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European Commission Presents Hera Incubator to Bolster Fight against Coronavirus

  • 19/02/2021
  • Articles

On 17 February 2021, the European Commission (the Commission) presented an updated version of the Vaccine Strategy which it had adopted in June 2020 to tackle the coronavirus (see, Van Bael & Bellis Life Sciences News Alert of 18 June 2020). The update was prompted by the need to address the increased threat of Covid-19 variants and is called somewhat bombastically the Hera Incubator because it foreshadows the future European Health Emergency Preparedness and Response Authority (HERA), whose advent was announced in November 2020 as part of the incipient European Health Union (see, Van Bael & Bellis Life Sciences News Alert of 12 November 2020).
The Hera Incubator has 3 main components that, in turn, cover a range of detailed action points:

  • To detect, analyse and assess variants – The EU will support the development of specialised tests to detect new variants and support with at least EUR 75 million the associated genomic sequencing. The research and data exchange on variants will be bolstered with separate funding of EUR 150 million. The Commission also plans to launch the VACCELERATE COVID-19 clinical trial network which brings together 16 EU Member States and five associated countries, including Switzerland and Israel, to exchange data and include children and young adults as trial participants. 
  • To speed up regulatory approval of adapted vaccines – The new rules will be modelled on the annual influenza vaccine model. The EU will also facilitate the certification of new or repurposed manufacturing sites by involving the regulatory authorities early. 
  • To increase the production of COVID-19 vaccines – The Commission plans to adapt existing Advance Purchase Agreements and conclude new such agreements to support the development of new and adapted vaccines through EU funding. On 17 February 2021, the Commission already approved a second contract with Moderna that provides for an additional purchase of 300 million doses. Furthermore, the Commission also promises to establish “a detailed and credible plan showing capability to produce vaccines in the EU”. The overall EU manufacturing capacity will be expanded by the “EU FAB” project, a network of emergency response production facilities for vaccine and medicine manufacturing at EU level. Separately, the Commission will develop a voluntary dedicated licensing mechanism to facilitate technology transfer. This is probably a signal that the Commission will not follow the path of compulsory patent licences. 

The attached documents contain detailed information on the Commission’s plans.

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    European Commission Accepts Aspen Commitments and Closes First Pharmaceutical Excessive Pricing Case

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