The Oxford-AstraZeneca saga: Chronicle of a setback

The more than understandable initial enthusiasm caused by the announcement of the availability of various vaccines to immunise us against COVID19 soon gave way to a string of disappointments and frustrations as the logistical challenge became evident. Beyond the episodes of roguish mischievousness by some officials who were supposed to have a better understanding, the effort to immunise the European population is highlighting the serious shortcomings of the European Union's institutions in managing a problem of this magnitude. The penultimate episode was the announcement by the pharmaceutical company AztraZeneca, producer of the Oxford-developed vaccine, that it would be unable to honour a commitment to deliver 400 million doses in 2021 - 80 million of which in the first quarter of the year - made to the EU under a confidential contract after receiving more than 330 million euros to boost its production efforts in Europe at four plants, two in the UK, one in Belgium and a third in Germany. The drugmaker indicated a 60% cut in deliveries, or a total of 32 million doses in the short term.

The announcement disrupts the vaccination plans of EU countries, especially since the cold storage requirements of the Oxford-AztraZeneca vaccine are less onerous than those of its Pfizer and Moderna counterparts. Pascal Soriot, AztraZeneca's CEO, tried to justify the situation on the grounds that the UK had signed a contract with the drugmaker three months before the EU, from which the Eurocrats inferred, not without some plausibility, that production at AztraZeneca's UK factories was dedicated to the UK market. The European Commissioners suspect that the fiasco is indicative of AztraZeneca's own botched modus-operandi, which, as a result of poor clinical trials, saw the approval of its vaccine delayed by both the US and European drug agencies, leading the company's management to offer the UK advantageous and opaque conditions in exchange for the urgent approval of the vaccine by the British pharmaceutical authority. 

The company argues that it is exempt from liability, given that according to them, the contract only obliges them to carry out the production and delivery of the vaccines on a "best endeavour" basis, a legal concept they translate as "good faith". It seems justified to think that the inclusion of this contractual ambiguity suggests a certain lack of expertise and naivety on the part of the European contracting party, especially if we consider that we are aware that the contract is subject to Belgian civil law, which, as is the norm on the continent, Belgian law, tends not to give a specific meaning to concepts along the lines of "best endeavours", favouring instead the use of contractual stipulations on "means" and "results", both of which are objectively quantifiable. However, the public part of the contract between the EU and AztraZeneca contains a detailed definition of the concept of "best endeavour" (i.e. "to the best of one's ability, including incurring additional costs") accepted by both parties, which at least in theory limits the interpretative scope of Belgian jurisdiction.

As previously mentioned, the contract itself is confidential, and we only have a published version that omits information that could clearly clarify who is in the right in the pending dispute. The disclosure of what we do not know may be decisive, given that the expression "best endeavours" is only used in relation to AstraZeneca's obligations in one instance in the text, specifically referring to the establishment of production capacities to achieve supply in the agreed volumes, and according to the delivery schedule, so that, a priori, and as AstraZeneca's management complied with the clause to provide "sufficient information" to the European Commission of the problems following the agreed protocol, it is very doubtful that AstraZeneca will be able to provide "sufficient information" to the European Commission in a timely manner, in due time and form, it is very doubtful that the European Union has any margin for legal action in this case, especially given that the vaccine has yet to be authorised by the European Medicines Agency, and in any case, there does not seem to be a clear correlation between the foreseeable failure to meet the objective of vaccinating at least 70% of the EU population by the summer of 2021, and the problems that have arisen with AstraZeneca. Indeed, the Standing Committee on Vaccines of the Robert Koch Institute, Germany's leading public health agency, has officially ruled out the use of the Oxford-AztraZeneca vaccine for the over-65s just when it has just received a large shipment of vaccine from Moderna, so in principle it will be countries such as Spain and Italy that will struggle to vaccinate the 18-64 age group, the rest being covered by Pfizer's vaccine deliveries.  

Tempting as it is to blame the situation on the "new abnormality" of the post-Brexit world, there seems little basis for accusations of perfidy, protectionism and health nationalism on this occasion, beyond one-off anecdotes. In reality, the British government is more likely to make a gesture of goodwill (by asking AstraZeneca to divert some of its surplus stockpile from Britain to the continent) than to seize production. Not least because AstraZeneca's vaccine is based on a non-replicating adenovirus vector, which requires generating the virus used in the vial in a highly complex biological process. The UK plants could be affected at any time by the same problems experienced by AstraZeneca's Belgian plant. Moreover, the UK authorities know that, since epidemiological insularity is not possible in the 21st century, the UK government has a strategic interest in seeing that its European neighbours are immunised as soon as possible. This is something that - quite apart from the fuss made by some European Commissioners who are probably motivated by a desire to distract attention from their own responsibility for the fiasco - Britain's continental partners are well aware of, as evidenced by the joint letter that Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia and Sweden sent to the European Commission demanding increased efforts to facilitate vaccination of countries in the European neighbourhood, both east and south of the continent, such as Ukraine and Tunisia. The worst way to overcome the pandemic would be to resort to fomenting national grudges, and to facilitating the hoarding and commodification of health resources as some European countries were quick to decree when COVID made its debut.19 Cooler heads must prevail. Cooler heads should prevail, leaving emotionality for a better occasion.