EU Announces New Criteria for COVID-19 Vaccine ExportsBy
The European Commission (EC) has introduced new criteria in its export authorization mechanism for COVID-19 vaccines for destination countries receiving vaccines from the EU.
The European Union’s (EU) transparency and authorization mechanism for COVID-19 vaccine exports was introduced in January 2021. Earlier this month (March 2021), the mechanism was extended until June 2021.
The new regulation introduces two changes to the existing mechanism. The first change relates to reciprocity by determining whether the destination country restricts its own exports of vaccines or their raw materials either by law or other means. The second change relates to proportionality by determining whether the conditions prevailing in the destination country are better or worse than those in the EU, in particular with respect to its epidemiological situation, its vaccination rate, and its access to vaccines.
“[T]he EU is the only major OECD [Organization for Economic Co-operation and Development] producer that continues to export vaccines at large scale to dozens of countries. But open roads should run in both directions” said Ursula von der Leyen, President of the EC in a March 24, 2021 statement, “This is why the European Commission will introduce the principles of reciprocity and proportionality into the EU’s existing authorization mechanism.”
In addition to evaluating the impact of a planned export in fulfilment of the EU’s advance purchase agreements with vaccine manufacturers, the EC say EU member states and the EC should assess whether the requested exports pose a threat to the security of supply of vaccines and their components in the EU.
The new act includes 17 countries previously exempted in the scope of the regulation, including: Albania, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Georgia, Israel, Jordan, Iceland, Lebanon, Libya, Liechtenstein, Montenegro, Norway, North Macedonia, Serbia and Switzerland.
The EU says it will continue to exclude from this scheme vaccine supplies for humanitarian aid or destined to the 92 low- and middle-income countries under the COVAX Advance Market Commitment list. COVAX is a global mechanism co-founded by Coalition for Epidemic Preparedness Innovations, a public–private partnership focused on vaccine development against emerging infectious diseases, and Gavi, a global public health partnership working with World Health Organization, UNICEF, civil society organizations, and industry groups to accelerate the development, production, and equitable access to new COVID-19 treatments and vaccines globally.
The EC says this implementing act is targeted, proportionate, transparent, and temporary. It notes that it is consistent with the EU’s international commitment under the World Trade Organization (WTO) and the G20, and in line with what the EU has proposed in the context of the WTO’s trade and health initiatives. EU member states decide on the requests for authorization in accordance with the EC’s opinion.
Since the start of this mechanism, (as reported on March 24, 2021) 380 export requests to 33 different destinations have been granted for a total of around 43 million doses. Only one export request was not granted.
The main export destinations include: (1) the UK (approximately 10.9 million doses); (2) Canada (6.6 million); (3) Japan (5.4 million); (4) Mexico (4.4 million); (5) Saudi Arabia (1.5 million); (6) Singapore (1.5 million); (7) Chile (1.5 million); (8) Hong Kong (1.3 million); (9) Korea (1.0 million); and (10) Australia (1.0 million).
EU’s vaccine strategy
The EC presented a European strategy on on June 17, 2020 to accelerate the development, manufacturing, and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the EC finances part of the upfront costs faced by vaccines producers in the form of advance purchase agreements (APAs). Funding provided is considered as a down-payment on the vaccines that are actually purchased by member states. The APA is therefore a de-risk investment upfront against a binding commitment from the company to pre-produce, even before it gets marketing authorization to allow for a quick and steady delivery as soon as the authorization has been granted.
As of March 24, 2021, the EC has signed APAs with six companies (AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech, CureVac, and Moderna) and secure access to up to 2.6 billion doses. Negotiations are advanced with two additional companies that were not disclosed. The four contracts with the companies whose vaccines have been granted conditional marketing authorization amount to more than 1.6 billion doses.