世卫组织总干事陈冯富珍博士在英国药品监管局的演讲（中英对照）

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英文版：WHO Director-General Addresses UK Medicines Regulatory Authority.doc

中文版：世界卫生组织总干事在英国药品监管局的演讲.doc

Address at UK Medicines Regulatory Authority

在英国药品监管局的演讲

 

Annual lecture of the Medicines and Healthcare Products Regulatory Agency

药品和保健产品监管局年度讲座

 

From health care products to trust and reliance: the expanded role of regulatory authorities in an era of global health perils

从健康保健产品到信任和信赖：全球健康危害时代监管机构的新增作用

 

Dr. Margaret Chan, Director-General of the World Health Organization

世界卫生组织总干事  陈冯富珍博士

 

London, United Kingdom

英国，伦敦

 

1 March 2016

2016年3月1日

 

Distinguished staff at the Medicines and Healthcare Products Regulatory Agency, distinguished guests, ladies and gentlemen,

 

尊敬的药品和保健产品监管局的职员们，尊敬的来宾、女士们、先生们：

 

Thank you very much for the invitation. It is an honour and a pleasure to deliver the 2016 MHRA annual lecture.

 

非常感谢你们的邀请。在2016年的药品和保健产品监管局的年度讲座上发表演讲，我感到荣幸，也很高兴。

 

The infrastructures, mechanisms, and agencies that protect public health on a daily basis often go unnoticed until something terrible goes wrong, like drinking water contaminated with lead, melamine in infant formula, counterfeit cough syrups and fever medications that kill hundreds of children, or falsified yellow fever and meningitis vaccines.

 

基础设施、机制和机构如此年复一日地保护着公共卫生，但常常不被人们所重视，直到发生了恶性事件，例如饮水铅污染、婴儿配方食品中含有三氯氰胺，假造的咳嗽糖浆和发烧药品，造成数以百计的儿童死亡，或还有假造的黄热病和脑膜炎疫苗。

 

The reasons for these breakdowns are multiple: human error, a slip-up in good manufacturing practice, the greed that motivates criminal behaviour, or the sheer lack of regulatory capacity that dominates much of the developing world.

 

发生这些事件的原因是多方面的：人为的过失、在良好的生产制造过程中的疏忽、贪婪诱发的犯罪行为，或是大多数发展中国家完全不具备的监管能力。

 

The recent catastrophe with the water supply in Flint, Michigan is a tragic reminder of what can happen when the need to cut costs takes precedence over the duty to keep the public safe. It also shows how quickly a mishap can topple politicians and health officials and destroy public confidence in government.

 

最近发生在密歇根州弗林特市的供水灾难是一次惨痛的记忆，说明了只考虑降低成本，之后才履行保护公共安全职责，任何事情都有可能发生。它还表明，一场灾祸要使政客和卫生官员一败涂地以及毁掉公众对政府的信任会如此之快。

 

Work done by the UK’s Medicines and Healthcare Products Regulatory Agency, or MHRA, quietly and effectively protects public health on a daily basis. More specifically, it protects millions of people every day, in multiple ways.

 

英国药品和保健产品监管局，或简称MHRA，所做的工作就是天天都在默默无闻和有效地保护着公众健康。更具体地讲，这项工作每一天都以多种方式在保护着数百万人。

 

Public confidence in the quality and safety of medical products translates into confidence in national health services and confidence in the government’s commitment to protect its people.

 

对医疗产品的质量和安全性的公众信任转换为对国家卫生服务的信任和对政府承诺保护人民的信任。

 

I wonder how many members of the general public know all the things you do to gather product-related intelligence and build systematic and broad-based barriers to harm.

 

我不知道公众当中有多少人知道你们做的所有事情是在搜集与产品相关的信息和建立系统的和有广泛基础的屏障去阻止危害。

 

Your drug and device alerts and your marketing authorization and licensing work are well-known components of the regulatory framework.

 

你们的药物和器械报警信号和你们的销售部门以及发放许可证的工作都是监管框架中众所周知的组成部分。

 

I am thinking of other functions that give the public such a wide and sturdy safety net, while also creating space for innovation.

 

我正在思考其它的功能，给公众一个广泛和健全的安全网，同时也为创新打造空间。

 

I am thinking about the new toolkit for pregnant women that will make them better informed about the risk of developmental disorders and birth defects associated with certain prescription drugs. About promising innovative medicines that may be eligible, based on early clinical data, for inclusion in your scheme for early access to medicines.

 

我正在考虑为孕妇提供一个新的工具包，使她们对发育障碍和出生缺陷与某种处方药之间的关联的风险有更好的了解。根据早期临床数据，考虑关于将有前途的或许是合格的创新药列入你们的早日获得药品的方案中。

 

About the way you keep watch over the content of websites, addressed to consumers that promote prescription-only medicines.

 

关于你们留意保护网站内容的方式，对消费者的内容，推广只开处方药。

 

The support you provide to WHO and world health is immense. The reporting forms used in our 50-year-old programme for international drug monitoring are adapted versions of the UK Yellow Card Scheme.

 

你们向世卫组织和全球卫生提供的支持是巨大的。在我们长达50年之久的药物监测国际规划中使用的报告表格是英国黄卡方案的改编版。

 

Your labs have helped us unravel some deadly cases of contaminated medicines in several countries.

 

你们的实验室帮助我们解开了在几个国家发生的一些污染药品的致命案例。

 

With your support, we will soon issue an international good practice for regulatory authorities and inspectors that can help reduce incidents of incomplete presentation of data by manufacturers or deliberate data falsification.

 

在你们的支持下，我们很快将为监管部门和检察员推出国际最佳实践手册，旨在可以减少发生制造商提供的数据不完整或是蓄意的虚假数据的情况。

 

Our joint work on international nonproprietary names for pharmaceutical products benefits patients everywhere in the world.

 

我们在医药产品国际非专利商标名开展的共同工作惠及世界各地的患者。

 

Within the Agency, the National Institute for Biological Standards and Control, or NIBSC, is a global leader in assuring the quality of vaccines and other biological medicines, in developing standards and reference materials for worldwide use, and in carrying out applied research.

 

在监管局旗下，设立的国家生物标准和控制研究所，或缩写NIBSC，是确保疫苗和其它生物药品质量，制定供全世界使用的标准和参考资料以及进行应用研究的领跑者。

 

You are the leading WHO International Laboratory for Biological Standards and a designated WHO collaborating centre for polio and influenza.

 

你们是世卫组织生物标准国际实验室和指定的世卫组织脊髓灰质炎和流感的主要合作中心。

 

For the R&D community, having biological standards is equivalent to what postal codes do to speed up the mail and how country codes standardize international telecommunications.

 

对于研发界而言，制定生物标准与邮政编码如何加快邮递和国家编码如何使国际通讯标准化如出一辙。

 

As another added value for world health, your work on biological standardization makes it possible for new high-quality competitor products to enter the market on an equal footing with those from established manufacturers.

 

世界卫生的另一个附加值是，你们在生物标准方面开展的工作使新的高质量竞争者的产品与那些老制造商的产品公平进入市场成为可能。

 

Doing so has changed the market for public health vaccines, increasing predictable supplies and getting prices down.

 

这样的做法改变了公共卫生疫苗市场，增加可预见性供给和降低价格。

 

Working with your European Union and global partners, including WHO, MHRA responds to the challenges created by an increasingly globalized world. Biological and pharmaceutical products and medical devices keep growing in number and complexity.

 

药品和健康保健产品监管局与你们的欧盟和全球伙伴共事，包括与世卫组织共事，应对一个日益全球化世界带来的挑战。生物和医药产品以及医疗器械的数量和复杂性不断增加。

 

Supply chains are becoming ever more complex. Products are often produced by several companies. They may move through multiple countries and distributors before finally reaching the patient.

 

供应链变得更加复杂。产品常常由几家公司生产。产品或许要经过多个国家和批发商之后，患者才能最后拿到。

 

WHO welcomes the meeting you will hold in May to look at the future of biological medicines, including ways to keep the vaccine pipeline flowing.

 

世卫组织欢迎你们在五月召开会议，研究生物药品的未来，包括保持疫苗渠道畅通的方法。

 

New vaccines can be breakthroughs for global health, but they can also help address the problem of antimicrobial resistance, which is moving the world ever closer to a post-antibiotic era in which common infections will once again kill.

 

新疫苗对全球卫生而言是个重要的新发现，但它们也有助于处理抗微生物药物的耐药性问题，这使世界进入一个后抗生素时代向前迈进了一步，新的传染病将再次肆虐。

 

While all of these functions of the Agency and Institute may be out of the spotlight on a daily basis, they certainly become highly visible, and vitally important, during public health emergencies of international concern, like the recent outbreaks of Ebola and Zika virus disease.

 

虽然每日都关注的焦点或许并不是监管局和研究所的所有这些功能，但在国际关注的突发公共卫生事件期间，例如近期暴发的埃博拉和寨卡病毒疫情，他们的可视度自然很高并且举足轻重。

 

To support the WHO response to Ebola, MHRA fast tracked the review of clinical trial applications for Ebola vaccines. NIBSC fast tracked the development and production of five reference reagents for use in the calibration of PCR tests and serological assays.

 

药品和健康保健产品监管局快速追踪了对使用埃博拉疫苗的临床试验进行了评审的情况，旨在支持世卫组织应对埃博拉。国家生物标准和控制研究所也快速追踪了在校准聚合酶链反应试剂和血清测定中使用的五种基准试剂的研发和生产情况。

 

The reference reagent for serology assays helps standardize methods used to measure antibodies in epidemiological studies and in clinical trials of candidate vaccines and immune therapies.

 

血清测定的基准试剂有助于将流行病学研究和在候选疫苗临床试验以及免疫疗法使用的测定抗体的方法标准化。

 

Endorsed by WHO last year, these five reagents are the global gold standards used by anyone undertaking Ebola R&D. All of this work leaves the world better prepared for the next Ebola outbreak.

 

去年经世卫组织批准的这五项试剂是供任何人从事埃博拉研发使用的全球金标准。所有这项工作的目的，是使世界在下一次暴发埃博拉疫情时做好更充分的准备。

 

The new collaborative mechanisms that brought scientists, national health officials, pharmaceutical companies, and regulatory authorities together during the Ebola response establish pathways that can expedite product development during other health emergencies.

 

在应对埃博拉疫情期间，新的协调机制聚集了科学家、各国的卫生官员、医药公司和监管部门，建立了在其它突发的卫生事件期间加速推进产品研发通道。

 

This is happening right now with Zika.

 

这正是应对寨卡形成的局面。