Urgent need to register quality generic versions of linezolid in South Africa
TB advocates request that the South African Medicines Control Council prioritize registration of quality-assured versions of generic linezolid for the treatment of drug-resistant TB.
On November 23, 2015 clinicians, health care workers, patients, and civil society organisations sent an open letter to the South African Medicines Control Council requesting that the Council prioritize registration of any dossiers received for quality-assured versions of generic linezolid, to facilitate greater competition and price reductions for this important drug used in treatment regimens of drug-resistant tuberculosis patients.
The letter follows from a communication with the Council on October 30, 2014, in which over 100 clinicians and healthcare workers, patients with drug-resistant tuberculosis (DR-TB), and civil society organizations urged the Medicines Control Council to assess as a matter of priority the dossiers of generic companies submitting for registration of the medicine, linezolid. This second letter is to reiterate the importance of urgently registering further quality generic versions of linezolid in South Africa, in order to improve its availability as a part of treatment regimens for patients with DR-TB.
Linezolid is increasingly recognized in international forums as a crucial component of robust DR-TB regimens, as evidenced both by systematic reviews, and its recent inclusion on the World Health Organization’s Essential Medicines List. Linezolid is recommended by the South African National Department of Health as a treatment for DR-TB in certain instances, if cost permits. At present, cost does not permit this - linezolid is one of the most expensive of many costly medicines in South Africa included in an effective multidrug regimen for treating DR-TB. Rapid registration of additional suppliers’ quality generic versions of linezolid in the country would facilitate a more competitive tender process.
A lack of access to linezolid means that some patients are prescribed regimens for DR-TB that are less robust than if linezolid were available. This potentially leads to amplification of drug resistance and transmission of drug-resistant strains of TB, potentially exacerbating the DR-TB epidemic in South Africa. Tuberculosis in general and the growing DR-TB epidemic in particular remain some of the biggest threats to the health of the South African citizenry.
“The current state of linezolid access in South Africa is not acceptable, given the right enshrined in section 27 of the country’s constitution, to have access to health care services.”
To download the open letter, click here.
Annex 1
Annex 2
Annex 3
