[Ip-health] Highlights from the EU's new HERA Incubator: Anticipating together the threat of COVID-19 variants
james.love at keionline.org
Wed Feb 17 04:43:46 PST 2021
COM(2021) 78 final
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN
PARLIAMENT, THE EUROPEAN COUNCIL AND THE COUNCIL
HERA Incubator: Anticipating together the threat of COVID-19 variants
. . .
This very real threat of variants requires determined, collective and
immediate action. Our response should build on our experience since the
emergency of the initial virus, learning the lessons from where there were
delays, disruptions and bottlenecks. To bring this together, the Commission
will establish and operate a new bio-defence preparedness plan called HERA
Incubator, to access and mobilise all means and resources necessary to
prevent, mitigate and respond to the potential impact of variants.
To this end, it will act immediately and as a matter of urgency on a number
of different fronts:
(1) Rapid detection of variants;
(2) Swift adaptation of vaccines;
(3) Setting up a European Clinical Trials Network;
(4) Fast-tracking regulatory approval of updated vaccines and new or
repurposed manufacturing infrastructures; and
(5) Enable upscaling of production of existing, adapted or novel COVID-19
This emergency plan will tackle the short to medium-term threat and
for the future. It will serve as the vanguard for the European Health
Preparedness and Response Authority (HERA)1
. . .
. . . The Commission will foster the creation, if need be, of a voluntary
licensing mechanism, which would allow technology owners to retain a
over their rights whilst guaranteeing that technology, know-how and data
shared with a wider group of manufacturers.
The Commission will support the pre-production cooperation between
undertakings for building-up manufacturing capacities12. The cooperation
should be limited to what is strictly necessary to achieve the specific
objective in terms of research and development, production or supply, which
the companies acting alone would not be in a position to do. The Commission
stands ready to provide pro-competition legal guidance in relation to the
production of vaccines or treatments, including in light of the criteria
set out in the Antitrust Temporary Framework.
The EU’s investment into creating state-of-the-art vaccine and drug
research, development and manufacturing capacities will be one of the
cornerstones of any future pandemic preparedness and response. It will also
strengthen open strategic autonomy in the area of health and the strategic
positioning of the European healthcare industry.
The above actions will contribute to the creation of an “EU Fab” project, a
network of ‘ever-warm’, single and/or multi-user, single and/or
multi-technology production capacities for vaccine and medicine
manufacturing at European level, thus becoming over time an asset of the
The Commission will:
* Work closely with manufacturers to help monitoring supply chains and
addressing identified production bottlenecks.
* Support the manufacturing of additional vaccines addressing new variants.
* Develop a dedicated voluntary licensing mechanism to facilitate
* Support pre-production cooperation between undertakings.
* Ensure EU’s manufacturing capacity by building up the “EU Fab” project.
This is the earlier: Temporary Framework for assessing antitrust issues
related to business cooperation in response to situations of urgency
stemming from the current COVID-19 outbreak
James Love. Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
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