Forslag til rådsforordning om en tiltaksramme for å sikre kriserelevante medisinske mottiltak i tilfelle av en folkehelsekrise på unionsnivå
Proposal for a Council Regulation on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level
Kompromiss fremforhandlet av representanter for Europaparlamentet og Rådet 13.6.2022
Red. anm.: Kommisjonsforslaget er ikke merket EØS-relevant
BAKGRUNN (fra kommisjonsforslaget, engelsk utgave)
Reasons for and objectives of the proposal
This proposal for a Regulation aims to put in place a framework of measures to be activated in case of a public health emergency by enabling the Union to take the necessary measures for a sufficient and timely availability and supply of crisis-relevant medical countermeasures.
On 15 June 2021, the Commission presented a Communication on the early lessons from the COVID-19 pandemic setting out the need for the Union to have special arrangements in place to better react in times of health crisis. In November 2020, the Commission had put forward proposals for a stronger European Health Union, and is now creating a new Union Health Emergency preparedness and Response Authority (HERA) within its services. This will provide an agile, robust and sustainable health security structure to improve the availability of medical countermeasures. It would operate during both preparedness and crisis situations.
The COVID-19 pandemic revealed significant vulnerabilities in the European health preparedness for and response to public health emergencies. The measures set out in this Regulation relate to the crisis response mode. They will complement the development of HERA as a new driver for Union action to address cross-border threats.
EU structures, Member States and the industrial sector involved in medical countermeasures were not sufficiently prepared to ensure the efficient development, manufacturing, procurement, and equitable distribution of key medical countermeasures in response to the pandemic. The pandemic also revealed too many fragmented research activities across the Union, often rather limited in scope and limited manufacturing capacities for medical countermeasures, as well as vulnerability in related global supply chains. These limitations ultimately resulted in delays and inefficiencies in the response, which cost lives and harmed the economy.
In particular, the following problems related to crisis-relevant medical countermeasures were identified.
● Insufficient and scattered intelligence gathering and analysis, which is crucial for underpinning preparedness and response plans for crisis-relevant medical countermeasures as well as for ensuring that response interventions adequately ensure availability and accessibility of crisis-relevant medical countermeasures.
● Sub-optimal intervention tools and the absence of fully functional public-private ecosystems, which did not allow the Union to take a proactive approach with strategic and well-informed interventions, which are required to mobilise resources and accelerate the short timeframes for the process of research to final market product.
● Impediments to swift manufacturing of crisis-relevant medical countermeasures, which can be linked to vulnerabilities and difficulties experienced in manufacturing and supply chains, emergency funding and regulatory frameworks, research and data sharing as well as insufficient manufacturing capacities in particular at the beginning of the COVID-19 pandemic.
● Fragmented and dispersed efforts at the Union and national levels, aggravated by inadequate coordination and information sharing, which resulted in an inability to secure the availability of crisis-relevant medical countermeasures and to provide timely access to them.
Some steps to address these shortcomings come through better preparedness. But others require powers, instruments and actions which are only appropriate to cross border emergency situations. The Union did not have a specific emergency mandate for the coordination of Union activities able to ensure rapid availability and accessibility of crisis-relevant medical countermeasures for all Member States. Member States each had different capacities to prepare, respond with and manage crisis-relevant medical countermeasures. Neither national nor EU level had the capacity to respond as required already in place: the response had to be created from imperfect foundations. This situation is likely to be replicated: probably no single country can adequately address all the challenges associated with public health emergencies that have the ability to affect one or more Member States, such as COVID-19. Rapidly changing technological and competitive environments make country-specific responses still more difficult. Uncoordinated efforts may also lead to fragmentation of an already complex market and duplication of public funding.
Moreover, due to globalisation, climate change, natural and man-made disasters, biodiversity loss, habitat encroachment as well as armed conflicts and terrorism, the continuation, emergence and threat of public health emergencies remains a serious likelihood globally, requiring swift availability and accessibility of crisis-relevant medical countermeasures.
Helse- og omsorgsdepartementet