By implementing Regulation (EU) 2021/111 of January 29, 2021, the European Commission introduced a new control system for exports of coronavirus vaccine. This article answers the key questions.
Evaluation and outlook
With its Implementing Regulation (EU) 2021/111, the European Commission has provided the EU member states with a new control system under foreign trade law to enable them to enforce compliance with contractually agreed delivery volumes more effectively. In doing so, it has at the same time sent a clear signal to the pharmaceutical industry not to be short-changed in the global distribution of COVID-19 vaccine doses in the future. However, the new measures have not only received a positive response. Critics accuse the Commission of unnecessary protectionism, saying that in times of global crises, "cooperation rather than confrontation" is needed.
The decisive factor for the effective implementation of the new controls will be smooth cooperation between the national authorities and the European Commission when issuing export licenses. Delays in the export of urgently needed vaccines would not only have economic consequences for the manufacturers concerned, but also lead to indisputable health risks for the population.
What changes with the regulation?
Following the European Commission's initial introduction of export controls on FFP2 masks and other items of personal protective equipment last year, the latest measures relate to the export of vaccines and active ingredients to combat the Corona pandemic. However, unlike what is currently observed in the U.S., the new regulations are not aimed at a general ban on the export. The main change under the implementing regulation is the introduction of a new licensing mechanism. Thereafter, all manufacturers of affected substances are required to submit an export license when they declare the goods for export, or at the latest when they release them.
Who is affected by the regulation?
The measures are aimed at manufacturers of vaccines against SARS-associated coronaviruses falling under CN code 3002 20 10, as well as active substances used in the manufacture of corresponding vaccines. The export license must be presented in principle for all deliveries to third countries outside the EU. This is intended to prevent exports in the event of a simultaneous threat of non-fulfillment of contractual acceptance guarantees between the manufacturers and the EU. But there are exceptions to this rule. Exports to a number of selected partner and developing countries, for example Switzerland, Israel or Ukraine, as well as exports in connection with emergency humanitarian aid are excluded from the new control system.
What is the licensing procedure?
Export licenses are examined and issued by the authorities of the EU member state in which the substances concerned are manufactured. For example, in Germany, the Federal Office of Economics and Export Control is responsible for this. After an application has been submitted, the authority prepares a draft decision, usually within two working days. This is forwarded to the EU Commission, which in turn issues an opinion within one working day of receipt. The final decision on whether to approve the export is then made by the member state in accordance with both opinions. When submitting an application, in addition to a detailed description of the product itself, information on previous shipments within and outside the EU must also be disclosed, which is intended to ensure greater transparency in the distribution of COVID-19 vaccines.
When do the measures apply?
The measures will come into force with immediate effect, applying from January 30, 2021. The practical significance of the new control system can be seen in the recent example of the British-Swedish pharmaceutical company AstraZeneca. In consultation with the European Union, Italy banned the export of a quarter of a million doses of vaccine to Australia at the beginning of March. The legal basis for the corresponding measure was the European Commission's new implementing regulation (EU) 2021/111. In the specific case, the manufacturer did not fulfill its contractually agreed delivery volume to the EU in the first quarter of 2021.