The Minister of Health, Carla Vizzotti, and the Legal and Technical Secretary of the Nation, Vilma Ibarra, confirmed that the president Alberto Fernandez made the decision to sign a DNU, which will be signed today, for Argentina to expand access to pediatric vaccines and to complete the vaccination plan with doses of Pfizer, Moderna and Johnson and Johnson vaccines.
The DNU will suppress the questioned assumption of “negligence”, but the contracts will define how the State will sign the acceptance of the vaccine batches. “We have the obligation to bring the greatest amount of vaccines to protect our children and adolescents and the general population and to protect the assets and interests of the State,” said the Legal and Technical Secretary.
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Also, as explained by Ibarra, the concept of “fraudulent maneuvers and malicious conduct” will be modified and replaced by “malicious conduct”, according to the national Civil Code.
The decree will also establish other modifications to Law 27,573, which regulates the purchase of vaccines, and will create a Covid-19 Repair Fund – equivalent to 1.25 of the free carrier value of each dose – to “respond to the payment of compensation in the event that a person is harmed by the application of the vaccine”, Ibarra advanced. The Legal and Technical Secretary explained that the reparation fund is not something exclusive to this agreement but is being applied in other countries and even in the Covax fund, created by the WHO.
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On the other hand, Ibarra pointed out that the royalties received by the national State and the private assets of the State will be exempted from immunity. “We received a very precise instruction from the president that all sovereign assets established in the Debt Sustainability Restoration law must remain sovereign“, Ibarra stressed, regarding some points that one of the North American laboratories had requested, that the State respond, for example, with reserves from the Central Bank. In case of a problem with the application of the vaccines, the new fund created will respond or, otherwise, the State, but with the exceptions set forth.
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Faced with the modifications that arose in the regulatory framework to be able to advance in the negotiations with the North American laboratories, Ibarra and Vizzotti rejected that the resolution through DNU is “political use of the pandemic”, after yesterday rejecting the modifications to the norm that he proposed the opposition in Congress. “If what the opposition proposed yesterday in Congress was voted on, these laboratories could not be hired,” declared Ibarra.
Negotiations with laboratories
“No one from the opposition was sitting at the negotiating table with the laboratories, it was very hard work. Congress is not prepared to respond in times of pandemic, infections do not follow parliamentary times,” added the Secretary of Legal and Technical and asked to “be responsible” for the treatment of the information.
In turn, Vizzotti added that the modifications that the DNU will establish will not only allow contracting the doses from the United States laboratories but will also facilitate the acquisition through the Covax mechanism and eventual donations. Among the donations that are expected is the one arranged by the United States government, which made some 80 million doses available to other countries, of which 3 million would reach the country.
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“The DNU is the result of a process of negotiations with the laboratories, which had declared the impossibility of contracting within the framework of the law passed by Congress to regulate the acquisition of vaccines”, Ibarra explained and clarified that: “The president gave us the instruction many months ago to start a process of conversations and find a way to reconcile the needs expressed by the different laboratories with the interests that we have to protect for the Argentine population.”
The Legal and Technical Secretary assured that an agreement was reached to “reconcile” the interests of the laboratories and the rights that the Government had to protect and clarified that the negotiation has “confidentiality contracts”, so there are parts of the agreement that cannot be disclosed. “Clauses, requirements, specific data we are not going to be able to give because we have to respect the legal framework, not because we do not want to give information because, in the end, all contracts are sent to the National Auditor’s Office,” he clarified.
The arrival of pediatric vaccines
Among the expectations for a possible agreement with the Pfizer laboratory was the possibility of acquiring the dose, which was enabled last May for pediatric application. In that sense, Vizzotti explained that, at the moment, no pediatric vaccine is authorized by Anmat and that Pfizer is not the only vaccine for minors with the possibility of contracting.
“We are working so that the vaccines are available as soon as possible, and arrive in the country as soon as possible,” the Minister of Health highlighted, adding: “Parents should know that the national State is working so that they have safe vaccines, effective and approved by the regulatory entity “.
