或按照原研药一致性标准新批准上市)的仿制药,以及企业整体搬迁的品种转移。在试点过程中,还出现了某些原研厂家授权国内企业做"独家授权"仿制药,帮助其通过一致性评价,再利用MAH制度将仿制药的生产继续外包给原研厂家来做,从而实现变相垄断原研和"高仿"市场的"创意"做法。如今上市许可持有人制度入法之后,应增强制度的普适性,并在持有人变更、生产场地变更等配套制度上进一步增强灵活性,以凸显其鼓励创新的意义,而不单纯是允许一些利用制度走捷径、本质上与创新无关的市场行为。

此外,新药法此次把境外上市许可持有人纳入了上市许可持有人的范畴,并规定境外药品上市许可持有人在中国境内的代理人与持有人承担连带责任。有部分专家学者展望这是否意味着可以实现跨境委托生产,也就是不再以生产场地区分国产药和进口药两条线,国内的持有人可以委托海外的CMO(这对于国内药企收购海外品种意义重大),而境外的持有人也可以委托中国的CMO实现当地生产供应当地市场(这对于部分血液制品、大分子药引进也意义重大)。但是笔者谨做客观保守解读,认为本次修法没有包含这层含义,愿望是良好的,但当局对于境内持有人在国外的外包生产行为持续监管条件还不成熟,而对于境外持有人在境内委托生产的质量控制也会持有担心;不再区分国产、进口在后市场准入环节也可能会带来一些混乱。

另外几个MAH制度悬而未决的相关问题诸如:是否新法生效前颁发的注册证持有人都在生效后自动成为上市许可持有人而无需像试点过程中要经过特别申请(理当是这个情况),最多可同时委托几个外包生产商,是否可委托不同生产企业负责不同生产环节与流程,实现分段生产。此等问题的正解且待新药法实施细则和《药品注册管理办法》修订来澄清。

2.对临床急需的短缺药品、防治重大传染病和罕见病等疾病的新药、儿童用药开设绿色通道,优先审评审批。其中新的亮点是儿童药,国家将采取有效措施,鼓励儿童用药品的研制和创新,支持开发符合儿童生理特征的儿童用药品新品种、剂型和规格,对儿童用药品予以优先审评审批。这针对目前市场上我国儿童用药严重短缺的现实,鼓励厂商开发儿童专用剂型和规格,申请人可以藉此获得优先审批资格。但实践中鼓励儿童药申报的措施可能需要多管齐下,在临床研究要求上应考虑实际性地简化,因为儿童药本身的临床试验风险较大,受试者招募不易,样本量很难达到成人试验的同等要求,开发儿童专用的剂型仍有难度。

3.临床试验药品的拓展使用。对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段的疾病的药物,经医学观察可能获益,并且符合伦理原则的,经审查、知情同意后可以在开展临床试验的机构内用于其他病情相同的患者。这一规定类似于国外的人道主义试验阶段拓展用药,突破了临床试验用药只限于受试者使用的原则,其首要意义是对于病人而言,在其知情同意的基础上可以自担风险、第一时间用上救命药;同时对于新药申请人/申办方而言,可及早获得试验方案外更大样本的临床经验数据(病源限于在试验机构内),其安全性数据可用于支持产品审批上市,也有利于医生及早积攒临床使用经验。

4.建立附条件批准制度。对治疗严重危及生命且尚无有效治疗手段的疾病以及公共卫生方面急需的药品,临床试验已有数据显示疗效并能预测其临床价值的,可以附条件批准,以提高临床急需药物的可获得性。这一制度可以缩短临床试验研发时间,使急需治疗的患者早日用上新药。当然,对这些附条件批准的药品也有严格的管理要求,如在药品注册证书中载明相关事项,药品上市许可持有人应当采取相应风险管理措施,在规定期限内按照要求完成相关研究,逾期没有按照要求完成研究、证明收益大于风险的,可能被注销药品注册证书。

5.鼓励、引导药品零售连锁经营。与国家不鼓励新设药品批发企业、希望行业整合的形势相比,药品零售连锁行业将喜迎政策红利,而单体零售药店的生存未来可能面临挑战。因连锁药店具有较强的规模化运营优势,新药法鼓励支持的同时,要求企业总部应当建立统一的质量管理制度,对所属零售企业的经营活动履行管理责任。

三、网售处方药终开口

这次新药法给网售处方药开了口子,这个过程非常曲折。现行的做法是明确规定网络不可以直接向公众销售处方药。《药品流通监督管理办法》第二十一条规定"药品生产、经营企业不得采用邮售、互联网交易等方式直接向公众销售处方药"。2014年5月有松动的苗头,发布了《互联网食品药品经营监督管理办法﹙征求意见稿﹚》提出"互联网药品经营者应当按照药品分类管理规定的要求,凭处方销售处方药;处方的标准、格式、有效期等,应当符合处方管理的有关规定",但后来一直没落地。一直到2019年4月份新药法草案修订稿审议时,也依然是明确规定不得通过药品网络销售第三方平台直接销售处方药。法规虽然久未落地,现实中的探索早已开始,有的实体零售商会在网售平台挂出相关处方药信息,但不留购买链接,仅要求购药者留下电话与药剂师沟通、远程核实处方,线下交易、货到付款,其合规性在现行法下存在很大问题。

根据人大法工委袁杰的发布会介绍,人大代表在审议和征求意见的过程中对于是否开放网售处方药有两种不同意见,一种认为应当禁止通过网络直接销售处方药,有的意见提出不要一刀切,是可以在加强监管的前提下允许网络销售处方药。有鉴于此,此次修法就网络销售药品作了比较原则的规定,即要求网络销售药品要遵守药品经营的有关规定,并授权国务院药品监督管理部门会同国务院健康卫生主管部门等部门具体制定办法,同时规定了几类特殊管理药品不能在网上销售,为实践探索留有空间。

当局透露正在起草《药品网络销售监督管理办法》,配套的合规要求正在酝酿之中。据药监法制司刘沛司长介绍,首要原则是"线上线下要一致",所以对于网售的主体,必须首先是取得了许可证的实体企业,线下要有许可证,线上才能够卖药。网上销售药品也要遵守新的药品管理法关于零售经营的要求。其次,考虑到网络销售的特殊性,对网络销售的处方药规定了更严要求,比如药品销售网络必须和医疗机构信息系统互联互通、信息共享,确保处方的来源真实,配送也要符合药品经营质量规范的要求。对于药监部门以经营质量保证为核心的规定能否与卫健委互联网医疗和远程医疗相关的规定就网售处方药进行有机对接,我们拭目以待。

四、从严监管、处罚到人

新药法的重大特色是落实了"四个最严",强化监督检查,并全面加大对违法行为的处罚力度。实体要求上,值得重点关注的是强调研究数据的真实性,强调批准上市后仍然必须严格按照标准和经注册的生产工艺来生产,还有药政监管要求几处都扩张到医疗使用单位,可能改变从前对药品使用环节监管薄弱的态势。法律责任的加强则主要体现在以下几方面:

首先,综合运用了多种处罚措施,包括没收、罚款、责令停产停业整顿、吊销许可证件、一定期限内不受理许可申请、从业禁止(资格罚),还有情节严重的对相关责任人员处行政拘留(自由罚)。同时,还大幅度提高了罚款的额度,对生产假药行为的罚款额度由原来的违法生产销售药品货值金额两倍以上五倍以下,提高到十五倍以上三十倍以下。而且规定货值金额不足十万的要按十万算。

其次,对一些严重违法行为实行"双罚制",处罚到人。新药法第146条之后是对监管部门的一些要求,监管部门都是对主要负责人进行处罚的。第146条之前有十处处罚到人,包括没收违法行为发生期间其所获收入、罚款、一定期限甚至终身禁业等。

新药法在民事责任上,设置了惩罚性赔偿,对生产假劣药或者明知假劣药仍销售使用的,受害人可以要求惩罚性赔偿。同时,明确药品上市许可持有人和药品生产经营企业赔偿责任,实行民事赔偿的首负责任制。

最后,新药法强调了各级政府、药品监督管理部门、卫生健康主管部门,按照三定方案的职责要分工协作、协同监管。监管部门在查处假药劣药违法行为有失职渎职行为的,要对直接负责的主管部门和其他责任人员依法从重处分。就是说,监管不作为的将严格处置。

五、假药范畴和少量进口

通过此次修法,未经批准的药品不再作为假药,未经审批的原料药、药包材也不再作为劣药,但仍然是被法律禁止的。新药法主要是从药品功效的技术标准上对假药、劣药的范畴进行了调整界定,去除"按假药、劣药论处"这一较为模糊不清的概念,并在法律责任一章继续对假药、劣药的生产、销售、使用苛以严罚。目前将假药调整为四种情形,包括:药品所含成份与国家药品标准规定的成份不符,以非药品冒充药品或者以他种药品冒充此种药品,变质的药品,药品所标明的适应症或者功能主治超出规定范围。

进口未经批准的药品虽然不再作为假药,后文规定的处罚标准其实不轻,第124条设置的起始标准是没收,罚款货值15-30倍,可由公安机关处以5-15日拘留。只是新药法加了一条"未经批准进口少量境外已合法上市的药品,情节较轻的,可以依法减轻或者免予处罚",故满足"少量"、"境外合法上市"、"情节较轻"这些前提的,可做减免处罚。

实际上,在现行药法里,患者自己或通过家人为了自用目的少量携带或邮寄药品进境,本来也不在禁止之列。法律所禁止的是职业化的代购行为,构成销售无证药品,依现行药法的规定即是销售假药,达到一定规模可能涉刑,既可能构成制售假药犯罪,也可能一并构成走私犯罪。

本次修法把未经批准进口药品从列为假药的清单里面拿了出来,这种行为仍然构成违反药品管理秩序的违法行为,但是刑事处罚风险确实是显著降低了,且辅以"情节较轻可予减免处罚"的补充规定,满足适用条件的情况下行政责任也会有所减轻。这一新规定出于人道主义精神,体现了立法对民情的体恤;但今后如何妥善监管海外代购药品的行为有待关注。

六、结 语

落地。此次新药法久经酝酿终于诞生,意义重大,充分体现了新时期党中央、国务院对保障药品的安全、有效性,提升产业的创新与质量水平的高度重视。其总体特点归纳成一句话为:落实改革、鼓励创新、响应症结、监管趋严。我们期待下位法早日出台,顺利推进新药法的实施。

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To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions