The EU's weak points in the 'vaccine war'

The Community Executive has managed to seal a truce with AstraZeneca to deliver 40 million doses until March.DADO RUVIC / REUTERS

The European Commission tries to turn the page after starring in an unprecedented escalation of tensions with the pharmaceutical company AstraZeneca on account of alleged problems in the manufacture of vaccines against covid-19.

Just a week ago, the Community Executive managed to seal a truce with the British company to deliver 40 million doses between now and next March.

However, the fact that that number of vials represents just half of the initially agreed (80 million) has raised doubts about Brussels' strategy in the so-called vaccine war.

There are citizens who are not clear if, at this stage of the pandemic, the European institutions have sufficient legal instruments to oblige the six laboratories to which they have financed their research (Pfizer-BioNTech, Moderna, AstraZeneca, Johnson & Johnson, Curevac and Sanofi) to honor their end of the bargain and prevent them from diverting production to third countries, which are now offering more money for drugs.

At stake is, neither more nor less, a total investment of 2,700 million euros and the continuity of the common vaccination program, which is expected to immunize 70% of the European population by the end of summer.

In order to clear up questions about the European management of the health crisis, the Commission made public the confidential contract signed with AstraZeneca and strongly defended its validity.

The professor of Private International Law at the University of Granada (UGR), Sixto Hernández, corroborates that "it is indeed an effective legal document, which can be executed before the Belgian courts."

It qualifies, yes, that there are "some peculiarities", apart from the studs that prevent seeing the final price per injection or the delivery schedule.

Reasonable efforts

In the first place, it is not a normal and current contract, or of results, but an agreement of wills by which the multinational undertakes to make all reasonable efforts (

the best reasonable efforts

) to produce a series of doses and, if not You succeed, you must notify the European Union (EU) in order for it to designate another manufacturer.

Still, the parties have a wide margin of interpretation on what is reasonable and what is not.

In the event of discrepancies, a period of 20 days is imposed to reach a new agreement before going to court.

Rosa Collado, professor of Administrative Law at Icade points out that this shared model of conflict resolution is "very different from the one normally used in Spain, where the State usually has the prerogative to impose its criteria in the preliminary ruling phase."

But, without a doubt, the most striking clause of the contract is the one that obliges Brussels to demonstrate that fraud or negligence has been committed in order to be able to claim compensation for damages and losses.

The MEP for Citizens and president of the Legal Affairs Committee of the European Parliament, Adrián Vázquez, indicates that this reversal of the burden of proof "places the EU in a very unfavorable position in a possible lawsuit."

Sources close to the Community Executive insist that the priority at this time is not to initiate a lawsuit, which could last for years, but to get vaccines as soon as possible.

In addition, they argue that the EU has the power to supervise the manufacture of drugs and to get them to the public quickly if there are problems again.

The first step, in that sense, was taken on January 29 by the cabinet chaired by Ursula Von der Leyen with the approval of a regulation that allows the 27 member states to control and restrict exports of vaccines.

But it is only a small part of the heavy weaponry that the community club could deploy.

This was implied by the President of the European Council, Charles Michel, in a letter in which he proposed the use of Article 122 of the Treaty on the Functioning of the European Union (TFEU), if necessary.

As the professor of Public International Law at the University of Granada, Luis Miguel Hinojosa, underlines, the precept invoked by Michel is a “true nuclear button” that would open the door to extreme measures such as the suspension of industrial patents, under the premise that the vaccines are a good in the public interest.

However, the teacher warns that the temporary confiscation of licenses could "have counterproductive effects" for the economy of the euro zone.

It is an opinion shared by the director of the patents department of Pons IP, Patricia Ramos, who recalls that European countries have traditionally been “strong defenders of intellectual property” and, in turn, are home to numerous companies in the biosanitary sector.

According to Ramos, a sudden change of position would encourage some developing states to confiscate licenses for all kinds of drugs, leaving European industry in a very delicate situation.

Vázquez, for his part, frames the movements of the last weeks in a coordinated EU plan to pressure AstraZeneca and maintains that "they should not be taken out of context."

For him the important thing is that Europe has managed to save its vaccination program, despite the contractual obstacles.

"The lesson that we must extract from this crisis is that we can no longer trust the good faith of the pharmaceutical companies," he remarks.

Compensation

According to the contract agreed between the European Commission and AstraZeneca, each member state will compensate the company and its subcontractors for “all damages, liabilities and legal costs” that could derive from the use or administration of the vaccine.

Luis Miguel Hinojosa, professor of International Law, reveals that this clause does not prevent individuals from taking the pharmaceutical company to court in the event that they or their family members suffer the adverse consequences of a defective item.

However, he points out that, if the company is finally convicted, "it will be the governments of the EU that will ultimately have to pay the compensation."