Cutting-edge health technologies – such as gene editing therapies for cancer – have the potential to save lives, and the international intellectual property system should be leveraged to drive innovation and bring those therapies to people who need them, said the leaders of global health, trade and intellectual property agencies at a Trilateral Symposium on Thursday.

The symposium, convened under the theme “Cutting-edge Health Technologies: Opportunities and Challenges,” is the eighth such open forum co-hosted by the World Health Organization (WHO), the World Trade Organization (WTO), and the World Intellectual Property Organization (WIPO) to foster collaboration around public health and intellectual property.

(left-right) Dr Tedros, Roberto Azevêdos, and Minelik Alemu Getahun.

“The essential insight is that while improving access to existing technologies remains an important priority, it will not suffice to meet future public health challenges,” said the WTO Director-General, Roberto Azevêdo, in his opening statement. He noted that advancements in new diagnostic tools, therapies, and prophylaxis treatments have greatly expanded the possibilities for treating and preventing certain diseases.

As an example, Azevêdo highlighted CAR-T (chimeric antigen receptor) cell therapy, a cutting-edge cancer treatment still under development. This form of cell therapy leverages advancements in gene editing by genetically altering natural white blood cells to attack cancerous cells. Public sector research institutions currently hold 40% of the patents in this area of medical research, while private firms hold 49%.

“How [the patent holders] choose to license these technologies will be an important factor in how therapies are rolled out in practice,” said Azêvedo.

The Director-General of the WHO, Dr Tedros Adhanom Ghebreyesus agreed, stating that “Advances in science and technology are opening up new horizons in public health that were considered science fiction not so very long ago… And yet we continue to live in a world marked by shocking inequality.”

Dr Tedros posed the question, “How do we harness the power of innovation to narrow inequalities, rather than widen them?”

“We must understand better the benefits, costs and limitations of mechanisms for incentivizing innovation and their impacts on the pricing of health products,” he added, reaffirming WHO’s commitment to Universal Health Coverage, including increasing access to medicines and vaccines.

The IP system also faces challenges as scientific advancements quickly move forward, WIPO Assistant Director-General Minelik Alemu Getahun said, noting that IP regulations must balance “incentivizing and rewarding innovation” while ensuring that knowledge to support “continued innovation” is shared.

“Today’s discussions will explore the landscape of cutting-edge health technologies and consider some of the opportunities and challenges of optimizing their use in a variety of settings. We should endeavour to make our discussions as accessible to the public as possible by elucidating concepts and providing clear, fact-based information related to these exciting and ever-evolving health technologies,” he said.

The three opening speakers set the stage for a broader technical discussion on the challenges and opportunities of cutting-edge health technologies. A morning plenary reviewed highlights of new medical innovations in biotechnology, information technology, and the application of big data to the medical sector. A second panel focused more on issues of access to new medical innovations, affordability and increasing costs for health care systems, along with the ethics of using patient data.

For more information, see the WTO press release.

Image Credits: WTO.

The UN COP Bureau has accepted Spain’s offer to host the COP25 Climate Conference in Madrid from December 2-13, following a tumultuous few days after Chile suddenly withdrew from hosting the conference due to a massive wave of protests in Santiago.

In a short statement released Friday, UN Climate Change Executive Secretary Patricia Espinosa said, “We are pleased to announce the COP Bureau has agreed that COP25 will take place from 2-13 December in Madrid, Spain.”

Spain offered to host the upcoming UN Climate Conference (COP 25) on behalf of Chile on Thursday, which said on Wednesday that it could not stage this year’s meeting in Santiago due to security concerns related to the civil unrest that has been raging for the past two weeks in the capital city.

“Following [Wednesday’s] announcement, the Government of Chile, as incoming Presidency, has informed me that they received a generous offer of support from the Government of Spain to hold the United Nations Climate Change Conference (COP25) in Madrid on the same dates as originally planned. We are hopeful that the COP Bureau can consider this proposed solution as soon as possible,” said Espinosa, in a curt statement on Thursday, released by UN media. “It is encouraging to see countries working together in the spirit of multilateralism to address climate change, the biggest challenge facing this and future generations.”

The Spanish offer shed a glimmer of light over the troubled preparations for the 25th annual meeting of the United Nations Framework on Climate Change (UNFCCC) after plans fell into disarray for the second time in a year. Late last year, Brazil withdrew its request to host the 2019 conference, after the election of the far-right President Jair Bolsonaro. Bolsonaro claimed the move was due to budget restrictions, but the new Brazilian leader has also appointed a climate skeptic as foreign minister, and has also taken steps to increase development in the sensitive Amazon rain forest region.

Madrid

The bold, face-saving measure by Spain to host the 2-13 December conference should help revive some of the momentum around this year’s COP event, which marks the 25th anniversary of the Framework Convention. This year’s COP is also significant as it comes on the heels of the 23 September UN Climate Summit, where countries made a lukewarm showing of commitment to key mitigation measures that climate experts say are desperately needed to keep global warming below 2° C.

Even if formal country commitments to climate action remain weak, the annual conference usually draws tens of thousands of participants – and features a wide array of events and exhibits not only for official delegates but also involving civil society, businesses and the public.

Observers close to the conference preparations had assumed that following Chile’s announcement, the meeting by default would be moved to Bonn, Germany, home of the UNFCCC Secretariat. Now, however, the UNFCCC has accepted the offer by Spain’s acting Prime Minister Pedro Sanchez to use Madrid as the alternative location, which the Chileans have accepted and recommended to the UN.

Under the proposed arrangements, Chile would still assume the presidency of this year’s COP, while Spain hosts the event. A similar arrangement occurred in 2017, when COP23 was held in Bonn, while Fiji held the presidency.

1 November 2019 – This story has been updated to reflect recent announcements from the COP Bureau confirming the new location of COP25.

Image Credits: Cuellar .

Non-communicable diseases (NCDs) such as cancer, heart disease and stroke, as well as road traffic injuries, are among the leading causes of death in cities – killing some 42 million people worldwide every year. A new report released by the World Health Organization shows how urban leaders can tackle these urban maladies through simple environmental design strategies and as well as food, tobacco and alcohol policy measures.

The report, The Power of Cities: Tackling Non-communicable Diseases and Road Traffic Injuries, suggests ten high-impact interventions for cities, based on WHO expertise as well as the experiences of 19 cities where the strategies have been tested in case-studies.

“Over half the world’s people live in cities, and the numbers are rising,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General in a press release about the initiative, released on the UN-designated World Cities Day.

“City leaders take decisions that impact on the health of billions, and for cities to thrive, everyone needs access to services that will improve their health – public transport, safe, clean and attractive outdoor spaces, healthy food, and, of course, affordable health services.”

The case-studies cover low-, middle- and high-income countries, with 15 of the 19 studies focusing on cities in developing countries, where 85% of premature adult NCD deaths and a whopping 93% of road traffic crashes occur. Currently, seven of the ten largest cities in the world are in developing countries, and 90% of future urban population growth will occur in low- and middle-income countries, the report notes.

The report’s stated goal is to share knowledge and best-case practices between city leaders and help them to “identify at least one area which could be changed for the better.”

“By replicating the most effective measures on a global scale, we can save millions of lives,” said WHO’s Global Ambassador for NCDs and injuries, and three-term New York City Mayor, Michael Bloomberg.

“We’re working to raise awareness among city leaders and policy makers about the real gains that can be achieved when effective programs are in place.”

High-Impact Interventions for NCDs and Road Traffic Safety
A man bikes in Fortaleza, a Brazilian city that implemented a bike-sharing scheme in 2014.

From anti-tobacco actions in Beijing and Bogor, Indonesia, to road safety initiatives in Accra, Ghana and Bangkok, a bike sharing scheme in Fortaleza, Brazil and actions to create more walkable streets that have reduced pedestrian deaths among older people in New York City by 16%, the report aims to share knowledge between urban policy planners.

Specifically, the report highlights ten key interventions that could reduce NCDs and road traffic accidents:

  • Monitor NCD risk factors – Conduct a population-based survey of behavioral risk factors for NCDs, such as tobacco use, alcohol consumption, dietary habits and physical activity.
  • Create a smoke-free city – Protect people from second-hand smoke through the introduction, passage and enforcement of legislation that makes all indoor public places 100% smoke-free.
  • Ban tobacco advertising – Ban all forms of direct and indirect tobacco advertising, promotion and sponsorship.
  • Reduce the consumption of sugar-sweetened beverages – Establish and implement policies to reduce sugar-sweetened beverage consumption, such as taxes on the production or sale of sugar-sweetened beverages.
  • Reduce salt consumption – Implement key components of the WHO SHAKE package for salt reduction in city communities, businesses, and institutions.
  • Create walkable, bikeable, and liveable streets – Improve pedestrian and bicycle networks and infrastructure across the city to ensure safe and equitable access to services, and to promote more walking and cycling for recreation and transport.
  • Clean the air – Reduce ambient air pollution through promotion of cleaner transport, municipal solid waste management, and controls on industrial emissions, and promote cleaner indoor air by improving access to cleaner fuels and technologies for cooking, heating and lighting.
  • Reduce drunk-driving – Increase enforcement of drunk driving laws
  • Manage speed – Establish lower speed limits and strengthen existing speed-limit enforcement.
  • Increase seatbelt and helmet use – Increase enforcement of seat-belt and motorcycle helmet use.

Many of the interventions are based on the WHO’s Best Buys for NCD Control that list policies that can not only help countries reduce the health impacts of NCDs, but also their economic costs.  It is estimated that implementing such measures could help low- and middle-income countries save some US$350 billion by 2030.

The report was produced as part of a Bloomberg Philanthropies-funded joint initiative the Partnership for Healthy Cities, involving WHO and the global health NGO Vital Strategies. The partners are now working with city leaders to implement variations of the ten interventions in 54 participating cities around the world.

The initiatives covered some 216 million people in urban areas with at least one intervention to help reduce the risk of NCDs or road traffic accidents in 2017. On a larger scale, the city-level initiatives are contributing to fulfilling countries’ commitments to the Sustainable Development Goals – to reduce premature deaths from NCDs by a third by 2030, and to halving road traffic deaths and injuries by 2020.

“With most of the world living in cities, bold action by urban leaders has greater potential to improve lives than ever before… Increasingly, we see cities rising to societies’ biggest challenges – from climate change and road safety, to obesity and tobacco use. They are engines of change, able to move quickly to implement life-changing policies that affect great numbers of people,” said José Luis Castro, president and chief executive officer at Vital Strategies, in a statement on World Cities Day.

Along with the report, WHO has provided a number of technical resources to city leaders to help guide policy-making for NCDs and road traffic safety – for more information, see the report webpage.

Image Credits: WHO/Vital Strategies, WHO/The Power of Cities: Tackling NCDs and Road Traffic Injuries.

Berlin, Germany – A “public interest R&D” model can bring effective treatments for neglected diseases to patients at comparatively low cost, through a collaborative, access-oriented development process.

The model is outlined in the new report 15 Years of Needs-Driven Innovation for Access, by Drugs for Neglected Disease Initiative (DNDi), released Wednesday.

The model etches an alternative formula to conventional for-profit R&D systems, highlighting both successes and challenges that are faced in developing treatments for over a dozen diseases, such as sleeping sickness and Chagas disease, that affect some of the poorest and hardest to reach populations in the world.

A healthcare provider screens people for African sleeping sickness, a disease for which DNDi developed the first all-oral treatment, fexinidazole.

“After 15 years I think I am proudest of the model. It was originally just an idea but now it is a reality,” Bernard Pécoul, executive director of DNDi, said during a day-long symposium reflecting on DNDi’s research experiences held on the occasion of the organization’s 15-year anniversary. He said that the report takes “30 pages to describe 15 years of a story.”

According to the report, the organization has delivered eight field-adapted and affordable treatments for diseases as varied as paediatric HIV, sleeping sickness, and Chagas disease to date, and expects seven or eight more treatments by 2023. Currently, DNDi has more than forty R&D projects across seven disease areas, as well as more than 20 new compounds – known as “new chemical entities (NCEs) – in early stages of development.

The report attributes DNDi’s success to an innovative funding, partnership and access model, among other factors. By partnering with academia and the private sector, for instance, the organization is able to access existing research databases holding information about millions of compounds, and has screened 4 million to date. It is through such screening that the organization has been able to identify compounds that had potential to treat serious diseases, but had simply been ignored or discarded in the R&D pipeline because their profit potential was low.

At the same time, the organization’s access policies ensure that the collaborations with industry are negotiated up front, in a way that any consequent drugs produced will be made widely available at affordable prices– e.g. through open licensing or generic formulations that are not limited by patent requirements to pay expensive royalties.

In addition, some 60% of DNDi’s funding still comes from public sources such as government grants, and the organization attempts to maintain financial independence by “not having one donor with more than a 25 percent share of contributions,” said Pécoul.

In terms of collaborations, DNDi’s model has stressed working in countries that are affected by the diseases that it is tackling, the report notes.

The organization is working with over 180 partners in more than 40 countries, with at least one third of the collaborating institutions based in lower-middle income countries. These partnerships include five new disease-specific clinical research platforms based in Africa and Latin America. Through these partnerships, the organization runs an average of 20 clinical trials enrolling over 2500 patients total at any given time.

“Public Interest R&D” – How Does This Model Work?

The report summarizes six elements identified as key to the success of DNDi’s alternative, non-profit R&D model. These include positioning the product development partnership as: needs-driven; independent; collaborative, open and transparent; globally networked; access oriented; and “transformative.”

In keeping with its public-interest mission, the organization publishes its financial data on an annual basis to remain “open and transparent,” informing the debate around R&D costs.

Adjusting for attrition, DNDi estimates that it can develop and register new combinations or new formulations of existing treatments for €4-32 million, and an entirely new chemical entity for €60-190 million. Conventional industry estimates are for a US$2.6 billion cost to bring a new drug to market. Although the numbers are not directly comparable because DNDi’s work is focused on a few key infectious diseases and industry estimates also include the “opportunity costs” of capital investments, they provide an order of magnitude comparison of how non-profit R&D can be cost-effective, DNDi experts say.

Public and private contributions pay for the cost of R&D up front, allowing the organization to focus on developing new drugs based on patient needs rather than the need to recoup R&D costs.

R&D is guided by the use of public-interest “target product profiles,” which include concerns around access and affordability from the outset.

For example, until 2009, the standard treatment for African sleeping sickness caused by a parasite transmitted by the tsetse fly, was an arsenic-based intravenous treatment that was so toxic that it used to kill one in twenty patients – but the disease itself was almost invariably fatal without treatment.

Sleeping sickness affects some of the poorest and hardest-to-reach populations in the world, with over 80% of cases occurring in the most remote regions of the Democratic Republic of the Congo. In the traditional treatment, highly trained staff had to deliver as series of infusions over a period of weeks, following diagnosis via a painful lumbar puncture.

The first DNDi breakthrough came in 2009, when it developed a less toxic and more effective oral nifurtimox-intravenous eflornithine combination therapy (NECT).

That replaced the arsenic-based Melarsoprol. However, the treatment still requires 21 days of hospitalization, or massive equipment if deployed in a field clinic, as well as highly trained staff who had to deliver a series of infusions, following diagnosis via a painful lumbar puncture.

In response to the need for a yet more adaptable and field-friendly treatment, DNDi identified fexinidazole out of a Sanofi library of chemicals as having potential efficacy against sleeping sickness.

In November 2018, the drug was approved by the European Medicines Agency as first oral medication for sleeping sickness, and it was registered in DRC just a month later, thanks to an EMA collaboration with African regulatory authorities, also facilitated by DNDi.

The 3C’s:  Collaboration, Coordination & Cooperation

The story of sleeping sickness illustrates how a collaborative, open and transparent process, driven by a global network of partners, has been key to the DNDi treatment breakthroughs.

Fexinidazole ultimately was developed in partnership with more than 15 organizations representing government, private industry, and civil society, while Sanofi remained the main pharmaceutical development partner. Clinical trials for fexinidazole were conducted in the DRC and Central African Republic.

“DNDi owes its successes to collaborations with a large global network of over 180 partners from the pharmaceutical industry, academia, health ministries, other NGOs, treatment providers, and patients and their communities, as well as our donors,” said Pécoul in a press release.

“We are the conductors of a ‘virtual orchestra’, and the eight new treatments we have delivered in the past 15 years would not exist without the commitment and shared vision of our partners and donors.”

One of the latest brainchilds of DNDi is not a product – it’s a new organization dedicated to tackling the growing threat of antimicrobial resistance, the Global Antibiotic Research and Development Partnership (GARDP).

Initially housed within DNDi after its inception in 2016, GARDP launched as an independent organization in July and is now running four R&D programmes for drug-resistance infections, applying the DNDi drug development model to the neglected area of developing new and improved antibiotic treatments.

Image Credits: Xavier Vahed/DNDi, DNDi/15 Years of Needs-Driven Innovation for Access.

Chile pulled out of hosting the COP25 Climate Change Conference on Wednesday, following two weeks of protests in the hosting city of Santiago. The announcement throws preparations for the conference, scheduled for December, into disarray for the second time, after Brazil withdrew its request to host the 2019 conference late last year.

COP25 logo

It casts a shadow over the efforts of UN Secretary-General Antonio Guterrez to ramp up climate action in the wake of the UN Climate Action Summit in New York City in September.

“Earlier today, I was informed of the decision by the Government of Chile not to host COP25 in view of the difficult situation that the country is undergoing. We are currently exploring alternative hosting options,” United National Climate Change Executive Secretary Patricia Espinosa said in a statement.

Following a wave of massive civil unrest with over 1 million people taking to the streets to protest inequality, president Sebastian Pinera announced the decision to withdraw from hosting COP25, along with dropping the Asian-Pacific Economic Cooperation (APEC) Summit, which was planned for next month.

“As a president, I have a duty to put the needs of Chileans first. Therefore, with pain, we have decided to cancel APEC and COP summits to guarantee order and social peace, focus on dialogue, and a new social agenda to provide urgent solutions to major demands,” the president announced on Twitter (translated from Spanish).

 

Image Credits: COP25 Twitter.

Berlin, Germany – The Drugs for Neglected Diseases Initiative (DNDi) is celebrating its 15th anniversary and in a special event Tuesday night, founders and supporters of the product development partnership (PDP) gathered in Berlin to reflect on lessons learned and challenges that still lie ahead. Here below are excerpts of what they had to say.  

Marie-Paule Kieny, Chair of the Board of DNDi

15 years ago the Drugs for Neglected Diseases was created as a response to the frustration of clinicians and the desperation of patients facing the reality that their treatment was either ineffective, highly toxic, or unavailable, when it even existed at all.

Against this background DNDi was established as an experiment. After 15 years, what are lessons to be learned from these experiments?

DNDi is a needs-driven organization, we put patients and not profits as a value. Scientific independence guarantees a needs-based approach. Our research is collaborative, open and transparent; knowledge is worth something when its shared, open science is a key strategy. DNDi is only possible through collaboration – networking is a key part of our innovation. Public leadership is imperative to promote coherent ecosystems to make medicines available to all patients. Without sustainable, affordable accessible and adaptable medicines we will not be able to meet the Sustainable Development Goals.

Veronika von Messling, Director-General of the Life Sciences Division, Federal Ministry of Education and Research, Germany

The overall mission was to improve the health and quality of life of people suffering from neglected diseases, filling a gap that was left by pharmaceutical industries, because neglected diseases were not a priority. It is to DNDi’s credit that game-changing treatments for diseases such as sleeping sickness have been developed.

Research and development, innovation and access are drivers worldwide. The German government is committed to funding global health research because we are convinced this will contribute to global health.

We are aware that despite the remarkable advances made there are still significant gaps, and therefore Germany remains committed to further development of PDPs [product development partnerships] that ensure no one is left behind.

Soumya Swaminathan, Chief scientist, World Health Organization; former head of the Indian Medical Research Council

I can remember as a practitioner in India, when we were still doing spleen punctures for diagnosis of Kala Azar (visceral leishmaniasis). And all we had available were very toxic treatments. Children would come to us who were already skin and bone, their abdomens would be all bloated with enlarged livers and spleens. So it was torture for the patients and it was difficult for us as the treating physicians to subject our patients to so much discomfort, and many of them came too late to be cured.

Now thanks to treatments like those developed by DNDi, Kala-Azar has almost disappeared from the Indian sub-continent. We still have pockets in the most vulnerable groups. And it is because of poor housing that the sand flies breed. You improve housing and leishmaniasis disappears. It’s all tied up to development. More recently, I met Nathalie [Strub-Wourgaft] of DNDi when we were in Sudan at the world’s only Mycetoma Research Center. Mycetoma is not immediately fatal but it is incapacitating. The amazing thing to me was that DNDi was there, doing this collaboration on a clinical trial for a new mycetoma drug. Most people would not have heard of mycetoma. The victims would remain invisible unless organizations like WHO and DNDi spoke about it. Investments in science and research are very important, not only at global level but also at country level – this is where we see the whole end-to-end approach is needed. We need to be talking about neglected populations, neglected pathogens and neglected products – and not only neglected diseases.

You can have the product on the shelf, but how do you ensure access? Our job at WHO is to think through all of these things with our partners, including DNDi. So we have created a forum for the PDPs and their funders to come together and discuss their common challenges, opportunities and plan strategically. To think about issues such as “what does access look like?”

When you have publicly funded R&D, if that product is successful, how is it going to reach populations, how will it be priced, and how are countries going to be able to adopt innovations? Financing is one aspect, but the other aspect is the capacity of countries to absorb these innovations into the health system, and to be able to prioritize based on local needs.”

John Amuasi, Executive Director of the African Research Network for Neglected Tropical Disease

There is indeed a constant tussle between having the high-level endorsements for a new treatment and moving fast enough with the evidence available to put it in place on the ground. I would recommend some effort be put into the assessment of these technologies as actionable on the ground. Health Technology Assessments are very context specific and can relate to things like cultural practices that do influence the final decision on implementation.

Public interest R&D and research that is in the interest of the public is really two different things. I recognize the challenges inherent in getting leaders of low- and middle-income countries to commit more. When people such as ministers have to make these decisions, if they don’t think that people are interested, they will not focus on it, even if it is in the interest of the public. So in looking at public interest R&D one key question is how to draw the public interest in it.

Do people really judge their governments to the degree which their health has improved? If we are able to demonstrate clearly that our R&D activities impact directly on improving primary health care… via health system strengthening, I think we would be even more successful in our efforts in promoting R&D. If we can show how this work directly impacts on improving primary health care and universal health coverage, if this link can be exposed and made more visible it would go a long way to supporting public interest in R&D.

Jeremy Farrar, executive director of the Wellcome Trust

We are at a really critical juncture in global health. There is no doubt that investments we have made are starting to bear fruit, but at that very juncture we see a world that is looking very fragile. We have a world challenged by climate change, persistent and emerging infections and of course non-communicable diseases – and that double whammy is going to be an enormous challenge. None of us should underestimate the challenges of delivering Universal Health Coverage in this context.

If you look at the trends in the pharma industry, I worry that industry, while having been sometimes a difficult partner, could become even less of a partner and that is a worry as they step away from antibiotics, for example. I worry that we have been through a relative honeymoon period. There is a vacuum, and that vacuum has to be filled.

I think we have to think through more as a community how we can fill that vacuum, including in financing. As we go forward, how are we going to fill that gap? In terms of all of these PDPs,  DNDi, Medicines for Malaria Venture, etc., how can we put this on a more sustainable footing, one that isn’t just reliant on charity and philanthropy, through more innovative financing. There is an incredible opportunity because interest rates are almost at 0%. And if we don’t use this moment in time to access capital, I worry that we won’t be able to rely on governments stepping up, or on philanthropy, and we may look back on the 15 years that have passed as the easy period. So should we start to change and adapt to that future when we are at our strongest? I wonder if now isn’t the time to do that, given the prevailing winds?

I also call on Germany to not lose sight of multilateralism, as other countries shift away and become more nationalistic, that Germany and Europe stand up for the values that have made it what it is over the past few decades.

Bernard Pécoul, executive director of DNDi

When Médecins Sans Frontières (MSF) received the Nobel Peace Prize [in 1999], the decision was to dedicate the prize money to the creation of DNDi.  We are not driven by profit but by patient needs, we focus on populations for which there is no solution or very bad solutions. Our close links to MSF have kept us on track. When we started researching drugs for sleeping sickness it was still being treated with arsenic.  First we improved the treatment, now we have registered the first oral treatment.

Our vision has been the best science for the most neglected diseases.  It was easy to formulate and a lot harder to implement. But the fact that we established a relationship from the start with the Institut Pasteur helped us to bring scientific credibility on the table.  They helped us to select the initial projects.  DNDi is strongly rooted in the countries where the majority of our patients live.  We commit to strengthen the research institutions close to patients and communities. DNDi has strived for countries to lead the response rather than being passive beneficiaries. This is part of the vision.

DNDi believes in sharing our lessons learned, to shape [the research environment].  We have from the start supported the WHO role and worked closely with WHO to facilitate implementation and support development of new guidelines for drugs that we develop.”

Representatives from the founding partners of DNDi

Image Credits: E Fletcher/HP-Watch, Lukas Schramm/DNDi.

The Drugs for Neglected Diseases Initiative (DNDi) celebrates its 15th anniversary this week, as a non-profit drug R&D organization that sought to create an alternative model for developing drug treatments for the most neglected diseases and the world’s poorest populations. Since DNDi’s launch in 2003, the organization has developed eight new treatments, including the first-ever oral drug for sleeping sickness, fexinidazole. Executive Director Dr Bernard Pé‏‏‏coul, who has guided the organization since its creation in 2003, looks back on the mission and its progress.

Dr Pécoul holds the malaria treatment artesunate and amodiaquine (ASAQ), DNDi‘s first treatment successfully brought to market.

Health Policy Watch: You are celebrating the 15th anniversary of DNDi.  How did DNDi come about and what gap has it filled in the R&D landscape?

Bernard Pé‏‏‏coul: We were created in 2003 and started operations in 2004 based on an assessment that the R&D for neglected diseases was totally abandoned. At the time I was director of [the Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines]. We documented this imbalance in a publication, saying that it’s time to create a different model, at the time the gap was big, and they were trying to find other solutions. The three gaps we documented included:

  1. The lack of new drug candidates. So [in DNDi] we created a consortium to not only screen [candidate molecules] but also to lead optimization [of those molecules] until we have clear chemical entities ready to enter into clinical development.  In our portfolio we [now] have 22 chemical entities in this process, some led by us and some by other partners as leads.
  2. Barriers to clinical development. Typically, the private sector was not ready to enter these complicated clinical settings. This is really the phase in which DNDi is very active.  Typically, we are in charge of the clinical development, and we develop most of the phase 2 and phase 3 studies. We are not alone because we always work in partnership with institutions at the country level, with global health, institutions. At the same time, we try to secure a partnership with Pharma, or with several pharma companies, as this is also a phase where we need to consolidate industry partners for the next phase – which is registration of the product and distribution. So, while we collaborate with pharma to identify the molecules, we “de-risk” pharma because we oversee the clinical studies.
  3. The gap between product and treatment. There is a still a gap at the end of the pipeline, or a lack of incentives to complete the development of new formulations in ways that are more adapted to the field. This means combining creating formulations for children or combining drugs into fixed-dose formulations, which is what we did for malaria. That’s why we talk about treatments and not products.  Our objective is to respond to patient needs, and treatments respond better than products.

HP-Watch: Can you summarize the 3-4 biggest breakthroughs you have experienced in drug development – up to the recent approval of the new drug fexinidazole for sleeping sickness?

Pécoul: Fexinidazole was the first time we developed a product from beginning to the end. The previous successes have been improving new drugs from new formulations.  Altogether there have been another 7 initial treatments that we developed.

The first breakthrough was a malaria treatment combining [the two most effective malaria drugs]. We completed development of that in 2007, with registration and prequalification, and in the last 10-12 years more than 500 million people have received this this treatment in Africa. Our partner in this was Sanofi; they accepted non-exclusivity in the contract, so that there are also generic companies producing the combinations.

Then there was a new formulation for children for Chagas disease [a chronic and disabling disease transmitted by the triatomine bug in Latin America]. Many children are affected, but when we entered this portfolio, the only formulation available was an adult formulation. We were not able to deliver a proper dose for children affected with Chagas. [People would have to split the pill into pieces]. We partnered with pharma companies in Brazil and in Argentina to devise two sources of a paediatric formulation.

A child with HIV takes a paediatric dose of antiretroviral medication, a formulation which DNDi developed.

Then, we achieved something similar in developing paediatric formulations [of antiretroviral drug combinations] for HIV. The existing formulations could be very difficult to take, or they would need special handling, such as refrigeration. So, we are developing a new formulation adapted to kids that was just submitted to the US Food and Drug Administration (FDA) in October this year.  That is a four-in-one combination of the first-line drugs recommended by WHO, but for which today there is no formulation adapted to the kids. We have done this in partnership with the Indian-based generic company CIPLA.  This required a lot of research work, going back to pre-clinical studies.

HP-Watch: What are the key lessons you think have been learned from DNDi’s model, in terms of:  sustainable financing, ensuring more returns on public investments, an end to end approach?

Pécoul: We are releasing today a “model paper”, [a report] on lessons we have learned over our 15 years.  These include lessons about how to facilitate the regulatory process; on how important it is to be very strongly linked with governments and to have public leadership on R&D reflecting commitment from the affected country; and the importance of target [drug candidate] profiles. I think having access [and therefore affordability] in mind from the beginning is very important, this influences your choice of partners but also the candidates you will develop.

Because we are a not-for-profit, and we position access as a key element of our investment, we are trying to develop public goods (i.e. generics) as much as possible. This means that the fruit of the innovation will go back to the public at an affordable price.  The return on investment is more about benefits for the population.  At the same time, because we are not making any profit from what we invest, we have very few mechanisms to secure sustainable funding.

When we are investing on treatments for very neglected populations, so the opportunities to establish sustainable funding to finance our investments are very few:  the populations we serve, by definition, have no purchasing power.

you had stable insulin that you could use in tropical conditions, this would be an interesting innovation.

HP-Watch: So, are you looking at some aspects of NCDs as another future gap or opportunity?

Sample preparation at bio-repository CEADES-DNDi, a partner for DNDi’s clinical studies on Chagas in Bolivia

Pécoul: Not for the time being, but we are not closing the door.  A few years ago, we revisited our mission statement, and we talk about neglected populations [a broader concept than neglected diseases]. But at DNDi we have so far not had the capacity to respond to the big issue of access. We have tried to demonstrate that a different R&D model could work. But we are not the only solution to the problem of innovation and access.

HP-Watch: At the same time, with regards to R&D costs, DNDi’s assessment of its own R&D experiences indicates that costs are not necessarily as high as some of the industry estimates that are out there.  Can you describe and explain why the gap is so high?

Pécoul: We have estimated the cost of improving the treatment of existing drugs to be on the order of US$ 10-30 million. When we talk about developing wholly new chemical entities from scratch, and including attrition, then we are more talking about US$ 60-200 million. True, we are still far away from the US$ 2 billion [quoted by pharmaceutical industry sources].

But we need to be careful about comparing things that are not comparable. We are developing treatments in a field that is very abandoned; we [only] must demonstrate superiority against treatments that are very bad.

Much of the new research is industry documenting that their drug is slightly better than the previous one, and that is very costly. Most of the big companies have abandoned the field of communicable diseases. Secondly industry includes their opportunity costs or costs of capital for investing for years in a product. What we calculate is the real cost of developing. So, the way that we calculate is not the same.

The DNDi model is more cost-effective because it is tailored to achieving the goal that we are trying to pursue. But I don’t think that we could expect that a large pharma company would do the job [in the same way]. What we have achieved is to get a lot of support and commitment from [big] Pharma to pursue our goal.

HP-Watch: What challenges lie ahead?  Do you see DNDi continuing to address infectious diseases only, or could NCDs also be a target, insofar as they are an increasingly large proportion of the burden in LMICs but receive very little investment for treatments geared to low-income populations.

Pécoul: We still have a big challenge with leishmaniasis, it is very prevalent in many parts of the world, and we still use old products that are very difficult to use. We have identified a series of new chemical entities and we want to complete the development of an oral treatment for leishmaniasis. [As of now, there are no all-oral treatments.].

HP-Watch: Are there diseases that might be ripe for elimination?

A doctor dispenses fexinidazole, the first-ever oral treatment for sleeping sickness, which was developed by DNDi.

Pécoul: The best example is sleeping sickness. Fexinidazole, the new oral treatment developed for DNDi in 2018 is taken for 10 days, and is already a massive improvement on early options. But we have one project in the portfolio [pipeline] that would be a single dose treatment for sleeping sickness. If we are successful in developing a single dose, we could be successful in eliminating the Gambiense form of the disease, which is the most common one, and where the reservoir is primarily other human beings, although tsetse flies are vectors.

HP-Watch: What about malaria? Can you explain your involvement with that disease?

Pécoul: We were involved initially in malaria, where we developed two combination dose formulations, as mentioned.  But we completed the job and then transferred to Medicines for Malaria Venture.  They are a close partner of MMV, and they continuing to monitor these projects.

HP-Watch: And other disease frontiers where you see DNDi playing a role?

Pécoul: We will remain focused on NTDs, but not exclusively. For instance, in the last few years we have worked on paediatric formulations for HIV, and we also worked on adult medications for hepatitis C. We could at some point include some NCDs or other issues. For instance, there is the issue of snakebites. It is a neglected disease area.

But in all choices, we would have to assess the needs and the science to see if the scientific background is there to create the basis for success. We are not going back to basic research and we also must look if others are better positioned to do the job.

Concerning antimicrobial resistance, together with WHO we helped incubate GARDP, in which we are trying to use the model of DNDi to develop a new generation of treatments for AMR.

HP-Watch: Recently, DNDi worked with the European Medicines Agency [EMA] to make use of a special section of its regulatory code, known as “Article 58” to help fast-track regulatory approval of the new drug for sleeping sickness, fexinidazole, bringing African regulatory authorities into the process. Can you describe why that process represents a precedent that can help get new treatments to patients more rapidly?

Pécoul. Article 58 is an agreement between WHO and EMA, and in this agreement EMA reviews a dossier for a product that will be used outside of Europe, and they agree to include regulatory authorities from the countries involved.  So, in this case, representatives of the Democratic Republic of Congo (DRC), [which is one of the primary areas affected by sleeping sickness], were involved. That, in turn, helped expedite the national regulatory process, since DRC representatives sat on the EMA body that approved the drug. It’s a good example of collaboration on regulatory issues.

_________________________________________________

Dr Bernard Pécoul has led the Drugs for Neglected Diseases initiative (DNDi) since its founding in 2003. Under his guidance, DNDi – a not-for-profit research and development organization – with hundreds of public and private partners, has delivered eight new treatments for the most neglected diseases (leishmaniasis, sleeping sickness, and Chagas disease) and for malaria. It has developed a robust portfolio of projects spanning from discovery to implementation for these diseases as well as filaria, paediatric HIV, mycetoma, and hepatitis C. As part of DNDi’s dynamic portfolio approach, Dr Pécoul also led the creation with WHO of GARDP, a new product development partnership to address R&D for new antibiotic treatments.

DNDi aims to deliver a total of 16 to 18 new treatments for neglected patients by 2023. The initiative, through its R&D work, also builds capacity in disease endemic countries through research platforms and technology transfers and advocates for greater public leadership to sustainably address the health needs of neglected patients.

Prior to DNDi, Dr Pécoul was Director of the Médecins Sans Frontières (MSF) Campaign for Access to Essential Medicines from 1998 to 2003, a position he took on after that of Executive Director of MSF-France. While working with MSF, Dr Pécoul carried out field missions in Africa, Latin America, and Asia. In 1988, he co-founded Epicentre, an MSF-affiliated NGO specialized in epidemiology.

Image Credits: Paul Kamau/ DNDi, FBBVA, Ana Ferreira/DNDi, Xavier Vahed/DNDi.

Berlin, Germany (29 October 2019) – Experts called on policy-makers to put human health and wellbeing at the centre of climate action decisions at the World Health Summit, which entered its third and final day Tuesday.

“There is a need for urgent action to reduce greenhouse emissions to protect health, because we have less than 30 years of emissions left to have a reasonable chance of keeping to a 2 degrees Celsius temperature rise above pre-industrial levels,” said Professor of Environmental Change and Public Health at the London School of Hygiene and Tropical Medicine, Sir Andy Haines.

His presentation during the session, “Climate Change and Public Health: Science Guiding Policy and Practice,” covered a slew of the health impacts of climate change, including those of the wildfires, infectious diseases and increased salinity, but also of the physical and mental health toll of floods, an expected rise in pollen allergies in Europe and the productivity of crops— among others.

Tuesday, the third day of the World Health Summit, also focused on Universal Health Coverage and The Global Action Plan for Healthy Lives and Well-Being for All, which aims to better align the work of 12 global health agencies to accelerate achievement of the Sustainable Development Goals.

A helicopter prepares to drop buckets of water on a forest fire near Yosemite National Park, California USA.

Wildfires around the world cause death, illness and disruptions in people’s lives- wildfires that feed on the hotter, drier weather brought about in certain areas by climate change.

Meanwhile, in Asia, hospitals struggle to accommodate hordes of dengue patients in severe outbreaks, while parts of southern Europe are seeing domestic transmission of this deadly virus for the first time— a virus carried by Aedes mosquitoes, which thrive in changes to rainfall patterns and warmer conditions.

Then, there are the “slow burn” effects of climate change: in Bangladesh, pregnant women living on the coast were found to have unusually high incidences of pre-eclampsia, linked to drinking groundwater with unusually high levels of sodium. Salination of groundwater and soil is linked to rising sea levels, and hypertension and blood pressure are linked to sodium intake.

These are just three examples of risks posed by climate change to human health, said Haines, a drop in the growing ocean of evidence indicating that the healthcare profession has a major stake in decisions on climate change — though the links range from the obvious to the highly complex.

According to Haines, the risks to health posed by climate change include the direct effects of increased exposures to heat and extreme events (e.g., floods or droughts), the effects mediated through ecosystems (such as changes in vector-borne diseases or nutrition) and those mediated through social systems (e.g., conflict or migration).

But it was not all doom and gloom.

“Decarbonizing the world economy will bring many benefits for health, for example, by reducing air pollution,” Sir Andy said, outlining the well-established benefits of healthy, sustainable cities, increased active travel and low carbon transport, and natural green spaces and trees.

For example, he said, the health co-benefits of decarbonising the European economy by phasing out fossil fuels would prevent about 430,000 people per year from dying from air pollution-related health problems in the European Union alone.

“There is an overlap between climate change and air pollution which allows us to bring to the negotiation table the 7 million deaths caused by air pollution, bringing then a very strong argument, because the burning of fossil fuels is a cause of climate change and air pollution,” said the WHO Director of Public Health, Environmental and Social Determinants of Health, Dr Maria Neira, in an interview with Health Policy Watch.

Dr Neira, presenting yesterday on a Roadmap for Climate Action for health, reiterated the point she made at the World Air Quality Conference in London last Wednesday – that putting heath at the centre of decisions would provide the policy coherence and “perfect arguments” needed to motivate people and spur action.

“There is the health argument— this is about noncommunicable diseases and communicable diseases, this is about our brain, how it is affected, this is about gender because of all those girls collecting wood instead of going to school,” she said.

It was also a political argument, she said: “It’s a question of telling our politicians 5 years from now, they will not be able to say ‘I didn’t know’. They are going to court in some places because they are not taking action to reduce their citizens’ exposure to air pollution.”

“There is also the financial argument— the externalities of using coal and fossil fuels are paid by our hospitals and health system,” Dr Neira continued.

As for questions of feasibility of action, Dr Neira was unfazed.

“Well, mayors are doing this. Last week in London, with the Mayor of London committing to endorse WHO Air Quality guidelines along with the C40 and the commitments made at the Climate Action Summit, so it’s feasible,” she said.

She was referring to the C40 network, a group of 94 megacities which had committed to bringing their air quality to safe levels by 2030, among other things by tracking and reporting on the health impacts of their policies.

“It’s a question of putting it on the political agenda as well,” she said.

Dr Neira emphasized that the health community had credibility and needed to use the strong arguments on how climate change was affecting people’s health, as well as the health benefits obtainable from executing the national commitments in the Paris Agreement, which the WHO has previously called “potentially the strongest health agreement of this century.”

Achieving the Health-Related Sustainable Development Goals

An afternoon keynote session explored how politicians can advance health, with speakers including WHO Director-General Tedros Adhanom Ghebreyesus and Brazil’s Minister of Health Luiz Henrique Mandetta.

Dr Tedros speaking at the keynote session, “Health is a Political Choice.”

“Universal health coverage is not a choice a country makes once. It’s a choice that must be made every day, in every policy decision. Disease patterns are always changing, and so are the needs and demands of populations. There are always people at risk of being left behind,” said Dr Tedros, listing antimicrobial resistance, air pollution and climate change as new challenges for countries to confront.

He repeated the call for countries to increase spending on primary health care by 1% GDP by 2030.

Dr Tedros also emphasized the role of global collaboration, noting that, “health is one of the few areas in which international cooperation offers the opportunity for countries to work together for a common cause. Multilateral engagement is not only the smart option, it’s the only option.”

The final session focused on the Global Action Plan for Healthy Lives and Well-Being for All, which aims to better align the work of 12 global health agencies to accelerate achievement of the Sustainable Development Goals.

The plan was introduced at the World Health Summit last year and launched in September at the UN General Assembly. The discussion led by Uganda’s Minister of Health Jane Ruth Aceng, Gavi CEO Seth Berkley, Wellcome Trust Director Jeremy Farrar, and Peter Sands, Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, reported on progress and plans for the future.

(left-right) Jane Ruth Aceng, Seth Berkley, Ilona Kickbusch.

Moderator Ilona Kickbusch, chair of the Geneva Graduate Institute’s Global Health Centre, asked the panelists how the 12 agencies that are signatories to the Global Action Plan can “accelerate” their coordination in a meaningful way, noting that, “if we can work together with countries, that will be for a joint good, but if we don’t, it will be a collective failure,” she noted.

Berkeley said that Gavi had tried to create “purposeful collaboration” with fellow agencies such as the Global Fund in areas such as health system strengthening and digitalizing health records – “it makes sense to work together and that is something that Peter and I have tried to do,” he said.

As another concrete example of better collaboration, Sands noted that the Global Fund had just signed an agreement with the World Bank on a template for how the two agencies would do finance transactions, sharing reporting and audit day in a simplified way. “When you think about sustainability, challenges, being able to do those kind of blended finance transactions is very important.”

On financing, Jane Aceng said that the most important things are strengthening collaboration and transparency, noting that sometimes agencies enter countries and directly offer aid to populations without clarifying to Ministries of Health what resources are being brought into the country. “I want to have [knowledge of all financial resources] aligned into my plan, so at the end of the day… we can ask what did this money do? What has it translated into?”

Aceng said that increased transparency will help ensure accountability from both countries and external agencies, and allow all stakeholders to better allocate resources.

The World Health Summit is one of the world’s premier global health forums. This year, approximately 20 ministers from around the world, the Director-General of the WHO, top scientists, and leaders from the private sector and civil society are among the participants. For three days, over 2,500 participants from 100 countries will discuss ways to improve global health.

Other topics in the World Health Summit 2019 programme included discussion of strategies to advance Universal Health Coverage, combat the double burden of noncommunicable and neglected tropical diseases many low and middle income countries now face, improve health systems in Africa and around the world, fight against antimicrobial resistance, advance digital health, and implementing the UN’s Sustainable Development Goals.

Image Credits: U.S. Army National Guard/Master Sgt. Paul Wade, World Health Summit.

Berlin, Germany – From antimicrobial resistance to drug access, climate change and emerging trends such as growing obesity in Africa alongside under-nutrition, this year’s World Health Summit’s is packed with an imposing agenda, dwarfed only by the staggering dimensions of the real-world challenges.

“Polio has almost been eradicated, HIV/AIDS has been driven back and we have managed to cut overall infant mortality worldwide in half. These are positive developments, but one question remains – is this where we want to be? My answer is no,” said German Health Minister Jans Spahn in a stocktaking of global health issues at Sunday’s opening ceremony.

The world is far from reaching the health-related Sustainable Development Goals (SDGs), and will fall even further behind if it carries on with a business-as-usual scenario, he added.

“NCDs such as cancer, diabetes, and heart disease are on the rise. There are almost 50 million premature deaths every year, not only in low- and middle-income countries, but also in high-income countries. As for pandemic preparedness, we all know that we’ll face another pandemic. The only thing we don’t know is when it will happen and how severe it will be. Is the world prepared for this?

“If we look at the robustness of health systems worldwide….we have to confess “no.” the world is not adequately prepared yet. Today more than 1.6 billion people live in areas where protracted crises and weak health care systems leave them without access to basic health care.

“Ebola [in the Democratic Republic of Congo] is only the tip of the iceberg – most people are dying from easily treatable and avoidable diseases like measles or malaria. Even simple interventions such as immunizations still remain a huge challenge for weak and under financed health systems.

“We have 10 years in which to fulfill our ambitious [SDG] agenda, so we have to intensify our efforts, embrace true commitment for global health and work in partnership across all sectors and stakeholder groups,” he said.

At the same time, economic development which has led to better health, nutrition and increased life expectancy have in some cases been achieved on the back of wasteful use of resources that threatens future progress, noted Detlev Ganten, World Health Summit chair and president.

“People live longer and healthier in most parts of the world but this progress comes with a price – the exploitation of resources, destruction of nature, unhealthy urbanization and lifestyles, toxic footprints, and the heating of the earth,” he noted.

Against that landscape, the “One Health” concept needs to be expanded to include a healthy ecosystem that can nurture a healthy population, he said.

“Planetary health defines climate and environment as important determinants of human health. Both imply that we need a holistic view on health which includes our biology our environment and our lifestyle and behaviour.” A more holistic view of health can help overcome barriers of silos, politics, and ideologies he added, saying “it is time to act and take responsibility in good partnership.  The 17 Sustainable Development Goals provide this holistic framework. Healthy lifestyles can reduce toxic footprints and at the same time provide immediate co-benefits regarding climate, mobility, and nutrition.

The World Health Summit, co-sponsored by the leaders of Germany, France, the European Commission and the World Health Organization, is one of the premier global health events of the year, bringing together hundreds of participants worldwide – from ministers of health to WHO and other UN agencies, industry and civil society.

Unlike the World Health Assembly, which as WHO’s governing body meets annually and is focused around the deliberations and decisions of official member state representatives, the Summit is a more eclectic gathering which involves official, civil society and industry participants on an equal footing. Its thematic focus around key health topics creates a venue where information and practical solutions to pressing challenges can be freely shared and debated.

This year’s agenda is highlighting the theme of climate change and health. Other topics in the 2019 programme include: improving health systems in Africa and around the world; finding solutions to antibiotic resistance; digital health; and strategies for implementing Universal Coverage as well as other health aspects of the Sustainable Development Goals.

Big Ideals – Complex, Nitty Gritty Solutions 

Against the high-minded ideals of partnership and progress, as expressed by the event’s patrons, the nitty-gritty nature of thorny issues like AMR was all the more apparent in the sessions that unfolded on Monday.

Wanton sales of unregulated antibiotics over the counter in some regions of the world such as South-East Asia; prescription of the wrong antibiotics; widespread dumping of pharma waste into watersheds; and the spotty global tracking of animal and human use of antibiotics worldwide –  are among the current practices stimulating antimicrobial resistance, noted participants in two panels that covered the issues Monday morning and afternoon.

Soumya Swaminathan

“We need a lot of behaviour change,” said WHO Chief Scientist Soumya Swaminathan. “This can be focused on different levels of health care providers but also on community pharmacists [who often distribute antibiotics] and the community at large,” she said, referring to a “red-line” campaign that India had sponsored, in which pills that should be distributed only with a prescription had to be marked with a red line.

Poor hospital sanitation systems also give rise to AMR, she said, referring to a recent WHO/UNICEF report showing that one in four health facilities in low and middle income countries lacked basic water services, and even more lacked basic sanitation.

As for the dumping of pharmaceutical waste in watersheds, she noted that WHO was looking at amending its Good Manufacturing Practice standards, required by companies that want to be quality for donor-supported procurement programmes – to require adequate waste disposal for drugs produced. “It may mean a slight increase in the product but this is the price that has to be paid,” she said.

There is also a dearth of rapid, low-cost diagnostics that can properly identify bacterial infections requiring antibiotics, as compared to other parasitic or viral infections that need other treatments, noted Catherina Boehme of the Foundation for Innovative New Diagnostics (FIND). “Every patient’s road to healthcare begins with diagnosis.. yet wherever we look, we see that within low and income countries, 50-70% of the patients do not get diagnosed. If we fail to diagnose half of the patients, that is a failure when it comes to medicines. It has to be an end-to-end model.”

Along with that, market systems and procurement processes need to be revamped, agreed both industry and civil society representatives on one panel. In some countries, the prices of certain antibiotics are so low that it is no longer profitable to produce them at all.  As a result, hospitals in high-income countries often face gaps in the supply of critical antibiotics while in many low-income countries, the right antibiotics may still be too expensive or not available at all.

“There is a market failure of antibiotics, and shortages of antibiotics, so there is a spectrum where you see significant shifts in the pricing of antibiotics,” observed Manica Balasegaram, Executive Director, of the Global Antibiotic Research & Development Partnership (GARDP).

GARDP Strategy to Bring 5 New Antibiotics to Market by 2025

To combat the shortage of new antibiotics in the drug development pipeline, the new Alliance formally launched a new strategy, initially announced in July, to bring 5 new or improved antibiotic treatments to market by 2025.

The GARDP strategy will focus on creating formulations that are accessible to people in low and middle income countries, Balesegaram stressed, noting that sustainable access, in terms of antibiotics means “treatments of a required quality; manufacturing standards and environmental waste management; affordable for patients in health systems; supplied in a timely and appropriate manner; and used in an appropriate manner.”

Although there is no doubt that new antibiotics are desperately needed to combat AMR, which is estimated to kill as many as 700,000 people a year now and could kill up to 10 million annually by 2050, more could also be done with existing drugs.

“One of the greatest challenges in low and middle income countries is just the lack of access to existing antibiotics, and that is triggered by the high prices, low API (active ingredient) production, and the failure to use and understand the molecules that we have,” said Mirfin Mpundu, of the Ecumenical Pharmaceutical Network (EPN). “As we look at new innovations, we have to be very considerate and realize that lack of access remains an issue in low and middle countries.”

So far, so-called “5×25” GARDP strategy has so far only received commitments for about €70 million of the estimated €500 million required to develop the drugs, including planned new formulations for neonatal sepsis as well as for the sexually transmitted infection gonorrhea, which has shown increased resistance to existing drug treatments in many parts of the world.   

However GARDP’s efforts received a further boost on Monday when several donor countries and agencies, including Japan, Germany and the United Kingdom, Japan, pledged more than €12.6 million more to the effort.

The program for the 2019 World Health Summit can be found here and the Summitb livestream can be accessed here.

Image Credits: World Health Summit, World Health Summit.

The World Health Organization has launched a plan to accelerate the use of digital technologies to meet global public health needs, following the first-ever meeting of a WHO Technical Advisory Group on digital health.

“All governments are facing increasing demands to provide health services to their citizens, and many digital technologies offer solutions to help meet these needs,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release issued on Friday at the close of the meeting.  “But countries require confidence in what works. The action plan agreed today focuses our efforts on helping the world benefit from digital health technologies and solutions while safeguarding the misuse of people’s data and protecting their health.”

Digital health experts developed an action plan to focus the new WHO Technical Advisory Group’s activities and priorities over the next two years at a two-day meeting  at WHO’s Geneva headquarters, focusing on defining WHO’s role in supporting digital transformation at the global and country level. Topics discussed included:

  • Developing a global framework for WHO to validate, implement and scale up digital health technology and solutions;
  • Recommendations for safe and ethical use of digital technologies to strengthen national health systems by improving quality and coverage of care, increasing access to health information;
  • Advice on advocacy and partnership models to accelerate use of digital health capabilities in countries to achieve better health outcomes;
  • Advice on emerging digital health technologies with global reach and impact, so no one is left behind.

WHO is particularly interested in using digital health as an “accelerator” to achieve Universal Health Coverage at the national level, said Bernardo Mariano, director of WHO’s Department of Digital Health and Innovation in a press conference. WHO is looking to achieve a “quadruple win” – for patients and providers, academia, governments, and the private sector – to “really use data to advance the achievement of Universal Health Coverage,” he said.

Steve Davis, co-chair of the new WHO Advisory Group and president/chief executive officer of Global Health at PATH, an international health technologies non-profit, added that the deployment of better data and digital health tools could particularly help in expanding primary health care coverage.

“The opportunity over the next 10 years, to be more precise about where the problems are, to get remote tools to reach new people, to empower the health workers, and to empower patients is extraordinary,” he said.

As examples, he said health systems would be strengthened by:  improving data flows; enabling health workers to be more productive by using electronic data collection systems; and getting new diagnostic and treatment tools into the hands of clinicians.

According to Mariano, the first Global Action Plan for Digital Health, covering 2020 – 2024, will be brought before WHO member states for approval at the World Health Assembly in May 2020. That will be two years after the passage of World Health Assembly Resolution (WHA/71 A71) that recognized the expanding role of role digital technologies in furthering health.

Image Credits: WHO.