The global community needs to reduce climate emissions by 45% by 2030 to avoid the most dire warming scenarios. But drastic action to confront the “climate emergency” would mean better health and more jobs, declared the UN’s top climate official, Patricia Espinosa, at Monday’s opening of the Bonn Climate Change Conference (SB50), the warm-up to September’s UN Climate Summit.

“This is the fight of our lives,” said Espinosa, executive secretary of the UN Framework Convention on Climate Change (UNFCCC), at a press briefing. She noted that the poor level of commitment so far by countries that signed the 2015 Paris Agreement “will take us to a warming of the atmosphere of 3°C ” – something that scientists have warned will lead to widespread disruptions in food production, water resources and other ecosystems – all affecting health.

“People will be getting sicker, it will lead to battles over resources like water, land of course,” remarked Espinosa. “Where are those communities displaced from coastal areas [by sea level rise] going to go?  It is important for all people open their eyes to how urgent things are, there is no time to waste.”

But while “reducing emissions may sound like a very technical concept”, it can actually generate huge benefits for health and well-being, Espinosa asserted. “What does it really mean? It means for instance, less air pollution, which leads to improved health, especially for children.” More than 90% of the world’s children breathe toxic air and some 600,000 children a year die from air pollution-related diseases, according to WHO estimates. That pollution is largely generated by the same dirty fuels and sources that spur climate change.

 

Referring to her home country, Mexico, Espinosa noted that due to high air pollution levels, schools last year were closed for some days, and on other days children were confined indoors. “They needed to stay inside because the air was so polluted…. So this is what reducing emissions means, having the clarity that your child can go out and play, and not having to worry about it. “It means cleaner water. It means that children in big cities doesn’t have to be restricted in the way we are seeing. It also means more new green jobs. And it means the possibility of achieving our 1.5°C degree goal,” she concluded.

The Bonn conference, 17-27 June, plays host to a wide range of events, meetings, and negotiating sessions that aim to “raise ambitions” for the September gathering by heads of state at UN Headquarters in New York City, followed by the December Conference of Parties (COP25) in Santiago, Chile.

UN Secretary General António Guterres has called on national leaders to bring concrete commitments to the UN Summit  for investments that will curb greenhouse gas emissions and accelerate climate resilience. To pave the way, Espinosa said that she hoped the Bonn meeting would advance an agreement for “solid rules for carbon markets to finally take shape.”

There are some “very good” climate finance initiatives happening around the world but “they are all over the place,” Espinosa observed.  “What is bringing them together? It is time to bring them together, and I think the [UN] Secretary General’s Climate Summit will be an enormous, important opportunity to move in that direction.” “We need more ambition on mitigation, more ambition on adaptation, more ambition on finance.”

She said the Bonn session would also focus on getting developed countries to deliver on the promise made in the 2015 Paris Agreement to mobilize US$ 100 billion annually by 2020 to fund climate mitigation and adaptation activities in developing countries. “Not all have lived up to it, so we need to remind them about this commitment that was made,” she quipped.

Other themes to be covered include: the role of local communities, indigenous communities, and youth in climate action. Referring to recent youth demonstrations and strikes over climate change, Espinosa said, “If your child is running into the room and saying there is a fire in the kitchen, everyone would run into the kitchen to do everything to put out the fire before it burns down the house. What the youth are saying now is that the house is burning. They shouldn’t be ignored in our process.

“The only option we have is to go for a low emissions future.  We have to do it very fast. We need to get to the 1.5 °C degree goal,” she said, referring to the 2015 Paris Agreement to keep warming below 2°C. “If we don’t do that immediately, we really don’t know what will be the result for humanity.”

 

 

Nine months after a historic high-level UN meeting where countries pledged to end the global tuberculosis epidemic by 2030, a chronic lack of R&D financing jeopardises that ambitious goal, said expert panelists at a briefing on the TB R&D landscape last week in Geneva, hosted by South Africa’s Permanent Mission to the UN.

While there are now more TB drugs in the development pipeline, massive funding as well as other types of policy and institutional support are needed to support the large and decentralized network of small and medium enterprises, research groups, and public-private partnerships aspiring to bring new tools to market, said panelists at the event on “The Way Forward for TB: Innovation and Research.”

In particular, global donors and policymakers need to harness the momentum of new research initiatives underway in the so-called “BRICS” countries of Brazil, Russia, India, China and South Africa – where TB remains very prevalent, some experts stressed. Speakers included representatives from the Stop TB Partnership, the  International Union Against Tuberculosis and Lung Disease (The Union), Medicines Patent Pool (MPP), Médecins Sans Frontières (MSF), the South Centre, and the Treatment Action Group (TAG).

Tuberculosis remains among the top 10 causes of death worldwide. In 2017, TB caused an estimated 1.6 million deaths, including 300,000 deaths among HIV-positive people, according to WHO’s Global Tuberculosis Report 2018 [pdf]. The situation is aggravated by growing incidence of multi-drug resistant TB (MDR-TB), where strains of Mycobacterium tuberculosis fail to respond to the most common forms of antibiotic treatment.

To meet the longstanding challenge of inadequate drugs and vaccine tools, the September, 2018 political declaration [pdf] of the UN High Level Meeting on the Fight to End Tuberculosis, was a milestone.  Notably, the UN declaration committed to increase global TB research investments to US$ 2 billion annually, closing an estimated $1.3  billion annual research funding gap.  Other assessments have concluded that $2.5 billion annually is in fact needed to make up for inflation and funding shortfalls in previous years.

TB and TB-MDR Detection and Treatment in Lima, Peru

TB Pipeline Improving But Funding Gap Slows R&D for Vaccines & Treatments

Funding is needed to speed up development for some of the most promising solutions, said Ezio Tavora dos Santos Filho, of REDE-TB, a Brazilian based NGO, and a member of WHO’s Civil Society Task Force on TB. As one example, Tavora referred to a new TB vaccine candidate that yielded positive results in a Phase IIb trial and, “urgently needs to be advanced into a Phase III trial.” The existing BCG vaccine for TB, the only one currently available, is often administered to infants in settings with high TB prevalence. But it is only partially effective and does not confer lifelong immunity.

Compared to the past, the TB R&D pipeline is looking better, said Estaban Burrone, head of policy at the Medicines Patent Pool (MPP). However, there remains an acute need for more affordable oral and short-term TB regimens.

Overall, the R&D landscape remains “very weak” in terms of new drugs, treatment regimens and diagnostics, asserted Viviana Munoz-Tellez, of the South Centre. Besides funding, another barrier is the lack of agreed-upon criteria for making choices about compounds and vaccine candidates to advance, she said, when such choices also involves taking calculated risks about what to move forward.

To address chronic under funding of TB strategies, Erica Lessem, deputy executive director, Programs, at TAG suggested that countries worldwide should each divert 0.1 percent of their research spending to tuberculosis. That “very realistic strategy” would close the funding gap, she said. She added that research should be guided by core principles of affordability, efficiency, and equity; end-user prices should also be “delinked” from the costs of R&D and production.

Old Model of R&D Needs Reform for TB Research to Advance

In fact, the TB research incentives landscape needs deeper reform, in particular for later-stage R&D, according to Suerie Moon, director of research at the Global Health Centre of Geneva’s Graduate Institute of International and Development Studies.

She noted that such R&D had  historically been focused in a cluster of large companies based in high-income countries, but TB research is now being carried out in dozens of middle-income countries as well. And critical TB research initiatives are increasingly led by small and medium-sized enterprises, as well as publicly-funded product development partnerships, and academic research institutions. Since TB research cannot often compete with more lucrative drugs, such as cancer treatments, in the portfolios of large pharmaceutical firms, an even greater focus on funding distributed to this broader network of actors, would be more effective, she said.

Encouraging transparency around R&D processes is also important,  Moon added. “In policy debates and in the public imagination,” R&D is a black box, with the assumption that R&D is complicated, extremely expensive, and takes forever, she said. Opening the black box would ensure that people understands how it really works, and see that it is “very feasible to do it in a different way.”

Other speakers, such as the South Centre’s Munoz-Teller, contended that patents are an insufficient driver for industry innovation when it comes to TB research. If and when patents are obtained, they can also limit access and delay competition for TB drugs, she said.

With close to 80 percent of research funding coming from a range of public or philanthropic sources, funders have considerable leverage to impose price and marketing conditions on new health products that reach regulatory approval so that they can be more accessible, MPP’s Burrone agreed. According to the 2018 Tuberculosis Research Funding report, by Stop TB and TAG, some 66 percent of global TB funding in 2017 came from public sources, 19 percent from philanthropies, 11 percent from private industry, and 4 percent from UN and other multilateral organizations.

Way Forward for TB Innovation and Research – Panelists (left to right): Paula Fujiwara, The Union; Erica Lessem, Treatment Action Group; Suerie Moon – Graduate Institute; Pauline Beatlie – EDCTP.

Data Sharing Key for Innovation

Data sharing is another key to unlocking the potential of TB research and innovation said Brigden. Data sharing allows for wider collaboration, helps decision-makers in their choices, and is directly linked to access to products. For example, data from failed trails is very important in guiding successful design of further trials. Data also serves to accelerate registration of new tools, promote good scientific practices in a cost effective and timely manner, and facilitate meta-analyses that further synthesize data useful to the development of global guidelines as well as market access analyses, she explained.

Contrary to some preconceptions, the academic world can be even more protective of its data than industry, said Pauline Beattie, operations manager for the European & Developing Countries Clinical Trials Partnership (EDCTP), which recently forged a partnership between the European Union and sub-Saharan African countries to accelerate clinical research on poverty-related diseases such as TB. Beattie also noted that low- and middle-income countries are sometimes reluctant to share their data, if in the past such data were used by others without their consent.

WHO Global Strategy on TB R&D In Progress

In order to meet the 2030 target to end the TB epidemic, WHO is meanwhile working on the development of a Global Strategy for TB Research and Innovation.  The strategy is currently open for consultation and comments by member states, said Teresa Kasaeva, director of WHO’s Global Tuberculosis Programme.

The strategy aims at creating an enabling environment for TB innovation; increasing financial investments in TB research and innovation; ensuring equitable access to the benefits of research; and promoting and improving approaches to data sharing. The draft global strategy will be presented to the next WHO Executive Board in January 2020.

According to Munoz, the draft strategy offers a useful approach insofar as it covers the whole value chain, and it also considers a wide range of actors in the arena of diagnostics, vaccines, and treatment.

However, she said, the access to treatment safeguards in the draft strategy should be more specific, including: recommendations for clear provisions in drug development contracts ensuring broad access to medicines thus developed, as well as more open innovation, collaboration and data-sharing.

BRICS Countries Are Moving

Another bright spot in the funding landscape is the recent investment of BRICS countries (Brazil, Russia, India, China and South Africa) into TB research that would yield safe and affordable drugs and diagnostics.  This includes the BRICS TB Research Network, said Tavora, an initiative to which Brazil has also made a major funding commitment. Such investments are significant insofar as BRICS countries represent some 40 percent of the global population and bear 50 percent of the TB burden, including 60 percent of multi-drug resistant TB incidence, Tavora noted.

During last month’s World Health Assembly last month, BRICS countries proposed that WHO’s Global TB department host the Network Secretariat, Brigden told Health Policy Watch.

 

 

 

Image Credits: PAHO/WHO, Catherine Saez.

In the lead-up to the United Nations High-Level Meeting on Universal Health Coverage (UHC) in September, the latest draft of a planned political declaration calls on member states to increase transparency of the cost of research and development (R&D) – in addition to drug prices – but falls short in the area of R&D incentive reform, with no mention of delinking R&D incentives from medicines prices.Continue reading ->

Image Credits: WHO.

A new Knowledge Portal that aims to ease policymakers’ access to reliable information about themes in medicines access, pricing and pharma innovation was launched today by the Global Health Centre of Geneva’s Graduate Institute of International and Development Studies.

The Portal currently covers some 17 topics grouped under three broad themes – Pricing, Intellectual Property and Innovation. But there are plans to double that number, through a hybrid approach of Wiki-style crowd-sourcing and academic curation of suggested content, says Suerie Moon, research director at the Global Health Centre and project lead.

Moon said that the project, supported by the Open Society Foundations, aims to demystify often complex topics and put existing knowledge at the fingertips of policymakers and their advisors – who need vital background on issues that are increasingly hot topics of debate in UN fora, as well as in national health systems.

Each theme (Pricing, Intellectual Property, Innovation) is covered by four main resources including: brief research syntheses, directories of data sources, listing of research gaps and webinars on related issues.

“The real added value is the research syntheses, which is hard to get anywhere else,” Moon observed. “Sometimes these are buried in a Masters’ thesis, or an academic article, but they are generally not produced for the policy practitioner community. “We have synthesized this research to provide concise, up-to-date summaries on the state of knowledge on each policy topic.”

For instance, under the “Pricing” tab, a user can find can find easy-to-read descriptions and assessments of the often highly technical tools and tactics used to make drugs more affordable in low- and middle-income countries, such as Tiered Pricing and Voluntary Licensing.

Under “Innovation,” initiatives such as Patent Pools, Priority Review Vouchers and Advanced Market Commitments, are described. These are often used to stimulate new drug development, while promoting broader medicines access.

The portal also seeks to present the oft-divided perspectives of different private sector, civil society and research stakeholders in an evidenced-based way, Moon said:

“For instance, with regards to accessible pricing, different stakeholders will say ‘why don’t we solve the issue with tiered pricing, or using donations, or we can solve it using bulk procurement?’ But when I engage in these debates, people don’t have easily at their fingertips the evidence that they need to assess whether any particular solution will work to solve the pricing challenge.”

“The issue area is quite sensitive and sometimes quite polarized. You have a lot of sides producing documents that might support one or another perspective, but not a lot of groups that have taken a step back to say what do we know about this issue?”

Other Key Features – Data Sources, Research Gaps and Webinars

Along with synthesis of each major topic, the Portal’s other key features include:

  • Compilation of open-access data sources where users can find further information related to medicines prices, pharmaceutical company policies, patent information, R&D funding and costs, among other topics;
  • A curated list of “Research Gaps” developed during the literature reviews that underpin the website construction; and
  • Announcements and recordings of webinars organized by the Knowledge Network and presented by leading medicines policy researchers.

Moon said that the research syntheses and other documentation are “living” instruments that will undergo open peer review and be periodically updated to incorporate feedback and new research.

In that respect, she hopes to harness some of the approaches used by open-source libraries such as Wikipedia, where the crowdsourced feedback will constantly improve the site.

“I’m a huge fan of the Wiki philosophy,” says Moon. “We want other people to send us their feedback and ‘what did we miss’,” noting that comments and suggestions for the online materials, as well as the webinar series, are welcome at globalhealthresearch@graduateinstitute.ch.

Building the Portal – Curation and Interpretation

At the same time, she draws a clear line between the Portal’s development by an academic sponsor such as the Graduate Institute, and the Wikipedia approach that relies almost entirely on crowdsourcing.

“The difference is in the expert curation and interpretation,” she said. “You know who wrote it, and that there is an academic reputation behind it. While we are not claiming that it is perfect, and we do want to spur a Wiki-type reaction, we also hope the resource will have a different level of credibility and value.”

She says that the focus themes and topics were originally chosen from a series of interviews and expert meetings. While it was impossible to do systematic literature reviews, the syntheses are the product of comprehensive literature reviews, supplemented by in-person meetings and peer review. Each topic synthesis is accompanied by referenced sources, which users can further explore.

Charting what is missing is as important as what exists, Moon added. In some areas the team found an abundance of recent research, whereas in others, a dearth.

For instance, with regards to medicines shortages – the subject of a World Health Assembly resolution in 2016 – the team found little recent published analysis of drivers and causes.

“Researchers follow trends like everyone else,” Moon observed. “So you have certain topics that are trendy and there may be multiple reviews in a single year. And then there are other areas where there are lots of gaps and we haven’t had a significant new review in 5-10 years.”

“We were constantly filtering through the most important pieces of research and policy analysis to put it together in a coherent story line,” she said, noting that the project is managed by a small team at the Graduate Institute. “Now, we will wait to hear back from the broader policy and practice community on our Version 1.0, and as we get input from different readers, we will be updating and posting the improved versions – although we will keep the older versions online.”

Image Credits: Marco Verch.

Following the adoption of the World Health Assembly resolution on the transparency of medicines markets last month, a new civil society group has formed in France to monitor the French government’s implementation of the resolution.

L’Observatoire Transparence Médicaments (Drug Transparency Observatory), was launched today in a statement calling on the French government and all countries to implement not only the adopted resolution on the transparency of medicines markets, but also the transparency measures included in the initial resolution draft, which go beyond just medicines pricing.

The French government “showed its support to this initial text proposed for the resolution going further than prices, and we now want full transparency to be implemented in France,” said Pauline Londeix, Co-founder of the Observatory, in the statement.

“Besides monitoring the advancement on the implementation of the transparency resolution in pricing, clinical trials, research and development, marketing and patenting,” the statement said, “the Observatory will also monitor the position of France within the international institutions (WIPO, WTO, WHO, etc), as well as at the European level, in particular as part of the European Commission (EC) negotiating Free Trade agreements such as MERCOSUR, Tunisia and Morocco. These agreements currently in negotiation include, on the request of the EC, provisions such as data exclusivity and trade secrets, that go in the opposite direction to transparency.”

“Transparency is critical for countries like France to face the unstoppable increases in medicines prices and to sustain their health systems,” Londeix said.

The Observatory “will work hand in hand with local and international NGO partners,” according to the statement, and can be followed on Twitter at @OTMeds.

In what should prove reassuring to many women, a large clinical study in four African countries has found no significant difference in the risk of HIV infection among women using progestogen-based hormones or copper-bearing IUDs as contraception.

However with “unacceptably high” rates of HIV infection among users of both contraceptive modes during the study, adoption of proven HIV prevention measures, such as partner testing and condoms, remains critically important, WHO officials noted in a press release on the study results.

The Lancet study by a World Health Organization-supported research consortium study fills a critical gap in knowledge about HIV transmission risks for women choosing between methods of contraception that are regarded as the most effective – IUD or hormonal contraception injections or implants.

The study also found that the contraceptive methods also had high levels of safety and effectiveness in preventing pregnancy – although a high proportion of women, and particularly younger women, using all three forms of contraception tested still became infected with HIV.

“After decades of uncertainty, we finally have robust scientific evidence about the potential relationship between hormonal contraception and the risk of HIV from a rigorous randomized clinical trial,” said Professor Helen Rees, Executive Director of Wits Reproductive Health and HIV Institute at the University of Witwatersrand in Johannesburg, South Africa, and a member of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) consortium that carried out the study.  “The results on this question are reassuring, but our findings are also sobering, because they confirm unacceptably high HIV incidence among young African women.”

The trial compared 3 different contraceptive methods to see if there were different levels of risks to users for HIV infection,  including:

  • DMPA (DMPA-IM) – a progestogen-only, injectable contraceptive effective for 3 months;
  • Levonorgestrel – a progestogen-only implant inserted under the skin of the arm that can be used for up to five years;
  • A copper-bearing intrauterine device (IUD), inserted in the uterus, which can be used for several years or more.

The study was carried out in four African countries in settings with high HIV incidence ‒ Eswatini, Kenya, South Africa and Zambia. and involved a total of 7829 sexually active HIV-negative women aged 16 to 35 years, who were randomly assigned to one of the three contraceptive methods.

According to the results reported in Lancet, among the 7829 women who took part in the study, 143 infections occurred in women who used DMPA-IM, while 138 infections occurred in women who used a copper-bearing IUD and 116 in women who used the progestogen-only implant  – not statistically significant differences between the three methods.

Unacceptably High Rates of HIV infection

While the results regarding choice of contraception may be reassuring, the high rate of HIV infections, particularly among younger women, remains a serious concern, leaders of the study noted. Incidence of HIV infections among all of the women participants averaged 3.8% per year – and this was even higher for women under 25 years of age, irrespective of method of contraception used.

“The study highlights the need to step up HIV prevention efforts in these high-burden countries – particularly for young women,” said Dr Rachel Baggaley from WHO’s HIV and Hepatitis Department. “These should include providing HIV testing and a range of HIV prevention choices within contraceptive service programmes.”

These services typically include HIV testing and linkage to antiretroviral therapy for those testing HIV-positive, partner testing and condom promotion.  Another option is pre-exposure prophylaxis (PrEP), which WHO recommends in countries where the incidence of HIV is above 3 percent, as appropriate.

Study Findings to be Incorporated into WHO Guidelines

Over the past 25 years, as the HIV epidemic took hold in many countries, a number of observational research studies had suggested a possible increased risk of HIV acquisition for women using progestogen-only injectables, particularly DMPA-IM. Because of limitations in the design of these studies, however, it was not possible to determine whether HIV infections were due to the type of contraceptive method used or other factors.

The results of the ECHO trial, led by FHI 360, University of Washington, Wits Reproductive Health and HIV Institute, and WHO’s  Human Reproduction Programme (HRP) are thus the most robust to date, said WHO in its press release.

“These results support making available to women and girls a broad choice of effective contraceptive methods that empower them to make informed decisions about their own bodies – including if and when to have children,” said Dr James Kiarie, from the Department of Reproductive Health and Research at the World Health Organization. “Better access to contraception and quality reproductive health services would have a dramatic impact in improving the lives of millions of women and their families.”

WHO says that some 214 million women in developing countries want to avoid pregnancy but do not use a modern contraceptive method, including for hormone based methods.

Following the results, WHO said that it would convene a Guideline Development Group to review its existing recommendations concerning women’s eligibility for using various contraceptive methods if they are at high risk of HIV. Updated recommendations will be issued by the end of August 2019,

WHO also said that it is amplifying its support to “countries with high HIV incidence rates, including the four countries in which the study was conducted, to develop plans to provide integrated family planning and HIV and STI services as recommended in the Call to Action on Sexual and Reproductive Health and Rights(SRHR)-HIV Linkages.”

Extending the reach of primary health care systems to provide malaria services to those in the most hard-to-reach places has become part and parcel to the global malaria response, and according to experts, is paving the way for the expansion of other essential health services – and moving the world closer towards realising universal health coverage (UHC).Continue reading ->

Image Credits: Fanjan Combrink / WHO, WHO, MMV, Ben Moldenhauer / MMV, Source: MMV, The Global Fund.