The US Food and Drug Administration (FDA) last week approved a tuberculosis (TB) treatment regimen containing a new drug, pretomanid, offering a shorter, more effective course of treatment for highly drug-resistant strains of TB, the world’s leading cause of death by infectious disease.

Pretomanid is only the third TB drug to be approved in over 50 years, and amidst the excitement from achieving this milestone, activists are calling for the developer and newly licensed producer of pretomanid to ensure that those most in need of the treatment will be able to access it.

“This newly approved regimen containing pretomanid could be a lifesaver for people with XDR-TB [extensively drug-resistant TB], but it’s not time to celebrate yet,” said Sharonann Lynch, HIV & TB Policy Advisor for Médecins Sans Frontières’ (MSF/Doctors Without Borders) Access Campaign. “The approval of this new regimen by the US FDA is just the first step. We now need pretomanid to be registered and available at an affordable price in all countries, prioritising those with the highest TB burden.”

José Luis Castro, Executive Director of the International Union Against Tuberculosis and Lung Disease (The Union), commented: “The Union welcomes a new shorter all-oral regimen for XDR-TB… and we emphasise the need that it will be affordable and made available to National TB Programmes to adopt and scale up to offer effective treatment options to people with this severe form of TB.”

Drug-resistant tuberculosis patient in Mumbai, India. Photo: MSF/Atul Loke/Panos Pictures

Unlike the two other new drugs in the TB arsenal, bedaquiline and delamanid, pretomanid is the first FDA-approved TB drug to be developed and registered by a non-profit organisation, the TB Alliance.

In 2000, resistance to decades-old front-line TB drugs was becoming increasingly common, yet there were no new antibiotics in the TB development pipeline. In response to this global gap in research and development (R&D), the TB Alliance was formed as a product development partnership (PDP) dedicated to “the discovery, development, and delivery of better, faster-acting and affordable tuberculosis drugs that are available to those who need them.”

After almost 2 decades and 19 clinical trials in 14 countries, pretomanid is the first TB treatment the Alliance has successfully registered with the FDA.

Mylan, a US based pharmaceutical corporation, was granted the first license to produce, register, and supply pretomanid in April 2019. Mylan is expected to bring the drug to market by as early as January 2020, pending anticipated guidance from the World Health Organization on the new treatment regimen.

A Potentially Game-Changing New Treatment

Pretomanid is listed to be given in a 3-drug regimen known as BPaL (bedaquiline + pretomanid + high dose linezolid) based on results from the landmark Nix-TB trial in South Africa.

Although the trial only enrolled 109 participants, results showed unprecedented cure rates of 89 percent in patients with extensively drug resistant tuberculosis (XDR-TB), representing a significantly higher success rate than the historical 34 percent cure rate.

The newly approved regimen is also much shorter and easier to administer – the 6-month treatment course consists of only 5 daily pills, taken orally.

Dr. Madhukar Pai, a TB expert and advisor for TB Alliance, explained in a recent article that patients often struggle to complete their full courses of therapy for XDR-TB due to drug toxicity and the long length of treatment.

Existing treatment regimens for XDR-TB require 6-8 drugs, administered both orally and intravenously, taken for up to 2 years. The intravenous drugs can cause serious side effects such as vertigo, deafness, and visual or auditory hallucinations, and patients can be required to take up to 40 pills a day.

While there are still concerns about contraindications from the high doses of linezolid required in the new BPaL treatment course, this shorter, simpler regimen holds promise for significantly improving adherence to treatment, quality of life while on treatment, and chance of complete cure.

More studies to test whether BPaL’s treatment efficacy can be maintained at lower doses of linezolid are underway.

Questions Around Treatment Access Remain

A number of TB stakeholders are cautiously optimistic about BPaL’s approval, claiming that the drug regimen means little if it cannot be delivered to patients in need.

Historically, there have been challenges in bringing new TB tools to scale. One of the necessary drugs in the newly approved BPaL regimen, bedaquiline, was approved for use against MDR-TB in 2012, yet MSF estimates that only 20 percent of people who require the drug are able to access it.

Bedaquiline remains priced out of reach for many people in low- and middle-income countries, and a number of high-TB burden countries have not yet registered the drug to allow importation and distribution.

MSF has been advocating for Janssen Pharmaceuticals, the only producer of bedaquiline, to halve the price of the drug to US$ 1 a day. They have recommended that the price for a 6-month course of BPaL be no more than US$ 500 per person.

Mylan has yet to release its launch price for pretomanid in low- and middle-income countries, and they hold exclusive rights for producing the drug until November 2020.

However, Daniel Everitt, VP and senior medical officer at the TB Alliance, says: “In all of the lower-income countries, [TB Alliance] will be encouraging other manufacturers, generic manufacturers, to get into the market — to get competition to drive down the price as well.”

TB Alliance is also poised to receive a Priority Review Voucher (PRV) as a reward for developing pretomanid. PRVs can be sold to pharmaceutical companies for as much as US$ 350 million, and activists have urged TB Alliance to apply potential profits from sale of a PRV to efforts to increase access to pretomanid.

On the regulatory side, TB experts have been calling on the WHO and high-burden countries, such as India and Russia, to develop guidelines and policies to ensure access to BPaL once it is brought to market. India has expressed interest in starting its own pretomanid trials soon.

WHO is in the process of updating existing treatment guidelines for MDR-TB which is expected to incorporate evidence on the BPaL regimen.

WHO is currently inviting health professionals, TB patients, policy makers, and other TB stakeholders to submit comments to the MDR-TB Guideline Development Group between August 8 and August 20 2019. New treatment guidelines are set to be released in late 2019.

Current Status of XDR-TB

“By the end of 2016, XDR-TB had been reported by 123 WHO Member States. Information from countries with reliable data suggests that about 6.2% of MDR-TB cases worldwide have XDR-TB. In 2016, there were an estimated 490 000 new cases of MDR-TB worldwide,” the WHO reports.

XDR-TB is highly underreported, so the true burden of disease is likely higher than official figures indicate.

Image Credits: MSF/Atul Loke/Panos Pictures.

[TB Alliance]

NEW YORK (August 14, 2019)—Pretomanid, a novel compound developed by the non-profit organization TB Alliance, was approved by the U.S. Food & Drug Administration (FDA) today for treating some of the most drug-resistant forms of tuberculosis (TB).1 The new drug was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) as part of a three-drug, six-month, all-oral regimen for the treatment of people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive (collectively “highly drug-resistant TB”).1,2

The LPAD pathway was established by FDA as a tool to encourage further development of antibacterial and antifungal drugs to treat serious, life-threatening infections that affect a limited population of patients with unmet needs.

“FDA approval of this treatment represents a victory for the people suffering from these highly drug-resistant forms of the world’s deadliest infectious disease,” said Mel Spigelman, MD, president and CEO of TB Alliance. “The associated novel regimen will hopefully provide a shorter, more easily manageable and highly efficacious treatment for those in need.”

The three-drug regimen consisting of bedaquiline, pretomanid and linezolid – collectively referred to as the BPaL regimen – was studied in the pivotal Nix-TB trial across three sites in South Africa. The trial enrolled 109 people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB.2

Nix-TB data have demonstrated a successful outcome in 95 of the first 107 patients after six months of treatment with BPaL and six months of post-treatment follow-up.2 For two patients, treatment was extended to nine months. The new drug application contains data on 1,168 people who have received pretomanid in 19 clinical trials that have evaluated the drug’s safety and efficacy.2 Pretomanid has been clinically studied in 14 countries.

TB, in all forms, must be treated with a combination of drugs; the most drug-sensitive forms of TB require six months of treatment using four anti-TB drugs.3 Treatment of XDR-TB or treatment-intolerant/non-responsive MDR-TB has historically been lengthy and complex; most XDR-TB patients currently take a combination of as many as eight antibiotics, some involving daily injections, for 18 months or longer.3,4 Prior to recent introduction of new drugs for drug-resistant TB, the World Health Organization (WHO) has reported estimates for treatment success rates of XDR-TB therapy at approximately 34 percent and about 55 percent for MDR-TB therapy.4

“Until very recently, people infected with highly drug-resistant TB had poor treatment options and a poor prognosis,” said Dr. Francesca Conradie, principal investigator of the Nix-TB trial. “This new regimen provides hope with 9 out of 10 patients achieving culture negative status at 6 months post-treatment  with this short, all-oral regimen.”

Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. TB Alliance acquired the developmental rights to the compound in 2002. It has been developed as an oral tablet formulation for the treatment of TB in combination with bedaquiline and linezolid, two other anti-TB agents, and is now indicated for use in a limited and specific population of patients.1 Adverse reactions reported during the Nix-TB trial of the BPaL regimen include hepatotoxicity, myelosuppression, as well as peripheral and optic neuropathy.1 Please see additional safety information in the Important Safety Information below and in the accompanying pretomanid Full Prescribing Information.

Pretomanid is only the third new anti-TB drug approved for use by FDA in more than 40 years, as well as the first to be developed and registered by a not-for-profit organization.5,6 Pretomanid was granted Priority Review, Qualified Infectious Disease Product, and Orphan Drug status. As a product development partnership, TB Alliance has collaborated with and received significant support from numerous governments, academia, philanthropic institutions, the private sector, civil society organizations and other partners over the course of pretomanid’s development.

Pretomanid is expected to be available in the United States by the end of this year. In addition to the U.S. FDA, TB Alliance has submitted pretomanid as part of the BPaL regimen for review by the European Medicines Agency and has provided data to the World Health Organization for consideration of inclusion in treatment guidelines for highly drug-resistant TB.

INDICATION

Limited Population: Pretomanid Tablet is an antimycobacterial indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug-resistant (XDR), treatment-intolerant or non-responsive multidrug‑resistant (MDR) tuberculosis (TB).  Approval of this indication is based on limited clinical safety and efficacy data.  This drug is indicated for use in a limited and specific population of patients.

Limitations of Use:

  • Pretomanid Tablets are not indicated for patients with:
    • Drug-sensitive (DS) tuberculosis
    • Latent infection due to Mycobacterium tuberculosis
    • Extra-pulmonary infection due to Mycobacterium tuberculosis
    • MDR-TB that is not treatment-intolerant or non-responsive to standard therapy
  • Safety and effectiveness of Pretomanid Tablets have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.

IMPORTANT SAFETY INFORMATION

Contraindications
Pretomanid Tablets used in combination with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid is contraindicated.

Warnings and Precautions 

  • Hepatic adverse reactions were reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Monitor symptoms and signs and liver‑related laboratory tests.  Interrupt treatment with the entire regimen if evidence of liver injury occurs.
  • Myelosuppression was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Monitor complete blood counts.  Decrease or interrupt linezolid dosing if significant myelosuppression develops or worsens.
  • Peripheral and optic neuropathy were reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Monitor visual function.  Obtain an ophthalmologic evaluation if there are symptoms of visual impairment.  Decrease or interrupt linezolid dosing if neuropathy develops or worsens.
  • QT prolongation was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Use with drugs that prolong the QT interval may cause additive QT prolongation.  Monitor ECGs.  Discontinue the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.
  • Reproductive effects: Pretomanid caused testicular atrophy and impaired fertility in male rats. Advise patients of reproductive toxicities in animal studies and that the potential effects on human male fertility have not been adequately evaluated.
  • Lactic acidosis was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid.  Consider interrupting linezolid or the entire combination regimen of Pretomanid Tablets, bedaquiline, and linezolid dosing if significant lactic acidosis develops.

Adverse Reactions
Most common adverse reactions (≥10%) are peripheral neuropathy, acne, anemia, nausea, vomiting, headache, increased transaminases, dyspepsia, decreased appetite, rash, pruritus, abdominal pain, pleuritic pain, increased gamma-glutamyltransferase, lower respiratory tract infection, hyperamylasemia, hemoptysis, back pain, cough, visual impairment, hypoglycemia, abnormal loss of weight, and diarrhea.

Please see Full Prescribing Information at www.tballiance.org/pretomanid

About Tuberculosis
Tuberculosis is a global disease, found in every country in the world. It is the leading infectious cause of death worldwide. In 2017, 10 million people fell ill from active TB and 1.6 million died. It is an airborne disease that can be spread by coughing or sneezing. There are more than half a million cases of MDR-TB annually, with about 6% of those cases being XDR-TB. Current WHO figures report that 127 countries have reported cases of XDR-TB. Drug-resistant forms of TB currently accounts for close to 1 in 3 deaths due to antimicrobial resistance annually.

About TB Alliance
TB Alliance (The Global Alliance for TB Drug Development, Inc.) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, European & Developing Countries Clinical Trials Partnership, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, United Kingdom Department for International Development, and the United States Agency for International Development.

For more information on the pretomanid application and regulatory approval process, please visit:

1. Pretomanid and BPaL. Full Prescribing Information. August 2019.

2. TB Alliance. Pretomanid and BPaL Regimen for Treatment of Highly Resistant Tuberculosis. Oral presentation at: Antimicrobial Drugs Advisory Committee; June 6, 2019; Silver Spring, MD.

3. The Review on Antimicrobial Resistance. Tackling Drug- Resistant Infections Globally. May 2016.

4. World Health Organization (WHO). Global TB Report 2018.

5. Fox W. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council Tuberculosis Units. Int J Tuberc Lung Dis. 1999;3(10):S231-S279.

6. U.S. Food and Drug Administration. Drug Approvals and Databases. Available at: https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases

Image Credits: TB Alliance.

[UNAIDS]

GENEVA, 14 August 2019—UNAIDS warmly welcomes the appointment of Winnie Byanyima as its new Executive Director. Ms Byanyima has more than 30 years of experience in political leadership, diplomacy and humanitarian engagement.

“I am honoured to be joining UNAIDS as the Executive Director at such a critical time in the response to HIV,” said Ms Byanyima. “The end of AIDS as a public health threat by 2030 is a goal that is within the world’s reach, but I do not underestimate the scale of the challenge ahead. Working with all its partners, UNAIDS must continue to speak up for the people left behind and champion human rights as the only way to end the epidemic.”

The United Nations Secretary-General, António Guterres, appointed Ms Byanyima as the UNAIDS Executive Director and United Nations Under-Secretary-General following a comprehensive selection process that involved a search committee constituted by members of the UNAIDS Programme Coordinating Board. The UNAIDS Committee of Cosponsoring Organizations made the final recommendation on the appointment to the Secretary-General.

Ms Byanyima brings a wealth of experience and commitment in harnessing the power of governments, multilateral agencies, the private sector and civil society to end the AIDS epidemic around the world. Ms Byanyima has been the Executive Director of Oxfam International since 2013. Prior to that, she served for seven years as the Director of Gender and Development at the United Nations Development Programme.

Ms Byanyima began her career as a champion of marginalized communities and women 30 years ago as a member of parliament in the National Assembly of Uganda. In 2004, she became the Director of Women and Development at the African Union Commission, working on the Protocol on the Rights of Women in Africa, an international human rights instrument that became an important tool for reducing the disproportionate effect of HIV on the lives of women in Africa.

She holds an advanced degree in mechanical engineering (in energy conservation and the environment) from the Cranfield Institute of Technology and an undergraduate degree in aeronautical engineering from the University of Manchester.

The Secretary-General wishes to extend his appreciation and gratitude to the UNAIDS Deputy Executive Director, Management and Governance, Gunilla Carlsson, for her service as the Executive Director, a.i.

Fifa Rahman, Unitaid NGO Delegation board member and PhD Candidate at the University of Leeds, moderated a panel at the recent IAS Conference on HIV Science in Mexico entitled “How To Fix Our Medical R&D Model: A Spotlight On TB Treatment.” The panel featured speakers from Médecins Sans Frontières’ (MSF/Doctors Without Borders) Access Campaign, Drugs for Neglected Diseases initiative, Treatment Action Campaign, Treatment Action Group, The International Union Against Tuberculosis and Lung Disease (The Union), and the Mexican National Institute of Health Sciences and Nutrition (National Institute Salvador Zubirán). Here, Rahman shares highlights from the panel on why the medical research and development (R&D) model needs to be ‘fixed’, as well as ways to go about fixing it, including greater transparency, new incentives for investment in R&D that are alternatives to intellectual property, and increased NGO and community participation throughout the research and development process.

Health Policy Watch: At the IAS Conference on HIV Science in July, you moderated a panel on how to fix the medical R&D model, with a focus on tuberculosis (TB). Can you describe some of the key themes discussed during the panel regarding what needs to be ‘fixed’ about the medical R&D model? What were some of the specific strategies or solutions presented to go about doing this?

​Fifa Rahman: The profit-driven medical R&D model means that so-called ‘poor nation’ diseases like tuberculosis are underfunded. And while there are 7 antibiotics for TB in the R&D pipeline, this is insufficient to address the sheer burden of the disease that we have today. In discussion of this broken R&D model, several themes emerged – notably the need for details on public funding into research of drugs to be made public and transparent; that other forms of delinkage to separate R&D costs from product prices, such as prizes for developing new antibiotics, be funded; and that companies license their drugs, including to the Medicines Patent Pool (MPP).

Paula Fujiwara from The Union spoke about the Life Prize, which is aimed towards delivering an affordable, short-course treatment regimen that is effective against all forms of tuberculosis. How this would work is that donors would put their monies into a prize fund, and this prize funding (pegged at US$ 30 million) would be given to companies producing drugs that enter clinical trials to develop a pan-TB regimen, and that also fulfil all predefined criteria, such as addressing stewardship concerns and licensing to ensure access. This plan is guided by principles of access and affordability, and removes the drug development process out of the faulty profit-driven system. It’s a brilliant idea – but needs political commitment from donor countries.

Sharonann Lynch from MSF Access was supportive of the Life Prize idea, and additionally spoke about the need to regulate the margin of income over the cost of manufacturing, and that countries needed to commit to transparency of the cost of R&D to make this work.

HPW: The need for public health-driven R&D has been a major theme this year, with intense debate over how best to achieve this in multiple United Nations fora, including the World Health Organization, the Human Rights Council and more recently the General Assembly in negotiating the political declaration on universal health coverage (UHC). Do you see progress taking place nationally and internationally in advancing public health-driven R&D, and if so how? If not, why not?

FR: It’s hard to say. On one hand you’ve got developed and developing nations, including Italy, Malaysia, Spain, Brazil, an entire African bloc of nations, and the United States, endorsing a World Health Assembly (WHA) resolution on drug pricing and research and development transparency, which is clearly a major milestone. We’ve also got increased visibility on drug pricing debates. High drug prices are no longer a developing country issue, with buyers clubs being established on the cystic fibrosis drug Orkambi in the UK, and people dying due to substitution of originator insulin in the United States. We also have some of Switzerland’s top university hospitals teaming up to tackle high CAR-T cancer therapy prices and offer them at a third of the cost.

On the other hand you’ve got the United Kingdom intensely resisting drug pricing transparency at the WHA, and uncertainty around Democratic Presidential Candidates in the United States, and how the election will go in 2020. Despite the diminishing global dominance of the U.S. for some time now due to the rise of emerging market nations, and of course China, the impact of United States’ regime-making capacity will be greatly dependent on who wins in 2020. For example, a Joe Biden presidency would be vastly different to an Elizabeth Warren presidency in terms of how the U.S. would advance public health-driven R&D internationally.

HPW: Intellectual property (IP) and patents are widely seen to be core drivers that incentivise R&D of new health products, and in this light are viewed by a range of actors as essential for innovation in public health, even while they can lead to monopolies that restrict affordable access to health products. What is your perspective on the role of intellectual property and patents in public health-driven R&D, and can you describe some of the challenges they pose, particularly when negotiated as just one aspect of much more comprehensive trade agreements?

FR: It’s no secret that there is a lot of patent abuse, over-patenting, and evergreening, and as a result patients are deprived of access to medicines which should now be off-patent. The system also encourages price gouging of which we’ve seen numerous examples, but which is particularly visible with stories like that of Tobeka Daki who died of breast cancer not having access to Herceptin.

Trade-related IP binds IP to enforceable regimes, and requires countries to increase intellectual property protection which enables price gouging and evergreening as described. But there are signs of hope. You see, trade-related IP responds to pharmaceutical markets, and as we move towards more biologic medicines and personalised medicines, the IP regime will respond accordingly. Over the past few years as we saw blockbuster drug lists increasingly dominated by biologic drugs, we saw the United States demanding specific intellectual property provisions for biologic drugs in the Trans-Pacific Partnership (TPP) and the United States-Mexico-Canada Agreement (USMCA). In the former, and as will be shown in upcoming research in my PhD, despite economic interdependence on the United States, countries including Australia, Malaysia and Chile formed strong coalitions based on common ideation rejecting intellectual property maximisation on biologics. So while trade-related IP responds to trends in the market, whether or not countries accept them is dependent on other political economy factors – including their economic interdependence on other large powers, the visibility and emphasis of drug pricing debates in developed nations, and the ability of developing nations to effectively utilise tools that can increase their bargaining power in trade negotiations.

HPW: You’re currently serving as a board member of Unitaid on behalf of the NGO delegation. Can you explain why Unitaid, a major global funder of public health-driven R&D, includes an NGO representative as well as a Community representative in its Executive Board? Do you think the medical R&D system can do better at including NGOs and affected communities in its R&D process, and if so how? Do you think this may also help to fix the medical R&D model?

FR: The Unitaid NGO Delegation represents NGO entities and experts within those entities, and the Communities Delegation represents communities living with the diseases. Both of these delegations play a very important role within the decision-making body of Unitaid because they bring unique perspectives to grant approval and governance processes.

As the Board Member for the NGO Delegation I can speak on its behalf but not the Communities, and I can say that the NGO Delegation draws upon expert opinion from over 200 NGOs across the world, including input on whether there are already suitable generics for a proposed investment; whether there is proper waste disposal for plastic canisters from malaria indoor spraying; whether the underinvestment in TB is best served by projects on digital adherence technologies; or whether we would be better placed investing in something like the Life Prize or investing in fixing broken paediatric pharmaceutical procurement systems. We also frequently engage with Unitaid grantees – which I think increases the robustness of our feedback to the Board and Secretariat. Alongside the role of the Communities and NGO Board Members, we always hope and expect that the other Board Members, and especially the Secretariat, also find ways to consult directly with NGOs and affected communities to sharpen their approach to ensuring affordable medicines and diagnostics.

We as a Delegation think that NGOs should be consulted more upstream in the R&D process, precisely because of our insight into access, affordability, and equitability issues, as well as to ensure that new medicines and diagnostics are designed in a manner that is best suited to use in particular settings, or to ensure that such products are acceptable to the people who must ultimately use them.

As to the question on ‘how?’ – there are a few approaches. One promising avenue is to ensure prominent NGO and community participation at the WHO as it continues to update and expand the Health Product Profile Directory, which was launched by TDR, WHO’s Special Programme for Research and Training in Tropical Diseases, earlier this year. It is also important that major public funders of R&D, whether in the U.S., Europe or elsewhere, find ways to consult and work directly with NGOs and communities – especially since so many of the crucial inventions that are ultimately brought to the market are brought forward by intramural or extramural research hosted by these institutions. Finally, major philanthropic funders such as the Wellcome Trust and the Gates Foundation, and many of their key recipients, and in particular product development partnerships, can play a crucial role in ensuring the participation of communities and NGOs both upstream and also as products enter the market, where their contributions are equally needed.

Such interventions can help to ensure that medical R&D, as far as initial investments made in the public sector and philanthropies, are more attuned to the needs of communities at the outset. Yet the breakdown of the R&D model requires much deeper changes to how R&D is conducted, including a need to search for incentives outside of intellectual property; the importance of public health funders demanding a public return on public investment; a need to promote transparency across the R&D process; and much more substantial political will of governments to both balance the power of pharmaceutical companies and to bring down prices of new medicines and vaccines when these other interventions fail to ensure affordability of new medicines.

Fifa Rahman is the Board Member for NGOs at Unitaid, working on good governance, timeliness of investments, and procurement transparency, among other things. She was formerly the head of policy at the Malaysian AIDS Council, and worked on a HCV compulsory licence. She is now based in the United Kingdom working on a PhD on trade negotiator tactics in intellectual property negotiations at the University of Leeds.

Air pollution in Delhi from a toxic mix of transport, coal power, waste and agro-waste burning; SouthEast Asia has some of the highest air pollution levels in the world, according to WHO regional analyses

Most big cities around the world are above World Health Organization-recommended safe levels of particular matter in the air, with 42 percent at dangerously high levels, and only 8 percent within safe limits, a new study finds. At just 2.5 microns in size or smaller, fine particulate matter (PM2.5) is “a leading environmental health risk” and the cause of fatal cardiovascular and respiratory diseases, as well as cancers.

The cities within safe limits are exclusively within wealthy countries, while those at dangerously high levels are located primarily in more recently industrialised Asian countries, where there are less emission controls to reduce particulate matter and less stringent environmental regulations, and where many wealthy countries have relocated polluting industries.

Utilising estimates of PM2.5 mortality rates in the 250 most populated cities in the world today, the study released by Nature on Friday concluded that city-level information will be critical in determining actions to improve air quality, reduce CO2 emissions, and design sustainable energy sources for the coming decades. According to the study, while regional and countrywide information on the health hazards of PM2.5 is plenty, there has been a severe lack of data at the city-level.

Pedestrians in Bangladesh cover their faces to keep from breathing in dust and smog. Air pollution takes 22 months off the average life expectancy in Bangladesh, according to recent analyses. (Photo: Rashed Shumon)

Among the cities examined, the study found that only 8 percent returned PM2.5 levels below what the World Health Organization has defined as an acceptable annual average. These cities were primarily found in wealthy, economically developed nations, including Sweden, the United States, Canada, Australia, and Brazil. In contrast, the study revealed that 42 percent of the examined cities returned dangerously high PM2.5 levels, with the remaining cities falling at or close to the WHO guideline.

Further findings challenged correlations between economic development and levels of PM2.5. While cities in Asia were present in both the top ten cities for population-weighted PM2.5 and the top ten cities for PM2.5 mortality rates, the former category was shared with cities in Africa while the latter was shared with those in Europe. This suggests that while African cities are experiencing an increase in PM2.5 levels during a period of industrial expansion, post-industrial European cities are reporting greater numbers of PM2.5 related illnesses and fatalities.

Unlike CO2 emissions, PM2.5 includes naturally occurring pollutants which can further worsen air quality in tandem with human-made sources stemming from different industrial sectors. For example, the Egyptian capital Cairo is geographically vulnerable to poor air quality because of its location within a valley where sand and dust blown in by western winds are trapped and combined with industrial pollution under the North African sun.

The map from the study below details the distribution of deaths linked to particulate matter across cities worldwide:

Source: Nature (2019)

Carbon Dioxide Independent from Fine Particulate Matter; Opportunities to Reduce Both

A result of production and manufacturing, CO2 emissions are another challenge in the mission to improve air quality worldwide. However, while capable of combining with fine particulate matter to create hazardous conditions in cities, the study reported that there was “no association between PM2.5 and CO2 emission rates.” Instead, increases or decreases of one rate may be independent of the other, a concept found to be true particularly among cities in wealthier regions.

Identifying three key factors, the study explained the independence of CO2 emission rates from PM2.5 levels in wealthier regions:

First is the ability of wealthy regions to develop and implement technology, such as “end-of-pipe emission controls,” which reduces PM2.5 levels at a greater rate than CO2 emissions. Second, the study focused only on the 250 largest cities in the world. This presents the possibility that production facilities may have been relocated to smaller cities or distant regions, causing air pollution levels within city limits to decrease while CO2 emissions remain minimally changed as a result of large populations. Relocation on a global scale is recognised as the third factor as wealthier nations, such as the United States, outsource large production facilities to cities in other regions of the world, thereby “simply (moving) pollution from one place to another.”

Declaring that “the challenge of urban PM2.5 can also be viewed as an opportunity,” the study suggests that government policy, along with continued innovations in green technology and sustainable energy sources, could reduce CO2 emission rates in cities already successful in PM2.5 efforts, and help manage air pollution in actively industrialising cities.

This call to action comes six weeks ahead of the United Nations Climate Summit on 23 September in New York, where discussions are expected to address climate-related health hazards and policies for climate change mitigation.

Image Credits: Flickr, Rashed Shumon, Nature.

[US National Institutes of Health]

12 August, 2019

The Pamoja Tulinde Maisha (PALM [together save lives]) study is a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola virus disease. The study began on Nov. 20, 2018 in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces.

As of Aug. 9, 2019, the trial had enrolled 681 patients toward an enrollment total of 725. Patients were enrolled at four Ebola Treatment Centers (ETCs) in Beni, Katwa, Butembo and Mangina. These ETCs have been overseen by staff from the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; and three medical humanitarian organizations: the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médecins Sans Frontières (MSF).

The Pamoja Tulinde Maisha (PALM) study logo. “Pamoja Tulinde Maisha” is a Swahili phrase which roughly translates to “Together Save Lives.”

The trial is monitored by an independent data and safety monitoring board (DSMB) that meets periodically to review interim safety and efficacy data and to make recommendations to the study team and the sponsors. As a result of their Aug. 9, 2019 review, the DSMB recommended that the study be stopped and that all future patients be randomized to receive either REGN-EB3 or mAb114 in what is being considered an extension phase of the study. This recommendation was based on the fact that an early stopping criterion in the protocol had been met by one of the products, REGN-EB3. The preliminary results in 499 study participants indicated that individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to participants in the other two arms.

The principal investigators of the study, its statistician and its co-sponsors accepted this recommendation, and the ETC staff at the sites were promptly informed. In addition to limiting future patient randomizations to REGN-EB3 and mAb114, patients who were randomized to ZMapp or remdesivir in the last 10 days now have the option, at the discretion of their treating physician, to receive either REGN-EB3 or mAb114.

While the final analysis of the data can occur only after all the data are generated and collected (likely late September/early October 2019), the DSMB and the study leadership felt the preliminary analysis of the existing data was compelling enough to recommend and implement these changes in the trial immediately. The complete results will be submitted for publication in the peer-reviewed medical literature as soon as possible.

The study is co-sponsored and funded by the INRB and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health; carried out by an international research consortium coordinated by the World Health Organization (WHO); and supported by four pharmaceutical companies (MappBio, Gilead, Regeneron, and Ridgeback Biotherapeutics).

NIAID, INRB and the WHO thank the extraordinary team of individuals who have worked under extremely difficult conditions to carry out this study, the members of the DSMB, and, most importantly, the patients who participated in the study and their families. It is through this type of rapidly implemented, rigorous research that we can quickly and definitively identify the best treatments and incorporate them into the Ebola outbreak response.

Image Credits: WHO/Chris Black, PALM.

[Sabin Vaccine Institute]

LONDON / WASHINGTON, D.C. – GSK and the Sabin Vaccine Institute (Sabin) announced exclusive agreements for Sabin to advance the development of the prophylactic candidate vaccines against the deadly Ebola Zaire, Ebola Sudan and the closely related, but lesser known, Marburg virus. No licensed vaccines against these three viruses are currently available. All three cause hemorrhagic fever with subsequent death in an average of 50 percent of cases [1,2]. More than 1,600 people have already died during the ongoing Ebola Zaire outbreak in the Democratic Republic of Congo (DRC) [3], leading the World Health Organization (WHO) to recently declare it a Public Health Emergency of International Concern [4].

Under the agreements between GSK and Sabin announced Tuesday 6 August, Sabin has exclusively licensed the technology for all three candidate vaccines and acquired certain patent rights specific to these vaccines. The three candidate vaccines were initially developed collaboratively by the U.S. National Institutes of Health and Okairos, which was acquired by GSK in 2013. The candidate vaccines, based on GSK’s proprietary ChAd3 platform, were further developed by GSK, including the Phase II development for the Ebola Zaire vaccine.

Sabin Chief Executive Officer Amy Finan commented, “As an organization committed to improving lives through immunization, Sabin is dedicated to preventing devastating outbreaks of the Ebola and Marburg viruses. Thanks to GSK’s longstanding engagement in global health, as well as its scientific expertise, the ChAd3 vaccine program is well positioned to be an effective weapon in the global community’s arsenal against Ebola. Sabin appreciates GSK’s years of work to advance the ChAd3 Ebola program and the productive partnership the two organizations have established. Sabin plans to continue the development and seek regulatory approval of Ebola and Marburg vaccines with our shared goal of making them available to the millions of people potentially at risk.”

Thomas Breuer, Chief Medical Officer of GSK Vaccines, said: “These agreements with the Sabin Vaccine Institute are an important next step in the fight against Ebola and Marburg viruses. Enabling Sabin to build on the scientific progress GSK has delivered up to Phase II increases the likelihood these candidate vaccines may help prevent potential future outbreaks, and exemplifies GSK’s approach to global health vaccines which supports partners in taking forward our innovations in a sustainable way. I am proud of the work that our world-leading vaccines scientists at GSK have contributed so far to the development of these vaccine candidates, including the Ebola Zaire candidate vaccine which has demonstrated encouraging results in studies to date.”

To further develop the ChAd3 Ebola and Marburg vaccines, Sabin has entered into a Research Collaboration Agreement with the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID). The ChAd3-based vaccines against Ebola Zaire, Ebola Sudan, and Marburg viruses have demonstrated a strong safety profile and encouraging immunogenicity results after being administered to more than 5,000 adults and 600 children, in 13 different clinical trials to date.
Specifically, the majority of the clinical volunteers were tested using the ChAd3 Ebola Zaire vaccine. In addition to numerous Phase I trials, the Ebola Zaire vaccine has been tested in three Phase II trials in Africa; two trials were conducted by GSK and one was conducted by the Partnership for Research on Ebola Virus in Liberia (PREVAIL), a clinical research partnership between NIAID and the Liberian Ministry of Health. The Ebola Sudan vaccine has been evaluated in three Phase I trials in Africa and the United States as a bivalent formulation with Ebola Zaire and will be evaluated in an upcoming Phase I study as monovalent formulation. A Phase I study of the Marburg vaccine is ongoing in the United States.

About the Sabin Vaccine Institute

The Sabin Vaccine Institute, a non-profit organization founded in 1993, is a leading advocate for expanding vaccine access and uptake globally, advancing vaccine research and development, and amplifying vaccine knowledge and innovation. Sabin’s R&D strategy focuses on continuing the development of candidate vaccines that have demonstrated early scientific value and target disease primarily impacting the world’s most vulnerable populations, but have little commercial value. The Blavatnik Family Foundation and the David E.I. Pyott Foundation provided seed funding to launch Sabin’s ChAd3 Ebola program. In past years, Sabin received more than $110 million for vaccine R&D programs from public and philanthropic funding sources, including the Bill & Melinda Gates Foundation, European Commission, Dutch Ministry of Foreign Affairs, Global Health Innovative Technology Fund and the Michelson Medical Research Foundation.

Unlocking the potential of vaccines through partnership, Sabin has built a robust ecosystem of funders, innovators, implementers, practitioners, policy makers and public stakeholders to advance its vision of a future free from preventable diseases. Sabin is committed to finding solutions that last and extending the full benefits of vaccines to all people, regardless of who they are or where they live. At Sabin, we believe in the power of vaccines to change the world. For more information, visit www.sabin.org and follow us on Twitter, @SabinVaccine.

About GSK

GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the world’s leading vaccine company, with a portfolio that helps protect people throughout life and an innovative pipeline of 16 vaccines in development. Our vaccines help prevent illnesses such as hepatitis A and B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, pneumococcal disease, influenza, rotavirus, shingles and meningitis. At GSK, more than 17,000 people worldwide deliver around two million vaccine doses per day to people in 158 countries. For further information, please visit www.gsk.com.

About Ebola Zaire, Ebola Sudan and Marburg

Ebola Zaire, Ebola Sudan and Marburg are members of the Filoviridae virus family and are commonly referred to as filoviruses. All can cause severe hemorrhagic fever in humans and nonhuman primates. No therapeutic treatment of the hemorrhagic fevers caused by filoviruses has been licensed to date.

The 2014-2016 outbreak in West Africa, the largest Ebola outbreak in history, was caused by Ebola Zaire, starting in Guinea and then moving across land borders to Sierra Leone and Liberia. The outbreak eventually spread to 10 countries and took the lives of more than 11,000 people. The ongoing 2018-2019 outbreak in eastern DRC is also caused by Ebola Zaire and has claimed the lives of more than 1,600 people. The outbreak has been further complicated by significant security issues adversely affecting public health response activities, and on July 17, WHO declared it a Public Health Emergency of International Concern.

Marburg and Ebola viruses are transmitted to humans by infected animals, particularly fruit bats. Once a human is infected, the virus can spread to others through close personal contact or contact with bodily fluids. Isolation of infected people is currently the centerpiece of filovirus control.

Marburg was the first filovirus to be recognized in 1967 when a number of laboratory workers, including some in Marburg, Germany, developed hemorrhagic fever. Ebola was identified in 1976 when two simultaneous outbreaks occurred in northern Zaire (now the DRC) in a village near the Ebola River and southern Sudan. The outbreaks involved what eventually proved to be two different species of Ebola virus; both were named after the nations in which they were discovered.

Citations:

[1] WHO fact sheet, Ebola virus disease, accessed 30 July 2019 – available at: https://www.who.int/news-room/fact-sheets/detail/ebola-virus-disease
[2] WHO fact sheet, Marburg virus disease, accessed 30 July 2019 – available at: https://www.who.int/news-room/fact-sheets/detail/ebola-virus-disease
[3] WHO, Ebola in the Democratic Republic of the Congo – Health Emergency Update, accessed 30 July 2019 – available at: https://www.who.int/emergencies/diseases/ebola/drc-2019
[4] WHO press release, Ebola outbreak in the Democratic Republic of the Congo declared a Public Health Emergency of International Concern, 17 July 2019 – available at: https://www.who.int/news-room/detail/17-07-2019-ebola-outbreak-in-the-democratic-republic-of-the-congo-declared-a-public-health-emergency-of-international-concern

Image Credits: Sabin Vaccine Institute.

A transformation of global diets away from red meat consumption and towards healthier plant-based alternatives is critical for the world to combat climate change and land degradation that threatens food systems, while meeting the nutrition requirements of a growing population, says a new report by the Intergovernmental Panel on Climate Change (IPCC).

The report, Climate Change and Land, by the UN’s top body of climate scientists, said that food security could be jeopardised unless there is a shift away from red meat to diets richer in plant-based foods, such as fruits, vegetables and legumes, supplemented by animal protein sources like poultry, eggs, pork and milk products – whose production generates comparatively fewer climate emissions than red meat.

The IPCC report, released Thursday in Geneva, is likely to shift the conversation around health and climate change – which has tended to focus on the health impacts of extreme weather and air pollution – to the less-traveled territory of sustainable agriculture, nutrition and food security.

Photo: USDA/Lance Cheung

“Consumption of healthy and sustainable diets presents major opportunities for reducing GHG [greenhouse gas] emissions from food systems and improving health outcomes,” says the 1500-page report by 103 experts from 52 countries.

“Examples of healthy and sustainable diets are high in coarse grains, pulses, fruits and vegetables, and nuts and seeds,” and are “low in energy-intensive animal-sourced and discretionary foods (such as sugary beverages),” the report notes.

The new IPCC report now says that shifts may not only be critical to health, but to the basic food security of millions of people, as the global population is expected to grow by several billion more people by the end of the century.

“Replacing beef in the US diet with poultry can meet caloric and protein demands of about 120 to 140 million additional people consuming the average American diet,” the report points out.

And because red meat production requires such heavy inputs of land, energy, and water, as well as grain for cattle feed, reduced meat consumption would also lessen pressure on those resources, and thus vulnerability to climate change, the report emphasises. For example, beef products sold in the US account for just 4 percent of food products sold (by weight), but 36 percent of climate emissions associated with food production.

The strong health messages in the report echo those issued by WHO at the last UN Climate Change Conference in December 2018.

A WHO Health & Climate Change report released at the conference in Katowice, Poland stated that: “Moderation of red meat consumption by high-income populations could result in some of the largest reductions in climate change and the greatest improvements in health associated with the agricultural sector, as a significant proportion of agricultural emissions come from livestock, especially methane from ruminants.”

Global Food System Threatened on Multiple Fronts

The IPCC report goes even further to explain that the global food production system is threatened on multiple fronts. Those include climate-induced changes in weather such as more droughts and flooding, other climate and environmental drivers of land degradation and desertification, and finally non-climate stressors, such as population and income growth.

“Without inclusion of comprehensive food system responses in broader climate change policies… food security will be jeopardized,” it warns.

Despite a 30 percent increase in global food production since 1961, current food production patterns have led to tremendous nutrition imbalances, which affect both rich and poor. For instance, an estimated 821 million people are currently undernourished and 151 million children under 5 are stunted, while 2 billion adults are overweight or obese, the report notes, citing WHO nutrition data.

The Food and Agriculture Organization (FAO) estimates that based on current trends, 50 percent more food would need to be produced by 2050 in order to accommodate the world’s growing population. But IPCC concludes that based on current production models, such an increase would “engender significant increases in GHG emissions and other environmental impacts, including loss of biodiversity,” which would contribute to further spiraling of climate change.

The IPCC report therefore calls for more sustainable patterns of global food production as well as consumption, in order to both mitigate and adapt to a changing climate, using measures that would also improve nutrition and food security.

“Agriculture and the food system are key to global climate change responses,” the report concludes. “Combining supply side actions such as efficient production, transport, and processing with demand-side interventions such as modification of food choices, and reduction of food loss and waste, reduces GHG emissions and enhances food system resilience.”

“Such combined measures can enable the implementation of large-scale land-based adaptation and mitigation strategies without threatening food security from increased competition for land for food production and higher food prices.”

Food Waste and Food Loss Also Big Problems

Tackling another neglected aspect of food systems, the IPCC estimates that between 25 to 30 percent of all food produced is lost or wasted. Such waste and loss is in turn responsible for 8-10 percent of all climate emissions from agriculture and land use.

Food loss refers to any food that is lost in the supply chain between the producer and the market. Food waste refers to more deliberate disposal of food that would still be fit for consumption. “A large share of produced food is lost in developing countries due to poor infrastructure, while a large share of produced food is wasted in developed countries,” the report notes. In 2007, for instance, around 20 percent of the food produced went to waste in Europe and North America, while around 30 percent of the food produced was lost in sub-Saharan Africa. Problems with food waste thus reflect the underlying problems developed countries face with over-consumption and obesity, while food loss is a problem in countries where many people also face food insecurity.

Technical solutions to food loss include improved harvesting techniques, on-farm storage, infrastructure, transport, and packaging to keep food fresher for longer, although some of these can also create new costs on local environments, the report noted. Non-technical solutions could include changes in behaviours and attitudes across the food system.

“Food loss and waste can be recovered by distributing food surplus to groups affected by food poverty or converting food waste to animal feed,” the report states. “Unavoidable food waste can also be recycled to produce energy based on biological, thermal and thermochemical technologies.” Additionally, the report notes that strategies for reducing food loss and waste should consider gender dynamics – involving participation of women throughout the food supply.

Image Credits: USDA/Lance Cheung.

A new study suggests that the deadly drug-resistant fungus, Candida auris, may have adapted to warmer ambient temperatures caused by climate change, enabling it to survive in human body temperatures and infect humans with weakened immune systems, primarily in hospitals.

The study, published in the journal of The American Society for Microbiology in July, posits that Candida auris may have originated as an environmental fungus in wetlands, and due to its adaptation to rising temperatures, it may have infected birds as an intermediary species before further adapting to the higher body temperatures of humans.

It proposes that Candida auris “is the first example of a new pathogenic fungus emerging from human-induced global warming,” and warns that as temperatures continue to rise in the 21st century, it may be the first of other fungal lineages to become more thermally tolerant and capable of infecting humans.

Primarily affecting people with weakened immune systems in hospitals, between 30 and 60 percent of people infected with the fungus die, according US Centers for Disease Control (CDC) estimates.

Candida auris was first discovered in 2009 in Japan and isolated in human ear canals, one of the cooler parts of the human body. The fungus was identified as causing disease in 2011 in South Korea, and subsequently spread through Asia and Europe, first appearing in the United States in 2013.

Below is an illustration from the study of the possible factors operating on the emergence of Candida auris:

Image Credits: Science Media Centre.

NEW YORK – Negotiations over a planned United Nations political declaration on universal health coverage (UHC) reopened last week after about a dozen countries reportedly objected to language in the final draft covering two sensitive issues – sexual and reproductive health and rights (SRHR) and the health needs of migrants, refugees, internally displaced persons and indigenous peoples.

The United States was one of the 10-14 countries posing objections, sources told Health Policy Watch, after negotiations over the draft were closed on 24 July. The draft was then put under a “silence procedure” for five days, a period in which countries may file objections to effectively reopen debate.

“We regret to inform you that the silence procedure has been broken by several delegations on paragraphs 29, 68, 69, 70 and 71,” the Ambassadors of Georgia and Thailand, co-facilitators of the UN High-Level Meeting on Universal Health Coverage, wrote in a 29 July letter to the president of the UN General Assembly, María Fernanda Espinosa Garcés.

As of Monday, 5 August, it remained unclear which other countries besides the US had broken the silence procedure, and over which paragraphs. But time is now running out for negotiators to reach agreement on the declaration, which will be the focal point of the 23 September UN High-Level Meeting on Universal Health Coverage, bringing heads of state and other political and health leaders to the UN in New York.

After the silence was broken, the negotiations were elevated from the level of expert to the level of ambassador, in order to ensure that national representatives with the highest possible level of authority would be engaged to finalise the declaration as soon as possible, sources said.

The emerging dispute over language on SRHR and migrants represented a shift in focus of the debate over the painstakingly negotiated declaration text. Earlier debates had centred around language calling for greater public disclosure of prices of health products, more transparency for related research and development (R&D), and alternative incentives for R&D beyond conventional patent monopolies.  However, member states have now reached consensus on those issues, according to civil society observers.

The sections of text that are now under debate (noted below) include final draft paragraphs 29, 68 and 69 on women’s and girls’ rights to “sexual and reproductive health, free of coercion, discrimination and violence;” as well as paragraphs 70 and 71 on addressing “the particular needs and vulnerabilities of migrants, refugees, internally displaced persons and indigenous peoples.”

According to sources, the US objected to the language on SRHR in the declaration because it can be interpreted to include abortion, which is inconsistent with the US rule under the “Protecting Life in Global Health Assistance” policy to not commit funds to international health activities that are in any way related to abortion.

The recent US pick for the Ambassador to the UN in Geneva, Andrew Bremberg, has also vowed to oppose any UN resolutions that allow for abortion, even in the case of sexual violence and conflict.

Health Policy Watch previously reported that the silence procedure was likely to be broken according to sources close to the negotiations, and due to the fact that the paragraphs on SRHR had remained unchanged since the initial draft of the declaration, despite the controversy in previous UN fora that SRHR can be interpreted to include abortion.

Sources said that the United States ultimately hopes to reach consensus on the declaration before the 23 September high-level meeting.

More information on universal health coverage and the UN High-Level Meeting on UHC is available here.

Medicus Mundi International, an international network of health NGOs, published a comparison of the revisions of each of the drafts of the UHC declaration, since the initial “zero draft” was released on 17 May.

Final Draft Paragraphs 29, 68 and 69 on Sexual and Reproductive Health and Rights

  1. “Take measures to reduce maternal, neonatal, infant and child mortality and morbidity and increase access to quality health-care services for newborns, infants, children as well as all women before, during and after pregnancy and childbirth, including in the area of sexual and reproductive health;”
  1. “Ensure, by 2030, universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes, which is fundamental to the achievement of universal health coverage, while reaffirming the commitments to ensure universal access to sexual and reproductive health and reproductive rights in accordance with the Programme of Action of the International Conference on Population and Development and the Beijing Platform for Action and the outcome documents of their review conferences;
  2. Mainstream a gender perspective on a systems-wide basis when designing, implementing and monitoring health policies, taking into account the specific needs of all women and girls, with a view to achieving gender equality and the empowerment of women in health policies and health systems delivery and the realization of their human rights, consistent with national legislations and in conformity with universally recognized international human rights, acknowledging that the human rights of women include their right to have control over and decide freely and responsibly on all matters related to their sexuality, including sexual and reproductive health, free of coercion, discrimination and violence;”

Final Draft Paragraphs 70 and 71 on the Health of Migrants, Refugees, Internally Displaced Persons and Indigenous Peoples

  1. “Ensure that no one is left behind, with an endeavour to reach the furthest behind first, founded on the dignity of the human person and reflecting the principles of equality and non discrimination, as well as to empower those who are vulnerable or in vulnerable situations and address their physical and mental health needs which are reflected in the 2030 Agenda for Sustainable Development, including all children, youth, persons with disabilities, people living with HIV/AIDS, older persons, indigenous peoples, refugees and internally displaced persons and migrants;
  2. Address the particular needs and vulnerabilities of migrants, refugees, internally displaced persons and indigenous peoples which may include assistance, health care, psychological and other counselling services, in accordance with relevant international commitments, and in line with national contexts and priorities;”

Image Credits: Wikimedia Commons.