Global progress against malaria continued to plateau in 2018 for the third year in a row, and the disease hit young children and pregnant women in Sub-Saharan Africa the hardest, according to the World Malaria Report 2019 released by the World Health Organization on Wednesday. Despite stalled progress at the global level, however, four new countries have successfully eliminated the disease in 2018 and 2019.

“We’re seeing encouraging signs, but the burden of suffering and death caused by malaria is unacceptable, because it is largely preventable. The lack of improvement in the number of cases and deaths from malaria is deeply troubling,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “Pregnant women and children are the most vulnerable to malaria, and we cannot make progress without focusing on these two groups.”

A village malaria worker is testing a young child for malaria in Battambang Province, Cambodia.

In 2018, WHO estimates that there were 228 million cases of malaria globally, causing 405 000 deaths, as compared to 231 million cases and 435 000 deaths in 2017. A dramatic reduction in malaria incidence and mortality was seen through 2010 to 2015, but global progress against the disease has stalled since then.

The report underlines that malaria continues to strike particularly hard at pregnant women and children in Sub-Saharan Africa,, with an estimated 11 million pregnant women infected in 38 countries with moderate-to-high malaria transmission in that region alone in 2018. Malaria infection in pregnancy can cause a variety of complications, including malaria-related anemia, low birth weight, and even maternal death.

An estimated 24 million children in the region were infected last year with the deadliest strain of malaria – P. falciparum –  with at least half experiencing moderate anemia and 1.8 million experiencing severe anemia. Malaria-related severe anemia is still a major contributor to child mortality in Sub-Saharan Africa.

Funding for malaria control and elimination 2010-2018, by source of funds (constant 2018 US$)

The plateau in progress may in part be caused by the shortfall in malaria funding – the report estimates that funding towards malaria control and prevention fell to US$2.7 billion last year with governments of malaria-endemic countries contributing an estimated 30% of the pool, falling far short of the US$5 billion needed to fully fund WHO’s Global technical strategy for malaria 2016 – 2030.

On the flip side, a handful of low-burden countries have seen progress. In 2018, WHO certified that endemic malaria was successfully eliminated Paraguay and Uzbekistan. Algeria and Argentina were recognized for eliminating endemic malaria in early 2019, and China, El Salvador, Iran, Malaysia, and Timor-Leste reported zero indigenous cases. Progress to achieve a global milestone to certify at least 10 countries for the elimination of malaria by 2020 is also on track.

Large reductions in malaria were also seen in WHO’s Southeast Asian region, said Dr Abdisalan Noor, lead author of the report and team leader of the Surveillance Unit in WHO’s Global Malaria Programme, in a press conference. Significant reductions in India, which had 2.6 million fewer malaria cases than the previous year, accounted for a large share of the success. Progress has also been made in the Greater Mekong sub-region – an important strategic area as resistance to antimalarial medications has historically been traced back to the region.

Protecting Pregnant Women and Young Children

Coverage of pregnant women and children by malaria treatment and prevention interventions has increased in Africa, but these two groups continue to be the hardest hit by malaria.

“We have brought back the focus to the key populations at risk that suffer and carry the brunt of malaria; pregnant women and young children in Africa. And by highlighting this space, we also signal that they must become our number one priority in the fight against malaria,” said Dr Pedro Alonso, director of WHO’s Global Malaria Programme.

The WHO report estimates that in 2018, 67% of all malaria-related deaths occurred in children under 5, and malaria continues to be a leading cause of infection-related maternal mortality in Sub-Saharan Africa.

“Now, [another] one of the consequences of malaria in pregnancy is children that are born with low birth weight, less than 2500 grams at birth,” Dr Noor clarified. Low birth weight is not only an immediate problem for the growth of the child, but is also “a significant predictor of early infant death,” he added. The WHO report estimates that of the 11 million cases of malaria in pregnancy in Sub-Saharan Africa in 2018,  872,000 children were born with low birth weight.

This is despite the fact that the number of pregnant women and children sleeping under insecticide-treated bed nets and receiving preventative medicine for malaria has increased in recent years. An estimated 61% of pregnant women and children in sub-Saharan Africa slept under an insecticide-treated net in 2018 compared to 26% in 2010.  Among pregnant women in the region, coverage of the recommended 3 or more doses of intermittent preventative malaria treatment, delivered during antenatal care visits, increased from an estimated 22% in 2017 to 31% in 2018. Some 72% of eligible children received seasonal malaria prevention medication in 2018.

A new WHO-recommended strategy to prevent malaria in infants – intermittent preventative treatment for infants (IPTi) – recommends delivering anti-malarials to very young children through the immunization programme, and is being piloted in Sierra Leone.

“IPTi offers a tremendous opportunity to keep small children alive and healthy,” said Dr Alonso. “WHO welcomes Unitaid’s new drive, announced today, to accelerate the adoption and scale-up of IPTi in other malaria-endemic countries in sub-Saharan Africa.”

Some “Elimination by 2020” Targets May Be in Sight

 Despite little progress being made on the global scale, certain regions and countries are inching closer to eliminating malaria, defined as completely stopping endemic transmission within national or territorial borders. Globally, a total of 38 countries and territories have been certified malaria-free by WHO, with Paraguay, Uzbekistan, Algeria, and Argentina just added to that list between 2018 to 2019. WHO grants the malaria-free certification when a country proves, beyond a reasonable doubt, that the chain of indigenous transmission of malaria has been interrupted for at least 3 consecutive years. At least 10 countries that are part of WHO’s “E-2020 initiative” are on track to reach the 2020 elimination milestone of the global strategy.

P. Falciparum cases in the Greater Mekong Subregion, 2010- 2018

The six countries of the Greater Mekong sub-region – Cambodia, China, Laos, Myanmar, Thailand, and Vietnam – have made significant progress. Across the subregion, there was an impressive 76% reduction in malaria cases and a 95% drop in deaths between 2010 and 2018. This includes a steep decline in cases of P. falciparum malaria, a primary target in view of the ongoing threat of antimalarial drug resistance.

Some 11 African countries and India account for approximately 70% of the world’s malaria burden – Burkina Faso, Cameroon, Democratic Republic of the Congo, Ghana, India, Mali, Mozambique, Niger, Nigeria, Uganda and the United Republic of Tanzania. The WHO and Roll Back Malaria Partnership launched a “high burden high impact” (HBHI) approach in these countries in 2018. By November 2019, the HBHI approach had been initiated in nine high burden countries in Africa.

Image Credits: WHO/ V. Sokhin, WHO/World Malaria Report 2019.

For the second year running, some 37 organizations have launched a week-long mini campaign to raise awareness and promote action against falsified and substandard medicines.  This year’s annual Fight the Fakes week aims to mobilize the public and international global health community to speak up more assertively about the growing threat of fake or substandard medicines under the theme “Be Aware, Speak Up, Fight the Fakes.”

“Poor-quality care is now as big a barrier to reducing mortality than insufficient access to healthcare. This is why ensuring high-quality medicines reach patients should be a key component of Universal Health Coverage initiatives,” said Grey Perry, assistant director-general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), a founding member of the campaign.

Drugs that deliberately misrepresent their identity and medicines that do not meet regulatory or quality specifications are particularly prevalent in low- and middle-income countries, where an estimated 1 in 10 medical products is falsified or substandard, according to a 2017 report by the World Health Organization.

But the problem can affect higher income regions too. A medical product alert issued earlier this year by the WHO found that a falsified version of the leukemia medication ICLUSIG containing none of the active cancer-fighting agent Ponatinib hydrochloride had been circulating in the WHO Region of the Americas as well as in WHO’s European Region.

There is also evidence that take and substandard products can fuel illicit trade, as well as organized crime, which has broader social and economic implications, according to a report released by the UN Office on Drugs and Crime in June. The report estimates that consumers in Southeast Asia alone spend between US$20 million and US$2.6 billion a year on falsified medicines.

Legitimate pharmaceutical producers in countries such as China and India often outsource parts of their drug production process to manufacturers in countries with weaker regulatory requirements, and that can lead to substandard medications, says the UN Office on Drugs and Crime report. The rapid proliferation of online pharmacies has also facilitated the trade of substandard and falsified medications, the report finds.

The Fight the Fakes campaign has received support from industry, product development partnerships, and civil society actors alike, who say that addressing the issue of falsified and substandard drugs is paramount to ensuring that patients have access to safe and quality essential medicines.

“The risk [of falsified and substandard medicines] concerns everyone in every corner of the world,” said the World Heart Federation’s Director of Partnerships and Programmes, Andrea Vassalotti.

Individual and Societal Risks of Substandard and Falsified Pharmaceutical Products

Antibiotics and antimalarials are among the most frequently reported falsified medical products – accounting for almost 65% of all products reported to WHO.

This also contributes to the growing resistance of many bacteria and parasites to commonly used drugs – known as antimicrobial resistance. Many falsified or substandard antibiotics or antimalarials do not contain the proper dose of the active ingredient. When ingested by patients, exposure to lower doses of the active ingredient allows pathogens to develop resistance to the drug. Although the extent of the effect is unclear, WHO has listed drug resistance driven by subpar medications as a global concern in its 2017 review, A study on the public health and socioeconomic impact of substandard and falsified medical products.

While antibiotics and antimalarials represent the lion’s share of reported falsified and substandard medical products, fake and substandard medicines for other life-threatening illnesses such as rabies, diabetes, cancer, cardiovascular disease, and HIV are also present on the market. This year so far WHO issued 11 alerts for falsified medical products that have been circulating in certain countries and globally.

Confirmed falsified hydrochlorothiazide 50mg

These medications at best fail to have any impact on the disease they purport to treat, and at worst contain other compounds that can have devastating consequences on individuals’ health.

In March, a falsified medication claiming to contain hydrochlorothiazide, a medicine used to control hypertension, caused blood sugar levels to crash in a number of patients who were prescribed the medication in Cameroon. According to the WHO alert on the product, the medication instead contained glibenclamide, an antidiabetic medication, and was the cause of the hypoglycaemia experienced by patients.

“Currently, cases come to light when high numbers of people are affected by very severe or unusual suspected side effects,” said Oksana Pyzik, senior teaching fellow at the University College London and founder of UCL’s Fight the Fakes chapter.

The combined effects of exposure to substandard and falsified medicines can also erode public trust in health authorities and health systems, mistrust that is already fueled by a growing anti-vaccination movement, said Pyzik.

“We have entered an interesting time in history where trust of science, fact and authority has never been so fragile, fleeting and called into question… As such leading health authorities cannot afford any further dents in credibility that damage trust in health systems,” she added.

“Awareness of the issue remains low amongst health care professionals (HCPs) and the general public globally. Education and training of HCPs, alongside wider campaign efforts such as Fight the Fakes, are of paramount importance to improve reporting rates of substandard and falsified medical products by pharmacists and patients,” said Pyzik.

As part of this year’s Fight the Fakes campaign, partners of the movement have organized events around the world, including a series of events at UCL, a photo competition hosted by the International Pharmaceutical Students Federation, and a panel that will be co-hosted by IFPMA and the Graduate Institute in Geneva on Friday.

Image Credits: WHO, WHO, Sanofi.

[Drugs for Neglected Diseases Initiative]

Geneva, Switzerland (29 November 2019) – The Indian pharmaceutical company Cipla has announced their commitment to price the ground-breaking new product Quadrimune, a “4‑in‑1” treatment for young children with HIV, at below a dollar a day. Quadrimune is currently under review by the US Food and Drug Administration (FDA) for use in children between 3 and 25 kg bodyweight.

This pleasant tasting, heat-stable fixed-dose combination of four antiretrovirals (ARVs) for infants and young children with HIV was developed in partnership by Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi) with financial support from Unitaid and other donors. If it receives FDA tentative approval in 2020, the 4-in-1 will represent a major improvement in the treatment of HIV in very young children and will replace older, bitter-tasting medicines, medicines requiring refrigeration, or regimens that are no longer recommended by the World Health Organization (WHO).

Demonstration of how to administer Quadrimune, a “4-in-1” treatment for young children with HIV

‘Cipla is happy that over the past 20 years it has contributed to making adult antiretroviral drugs available at affordable prices for patients throughout the developing world, in particular Africa, and has pioneered the development of paediatric fixed-dose combinations of ARVs for children,’ said Dr Yusuf K Hamied, Chairman of Cipla. ‘Over the years, the treatment of children with HIV has been neglected. In order to ensure faster access, particularly in sub-Saharan Africa, our product Quadrimune, once approved, will be offered for less than one dollar a day for children.’

‘Children living with HIV have been neglected for too long, with the recommended treatment for years consisting of a bitter-tasting syrup with 40% alcohol content,’ said Dr Bernard Pécoul, Executive Director of DNDi. ‘Mothers were often forced to bury the syrup in the sand to keep it cool, because it required refrigeration. The new Quadrimune is pleasant-tasting, heat-stable, and easy-to-use. We will finally have a treatment designed specifically for infants and young children, who are at the highest risk of dying if they do not receive treatment.’

It is estimated that 1.8 million children are living with HIV, almost 90% of whom live in sub-Saharan Africa. Only an estimated 54% of these children have access to HIV treatment and over 300 children still die from the disease every day. Inappropriate, suboptimal treatment options have contributed to low treatment coverage.

Cipla will provide Quadrimune at an ex-factory price of US$ 15 per pack of 120 capsules, giving a price of $1 per day ($360 per year) for children in the medium weight bracket of 10 to 13.9 kg, with prices lower, at 50 US cents per day, for younger children and infants. Quadrimune contains the WHO-recommended ARVs abacavir, lamivudine, lopinavir, and ritonavir in the form of granule-filled capsules. If approved, parents and caretakers will be able to administer the drugs to children by sprinkling the granules on soft food, water, or milk. The 4-in-1 does not require refrigeration and is easy to administer to infants and children of different weights and ages.

‘This optimal child-adapted all-in-one ARV regimen, that meets WHO recommendations, will be a game-changer for millions of infants and young children,’ Unitaid Executive Director Lelio Marmora said. ‘Unitaid is proud to have supported from day one the development of this new 4-in-1 treatment that is safe and effective, adapted and palatable, easy-to-use and with no requirement for refrigeration. Once adopted, this innovative formulation will enable great advances in the treatment of the youngest kids.’

Since 2013, WHO has recommended regimens that include a class of ARVs called protease inhibitors, which includes lopinavir/ritonavir (LPV/r), for infants and young children. Cipla and DNDi worked closely to develop Quadrimune, testing over 30 formulations of abacavir, lamivudine, and LPV/r, ensuring good taste-masking, and selecting one which met the standards required to enable regulatory submission.

The 4-in-1 could be the first of several new treatment options now on the horizon for young children with HIV.

 

Image Credits: Emmanuel Museruka/DNDi.

African leaders, scientists, and activists are mobilizing to address the scientific, political, and social challenges inherent to ending the HIV epidemic. That was the key message as the 20th International Conference on AIDS and STIs in Africa (ICASA) kicked off on Monday in Kigali, Rwanda under the theme, “AIDS-free Africa: Innovation, Community and Political Leadership.”

“HIV, Hepatitis B and syphilis are all endemic in Africa. All three can be maternally transmitted; are devastating; take a heavy toll on health systems, with catastrophic expenditures for families leading to poverty in our communities. And all three can be prevented,” said World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus at the conference opening ceremony.

(back row, left-right) Rwandan President Paul Kagame, Rwandan First Lady Jeannette Kagame WHO Director General Dr Tedros, and UNAIDS Executive Director Winnie Byanyima along with other First Ladies of African States (first row) at the ICASA 2019 Opening Ceremony.

Rwandan President Paul Kagame added that AIDS is an “epidemic without borders.” In a brief opening statement, the president of the host country highlighted a number of key challenges that the HIV/AIDS response faces – themes around which the conference has organized.

When it comes to sexually-transmitted infections, Kagame said, stigma and silence “are the real killers, just as much as the underlying virus.”  Stigma discourages people with STIs, including people with HIV, from seeking life-saving care, he explained.

On the care provision side, sustained investment in strengthening health systems is needed to “win the fight” against HIV/AIDS, and “build the resilience required to handle other challenges down the line,” he said.

He stressed the importance of “good politics and good governance,” highlighting that governments in Africa must prioritize domestic financing for healthcare, investing in infrastructure, technology, and a highly-skilled medical and administrative workforce. Additionally, investment in community health workers can help build trust in the health system so that citizens will to “act on health guidelines from public institutions and change their behavior accordingly.”

The conference is organized along three thematic tracks that address the major opportunity areas for improving HIV/AIDS response. A scientific track features sessions that focus on tools for HIV prevention and treatments regimens, including topics such as “operationalizing the implementation of innovative biomedical prevention such as PrEP, microbicides, and long-acting antiretrovirals.”

A second track focuses on leadership and issues around the political mobilization required in the fight against HIV/AIDs, including sessions such as “Stronger positioning of women leadership in Africa in the HIV response.” A third stream focuses on community-based work in the HIV response, with sessions such as “accessing services for people living with disabilities.”

The six-day conference is co-sponsored by the Society for AIDS in Africa (SAA) and the Government of Rwanda, and runs from December 2-7. Co-organized by WHO, UNAIDS, and the UN Population Fund (UNFPA), as well as the pharmaceutical companies Gilead and Mylan, it brings together thousands of delegates to share lessons learned and chart the way forward for reaching the 90-90-90 UNAIDS targets for HIV/AIDS and sexually transmitted infections (STIs) on the African continent. Those targets aim to ensure that by 2020, 90% of all people living with HIV will know their HIV status; 90% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy; and 90% of all people receiving antiretroviral therapy will be have the virus supressed.

 

Image Credits: Twitter: @DrTedros.

The World Health Organization has issued new HIV testing recommendations to help countries expand treatment coverage and reach the estimated 8.1 million people living with HIV who have not yet been diagnosed. The WHO guidelines were released on Wednesday ahead of World AIDS Day on December 1 and the International Conference on AIDS and Sexually Transmitted Infections in Africa (ICASA2019), which will take place in Kigali, Rwanda on December 2-7.

“The face of the HIV epidemic has changed dramatically over the past decade,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus in a press release. “More people are receiving treatment than ever before, but too many are still not getting the help they need because they have not been diagnosed.”

A woman prepares for an HIV test in Uganda.

The launch of the WHO guidelines comes right on the heels of a UNAIDS report published Wednesday that highlighted mixed success in tackling the HIV/AIDS epidemic. Access to HIV treatment has expanded and new HIV infections have declined by 28% from 2010 to 2018 in eastern and southern Africa, the region most affected by HIV, but women and girls are still disproportionately affected. Four out of five new HIV infections among adolescents in the Sub-Saharan Africa region occur in girls. Additionally, new HIV infections are increasing in eastern Europe, central Asia, northern Africa, and parts of Latin America.

WHO estimates that at the end of 2018, there were 36.7 million people with HIV worldwide. Of these, 21% have not yet been diagnosed. Expanding testing for HIV helps ensure that people are diagnosed early and can start treatment. Testing also helps identify people who are HIV-negative but may be at high risk for contracting the infection and link them to appropriate and effect prevention services.

Both publications highlight that key populations such as injecting drug users, sex workers, transgender people and prison populations are at higher risk of testing positive for HIV, but may be less engaged in HIV decision-making and have less access to healthcare services. Additionally, in countries where high proportions of people have already been tested and treated, it can be difficult to reach the remaining proportion of people living with HIV who have not yet been tested, according to WHO.

The new “WHO consolidated guidelines on HIV testing services” recommends strategies for expanding a package of HIV-related services to those hardest to reach including:

  • Adoption of a standard HIV testing strategy which uses three consecutive reactive tests to provide an HIV positive diagnosis. Previously, most high burden countries were using two consecutive tests. The new approach can help countries achieve maximum accuracy, particularly in high-prevalence settings.
  • Use of HIV self-testing as a gateway to diagnosis based on new evidence that finds people who are at higher HIV risk and not tested in clinical settings are more likely to be tested if they can access HIV self-tests.
  • Implement social network-based HIV testing to reach key populations who are at high risk but have less access to services, and use peer-led, innovative digital communications such as short messages and videos to build demand and increase uptake of HIV testing.
  • Focus on community-based delivery of rapid testing through lay providers for relevant countries in the European, South-East Asian, Western Pacific and Eastern Mediterranean regions. Rapid testing methods cost less and can provide results up to 2-3 weeks earlier than traditional laboratory-based diagnostic tests.
  • Use HIV/syphilis dual rapid tests in antenatal care as the first HIV test to help eliminate mother-to-child transmission of both infections.
Power to Choose, Power to Know, Power to Thrive, Power to Demand

The UNAIDS report, Power to the People, found that significant progress has been made in expanding access to treatment, with an estimated 24.5 million people with HIV accessing anti-retroviral drugs and other therapies. However, progress to slow HIV transmission has stalled, and an estimated 1.7 million people were newly infected with the virus in 2018.

In Eastern and Southern Africa, the hot spots of the global HIV/AIDS epidemic, new infections declined by 28% between 2010 and 2018. However, outside of eastern and southern Africa, new HIV infections have declined by only 4% since 2010. Of concern is the rise of new HIV infections in certain regions. The annual number of new HIV infections rose by 29% in eastern Europe and central Asia, by 10% in the Middle East and North Africa and by 7% in Latin America. the report notes.

“In many parts of the world, significant progress has been made in reducing new HIV infections, reducing AIDS-related deaths and reducing discrimination, especially in eastern and southern Africa, but gender inequality and denial of human rights are leaving many people behind,” said Winnie Byanyima, executive director of UNAIDS in a press release.

The report aims to highlight the importance of including people and communities affected by HIV in HIV service delivery and policy-making. Specifically, stigma and discrimination can still prevent people from seeking knowledge on how to prevent HIV transmission, or accessing diagnosis and treatment.  But when people living with HIV are empowered, these barriers are more frequently overcome. Specifically, the report notes four areas of empowerment for programmes to target:

  • Power to Choose – The report finds almost 40% of adult women and 60% of adolescent girls (aged 15–19 years) in sub-Saharan Africa have unmet needs for modern contraception. Family planning services are closely tied to HIV treatment and prevention services. In sub-Saharan Africa, young women’s uptake of medicine to prevent HIV—pre-exposure prophylaxis (PrEP)—is high in projects that integrate PrEP into youth-friendly health services and family planning clinics and when provision of PrEP is separated from treatment services.
  • Power to Know – Knowledge of HIV among young people is alarmingly low in many regions. In countries with recently available survey data, just 23% of young women (aged 15–24 years) and 29% of young men (aged 15–24 years) have comprehensive and correct knowledge of HIV. This can lead to people finding out their HIV status too late, sometimes years after they became infected, facilitating transmission and leading to a delay in starting treatment.
  • Power to Thrive – Certain populations are being left behind. In 2018, 160 000 children (aged 0–14 years) became newly infected with HIV, and 100 000 children died from an AIDS-related illness. In Eswatini, a recent study showed that adolescent girls and young women who experienced gender-based violence were 1.6 times more likely to acquire HIV than those who did not. The same study also showed that economic empowerment of girls and women helped reduce new HIV infections among women by more than 25% and increased the probability of young women and girls going back to school and finishing their education.
  • Power to Demand – There have been reports of crackdowns, restrictions and even attacks on groups and campaigns supporting key populations most affected by HIV. Some governments refuse to recognize, support or engage community organizations in their national responses to HIV and are subsequently missing out on their enormous potential to reach the people most affected by HIV.

Image Credits: 2011, Sokomoto Photography for International AIDS Vaccine Initiative (IAVI).

The lower house of the French parliament has approved a milestone requirement that pharmaceutical companies must disclose the amount of public funding that was used in the research and development of new medicines entering the national market, as well as allowing those contributions to be factored into negotiations over final drug pricing.

After being initially rejected by the government, the new provision was adopted as an amendment to the French Social Security Budget Bill for 2020 in a nearly unanimous vote by the National Assembly, with 40 Members of Parliament voting in favor and only one opposed. The bill must still pass the French Senate in order to become law, but observers said the upper house was unlikely to drop the amendment after being approved in the National Assembly.

“Of course the adopted amendment is not perfect, but it’s still a historical first step toward the implementation of transparency at the French Parliament, and another proof that mobilization works,” said Pauline Londiex, co-founder of  l’Observatoire Transparence Médicaments (OTM), a French civil society watchdog that had lobbied heavily to see the provision passed by parliament.

The new requirement, enshrined in amendments n°474, n°505 and n°520 of the budget bill, stipulates that pharma companies must disclose the amount of public funding that was received for R&D of a new drug when applying for approval to market the product in France. Moreover, the government body in charge of negotiating drug prices, CEPS, will be able to take into account such public investments when negotiating the final drug price to be paid.

A series of other proposed requirements to disclosing the manufacturing costs of drugs, including costs of active ingredients, as well as profits such as the margins of intermediaries, were dropped from the final approved version of the amendment. A last minute sub-amendment was added to National Assembly approved-bill to further clarify that CEPS’ consideration of public R&D funding in drug price negotiations was optional.

Véran presenting the transparency amendment at the National Assembly on November 25.

Still, the parliamentary move is an important win for civil society groups advocating greater price transparency for health products after months of mobilization, following the approval in May of a landmark World Health Assembly (WHA) resolution on transparency in medicines markets.

The French National Assembly amendments appear to take the WHA resolution a step further – unlike the watered down WHA-approved language to only recommend voluntary disclosure by industry of public contributions to R&D costs, the National Assembly amendments appear to require companies report public funding.

The parliamentary proposal to require disclosure of public funds used for R&D costs had initially been shot down by French Minister of Health Agnéz Buzyn and the general rapporteur Olivier Véran at the first reading of the Social Security Budget Bill on October 24.

A month of political tensions followed, including the French Senate’s rejection of the original budget bill on November 14 in the wake of Prime Minister Emmanuel Macron’s announcement of an Emergency Funding Plan for Hospitals. Civil society groups continued to pressure the government to adopt the transparency amendment, publishing an open letter signed by over 80 notable French personalities that urged the government to support the amendment.

In a turn-around show of support, Véran presented the R&D cost amendment alongside presentations by La France Insoumise, and MP Caroline Janvier at a second meeting of the National Assembly on Monday where it was finally approved.

The final Social Security Budget Bill for 2020 must still be sent to the Senate for a first reading of the bill on Saturday, where the transparency amendment could then still be dropped  – or further expanded. But observers predict that the amendment may remain unchanged due to the wide consensus reached by the National Assembly, although there might be more attempts to weaken rather than strengthen the amendments in the Senate.

Image Credits: http://www.assemblee-nationale.fr.

Unitaid will expand its work in malaria to include chemoprevention for infants in the first year of life and pilot a new “agility” mechanism to support global health innovation in 2020, following approval granted by Unitaid’s Executive Board on November 20 to 21.

(left-right) ED Lelio Marmora, Board Vice-Chair Maria Luisa Escoral de Moraes, Board Chair Marisol Touraine, Deputy ED Philippe Duneton

The Board’s approval will allow Unitaid to launch a call for proposals for projects on malaria chemoprevention for infants.

“Chemoprevention is a key piece of the puzzle in the fight against malaria,” said Unitaid Executive Director Lelio Marmora in a press release.

“Adding infant malaria chemoprevention to Unitaid’s expanding malaria portfolio will not only protect millions of babies from this deadly disease but also help reignite the stalled progress in the global malaria response.” 

Infants and children are highly vulnerable to malaria because they have not yet developed protective immunity, according to Unitaid. Of the 435,000 malaria deaths in 2017, more than 60 percent occurred in children under 5.

Currently, malaria chemoprevention, or the strategy of providing medication to prevent malaria, is used by Global Fund financed programmes protect children 3 to 59 months old during the four-month rainy season in 12 countries in the Sahel, based on evidence from a Unitaid/Malaria Consortium project (ACCESS-SMC). Unitaid also invests in projects to expand and monitor malaria chemoprevention in pregnant women.

In a separate decision, the Board approved up to US$20 million in 2020 to fund a new framework to respond quickly to global health innovation, delegating the authority to enter into legal agreements under the pilot to the Executive Director. Current ED Lelio Marmora also announced to the Board that he will be stepping down by March 2020, and Deputy Executive Director Philippe Duneton has been identified as acting ED in the interim.

Image Credits: Unitaid.

A global campaign focusing on the issue of rape as a form of violence against women is being launched Monday on International Day for the Elimination of Violence against Women. The annual sixteen-day campaign, which is set to end on 10 December, Human Rights Day, will bring together activism against gender-based violence under this year’s theme “Orange the World: Generation Equality Stands against Rape.”

“We must show greater solidarity with survivors, advocates and women’s rights defenders. And we must promote women’s rights and equal opportunities,” said UN Secretary-General Antonio Guterres in a video message. “Together, we can – and must — end rape and sexual assault of all kinds.”

WHO has called violence against women a “public-health problem,” estimating that one in three women globally have experienced some form of sexual or physical violence in their lifetime. Most violence is perpetrated by intimate partners or other people the women know; almost one third of women who have been in a relationship report that they have experienced some form of physical or sexual violence, including rape, by an intimate partner in their lifetime according to the WHO.

The statistics around the prevalence of rape can be unclear, but UN Women’s Executive Director Phumzile Mlambo-Ngcuka notes in an official statement that “almost universally, most perpetrators of rape go unreported or unpunished.”

Mlambo-Ngcuka further adds that women require a great deal of “resilience to re-live the attack, a certain amount of knowledge of where to go, and a degree of confidence in the responsiveness of the services sought – if indeed there are services available to go to” in order to decide to report sexual violence. For those who do report, especially adolescent girls, less than 10% go to the police, Ngcuka says.

Health-care providers are often the first point of professional contact for a woman experiencing violence, according to the WHO. Women who are abused are more likely to seek health services even if they do not explicitly seek care for violence, making providers important first responders for survivors of sexual violence.

WHO launched global guidelines for healthcare providers to respond to sexual violence in 2013 and began working with partners to implement trainings for healthcare workers in India, Namibia, Pakistan, Uganda and Zambia. A pilot of the trainings was completed in two tertiary hospitals in the State of Maharashtra India, and a recent assessment of the impact of the trainings done by the Center for Enquiry into Health and Allied Theme (CEHAT) will be used to inform a potential national-roll out of the trainings.

See here for more information about the WHO Guidelines for Healthcare Providers and WHO and CEHAT’s work in Maharashtra.

See here for more information about the “16 Days of Activism Against Gender-based Violence.”

 

Image Credits: UNICEF/Nesbitt.

Oslo – Norway has launched a milestone “Better Health, Better Life” strategy to combat deadly non-communicable (NCDs) diseases as part of its international development assistance. This makes Norway the first to develop a strategy for combating this large and growing global health threat, which currently receives only about 1% of international health assistance.

NCDs are the cause of some 70% of deaths worldwide – and are now a major, growing cause of illness and premature death in low- and middle-income countries.

‘Worldwide, 41 million people die each year as a result of respiratory disease, cancer, cardiovascular disease, diabetes, mental disorders and other non-communicable diseases. This cannot continue,” said Norwegian Minister of International Development Dag-Inge Ulstein.

“Therefore, Norway will triple its assistance to fight NCDs, allocating over 200 million NOK to these agendas for 2020. This is just the start, we will step up the funding towards 2024,” said Ulstein.

Norwegian Minister of International Development, Dag Inge Ulstein

Speaking at a launch of the strategy in the Norwegian capital at a “Gathering for The Future of Global Health,” the minister noted the “strong upward trend” in the number of deaths from non-communicable diseases in countries at the lowest income levels.

“Tobacco, air pollution, alcohol, unhealthy food, lack of physical activity…These silent killers cause 70 percent of all premature and unnecessary deaths worldwide – yet the fight against them receives only 1 percent of the international development funding that goes to health. 70 percent – One percent,” said Ulstein.

“That has to change – and that is why we are here today. In Africa, the deaths from non communicable diseases are projected to increase from around 35%  to over 50% of total deaths by 2030. We are going the wrong way.”

NCDs often develop into chronic conditions, and when they are not treated or managed early enough, the result can be catastrophically high costs for individuals as well as health systems, he observed.

“If you cannot go to work – or plow your fields – there will be one less bread-winner in the house – and one less co-fighter in our collective quest to win the 2030 race to meet the SDGs,” he said.

Norway Asks Other Donors To Step Forward on NCDS
Norwegian Minister of Health, Bent Høie. (Photo: Stine Jenssen).

In launching the strategy, Norwegian officials were clear that they hope other high income countries which provide billions of dollars in international development assistance will also step forward and follow their example.

“No country until today has presented a programme on how to use development aid as a tool … to address the NCD epidemic. This is what makes this day so special,” said Norway’s Minister of Health, Bent Høie who co-hosted the strategy launch.

Referring to Norway’s longtime record of promoting health in development aid, he said that “this strategy will take it a step further, I urge other countries to follow up and develop their own NCD strategies for development assistance.”

Historically donor aid from high income countries has been used almost exclusively on communicable diseases, he noted, referring to the billions of dollars spent every year on global health programmes to fight AIDs, TB, malaria, other neglected infectious diseases, as well as to promote immunization.

Historically those programmes “corresponded to the disease burden and the biggest challenges in global health,” he noted, but, “today, this has changed.

“The NCDs are claiming far more lives than communicable diseases with many people dying prematurely. With this change in the disease burden, we need to change our priorities accordingly.”

WHO’s Bente Mikkelsen talks about the need for collaboration between health, finance, urban development, agriculture, food and pharma sectors to reduce NCDs, at the launch of the Norway’s NCD Strategy.

While some NCD treatments can be extremely expensive, others are “relatively cheap, like getting medication to lower blood pressure. But in many low income countries, this is out of reach,” he added.

“The [Norwegian] strategy recognizes these challenges and underlines the need to provide treatment based on universal health coverage. Primary health care is the basis.”

He noted that the strategy builds upon the 16 WHO-recommended Best Buys for preventing and controlling NCDs, which include comparably simple and inexpensive measures such as reduced salt and sugar intake and increasing physical exercise. The Best Buys were agreed upon by UN Member States at last year’s Third High Level UN Meeting on NCDs.

“If these were implemented, over 8 million lives could be saved annually by 2030,” Høie said, adding that according to WHO estimates, that would also lead to a savings of $US 7 trillion in low- and middle-income countries over the next 15 years.

Three-Pronged Strategy 

The new strategy has three main points of focus: Strengthening primary health care services: Prevention of leading NCD risk factors like air pollution, tobacco and alcohol consumption and unhealthy diets; Better data management and health information systems.

Strengthening Primary Healthcare Services as part of Universal Health Coverage.

Many NCD interventions, can be delivered effectively and affordably at primary health care level, with greater benefits to patients and savings for health systems.   Examples are checks for hypertension, diabetes, prevention of cervical cancer with HPV vaccination, as well as capacity for prevention and early diagnosis and treatment of mental health disorders in primary health services.  Norway will support the strengthening health services so that primary health care services are well-equipped to support NCD prevention, early diagnosis and treatment, as well as ensuring everyone has access to health services, subsidized in part, by the public authorities.

A woman gets her blood pressure measured to test for hypertension.
Preventing and reducing risks through intersectoral action, including regulation, taxation and other measures.

Norway will help to prevent non-communicable disease through development cooperation that contributes to healthy and sustainably produced food, a healthy environment with clean air and the consumption of clean energy, opportunities for physical activity, access to high-quality education and stronger tobacco and alcohol regulations. Emphasis shall be given to social sustainability and reducing health differences from childhood to old age.

In this context, Norway will also support countries requesting assistance to improve taxation and regulation of products that are harmful to health,  through its Tax for Development Programme (Skatt for utvikling). Such measures can be used to effectively discourage consumption of health-harmful products such as tobacco, alcohol, sugary drinks, saturated and trans fats, and encourage healthier alternatives.  Similarly, pollution taxes and regulations can encourage shifts to clean energy and transport, reducing health-harmful air pollution. These are all among the key risk factors contributing to NCDs, including cancer, hypertension and heart disease as well as obesity-related disease such as diabetes.

Unhealthy, unregulated street foods are commonly sold in low- and middle- income countries.
Strengthening data management, digitalization and other health information needs.  

The strategy also calls for assisting countries in developing better health information systems, to  improve access to health data critical to facilitating early stage NCD diagnosis, treatment; supporting NCD-related health norms and standards, as well as efforts to improve access to medical equipment and medication, particularly  in areas hit by crises and conflict.

Norway’s officials say that the strategy will support the SDG 3 goals of Universal Health Coverage (SDG 3.8) and reducing premature deaths from NCDs by one-third by 2030 (SDG 3.4), as well as the commitments reached at the Third UN High Level Meeting on NCDs  in 2018 as well as the recent UN High Level Meeting on Universal Health Coverage,” Høie added.

The strategy also supports other SDG 3 targets for reducing deaths and illness from hazardous chemicals and air pollution, as well as preventing and treating harmful use of alcohol.

Strategy Launched At Oslo “Gathering for Global Health” Event

Norway has become “the first in the world to launch a strategy to include non-communicable diseases in its international development policy,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus in a videotaped message broadcast at the strategy “Gathering for Global Health” launch in Oslo on Friday.

Tore Godal

“Non-communicable diseases are the leading killers of our time. As is so often the case, the world’s poorest bear the heaviest burden,” the WHO Director-General added. “The risks of dying between the ages of 30 and 70 from a heart attack, stroke, diabetes, cancer or asthma are 4 times higher in most countries of Africa than in Norway.”

“You have anchored this strategy in the political declaration on NCDs and Universal Health Coverage, which were adopted this year and last year at the UN General Assembly.”

“And you have built it on the WHO Global Action Plans on NCDs and Mental Health and the WHO Best Buys. I appreciate the central role in the strategy of primary health care, both in preventing and managing NCDs.”

“Thank you for your leadership in this important area.  WHO is delighted to accept your invitation to be a co-sponsor of this strategy. Together we can ensure more people get the health services that they need for NCDs and for all their health needs.”

The launch event included Dr Tore Godal, as a guest of honor, celebrating Godal’s lifelong service to global health on behalf of the Norwegian government and the global community.

Godal, a special advisory on global health at the Norwegian Ministry of Foreign Affairs, compared today’s NCDs challenge to the battle against tobacco, which mobilized the global health community several decades ago and is still ongoing today. Like the fight against tobacco, we need a multi-pronged strategy including legal action, awareness and taxation to achieve meaningful progress,” he said.

 

A video describing the challenge of NCDs in low income countries here:

Image Credits: Twitter: @NorwayMFA, Stine Loe Jenssen, E Fletcher/HP-Watch, Twitter: @NorwayMFA.

Lelio Marmora is stepping down as Executive Director of Unitaid in March 2020, sources told Health Policy Watch. Marmora, who has led the organization since 2014, told staff on Monday that he would be leaving to seek “new challenges.”

His departure is not likely to bring “unexpected or drastic changes” to Unitaid’s funding priorities over the next few months, Unitaid Board Member for NGOs Fifa Rahman told Health Policy Watch. The organization has already set its strategy for the next two years, and has identified an acting ED committed to the same goals.

Rahman confirmed that Philippe Duneton, current deputy executive director of Unitaid, will step in as interim Executive Director. Duneton has been with the organization since its founding in 2006, and has taken on this role at least once before.

Lelio Marmora

Still, it will be important for Unitaid to find a new ED who understands the “unique role [of the organization] in funding change in how medicines are developed and made accessible for people,” Ellen ‘t Hoen, director of Medicines Law & Policy, told Health Policy Watch.

The director of Medicine Law & Policy, which provides legal and policy analysis on issues related to access to medicines and international law, further added that Unitaid is the only funder that explicitly focuses on thorny issues such as intellectual property.

Additionally, according to observers, Marmora did exert a strong influence over the organizational culture. While Marmora doubled the staff during his tenure, sources close to the organization told HPW that there was dissatisfaction among staff about the management style, and hopes that there would be some improvements.

Rahman told Health Policy Watch that the Board will be “monitoring risks” to ensure that any organizational change moves in a “positive direction.” She further added that the Board will be making a final decision on a new ED in 6-8 months.

The announcement was first made to Unitaid’s staff on Monday, and a second announcement was made by Marmora to the Board of Unitaid at the annual Board meeting on November 20-21. The announcement comes less than a month after Unitaid’s success in helping to negotiate a new deal with rifapentine drug manufacturer Sanofi to slash prices for the essential tuberculosis drug by up to 70% in 100 low- and middle-income countries. The volume-based deal between Unitaid, the Global Fund, and Sanofi was announced at the Union World Conference for Lung Health on October 31.

UNITAID’s Role in Global Health Financing

In its 13-year history, Unitaid has emerged as a major donor of upstream health product innovation and downstream access to medicines work in the “big 3” – HIV/AIDs, tuberculosis, and malaria. Among other projects, the organization funds access to medicines work around intellectual property and pharmaceutical innovation.

Notably, Unitaid does not have a United States representative on its board, which may be why the organization can fund work on controversial issues such as intellectual property and pharmaceutical development. Experts in access to medicines work further added that unlike the other, larger “big 3”-focused organization, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Unitaid is a much smaller and more nimble organization.

It has historically helped negotiate major deals to reduce antiretroviral drug prices and is currently the largest multilateral funder of tuberculosis research and development. Some of its major grantees include The South Centre, the Medicines for Malaria Venture (MMV), the Drugs for Neglected Diseases Initiative, the Stop TB Partnership, and the Foundation for Innovative Diagnostics (FIND). Unitaid also funds a significant portion of WHO’s Prequalification Programme, which provides international regulatory guidance on the safety and efficacy of new health products.

Initially formed by France, Brazil, Chile, the UK, and Norway at the height of the global HIV/AIDs crisis in 2006, Unitaid uses so-called “innovative financing” mechanisms to raise money for the “big three” – HIV/AIDs, tuberculosis, and malaria. As of 2019, the organization reports it has received some US$3 billion from donors, with 70% of its funding coming directly from a “solidarity levy” on airline tickets – a funding mechanism first piloted by France and since adopted by nine additional countries. Other member states earmark a portion of specific tax revenues for the organization, such as Norway, which contributes part of its carbon emissions tax revenue to Unitaid.

This article has been amended on November 23 to update Ellen ‘t Hoen’s name and title.

Image Credits: UN Photo/Rick Bajornas.