Patients & MSF doctors elated as MCC approval for MSF to use generic
linezolid paves the way for national registration and access
02 July 2014
After a three-year long struggle, Médecins Sans Frontières (MSF) has received approval from the South African Medicines Control Council (MCC) to import a dramatically more affordable version of an antibiotic, linezolid, in order to expand access to the medicine and provide better treatment options to patients with drug-resistant tuberculosis (DR-TB) in Khayelitsha, Western Cape.
MSF has been using linezolid in individualised drug regimens to treat
patients with DR-TB in Khayelitsha since 2011, by purchasing the drug at
the private sector price of over R700 (~US$65) per 600mg tablet. Linezolid
is only one drug in an already expensive regimen for extensively
drug-resistant TB (XDR-TB), and the cost of the drug during up to two years
of treatment can exceed R520,000 (~US$49,000) per patient.
“The high price of the brand name product was consuming up to 10% of the
entire annual budget for MSF’s HIV and TB project operations in
Khayelitsha, which limited the number of patients to whom we could offer
linezolid,” says MSF’s TB Doctor, Jennifer Hughes.
With the MCC approval, MSF can now import the first quality assured generic
version—that has been approved by the UK regulatory authorities—at a
purchase price of US$8 per tablet (~R85). This is an 88% price reduction on
the brand name private sector price. While this generic linezolid is not
yet registered in South Africa, MSF is now allowed to import the product
after applying for permission from the MCC under section 21 of the
Medicines and Related Substances Control Act 101 of 1965.
“Linezolid was the drug that helped me beat XDR-TB,” says Phumeza Tisile,
the first DR-TB patient offered a linezolid-containing regimen by MSF in
Khayelitsha, who was cured in 2013. “But others did not have access to
linezolid, and didn’t survive. We need promising drugs like linezolid
widely available at affordable prices to give more patients a better chance
at a cure, because the treatments for DR-TB we have are so terrible, and
don’t always work,” Tisile says.
“Obtaining approval for MSF to use a generic linezolid is an important
first step toward guaranteeing broader access to the drug for DR-TB
patients across South Africa,” Dr Hughes explains. “Other health care
providers, including the National Department of Health, could take similar
action to MSF. This would allow them to overcome budgetary constraints, and
offer linezolid to more DR-TB patients, in accordance with national
treatment guidelines and protocols,” she says
While this version of generic linezolid will only be available to MSF
patients in Khayelitsha, the MCC is currently reviewing generic linezolid
for registration in South Africa—including the same product MSF will be
using. Full registration by the MCC of a quality assured generic linezolid
would allow a more affordable version of the drug to be procured nationally
for provision to DR-TB patients through the public sector. MSF is hopeful
that the MCC will make such registration a top priority.
The precedent set by this MCC decision comes at the same time as South
Africa’s Department of Trade and Industry has been leading a six-year
process to amend the country’s intellectual property (IP) laws. “Reforms to
South Africa’s IP laws would help control medicine costs by preventing
abusive patent monopolies, but a national policy has yet to be finalised or
implemented. MSF urges rapid finalisation of a national IP policy that
promotes access to affordable medicines, so lengthy battles like the one
for generic linezolid will not repeat for other lifesaving drugs,” says
Julia Hill, MSF Access Advocacy Officer.
 Section 21 of the Medicines and Related Substances Control Act 101 of
1965 states that the “[Medicines Control] Council may authorize sale of
unregistered medicine for certain purposes.” This authorization is given
for a specified period of time, and for use, purpose and duration as
determined by the council.