César Hernández (Madrid, 1963) is the head of the Medicines for Human Use department of the Spanish Medicines Agency and has been part of the European Union advance purchase negotiating team since last year.
He is one of seven representatives of the Member States who have come face to face with the laboratories.
He answered the phone last Thursday, in the midst of the storm due to the slow immunization and non-compliance of the Anglo-Swedish company AstraZeneca.
Question.
The distance in vaccination rates in the EU compared to the United States or Israel is striking.
Answer.
I get it.
It is mainly due to the lack of arrival of AstraZeneca vaccines.
But the vision I have is of a really successful experience, and that for the EU has been a before and after.
Vaccines are reaching large, medium and very small countries where drugs do not usually reach.
Now, as the doses are arriving at a different time, there is noise.
It is normal.
But overall, the experience is going reasonably well.
Q.
Is reconciliation with AstraZeneca possible?
Or are we going into litigation?
R.
The word reconciliation would apply it to other types of human activities.
AstraZeneca must be required to comply with its commitments.
You have to explore common ground for the doses to arrive, but it is not being easy.
All the discussions about delays in vaccination campaigns have one common denominator: AstraZeneca's ability to deliver those doses.
Q.
Are we able to demand that you comply?
A.
The contract says that you agree to deliver an amount and that you will use a series of capacities for that and that there will be no other contractual events that may affect your commitment.
I think everyone has understood.
It is not a problem that a factory may fail or that a clinical trial does not come out.
The problem is that, at one point, what is a normal relationship between a customer and a supplier begins to deviate from what one expects.
Q.
You are delivering a quarter of the committed doses for the first trimester.
A.
The deviation is huge.
It is not completely understood.
Q.
With these cuts, is the goal of immunizing 70% of adults in summer viable?
R.
I think so, but it depends on factors that are subject to uncertainty and that could stop a vaccination campaign, such as a pharmacovigilance issue.
Can we do it without a company?
I think that with a medium pace or even less, we still have room for maneuver.
The EU adjusts the distribution of vaccines due to the disaster with AstraZeneca
P.
Brussels suspects that AstraZeneca would have delayed the request for certification of a factory in the Netherlands to avoid delivering 15 million doses produced in it to the EU.
A.
This is one of the elements that one does not understand.
I cannot say whether or not there has been an intentional delay.
But if a company wanted to dedicate the production of a factory to market B, it would be enough to not present the authorization of that factory for market A or to present it later and then justify itself.
That is what would be understood as an absence of good faith.
Other companies, when they have had problems, have said: okay, I can't serve you the 30 loaves you have ordered, but I'm going to distribute the ones I have to all my clients.
Q.
There are countries, like Austria, that have gone into a rage because they bet on buying more from AstraZeneca than from others.
Is it the case of Spain?
R.
In all the contracts in which we had to have purchase commitments, we have asked for the option of what would correspond to us in a population-based way.
Q.
How has this distribution been?
At first it seemed that they were distributed according to the population, but then there have been differences.
R.
There have been countries that have made some kind of adjustment.
They have asked for more of one, less of another.
It is a bit more complex.
In the end, the overall idea, the spirit of the negotiation, has been apportionment based on the population.
If you look at the vaccination rates of the EU countries, you can make the criticism that they are low compared to those of the US and the UK.
But they are very homogeneous across all countries.
When someone is left behind, the system itself generates solidarity so that they can recover.
Spain faces a rise in cases with only half of those over 80 vaccinated
Q.
Did Spain bet too much on AstraZeneca in the first quarter?
A.
AstraZeneca had a very high part of deliveries in the first quarter because their production plans, as presented, included manufacturing from the last quarter of 2020. When the prospecting was done in April of last year, yours it was the vaccine that was in the imaginary that was going to be the first to arrive.
But Spain does not have more AstraZeneca eggs in the basket than it does from Pfizer or Moderna.
Q.
Is a new vaccine, such as the Russian Sputnik V or one of the Chinese, going to be included in the European strategy?
A.
There has never been any kind of limit when it comes to saying with whom you negotiate or not.
It has always been sought to provide sufficient volume of vaccines in a reasonable time to a significant proportion.
Q.
Sputnik V is being reviewed by the European Medicines Agency (EMA).
R.
I cannot say if it will be part of the European strategy.
What I can say are the criteria with which the decision of which they are already part has been made.
Can you bring in enough volume in a short time?
Am I going to have some control, in quotes, of the production capacity?
And then they have to be authorized.
If those circumstances arise, I am sure there will be countries that will say yes.
And others will say that they no longer need it.
But there is nothing to prevent it from negotiating with the Russian or Chinese or with any of those that are being developed, some of them in Spain.
