ŽĐƵŵĞŶƚ03
Ref. Ares(2020)2083839 - 16/04/2020
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Health systems, medical products and innovation
Medical products: quality, safety, innovation
Summary minutes: Call with
Commissioners Kyriakides and Breton
and pharmaceutical and medical device
industry on 03/04/2020
Summary
Commissioners Kyriakides and Breton held the fourth call with representatives of the
pharmaceutical and medical devices industry as well as EMA to discuss possible
shortages of medicines and medical devices for the Covid-19 outbreak. Commissioner
Kyriakides called on the pharmaceutical to increase production to meet the vastly
increased demand for critical hospital medicines. In general, demand for medicines and
medical devices also continues to be high. Industry continues to report shortages of
PPE, ventilators and diagnostic tests. While industry is generally able to increase output
to satisfy demand, their main concerns continue to be disruptions to transport, the need
to maintain international supply chains, and need for coordination and guidance on
allocation of stocks as companies are receiving a multitude of requests at regional,
national, EU and global level.
Report
Commissioner Kyriakides thanked EMA for compiling data from MS on the
availability of stocks of ICU medicines and medicines on the Indian export ban list.
There are increasing concerns about shortages of ICU medicines, paracetamol and
COVID-19 therapeutics. Commissioner Kyriakides informed industry that she has sent a
letter today with a strong call on all producers (originators, generics, OTC and API) to
increase production capacity. She also reported that she had alerted the EU Health
Ministers of the current pressing issues, including national stockpiling.
She explained that EMA is collecting information on demand from MS for the APIs and
medicines subject to the Indian export ban. From her side, she will speak to her Indian
counterparts again. She reported that the Commission has issued guidelines on
coordinating COVID-19 healthcare responses between MS, including taking patients in
ICU and allowing healthcare professionals to work in another MS. The Commission has
also updated the clinical trials guidelines and published guidance to manufacturers
producing medicines equipment. The Commission is currently discussing with ECDC on
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recommendations for the use of masks. The proposal to delay the implementation of
Medical Device Regulation by one year has been adopted by the Commission.
The Emergency Support Investment has also been launched including EUR 300 million
for rescEU to purchase medical devices and to allow the Commission to directly support
MS to buy PPE. The Commission is currently working on an exit strategy.
Commissioner Breton thanked the participants for their efforts. He said that we are
currently experiencing the peak of the epidemic. The Commission is monitoring the
situation closely. For medical devices, he reported further progress on the efforts to
increase production of ventilators. For example, in FR, there is a cluster of companies
working to produce 10,000 ventilators by mid-May. The Commission has reached out to
traditional manufacturers, other industries (automotive and aeronautic) in the EU, as well
as third country producers. For PPE, there is now better clarity on the ability to supply
masks. We need EU self-sufficiency for masks and EU production capacity has increased
considerably. There should be an additional 15 million masks produced in the coming
weeks. Solidarity between MS is important and we have positive examples of EU
solidarity (FR sending masks to IT). Commissioner Breton stressed the importance of the
single market and shared industries concern about free flow of goods. He explained that
guidelines on critical workers were published this week. The Commission is still working
to eliminate export restrictions and has been clear that total export bans are against the
EU treaties. He asked on industry to inform of any new measures. On the
hydroxychloroquine bans in FR and HU, the Commission is in contact with the MS
concerned. This is also true for the component ban from IT. On Monday, he called on
ministers to lift any export restrictions that endanger the single market. Commissioner
Breton stressed the usefulness of the weekly calls and the need to enhance efforts to meet
the increase in demand for medical products in the coming days and weeks.
EMA reported from their industry contacts that many of the issues raised in previous
calls are still valid. The EU pharmaceutical industry still reports issues in relation to
stockpiling, logistics and EU export bans. EMA reported that they are currently working
on the industry requests for regulatory flexibility and will inform industry of the
outcomes. EMA is also compiling additional information on ICU medicines and national
demands for APIs subject to the Indian export restrictions.
EFPIA thanked Commissioner Kyriakides for her letter calling on increased production
which they have shared with their members.
EFPIA continues to be concerned about national stockpiling. Although they have
implemented pandemic plans and increased production, they are still under pressure due
to stockpiling of experimental treatments. This has implications for on-label use and they
have been working with patient organisations. They would like a concrete set of
measures from the Commission to discourage and act on MS implementing stockpiling.
They would also like to use the I-SPOC, rather than joint procurement, to discuss with
MS on where to allocate production and stocks at EU level.
In terms of logistics, EPFIA reported that air freight remains a problem. Prices have
increased up to 300% due to a reduction in capacity. Usually, 40-50% of their cargo is
sent on passenger flights.
For experimental COVID-19 treatments, the EFPIA companies reported that a number of
clinical trials are ongoing but there is limited evidence on effectiveness so far. EFPIA
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asked that the Commission ensure that MS apply the clinical trial guidelines in the same
way.
Medicines for Europe thanked Commissioner Kyriakides for her letter. Due to the
current problems for ICU medicines, they have set up a group to assess supply
imbalances and increase production. They are inviting all companies producing ICU
medicines to participate. MfE asked for a clear mandate and legal certainty from the
Commission to continue their data collection and cooperation, as managed by a
contractor. They will share all the information they collect with authorities.
MfE stressed the need to better calibrate their information on EU stock levels to MS
demand and would like a structured exchange with MS managed by the Commission and
EMA. Many MS are setting up national coordination mechanisms and they would like
this replicated at EU level. MfE would also like the Commission to take action against
MS acting unilaterally on ICU medicines.
AESGP welcomed the progress so far, especially in setting up the I-SPOC. Their
members’ main challenge is increasing production, especially considering the continued
export restrictions from India. AESGP asked again to have the ECDC projections to help
estimate future demand. AESGP does not support joint procurement for OTC medicines
since it would impact their supply through regular channels (community pharmacies).
They reported that the RO export ban has created problems on the RO-Moldova border.
In terms of PPE, their companies have another week of stock and are concerned about
increasing demand for masks in the US. They would like MS to adopt harmonised
standards on the use of masks for the public versus masks for manufacturing and health
care workers.
Vaccines Europe reported that their manufacturers see an increase in demand for
respiratory vaccines in 12 countries due to WHO guidance to vaccinate against influenza
and pneumococcus during the pandemic. Vaccines Europe stressed the need for
regulatory flexibility, in particular on packaging, to allow them to reallocate stocks
within and from outside the EU. They said that it takes a long time to increase production
of vaccines. Vaccines Europe asked for Commission support to ensure that MS consider
service and raw material providers for pharmaceutical companies as essential businesses.
They also reported good progress on the development of COVID-19 vaccines but asked
for help to ensure quick GMO authorisations in the MS to start clinical trials as soon as
possible.
MedTech Europe (MTE) thanked the Commission for all efforts and measures taken
during the last week. They alerted that a growing number of availability concerns for
many types of devices such as tests, personal protective equipment and ventilators have
been noted as a result of the massive spike of demand in the United States which is
depleting the supply across the world. Additionally, MedTech Europe raised concerns on
export restrictions being undertaken at global level, which is rendering meeting demand
extremely difficult. They warned that if the US chooses to impose similar restrictions,
then the EU’s capacity for production would be crippled. Additionally, continued issues
with regards to movement of devices in the EU for protective equipment, ventilators and
ventilator parts/accessories were raised. As an example, they remarked that FR
companies were still not capable of exporting surgical facemasks. They also raised
concerns, notably in IT, which produces ventilator accessories such as tubes, filters,
suction systems, as well as in PL, CZ.
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MedTech Europe reminded that the changing recommendations on use of PPE and IVD
assays at national level severely impacted demands and those impacted companies
required notice in advance or time to adjust. EU recommendations on the different uses
of PPE and tests would be welcome. They highlighted that increasing concerns regarding
medical glove supplies have also been noted and underlined that unlike surgical
facemasks, the production process was rather complicated. They informed that
companies are working closely with the WHO on disinfection protocols for gloves with
the aim of increasing glove lifespan.
Market access problems for IVDs were also raised. They informed that many
manufacturers have been able to access other markets such as the US, AU, CN and JP but
that the access route in the EU was proving to be the most difficult. MedTech Europe
alerted that unlike those other countries, the EU doesn’t not have a simple pathway which
provides access to the entire EU. They complained that Member States were hesitant of
issuing national derogations and that much of the already available stock was not being
made available to the EU. They stressed for the need of a new mechanism to enter the
market without the CE marking process.
MedTech Europe welcomed the news on the new requirements for cross-border workers
but highlighted that in many member states, medical device workers were not considered
as ‘critical industry’ (referencing the Czech Republic). Regarding logistics, new
measures under the emergency support instruments funds will be useful in mitigating the
rapidly accelerating price and availability of airfreight transportation. MedTech Europe
enquired if it would be possible to have a list of contacts of those responsible for access
to these funds. They stressed that this would support shipment for individual member
states but not necessarily for ‘bundled shipments’ intended for distribution in multiple
member states.
A recurrent issue is possible shortages of components and MTE highlighted the need to
designate manufacturers of components as essential suppliers. Many of these are SMEs
and need financial assistance.
COCIR thanked the Commission for all the hard work and activities undertaken during
the last week. They underlined the need to keep the internal market open including
movement of essential staff, and requested that clear guidance be given to MS on this in
particular regarding common understanding on what are critical goods and suppliers.
They enquired whether any initiatives regarding temporary waivers of tariffs on medical
equipment would be undertaken to alleviate difficulties faced for import of needed
materials. COCIR highlighted that a similar approach such as the one currently underway
for medicinal products should be undertaken for medical devices. They stressed that in
order to ensure the effective functioning of the global supply chain where many parts and
components come from different parts of the world, governments and regions need to
refrain from protectionist actions. COCIR informed that they are experiencing similar
issues raised by the medicinal products associations regarding airfreight limitations and
increase in pricing up to 300%. COCIR enquired whether prioritisation of flow of goods
for medical devices is possible and if the letter sent by Commissioner Kyriakides and
Breton to Member States could be shared with industry. They re-iterated that devices
other than ventilator devices need to also be prioritised such as those used for patient
monitoring (portable x-rays and CT equipment). They also informed that besides
COVID-19 patients, other patients, such as those with critical health complications still
need access to healthcare.
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COCIR welcomed the announcement made by Commission President VDL on the
emergency support mechanism budget, of which a considerable amount is being
allocated to the healthcare system. They underlined that it was not yet clear how this
budget would work in practice and if financing of transportation of medical equipment
would be included. They stressed the need to ensure a fair allocation of critical supplies.
They highlighted that a Commission led fast track procedure/mechanism was needed for
medical devices so that to avoid unnecessary administrative burden. The need for a more
structured dialogue between the Commission, Member States and EU associations was
requested. They called for a similar mechanism as the one put in place for medicinal
products.
DG SANTE reported that they are working with DG COMP to see how to facilitate a
structured cooperation on ICU medicines. This would allow companies to share
information on stocks and manage production. Industry will receive updates as soon as
they are available.
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