EUU, Alm.del - 2020-21 - Bilag 325: Høringssvar vedr. etableringen af et europæisk agentur for kriseberedskab på sundhedsområdet (HERA)

Europaudvalget 2020-21
EUU Alm.del Bilag 325
Offentligt

Holbergsgade 6

DK-1057 Copenhagen K

P +45 7226 9000

F +45 7226 9001

M [email protected]

W sum.dk

Minister for Health

European Commission

DG Health and Food Safety

Date: 24-02-2021

Section: MEDINT

Case Officer: DEPJAR

Case: 2018337

Doc.: 1601386

Consultation response on Inception Impact Assessment on

European Health Emergency Preparedness and Response

Authority

The Danish Government would like to thank the European Commission (EC) for the

opportunity to comment on the HERA inception impact assessment.

We acknowledge that the outbreak of the COVID-19 pandemic has revealed

vulnerabilities in European health preparedness and crisis response for serious cross-

border threats to health and that action needs to be taken at EU level. In this regard,

we are pleased that the Commission with the pharmaceutical strategy and the EU

Health Union proposals has started the process towards possible solutions.

The current COVID-19 crisis has amplified the need for permanent structures in order

to prevent and respond to threats in an agile, comprehensive and timely manner.

Common strategic investments can potentially ensure better value for money and

shared responsibility in

today’s reality ith a glo al life s ie e se tor hara terized

by increasing complexity and a high innovation rate.

Therefore, HERA could become a critical entity in terms of safeguarding public health.

Ho e er, a u er of issues eed further larifi atio . These i lude HERA’s

proposed tasks as well as any interfaces with existing agencies and bodies. If

established, HERA will have many interfaces with existing agencies such as the EMA

and the ECDC, but these interfaces are not fully mapped in the inception impact

assessment. Member States have not received a detailed description of the Agency

and thus there are still uncertainties with regards to overlapping tasks. First, the

proposed regulations on the strengthening of the mandates of the EMA and the ECDC

as well as the proposal on serious cross-border threats to health are still under

discussion in the Council and the European Parliament. Secondly, the interface

between other initiatives such as rescEU and the Civil Protection Mechanism are

currently also lacking in transparency.

Due to these uncertainties, The Danish Government currently refrains from pointing

to a particular preferred choice among the various policy options described in the

inception document. However, having taken note of the proposed timeline, we

would like to use this opportunity to further stress the need for a swift and timely

response to address the current challenges of vaccine delivery.

We would like to highlight some observations that we deem vital for the further

planning of HERA.

EUU, Alm.del - 2020-21 - Bilag 325: Høringssvar vedr. etableringen af et europæisk agentur for kriseberedskab på sundhedsområdet (HERA)

Interfaces

More information regarding

HERA’s i terfa es, i tera tio s a d possi le k o k-on

effects with other agencies need to be examined and clarified. Furthermore,

interfaces with i.e. national competences, other sectors and global outreach need to

be explored. However, The Danish Government notes that the new body will respect

the competencies of Member States and relevant national authorities.

In this regard, it is worth mentioning the positive experiences gained through

regulatory measures such as regulatory flexibilities/rolling reviews related to the

authorization of pharmaceuticals, which may be translated into the pharmaceutical

strategy with potential footprints in a HERA setting and collaboration with the EMA.

With a reference to the acquired regulatory experiences with pharmaceuticals

(conditional approval), the need for evidence generation and use thereof is

accentuated. Pandemic coordination would on the other hand be well suited for such

an agency, leaving e.g. EMA to concentrate on the regulatory tasks. Furthermore,

HERA should also have strong ties with i.e. EDA, as well as international actors such as

WHO and US BARDA.

The need for highly skilled employees, interfaces with other sectors, and global

outreach

Regulatory agencies have multifaceted and highly complex mandates. Obviously, this

requires recruitment and retention of highly skilled staff, in particular staff that

possess STEM qualifications. In addition, an agency like HERA may also need to be

part of an academic eco-system/interact with academia.

The Commission briefly mentions the interface with SME-measures. As the

Commission rightly points out, we have seen small companies using break-through

technologies for the benefit of public health, and we support a strengthened and

increasingly sound business environment for SMEs and start-ups in order for these

businesses and their indispensable knowledge to remain within the Union. This

should first and foremost be done by ensuring a well-functioning Single Market with

good framework conditions for all businesses. Attention to these aspects should

therefore be given in strategies in areas such as industrial environment, competition,

research/innovation, environment/Green Deal and education, in order to pave the

way towards these valuable common goals that all support the work of the existing

health agencies as well as the future one.

Public-private partnerships and mobilization of research funds

The Danish Government welcomes the fact that the Commission also points to the

need for public-private partnerships and mobilization of funds in the inception impact

assessment. Despite scarce knowledge on how this may translate into practice, we

consider it vital that these measures are highlighted, as they will inevitably be among

key drivers in the future system.

A close and thorough public-private partnership regarding vaccines would be fruitful.

The partnership should include all steps from R&D, to effective clinical and regulatory

mechanisms, production, fill and finish. With this in mind, it is important not to focus

on a single or few technologies, but a wide range of technologies, as future threats

can take many forms.

It is positive that HERA is expected to increase the incentive for the industry to invest

in unmet public health needs, such as research and development of scarce medical

countermeasures. However, it is important that such measures do not come at the

Side 2

EUU, Alm.del - 2020-21 - Bilag 325: Høringssvar vedr. etableringen af et europæisk agentur for kriseberedskab på sundhedsområdet (HERA)

expense of general incentives for innovation in other parts of the industry. Any

measures must be in addition to already existing incentives for manufacturers to

produce innovative products and solutions so that the general market works

efficiently.

On another note, we also welcome the statement from the Commission that

attention will also be given to the challenges of AMR and technologically advanced

products. There is no doubt that a future crisis could involve resistant bacterial

infections.

Scope

Regardless of the policy options, a common EU overview of the supply of medical

countermeasures overall, including in particular manufacturing and development

capacities and demand and supply monitoring of raw materials, is vital to strengthen

the EU’s prepared ess

and response.

The Danish Government understands that one of the policy options may include a

Union level stockpiling and thus also a distribution mechanism. Even though the

scope of such potential initiatives is not yet defined, some challenges in this respect

should be highlighted. On a general level, it should be noted that to alleviate some of

the need for stockpiling, a

appi g of the i dustry’s

ability of adapting production

could also be taken into consideration, thereby decreasing the need for stockpiling

products.

It is vital that an eventual stockpiling benefits all Member States and takes into

account different needs. Thus the issue of which products to stockpile and the

decision-making process around this need to be clarified. The interface with the

rescEU stockpiling effort and the proposed regulation on the strengthening of the

EMA mandate on preparedness also needs clarification. Differences in terms of

treatment regimens across Member States may also add to the complexity and needs

consideration.

Another key issue will be to ensure that individual Member States may receive a

sufficient and timely quantity of products. In this regard, differences in distribution

times between the Member States should also be considered. Finally, it is important

that an eventual stockpiling at Union level will serve as a supplement to the national

emergency supply in the Member States.

To conclude, it is the view of the Danish Government that HERA could become a

critical entity in terms of safeguarding public health in crises where solid and timely

reactions are vital for the benefit of patients and society. A number of issues need

further clarification and Denmark would urge the Commission to put forward a more

detailed outli e of HERA’s proposed tasks a d i terfa es ith other age ies as soo

as possible.

Yours sincerely,

Magnus Heunicke

Side 3