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Info Service on Intellectual Property Issues (Jun19/01) Geneva, 5th June (TWN): Member states participating in the 72nd World Health Assembly (WHA) renewed their commitment to end tuberculosis (TB) while expressing serious concerns about drug-resistant TB (DR-TB), the treatment of which is presently costly and beyond the reach of many national TB programmes. The agenda item “Ending Tuberculosis” deliberated at the WHA, which took place in Geneva from 20-28 May 2019, is a follow-up to the first High-Level Meeting of the United Nations General Assembly on the Fight against Tuberculosis convened by the President of the General Assembly on 26 September 2018 under the theme “United to end tuberculosis: an urgent global response to a global epidemic”. Tuberculosis is the tenth global cause of death, the leading cause of death of people with HIV infection, and a major cause of death due to antimicrobial-resistant infections. In 2017, an estimated 10 million people globally fell ill with TB, with an estimated 1.3 million deaths and an additional 300 000 deaths among HIV-positive people worldwide. In 2014, the 67th WHA adopted the global strategy and targets for tuberculosis prevention, care and control (subsequently known as the “End TB Strategy”) which includes the reduction in the number of deaths due to TB by 90% and the TB incidence rate by 80%, compared with 2015, between 2016 and 2030. The Strategy and the 2030 Agenda for Sustainable Development aim to end the TB epidemic by 2030. The WHO Director General’s Report (DG’s report) on the agenda item (A72/20) recalls WHO’s report to the 70th WHA on the progress made in implementing resolution WHA67.1,4 which “cautioned that, on the basis of national data reported to WHO, current actions and investments are falling far short of the levels needed” adding that “[t]he Global tuberculosis report 2018 continued to signal that the world is not on track to end the epidemic by 2030.” The action-oriented political declaration resulting from the High-Level Meeting reaffirmed commitment to meet the targets for 2030 set for ending tuberculosis under the Sustainable Development Goals and in the End TB Strategy. The DG’s report highlights some of the new commitments made by the political declaration including: -“commit to providing diagnosis and treatment with the aim of successfully treating 40 million people with tuberculosis from 2018 to 2022 including 3.5 million children, and 1.5 million people with drug-resistant tuberculosis, including 115 000 children…… and thereby aiming to achieve effective universal access to quality diagnosis, treatment, care, and adherence support, without suffering financial hardship, with a special focus on reaching those who are vulnerable and the marginalized populations and communities among the 4 million people each year who have been most likely to miss out on quality care”; -“commit to preventing tuberculosis for those most at risk of falling ill through the rapid scaling up of access to testing for tuberculosis infection, according to the domestic situation, and the provision of preventive treatment, with a focus on high-burden countries, so that at least 30 million people, including 4 million children under five years of age, 20 million other household contacts of people affected by tuberculosis, and 6 million people living with HIV, receive preventive treatment by 2022, and with the vision of reaching millions more…… The DG’s report however warns WHO Members that “the ongoing burden of and poor access to treatment for drug-resistant tuberculosis represents a public health crisis and health security threat. In 2017, about 558 000 people were in need of treatment for drug-resistant tuberculosis, but only one in four of them were enrolled in care, and treatment success globally remains low at only 55%, versus a target of 90%”. Two new medicines considered important for the treatment of drug resistant TB are bedaquiline and delamanid, both of which are highly priced. According to Médecins Sans Frontières (MSF) “[t]he estimated price of longer individualised treatment regimens could now reach more than US$2,000 for people who need at least 18 months of bedaquiline, which would represent a 50 per cent price increase over previous standard treatment. For people who might need both bedaquiline and delamanid for as long as 20 months, the price increase could reach 500 per cent, with a treatment regimen priced at around $9,000.” In August 2018, the World Health Organization (WHO) recommended expanding use of bedaquiline (produced by J&J) by making it a core drug for treatment of DR-TB, setting aside treatment with more severe side-effects as the last resort. MSF notes that its “research shows that DR-TB treatment regimens containing the two newer drugs bedaquiline and delamanid represent a significant price increase over older treatment regimens that are no longer recommended. People with DR-TB must receive individually tailored treatment consisting of at least five drugs for different durations, according to the type of drug-resistant TB that affects them”. Bedaquiline and delamanid are extensively patented in countries with a high TB burden such as China, India, Indonesia etc, blocking entry of generic competition and more affordable sources of the treatment. Members states and civil society interventions during the WHA reflected the challenges they face in this regard. Nigeria speaking on behalf of African region noted the high burden of TB in the region, the importance of placing such treatment within the context of Universal Health Coverage (UHC) and the resulting financial challenge of TB treatment. South Africa raised its concerns about the high prices of diagnostics. Algeria noted the challenge of multi drug resistant (MDR) TB as well as the importance of integrating TB treatment programme with that of HIV/AIDS. Iran, Kiribati on behalf of Pacific Island Countries, Tanzania, Thailand and Zambia also mentioned MDR-TB calling upon the Secretariat for support to address it. The Maldives, speaking on behalf of South East Asia, called for more affordable treatment and diagnostics through the use of TRIPS flexibilities and local drug production. The social and economic determinants of TB have to be considered when addressing the disease as highlighted by several countries such as Argentina, Mexico, Morocco and Paraguay, which also pointed out to the importance of adopting a human rights approach. Romania on behalf of the European Union called upon donors to mobilize funds, with reference to the Global Fund as having an important role particularly for low-income countries. Médecins Sans Frontières International (MSF) asked member states to update their national guidelines to include oral bedaquiline-containing MDR-TB treatment regimens and to reject proposals that block the full use of TRIPS flexibilities, including compulsory licensing. MSF also called upon countries to reject value-based pricing and tiered pricing models for TB medicines, diagnostics and vaccines, which hinder affordable access. Medicus Mundi International, supported by Peoples Health Movement and Third World Network highlighted the high cost of treatment of MDR-TB i.e. delamanid and bedaquiline, noting that the cost of delamanid is 1700 USD for a six-month course which compromises the ability of States to provide treatment to patients. They added that while South Africa negotiated and reduced the price of bedaquiline to USD400, research has shown that it could be produced and sold at a profit for only $16 per month at volumes of 108,000 treatment courses per year. The statement also observed that bedaquline is patented in most of the high burden countries such as India, China, Russia and South Africa, calling upon member states to make use of legitimate TRIPS flexibilities such as compulsory license or government use to ensure access at affordable prices, rather than relying on unsustainable donation programmes. Countries where TB medicines are not patented were called upon to explore opportunities for generic production to supply those with high TB burden. The International Federation of Medical Students’ Association, the World Medical Association and the International Pharmaceutical Students’ Federation, supported by the International Veterinary Students’ Association recalled the urgent need for Members States and donors to fill the funding gap for new therapeutic options, prevention, surveillance and diagnostics. They further stressed that “TRIPS flexibilities should be utilized to reduce the cost of MDR-TB treatment regimens and the rollout of point-of-care diagnostics, particularly for rapid diagnosis of MDR and XDR-TB” adding that “[t]his should be done on a large scale in countries with the largest disease burden”. They called on Member states “to urgently develop and implement stewardship mechanisms for anti-TB drugs, particularly for the outpatient setting, to support a multi-sectoral effort towards ending TB, urged all stakeholders to prioritize the education of students and healthcare professionals on the diagnosis and management of MDR and XDR-TB and assure access to personal protective equipment for health professionals. The statement emphasized that “ending TB is closely linked to the UHC agenda. Access to care, appropriate diagnostics and the full treatment course without financial hardship is a prerequisite for halting the epidemic”
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