Access to future coronavirus vaccines is subject to global competition comparable to that for basic necessities during the first wave.
In order to guarantee access for European citizens, the European Commission has built a strategy upstream of the identification of the most suitable vaccine. How to organize the unforeseeable? The Commission responds in two ways: by simplifying the evaluation process, which usually takes around 10 years, and by concluding agreements with companies engaged in such development in order to enable them to support it financially, whatever the result of the developments undertaken.
Among the necessary flexibilities, we can cite in particular the exception adopted by the Commission to the requirements applicable to genetically modified organisms which may be included in the composition of candidate vaccines (Regulation (EU) 2020/1043 of 15 July 2020). In particular, it is planned to grant, for clinical trials of vaccines against COVID-19, a temporary exemption from the prior assessment of environmental risks required by EU legislation on deliberate release into the environment and the contained use of GMOs.
In addition, the Commission relies on the flexibility of the current assessment system which already includes a conditional authorization system. In this context, the benefit-risk ratio of the product is indeed considered positive but on the basis of less complete data than in the traditional framework, data which will have to be enriched in post-marketing. As the Commission points out, Member States can also grant faster access via national tools. Finally, procedural deadlines will also be tightened.
Furthermore, emphasizing that no Member State individually has sufficient financial strength, the Member States have mandated the Commission within the framework of the implementation of a centralized call for tenders aimed in particular at negotiating the prices of products. The funding granted is considered as a down payment on any vaccines which will actually be purchased by the Member States and will be taken into account in the conditions of the final purchase of the vaccines. This operation, estimated at 2.4 billion euros, will be financed through the Emergency Aid Instrument. If additional funds are required, Member States have the option of supplementing them. However, the announced distribution key for vaccines does not depend on the potential investment of states but on their respective populations.
This approach is in line with the provisions of Regulation (EU) 2016/369 aims to provide a set of rules concerning emergency humanitarian aid granted to European Union countries during disasters of human or natural origin under the terms which the Commission can engage in the procurement process by the Commission on behalf of EU countries. In order to speed up the award and execution of contracts resulting from procurement procedures, the regulation allows certain derogations from Regulation (EU, Euratom) 2018/1046, the EU Financial Regulation. In application of these provisions, the Member States will be able to acquire the vaccine or vaccines finally placed on the market directly, without having to resort to a national procedure. As a reminder, the Commission had already launched four joint procurement procedures in order to enable Member States to have access to health products deemed essential, applicable in particular to masks and respirators, of sometimes criticized quality (see the report Senate information on the European Union and health July 16, 2020 on the European Union and health n ° 648 (2019-2020) by Ms Pascale GRUNY and Laurence HARRIBEY, made on behalf of the Committee on European Affairs, tabled on July 16, 2020). Here she takes a further step.
In this case, the strategy described, which resembles the setting up of a central purchasing body, organizes a sharing of risk: the Commission is responsible for that linked to compliance with the award procedure and the drafting of contracts and to the Member States that attached to the products concerned within the framework of “their deployment and (their) use of vaccines including any specific compensation required by a given advance purchase contract”. The proposed framework is “an insurance policy” for the benefit of candidate companies. In fact, responsibilities are intricate: the part of the risk weighing on the States, associated with the process of choosing subsidized candidates, would depend on the drafting of the liability clauses negotiated by the Commission.
Some of these aspects also figure among the criteria for selecting candidate companies put forward by the Commission, including the sharing of risks in the two hypotheses likely to be achieved “namely a) the production of a conclusive vaccine or b ) the absence of vaccine ”and the special liability cover that companies might need.
To date, several contracts have been concluded without the precise terms having been revealed, in accordance with business secrecy. The strategy unveiled by the Commission nevertheless provides valuable details on their content:
• expected payments (amounts, schedule and financial structure),
• the terms of supply of the vaccine, if and when it will be conclusive, in particular the price per person vaccinated, the quantity of vaccines and the delivery time after approval. The approach therefore leads to a European price, which is quite remarkable.
•and any other relevant modality. The production capacity in the EU, at the heart of a concern to relocate the production of health products, as well as the possible availability of production facilities for the manufacture of other vaccines or medicines in the event of failure is cited. .
Insofar as the companies concerned have entered into commitments with other markets outside the EU, the obligations relating to the quantity and delivery time, as well as the penalties in the event of non-supply, are of course absolutely crucial to guarantee concrete access to the vaccine.
On August 21, the European Commission also decided to register the European citizens’ initiative “Right to vaccines and treatment“. The initiative’s organizers call on the Union to “put public health ahead of private profit [and] ensure that vaccines and anti-anemia treatments become a global public good, freely available to all”. On the basis of Articles 114, 118 and 168 of the Treaty on the Functioning of the European Union, they ask the Commission to propose any regulations so as, in particular, that intellectual property rights, in particular patents, do not hinder nor ‘access or availability of any future vaccine against the coronavirus or any other treatment and that obligations be laid down for the beneficiaries of European funds under the transparency of public contributions. In fact, the conditions and deadlines governing this approach seem hardly compatible with the actions already undertaken.