On Wednesday 17 June, the European Commission formally adopted its strategy for vaccination, which proposes that Member States jointly enter into advance purchase agreements with pharmaceutical companies developing a vaccine against Covid-19 (see EUROPE 12503/2).
The communication, which received the informal support of EU Health Ministers last week (see EUROPE 12505/1), is accompanied by a proposal for a Regulation to temporarily derogate from the rules on genetically modified organisms (GMOs). It also announces a subsequent legislative proposal to relax the rules on labelling and packaging.
Taking out an “insurance policy”
The Commission confirms its idea to mobilise the Emergency Support Instrument (ESI) to conclude, on behalf of the Member States, Advance Purchase Agreements (APAs) with vaccine manufacturers. “In exchange for the right to purchase a set number of doses of vaccine within a given timeframe and at a given price, part of the initial costs incurred by vaccine producers will be funded through the emergency support instrument”, the document explains.
The Commission compares this mechanism to a kind of “insurance policy” which transfers part of the risk from industry to the public authorities, bearing in mind that the success rate of clinical trials for a vaccine is generally estimated at between 20 and 40%.
An agreement with manufacturers and participating States
However, at the Health Council on 12 June, the European Commissioner for Health, Stella Kyriakides, acknowledged that the ESI, with an initial budget of €2.7 million, already had only €2.4 million available and may need to be supplemented.
In terms of details, the document suggests a “non-exhaustive” list of criteria for selecting candidate vaccines. According to a Commission source, it should be a handful of manufacturers (five or six). The advance purchase agreements to be concluded with the manufacturers “will specify a number of points concerning the expected payments (amounts, timing and financial structure), the modalities of vaccine supply, if and when it will be concluded (price per person vaccinated, quantity of vaccine and delivery time after approval) and any other relevant modalities (production capacity in the EU, possible availability of production facilities for the manufacture of other vaccines or medicines in case of failure, or liability provisions)”, the Commission states. It also proposes to conclude an agreement with the participating Member States to formalise their reciprocal commitments.
Regulatory flexibility
In parallel to this communication, the Commission is publishing a draft Regulation allowing derogations from certain provisions of the GMO Directive for clinical trials involving vaccines (as well as treatments) against Covid-19 that contain or consist of GMOs. This flexibility, which now needs to be validated by Parliament and the EU Council, will apply to the operations necessary for the clinical trials phase and for compassionate or emergency use in the context of Covid-19 and for the duration of the pandemic.
The Commission also announces its intention to propose to Member States to relax language requirements and ensure the acceptability of multi-dose presentations for Covid-19 vaccines in order to facilitate a more rapid deployment of a new vaccine and a more homogeneous distribution of doses between Member States. See the vaccines strategy: https://bit.ly/30ScEs8 and the GMO regulation: https://bit.ly/3fyZAff (Original version in French by Sophie Petitjean)