Questions and Answers: Coronavirus and the EU Vaccines Strategy
On 17 June, the European Commission presented a European strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. The EU Vaccines Strategy intends to ensure the production in Europe of qualitative, safe and efficacious vaccines, and to secure swift access to them for Member States and their populations. Moreover, the Strategy reflects the global solidarity effort and ensures equitable access to an affordable vaccine as early as possible.
Joint action at EU level is the surest, quickest and most efficient way of achieving these objectives. No Member State on its own has the capacity to secure the investment in developing and producing a sufficient number of vaccines. It is only through swift and unified action by the EU and its Member States that sufficient and speedy supplies of a safe and effective vaccine can be ensured. A common strategy allows better hedging of bets, sharing of risks and pooling investments to achieve economies of scale, scope and speed.
So far, the Commission has signed a first contract to allow the purchase of a vaccine once proven safe and efficient with AstraZeneca (first contract entered into force on 27 August). Successful exploratory talks were concluded with Sanofi-GSK on 31 July, Johnson & Johnson on 13 August, CureVac on 18 August, Moderna on 24 August and BioNTech on 9 September.
Are all Member States represented in the Steering Committee and in the Negotiation Team?
All Member States have endorsed the approach set out by the Vaccines Strategy and signed up to an agreement for its implementation. As a result, all Member States are represented at the Steering Committee which discusses and reviews all aspects of the Advanced Purchase Agreement (APA) contracts before signature. The Committee appoints the members of the Joint Negotiation Team, which negotiates the APAs with the vaccines developers and reports to the Committee. All participants in these instances have been appointed by their Governments and have signed declarations of absence of conflict of interest and confidentiality.
What is the difference between concluding an Advanced Purchase Agreement (APA) and signing a contract with a pharmaceutical company?
Before an Advanced Purchase Agreement (APA) is negotiated, the Negotiation Team holds exploratory talks with the company to find out whether proceeding into detailed contractual negotiations is reasonable. If this is the case and a common understanding is reached on a terms sheet, a tender invitation is sent to the company, which then has to propose an offer.
An APA is concluded when both sides have finalised the contractual work. This is discussed and agreed with the Steering Committee. The conclusion of an APA requires the approval of the Commission.
If the APA provides for an obligation for the Member States to purchase vaccine doses (even if there might also be additional optional doses in the APA), Member States have 5 working days to notify if they wish to opt-out. The contract is only signed if at least four Member States are ready to be bound by it.
If the APA provides only for an option for Member States to purchase vaccine doses at a later date, the Commission can approve and sign the APA directly with the company concerned. Member States can decide later whether to exercise the option. It are the Member States that are responsible for purchasing the vaccines when they become available.
Will the Commission publish the contracts signed with pharmaceutical companies?
The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious. Contracts are protected for confidentiality reasons, which is warranted by the highly competitive nature of this global market. This is in order to protect sensitive negotiations as well as business related information, such as financial information and development and production plans.
Disclosing sensitive business information would also undermine the tendering process and have potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set out in the legal instruments that form the basis of the negotiations. All companies require that such sensitive business information remains confidential between the signatories of the contract. The Commission therefore has to respect the contracts it concludes with the companies.
Finally, the Commission is accountable towards the other European institutions and the European citizen. The Commission is acting in full compliance with all applicable rules regarding financial management, which can be subject to audit at a later stage.
Liability & Indemnification
Has the Commission made concessions on liability to the industry, in particular on indemnification for certain liabilities?
The Commission ensures that any agreement made to secure vaccines through the Vaccines Strategy will be fully compliant with EU law. The contracts the Commission is negotiating fully respect and protect citizens' rights, in line with the Product Liability Directive.
In line with EU product liability rules, liability remains with the company. However, in order to compensate for potential risks taken by manufacturers due to the unusually shorter timespan for vaccines development, the APAs provide for Member States to indemnify the manufacturer for possible liabilities incurred only under specific conditions set out in the APAs.
The Commission has made clear throughout the implementation of the Vaccines strategy that it is not prepared to make compromises on the application of the existing rules that apply to bringing a pharmaceutical product into the market. These principles are equally valid for any indemnification clause the Commission negotiates.
Thus, the provisions on liability and indemnification do not alter in any way the regulatory burden of proof borne by the companies to demonstrate the safety and efficacy of their products. Any vaccine put on the market will have to meet the necessary safety requirements and undergo the independent scientific assessment by the European Medicines Agency as part of the EU market authorisation procedure.
The EU and Member States will continue taking all necessary measures to protect citizens, ensuring that:
- a strict, independent scientific assessment (looking at quality, safety and efficacy) must be carried out before a vaccine is approved;
- citizens' rights remain fully protected;
- Member States are ready to financially cover certain of the companies risks to ensure that vaccines are actually available for EU citizens to protect public health.
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