As leaders from across the globe met in Paris today to renew commitments against malaria on World Malaria Day, a Geneva-based group announced the scale-up of a project in rural Zambia that reduced severe malaria fatality by 96 percent. The innovative project administers life-saving drugs to children with malaria in rural communities, and provides immediate rapid transport via bicycle ambulance to health centres.

On World Malaria Day today, Medicines for Malaria Venture (MMV) announced that they will expand their innovative project in collaboration with Transaid to further reduce fatality due to severe malaria through rapid community-based treatment in rural Zambia, according to a press release.

Rabbecca Chisenga, an emergency transport system (ETS) rider and community health volunteer (CHV) in the village of Mupola, Serenje, Zambia.

Also for World Malaria Day, leaders from across the globe met in Paris today for a high-level conference organised by Roll Back Malaria (RBM) Partnership “to renew commitments and announce new initiatives to accelerate the global movement to end malaria in our lifetime,” according to an RBM Partnership news release.

Among the speakers at the conference were Dr Abdourahmane Diallo, CEO of RBM Partnership; Peter Sands, executive director of The Global Fund to Fight AIDS, Tuberculosis and Malaria; and Anne Hidalgo, mayor of the city of Paris.

This year’s World Malaria Day is particularly significant because it “comes ahead of the Sixth Replenishment Conference of the Global Fund to Fight AIDS, Tuberculosis and Malaria which takes place in Lyon on 10th October,” at which the Global Fund “seeks to raise at least US$14 billion to step up the fight against AIDS, Tuberculosis and Malaria,” the RBM Partnership release said.

“2019 presents a crucial opportunity for celebrating and continuing to commit to ending malaria,” David Reddy, CEO of MMV, said at a World Malaria Day event yesterday in Geneva organised by the Swiss Malaria Group. “We are working closely with the Global Fund to support its funding efforts in countries by developing innovative tools to broaden impact and helping make these tools available to the people in need.”

“Most importantly,” he said, “access and uptake of innovative medicines has still to be considerably scaled up, including in remote communities: innovative partnerships for access is now part of our vision and an important component of our business model.”

Scaling Up Community-Based Malaria Treatment in Zambia

The MMV project, MAMaZ against Malaria, effectively reduced severe malaria fatality by 96 percent, from 8 percent to only .25 percent of cases resulting in death, according to the MMV release.

“This was achieved through effective community engagement, a functioning drug supply chain, implementing an innovative emergency transport system for patients using bicycle ambulances and increased access to key medicines for severe malaria,” it said.

The project administers rectal artesunate suppositories (RAS) to children at the community-level as soon as severe malaria is suspected, and transports these children to health centres using bicycle ambulances to receive the remaining doses of artesunate. See also: (HPW, MMV: Zambia Pilot Project, 3 September 2018).

The pilot project reached a population of 54,000, and the expanded project will now reach around 200,000 people.

“Children under 5 years of age are one of most vulnerable groups affected by malaria. In Africa, about 285,000 children died before their fifth birthdays in 2016,” the World Health Organization website states. “Because the clinical condition of children with malaria can deteriorate rapidly,” it says, there should be a “low threshold” for treating children as soon as possible with non-oral artesunate.

“Malaria can become deadly all too quickly, especially for children under 5 living far from health facilities,” George Jagoe, head of Access & Product Management at MMV, said in the release.

“The dramatic 96% reduction in case fatality achieved by the pilot project,” he said, “demonstrates not only the undeniable benefit of using RAS and emergency transport in tandem but also the incredible life-saving impact this project could have at full scale in Zambia as well as other high-burden malaria countries.”

The new project, MAMaZ against Malaria at Scale, will be implemented by a consortium of partners including Development Data, DAI Global Health, Disacare, Transaid and MMV, and will work closely with the National Malaria Elimination Centre (NMEC) in Zambia.

MMV, “a leading product development partnership (PDP) in the field of antimalarial drug research and development,” has secured the funds for this expansion and will provide the technical malaria expertise for the new project, the release said.

Image Credits: MMV.

Scientists from a range of countries are calling for an update to World Health Organization guidelines on biosimilar products in order to help national authorities better implement policies to make biosimilars less costly. Current guidelines are outdated and are being misused, they say. But a WHO official told Health Policy Watch the guidelines document should not be made “over-prescriptive”, and that a thorough assessment by an expert group last year found a revision unnecessary but will keep considering it. Continue reading ->

Image Credits: Louis Reed/Unsplash.

[Gavi, The Vaccine Alliance, Press Release]

With support from Gavi, The UPS Foundation and other partners, Zipline drones will serve up to 2,000 health facilities and 12 million people in Ghana.

Omenako, Ghana, 24 April 2019 – Gavi, the Vaccine Alliance today announced support for the expansion of a medical drone network into Ghana. Zipline, a California-based automated logistics company, will use drones to make on-demand, emergency deliveries of high priority products including emergency and routine vaccines and other health products.Continue reading ->

Image Credits: Gavi/2019/Tony Noel.

[Medicines for Malaria Venture Press Release]

PATH and Medicines for Malaria Venture (MMV) announce a 5-year, jointly-led initiative, VivAccess, to support countries in the elimination of Plasmodium vivax (P. vivax) malaria. The initiative is part of the larger global effort to support malaria-endemic countries in the adoption and use of new and existing tools, to facilitate well-tolerated and effective radical cure to prevent relapse. VivAccess’s work is funded by the Bill & Melinda Gates Foundation.Continue reading ->

Image Credits: Damien Schumann/MMV.

Global health policymakers need to adopt a “bench-to-bedside” approach to research and development, to ensure that new drugs and vaccines are not only put into the development pipeline, but are also readily available for responding to global health crises such as Ebola, says Michelle Childs of the Drugs for Neglected Diseases Initiative (DNDi).Continue reading ->

Image Credits: MSF, DNDi, MSD.

European Union health ministers’ meeting last week in Romania addressed ways to ensure access to medicines and treatment, especially for youth or those with rare diseases. For innovative and expensive medicines, they discussed possibilities “for the time period between the granting of the marketing authorization, the actual placement on the market and the decision to reimburse the product in that Member State.”Continue reading ->

The World Health Organization’s new guidelines on digital health highlight the value of digital health technologies in helping to close health system gaps, while emphasising that they do not replace investments in health system infrastructure. The guidelines assess the appropriateness of a range of digital health technologies and provide recommendations on making informed investments in these technologies and how best to integrate them into health systems.

The new WHO guidelines, Recommendations on Digital Interventions for Health System Strengthening, released today, present recommendations that “examine the extent to which digital health interventions, primarily available via mobile devices, are able to address health system challenges along the pathway to UHC [universal health coverage].”

“Harnessing the power of digital technologies is essential for achieving universal health coverage,” WHO Director-General Dr Tedros Adhanom Ghebreyesus (Dr Tedros), said in a press release. “Ultimately, digital technologies are not ends in themselves; they are vital tools to promote health, keep the world safe, and serve the vulnerable.”

The recommendations cover a range of technologies in the areas of birth and death notification by mobile device, stock notification and commodity management by mobile device, telemedicine between clients and providers, digital tracking of patients’ health status and services by mobile device, and health worker training and decision support by mobile device.

“By reviewing the evidence of different digital interventions against comparative options, as well as assessing the risks,” the guidelines aim “to equip health policy-makers and other stakeholders with recommendations and implementation considerations for making informed investments into digital health interventions.”

“Digital interventions depend heavily on the context and ensuring appropriate design,” Dr Garrett Mehl, WHO scientist in digital innovations and research, said in the release. “This includes structural issues in the settings where they are being used, available infrastructure, the health needs they are trying to address, and the ease of use of the technology itself.”

The guidelines emphasise that “digital health interventions are not a substitute for functioning health systems, and that there are significant limitations to what digital health is able to address. Digital health interventions should complement and enhance health system functions through mechanisms such as accelerated exchange of information, but will not replace the fundamental components needed by health systems such as the health workforce, financing, leadership and governance, and access to essential medicines.”

The guidelines also clearly prioritise the needs of vulnerable communities, stating that implementation of the recommendations “should not exclude or jeopardize the provision of quality non-digital services in places where there is no access to the digital technologies or [where] they are not acceptable or affordable for target communities.”

“Digital health is not a silver bullet,” Bernardo Mariano, WHO’s chief information officer, said in the release. “WHO is working to make sure it’s used as effectively as possible. This means ensuring that it adds value to the health workers and individuals using these technologies, takes into account the infrastructural limitations, and that there is proper coordination.”

Due to the rising interest in digital health technologies in recent years, many have been “rolled out in the absence of a careful examination of the evidence base on benefits and harms,” which, according to the guidelines, has “driven a proliferation of short-lived implementations and an overwhelming diversity of digital tools, with a limited understanding of their impact on health systems and people’s well-being.”

“While recognizing the innovative role that digital technologies can play in strengthening the health system,” the guidelines conclude that “there is an equally important need to evaluate their contributing effects and ensure that such investments do not inappropriately divert resources from alternative, non-digital approaches.”

The term “digital health” was introduced to encompass the previously applied terms eHealth (using information and communications technologies) and mHealth (using mobile technologies), while also incorporating emerging new technologies such as the advanced computing of “big data,” genomics and artificial intelligence.

The guidelines were developed based upon the World Health Assembly Resolution on Digital Health, which was unanimously approved by WHO member states in 2018. According to the guidelines, this resolution “demonstrated a collective recognition of the value of digital technologies to contribute to advancing universal health coverage (UHC) and other health aims of the Sustainable Development Goals (SDGs).”

In March 2019, WHO also announced a plan to create a new Department of Digital Health, “to enhance WHO’s role in assessing digital technologies and support Member States in prioritizing, integrating and regulating them,” according to the release.

Image Credits: WHO.

[Medicines for Europe Press Release]

BRUSSELS, BELGIUM – 17 APRIL 2019

  • The European Parliament adopted the SPC manufacturing waiver with a huge majority.
  • The waiver will improve access to medicine and create manufacturing job opportunities for Europe as of July 2022.
  • Medicines for Europe will work with its members to facilitate the practical use of the waiver and will monitor and act against any potential misuse of the notification system for frivolous litigation.

The European Parliament today voted overwhelmingly with 572 Members of Parliament in favour to adopt the Supplementary Protection Certificate (SPC) manufacturing waiver.  The SPC manufacturing waiver is now expected to be formally adopted by the European Council in the coming weeks.

Medicines for Europe commends the EU institutions for successfully concluding this important step in the adoption of the waiver. We congratulate the European Commission for proposing the waiver and the rapporteurs and shadow rapporteurs of the Legal, Trade and Health committees of the European Parliament as well as the European Council for substantially improving the manufacturing waiver to deliver access to medicines for European patients.

The SPC manufacturing waiver will enable the European pharmaceutical industry to compete on a level playing field globally for manufacturing opportunities in generic and biosimilar medicines which is growing year on year.

The waiver will come into force in July 2019 and companies will be able to start manufacturing under the waiver from July 2022. The Commission has evaluated the tremendous investments in new, high-skill jobs that this manufacturing for export and for day 1 launch can deliver for Europe[1]. The waiver’s notification measures should therefore not be misused to block generic and biosimilar medicines competition.

Adrian van den Hoven, Director General of Medicines for Europe commented “Today’s vote on the SPC manufacturing waiver reflects the EU’s commitment to access to medicines, manufacturing jobs in Europe and putting EU industry on a level playing field globally. Europe has everything to gain from fully implementing the waiver to enable more competition on the pharmaceutical market and to improve its own security of medicines supply.”

[1] https://ec.europa.eu/docsroom/documents/29463