On January 29, 2021, the European Commission put in place a temporary authorization scheme for exports to non-EU countries of COVID-19 vaccines covered by Advanced Purchasing Agreements (APAs). Under the APAs, the vaccine producers concerned have committed to deliver a number of vaccines. In return, the EU has provided upfront funding to companies to strengthen their manufacturing capacity, necessary to produce vaccines and to ensure their roll-out as soon as conditional authorization is granted by the European Medicines Agency.
As of early January 2021, the EU had concluded APAs with AstraZeneca, Sanofi-GSK, Johnson and Johnson, BioNTech-Pfizer, CureVac, Moderna, Novavax which meant securing a portfolio of more than 2.3 billion doses. Most recently, the Commission concluded talks with Valneva opening-up the possibility of purchasing up to 60 million doses. Given the fact that the European Union has concluded such Agreements with practically all COVID 19 vaccine producers, most exports of COVID-19 vaccines will be affected.
Under the new rules, which will apply for the next two months, companies will have to notify their intention to export EU manufactured COVID-19 vaccines covered by APA’s to third countries. The competent authorities of the Member State where the vaccines are manufactured are responsible for granting or refusing export authorizations. However, the authorization requirement does not apply to exports to a number of third countries, such as Switzerland and Norway, various low and middle-income countries, as well as countries supplied under certain humanitarian aid schemes.
Crucially, an export authorization may only be granted if the volume of exports is not such that it poses a threat to the execution of EU APAs concluded with vaccine manufacturers. To make such an assessment, companies will have to disclose information on the exports, destinations, and quantities for the period covering three months prior to the new legislation entering into force. Given that the new legislation entered into force on January 30, this means that those vaccines producers concerned will have to disclose information back to the beginning of November 2020.
Further, the authorization scheme provides for an important coordination and supervision role for the Commission. The competent Member State’s authority shall notify the Commission of its draft decision on whether or not to grant an export authorization. In case of disagreement over such draft decision, the Commission will issue an opinion to the competent authority within one working day. In the opinion, the Commission shall evaluate the impact of exports for which an authorization is requested on the execution of the relevant APAs with the EU. The Member States’ authorities will then make a decision on the request for authorization in accordance with the Commission’s opinion.
Additionally, the authorization scheme provides for increased transparency. The Commission is tasked with making the information on the authorizations granted and those refused publicly available while taking account of the confidentiality of the data.
The EU’s export authorization scheme aims to ensure that all EU citizens can access the COVID-19 vaccine as a matter of priority and to overcome the current lack of transparency around vaccines production and exports outside the EU. The new rules were adopted in a context of uncertainty as AstraZeneca, the first company with whom the Commission contracted to produce vaccines and one of the biggest contractors, announced delays in delivering vaccines. The basic problem results from the fact that AstraZeneca supplied the UK facilities with products from the EU when there were production issues in the UK but absolutely refused to supply the EU from UK facilities when the problem was reversed. The Commission has stated that no exports of COVID-19 vaccines have been blocked under this framework to this date. This could be an indication that the new tool effectively allows to control and restrict the flow of vaccines to third countries depending on the ability of EU manufacturers to meet the production targets previously agreed under the APAs.