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The plenary session of the Chamber of Deputies today approved an MP (Provisional Measure) that facilitates the purchase of vaccines and supplies against covid-19. There were changes to the original text prepared by the federal government. Now, the bill derived from the MP goes to be analyzed by the Senate.
The text provides for the exemption of bidding for the purchase of products for vaccination against covid-19, even before the sanitary registration or temporary authorization for emergency use by Anvisa (National Health Surveillance Agency), and for logistics contracts , information and communication technology. to help with immunization. Other points of the purchasing process are also made more flexible.
The Provisional Measure, however, contains measures that must be followed to prevent corruption and provide transparency. It does not dispense with the need for an administrative process that contains the technical elements related to the choice of the contract and the justification of the determined price, for example.
In the allowed bidding exemptions, a public health emergency derived from the new coronavirus and the need for emergency care are presumed proven.
Even so, according to the approved text, the states, municipalities and the Federal District are authorized to buy, distribute and apply the vaccines against the coronavirus if the Union does not provide sufficient doses for the vaccination of the groups provided for in the National Operationalization Plan. of Vaccination Against Covid -19, according to the rapporteur Pedro Westphalen (PP-RS).
The foreseen rules apply to the acts carried out and contracts signed until July 31 of this year, regardless of the execution period or extensions.
An article provides for the possibility of special clauses in contracts, such as advance payment, loss of the anticipated amount and hypothesis of no penalty for the contractor.
In the event of fraud, fraud or sole fault of the supplier, the loss of the anticipated amount and the contractor’s non-penalty clause will not apply. The issue generated controversy among the deputies, but ended up remaining in the text that follows the Senate.
The precautionary measures that the public administration must provide have been included, such as the monitoring of the assets and proof of the execution of part of the same for the payment of amounts.
After disagreements between parliamentarians, Pedro Westphalen decided to withdraw a section that authorized private companies to buy, distribute and apply vaccines in the country, even with the counterpart of dose transfers to the SUS (Unified Health System).
According to Westphalen, the aim of the text is to simplify procedures. “It is for the government to anticipate what will happen in the market, to anticipate problems,” he told the report.
Within 7 days for Anvisa to issue an opinion
The approved text establishes that Anvisa must issue, within a period of seven working days, an opinion, favorable or not, to the requests for temporary permission for vaccines against covid-19, provided that they are registered or authorized for emergency use by 11 foreign doctors pre-approved determined authorities.
Other foreign institutions with international recognition and pre-established certification are also considered. According to Westphalen’s notice, this period does not refer to an automatic authorization by Anvisa.
If there is no technical report from an international health authority that certifies the quality, effectiveness and safety standards, the term for an opinion from Anvisa will be up to 30 days.
In February this year, Congress approved another Provisional Measure with the provision that Anvisa will authorize vaccines with up to five days with the guarantee of at least one of the nine international organizations. The president of Anvisa, Antônio Barra Torres, considered the deadline “unreal” and asked for a veto on that point. The text has not yet been sanctioned by President Jair Bolsonaro (no party).
The text voted today also establishes that a medical or dental prescription for medications subject to prescription and continuous use will be valid until the end of the National Vaccination Operationalization Plan against covid-19. This does not apply to the prescription of drugs subject to special sanitary control.
Provisional Measures have the force of law when they are drafted by the Executive, but must be approved by the National Congress within 120 days so as not to lose their validity. The MP analyzed today by the Chamber was published at the beginning of January of this year.
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