Bend but don’t break: Future-proofing the pharmaceutical supply chain

Summary

这场名为'弯而不折：未来制药供应链'的活动探讨了在疫情期间，欧洲药品供应链面临的挑战及应对措施。专家小组包括国家及欧盟级别的代表和行业领导者，讨论了供应链的脆弱性、应对方法及未来改进措施。话题涵盖了疫情对制造、贸易、物流和患者用药获取的影响，并提出了通过信息共享、风险管理和全球合作来增强供应链弹性的建议。总结指出，供应链的强韧性需要多层次的合作与有效的政策实施。

Takeaways

• 🌐 欧洲药品供应链在新冠疫情的考验下暴露出了问题，需要加强其弹性和效率。
• 💊 药品短缺问题在疫情之前就已存在，疫情加剧了这一问题，需要更好的准备和解决方案。
• 📈 供应链的复杂性和全球化导致了难以预测的脆弱性和依赖性，需要更好的信息共享和透明度。
• 🤝 行业和公共机构需要合作，通过共享风险管理方法来提高供应链的弹性。
• 🛂 欧盟委员会正在采取行动，包括强化立法和建立新的管理机构来应对药品短缺问题。
• 🔍 欧盟委员会发起了结构性对话，以更好地理解、映射和解决供应链中的脆弱性。
• 🏛 国家机构在药品供应链管理中扮演着关键角色，需要与欧盟机构合作，共享最佳实践。
• 🔗 强化信息共享和数字倡议，如电子处方和远程咨询，可以提高供应链的效率。
• 💡 公共采购政策可以被用来支持药品供应链的安全，通过奖励那些超越立法要求的公司。
• 🌍 全球供应链在某些情况下是资源而非风险，但也需要确保欧洲在制造和研发方面保持强劲。

Q & A

如何理解欧洲药品供应链面临的挑战？

欧洲药品供应链面临的挑战主要包括生产、贸易、物流的中断，以及对药品的最终患者获取的影响。这些挑战可能由极端天气、工人短缺等因素引起，导致药品供应链出现所谓的“完美风暴”。

新冠疫情对药品供应链有哪些具体影响？

新冠疫情导致了药品活性成分的短缺、药品的囤积行为、分销的中断以及关键工作人员的短缺，这些都对药品供应链的稳定性和效率提出了考验。

如何提高药品供应链的弹性和效率？

提高药品供应链的弹性和效率需要从多个方面入手，包括加强信息共享、风险管理、供应链的多元化以及提高透明度。此外，还需要考虑如何在全球范围内合作，以应对潜在的供应链危机。

为什么需要在欧盟层面上合作来解决药品供应链的问题？

在欧盟层面上合作可以确保成员国之间的协调一致，共享最佳实践，避免市场失灵，并共同应对跨国界的供应链挑战。此外，欧盟层面的合作还可以促进立法和政策的统一，提高整个欧洲药品供应链的安全性和稳定性。

为什么说药品供应链的透明度对于确保药品供应至关重要？

透明度能够让所有利益相关者了解药品供应链的各个环节，从而及时发现潜在的风险和问题。通过提高透明度，可以加强供应链的风险管理，确保药品供应的连续性和安全性。

在新冠疫情期间，意大利药品监管机构采取了哪些措施来应对药品短缺问题？

意大利药品监管机构（AIFA）通过科学的方法来应对药品短缺问题，包括与各个利益相关者合作，建立系统来识别和管理药品短缺的不同原因，并在疫情期间成功地避免了药品短缺的风险。

为什么需要对药品供应链进行风险评估？

风险评估有助于识别和理解药品供应链中的潜在脆弱性，从而可以提前制定应对措施，减少药品短缺的风险，确保药品供应的稳定性。

如何定义和识别关键药品？

关键药品通常是指在特定危机情况下必需的药品，如新冠疫情期间的ICU药品。识别关键药品需要考虑药品的供应链脆弱性和药品的临床需求，以确保对最需要的药品进行重点关注和保护。

为什么说信息共享对于提高药品供应链的弹性至关重要？

信息共享可以加强各个利益相关者之间的沟通和协作，使得供应链中的每个环节都能够及时响应变化，共同应对挑战。通过信息共享，可以更有效地管理风险，提高整个供应链的透明度和响应速度。

为什么需要在国家和欧盟层面上同时关注药品供应链的挑战？

由于药品供应链的复杂性和跨国性，需要在国家和欧盟层面上同时采取措施。国家层面可以针对具体的国内情况制定和实施政策，而欧盟层面则可以确保成员国之间的协调和一致性，共同应对跨国界的挑战。

如何确保在制定新的欧盟药品立法时，各成员国不会采取相互矛盾的措施？

确保各成员国在制定药品立法时保持一致性的关键在于加强欧盟层面的协调和沟通，分享最佳实践，并确保所有成员国都参与到立法过程中，以便在尊重各国特定情况的同时，实现整个欧盟范围内的协调一致。

为什么说药品不仅仅是消费品，而是涉及到患者生命的重要物资？

药品不同于一般消费品，它们直接关系到患者的健康和生命安全。因此，在药品供应链管理中，需要特别关注药品的安全性、有效性和及时供应，以确保患者能够得到必要的治疗。

为什么需要在药品供应链中实施基于风险的管理方法？

基于风险的管理方法可以帮助识别和管理药品供应链中的潜在问题和威胁。通过对不同药品和供应链环节进行风险评估，可以采取针对性的措施，优化资源分配，提高供应链的整体弹性和效率。

如何在全球范围内提高药品供应链的质量和效率？

在全球范围内提高药品供应链的质量和效率需要国际合作，包括制定和实施全球统一的质量标准，加强跨国界的监管协调，以及促进信息共享和技术交流。此外，还需要考虑如何利用全球供应链的优势，同时减少其潜在的风险。

Outlines

00:00

😀 欢迎与开场介绍

本段作为视频会议的开场，由独立健康记者Sue Savil主持，介绍了会议主题为'Bend but don't break: future proofing the pharmaceutical supply chain'，强调了新冠疫情对欧洲药品供应链的考验，包括制造、贸易、物流等方面，并最终影响到患者的药品获取。提到了活性药物成分短缺、药品囤积、极端天气条件、关键工人短缺等问题，这些问题共同导致了全球供应链的困境。会议旨在探讨如何从疫情中学习，以及如何提高供应链的弹性和效率。Sue邀请了包括罗马尼亚慢性疾病患者组织联盟(KOPAK)主席Radu Ganesku在内的一系列优秀演讲嘉宾，并鼓励观众通过提问功能参与讨论。

05:01

🌐 疫情对供应链的影响及未来展望

Radu Ganesku在本段中讨论了新冠疫情对供应链的具体影响，包括对患者和公民的影响，以及由此引发的可持续性问题和各种危机。他强调了不同健康系统和不同法规对供应链构成的挑战，并指出了生产依赖特定行业或地区（如亚洲）可能带来的风险。Radu提到了医疗设备短缺和血浆采集问题，强调了减少对外部依赖、增强欧盟内部资源的重要性，并呼吁在未来几年内就此问题进行深入讨论。他还提到了数字解决方案如电子处方和远程咨询，但指出这些解决方案的实施并不均衡，且研究表明供应链中断可能导致数千例额外死亡和发病率。Radu强调，患者更关注解决方案而非造成中断的原因，并呼吁在微观和宏观层面上寻找解决方案，同时强调了患者组织在信息传递和与各利益相关者合作中的作用。

10:03

🤔 供应连弹性的关键议题

在这一段中，讨论转向了如何确保药品供应链的弹性。Sylvain Jiro作为欧洲委员会的代表，强调了信息、知识和证据在良好政策制定中的重要性，并指出了市场持有者有义务确保持续供应的现实，以及当前面临的系统性短缺问题。他提到了供应链的复杂性、全球化带来的脆弱性和依赖性，并强调了需要更好地理解这些因素以应对挑战。Domenico Di Giorgio，意大利药品局的主任，分享了意大利药品局在药品短缺问题上的科学方法和经验，包括与不同利益相关者的合作，以及在疫情期间如何有效应对药品短缺风险。他还提到了意大利在2005年就建立了可追溯系统，用于监控产品流动和保护分销网络。

15:03

🛠️ 供应链弹性的行业视角

AstraZeneca的供应链经理Marco Farinelli在本段中分享了他对供应链弹性的看法。他强调了信息共享的重要性，并提到了疫情期间行业如何通过与监管机构的紧密合作来管理风险。Marco提到了业务连续性计划或短缺预防计划作为新工具，以共享供应链信息，并与监管机构共同设计风险管理方法。他还强调了基于风险的方法来确定不同药品的特定需求，如API级别的库存或第二来源，并呼吁行业、监管机构和公共当局之间的合作，以提高供应链的透明度和弹性。

20:04

🔍 欧盟在供应链中的角色

Silva在本段中讨论了欧盟在药品供应链中的角色，包括管理短缺情况、修订立法以及在全球范围内合作确保供应链安全。他提到了欧盟已经采取的措施，如加强VMG和EMA的授权、创建新的HERA机构来专门负责危机管理，以及提议修订制药立法以增强供应安全和解决短缺问题。Silva强调了与成员国和行业合作的重要性，并提到了结构化对话作为理解、记录和映射供应链脆弱性的工具。他还提到了最近发布的关于短缺根本原因的研究，以及如何将这些见解纳入制药立法的修订中。

25:06

🌟 国家层面的行动与合作

Domenico在这一段中强调了国家当局在增强供应链方面所需的工具，以及他们在2020年危机期间从欧盟委员会获得的支持。他提到了集中化的程序，用于从国外进口药品，以及紧急计划用于关键产品的国家生产。Domenico还强调了在不同成员国之间协调的重要性，以避免在请求和资源使用上的重复，并优化可用资源。他还提到了意大利自2015年以来建立的多方利益相关者对话机制，以讨论限制未来短缺影响的不同政策，并强调了开放对话的重要性，以便从患者的角度预测和应对挑战。

30:08

🔗 行业对供应链弹性的贡献

Marco在这一段中讨论了行业如何通过信息共享和与监管机构的合作来增强供应链弹性。他强调了在COVID-19大流行期间确定关键药品清单的重要性，并在这些特定产品上集中工作以提高供应链的弹性。Marco提到了全球供应链的复杂性，并强调了在某些情况下全球供应链如何帮助快速恢复和缓解潜在的短缺风险。他还提到了与贸易伙伴合作的重要性，尤其是那些与欧盟有相互认可的伙伴，并强调了在欧洲拥有强大的制造基础和能力的重要性。

35:08

🤝 合作与透明度的重要性

在这一段中，讨论集中在行业如何通过合作和透明度来提高供应链的弹性。Silva强调了在结构化对话阶段行业提供的信息不够细致，需要进一步分享更具体的信息以进行风险评估。Marco回应说，行业认识到需要在信息共享和风险管理方面进行更深入的合作，并提到了最近发布的关于脆弱性的研究报告作为朝这个方向迈进的一个例子。他还强调了在结构化对话中已经开始的基于风险的方法，并呼吁继续在这一基础上发展，以实现更实用的解决方案。

40:09

🏛️ 立法与市场失灵

在这一段中，讨论了立法在解决药品短缺问题中的作用，以及市场失灵的问题。Silva对于立法解决市场失灵的具体含义表示了疑惑，并强调了在现有立法中已经有关于供应义务的条款，但仍然存在问题。他提到了需要采取一系列措施，包括合作、公共采购政策以及全球质量标准的制定，以增强供应链的安全性。此外，他还提到了公共资金和补贴的重要性，以及如何有效地使用这些资金来支持制造业的绿色化和现代化。

45:10

🗺️ 欧洲与全球视角

在这一段中，讨论了在药品供应链问题上应采取的欧洲和全球视角。Domenico强调了在不同层面上的对话的重要性，包括私人和公共部门以及不同国家和地区之间的对话。他提到了在2020年危机期间意大利如何避免实施出口禁令，并强调了开放对话的重要性。Silva补充说，需要在全球政策中整合这些挑战，并强调了欧盟在全球标准制定和质量提升方面的作用，以及与全球合作伙伴的合作。

50:11

📋 结论与未来方向

在会议的最后，每位发言人都分享了他们对如何确保供应链弹性的最终想法。Radu Costa Ganescu强调了合作的重要性，并指出药品不是普通消费品，而是关乎患者生命的重要物资。Domenico Di Giorgio提到了建立科学基础、共享最佳实践以及促进欧洲和全球方法的重要性。Marco Farinelli强调了继续发展基于风险的框架和加强信息共享的重要性。Silva则强调了知识发展和证据收集的重要性，并提到了需要进行影响评估以确定解决特定问题的正确方法。最后，主持人Sue Savile感谢了所有发言人和观众的参与，并宣布会议结束。

Keywords

💡供应链

供应链指的是产品从原材料获取、生产、分销直至最终用户手中的整个流程。在视频中，供应链的主题是围绕药品供应链的韧性和效率进行讨论，特别是在新冠疫情对欧洲药品供应链造成前所未有的考验后。例如，讨论了如何通过改进供应链来应对药品短缺、物流中断等问题。

💡药品短缺

药品短缺是指药品供应无法满足市场需求的情况。视频中提到了由于生产、贸易、物流等因素影响，导致药品短缺，这直接影响了患者获取药物的能力。例如，提到了活性药物成分的短缺和极端天气条件对分销的干扰。

💡韧性

韧性通常指在面对压力、冲击或变化时保持功能的能力。在视频讨论中，韧性是指药品供应链在面对如疫情这样的危机时，能够维持药品供应并快速恢复正常运作的能力。例如，讨论了如何通过更好的信息共享和风险管理来增强供应链的韧性。

💡信息共享

信息共享是指不同组织或个体之间交换和利用信息的过程。视频中强调了信息共享在提高供应链透明度和效率方面的重要性。例如，提到了通过信息共享来更好地管理风险和预防短缺。

💡风险管理

风险管理是指识别、评估和控制可能导致供应链中断的风险的过程。视频中提到了在疫情期间，通过更紧密的合作和信息共享来进行风险管理，以确保药品供应链的稳定性。

💡法规修订

法规修订涉及对现有法律法规进行更新或改进以适应新的情况或挑战。在视频中，讨论了为了提高药品供应链的安全性和减少短缺，可能需要对药品法规进行修订，例如加强供应义务和透明度。

💡市场失灵

市场失灵是指市场无法有效分配资源或提供商品和服务的情况。视频中提到了市场失灵可能是导致药品短缺的原因之一，暗示可能需要通过立法或其他政策干预来解决这一问题。

💡关键药品清单

关键药品清单是指在特定情况下，如公共卫生危机，对医疗系统至关重要的药品列表。视频中提到了制定关键药品清单的重要性，以识别和优先解决这些药品的供应链问题。

💡全球供应链

全球供应链涉及跨越多个国家和地区的货物和服务流动。视频中讨论了全球供应链在药品生产和分销中的作用，以及如何平衡全球供应链的优势和潜在风险。

💡国家和欧盟层面

视频中提到了在国家和欧盟层面上采取措施来解决药品供应链的问题。这包括通过国家法规和欧盟层面的合作来提高供应链的韧性和效率，以及共享最佳实践和科学依据。

Highlights

新冠疫情对欧洲药品供应链造成了前所未有的考验，影响了制造、贸易、物流，并最终影响了患者获取药品。

出现了活性药物成分的短缺、药品囤积现象，极端天气条件扰乱了分销，以及关键工人的短缺等因素，为全球供应链带来了完美风暴。

疫情揭示了供应链中存在的问题，需要更多的信息和覆盖，以及在欧盟层面上的伦理覆盖。

依赖特定行业或像亚洲这样的中心地区可能会危及我们生产的稳定性，并导致不同的短缺。

未来可以通过改进医疗设备收集血浆的问题，因为欧盟目前高度依赖美国，而我们更希望在欧盟有自愿非报酬的献血者。

不同欧洲国家采用的数字解决方案，如电子处方和远程咨询，可能有助于解决供应链问题，但目前的应用不均衡。

研究表明，分销中断可能导致数千例额外死亡和发病，因此患者需要在正确的时间获得正确的治疗方法和正确数量的治疗。

患者对造成中断的原因不感兴趣，而是对解决方案感兴趣，并希望积极参与发现微观层面的真正解决方案。

欧洲委员会提出了多项倡议，包括发布关于药品短缺根本原因的研究，并考虑如何将其纳入修订的农民立法中。

意大利药品监管局（AIFA）从科学角度处理药品短缺问题，并在疫情期间成功地应对了药品短缺的风险。

供应链的弹性在疫情期间被置于聚光灯下，信息共享和风险管理是提高供应链弹性的关键。

全球供应链的多样性对欧洲的药品生产至关重要，需要确保欧洲在研发和制造方面的强大地位。

欧盟委员会强调成员国之间的合作，以及与制药行业的利益相关者合作，共同应对药品短缺的挑战。

欧盟委员会将提出修订药品立法，以增强供应安全，并通过具体措施解决短缺问题，包括加强供应义务和透明度。

结构化对话过程旨在让国家当局和利益相关者聚集一堂，更好地理解和绘制供应链的脆弱性。

技术顾问Technopolis的报告强调了药品短缺不仅仅是供应问题，而是供应在哪里的问题。

欧盟需要在全球范围内整合药品政策，以应对全球性的挑战。

意大利的经验表明，通过国家层面的多方利益相关者对话，可以有效应对药品短缺问题。

结论是，为了确保供应链的弹性，我们需要共享信息、分享最佳实践、合作，并在国家和欧盟层面上采取行动。

Transcripts

well hello

and welcome to this fp event entitled

bend but don't break future proofing the

pharmaceutical supply chain well how

timely this is of course because the

pandemic has tested europe's medicine

supply chain like never before it's

affected manufacturing trade logistics

and of course ultimately patient access

to medicines

we've seen shortages of active

pharmaceutical ingredients we've seen

stockpiling of medicines as well as

things like extreme weather conditions

disrupting distribution and also

shortages of critical workers and other

factors which have created something of

a perfect storm for the global supply

chain

well keeping up with fluctuating demand

can be challenging at the best of times

so what has been learnt from this

pandemic

how can the resilience the efficiency of

supply chains better be enhanced and

ensured

well with us to address some of these

questions we have an excellent panel of

speakers and you'll be able to put your

questions to them you can use the

question q a function

on your screens if you have any other

issues like technical use the chat

function but please do submit your q a

questions we look forward to putting

those to the panel later on in this 55

minute rather brief session to cover

such an important topic

the event is being recorded and it will

be available later on replay on the fpa

youtube channel you can promote it on

social media using the hashtag we won't

rest

my name is sue savil i'm an independent

health journalist and i'm delighted to

be guiding these discussions today and

very pleased now to introduce to you

radu ganesku who is the president of the

national coalition of organizations of

patients with chronic conditions of

romania known as kopak also the vice

president of the european patients forum

epf so radhu welcome to you and over to

you to set the scene for us now

hello and thank you and hello everyone

to that are participating here thank you

to be here and i'm delighted to

point some some

discussion subject

so indeed kobe 19 affect the supply

chain and like you say in the end they

affect the patient and the citizen of

the european citizens that leads to a

lacking the sustainability which leads

to various crises uh from different

reasons

where we're talking about logistics or

talking about production or distribution

we can put here also different health

system with different regulation and we

know that

this can be a problem in

in the supply chain

the pandemic has shown us

what we do

we are not yet prepared and

we need more information we need uh more

coverage uh ethical coverage in the

european union

uh for example raw material and

manufacturing are very important in the

part of the supply chain and it show us

in this period that

when we are depending on the certain

industry or a central region like asia

continent

can be endanger our stability of

production and can

go to different shortages

so

we

we have the example of medical equipment

that happen in this period and a lot of

uh

medical staff didn't have the the

material to work with the patients uh

another example that

maybe you can improve it in the future

and show us that the collection of the

blood plasma it's uh now uh well

becoming the issue because we are

depending about the united states and uh

i think we preferably

want to have voluntary non-remunerated

donors here in european union and

this dependency rate is quite high and i

think it's a relevant topic to discuss

in the coming years about

this subject because we will have eu

blood direct blood directive so it's

important to approach the subject

one of the

known

thing that would think that we have here

in

as a patient we have

different uh

shortages in uh

in the past years and not only because

of pandemic this kind this kind of stuff

is happening before the pandemic and

i think we need to prepare better in

order to understand

what solution we need to do we have some

countries in europe that apply a digital

solution maybe it's one of the the thing

that we can discuss about

e-prescription teleconsultation but

unfortunately the axis is unequal and

the study already suggests that the

distribution disruption may result in

thousands of excess

deaths and morbidity so uh

it's nothing new what i say now but the

patients need straight treatment in the

right moment at the right time and in

the right amount and this kind of

problems that happen in the pandemic

show us that

maybe we need to to improve many many

things

so

practically the patients are not very

interesting about the causes that make

these disruptions but

we are interesting in the solution and

we are

this doesn't mean that we don't want to

be actively participating discover the

real solution at the micro level of

course and uh make the

big solution at the macro level so

because of this

as a patient organization we always uh

can have the information and we always

can uh put our organization to to work

with

every stakeholder and of course we can

make and

assure an effective communication with

our patients so as a

member of apf

we apf fully support stronger eu

cooperation on assessment of value cost

effective rising reimbursement

procurement and in addition we strongly

support action to increase transparency

in sector so i think

i just put some some uh points over here

it's important to have this debate and

it's important to think about the future

to think about the future of our patient

patients of our citizen and uh we as an

organization will always be here to to

support that so thank you and uh i think

it's uh uh will be a great discussion

today and maybe not the the last one

maybe the first

one radhu thank you very much indeed and

as you say it's not new that we have

shortages and you highlight as well

equipment not just medicines thank you

very much for giving us that overview do

stay with us radu

for the questions coming up later and

our conclusions at the end be interested

to hear what you make of it all and as

you say the patient isn't so interested

in the causes but the but the solutions

and i think we're going to touch on both

of those so let's now meet our esteemed

panel of speakers to find out how we can

future proof the pharmaceutical supply

chain we're delighted to have with us

cameras on and microphones on please

panel we have sylvain jiro who is the

head of unit with medical products i'm

concerned about quality safety

innovation at dg sante at the european

commission

we also have domenico di giorgio who is

the director at the italian medicines

agency known as afer

and also marco farinelli supply chain

manager at astrazeneca and chair of the

supply chain working group for fp

welcome to you all we also have

apologies from mep dolores monserrat who

very much wanted to be with us today but

she has parliamentary business at the

european parliament uh and sends her

apologies so

perhaps to start with again to get an

overview of your positions it'd be

really useful to hear from each of you

in turn

what is your take on the key issues in

supply chain resilience uh silvajarro

perhaps i could turn to you first

thank you thank you sue good morning

everybody and thank you for inviting us

on me to join this

interesting conversation um thank you

also to raju because he said already a

lot of very very important things

um

in his introductory in his introduction

you know what is the the biggest

challenge we face and this is something

that you said already i think it's the

challenge of of

information the challenge of knowledge

the challenge of

uh evidence to base a good policy making

i'm speaking of course from the point of

view of public authorities here um it is

uh

and there is an article in the

legislation that says that uh the

marketplacation holders are

obliged to ensure appropriate and

continuous supply but the reality is

that as it has already been said we are

facing systemic shortages situation and

we're facing not only during crisis even

in time time of ease if i may say we're

facing a situation where um patients

and health professionals uh health

systems generally are not supplied with

the product that they would need to have

so this is a very critical situation

that

has been already mentioned many many

times even before the crisis and what

we're facing is a lack of understanding

a lack of information a lack of

knowledge about what is

what are the driving factors for that

it's because the supply chains have

become extremely complicated

many multiplexers many multiple steps

um and increasingly globalized with a

certain number of vulnerabilities

dependencies that sometimes are

difficult to map but difficult to

understand and this is what the

commission said we would do we would

want to do together with member states

with the stakeholders um in the pharma

strategy and we've launched a certain

number of initiatives including

yesterday we published a

study

on the root causes of shortages and how

that could

be

factored into the revision of the farmer

legislation so i stopped there and we

can come back to some of the actions the

commission is proposing

yes thank you very much indeed sir i'd

be really interesting to get the

exclusive uh top news for top live news

on your uh latest publication on that

but first uh let me turn now to uh

domenico for your overview of the

situation

yes thank you um

the

ifa uh started working from a scientific

point of view on the short supply of

medicines from many years and

we we were forced to face the

the different challenges of this

issue

since we

we had plenty of general press

information

regarding the

lack the

short supply of some specific medicines

that were not

covered by the regulation that was

already mentioned we know that we had

different issues related to the short

supply that were mixed up in the general

press report and even in the complaints

and in the studies that we

received from the field but

one of the

problem was that

the the issues that we were facing were

not always covered by the confidence of

the agency because if you are lacking

the supply of a specific medicine

it may be

for an issue related to manufacturing

that's in the duties of the

drug regulatory agency but it could also

be related to other issues like the ones

in connection with distribution that's

not always under the competence of the

pra

moreover we know that in the general

press mix up also the

difficulties in tenders related to

hospitals were considered as a shortage

issue but it was another another kind of

problem related to the

let's say the

resiliency of the distribution network

with respect to the rules for the supply

to hospitals so we know that that short

supply is a symptom

and we

set up

since the symptom is affect affecting

the patients and it's it makes no sense

to say that it's not in our duty

to

work on distribution we set up systems

for having all of the competent

authorities and the private stakeholders

cooperating

for

facing the different root causes of

short supply

considering

the

the disease

and not the symptoms so this scientific

approach was uh

proven to be effective and during the

pandemic italy was one of the countries

that better phased

the risk of short supply

and so we we are really happy that the

commission is working in

[Music]

let's say fostering the operation and

using the

best practices that member state

developed it is i think the right road

for getting out of this kind of issue

thank you

thank you very much really interesting

to hear there about your experience and

perhaps we'll share a bit more about

those best practices uh marco farinelli

what was your take on the the key issues

about supply chain resilience

thank you sue and thank you for inviting

me today first of all um so i

i was hearing so far um

important elements of of supply chain

resilience first of all let me highlight

yes definitely the pandemic had a role

in putting supply chain resilience under

the spotlight

so there is no doubt how supply chain

resilience is important for patients and

and and societies that that needs to be

uh a bit the object the shared objective

that we um that we that we all have here

uh i've heard about um

information sharing as an important

element and i've heard about risks and

there are risks of course in the in in

in the supply chain of medicines and we

have seen some of those risks coming

through in a negative way during the

pandemic that led to shortages or also

before but then we we had a bit of a

mixed bag i would say we also had cases

where risk was successfully managed and

at the end

uh patients continue to be supplied

despite a dramatic change in the in the

overall ecosystem demand has changed

there were limitations on uh you know on

workers moving for example uh

you know within borders and across

borders a little bit of a crumble of the

logistics services at the at the very

first stages

so the the work both cases of you know

of of good resilience and where

resilience can be improved

so resilience is definitely under the

right spotlight here um and i think one

of the keys to unlock the next level of

supply chain resilience because i have

said we we don't need to throw out the

baby with the with the bad water in a

way in this case is really working

together on information sharing on one

side leveraging as much as possible

digital initiatives that we see

growing uh in the in the eu i just want

to mention very briefly the european

medicine specification system or

traceability systems in general they can

be a way there can be a way to share

information across the supply chain

of course this doesn't need to replace

at all

voluntary uh sort of uh

voluntary notifications from from

marketing authorization holders that is

more a complementary aspect and a new

aspect we could we could explore when it

comes to risk i think what the pandemic

has taught us is

what what can we do uh with more

collaboration on risk management

this is what happened during the

pandemic we we provided

more more information more visibility we

have worked closely with with regulators

we started to work together on risk risk

mitigations and i think we can work

together also on risk prevention

honestly this wants to be one of the one

of the proposals for example we have

heard several times the importance of

business continuity plans or shortage

prevention plans as they are also

also known potentially they um

that they can be a new a new tool uh to

share more information around our supply

chain especially with regulators

so that a shared risk management

approach can be can be designed and then

the adequate policies will

sorry the adequate measures in the

supply chain can follow because

not every medicine needs the same

intervention

there are medicines that will need more

inventory for example more inventory

maybe at api level or at both level

other medicines will require a second

source for instance but it really needs

to be based on a risk-based approach to

be

the most effective and successful

thank you

well

thank you each very much indeed for for

setting out your stalls there um and

please mayor remind the audience we want

your questions you you have a fabulous

panel here to quiz it's your opportunity

to put your questions to them so do pop

those in the q a function and we'll come

to those and take as many as we can but

meanwhile i just want to tease out a

little bit more from that silva you were

saying there about the

the study that was published just

yesterday into the root causes and the

european commission has of course had

many initiatives looking into the causes

the vulnerabilities of supply chains

what are your your key insights where do

you see the role of the european

commission and indeed the eu's

pharmaceutical strategy

in tackling this

thank you

no it's it's very interesting to hear

what macro was saying and the different

solutions that the industry is uh

thinking of i think this is this is very

important indeed that the industry does

that i think public authorities in fact

very much uh

trust that industry will assume the

obligations that the

legal obligations but also

responsibility from a social response a

socially responsible industry to ensure

the security of supply and to develop

reliable and robust supply chains and to

address some of the issues whether they

are in times of crisis or whether they

are

more systemic to ensure that there is a

continuity of supply and security of

supply and to ensure also the necessary

coordination within their commercial

supply chain with their within their the

different

industries that are involved because

it's a very complex process we are aware

of that

but

we also recognize that there is a

a role for a

cooperation between the national

authorities and in fact the national

authorities have realized that they need

to as i think domenico said

they they are they are facing a

situation where they don't have the

knowledge or the competence or the

capacity or the information to be taking

measures and then ultimately they are

the ones that have to face the

difficulties in terms of public health

so they are the ones that need also to

put in by certain number of measures so

what we're saying in the pharma

strategies that we need to be looking at

this

from two angle

one is the management of shortages

situation whether systemic or crisis

related and we have already put a

certain number of

each of um tools in place in particular

for the time of crisis we've reinforced

the mandate of vma and through ema and

the network of national authorities

national competent authorities national

agencies for medicines through that

network we have now developed

because we've also learned from the

crisis tools to work together and

address some crisis situation we've also

created a new authority that is going to

be specifically responsible for crisis

management including in relation to

shortages and supply security of key

medical products this is hera you've

heard about that and this is also an

action in that context so that that's

the first uh

center of of issue of actions the second

set i think is the revision of the

legislation we have announced in the

strategy that we will revise the

legislation and in fact we have said

very i read from distract from the

strategy here the commission will

propose to revise the pharmaceutical

legislation to enhance security and

address shortages through specific

measures including stronger obligations

of supply and transparency earlier

notification of shortages and withdrawal

and hence transparency of stocks and

stronger your coordination and

mechanisms etc so i'm from what i heard

from marco i think i understand that

these are also the kind of measures that

the industry is prepared to

work with and this includes indeed the

type of things he's talking about in

terms of management plan risk assessment

your information

and so on

so that's the second set if you want

there is a third set i said there would

be two but there's a third one which is

um

cooperation on uh supply chain

uh uh

security

uh from a more global point of view and

on that we have uh set a process that we

call the structured dialogue

where we brought together the national

authorities and the stakeholders to

discuss and try to understand better

document better map better those

vulnerabilities try to answer the

questions

what is a robust supply chain

what are the criteria that make them

vulnerable what are the how do we assess

dependencies are dependencies from the

country a problem or not what are the

conditions for it not to be a problem i

mean we've had millions of well not

millions but quite a few questions that

the commission asked to the participants

in this

conversation and we only got

i mean we got a good feedback but

probably we were a bit disappointed by

the information we got in the way that

we don't feel that we now have a very

strong

body of evidence as to what the actions

needed to be done in parallel we were

developing this study or we were

commissioning this study uh which i i

mentioned and which was published

yesterday

which is looking specifically also at a

certain of these aspects including the

revision of the legislation and the

consultant this is i have to emphasize

that this is done externally by the

consultant that has worked independently

so everything they said do not

necessarily reflect the views of the

european commission but the the this

consultant has done this the work and

has actually relied on a lot of

consultation discussions uh workshops

and different uh

consultation mechanisms they're making a

series of 16 recommendations um which in

a way uh also uh reflected to what a

certain number of things that we've been

saying um in the pharmaceutical strategy

uh in november last year and that we've

been started to implement and discuss

and work together

um i want to say that this is something

that is now very very much

um

a multi-level policy making

between member states and the eu level

there are things we can do together at

each level and there are things that are

also national policy making and we need

to make sure through the european tools

that we can also support and accompany

the national policy making

silva thank you and let's put that

straight over to domenico you talk about

the national authorities and what their

competencies are and their role in this

um dominica what what tools do you need

as a national authority in order to to

enhance the supply chain and you made

the point yourself the distinction

between what the shortages are where

they are whether it's manufacturing or

distribution

i think that during the

during the 2020 crisis we had

good support from the commission with

respect to

joint procurement for instance

because it was a very good tool for some

specific product that were under short

supply

and that were not considered before as a

possible

crisis point so icu medicines are a good

example

um

we already have immediately a

similar tool for

similar tools for managing this kind of

crisis so we have centralized the

procedure for importing medicines from

abroad for instance in case of shortages

and we also have emergency plans for

[Music]

state manufacturing of some key products

but having

the

euro support in the member states this

way by looking for

these

short sublime medicines in third

countries was really effective also

because

it was again a good way for duplicating

some of the good practices that member

states were

put in in operation during this crisis

so we had

member states coordinating the the field

structures

like italy did

for avoiding duplication in requests and

optimizing the use of available

resources at this level

as you know and i can also answer to one

of the questions that i noted in the

meantime that italy had traceability

system in place in

2005. so we we use

at the state level processibility data

for uh

checking the

for protecting the distribution network

but also for knowing

the movement of key products so that

we are

using this information in a very

restricted way without interfering with

the competition between companies but

having an eye

to the risk of a

short supply of

critical medicines

using the different tools that we have

available is uh

clearly another value and

learning from the experience of other

countries

is

also relevant from this point of view

the role of europe is critical because

the commission

supported member states in sharing good

practices and in the

study that was already mentioned there

are also

the country fish related to the good

practices that are

available in the different member states

that will be published i think during

this week

that are a very good source for

inspiration

for

the member states in sedina policies

so the there is uh there are many

different roles from the practical one

supporting with the joint procurement

to the let's say scientific ones

giving

scientific basis for for

working together that are up to the

european authorities and we are happy to

see that we can work together this way

thank you

turning to marco now from an industry

perspective what would you say actually

constitutes a strong supply chain um how

did the industry cope and avoid worse

shortages than during covert

yeah i think there were two elements

you know with the risk of repeating

myself but you know to work around

information sharing and the and the

support that only an authority could

give you know conscious that you know we

we need to adhere you know we don't need

to distort competition

was key so we we need to play your part

with information sharing and then

authorities can help to uh tackle where

there is an actual need of a product and

that's the in a way the transparency

that we are missing

um at this stage um what i want to

highlight is is also very important to

have the right uh focus so uh all this

needs to be managed through um a clear

risk assessment exercise that that that

is done up front with covid of course

that that exercise was was done you know

very early on uh sort of a critical

medicines list was identified and then

focus and work on supply chain

resilience has been put on on those

specific products now we cannot work

under emergency all times but definitely

the concept of a list of criticalities a

list of vulnerabilities for example or

products that are at higher risk that we

need to address can be sort of a

business business as usual um approach

to take where you know where to provide

additional information

where to put the focus as a

as a supply chain the other element i

would bring

and maybe is also linked to one of the

questions i have uh seen coming through

is around the role of global supply

chains again we have seen a mixed bag

there there were examples of where

global supply chains don't help and and

though in that case we do have a

vulnerability that needs to be addressed

but in other cases actually global

supply chains have have helped us to

more quickly recover uh from uh from a

potential shortage risk and and to

mitigate that and also let's be aware

that for uh for certain medicines or

vaccines uh we in a way we cannot avoid

a globalized supply chain so sometimes

we don't have as manufacturers they look

the the

luxury of choice in a way

we need to you know we need to tap into

specific technology specific

capabilities and in that case you know

looking at the at the broader global

environment it's a resource

for us rather than

rather than risk so in a way

we we are definitely happy with a strong

european footprint when it comes to

manufacturing

and to have

you know as european manufacturers uh

capabilities and technologies close to

home in a way but we also need to make

sure we leverage on the strengths of

global supply chains uh where uh where

there are strengths in the

in the

in the global supply chain of course and

then maybe the last element when it

comes to global supply chain is is also

uh maybe maybe working um also with um

with some of our trade partners

especially those where we have mutual

recognition

because of course we have very valuable

and capable uh

trade partners even inside you know

right at the heart of europe for example

so

uh i think that also needs to be needs

to be

acknowledged

thank you oh gosh a lot covered there a

couple more things i want to put you and

then we will go to the the questions

that are coming in and thank you for for

putting all of those um and if i could

ask our speakers perhaps to be quite

concise now in answers so we can crack

through as many of the questions as

possible silva to pick up on a couple of

the points there uh marco's saying that

there's a need then to keep that

diversity of the global supply chain but

also to make sure that europe is strong

it is a strong europe a strong ecosystem

in europe actually um

essential in terms of investment there

investment in terms of r d making sure

that europe is a strong place so that

where marco is describing about

re-shoring the bringing back of of

things into the supply chain in europe

if you've got a strong system in europe

that's going to be your good base silva

yes no but certainly i agree with all

this uh

this um the this is uh what we're saying

also in the pharmaceutical strategy i

mean we in the commission we've always

been at least that technical level that

i have to say quite prudent about this

concept of restoring and in fact we've

always

sold that what is important is not

restoring for reassuring

from the point of view of public health

authorities what is important is to end

systemic shortages

so if

some reassuring is an answer to that

objective because it makes sense

because it has been demonstrated by

evidence-based policy making that this

is a useful

action yes

but we're looking at this from the point

of view of a public health objective

of course it can be combined with other

policy objectives and it has to be

combined with other policy objectives

including industrial policy objectives

and objectives that are relating to

the competitiveness of the industry and

all these different objectives have to

be looked at it together and this is the

holistic approach we propose in the

strategy and the one we follow

uh i think i you know it's very

important that the things that markus

said that the industry would want to see

in particular in relation to a a system

that would allow for competitors to talk

together uh within a a comfortable um

within a sort of comfort zone that

would be uh cleared with competition

authorities i mean you know that the

commission is open to that and we have

discussed we've done something like this

during the pandemics and there are

possibilities for that so i think it

would be useful that you share with us

what exactly you're looking for and what

exactly you'd like to see

same thing in relation to uh

to you said we need a clear risk

assessment exercise

yeah i think this is what we in a way

unless i misunderstood you but

from what you said what you described as

the need for a clear risk assessment

exercise is exactly what we wanted to do

and still probably want to do and need

to do with the structured dialogue phase

one but the reality is that

to be very frank with you um

we were a bit disappointed by the

the the quality of the information the

granularity of the information we've be

getting from

the industry players so if we want to

really do this risk assessment we will

have to go one step further in how we

share information

um and this is this is i think an

important thing to say

thank you and let's put that then to

marco to to respond to

uh is industry doing enough then playing

its part i mean perhaps there's

something more that could be done in

terms of better use of the existing

national and european medicines

verification systems um collaboration on

a wider scale marco

yeah definitely so i think sylvan is uh

uh

pointing out right right on the spot you

know some of the some of the limitations

we have seen during the structure

dialogue okay so uh but i i think it's

it's a process you know that we started

with the structure dialogue so i i also

agree was was the information granular

enough

uh for you to have a clear understanding

of where the vulnerability these are

probably not we were more at a principal

level there

but i think a next step can come i mean

recently i have seen for example the the

study that has been published by dg grow

in the commission around around

vulnerabilities i think that's a very

good example of how we are trying to

move to the next step trying to identify

clearly the areas of risk and then of

course we can continue working on there

to make it more more tangible and

pragmatic because at the end of the day

uh you know we we

we need to you know we need to try to

foster this uh risk-based approach in

in our view during the structure

dialogue we started to do that

especially in work stream too i think we

have seen some

very important and good good work coming

through on some potential principles on

how to do that but it's something new so

in a way we need to

we need to learn from work uh and

understand how to um

how to best best move forward uh on

these basically uh but yeah definitely

if i can reiterate information sharing

slash transparency and and working on

you know on risk management together is

for us it definitely holds all the keys

to unlock a better level of

vulnerabili of supply chain resilience

yeah thank you we've got some great

questions coming in let's take some of

these now from from our audience

one here saying a question for silva we

hear that the commission considers

supplier obligations or distributor

obligations are important to reduce

shortages but an increasing body of

evidence points to market failure

um so is will the commission also

legislate on market failures perhaps

briefly silver and what's your response

to that one

well i'm i i'm sorry maybe i missed a

point but i'm not sure what what would

what would be legislating on market

failure i mean what exactly that would

mean

i'm not very clear

i think for us anyway legislation and in

particular the type of measures i listed

that the strategy

mentions and that have been also

reviewed through the study and it's only

one aspect of

of the way we we think we should address

the situation i mean it's

reinforcing obligations in the trick in

the in the art in the legislation

i'm not sure this is the answer because

you know there is already an article in

the legislation that says that there is

an obligation to supply and despite this

obligation there is a uh there are

problems so i mean we can always uh put

all the religiously you know you can

forbid people to park on pavement and

they still park on pavement so there is

a limit to what can be done with the

legislation there are other actions uh

in terms of collaboration in terms of

cooperation in terms of

other tools like public procurement uh

how public procurement can be uh

developed in a way that is actually uh

supports uh security of supply

how uh we work globally uh marco

mentioned that how do we work globally

with our partners um our i love trade

partners but also globally in global

forest uh on quality

standards on

developing level playing field i mean

these are elements that we mentioned in

the uh

in the in the strategy and and you know

they are definitely also a dependency of

instruments that are useful for uh

intensifiesing the the the the security

of supply chain uh there are also others

internal exams how do we reward um

companies or sectors that go beyond

the the legislative requirements in

greening manufacturing in greening

in in modernizing their production

process

how do we reward those that are

taking

socially responsible

actions in relation to the way they

produce in other parts of the world

where the social and environmental

standards are much lower i mean there

are many ways that we can look at these

things and we open to look at all the

different

policy but i want to insist on one thing

is that you know the panoply of

instruments we kind of know of course

there's also public money i should

mention that because yeah public money

subsidies um

state aids yes of course it's there too

but you know that it also needs to be a

good use of public money so all these

these instruments are there but you know

it's not very difficult to map those

instruments and we've done that what is

difficult is to have the evidence on

which

how to mobilize this instrument on the

basis of what we know the um the problem

is and it's this this is where this is a

bit the challenge we're facing at the

moment

thank you

another question that's come in um

margaret you touched on the need for a

critical medicines list could you just

briefly talk about is that needed um a

european level is it needed a global

level and who defines what's critical

yeah thank you that i i think this is

this is a very good question okay so um

i think i think a list of critical

medicines okay uh which which which

doesn't necessarily mean you know what

is more

medicine is more important than the

other that's not the concept you know

but but looking at critical medicines

list is usually what what kind of

medicines do i need to tackle a certain

crisis for example like like during

covet so

and and then the list of critical

medicines needs to look also supply

chain vulnerabilities so if you know if

i need a product but that supply chain

is very robust for example that's going

to be probably at a lower risk so it's

it's a way to really drive the focus of

all stakeholders on working toward what

is really needed okay so where are the

vulnerabilities that depends or you know

of um of where is the criticality that's

the first step okay

uh to do that uh now if it's eu or

national uh i think this is this is

where uh probably we need to you know we

we need to discover it a little bit um

of course i mean there could be market

specificities on certain product

registrations for example that we need

to that we need to account for but

ideally uh the more eu

let's stop at eu level for a second

because because global level brings

another

uh additional challenges but an eu level

list would definitely ensure we have a

harmonized way of looking at things

but we still need to recognize there may

be uh country specificities uh on this

so that is really the first step that

would that would then

allow us to

focus and work on uh supply chain

vulnerabilities increasing uh

transparency really addressing the the

remit in a very pragmatic way we have an

issue

and we and we see how to how to fix it

to trans through transparency and

and the shared risk management approach

thank you and another question that's

coming domenico i think this might be

for you because uh the point there marco

is making about what's done at uh eu

level a question coming in about while

we're working on new eu legislation some

member states start proposing national

legislation to manage the shortages so

the question is how can we ensure to

keep an eu approach to the common

challenge that's faced

that's uh

that's i think in the

previous part of our discussion because

the role of the commission in

[Music]

supporting the sharing of good practices

and

to support the discussion between

different stakeholders is

way granting this kind of coordination a

few levels

please consider that part of the issues

that we are discussing are related to

distribution and distribution is

nationally regulated and so it is clear

that the commission had to support

member states not in uh reinventing the

wheel or in

creating barriers against the

the

the market for instance

so that it is important always to

consider that we should

look at the problem in a global way

as it

was mentioned we

should consider

the dialogue between stakeholders and

between

member states and between regions and

countries as

the

the key for facing this issue

one of the points that we made during

the 2020 crisis in italy was that we

wanted to avoid any

block ban for export that was one of the

tools that were discussed during the

crisis and we never never did it in

spite of being one of the countries that

had uh most part of a product

in because we we are the manufacturers

key manufacturers of icu medicine so

propofol

for instance is basically manufactured

in italy we did not want to act in this

way because the better way for facing

the shock supply is to overrate not to

create barriers

the

i can give you an example of the

strategies that we put in place and it's

again on dialogue that the kind of

dialogue that the commission is

supporting

we know that we may have issues in the

medium term with the plasma derived

product with blood product

and so we

started as we

are doing at national level since 2015

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in general against short supply we set

up an adult group

of discussion with industries patients

association regional devices dealing

with blood gathering

for discussing the different possible

policies that we have for limiting the

impact of this fort comey

short supply

it means that we may act on economic

incentives as industry is proposing we

can work on

strengthening the blood gathering

supporting the regions in

in their gathering exercises we can

support industries in strengthening

their manufacturing lines in order to

have better production shares for the

blood that we gather

and we also can develop policies at the

ministry and urgency level

guidelines for us

optimized use of these short supply

products it means that having all of the

stakeholders around the same table gives

you

all of the available tools you you

cannot look at these problems

with the monodimensional approach

because we always have different

stakeholders private and public and you

have different approaches in

different countries and regions so we we

have to look at these issues as global

problems not with the

local view and i think that the

commission is in the right place for

supporting member states in

[Music]

changing their view from

the local

to a more regional and

global one

thank you and let's uh we'll put that to

to silva and to respond on that and the

reference um to the report that came out

by uh the consultant's technopolis

they're talking about it's not shortages

are not so much necessarily um of

something that whether it's available

but where it's available um silva i'm

picking up then from domenico's point

about uh whether it should be a global

perspective briefly

how much should europe uh give a global

perspective to this

well first i want to say that you know

dominica explained very very well i

think the situation in how this is

multi-level governance and how this

needs to be uh

addressed through a different level of

of government at national level this is

this is the reality we face in the eu i

mean

we have a system that uh for very good

reasons very legitimate reasons uh uh

has uh some eu level rules but also

national ones and it's a the product

we're not talking about any products so

the internal market is maybe different

from than it is for cars or for products

like this so they are for very obvious

reasons a very strong national level

that needs to be recognized and that is

very legitimate and so you know there's

a certain number of things that can be

done together there's a certain number

of things that can be done through eu

level legislation but there's also a

very high number of things that are done

at national levels through the national

rules and this national uh regulatory

context and that is i think very

legitimate uh so uh they when you're

talking about global well i think before

i i mentioned the need to integrate

those dimensions and those challenges

into the global policy our global policy

on on medicines and as i as i said you

know we we want to continue to do that i

think he used for example a very

important player with other parts of the

world in the in ich the global forum for

standard setting or quasi-standard

setting at global level uh and this is a

this is something we need to continue

there's also something called brcs which

is a cooperation on inspections between

authorities across the world i mean this

these are the kind of things we want to

continue and reinforce the presence of

the eu team as we now say member states

and commission in in the way that we

work on developing

highest quality standards or higher

quality standards across the world

thank you and thank you to everybody

who's put questions in

we have a very short session today and

there isn't time to address them all but

some of them touch on the same sort of

issues looking outside europe looking

how global we should be so thank you so

much for those in the last few minutes

i'd like to ask each of our speakers

and bring back radu costa

ganesku here to also

have a word with us about what you see

as your concluding thoughts on this

where could we go in terms of ensuring

resilience within these supply chains

and from what we've discussed today and

the points that you've considered um

perhaps right just a word or two to sum

up what would you say from the

discussions you've listened to

i think if you if you ask me it's clear

that we need to work together we need to

join action and uh if we want to have

results we need knowledge and

practically everyone here said about the

information we need to share this

information we need to share this best

practice and collaboration without that

it's impossible to to results to find

solution uh each one on his on his way

so working together have the same common

goals and uh we need to emphasize that

the medicine are not consumer goods like

any others

medicine are practically discussing

about patients life so that's why it's

important to have solution at national

level as a member state and also as

european level because otherwise it's

impossible to

take

to take the the tackling the problem and

uh find solution and i thank everyone

here today that participating and being

in this panel of discussion

thank you radu um domenico what's your

up some thought where do you see

the best solutions lying

i think that the

best

way for addressing the issue is to set

up together the

basis for the discussion the scientific

basis so dialogue sharing best practices

and fostering

the

european in this case and global

approaches

to the

key issues so the dialogue just like

we experimented in the last year thanks

to the many lines of action that the

commission set up all for also

the multilateral

dialogue that we have in place in italy

since 2015

the

having all of the stakeholders around

the same table

means that we can look at the issue

from the patient point of view because

as we mentioned during this

discussion this is the the key point we

have to support the patients and if you

do not have all of the stakeholders

around the same table you cannot

forecast what will happen because icu

medicines are clearly not in the

critical list

of the patients association because

that's something that we you can only

use during emergencies but if you have

an open dialogue you can

also work on the

forecasting thing that are not easy to

spot thank you um open dialogue uh

briefly marco and then silva your very

brief uh thoughts what is the priority

action to improve the situation marco

okay so i um i go first uh

maybe summing up i would say um priority

actions are uh really

continuing on what we have discovered uh

through the work we have done together

on uh on kovit so uh fostering and

trying to develop that risk-based

framework that we can that we can work

together on a harmonized approach across

the

um across the eu

and then strengthen information sharing

within within this remit thank you uh

silva briefly

priority action

well um

this is what i i started to say at the

beginning i mean i would say prior to

action is knowledge development evidence

uh gathering uh but i i want to say that

you know i also i liked it i needed to a

certain number of instruments in many

instruments

and to put them in motion we need to

do the the sort of impact assessment

that we usually do in a way that we need

to understand what is the right answer

to the specific types of problems we

have

thank you well thank you to all our

speakers for those contributions

uh thank you to fpf for organizing this

event thank you to all the audience for

your participation today and for the

questions coming in sorry we didn't get

to all of them but i hope that's given

you some food for thought the event has

been recorded and will be available

later on the fpa youtube channel to look

back at and think about my name sue

savile and it's been my pleasure to

guide these discussions today thank you

all very much for joining us goodbye