EUU, Alm.del - 2019-20 - Bilag 725: Fælles brev og positionspapir fra Belgien, Danmark, Tyskland, Spanien, Frankrig og Polen om forberedelse ifm. fremtidige pandemier

Europaudvalget 2019-20
EUU Alm.del Bilag 725
Offentligt

How to ensure EU's preparedness for pandemics

The corona virus has taken a heavy toll in terms of human lives and let to an unprecedented economic

downturn. The present situation has

raised questions about Europe’s preparedness for pandemics

and

underlined the need for a common European approach, so that the EU and its member states find

themselves better prepared for a second outbreak of the virus and future pandemic crises. The stakes are

high and a solution will require a holistic approach that draws on a wide range of instruments in the EU

toolbox including industrial policy, research, digitization and EU funding.

This paper will attempt to zoom in on some of the key parameters for

ensuring the EU’s

long-term

resilience in case of future public health crises in the EU. These include a sufficient supply of personal

protective equipment (PPE), medical devices, critical medicines, and vaccines. Understanding the

shortcomings is essential, as was also pointed out in the Spanish non-paper previously circulated

regarding the need for stress testing of national health systems.

The

backdrop for an initiative to ensure the EU’s preparedness for future pandemics

is Member

States’

experiences of varying degrees of shortages during the current COVID-19 crisis. A key goal is therefore

to identify ways to ensure stronger long-term European resilience to withstand future crisis. A broader,

holistic EU strategy could be more efficient than each member state attempting to enhance preparedness

on their own, as also emphasized by the BENELUX-countries in their letter to the Commission of 16

April 2020 on joint procurement.

As an initial step, a comprehensive diagnosis is needed in order to get a clear picture of the magnitude,

the character and the believed causes of the supply deficiencies and challenges observed during the first

stage of the COVID-19 crisis. An EU strategy on availability of critical medicines, medical devices, PPE

and vaccines to prepare for potential future health crises should address: (i) efficient monitoring and

possibility of data sharing, (ii) coordination of supplies, (iii) research and innovation, (iv) the regulatory

framework, (v) global value and supply chains, and (vi) production facilities. Below are some preliminary

considerations on these issues.

1. Efficient monitoring and data sharing

In order to boost resilience and preparedness, efficient surveillance, sharing, analysing and comparing

data will be key. With respect to privacy and use of personal data, an EU strategy that aims to enhance

preparedness for future pandemics should look into how the EU could significantly increase its ability to

track pandemic development in order to help identify health emergencies on the rise, and to increase

situational awareness across the EU. Key considerations in this respect would be:

Central data points should be identified

in order to ensure monitoring and thereby obtain a

common baseline and understanding of key measurements in the prelude to a crisis. Key

measurements could include the spread of a given pandemic, but also available stock etc. The

potential for establishing common European standards or harmonised methodology for health data

interoperability and key figures of future epidemics should also be explored.

Continuous monitoring, comparing, sharing and analysis

of such data is necessary in order to

be able to have a shared and up-to-date understanding of the situation and identify the right actions

in order to respond firmly and swiftly.

EUU, Alm.del - 2019-20 - Bilag 725: Fælles brev og positionspapir fra Belgien, Danmark, Tyskland, Spanien, Frankrig og Polen om forberedelse ifm. fremtidige pandemier

A strengthened mandate for

The European Centre for Disease Prevention and Control

(ECDC)

to coordinate, with national health authorities, prevention and reaction plans against future

epidemics within a future EU health task force.

2. Coordination of supplies

To ensure better distribution and coordination of supplies, the strategy should look into:

Efficient division of labour within the EU

in order to optimize European production, drawing on

national and regional expertise in existing life science clusters and production facilities. A key feature

of the division of labour could be cooperation agreements and legal commitments on a voluntary

basis from Member States towards common EU goals and targets. Experiences from shared

responsibilities and management in cohesion policy could be considered as inspiration for the

working methods. Such an approach would allow for the use of smart specialisation and place based

mechanisms.

Size of the stocks,

where Member States could seek to agree on dynamic criteria ensuring flexibility

in terms of the crisis to be addressed, resulting in:

Lists of critical medicines, critical protective equipment, critical medical devices, and critical

vaccines that need to be stocked as a minimum;

ii.

Size of the stocks - e.g. 3 months of supplies for the entire EU.

Common goals should reflect the responsibilities of each Member State to secure its own resilience,

and how quickly the industry can be expected to restructure their production. It is to be expected

that it will be more time-consuming and economically burdensome to switch production to advanced

pharmaceuticals than to PPE such as masks.

The EU should establish

common strategic stocks of critical medicines and medical products

(protective equipment, testing kits etc.). In this respect,

The European Civil Protection

Mechanism's rescEU-program

should be evaluated with a view to ensure that it is being used

adequately to build (relevant) stocks of critical medicines, medical devices, PPE, and vaccines.

As a supplement to national crisis management,

the capacity of the European Civil Protection

Mechanism,

to coordinate distribution across Member States, including whether Member States

need to play a greater role in the distribution based on common criteria for access and cooperation

between member states.

As these programs and mechanisms are meant to be utilised in a time of crisis, further consideration

should be given to more long-term solutions, which would allow time for capacity building. Joint

Procurement Actions could hold considerable potential and be deployed more broadly, notably with a

view to encourage EU capability build-up.

3. Research and innovation

Strong investments in fundamental research and alignment of research and innovation efforts and better

linking of these to European manufacturing of products and medicines are essential in order to be better

prepared for the next pandemic, in terms of both vaccine development, diagnostics, treatment, sharing

research data and the understanding of public behaviour. It is vital to increase European capacities on

research and development for vaccines and treatments, as well as to coordinate at the international level

EUU, Alm.del - 2019-20 - Bilag 725: Fælles brev og positionspapir fra Belgien, Danmark, Tyskland, Spanien, Frankrig og Polen om forberedelse ifm. fremtidige pandemier

(ACT-A initiative) in order to ensure capacity to develop and produce vaccines. Drawing on expertise

from all Member States, the following initiatives could be considered:

Joint vaccine development.

Developing a vaccine is a huge and expensive task, and a unified

European strategy holds great European added value; in this regard, it is necessary to ensure

coordinated dialogue with the pharmaceutical industry as regards critical components and

procedures. This includes a coherent, transparent, and coordinated approach towards the selection

of vaccine candidates, support mechanisms, possibly including financial support via EU funds. Fast

track procedures, mapping the most promising candidates with manufacturing capacity in close

dialogue with industry for instance on how to limit the liability in engaging in such production can

play a role. It should be considered, whether funds should be allocated at EU level specifically for

the establishment of a clinical preparedness platform, as this would accommodate the urgent need

of enabling EU to speed up the time from the outbreak of a future pandemic to the successful

deployment of a vaccine. Decreasing liability of producing vaccines through guaranteed public

purchase could make such efforts more attractive to engage in and EU-level contracts in order to

scale up the production of developed vaccines could be explored.

Diagnostics.

A coordinated European approach and more precise diagnostic tools, test reliability,

and better knowledge of the impact of different test strategies is needed. Establishing networks of

laboratories that can be activated when the need occurs, i.e. in case of a pandemic, could be explored.

Treatment.

The development of innovative medicines is essential for progress in preventing and

treating new diseases. This calls for long-term, continuous R&I investments e.g. in the fields of

virology end epidemiology

and the implementation of large-scale clinical trials in order to obtain

robust results in a timely manner. It should be examined whether EU should aim to scale up

innovation capacity by strengthening the framework conditions for conducting medical research and

medical trials and how EU-funds could to a greater extent finance large-scale clinical trials and getting

medical products ready for the market.

Sharing research data.

Swift dissemination of research results throughout the EU will increase

chances of breakthroughs. To realise the objectives of the European Open Science Cloud (EOSC),

initial deployment of a new European COVID-19 Research Data Platform Pilot should be a priority.

The value of social sciences and humanity (SSH).

A key aspect in a pandemic is the regulation

of public behaviour. Research in the effects of public communication, (mis)information campaigns,

the role of social media, and other IT communication, including tailor-made apps for tracking and

information sharing, will be highly relevant.

4. Regulatory framework

In order to support cooperation between public and private partners there might also be a need to look

further to the regulatory framework, building on the EU’s

own

strengths and principles:

Ensure resilience through a

strategically strengthened Single Market

as this is one of our greatest

assets and a key element in building resilience. The free flow of trade across borders, common rules

and standards can accelerate the development of optimal solutions to future crisis.

Examine the option of more permanent antitrust guidelines relevant in times of crisis

concerning limited and temporary cooperation among businesses in response to urgent situations

related to pandemics. In the current situation, the

‘Temporary

Framework Communication’ has been

EUU, Alm.del - 2019-20 - Bilag 725: Fælles brev og positionspapir fra Belgien, Danmark, Tyskland, Spanien, Frankrig og Polen om forberedelse ifm. fremtidige pandemier

valuable to companies willing to temporarily cooperate and coordinate activities in order to increase

production.

Examine the effectiveness of the public procurement procedures and Joint Procurement

Agreement (JPA).

The

‘guidance

for public buyers’ has helped to ensure rapid and efficient

purchases of necessary equipment, but evaluations of national and European level procurement

processes should be conducted to examine how the practical modalities, speed of the implementation

etc. could be improved .

5. Global value and supply chains

As commodities from international trading partners are essential, the following should be considered:

Ensure open, fair and flexible global value chains.

A key part of ensuring affordable supply of

commodities and critical products involves diversifying supply lines and upholding a level playing

field globally. This includes identifying new trading partners with the aim to decrease the

dependency of EU countries on single suppliers.

The EU should also strengthen EU and national

investment screening towards non-EU investments in the EU in strategic sectors (including health,

pharmaceuticals, biotech etc.), while at the same time encouraging investments (re)located in the EU.

While making value chains more robust it is important to consider the

need for sourcing certain

critical input.

This requires openness in terms of ensuring continued access, but also points to the

possible further potential in circular models, which could improve access to relevant materials. Also

in this area resilience of supply chains is important and it could be also necessary for companies to

diversify their sourcing regarding critical medicines in order to have more than one active substance

supplier.

Amidst growing global trade tensions,

preventing protectionism will be key

when considering

temporary measures. There is a real risk of the current situation leading to withdrawal from global

markets, which should be tempered through a focus on flexible and robust value chains within and

outside the EU as well as drawing on expertise from global markets. Consideration should be given

to important trading partners and in particular developing countries, who depend on imports from

the EU and are vulnerable because of weak capacity and health systems.

Ensure flow of trade by transport.

During the COVID-19 pandemic open European supply lines

has been essential in ensuring the regular flow of trade by sea, land and air and the operation of

supply chains. Therefore, it should be considered how the EU in the future could facilitate regular

flow of trade for the undisrupted availability of critical commodities to e.g. the life science industry.

Any trade measures should be

compliant with WTO-rules, IPR regulation

and

support the

multilateral trading system,

minimizing the risk of retaliation or dispersion of measures in other

sectors than health.

6. Production facilities

In order to ensure supplies, looking into increasing the production facilities in the EU, could be relevant.

Here, the following could be considered:

- A

public commitment to buy a certain number of specific products

could ensure the incentive

to increase production facilities in the EU and alleviate insecurity of companies in terms of whom

EUU, Alm.del - 2019-20 - Bilag 725: Fælles brev og positionspapir fra Belgien, Danmark, Tyskland, Spanien, Frankrig og Polen om forberedelse ifm. fremtidige pandemier

to sell the products in times of low supply. Consideration could be given to guidelines, the current

state aid rules, the principle of equitable global access, distribution keys and how to best ensure

smooth operations, transparency and trust

–

through EU-level decisions or bottom-up

cooperation.

- The European Commission should

allow incentives to develop and invest in production

capacity

for select and critical active ingredients, raw materials and medicines in the EU including

support for innovation and more efficient production technologies as well as reduction of

regulatory burden.

Encouraging adaptability as an economically efficient way of strengthening resilience.

During the current crisis, many European businesses have shown excellent adaptability and been

able to produce i.e. hand sanitizer and face shields to cope with the increasing demand and to shift

production depending on different suppliers. The particular Danish experience shows that

digitization and public-private partnerships can help build resilience. Based on this, the

Commission could study similar experiences across the EU to explore to what extent

adaptability

- based on modern and digitalized production

- could be an economically efficient way to

ensure self-sufficiency and resilience without initiating large-scale production with risks of

overproduction etc. Such adaptability could furthermore be underpinned by

collaboration

agreements between Member States and larger companies

where these agree to produce a

number of specific products in times of crisis against expected sales to governments and national

health care systems and thus not jeopardizing businesses normal production with limited or no

benefit. The role of Small and Medium-sized companies should also be taking into account in these

consideration (e.g. by open calls to participate in collaborations agreements). Finally, a broader

focus on digitalization and automation could be explored to strengthen the structural capacity of

our industry to quickly adjust production processes.

Exploring the potential of fostering industrial ecosystems and structuring them within

European projects,

for critical medicines, medical devices, PPE and vaccines, maintaining an

innovative and competitive life-science sector in the EU through solid IPR protection, favourable

framework conditions for conducting medical research and clinical trials, and sharing of data and

coordination of R&D. We should consider the creation of

Important Projects of Common

European Interest

for the production of active substances, vaccines, medical equipment and for

e-health, health data and biotechnologies, where appropriate to address specific market failures

special focus could be on removing regulatory barriers in order to allow for innovation and greater

control of supply lines of critical products and also the role of Small and Medium-sized companies.