Covid vaccines: the EU on trial! By Riccardo Perissich former General Director of the EU Commission 08/09/2021

The indictment is severe: the EU is accused of gross mismanagement and of having badly failed its attempt to centralise the delivery of vaccines against Covid. Or has it? This reporter has the privilege of watching the trial in real time and shall try to report on it.
If convicted, “the bloc” as the Anglo-Saxon press likes to call it, risks a sentence that can go from a severe loss of face, to being banned from ever again meddling with health matters. We must note that in this trial the very identity of the defendant is not absolutely clear. The term EU stands for a complex organisation that includes 27 member states who wield most of the power and are responsible for nearly all decisions, plus some central institutions.
However, for reasons that we shall briefly mention later, the defendant cage is occupied by one entity only. In the media it goes under the name of “Brussels”, but we shall designate it with its appropriate official name: the Commission.  

The case against the defendant is prima facie strong. The main exhibit is the comparison with the US and the UK; the prosecution has determined that the vaccination campaign of the EU runs six to eight weeks behind that of those two competitors that have already vaccinated two to four times more people.
Having already protected many of the most vulnerable citizens, the UK and the US can enjoy a rapid fall in the death rate despite a spread of the disease that is persistent due to the new aggressive variants. As a result, they can start to make plans for the gradual elimination of restrictions and lock downs against which citizens show everywhere increasing resistance.
Having failed to vaccinate enough people, the EU is now confronted with both stubbornly high death rates and persistent contagion due to the variants; it therefore faces the necessity, unlike the competitors, to strengthen rather than relax the restrictions. The result is not only a worse heath situation, but also a lower prospect of speedy economic recovery and a big political boost for Eurosceptic forces in Europe; the Brexiteers’ cheers can be heard from Berlin to Palermo.

The defence doesn’t deny the facts; how could it? Its case follows two main lines: context and time. It starts with a detailed account of a difficult context. When the pandemic struck, the EU had no competence in the field of health that was entirely the responsibility of member states.
They reacted in a clumsy and disorganised way; in doing so they behaved in serious breach of their duty of mutual solidarity and thus aggravated the economic impact of the pandemic. In deploying its argument, the defence cannot resist reminding the jury that the initial reaction of the allegedly virtuous competitors (US and UK) was even more deficient, as proved by their higher death rate.
The Commission’s lawyers also point out that, despite that bumpy start, it has managed to re-establish some order in the internal market and, more importantly, it has masterminded a big coordinated program of economic recovery. The prosecution objects that those arguments lack relevance to the case, but the objection has been overruled by the Court.  

Then, the defence goes on, the prospect of the availability of vaccines materialized earlier than most people expected. The entire Big Pharma was involved and many governments were pouring a lot of money to finance and speed up research.
Again, the Commission notes that it lacked the money and competence to take part in that game and it’s not its fault if EU members were less active than the UK and the US in promoting vaccine development. Come what may, at the beginning of the summer, all governments started to make plans to ensure availability of the hopefully forthcoming jabs. In the EU, some governments (Germany, France, Italy, the Netherlands) started a joint effort to negotiate with the potential suppliers. The Commission pointed out that, while joint procurement was an excellent idea, to do it in a small group of rich countries could have a devastating effect on the EU as a whole and particularly on smaller and poorer members in the east and the south. The argument was accepted and the Commission was given the task to negotiate on behalf of the EU.

The Commission had a long and proven expertise in trade negotiations, but neither experience nor technical expertise in the field of heath, let alone the very specialised area of vaccine production. It was therefore a dangerous bet. For the prosecution it is a prove of the bureaucratic arrogance of the defendant, while the defence presents it as an evidence of its courage and determination: a bold move that helped to preserve to unity of the EU.

In practice the Commission team negotiated drawing on what the initial small group of countries had already achieved and in close contact with a committee that included all member states. It should be noted that, when the negotiation started, nobody could safely predict which firm would meet early success. As it happens, the Commission negotiated with nine companies, including all the four that have been successful until now (Pfizer, Moderna, AstraZeneca and Johnson&Johnson).  
At this point, a distinction must be made between the strategy and the actual drafting of contracts with individual firms. Concerning the strategy, probably dictated but at the very least agreed by the member states, it had two clear guidelines: minimum price and minimum risk. Although prices paid by the different countries are not public, it seems established that the EU has negotiated a better price than both the UK and the US. Unlike the two competitors, the Commission also refused to relieve the producers of their liabilities in case of failure. The contracts with the different companies, included a commitment to deliver the jabs in proportion of the population of the member states of the EU, but each of them was free to pick the mix of its choice: for instance, a bit more of Pfizer, a bit less of Astra, and so on.

We must take into account other factors that have had a strong influence on the delay. No serious country, this includes the US and the UK as well as the EU, allows the use of a vaccine unless it has been approved as safe and effective by a competent authority; in the case of the EU, national authorities could do it but as a rule they refer to the EMA (European Medicine Agency).
It is a well-respected centralised and independent body previously based in London and now in Amsterdam; it’s work is shared with the national authorities in a typical EU way. All authorities follow a clear and rigorous protocol that examines carefully the results of the clinical trials progressively supplied by the producers (the so-called Rolling review). It is in practice an exercise of risk assessment where the authorization, that can be provisional, is granted when the vaccine is deemed to be sufficiently both safe and effective.
The moment in which the authorization is granted is crucial because of its impact on the technically and logistically complex process of mass production and distribution of the jabs. That is where the EU departed from its competitors that decided to grant some of the authorizations earlier than the EMA. This different behaviour accounts for about half of the 6 to 8 weeks delay. The Commission doesn’t deny all this.

However, in defence of the EMA and of the minimum risk strategy, it points out the presence in many European countries of an active and influential no-vax movement and thus the necessity to do everything possible to reassure the public. It should be noted that, apart from some marginal deviations and occasional grumblings, no government put great pressure on the EMA to accelerate the process.

The substance of the case for the defence is therefore the following. By centralising the procurement, the EU avoided a mortal danger of internal conflict. However, its baroque institutional structure made it inevitable that procedures would be slower and more complex. Furthermore, the minimum risk strategy was justified by the political context. Finally, as the vaccination campaign gathers speed, the delay will be absorbed and by the summer the EU will be at par with the competitors.

The prosecution doesn’t deny the context. It however severely criticises the minimum risk strategy and it points out that, even if we can hope to be all equally happy by the end of summer, those additional deaths incurred by the EU during the delay are due to the obsession to minimise the risk. It also adds viciously that the cost of the additional contagion and of the deaths is probably higher than what was gained by negotiating lower prices.

An additional difficulty has occurred since the start of the campaign. Some potential suppliers have experienced technical or other delays in the production of vaccines. Such problems could have been expected in a complex operation like this one, but in the emotionally charged atmosphere of the moment they have instantly become political and have encouraged suspicions of privileged treatment of some countries. The question concerns mainly the AstraZeneca vaccine and the relations with the UK. The potential conflict has been compounded by the already fraught post-Brexit relations, by the fact that the vaccine has been developed by Oxford university with financial support from the UK government and, last but not least, by an opaque and at times arrogant behaviour of the AstraZeneca management.
The dispute has escalated rapidly, particularly when the Commission and some governments threatened to block exports. Such a move would in fact be legal and perhaps justified, but the way in which it was announced gave an impression of panic. More serious is the allegation that the contract signed by the UK are stronger than the one signed by the Commission. The jury will no doubt pay attention to this, but it must be said that the situation is at the moment not very clear. The Commission denies that its contract is weaker; a question that could probably only be settled in a Belgian court, something that hopefully all parties will want to avoid.

While the verdict of the jury is still unknown, it is difficult to imagine that the Commission can come out of it totally unscathed. It clearly hopes that with the progress of the campaign the issue will gradually fade away. There are nevertheless people that are not equally relaxed about the timing. This concerns particularly countries like France and Germany that face critical elections within a year. While one can imagine that, whatever the outcome, basic German support for the EU will not be undermined, the same is not true in France where the danger of a Eurosceptic success cannot be excluded.
More generally, any complacency about timing should take into account that after more than one year and several closures followed by partial openings and by new closures, public opinion in all countries is becoming increasingly restless. The whole thing is becoming a political race against time and the prospect of a speedy vaccination campaign is the only argument that can avoid serious unrest.

This brings this reporter to the question what he thinks is the main issue of this trial. Why is the Commission and not all the member states in the defendant cage? One cannot exclude that at some stages of the process mistakes were made by the machine of the Commission, the loathed and by definition guilty “Brussels bureaucracy”. However, there is no doubt that in so far as major mistakes were made, they were collective. Why haven’t the member states been called at least at the witness bench?
Those that know how the EU works are familiar with one perverse silent pact. The Commission refrains as far as possible from blaming too strongly the members states when something goes wrong. On their part, the member states are at leisure to blame the Commission for anything that they dislike, but to claim the merit for what they regard as a success. This communication asymmetry is amplified by the fact the information channels in the EU are still, if only for linguistic reasons, largely national and by the well-known lack of communication skills of the Commission.

It is interesting to note that in this particular situation some of the member states have broken ranks and done extravagant things like buying doses of the not yet authorized Russian vaccine, or rush to Israel to negotiate possible and yet undetermined agreements for future discoveries. However, these were all marginal cases, largely the product of local politics. The majority of governments including those that matter, seem to understand that they cannot deny responsibility. They have refrained from joining the chorus of the critics, but have kept a low profile defending the process rather than the institution.

There is an additional reason for the governments to keep low profile. In the eyes of the jury (which is in fact the citizens) what matters is the end result. The availability and supply of vaccines is an important factor, but not the only one. The distribution and injection of the jabs is a complex logistical and administrative process that requires the establishment of clear and fair priorities and is entirely in the hands of national governments. While also the US and (but much less so) the UK can also be accused of bad management of this delivery phase, the performance of practically all the governments of the EU has been unsatisfactory.
This concerns both those countries like France with a highly centralized structure and those like Italy and Germany that delegate functions to the regional authorities.

Criticism of the governments in the distribution of the vaccines is compounded by the fact that many of them are also been judged insufficient in the general response to the pandemic. The criticism goes from erratic behaviour, to contradictory messages, non-transparent communication and lack of proper enforcement of the rules that have been decided. It is interesting to note that during the first wave of the pandemic that occurred in the spring of last year, there were clear differences in the performance of the various countries with Germany and some Nordic countries doing better than others. On the contrary, during the second wave that started last autumn, everybody seems to be equally bad. The fact that many of these criticisms can also be levelled at the US and the UK is only a partial consolation.    

The EU vaccine saga is also experiencing a peculiar incident that concerns the already controversial AstraZeneca jab. EMA initially authorised it as generally safe. The controversy about delivery led to some loose talk by national politicians; for instance, top figures in France declared the jab “almost useless”, only to retract quickly and recommend it use.
Despite the general green light delivered by EMA, some national authorities decided to restrict its use to particular age groups, but not necessarily the same. All this would have only remained one hitch in a bumpy start, if collateral problems of blood clots had not been detected in some patients, mainly younger women. They were and still are extremely rare, statistically almost irrelevant, compared to the total numbers; their link with the vaccine was not even clearly established, but were badly communicated and spread panic.

As a result, some countries suspended its use or rushed to limit it to some, mainly younger, age groups. EMA, after some wavering and occasional loose talk from officials, while it admits a possible link between the adverse events and the vaccine, it confirms that the benefits are far bigger than the dangers; it therefore recommends general use, but… lets the members states free to define the criteria to administer it.
The MHRA, the British authority, and the government come out of this only marginally better. After having staunchly defended the AstraZeneca jab against all criticisms, the MHRA now recommends its use only for those over 30 years of age. We can safely predict that in the EU governments will end up doing different thinks for different age groups in a confused patchwork of national decisions. The paradox is that a jab initially suggested for younger age groups, is now recommended or even restricted to older people.

After such a disgraceful performance at national level against which the Commission is powerless, who can be surprised if the result is that the confidence of potential recipients could be undermined?  This particular jab is at present the bigger potential source of available supply, while Pfizer and Moderna are being reserved as a priority to older people; the damage could therefore be considerable and it could compromise the speedy completion of the campaign mainly for the younger age groups.
It must be noted that there is nothing the Commission can do in this unfolding drama; it doesn’t control EMA and it has only very limited influence on the governments. It is difficult not to conclude that the potential consequence of the mess created by the conflicting signals delivered by the governments in this case, dwarfs any mistake that could have been made by the Commission when it negotiated the supply.

Pending the verdict of the jury, it is the conviction of this reporter that it is not only the identity of the defendant, but the very object of the present trial that should be open to question. One possible conclusion is that, in so far as something went wrong (and it surely did), the roots are deeper. Two issues come to mind.  

The first is industrial. The EU has some of the biggest pharmaceutical industries in the world. And yet of the four vaccines approved so far, two are entirely American (Moderna and J&J), one is Anglo-Swedish but mainly British (AstraZeneca) and one is German in concept, but it relies on the mass production of an American company (Pfizer-BionTech).
Other very important EU companies, mainly Sanofi the big French multinational, are missing; some will no doubt arrive soon, but are not there at the moment. Was it purely that fault of the management that backed the wrong scientific horse, or was it also a more general lack of foresight by the governments? It is a difficult question to answer. After all, despite all the funding, Oxford could have got it wrong and the Institut Pasteur got it right. On the other hand, the massive Warp Speed program enacted by the US is a typical example of American faith in the importance of innovation and in the strength of a joint effort that is necessary to achieve extraordinary results.

The other related issues also go well beyond the vaccine problem. There are a number of troubling questions. Why is Europe apparently more vulnerable to no-vax movements? Why, in a situation where science should have earned general respect, are we experiencing two strange and not unrelated reactions?
On the one hand there is a widespread scepticism of science and the advice of scientists. On the other, the scientists themselves irresponsibly encouraged by the media have delivered a very poor performance of conflicting theories and confusing advice; this process has perversely included virologists and anybody with some link to the medical sciences, statisticians, sociologists and even philosophers; the latter, a special French feature. Instead of doing what science requires, to explain clearly what is established and what is still in doubt, many of them have spread the impression that science is like a blind black cat in a dark room.
In the US the scientific process has been deliberately challenged for partisan reasons, but the scientific community has held steady. In the UK, science has been largely uncontested. In the EU many governments have failed to streamline and better communicate the advice of scientists. Admittedly, the situation is rather diverse with some countries better than others, but there are extreme bad cases like France and Italy.

This combination of insufficient management by the governments, of sizable no-vax movements and of confusing messages from the scientific community varies from country to country. However, there is one feature that is common across the Atlantic, in the EU as well as the UK and the US: a libertarian streak that considers all restrictions an intolerable limitation of constitutional liberties and of our privacy.
This reaction, typically exemplified by the “war of the masks” has been politicised in the US and elsewhere, but it is present everywhere. It is one explanation for the bad failure of the attempt to operate apps to help to track the spread of the virus and it is a striking difference with the very different behaviour of the Asian democracies that have demonstrably achieved much better results.   

Finally, there is the question that could well be the most important. Why the minimum risk strategy was adopted and adhered to till the end despite its visible shortcomings? To avoid any misunderstanding, the issue here is not the hypothetical trade-off between health and the economy. It has been extensively debated and it is now accepted that health must be a priority also for the sake of the economy.

The deep European problem is of a different nature. All western countries are experiencing a process of rapid transformation of which the pandemic is only one factor; other elements are climate change, the digital revolution and the changing geopolitical balance. All countries are confronted with the challenge of striking the right balance between risk, innovation, growth, precaution and sustainability. Unlike the US and the UK, the EU gives the impression to believe that either there is no trade off involved, or that the choice must automatically be in favour of precaution and against risk even at the expense of innovation and growth. But this would take us very far. It would be another, probably far more exciting, trial.             


Riccardo Perissich
Former general director of the EU Commission

Riccardo Perissich est ancien directeur général de la Commission européenne ; il est senior fellow de la School of European political economy de la LUISS University à Rome, auteur de « L’Unione europea, una storia non ufficiale (Longanesi) » , « Stare in Europa : Sogno, incubo e realtà (Bollati Boroghieri) ». Il est membre de la Fondation Notre Europe – Institut Jacques Delors (Paris), de l’International Institute for Strategic Studies (Londres), de l’Istituto Affari Internazionali (Rome) et de l’Aspen Institute Italy (Rome) –

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