Médecins Sans Frontières has obtained an important but long-delayed victory in a a challenge to the refusal of the Medicines Control Council in South Africa to issue section 21 permission allowing the temporary importation and patient use of a generic version of a key, tuberculosis medicine, linezolid. Linezolid can be effectively used as a treatment of drug-resistant tuberculosis, but the private sector cost of taking one pill a day for two years was approximately $49,000 when the medicine was sourced from the brand-name patent holder, Pfizer, at $65/pill. Generic versions of linezolid are manufactured in India by Hetero at significantly reduced cost of only $8/pill.
MSF tried for seven months to get a temporary waiver allowing importation and use of the generic equivalent even though the equivalent had not yet received full marketing approval in South Africa (though it was quality approved and registered by the UK in 2013). After a needlessly long delay, on June 26, 2014, the Medicines Control Council finally granted section 21 approval.
The MCC decision temporarily overcomes the registration barrier, but a patent barrier remains at least for a short period of time. The primary patent on linezolid is held by Pfizer and doesn’t expire until August 2014. Several secondary patents has reportedly lapsed and it is not yet clear whether Pfizer will try to reinstate them. Similarly, it is unclear that Hetero’s product would violate any of the secondary patents.
Technically therefore, Hetero and MSF face some degree of risk if they operationalize the importation of linezolid, but they may take that risk anyway. Pfizer appears to be withdrawing from the public sector market in South Africa and has not responded to a new government tender for linezolid (formerly it sold at a discount price of $27/pill for public sector use). It is hoped that Pfizer will formally agree to allow the requested importation or that it will at least refrain from claiming infringement for what is clearly humanitarian use by MSF.
Patents are all to easy to get in South Africa until it amends its patent law as demanded by the MSF, TAC, and Section27 Fix the Patent Act campaign. Conversely, registration, including section 21 temporary waivers are all to hard to get. South Africa should address both of it inefficient regulatory bureaucracies – patients need more expedited access to affordable generic TB medicines.