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TB Policies in 29 Countries

Quality assurance TB medicines should be quality-assured – either WHO-prequalified or approved by an SDRA – to avoid substandard or falsified products. In 2011, WHO reported that 11% of certain first- and second-line TB medicines gathered from public TB treatment centres and private pharmacies in Armenia, Azerbaijan, Belarus, Kazakhstan and Ukraine failed quality standards, including 28% of rifampicin capsules. 121 A recent study of anti-TB medicines from private-sector pharmacies in 19 cities reported that 9% of all tested medicines were substandard; over 16% in 11 African countries, over 10% in India, and nearly 4% in Brazil, China, Russian Federation, Thailand and Turkey. 122 Many NTPs use pooled procurement mechanisms for quality-assured TB medicines, such as through the

GFATM. However, the GFATM has been changing its co-financing and allocation policies to fully or partially move out of MICs, including those with high burdens of TB and DR-TB. In the EECA region, home to 8 of the 16 MDR-TB high-burden countries, the GFATM’s policies led to a 15% funding cut in the 2014–2016 allocation period; additional cuts of 40–50% are anticipated in the next allocation period (2017–2019). As EECA and other governments are forced to pay for a larger share of their TB medicines and diagnostics, they may transition from pooled procurement to national-led procurement. This could result in a lower quality of medicines being procured and also split the market for TB medicines and diagnostics between pooled procurement mechanisms and national procurement, which may have an impact on the pricing and quality of these commodities.

Early access provisions Lack of registration can be a primary barrier to accessing medicines in high-burden countries, since some countries do not have mechanisms in place to provide access to unregistered medicines. Manufacturers may be reluctant to register their medicines in LMICs, even though these countries bear the brunt of the global TB epidemic. Some medicines that are used to treat DR-TB are registered for a different purpose (such as linezolid, clofazimine and imipenem/cilastatin) may also be unavailable. Bedaquiline and delamanid have not been registered in many countries, and delamanid has not been registered in any high MDR-TB burden country. To offer a few examples from different parts of the world, neither drug has been registered in Kyrgyzstan, Myanmar or Mozambique, which have a high burden of MDR-TB; furthermore, clofazimine has not been registered with a TB indication, limiting the possibility to import it into these three countries. In Kyrgyzstan, MSF worked to provide access to these life-saving medicines by applying to the MoH Commission for import waivers, which are granted under certain conditions: for medicines that are on the National EML or included in the MoH treatment guidelines or protocols for first-line treatment.

FINDINGS: •  In South Africa, bedaquiline and linezolid can be accessed through national access mechanisms. Access to delamanid is only allowed through Otsuka’s compassionate use programme with individual approval from the Medicines Control Council (MCC). Access to clofazimine is granted through an import waiver by the MCC on a named patient or group basis, and must be renewed every 6 months; • According to national guidelines, 89% (25/28) of the countries surveyed for this report can procure unregistered TB medicines through compassionate use or other legal mechanisms. The countries where these mechanisms are not in place include CAR, China and Ukraine. See table 10 for mechanisms across four countries.

TABLE 10: EXAMPLES OF MECHANISMS BEING UTILISED IN THE COUNTRIES SURVEYED Country name

Mechanism being utilised

Ethiopia

Waiver

Georgia

Compassionate use, regular import procedure, exemption mechanisms, importation for unregistered medicines, under programmatic use

Tajikistan

Humanitarian access channel

Viet Nam

Research framework and Expanded Access Programme

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결핵: 새 보고서 – 세계에서 가장 치명적인 감염병 결핵을 각국이 아직도 해결하지 않고 있다는 사실 드러내  

국경없는의사회와 세계보건기구(WHO) 산하 ‘결핵 퇴치 국제협력사업단’(Stop TB Partnership)은 ‘Out of Step’ 보고서 3판을 발표했다. 이 보고서는 세계에서 가장 치명적인 감염병인 결핵에 맞서기 위해 각국 정부가 더 큰 노력을...

결핵: 새 보고서 – 세계에서 가장 치명적인 감염병 결핵을 각국이 아직도 해결하지 않고 있다는 사실 드러내  

국경없는의사회와 세계보건기구(WHO) 산하 ‘결핵 퇴치 국제협력사업단’(Stop TB Partnership)은 ‘Out of Step’ 보고서 3판을 발표했다. 이 보고서는 세계에서 가장 치명적인 감염병인 결핵에 맞서기 위해 각국 정부가 더 큰 노력을...