TWN Info Service on Health Issues (Feb20/02)
5 February 2020
Third World Network

WHO Secretariat documents silent on patent barriers to scale up drug resistant TB treatment

Geneva, 5 February (Geneva) – Two documents prepared by the World Health Organization Secretariat for the consideration of the 146^th meeting of its Executive Board is silent on the use of TRIPS flexibilities to scale up the TB treatment.

The meeting is currently taking place at the WHO headquarters in Geneva from 3 to 8 February.

The first document is a progress report on the “Global strategy and targets for tuberculosis prevention, care and control after 2015” (End TB Strategy). However, it is silent on the implications of patents on TB drug resistant treatment.

The second document is WHO’s “Draft Global Strategy for TB Research and Innovation”. A summary of the draft is placed before the EB to recommend for its adoption at the 73^rd World Health Assembly (WHA) in May 2020. (This document is prepared in pursuance of Resolution WHA 71.3 adopted in 2018, which requested the WHO Director-General to prepare a global strategy for tuberculosis research and innovation.)

Though the  progress report on the End TB Strategy acknowledges the low number of treatment it fails to mention one of the main causes for the low uptake of treatment particularly for drug-resistant TB (DR-TB), which is the non-availability of affordable generic medicines. According to the progress report, in 2018 alone 156,071 people with drug-resistant tuberculosis were enrolled for treatment. It further states that: “The number of people enrolled in 2018 was equivalent to only a third of the nearly half a million people estimated to be in need of care. Therefore, multidrug-resistant tuberculosis remains a public health crisis”.

The progress report acknowledges that TB affected households incurred catastrophic cost for treatment. It states: “According to national surveys conducted from 2016 to 2019, between 27% and 83% of tuberculosis patients and their households were estimated to face catastrophic total costs. The proportion was higher for patients with drug-resistant tuberculosis and their households: between 67% and 100% faced catastrophic total costs.”.  

(A catastrophic cost is “Defined by the WHO standardized survey protocol as having direct medical costs, indirect costs and/or income loss of over 20% of annual household income”.)

WHO’s Global TB Report 2019 states that 10 countries bear “75% of the global gap between treatment enrolments and the estimated number of new cases of MDR/Rifampicin Resistant-TB in 2018”. These 10 countries are: China, India, Indonesia, Mozambique, Myanmar, Nigeria, Pakistan, the Philippines, the Russian Federation and Viet Nam.  China and India alone account for 43% of global gap.

After a gap of nearly 50 years, there are now three new medicines for the treatment of drug resistant TB: Bedaquiline, Delamanid, and Pretomanid. WHO is advocating for the replacement of injectables with fully oral therapy for drug resistant TB using these new medicines.

WHO’s TB treatment guideline prescribes these three medicines to treat drug resistant forms of TB. The guideline states that Bedaquiline should be used as the core medicine for treatment of drug resistant TB i.e. Rifampicin resistant TB. WHO recommends the Delamaind and Pretomanid combination for extensively drug-resistant TB (XDR-TB), a form of TB that is resistant to at least 4 of the core anti-TB medicines. The WHO Model List of Essential Medicines now includes both Bedaquiline and Delamaind.

The Medspal patent database shows that Bedaquiline and Delamanid are patented in nine out of the 10 countries that bear the 75% treatment gap.  There is no voluntary license from the patent holder to produce the generic version of Bedaquiline except in Russia. As a result, the critical medicines available for the treatment of drug-resistant TB are not available at an affordable price.

According to the Medecins Sans Frontieres (MSF) press release dated 30^th October 2019, since its marketing approval in 2012, just over only 37,000 persons have ever received treatment with Bedaquiline. Bedaquiline is available through the Stop TB Partnership’s Global Drug Facility at USD 400 per person for 6 months’ treatment. The cost reaches USD 1200 if the treatment is prolonged to 20 months.

The MSF press release also states that the medicines could be produced and sold at a profit at a price of USD 0.25 per day i.e. USD 8 per month against the Global Drug Facility price of USD 67 per month. It is worth noting that the patent holder of Bedaquiline, Johnson & Johnson is a board member of the Stop TB Partnership, a WHO-hosted partnership.

Delamanid is sold at USD 1700 for six months’ treatment i.e. about USD 283 per month. According to the MSF press release, “Delamanid could be produced and sold for a profit for as little as USD 0.16 per day (less than USD 5 per month)”. Delamanid is licensed by the patent holder to Mylan (a multinational generic company) to supply to certain countries, which include high burden countries like India, Nigeria, Pakistan etc.

Pretomanid is used in combination for the treatment (BPaL: bedaquiline + pretomanid + high-dose linezolid).  This new combination is approved for the  treatment of patients with XDR-TB and certain types of multidrug-resistant TB treatment (i.e. those who cannot tolerate or have not responded to standard treatment for multidrug resistance). TB Alliance, the license holder of this combination, has licensed it to two companies i.e. Mylan and Macleods Pharmaceuticals. Though Pretomanid is an off-patent medicine, patents on Bedaquiline de facto provides a monopoly to the license holder for this combination.

The WHO progress report is conspicuously silent on patents as the real cause behind the low treatment for drug-resistant.

At the same time, the Draft Global Strategy for TB Research and Innovation does not make any direct reference to the use of flexibilities in the Trade-related Aspects of Intellectual Property (TRIPS) Agreement even though it acknowledges that over the past 50 years “the IP and patent systems do not appear to have provided sufficient incentives for innovation in the TB field” and further acknowledges that “the high price of medicines due to the lack of robust competition for certain treatments, is a particular challenge for DR-TB care”.

It also acknowledges that “a disproportionately high share of national tuberculosis budgets is allocated to the treatment of drug-resistant tuberculosis, owing to the complexity and high cost of managing this form of the disease. Improvements in the treatment of drug-resistant tuberculosis will therefore increase the budget available for scaling up services in other aspects of tuberculosis prevention, diagnosis, treatment and care”. 

There is an indirect reference to TRIPS flexibilities through a cross reference to the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) adopted back in May 2008 (Resolution WHA61.21).  In its objective No. 4 the draft global strategy promotes equitable access to the benefits of research and innovation. The proposal to Member States is to develop “policies on trade, health and IP through multisectoral collaborative frameworks, to address access and innovation simultaneously, to meet the needs of people infected with TB, as highlighted in the [GSPOA]”.  The GSPOA addresses the patent barrier to access to medicines and recommends the use of TRIPS flexibilities.

However, the solution that the Draft Global Strategy for TB Research and Innovation suggests is not the use of TRIPS flexibilities but rather public health oriented voluntary licences and basically the goodwill of patent holding pharmaceutical companies. The document states: “Pharmaceutical companies should consider adopting patent and enforcement policies that facilitate the greater access to TB vaccines, medicines and technologies that is needed in low and middle income countries. Companies are also encouraged to grant non-exclusive voluntary licences in these countries, where this will facilitate greater access to safe, effective and high-quality products; such licences should be accompanied by data exclusivity waivers and technology-transfer activities” (emphasis added).

This approaching is surprising considering Paragraph 19 of the UN Political Declaration on TB, which clearly calls for the use of TRIPS flexibility: “Commit to promote access to affordable medicines, including generics, for scaling up access to affordable tuberculosis treatment, including multidrug-resistant and extensively drug-resistant tuberculosis treatment, reaffirming the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) as amended, and also reaffirming the 2001 WTO Doha Declaration on the TRIPS Agreement and Public Health which recognizes that intellectual property rights should be interpreted and implemented in a manner supportive of the right of Member States to protect public health and, in particular, to promote access to medicines for all, and notes the need for appropriate incentives in the development of new health products”. +