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

Image Credits: WHO.

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

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

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

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

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

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

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

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

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

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

Other Key Features – Data Sources, Research Gaps and Webinars

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

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

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

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

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

Building the Portal – Curation and Interpretation

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

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

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

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

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

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

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

Image Credits: Marco Verch.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Unacceptably High Rates of HIV infection

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

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

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

Study Findings to be Incorporated into WHO Guidelines

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

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

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

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

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

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

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

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

A medical doctor and epidemiologist, Dr Seth Berkley joined Gavi, the Vaccine Alliance, as its CEO in August 2011. Under his leadership, Gavi reached the milestone in 2015 of more than half a billion children vaccinated in the world’s 73 poorest countries. In the same year, Berkley led Gavi to its second successful replenishment, raising US$ 7.5 billion in donor commitments to support immunisation of 300 million more children by 2020. Berkley has been recognised by TIME magazine as one of the “100 Most Influential People in the World” and by Wired Magazine as among “The Wired 25 — a salute to dreamers, inventors, mavericks and leaders.” His TED talks have been seen by more than 1.5 million people.

Seth Berkley, CEO of Gavi, the Vaccine Alliance. Photo: Gavi/Tony Noel

Health Policy Watch: Please describe what Gavi does, why it is relevant, and what has been the impact.

Seth Berkley: Gavi’s ultimate aim is to create equal access to new and underused vaccines for children living in the world’s poorest countries.

Toward the end of the 20th century, global immunisation coverage was beginning to plateau. Despite the huge progress the global health community had made, there were still 30 million children worldwide not receiving a full course of basic vaccines. At the same time, powerful new vaccines were becoming available, but not reaching children in the poorest countries because these governments could not afford them.

So, in 2000 Gavi, the Vaccine Alliance, was created to address this issue. Our unique public-private partnership model brings together UN agencies, governments and philanthropy organisations, along with the vaccine industry, the private sector and civil society, to improve vaccine coverage and accelerate access to vaccines for the world’s poorest and most vulnerable children.

By simultaneously bringing down the price of vaccines for low-income countries, improving availability of new and underused vaccines, and helping governments to improve on vaccine delivery, we have helped vaccinate more than 750 million children, saving over 10 million lives. This has not only ensured that new vaccines are rolled out rapidly in some of the world’s poorest countries, but it does so in a way that ultimately sees the governments of these countries fully financing their vaccine programs. We’ve seen 15 countries successfully transition out of Gavi support in the last four years.

Similarly, newly developed vaccines could take a decade or more to reach the world’s poorest countries. Through partnering with manufacturers, Gavi works to change that. An example of this is the pneumococcal conjugate vaccine. Back in 2008, Gavi launched an ‘Advance Market Commitment’ for pneumococcal vaccines. As part of this agreement, donors committed funds to provide an incentive for manufacturers to invest in developing vaccines appropriate for developing countries. In exchange, manufacturers committed to supplying the vaccine to low-income countries at a fraction of the price paid by industrialised countries. With the help of the AMC, low-income countries began to introduce the latest formulations of the pneumococcal vaccine, PCV10 and PCV13, within a year of them becoming available. And manufacturers even continue to lower the price: earlier this year, Pfizer reduced the price of the pneumococcal vaccine for low-income countries for the third year running.

Since our launch, immunisation coverage in Gavi-supported countries has increased by 21 percentage points, from 60 to 81 percent. But these figures can hide huge variation in coverage and pockets of low immunisation coverage. Gavi’s focus now is to use innovative approaches to reach the 1 in 10 zero dose children – the children who are still not receiving any vaccines – with particular focus on communities and demographics that have historically been missed.

The introduction of the pentavalent vaccine in Nigeria, is estimated to save the lives of at least 30,000 children from death as a result of vaccine preventable disorders every year. Nigeria has also introduced the pneumococcal vaccines, helping to protect against pneumonia, still the world’s biggest killer of children under the age of five. Photo: GAVI/2013/Adrian Brooks

HPW: How would you describe the Gavi model? How has it changed since you started and what changes do you anticipate in the future?

SB: There are many aspects of the Gavi model, but a key part of what we were set up to do is market shaping. Gavi pools demand from the world’s poorest countries and leverages this to negotiate more affordable prices for vaccines. It creates a large, stable market that can incentivise manufacturers to invest in affordable vaccines for low-income countries.

Since I joined in 2011, we have taken this approach further and created incentives for pharmaceutical companies to invest in developing new vaccines. In 2014, during the biggest Ebola outbreak in history, Gavi committed up to US$ 300 million to buy licensed Ebola vaccines, as well as US$ 45 million for operational costs. This provided an incentive for manufacturers to speed up the development of candidate vaccines. In 2016, we signed an agreement with Merck: we committed US$5 million to buy doses of their vaccine once fully licensed, and in exchange, Merck promised to create an emergency stockpile of the investigational vaccine.

Last year, this stockpile became an invaluable resource when Ebola broke out in the Democratic Republic of the Congo (DRC), helping to contain an outbreak in Equateur Province. The vaccine is now being rolled out again in response to a second outbreak in a different part of the country, North Kivu.

With the threat of pandemics on the rise, I anticipate further innovative mechanisms will be required to boost investment in vaccines against emerging disease threats.

Another area that Gavi is increasingly focusing on is health system strengthening, because we recognise that strong health systems are vital to ensure the delivery of vaccines to those who need them the most. We work with countries to strengthen their own immunisation programs, which are eventually sustainable without Gavi support. All countries pay a share of the cost of their Gavi-supported vaccines. As their economy grows, so too does their contribution until they eventually fully fund their own programs.

In recent years, we have seen the first countries start to transition out of Gavi support. In some cases, this has been hugely successful – take Sri Lanka, which has been fully-financing their immunisation programs since the start of 2016 and has maintained vaccine coverage at 99 percent ever since. However, some others have faced difficulties. The key here is that we remain flexible to respond to the needs of individual countries and tailor our approach to ensure their success.

HPW: The world is changing quickly – what are some key shifts you have identified that affect your work, and what are you doing to plan for them?

SB: The number of children missing out on vaccines is lower than it was in 2000, even though the total number of children continues to increase year-on-year. But despite such progress, a shift in demographics is proving challenging. Geography used to be the predominant barrier to immunisation, with the majority of under-immunised children living in remote or hard-to-reach areas. Today, many children missing out on vaccines are living in fragile or conflict settings; more are refugees; more are living in rapidly-growing urban areas.

This presents new challenges that require us to shift our approach. When it comes to reaching children in conflict settings or refugees, we have a new Fragility, Emergencies and Refugees’ Policy, which enables us to tailor our support to better help countries that are facing humanitarian emergencies or hosting refugees.

This year, our technology innovation platform, INFUSE, is looking at solutions to increase access to vaccines for kids in urban settings. INFUSE identifies and scales-up innovative but proven technologies that address immunisation bottlenecks. Previous years have focused on digital identity and data quality.

There is also a perhaps more surprising shift in the distribution of under-immunised children. When Gavi was set up in 2000, most children missing out on vaccines were living in the poorest countries in the world. But this is starting to change – in fact, a growing proportion are now in middle-income countries. As we shape Gavi’s strategy beyond 2020, discussions are underway as to whether we should be offering support to middle-income countries and if so, what form this might take.

Families arrive at the Dedza health centre to receive the measles-rubella vaccine in Malawi. Photo: Gavi/2017/Karel Prinsloo

HPW: Does the rise in anti-vaccination thinking affect your work and what can be done about it?

SB: In our experience, vaccine hesitancy is not as widespread in Gavi-supported countries as it seems to be in high-income countries. Service delivery, lack of knowledge and distance to the nearest health centre all tend to be larger barriers to vaccine coverage. But it is a worrying trend, and with the rise of social media we are seeing unsubstantiated anti-vaccine rumours spreading rapidly.

A study published recently in Lancet Infectious Diseases found that one-in-four people interviewed in two Ebola hotspots in eastern DRC didn’t even believe that the Ebola virus is real. Addressing such intangible barriers to increasing coverage can be complex but getting the community on board really is a crucial step to ensure the success of any vaccination campaign.

Gavi is working hard to tackle these issues. Take DRC as an example. In 2017, community health workers made 15.8 million home visits to lower coverage areas to discuss primary care issues and rumours around vaccination.

We work closely with civil society organisations (CSOs) on the ground to generate demand and spread the word about the benefits of vaccines. In Kenya, Malawi and Ethiopia, for example, we are partnering with Girl Effect, an organisation that leverages social and mass media to generate demand for the human papillomavirus (HPV) vaccine.

HPW: How do you partner with other organisations and at the government and local levels in the regions?

SB: Gavi is an Alliance. We rely on governments to implement immunisation programs and partners, such as WHO, UNICEF and CSOs to offer technical support on the ground. The Secretariat also works closely with the governments of Gavi-supported countries, because our business model is built on the principle of empowering countries to strengthen their own immunisation programs.

HPW: You have been in your role for some years now – what are some lessons you have learned? What has been the biggest challenge, and have there been any surprises?

SB: I’ve learnt how fragile progress in immunisation can be. As we are seeing with the measles outbreaks across the world, eliminating a disease is not the finish line – we must continue to work to maintain that progress.

New challenges – from fragility to economic decline, from a major disease outbreak to climate-related pressures – can put strain on a previously well-functioning health system. We must focus on building strong, sustainable and resilient health systems that are able to cope with the unexpected.

The biggest challenge has been continuing to move forward as these global challenges make it increasingly harder to reach kids with vaccines. The children currently missing out are not just the last to be reached, but the hardest-to-reach. Increasing coverage requires us to continually innovate. Luckily, this is something Gavi, as a learning organisation, does well – we are not afraid to adapt our approach if it will help us have a greater impact.

Image Credits: Gavi/Tony Noel, GAVI/2013/Adrian Brooks, Gavi/2017/Karel Prinsloo.

[UNAIDS Press Release]

GENEVA, 11 June 2019— UNAIDS applauds the landmark decision of the High Court of Botswana to declare unconstitutional key provisions of Sections 164 and 167 of the Botswana Penal Code. Those provisions criminalized certain private sexual acts and have led to discrimination and violence against lesbian, gay, bisexual and transgender (LGBT) people in Botswana.

“This is a historic ruling for lesbian, gay, bisexual and transgender (LGBT) people in Botswana,” said Gunilla Carlsson, UNAIDS Executive Director, a.i. “It restores privacy, respect and dignity to the country’s LGBT people, and it is a day to celebrate pride, compassion and love. I commend the activists, civil society organizations and community groups that have campaigned so hard for this moment.”

UNAIDS has been working with LGBT groups, civil society organizations and other partners to promote a more enabling legal environment in the country. In recent years, the courts in Botswana have taken a lead in protecting and promoting the human rights of marginalized groups.

Criminalization of consensual same-sex sexual relations is a violation of human rights and legitimizes stigma, discrimination and violence against LGBT people. Criminalization stops people from accessing and using HIV prevention, testing and treatment services and increases their risk of acquiring HIV.

Globally, the risk of acquiring HIV is 28 times higher among gay men and other men who have sex with men than among the general population and 13 times higher for transgender women. Prohibitive legal and policy environments and a lack of tailored services for key populations increase their vulnerability to HIV. UNAIDS urges countries to ensure the full respect of the human rights of all people, regardless of their sexual orientation, through repealing laws that prohibit sex between consenting adults in private, enforcing laws to protect people from violence and discrimination, addressing homophobia and transphobia and ensuring that crucial health services are made available.

“I hope that this decision reflects a move towards a more humane, compassionate and rights-based approach towards same-sex relations worldwide. It should encourage other countries to repeal unjust laws that criminalize same-sex sexual relations and block people’s access to essential services, including to health care,” said Ms Carlsson.

Consensual same-sex sexual relations remain criminalized in at least 67 countries and territories worldwide.

UNAIDS

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals.

Image Credits: UNAIDS.