The new
Clinical Protocol and Therapeutic Guidelines for Hepatitis C (PCDT) was put
into effect last March. Since de Ordinance effectiveness on, the Ministry of
Health must make available the new drugs introduced by the protocol to
population in 180 days.
Unfortunately,
the drugs newly introduced might not achieve those one in need so early. It is
easy to predict that by a simple reading of the Circular Letter n° 8/2018/CGCEAF/DAF/SCTIE/MS,
in which the Ministry of Health declares that “it keeps studying new strategies
in order to optimize the medicine distribution, and that is “affecting the start
of the Hepatitis C new drugs purchase process, resulting in an additional
waiting time for them to commit with what was agreed.
The
lack of medicine is quite predictable due to the State of São Paulo Health Care
System situation so, since the first trimester, more than 500 patients are not receiving
Hepatitis C treatment. In the context presented, the FOAESP sent an Official
Letter to Gilberto Occhi, the Minister of Health, raising questions about the
subject, among other points.
The document was registered at the Ministry of
Health headquarters on April 26.
Check out the document below.
São Paulo, Abril 25, 2018.
The Honorable Mr.
Gilberto Magalhães Occhi
Minister of Health
Adeilson Loureiro Cavalcante
The Ministry of Health Executive
Secretary
Copy to Dr.
Adele Benzaken
STI, Aids and Viral Hepatitis Department
Renato Alves Teixeira Lima
Department of Pharmaceutical Services and Strategic Imputs
Brasília – DF
Ref.: Situation
of the Hepatitis C antiviral medicine in Brazil
Mr.
Minister,
The State of São Paulo Forum on NGO/AIDS
(FOAESP), collegiate body set up of more than one hundred Civil Society
Organizations policy advocating for the Human Rights of people living with
HIV/AIDS (PLWHA) and the
valorization of the Unified Health System, hereby brings questions regarding to
the Circular Letter n. 8/2018CGCEAF/DAF/SCTIE/MS and the alignment of HCV
medicine allocation as prescribed by the Clinical Protocol and Therapeutic
Guidelines on Hepatitis C”, for instance:
In item 3
of the Circular Letter it is emphasized that the drugs elbasvir+grazoprevir and
sofosbuvir+ledispavir were incorporated to the Unified Health System on March
13, 2018, through the Ordinances SCTIE/MS n° 11 and n°13, respectively.
Item 4,
however, affirms that the Ministry of Health “is studying new strategies, aiming
at optimizing the purchase process, but that is obstructing the beginning of
the processes of the new Hepatitis C medicine acquisition and distribution”.
Finally,
the item 6 states then “patients whom have the prerogative on receiving the
newly incorporated medicine must wait until there is a definition regarding the
procedures and deadlines of their acquisition and distribution.
Considering
the request letter for treatment supply sent by the São Paulo state manager on February
2nd, of 14.336 declastavir 30 mg pills, 5.404 declastavir 60 mg pills, 8.120
simeprevir pills and 2.520 sofosbuvir pills, as well as the request letter for treatment
supply for the second trimester of 2.520 declastavir 30 mg pills, 16.800
declastavir 60 mg pills, 1.512 simerevir pills and 19.656 sofosbuvir pills, which
would serve 557 patients benefited by the 2017 PCDT were not met, we ask:
- How many patients and the amount sent by the State
of São Paulo in order to fulfill the request made for the first trimester and
the purchase plan for the second one?
- How many HCV antiviral are there in stock in Brasilia?
- Will the medicine distribution start in 180 days deadline,
as recommends the 2018 PCDT, I accordance with Art. 25 of the Decree n° 7.646, from
December 2011?
- What was the resources invested to buy Hepatitis C
treatment, as well as how much is still in the 2018 budget?
- What is the 2018 budget on the purchase of HIV and
HCV treatment?
Expecting to have access to the
information above requested well soon, we lay emphasis,
Cordially and cooperatively,
Rodrigo Pinheiro
President
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