Agencia Fiocruz de Noticias e Bio-Manguinhos/Fiocruz
On October 26th the Oswaldo Cruz Foundation (Fiocruz) sent to the External Commission of the House of Representatives for the Fight Against Covid-19 the Technological Order Agreement signed with AstraZeneca for the production of a Covid-19 vaccine. Although the contract contains classified information, common in contracts of this nature and classified according to Brazilian law, the document was sent to the Commission in its full version for the acknowledgment of the Legislative Power. Fiocruz thus once again states its commitment with transparency in its action, a constant throughout its 120 years of history.
“As a strategic institution of the Brazilian State, Fiocruz has always based its negotiations on the search for reducing public expenses and for the national interest of ensuring universal access to the Brazilian population, on a favorable basis. This agreement was no different, and the contract was the result of the union between our institutional compromise and the basis and premises established by the Ministry of Health”, highlights the President of Fiocruz, Nísia Trindade Lima.
According to the Vice-President for Production and Innovation in Health of Fiocruz, Marco Krieger, when faced with an exceptional context, in which the entire planet is looking for a vaccine against this disease that has killed over a million people, the terms under negotiation place Brazil in the spotlight in the global scenario. “The agreement with AstraZeneca guarantees not only access to an expressive volume of one of the most promising vaccines undergoing phase 3 of the clinical trial, it also ensures full transference of technology to Bio-Manguinhos/Fiocruz. The agreement also guarantees the inexistence of profit margins obtainment for AstraZeneca or for Fiocruz until July 1st, 2021”, explains Krieger.
As a response to the global public health emergency, Fiocruz and AstraZeneca have signed a compromise to work without profit margins, in the acquisition of the products required for production until July 1st, 2021, that is, during the validity of the contract, when Fiocruz will have fully concluded the phase of technology absorption. After this period of reference, there will be no acquisition of products, and Fiocruz will have autonomy for the production, being qualified to attend to national needs in an autonomous fashion, even should the pandemic last for longer than initially expected.
According to Marco Krieger, the cost of the vaccine was a differential during the negotiation. “At the price of US$ 3.16 per dose, this is considered one of the cheapest ones, when compared to other ongoing negotiations in the world. This value, including the transference of technology that will result in national autonomy starting in 2021, is the direct result of a differentiated action made possible by the existing production and technological capacity”, highlights the vice-president.
The original premise of the contract is to guarantee the national production of the vaccine for the Brazilian population, via SUS (the Brazilian Public Health System), and fulfill the demand of the National Vaccination Program (NVP). The subject of the Technological Order agreement is initially limited to 100.4 million doses, fully destined to be delivered to the Ministry of Health and the SUS. However, after concluding the incorporation of the technology, Fiocruz will be capable of producing an additional 100 million doses in the second semester of 2021. After responding to the national demand, it will be possible to evaluate, in the event of exceeding production, its destination to other nations.
Another version of the document, which preserves confidential information classified as “industrial secret”, is available for access by the general population. The contractual model used as the basis for the negotiation was drawn up by the Permanent STI Chamber of the Attorney General’s Office (AGU in the Brazilian acronym), as well as the procedures for negotiation and elaboration of the documentation that makes up the administrative process followed the Project of Innovation Hiring for Public Administration of the Federal Court of Auditors (TCU) and the General Guide of Good Practices for Technological Orders of the Institute of Applied Economics Research (Ipea), providing legal safety to the hiring procedure.
The previous experience and infrastructure of the Institute of Technology in Immunobiological Products (Bio-Manguinhos), the Fiocruz unit responsible for manufacturing the immunizer, supplying vaccines, biodrugs, pharmaceutical drugs, and diagnostic kits were decisive for the result achieved. “Bio-Manguinhos has been working tirelessly to offer solutions against this pandemic, and our activity has always been guided by public interest. The results achieved in this contract make an explicit display of the importance of well-equipped, State-run laboratories, with qualified personnel in the country. Without these two links, the fight against the pandemic would take much longer, and it would not be possible to take up the challenge of incorporating a technology that is still under development, which will bring benefits for the Brazilian society that are yet to be measured, be it in the mastering of an innovation that can help develop new products, or in the permanent updating of a corps of professionals working for national public health”, highlighted the director of Bio-Manguinhos, Maurício Zuma.
The contract was agreed between the parts, with clauses that provide safety and institutional benefits to all parties involved. Like all initiatives based on the scientific knowledge that is still being developed, the technological risk is inherent to the process. However, since the beginning Fiocruz has strived to base its activities on solid legal bases that regulate the Legal Framework for Science, Technology and Innovation, such as the so-called technological orders, starting with complementary parameters that evaluate the sanitary emergency, the technical components, the economy and others. This movement has been additionally been followed by the Technical-Scientific Committee of Initiatives Associated to Covid-19 Vaccines, consisting of Fiocruz researchers and specialists of other institutions with plenty of experience in the field of immunobiological drugs, to assess all actions of the Foundation on the subject.