1. Steering note
Description of the agenda, the topics to be discussed and the context
The teleconference wil take place on Tuesday 10 of March from 11:00 to 12:00.
The teleconference is planned to be private with senior management of Personal
Protective Equipment manufacturers and suppliers operating in the European Union.
Commissioner Breton wil chair the meeting. He wil open the meeting and after
introductory remarks he wil give the floor to the CEOs of PPE companies to discuss the
issue on COVID-19.
The teleconference takes place at a moment where the supply of Personal Protective
Equipment (PPE), mainly masks, is under particular strain.
Several MS have announced measures, such us seizing of stocks or export bans. On 4
March France introduced a measure requisitioning al stocks of FFP2 type masks as wel
as any further production on the national territory until 31 May. On the same date,
Germany introduced a restrictive measure covering a broader range of PPE (FFP-type
and surgical masks, protective gowns, gloves etc). Unlike the French export ban, the
German measure contains specific exceptions, subject to prior authorisation, including
regarding exports for the purposes of the Joint Procurement launched by DG SANTE.
Final y, the Czech Republic also adopted an export ban on FFP3 type masks, with no
exceptions. While there are indications that other Member States seem to be
considering adopting similar measures (LT, PL and BG), there are no indications that
such measures have been effectively adopted (see info in background).
A European procurement procedure for personal protective equipment is ongoing
under the Joint Procurement Agreement for medical countermeasures.
20 EU MS joined this joint procurement procedure that was launched on 28 February
2020. The companies wil have until 9 March to submit their offers. The Public
Procurement Committee wil assess these offers by April and the contracts are expected
to be signed in the course of April. The joint procurement asks for 220 mil ion face
masks.
The letter of invitation for the conference cal contained the fol owing 4 questions:
1.
Has your company taken steps to increase the supply of personal protective
equipment, which is in particularly high demand, such as disposable facemasks?
2.
Have you identified any bottlenecks, including of a regulatory nature, which
protective
equipment?
3.
Do you believe that there are any specific support measures that could be put in
place by the European Commission to support the various actors along the supply chain
of personal protective equipment?
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4.
What has been your compan
demand for personal protective equipment? According to your observations, is the
increase in demand being channel ed via your usual commercial channels or are you
also being solicited by new prospective clients?
2. Objectives
The objectives of the meeting are:
1) To obtain information on the current state of the market for Personal
Protective Equipment in the European Union.
2) To identify any remaining bottlenecks in the supply of Personal Protective
Equipment in the European Union.
3) Take stoke of request from the companies on where the European Commission
can help.
3. Key messages and Speaking points
The Commission is aware that at the moment, the supply chain for PPE products
and in particular of surgical and FFP type masks is under severe strain.
This constraint is due to the exponential growth of the demand, and the restriction
of exports of such equipment from China, which used to account for a significant
share of the global market.
The Commission is also aware that most of your companies have already taken the
relevant steps to either increase your manufacturing capacity, to relocate
manufacturing facilities or to diversify suppliers.
We welcome these measures and we would like to encourage you to pursue them.
I am confident that the European industry, which you represent, has the capacity
to respond to the current chal enge posed by the rapid spread of the virus in the
EU.
I also interpret the fact that you have responded positively to my invitation as a
sign of your wil ingness to take on this chal enge. My plea to you today would be to
act swiftly.
We al see that the wider spread of the virus induces panic. This panic puts
additional strain on a supply chain, which is already stretched thin on two fronts:
1. Citizens are rushing to buy PPE (face masks in particular), which creates
additional demand alongside your usual supply channels.
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2. Some Member States have introduced restrictions on the export of certain
types of PPE, which have a direct impact both on the manufacturing but also on
the distribution of PPE.
The Commission is committed to deploy al the tools at its disposal to fight against
this further spread of panic.
In particular, the Commission is working on guidance for the Member States who
intend to adopt measures to mitigate the risks related to the COVID-19 virus crisis.
The purpose of the guidance is to recal some relevant legal provisions and
common objectives to be pursued also at EU level, in order to support al Member
States in their current efforts.
The overal message is that any national measure should respect the spirit of
synergy and solidarity which would make the containment of the virus as effective
and as extended as possible at both national and cross-border level.
Final y, we are working closely with the Ministries of Health to identify and
coordinate the needs for PPE in each Member State and region.
From an industrial perspective, I am convinced that the only way to bring an
effective and timely response to the threat is to work together.
I know that a number of Member States have already reached out to the
respective PPE economic operators on their territories in order to discuss the need
to improve cooperation and the possible support measures.
The reason for
cooperation and elevate it at EU level.
I know that a number of your companies have manufacturing facilities or
distribution centres located in different Member States. Others among you have
suppliers located in two or more different Member States. Therefore, I believe that
only EU wide solutions could be effective enough to meet the needs of companies
such as yours who operate on a wider EU market.
Thus, I look forward to further discussing the points raised in my invitation. I am
grateful for the initial elements of response that most of you have provided. I
would welcome any further comments on your side with a particular focus on the
biggest chal enges that you identify today as wel as the possible support measures
that you would expect form the side of the Commission.
Any other issues:
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a. In addition to the mouth masks: Is the industry aware of any shortages
for testing kits?
b. DG Sante is also looking into launching another joint procurement for
ventilators, which could be raised today as wel .
c. The deadline for application of the EU Joint Procurement ends this
morning. The representative of DG Sante might be able to provide an
update.
4. Defensives on issues raised by the industry in response to
the invitation
Q:
What is the European Commission doing against Member State decisions to
restrict the trade of personal protective equipment?
The Commission is preparing a guidance document on restriction to export of
protective equipment and is in a constructive dialogue with the national
authorities in view of ensuring that public health needs in al Member States
continue to be addressed.
The national measures should be assessed under Article 36 of the TFEU, which
al ows restrictions of the free movement of goods. This provision al ows
Member States to temporarily restrict, under certain conditions, the sales of
products to other Member States, for instance to ensure the protection of
health and life of humans. It is for the Member States, within certain limits, to
decide the level of protection they wish to afford to their population.
Additional y, national measures have to be notified under directive 1535/2015.
In the spirit of EU solidarity, we favour a col ective and coordinated approach to
meet the health needs of the EU citizens, and in particular to ensure adequate
supplies where most needed in the public health services of the Member States.
The Commission understands the need of Member States to take actions in
order to protect public health. At the same time, the Commission supports
European-wide solutions that protect EU citizens on an equal footing without
unnecessarily hampering the free movement of goods in the internal market and
without creating or aggravating shortages or risk of shortages.
Q:
of personal protective equipment?
The European Commission is concerned by any measure that prevents the
arrival of vital equipment to the health professionals and patients in need.
We are monitoring the situation and exploring the possibility to react as
necessary.
Q:
What is the Commission doing to address the general disruption in the global
supply chains caused by the Corona health crisis?
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The Commission is careful y monitoring the situation, and gathering intel igence
from industry and respective trade associations. This is not only the case for the
Personal Protective Equipment industry but al other industries.
On the basis of the information col ected, we wil explore the need to adopt
possible support measure that would ensure that there is enough appropriate
equipment in the EU.
As such, could we ask that you provide us for precise information on materials
and other resources that are in short supply.
Q:
Today, healthcare services and institutions appear much focussed on single-use
mouth masks. However, there exists also re-usable mouth protection devices. What is
the Commission doing to promote re-usable mouth protection devices.
The Commission encourages healthcare services and professionals to consider
al appropriate equipment that can help to contain the disease.
We would be happy to receive ideas on any concrete actions that could be
undertaken to raise awareness on the possibility of re-usable mouth protection
equipment.
Q:
Around the world, different regulatory frameworks and requirements exist for
Personal Protective Equipment. This in turn limits and shapes the global supply and
manufacturing base of these PPE products. What measures could be taken to al eviate
such burden?
The PPE Regulation does not foresee any derogations to the requirements to
affix the CE marking, or to any of the other obligations, imposed upon the
manufacturers.
However, the PPE Regulation makes a distinction between formal non-
compliances, such as the absence of CE-marking, and more substantive non-
compliances. The enforcement of formal non-compliances is organised in such a
way that Member States are only required to prohibit the placing on the market
once non-compliance persists.
In this context, we could imagine that national market surveil ance authorities
may make use of this flexibility in the enforcement of the legal obligations.
Final y, there are some treaty provision under the TFEU, such as TFEU 114(8),
that may al ow for adapted measures by the Commission. However, these need
to further be investigated.
Q:
What is the Commission doing to promote a multilateral response that ensures
the supply of PPE across the world and within the EU? For example, by having an agreed
priority list for supply to healthcare professionals?
The Commission is supporting 20 EU Member States to jointly procure personal
protective equipment for healthcare workers for the care of patients with
suspected or confirmed novel coronavirus (COVID-19) under the Joint
Procurement Agreement for medical countermeasures.
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By pooling needs and increasing volumes to be procured, the Agreement
more balanced prices and shows a high level of solidarity between EU Member
States agreeing to share a limited availability of personal protective equipment
in the context of the ongoing COVID-19 outbreak.
It al ows for a greater exchange of best practices and pooling of expertise, and
ensures equal access to al participating Member States.
5. Background
Please note that the Background section comes straight from the Background
section provided for the EPSCO Health Council meeting of last Friday.
Therefore, the content of this section is not specifically adapted to the current
Teleconference.
Availability of stocks of personal protective equipment (PPE)
Since the outbreak of the crisis, the Commission has been in continuous contact with
manufacturers and distributors of PPE products designed to protect against biological
hazards. These include in particular: disposable face masks, re-usable face masks,
coveral s, gloves and skin care products. The aim has been to gather intel igence on
available stocks, manufacturing capacity and evolution of demand.
On the basis of the information gathered we can conclude that disposable FFP2 and
FFP3-type masks, as wel as surgical masks are the products where shortage is mostly
felt. 1 The supply chains of other PPE product such as protective goggles, gowns or
gloves are less impacted as the increase in demand is less drastic. A contributing factor
to this discrepancy in the demand between the different types of PPE products lies with
the fact that a high number of private citizens have rushed to buy face masks. The
unexpected/unusual demand from consumers has thus added on top of the already
high demand from the usual supply channels (e.g. healthcare providers, emergency
responders etc.).
1 FFP-type masks are items of PPE are tight fitting masks, designed to create a facial seal. Designed to
filter the air breathed in, the FFP-type masks can serve to protect healthy individuals from becoming
infected with the coronavirus, which is mainly spread by means of small droplets in the air.
There are three classes of FFP-type masks:
Respirator Standard Filter Capacity (removes x% of of all particles that are 0.3 microns or
larger)
FFP1
80%
FFP2
94%
FFP3
99.95%
Conversely, surgical masks fall within the scope of the Regulation Medical Devices. They are loose
fitting, covering the nose and mouth and designed for one way protection, to capture bodily fluid
leaving the wearer. Thus surgical masks may be used to avoid the further spread of the virus by
infected persons but not to protect healthy individuals from becoming infected.
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Available intel suggests that there has been contacts between the Member
launch of possible new manufacturing lines.
Similarly,
has started the production of
protective masks at the
manufacturing plant, as part
A new manufacturer of face masks has also started production recently in NO,
highly praised by the national authorities.
Joint Procurement Agreement
The overall framework for any joint procurement procedure is the overarching Joint
Procurement Agreement (JPA). This is a framework, which lays down common rules for
the practical organization of joint procurement procedures of medical countermeasures
for cross-border health threats, like diagnostic kits and services, laboratory services,
medication, vaccines, antivirals-treatments, medical devices and other goods and
services, decontamination kits, masks and protective equipment.
The Agreement adopted in 2014 is so far signed by 25 Member States and the UK.
Poland and Finland have not signed. Sweden joined the JPA last Friday, the 28th
February 2020.
For non-signatories of the JPA, any participation in future joint procurements is possible
but would necessitate becoming signatories of the JPA first. The UK, currently a third
party, may not participate in any new procurement procedures
Two procurement procedures are currently ongoing: one for pandemic influenza
vaccines and one for personal protective equipment.
Joint procurement for personal protective equipment - 2020
In line with Council Conclusions of the Health Ministers Council on 13 February, a
procurement procedure for personal protective equipment is ongoing under the Joint
Procurement Agreement for medical countermeasures.
20 EU MS joined this joint procurement procedure that was launched on 28 February
2020. (Austria, Belgium, Cyprus, Czechia, Germany, Estonia, Spain, Greece, Croatia,
Hungary, Ireland, Italy, Luxembourg, Latvia, Malta, the Netherlands, Romania, Slovakia,
Sweden and Slovenia. France is not among the MS who expressed interest in the
procedure.)
The companies will have until 9 March to submit their offers. The Public Procurement
Committee will assess these offers by April and the contracts are expected to be signed
in the course of April. The request is for 220 million face masks inter alia.
Further Joint Procurements
It is possible to launch further joint procurements, if the need arises.
Concerns about the potential strain on access to medicines were raised in the last
months. The press reported on Tuesday 3 March about suspension of exports to the EU
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of basic medicines (paracetamol, hormones, and antibiotics) due to delays of active
pharmaceutical ingredients from China.
As such, just like with the joint procurement of the personal protective equipment, any
additional joint procurements would also be subject to availabilities on the market.
Nonetheless, the mechanism is there and al ows for the procurement for medical
counter measures for serious cross-border threats to health, including COVID-19.
The Commission has been asking countries to provide information on any additional
needs already, but could specifical y enquire with Member States about the need to
begin additional joint procurements. A particular need could be for example on
respiratory equipment for treatment of coronavirus patients.
Regulatory/non regulatory bottlenecks
DG GROW assessed whether there may be any regulatory obstacles to increase in PPE
production.
Their conclusion is that the possible increase of production of PPE would not lead to an
increase in the administrative burden for the manufacturers. In particular, in the case of
manufacturers that are already producing such items of PPE, one could expect that no
particular impact on their ability to ramp up the production would stem from the
regulatory requirements. Also there wo
barriers/bottlenecks to the possible entry of new prospective manufacturers of PPE,
which may be foreseen at this stage.
To our knowledge there are no major non-regulatory barriers to entry/capacity
increase.
EU wide export restrictions under Regulation 2015/479
By Regulation 2015/479, the Commission may adopt measures, such as quantitative
restriction on exports, in order to prevent or remedy critical situations caused by a
shortage of essential products on the EU market and where Union interest cal s for
immediate intervention.
This Regulation was only exceptional y used in the 70s/80s in order to restrict exports of
steel scrap, but since then the situation has changed, the EU does no longer apply
quantitative restrictions and the EU usual y opposes export restrictions in the
international trade context. In any event, the Regulation was never used in order to
address considerations of public health, including in the context of the SARS outbreak.
Germany approached DG Trade in order to enquire whether this Regulation could be
used to restrict exports of protective equipment, and we believe it could indeed be used
in order to address the exceptional current circumstances.
From a procedural point of view, Regulation 2015/479 offers two possibilities:
measures (in the form of a Commission decision under a normal procedure or urgency
measures.
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Under a normal procedure option, the Commission can adopt measures under
examination procedure, after having consulted MS. The Commission proposal
should be submitted to MSs two weeks in advance of the Consultation
Committee. If the act concerns the protection of health or safety of humans, a
positive QMV of MS is required2.
In case of emergency (Article 5), the Commission can, on its own initiative or at
the request of a Member State, take restrictive measures for a limited time
period, by invoking an urgency procedure. These measures can only take the
form of subjecting exports to a prior authorisation3. This is therefore not an
export ban but an export authorisation. They can be adopted by the Commission
before consulting MSs. The duration of such emergency measures is however
limited to a maximum period of 6 weeks, during which the Commission should
decide whether to adopt appropriate measures as described above under a
normal procedure. If the emergency procedure is taken at the request of the
MS(s), the Commission should decide within five working days. No time limits
are set out in the Regulation in case of the own-initiative action.
In terms of substance, the Commission act should demonstrate that there is, at EU
level, the existence or the possibility of a critical situation it caused by a shortage of
products. The justification could fol ow the one made by Germany in its own export
restriction decision adopted on the 4 March 2020, albeit at an overal EU level: an
indication of an expected sudden increase of the demand for protective products, which
could only be satisfied if the EU production remains domestical y available, considering
export restrictions applied by other third countries.
The regulation would have to identify the products subject to the authorisation /
restriction with a sufficient level of precision to al ow the Member States and their
customs offices to implement it.
From a political point of view, the decision to restrict import at EU level is a balance of
interest between public health considerations and avoiding a patchwork of different
measures taken by individual MS. If a political decision is taken that the Commission
should provide for a framework to restrict EU exports in this particular case, there are
arguments to act both at the request of the MS or ex-officio under the urgency
procedure. In communication terms, it would be important to insist on the terminology
(ie. making exports of protective equipment subject to a prior authorisation vs an
export ban). We would suggest to leave the modalities of granting these authorisations
to MSs, so they can stil modulate the measures in terms of specific products (e.g. the
French measures covers only face masks while the German measure covers a wider
range of protective equipment) or individual situations (i.e. domestic spread of the
virus).
2 Regulation 182/2011, Article 5(4)a.
3 The Commission should specify the modalities of the authorisation.
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They only manufacture chemical suits. The company tries to increase the
production, to deliver in the field of disposal (e.g. asbestos and other
hazardous waste) restauration and cleaning.
Focus on the hospital market and more specific the CSSD (Central
Sterilization Service/Supply Department) in the hospitals.
Increase in demand for masks FFP1+FFP2 from Dutch hospitals.
Question 2: What are the bottlenecks, including of a regulatory nature, that
protective equipment?
There are serious bottlenecks to supply from Asia.
The most urgent and impactful bottlenecks are the new orders published in
France and Germany that restrict the normal supply of PPE within the EU.
Restrictions by Germany make it impossible to deliver FFP2 and FFP3
products within the EU.
Reusable masks: WHO and other respected organisations have gone out
with information only stating that N95/FFP2/3 masks protect. Since
manufactures masks conforming to much higher standards (EN12942
TM3P), people responsible for purchasing safety equipment, do not see our
products as an option.
PPE regulations around the world have distinct differences, which shape
the makeup of our global capacity.
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Mask production capacities and mask stock in China are under restriction to
be exported out of China.
is working on replacement products,
which will contain a revolutionary layer of fabric with
which deactivates all viruses and bacteria with a 99.9%
efficiency.
The biggest bottle neck is the amount production staff connected to the
production of half masks. Over time the component could be an issue.
Ban of exports is not clear if is also valid for reusable suits.
Question 3: What specific support measures could the European Commission put
in place to support the various actors along the supply chain of personal
protective equipment?
.
Urgently and quickly prevail upon the health ministries across Europe, and
particularly in Germany and France, to rescind their orders restricting trade
within the EU.
Develop a cohesive joint multilateral European Union response to
safeguard the supply of healthcare institutions across Europe. This would
include deployment of a robust and effective campaign against misuse and
unreasonable purchases, which is among the root causes of the current
supply shortages.
Apart from the belief that export restrictions within Europe do not help we
do not see any specific steps.
Commission to inform all purchasing bodies the ladder in which respiratory
protection equipment is classified and also publicise information about the
cost savings of going reusable.
The Commission to help provide recognition of equivalent performance
standards.
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The Commission to prioritise demand among member states according to
the need.
Strategic collaboration between the EU and key industry players for future
pandemic crises.
The Commission to urgently and quickly prevail upon the health ministries
across Europe, and particularly in France, to rescind their orders restricting
trade within the EU.
Question 4: Is the increase in demand channel ed via your usual commercial
channels or are you also being solicited by new prospective clients?
blocked access to our PPE from all new customers. Historic
customers are very carefully allocated quantities at a ratio of their historic
purchases.
The demand is overwhelming we have reserved a part of our capacity for
the health sector. A central distribution center in Europe would surely help.
We are currently building new production lines to support EU, and taking
different approaches to protect our staff. In regards to new clients, we have
nearly no clients within the EU, almost everything we manufacture goes to
Asia.
Prioritisation of orders and work with government agencies around the
world to finalise the response to the Commissions recent tender for PPE.
only supplies the existing and approved distributors.
Main reason of increase of demand was that other suppliers (e.g.,
) were
not able to do so in the Netherlands.
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