Bend but don’t break: Future-proofing the pharmaceutical supply chain
Summary
TLDR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
😀 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。
🌐 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。
🤔 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。
🛠️ 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。
🔍 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。
🌟 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。
🔗 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。
🤝 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。
🏛️ 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。
🗺️ 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。
📋 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。
Mindmap
Keywords
💡供应链
💡药品短缺
💡韧性
💡信息共享
💡风险管理
💡法规修订
💡市场失灵
💡关键药品清单
💡全球供应链
💡国家和欧盟层面
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
[Music]
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
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