Before the end of this year, the federal government is to create the Brazilian Radiopharmaceutical Corporation (EBR in the Portuguese acronym) for the production of radioactive compounds used in diagnosis and in therapies for various diseases. The new company – which will be state-owned, since the Union holds a monopoly over the exploration, production and marketing of nuclear minerals and their byproducts – is going to incorporate the radiopharmaceutical plant from the Institute of Nuclear Energy and Research (Ipen), in São Paulo, and from the Nuclear Energy Institute (IEN), in Rio de Janeiro, both run by the National Nuclear Energy Commission (CNEN), linked to the Ministry of Science and Technology. “The company will have more agility and flexibility to supply the market than a self-managed foundation”, explains Odair Dias Gonçalves, the CNEN’s president.
The federal government is in a hurry and is analyzing the possibility of founding the EBR by means of a provisional measure. But the hypothesis is not totally ruled out of transforming the proposal into a bill, which, however, would result in a long and imprecise course of processing in the National Congress. “We are already ready to start the transition. All that is missing is to agree the model of work with the federal employees”, says Dias Gonçalves.
The company will start in São Paulo, with the incorporation of Ipen’s activities. The institute produces about 30 radiopharmaceuticals to meet the demand from some 2 million patients in 300 hospitals and clinics specialized in nuclear medicine from all over the country. Ipen’s production accounts for 98% of the domestic market for radiopharmaceuticals, estimated at US$ 15 million.
Besides Ipen, EBR is going to encompass, later on, the production of the IEN, in Rio de Janeiro, and of the Regional Nuclear Sciences Center (CRCN), in Recife, which has now started an international tender process for buying a particle accelerator (cyclotron) dedicated to the development of radiopharmaceuticals. There are also plans for the installation of a cyclotron at the Nuclear Technology Development Center, in Belo Horizonte.
The first radiopharmaceutical to be produced at the Regional Nuclear Sciences Center, in Recife, will be FDG (fluorodeoxyglucose), or fluor-18, a radioisotope used in 95% of positron emission tomographies (PETs). PET revolutionized image diagnosis all over the world. It uses positron emitting radioisotopes, particles with a mass equal to that of an electron – like fluor-18, nitrogen-13 and oxygen-15 – that work like markers of organic molecules. This technology makes possible direct studies of the metabolic functions and of the cellular biochemistry that precede the structural and anatomical alterations in tissues and organs, thus making possible an early diagnosis of heart and neurological diseases and of tumors.
Ipen started the production of fluor-18 about three years ago. “It is the most recent technology, with more precise diagnoses for the early detection of tumors”, underscores Claudio Rodrigues, the superintendent of the institute. The security of the supply of the radioisotope for the examination stimulated four hospitals and one laboratory from the city of São Paulo to invest in the purchase of PET tomographs, quoted at US$ 2 million.
Fluor-18, though, is a radioisotope with a short half-life, and has its radioactive activity reduced in a period of between two and four hours. At the Ipen, for example, fluor-18 is produced every day, differently from the other radiopharmaceuticals. For this reason, fluor-18 is only distributed amongst hospitals and clinics installed in a radius of 200 kilometers from the city of São Paulo.
For not having this input, PET tomographs do not exist in Brasilia, in Minas Gerais or in Rio Grande do Sul, for example. The Pontifical Catholic University of Rio Grande do Sul, incidentally, has now forwarded to the CNEN a request to authorize the installation of a cyclotron for the production of fluor-18. The expectation is that the guaranteed supply will stimulate the hospitals to join together to acquire a PET. In Pernambuco, for example, the first Pet will only start to operate after the cyclotron is installed at the Regional Nuclear Sciences Center.
Ipen is looking for funds to buy another particle accelerator dedicated exclusively to the production of fluor-18, according to Rodrigues. The increase in the production should stimulate other hospitals to acquire new PET tomographs. “The installation of a new cyclotron calls for US$ 3 million in investments, besides the training of the personnel”, reckons Ipen’s superintendent.
In parallel to the representations of the federal government for the creation of EBR, the Chamber of Deputies is getting ready to vote Proposal for a Constitutional Amendment (PEC) 199/03, which modifies, to a regime of permission, the monopoly of the Union for producing, marketing and using radioisotopes with a short half life, of up to two hours, like fluor-18.
Monopoly of the Union
The PEC was presented by Senator Jorge Bornhausen (PFL/Santa Catarina), who, in 2003, had to resort to an American clinic to carry out an examination to locate a tumor in his wife, since there was not yet any PET equipment available in Brazil. “The amendment has the objective of benefiting the whole of the Brazilian population”, the senator explains.
The proposal has now been approved in two votes in the Senate and is beginning to be analyzed by a special commission of the Chamber of Deputies, created last year, but only installed on May 18. “If private companies are able to buy a cyclotron to produce radioisotopes used in PET, the population of the other states of the country will be able to count on this exam”, says federal deputy Kátia Abreu (PFL/Tocantins), who is in charge of guiding the PEC through the Chamber.
The increase in the number of cyclotron apparatuses for the future state-owned company and, if the PEC is approved, also by the private companies, and the multiplication of PETs in all regions of the country, should permit the access of a greater number of Brazilians to this cutting edge technology for the early diagnosis of diseases like cancer. Positron emission tomography, though, is still not part of the table of the Public Health System and the examination does not therefore have cover from the health insurance plans. “Once the proposal is approved, we will set out for the second fight, which is to include the examination in the SUS and to guarantee cover under the health insurance plans”, Senator Bornhausen promises. “When the range of apparatuses is wider, with privatization, the SUS is going to be interested”, foresees Deputy Kátia Abreu.