EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
EU当局同意采取新措施保障COVID-19疫情期间所用药品可及性
Press release06/04/2020
The continued availability of medicines, in particular those used for patients withCOVID-19, is of criticalconcern for EMA and its partners in theEuropean medicines regulatory networkin light of the medical emergency presented by the pandemic.
根据疫情期间药品紧急方案，保证药品持续可及性，尤其是新冠患者所用药品是EMA及其欧洲药品监管网络中伙伴们的首要关切。
Some EU Member States have indicated that they are starting to see shortages of certain medicines used for patients with COVID-19 or are expecting such shortages to occur very soon. These include medicines used in intensive care units such as certain anaesthetics, antibiotics and muscle relaxants as well as medicines used off-label for COVID-19. EU authorities are therefore putting in place additional measures to mitigate the impact of the pandemic on the supply chain of medicines in a coordinated manner.
有些EU成员国已表示其开始看见到或预期在非常近期即会出现新冠患者所用特定药品的短缺。其中包括重症监护室所用药品如一些麻醉剂、抗生素和肌肉松驰剂，以及COVID-19不在其使用范围内的药品。因此EU当局正与各方合作采取更多措施降低疫情对药品供应链的影响。
The number of shortages of medicines hasincreased in the past few years and the issue is aggravated in this pandemic by many different factors, e.g. lockdown in factories due to quarantine, logistical issues caused by border closures, export bans, lockdowns in third countries supplying medicines to the EU, increased demand due to the treatment of COVID-19 patients, stockpiling in certain hospitals, but also individual stockpiling by citizens as well as at Member State level. To avoid shortages due to stockpiling, some Member States have imposed restrictions onthe number of packs that can be prescribed to patients or purchased by citizens.
在过年几年中，药品短缺数量已逐步增加。在疫情期间，短缺问题更加突出，原因有很多，例如，由于隔离而关闭工厂、由于边境关闭导致的物流问题、出口禁令、第三国向EU供应药品封锁、由于新冠患者治疗增加药品需求、一些医院大量储备药品等，还有市民和成员国大量储备药品的情况。为避免因大量储备而导致短缺，有些成员国已限制患者处方数量和市民购买的数量。
To help mitigate supply disruptions, the EU Executive Steering Group on Shortages of Medicines Caused by Major Events, which provides strategic leadership for urgent and coordinated action on shortages within the EU in this pandemic, is currently setting up, with the pharmaceutical industry, a system, the i-SPOC (industry single point of contact) system, to fast-track interaction on shortages between industry and the EU Executive Steering Group. With this system, each pharmaceutical company will report directly to EMA, both for centrally authorised and nationally authorised medicines, anticipated shortages or current shortages of critical medicines used in the context of COVID-19. It should be emphasised that, in arallel, these companies will continue reporting such shortages to thenational competent authoritiesconcerned.
为帮助缓解供应中断情况，为EU在此疫情期间提供药品短缺紧急协调措施战略领导的EU重大事件导致药品短缺执行委员会正在与制药行业设置一个称为i-SPOC（企业单点联系）的系统来快速追踪企业和EU执行委员会之间关于药品短缺的沟通。在该系统中，每个制药公司会直接向EMA报告集中审评批准和国家批准的新冠用药品可预期的短缺或当前的短缺情况。同时要强调的是这些公司亦会继续向相关国家药监当局同步报告短缺情况。
The i-SPOC system, which is similar to thesingle point of contact (SPOC) networkwhich was set up in 2019 between EMA and thenational competent authoritiesto share information on medicine shortages, is based on the appointment of an i-SPOC in each pharmaceutical company, who will feed information on current or anticipated shortages of COVID-19-related medicines to EMA. This new mechanism will allow better oversight of ongoing supply issues irrespective of the licensing route and a quicker flow of information with the pharmaceutical industry with the objective of mitigating and, if possible, preventing shortages in the context of COVID-19 medicines.
该i-SPOC系统类似于2019年建立的EMA与国家药监局之间共享药品短缺信息的单点联系（SPOC）网络，由每个制药企业中指定的i-SPOC向EMA反馈与新冠有关药品的当前和预期短缺信息。新机制将更好监管持续供应问题，不需要理会该药品是由何种方式批准，并能更快跟踪制药企业的信息，从而在可能情况下缓解和防止新冠药品的短缺。
In the context of the pandemic, EMA and the EU network are considering mitigation measures such as regulatory actions to support increased manufacturing capacities, e.g. through speeding up the approval of a new manufacturing line or site. Discussions are also ongoing with the pharmaceutical industry to increase production capacity for all medicines used in the context of COVID-19, and in particular for medicines potentially atrisk of supply shortages.
在新冠大流行情况下，EMA和EU网络正在考虑采取缓解措施如监管措施来支持企业增加生产能力，例如通过加快批准新生产线或生产场所。我们亦在与制药企业讨论增加COVID-19期间所用所有药品的生产能力，尤其是可能发生供应短缺的药品。
In addition, the EU Executive Steering Group is considering areas where regulatory rules could be applied with greater flexibility during the pandemic to secure supply of critical medicines. Further information will be given in a question-and-answer document, currently under development.
另外，EU执行委员会还在考虑在疫情期间哪些方面可采用更为灵活的监管规则，从而保证关键药品的供应。目前我们正在制订一份问答文件，更多信息将放在其中。
Although medicine shortages are dealt with at national level bynational competent authorities, EMA has been asked to take on the role of a central coordinator to actively support Member States’ prevention and management actions during this extraordinary health crisis. This is a new type of activity that cannot make use of existing mechanismsand means the Agency is having to put in place new ad hoc processes and prioritise resources to this activity. The Agency has been, for example, proactively gathering information from Member States to monitor or anticipate EU-level shortages in hospital settings. It has also liaised with Member States regarding how the export ban on 14active substances(APIs) issued by the Indian authorities impacts the availability of certain medicines in Member States.Together with its partners in the regulatory network, EMA is monitoring the situation very closely.
虽然药品短缺是由国家药监局在国家层面处理的，但EMA已被要求在当前特别卫生危机期间进行全面协调，主动支持成员国采取预防和管理措施。这是一个全新的活动，无法利用EMA的任何现有机制和方法来制订新的特别流程，对该活动所需资源进行优先排序。EMA已经，例如，主动采取成员国信息进行监测或预测EU层面医院设施中的短缺。我们已与成员国就印度禁止出口14种原料药的禁令对成员国特定药品可及性影响进行了联系。EMA目前正与监管网络的伙伴们一起密切监测药品短缺情形。
（译注：印度禁止出口的14种API为扑热息痛、替硝唑、甲硝唑、阿昔洛韦、维生素B1、维生素B6、维生素B12、黄体酮、氯霉素、红霉素盐、新霉素、克林霉素、奥硝唑、羟氯喹）
