New maximum residue limits for more than 30 different types of pesticides in animal feed and foodstuffs, updated standards for food additives, and a new standard for high value vegetable oils, and well as for hybrid varieties of palm oil, were approved today at the 42nd meeting of the Codex Alimentarius Commission (CAC42), the UN member state body that sets international food safety standards guiding the world food trade as well as significant national legislation.

Closing a week-long session in Geneva, delegates from some 100 countries also agreed to a code of practice for reducing chemical contaminants common to palm oil production, as well as to launch new work on allergen labeling, e-commerce, aflatoxins in cereals and cereal-based products, and bio-pesticides, among other topics.

42nd meeting of the Codex Alimentarius Commission (CAC42), Geneva

The Commission also agreed to develop guidelines for the control of Shiga toxin-producing Escherichia coli (STEC) in beef meat, leafy greens, raw milk and cheese produced from raw milk, and sprouts (sprouted seeds). While most E. coli bacteria living in human and animal intestines are harmless, those producing shiga toxin (STEC) are an important cause of foodborne disease, and infections. WHO estimates that Shiga toxin E. Coli caused about 1 million cases of illness In 2010, ranging from mild diarrhoea to kidney failure.

The Commission, however, delayed the final adoption of a standard for maximum levels of cadmium in certain cocoa products of .3 mg/kilogram – due to controversies between member states about whether the proposed standard was high enough – or higher than required – to protect public health. Some delegates noted that the standard for cadmium levels is even higher in grains and rice (.4 mg/kg), which are far more heavily consumed. Cadmium, a heavy metal, is naturally-occurring in some soils, and its presence in areas of cocoa cultivation has posed a barrier to international sales for some countries, particularly in Africa.

In 2015, WHO estimated that over 420,000 people every year die from foodborne diseases, and almost 30 percent of those deaths are in children under the age of 5. The report, which considered diseases and deaths caused by some 31 agents – bacteria, viruses, parasites, toxins and chemicals – found that almost 10 percent of the world’s population fall ill from some form of foodborne contamination every year. The risks are most severe in low- and middle-income countries, where unsafe water and sanitation, and poor hygiene conditions in food production, storage and preparation, as well as weak regulatory systems, all contribute to food safety risks, said WHO.

The Codex Alimentarius (Food Code), established in 1963, is jointly administered by WHO and the Food and Agriculture Organization (FAO). While the Codex standards are voluntary, in principle, the World Trade Organization (WTO) agreement on Sanitary and Phytosanitary Measures (SPS) refers to the Codex as a benchmark reference for international food trade. So along with country delegations, industry and some civil society representatives regularly attend the annual Codex Commission meetings, insofar as Commission decisions will have far-reaching impacts of what foods can be internationally traded, how and where.

Balancing Health and Trade 

Short of standards, the Codex also is active in creating codes of practice, which can provide guidance for reducing key health risks. One example is new work to get underway in the area of aflatoxins in cereals, particularly children’s cereal preparations. There is emerging evidence that such aflatoxins, poisonous substances produced by some forms of mold, can play a role in childhood malnutrition and stunting, said Sarah Cahill, a senior food standards officer with the joint FAO/WHO Food Standards Programme that supports the work of the Commission. “We know it is a carcinogen and that is why we have been regulating it for many years. But we now have new data emerging, and we are seeing that it is contributing to stunting in children. So the consequences of having these contaminants in foods are really far reaching.”

The new work would build on existing codes and standards to provide guidance on good harvest and storage practices – a stage where contamination can become very widespread. It will focus on maize, rice, semolina, sorghum, and cereal-based foods for infants and young children, Cahill said.

Placing pheromone lures in a citrus orchard near Agadir, Morocco, as a bio-pesticide strategy to prevent and control medfly and Ceratitis Capitatata pests.

Another emerging area is in the regulation of “bio-pesticides,” biological alternatives to traditional chemical pesticides, which are increasingly being used in integrated pest management and organic agriculture.

Bio-pesticides may include so-called “beneficial” bacteria, insects, fungi or other biological tools that attack a plant’s pests. Proponents say that these can offer healthier alternatives to conventional chemical compounds, to which farm-workers may be heavily exposed and which leave residues on foods. But little formal assessment has in fact been conduced into the health impacts of bio-pesticides, and regulation is inconsistent between countries. “We don’t have a harmonised regulatory approach when it comes to food safety. This work is trying to develop a framework by which we could approve the use of these in a harmonised way, and understand if there are any implications for human health,” said Cahill.

While much of the Commission’s work is aimed at assessing and limiting risks to health, in other areas, setting standards can help spur trade of both high value and healthier foods. The new standard adopted by the Codex Commission for quality and food safety of almond, flaxseed, hazelnut, pistachio and walnut oils may do just that.

The oils are some of the oldest types of edible oil consumed by humankind and have been traditionally produced and consumed in Middle Eastern countries, Africa, Europe and South America, notes the CODEX news portal, in a summary of today’s final decisions. “The oils are sought as healthy options due to their essential fatty acid and micronutrient content. This standard sets quality and as well as food safety criteria for these edible oils to facilitate international trade.”

Said Cahill, “These are high value, but low volume oils,” in terms of total amounts traded. As a result of the price they can command, such products are also vulnerable to fraudulent marketing claims. “The idea was to set a commodity standard that would identify the key characteristics of these oils in trade, so that if you are buying oil, you know it meets these standards.”

Such a standard, she noted, is “very important for developing countries in the Middle East, which produce a lot of these oils. It ensures that they can direct their industry in terms of the quality standards that they need to meet and facilitate their access to other markets.”

Image Credits: FAO/Bob Scott, FAO.

If the fight against cancer has yielded substantial results on survival rates in high-income countries, low- and middle-income countries are lagging behind, while cancer is gaining ground, with a particularly worrying trend in children.

A first-ever International Health Congress on Integrative Oncology, held 28-30 June in Geneva, presented traditional and alternative medicines as precious allies for conventional medicine, including for promoting good health and cancer prevention.

The Congress was organised by Swiss Alternative Medicine, in partnership with Globethics.net and the World Health Innovation Summit. The event brought together academics, pharmacists, laboratories, doctors, and international organisations to promote a holistic integrative cancer patient care that also engages communities.

Meditation after chemotherapy

What Is Integrative Oncology?

Integrative oncology refers to the use of traditional and complementary medicines (T&CM) for cancer prevention and treatment. These are generally understood to include a wide range of methods, such as acupuncture, ayurvedic medicine, chiropractic, herbal medicine, homeopathy, naturopathy, osteopathy, traditional Chinese medicine, and Unani medicine.

Iranian-born pharmacist Shima Sazegari, founder of Swiss Alternative Medicine, told Health Policy Watch that the event gathered professionals from diverse disciplines to integrate knowledge, bring about synergies, and spark collaborations. The Congress also aims to build bridges between patients and T&CM medicine practitioners, as well as between practitioners and researchers.

Traditional therapies can support cancer prevention by promoting healthy approaches to diet, physical activity and stress reduction, speakers and participants said. For people with cancer, T&CM can be complementary to allopathic (conventional) cancer treatments, by reducing pain, improving quality of life and certain forms of care, as well as helping patients to be aware of treatment choices. This is important in light of growing cancer incidence and soaring treatment costs, affecting low and middle-income countries in particular.

Cancer is Gaining Ground, Low- and Middle-Income Countries Most at Risk

Approximately 70 percent of deaths from cancer occur in low- and middle-income countries, WHO’s André Ilbawi told conference participants. In 2018, some 9.6 million deaths were attributable to cancer – now the second leading cause of death globally – which is far more than HIV/AIDs (1.1 million) and malaria (1.4 million) combined.

Half of all cancers could be prevented, Ilbawi said, adding: “Smoking still kills too much everywhere” – a risk that WHO holds accountable for some 22 percent of cancer deaths. Lack of adequate treatment for infectious diseases that can cause cancer, such as hepatitis C and human papillomavirus, is another significant factor, he said, while other major cancer risks include obesity, and exposure to indoor and outdoor air pollution.

In high-income countries, the chances of surviving cancer are much higher than the global average. Those countries offer adequate and early diagnosis, which leads to effective treatments that see diminishing rates of relapse, pushing the chance of survival at 5 years to 70-80 percent.

Low- and middle-income countries generally suffer from weak national cancer control planning, including late or incorrect diagnosis, inaccessible and/or unaffordable care, and low-quality treatment, Ilbawi added. On cancer management in LMICs, “it is the wild west out there,” he said.

Only 7 percent of low- and middle-income countries have cancer monitoring mechanisms (e.g. cancer registries) and only 10 percent have a dedicated cancer budget. While high-income countries’ total health expenditure averages US$ 4,800 per capita per year, with about 5-10 percent spent on cancer medicines, the total average health expenditure of middle-income countries is only US$ 90 dollars per capita per year, with a substantial portion of this going to cancer medicines. As such, most of cancer treatment in middle-income countries must be financed through private means.

While some low- and middle-income countries have breast cancer screening programmes, there is often no affordable access to treatment for women who are diagnosed with a malignancy, leading to financial catastrophe for patients, Ilbawi said.

Dr André Ilbawi of the WHO at the International Health Congress on Integrative Oncology, held 28-30 June in Geneva.

Sazegari also told Health Policy Watch after the event that in low- and middle-income countries, the lack of robust health systems and infrastructures often leads to late diagnosis. Clinics are typically hard to reach by the population, with people who have to walk long distances bearing the cost of travel. Alternative medicine provides local medical care, fostering early detection of cancer, and can also relieve some side effects associated with allopathic cancer medicine, commonly resulting from chemotherapy, radiotherapy, and immunotherapy. She underlined the importance for patients to be able to understand and manage their illnesses.

Reducing Risks – Promoting Health Holistically

Against this difficult landscape, reducing exposure to risk factors such as tobacco use would significantly reduce cancer incidence, but so would a comprehensive health and wellbeing approach, according to speakers like Gareth Presch, founder of the World Health Innovation Summit (WHIS).

The current health system is designed around a pathogenic approach (process of disease), when it should really be focused on a salutogenic approach (factors of health), according to Presch.

He made the case for stronger community engagement in health promotion activities, and WHIS has launched a number of such initiatives: for pregnancy wellbeing; WHISatwork (Stress management within the workplace); WHISSeniors (Elderly care to improve quality of life); and WHISGreen (Energy, waste, water).

Presch also talked about the “alarming number” of child cancers occurring worldwide. Some 300,000 children and adolescents die each year of cancer around the world, he said (see WHO fact sheet). The WHISkids six-week, school-based programme helps children improve their physical and emotional wellbeing, and can be tailored to ages 4 to 11. WHISkids Switzerland was launched on 28 June, Presch told Health Policy Watch.

WHO implementing its Traditional Medicine Strategy

According to the World Health Organization’s 2019 Global Report on Traditional and Complementary Medicine, interest in such treatments is undergoing a revival in the face of soaring health costs, and tight health budgets. The report notes that those medicines are “an important and often underestimated health resource with many applications, especially in the prevention and management of lifestyle-related chronic diseases, and in meeting the health needs of ageing populations.”

The WHO is also halfway through the implementation of its Traditional Medicine Strategy 2014-2023, aiming to develop norms, standards, and a technical document “based on reliable information” to help countries provide safe, qualified and effective traditional and complementary medicines services, and integrate them into health systems for achieving universal health coverage.

Growing Interest in Countries

Some 170 WHO members are using traditional and complementary medicine (T&CM), according to the WHO report on T&CM. Those countries have developed policies, laws, regulations, programmes and offices for T&CM. For example, 34 countries across the six WHO regions included traditional or herbal medicines in their national essential medicines lists. Some of them, such as Ghana, have a separate list of essential herbal medicines.

As of 2018 some 50 percent of WHO members had a national policy on T&CM, most of them in the African region (40), followed by the Western Pacific region (17), the Southeast Asia region (11), the European region (11), and the Eastern Mediterranean region (9).

In a survey conducted by WHO prior to the report, Benin, Brazil, Chile, China, Cuba, South Korea, India, Mali, Oman, Peru, Thailand, and the United States said they had government or public research funding for T&CM.

Benin, Bolivia, Brazil, Cuba, South Korea, Ghana, Guatemala, Haiti, India, Mali, Mexico, Nicaragua and Thailand said they had an existing national plan for integrating T&CM into their national health service delivery.

The top five difficulties faced by countries in implementing T&CM, as listed by the countries, are: the lack of research data; the lack of financial support for research on T&CM; the lack of mechanisms to monitor safety of T&MC practice; the lack of education and training for T&CM providers; and the lack of expertise within national health authorities and control agencies.

Evidence of efficacy from scientific trials is also a common challenge for health systems. In France, for instance, a commission of the French National Health Authority (Haute Autorité de Santé) recently recommended that public reimbursement of costs of homeopathic medicine be halted, after a scientific assessment found there was insufficient evidence of efficacy. The assessment was requested by French Health Minister Agnès Buzin, who made the decision this week to follow and implement the National Health Authority’s recommendations.

Alternative medicine does not yet have a universal legal framework, unlike allopathic medicine. Sazegari told Health Policy Watch after the event that once an alternative medicine discipline has been academically and legally recognised, it should be integrated into the health system. That would allow alternative medicine to grow and would represent and economic gain for countries, and globally. Switzerland recognises four disciplines which are reimbursed by basic health coverage schemes (mostly private in Switzerland). The four disciplines are: anthroposophic medicine, homeopathy, traditional Chinese medicine, and phytotherapy.

Ethics Key to Sustainable Health

Advocates of alternative therapies contend that while patients should be well informed, they should also be given choices for treatment, and advice about the different complementary options at their disposal.

Swiss Alternative Medicine founder and pharmacist Shima Sazerari advocated for a multidisciplinary approach and “proven techniques” in natural medicines to restore health.

“Healthily living is grounded on living ethically,” according to Obiora Francis Ike, Globethics.net executive director and Nigerian Catholic priest.

He attributed a number of shortcomings in health care to “fraud and redundancy” and “corruption around governments,” leading to funds disappearing “in the pockets of people doing the budget,” as well as lack of morals from pharmaceutical companies, lobbies, and insurance companies.

If governments understood that sustainable health is founded on good character and ethics, the health issues would be halved, he insisted, while at the moment, “people die at the hands of doctors who bought their degree.”

A second Congress is expected to take place in April 2020, with a focus on mental health.

Image Credits: Phillip Jeffrey, Catherine Saez.

A new plan to improve collaboration across 12 United Nations and multilateral agencies to support UN member states to reach 2030 targets on health includes not only the ambitious aim of reducing bureaucracy and increasing efficiency, but of working better across sectors to address environmental, commercial and social factors that harm health.

These factors, which lead to serious health risks such as air pollution exposure and unhealthy foods, as well as health inequalities such as gender discrimination, pose a formidable barrier to reaching many targets of the 2030 Sustainable Development Goals (SDGs). The new plan, rooted in national strategies and leadership, aims to address these complex challenges and accelerate progress on SDGs.

The Global Action Plan for Healthy Lives and Well-being for All, or GAP, “is the key vehicle for greater collaboration, and a good example of how countries and agencies can work together to accelerate progress,” a representative of Norway said yesterday at a side event of the UN High Level Political Forum on Sustainable Development.

“Not surprisingly, some of the biggest gaps are in the targets that need action across sectors,” she said, “and that is why we are here together.”

Led by the World Health Organization, and spearheaded by the governments of Ghana, Germany and Norway, GAP aims to accelerate progress to reach SDGs by 2030, in what has been dubbed the “decade of delivery,” to make up for the shortfall on progress since the SDGs were launched in 2015.

The 12 UN and multilateral agencies GAP will unite include Gavi, the Vaccine Alliance; the Global Financing Facility; the Global Fund to Fight AIDS, TB and Malaria; UNAIDS; UNDP; UNFPA; UNICEF; Unitaid; UN Women; World Bank Group; World Food Programme; and WHO.

The plan, which is flexibly structured to respond to country demand and to build on existing interagency collaboration, identifies seven cross-cutting areas where collective action has a high potential to accelerate country progress on the health-related SDGs.

These “accelerators” include: 1. Sustainable financing; 2. Primary health care; 3. Community and civil society engagement; 4. Determinants of health; 5. Research, development, innovation and access; 6. Data and digital health; 7. Innovative programming in fragile and vulnerable states and for disease outbreak responses.

Developing this plan involved an extensive consultation process with member states, including discussions at the World Health Assembly in May along with country dialogues, as well as a public consultation process during which other stakeholders were invited to provide feedback on the draft plan.

The Global Action Plan will be launched this September in New York as part of the UN General Assembly’s High-Level Week, during which the UN High-Level Meeting on Universal Health Coverage will also take place.

Cross-Sectoral Action to Address Determinants of Health

“Health is a broader concept than healthcare,” one of the coordinators of the GAP process said at the side event. It includes environmental, commercial and social “determinants,” which are those factors that, in turn, can lead to specific health risks and disease threats.

A number of the panelists also cited that 7 million people die each year from air pollution, which one noted is equivalent to the entire population of Switzerland dying each year.

Mandeep Dhaliwal, Director of UNDP’s HIV, Health and Development Group highlighted at the event that throughout the GAP consultation process, there has been a lot of feedback on accelerator 4, “Determinants of health.”

One of the major complications of this accelerator in particular are the competing policies which play out at the national level and limit progress on health-related SDGs.

Dhaliwal asserted that GAP will help member states to deal with these “unhealthy contradictions,” which include: committing to health and wellbeing while providing fossil fuel subsidies; promoting gender equality while criminalizing LGBT communities; committing to health and wellbeing while not creating awareness of healthy diets and prevention of noncommunicable diseases (NCDs).

Taking a multi-sectoral and multi-stakeholder approach has proved successful in the AIDS response, particularly in addressing the broad social determinants of infection and transmission, Simon Bland of UNAIDS noted at the event. But such collaboration doesn’t come easy, he said; it requires “the leadership, incentives, and demands that force determination.”

Dhaliwal noted that such determination has already been put in writing in a number of high level declarations including the Rio Declaration on Environment and Development, the recent political declarations on HIV/AIDS, tuberculosis, and NCDs, as well as in the draft declaration on universal health coverage, to be issued this September.

Effectively addressing these determinants will require multi-stakeholder and multi-sectoral responses, but also inclusion, which she clarified as meaning “women and men in all their diversity.”

Mandeep Dhaliwal, Director of UNDP’s HIV, Health and Development Group, at the side event.

Addressing determinants of health, such as gender equality, has the potential to advance multiple other SDGs, a representative from UN Women said, stressing that achieving gender equality requires strengthening comprehensive healthcare, which includes sexual and reproductive health and rights (SRHR). “By 2030 and beyond, we want to see more women and girls with greater control of their bodies.”

The representative of Women Deliver clarified that addressing determinants of health is not a new agenda, noting that “these issues have been longstanding and under-addressed because they are sticky.” She then strongly advocated for a gender lens for health to be included throughout the entire action plan, which she said should include gender budgeting and auditing, health data collection disaggregated by gender, and research and development (R&D) of health products to meet the needs of girls and women throughout the life course.

“In order to make progress, we need to address the intersectionality of all the SDGs – that is why we can only succeed if we work together,” Norway’s representative said.

GAP Designed to Improve Efficiency, Not to Develop New Policies

Concerns were raised by member states during the side event regarding the accountability of the Global Action Plan, and whether or not it has a role in developing new policies.

A representative of the United States clarified that it is important to recognise that GAP is not a member state-negotiated document, and that the plan is not the outcome of member state consensus. The representative noted that the US does not agree with particular aspects of the plan, which include references to sexual and reproductive health and rights (SRHR) and drug decriminalisation.

The US representative also called for more positive references to the private sector to be added to the plan, saying that the current draft focuses too heavily on the private sector’s health-harmful role. The representative emphasised that the private sector will play a pivotal role in achieving the SDGs.

A representative of Russia echoed the US concern that the plan does not represent member state consensus, but did not clarify the aspects of the plan with which Russia disagrees. The representative also raised concern regarding the accountability of GAP, in particular to the governing boards of its agencies and to member states, as well as whether or not GAP will play a role in determining policies.

A WHO representative involved in process of developing the Global Action Plan responded to these concerns. He clarified that there is broad agreement that this is not a policy-creating mechanism, but that it is designed to help countries implement already agreed-on policies at the country level.

“There’s a wide recognition that each of the agencies have their strategies which have been adopted by their respective governing boards… and the Global Action Plan is not meant to supersede, but to spell out how collaboration in implementing these strategies will happen, to really enhance the impact of working jointly,” which he said “is very much in line with the efforts of UN reform, to provide coherent support for member states in driving the SDG agenda.”

The WHO representative also took note of the US request for more positive references to the private sector in the GAP document.

A representative from Morocco, one of the countries actively embracing the Global Action Plan, underlined that the plan will help to prevent “doubling work.” There are many UN agencies represented in Rabat, she said, and the government had to work with each agency bilaterally; but now, “this platform will prevent extra work and achieve efficiency.”

The political declaration on UHC is now being negotiated, she said, stressing that what comes after the declaration is the most important step. “Implementation is always hard,” she said, and “GAP will help with implementation at the national level.”

Image Credits: UN Web TV.

Kawaldip Sehmi, CEO of the International Alliance of Patients’ Organizations (IAPO), answers 5 questions on why the Essential Medicines List is important for patients. IAPO is a United Kingdom-based alliance of 276 member organisations from 71 countries representing 50 disease areas, and working in collaboration with civil society, UN agencies and the healthcare industry. Sehmi holds a Masters in Public Health from the London School of Hygiene and Tropical Medicine, and has previously served as Director of the Global Health Inequalities Programme and as Chairman of the European Network of Quitlines. This article is republished from “Global Health Matters,” a blog of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

IFPMA: What does the addition of new medicines on the 2019 Essential Medicines List (EML) update mean for patients?

Sehmi: The inclusion of any medicine, including innovative and specialty medicines, on the World Health Organization’s Essential Medicines List is good news: it should increase patient access to new treatment options, including to the latest innovative generics and biosimilar medicines. But this will only happen if the necessary steps are taken in each and every country to support delivery and uptake of these medicines. Getting a medicine on the list is an important but relatively tiny first step.

Countries need to strengthen their health systems and work with stakeholders, including patients, public and private funders of health systems, to ensure that sustained funding is available and that the health system infrastructure is robust and resilient if they are to safeguard the effective delivery of essential medicines to the patients and the community.

Even so, it is positive to see that more and more medicines are being included with each EML update, thus keeping abreast of medical innovation while recognizing that there are still unmet medical needs and increasing societal expectations, with more treatments added in areas such as Hepatitis C and Cancer.

IFPMA: How is the EML useful for patient representatives in your advocacy efforts?

Sehmi: There is a sea change in healthcare policy and decision-making as patients are increasingly being asked to support healthcare service development through experience-based co-design and co-creation partnerships. Expert-patients’ engagement on national essential medicines lists is slow to catch up with this approach.

It is important to have the patient perspectives on essential medicines lists. EML is just the tip of a huge healthcare infrastructure, workforce and resources iceberg. By just concentrating on the EML is like applying a sticky plaster to a compound fracture within the healthcare body.

However, the List is an important guide to what medicines should be available anywhere at any time – these should be seen as the bare minimum that any health system should be able to deliver. It should not become a box-ticking exercise, a bare minimum standard, the delivery of which absolves the State’s obligation to do much better. But, at the end of the day, the patient-physician partnership must be able to decide what is the most appropriate treatment for patients. For patient organizations, one idea is that the EML can be used along with individual country medicines lists to advocate for ‘missing’ treatments.

They can also benchmark their own country list with those used by neighboring countries, or countries with similar medical needs/health systems. We will be informing, educating and developing capacity within patient organizations to work towards this partnership-based approach now that the new list has been released. We need to do more work post-launch of EMLs.

IFPMA: What do you mean by doing more on “post-launch” of EML?

Sehmi: This year we are going to be marking the first World Patient Safety Day [17 September]. Medication safety is a central pillar in the WHO Director General’s global action on patient safety. When new medicines are included on the list, it is crucial that clear guidance be given to patients and health professionals on how they should be properly utilized (i.e., treatment guidelines, safe medication practices) and any necessary supporting systems, such as disease surveillance systems/registries, pharmacovigilance systems, diagnosis, patient monitoring, adherence, and management of comorbidities. Proper utilization of medicines is an issue very close to my heart and at the core of IAPO’s work. Unsafe medication practices and medication errors have become a global public health problem. The number of patients either injured, disabled or killed while accessing unsafe healthcare has become a huge global concern.

As one patient advocate said at the 72nd World Health Assembly: “In my country, people are afraid to go to hospitals as they think they will come out in a coffin or with a severe disability. Hospitals and healthcare services stand the risk of being empty if the community does not trust them.” I’m therefore delighted that the WHO Member States from all 194 countries endorsed the establishment of a World Patient Safety Day to be marked annually on 17 September and officially included on the WHO list of health dates.

IFPMA: WHO’s Report on Pricing of cancer medicines and its impacts released last year makes considerations about different pricing approaches to cancer medicines listed on the EML. What is IAPO’s view on this topic?

Sehmi: Ultimately, every patient must be able to access and afford the healthcare services they need – this is also one of the five principles outlined in IAPO’s Declaration on Patient Centred Healthcare. Our vision is that the needs of patients are placed at the center of all healthcare decision-making and, equally importantly, that patients have a direct role as partners in all matters from policy to individual choices. I think we all agree that there is no point in innovation if people cannot benefit from it.

But, equally, we should not lose sight of the fact that many medicines such as antibiotics, malaria treatments and statins, albeit relatively cheap, still do not reach patients who need them. For example, all the basic hypertension medicines are generic, inexpensive, safe and effective; they have been used in high income countries for more than half a century, but they are still not being used routinely in low income countries. In the case of oncology medicines, because of the complexities associated with cancer treatment, issues with supply chain integrity, insufficient health workers, low capacity for diagnosis and overall infrastructure limitations have to be part of the debate on access, along with pricing.

IFPMA: Looking ahead, what would you like to see in the next EML update?

Sehmi: A multi-stakeholder approach to the next EML update is key, starting with greater patient engagement and participation. Engaging patients in health policy decision-making is essential in order to ensure that policies adequately reflect patient and caregiver needs, preferences and capabilities. It is also important that the processes around the EML are open, inclusive and impartial. Deliberations of the advisory working groups established to advise the Expert Committee would be significantly improved with a wider membership, including patient organizations, National Regulatory Agencies, and NSAs, as official interlocutors with the WHO. Especially for innovative medicines, involving regulators in the discussion is key, as regulators are the ones reviewing the most detailed data regarding safety and efficacy of these medicines.

Image Credits: UNICEF/Noorani, Kawaldip Sehmi.

WHO has added ten new cancer drugs, including some pricey ones, to its 2019 Essential Medicines List, which provides global guidance to countries and health systems about drugs deemed most essential to patients and public health systems.

The addition of major new cancer treatments in five categories, melanoma (skin), lung, blood and prostate cancers, reflects both the rapid pace of cancer drug research – as well as the growing need to respond to the worldwide increase in cancers and other non-communicable diseases.

In another long-awaited development, WHO also promoted the drug mifepristone-misoprostol for induced abortions from a complementary list to a more select core list, which together comprise over 450 essential medicines. However, it preserved a footnote saying that the drug should be used “where permitted under national law and where culturally acceptable,” which WHO’s Department of Reproductive Health and Research, backed by the United Nations Population Fund and numerous civil society groups, had requested be removed. However, WHO’s Director General Dr Tedros Adhanom Ghebreyesus ultimately decided to retain the longstanding nod to national and cultural norms, sources told Health Policy Watch.

In a press release, issued Tuesday, WHO said that improved survival rates were a key criteria for including the new cancer therapies as “essential medicines” – even if some of the treatments are costly.

“The inclusion in this list of some of the newest and most advanced cancer drugs is a strong statement that everyone deserves access to these life-saving medicines, not just those who can afford them,” said WHO’s Dr Tedros in the press release.

The new cancer therapies included two recently developed immunotherapies (nivolumab and pembrolizumab) “that have delivered up to 50% survival rates for advanced melanoma, a cancer that until recently was incurable,” the WHO release said. The therapies are produced by Bristol-Myers Squibb and Merck & Co.

Other new cancer drugs included Roche’s erliotinib treatment for lung cancer, which the report said demonstrated survival benefits similar to chemotherapy and improved quality of life. Jannsen Biotech’s abiraterone was included for treatment of patients with metastatic prostate cancer, following a request by the civil society organization Knowledge Ecology International (KEI). Other new treatments also were included for leukaemia and multiple myelomas.

The publication of the long-awaited update unleashed a wave of reaction from civil society, while sending a ripple through the pharma industry, as winners and losing drug candidates were examined and evaluated.

In South Africa, a coalition of nearly 45 patient advocacy groups said the WHO announcement offers new Health Minister Dr Zwelini Mkhize an “historic opportunity” to save lives by increasing access to one of the new drugs for multiple myeloma on the list, lenalidomide.

“Currently, the majority of cancer patients in South Africa who could benefit from lenalidomide cannot access it due to its prohibitively high cost – depriving many people of a chance at life,” said Salomé Meyer, from the Cancer Alliance in a blog posted online. In South Africa more than 400 new cases of multiple myeloma – a blood cancer of the plasma cells of bone marrow – are reported annually.

Other civil society advocates, however, said that WHO did not go far enough in embracing other cancer drugs that can improve survival rates for people with metastasised cancers.

KEI’s Director James Love told Health Policy Watch that two such breast cancer drugs, pertuzumab and trastuzumab–emtansine [TDM1], supported by KEI for inclusion into the list, didn’t make it, despite what he described as “robust evidence of efficacy.”

“What you now have is a list that has some effective and expensive drugs and not others, with a bias against metastasized cancers,” said Love of of the two breast cancer drugs; KEI had itself proposed inclusion of the trastuzumab-emtansine [TDM1] combination.

The WHO Executive Summary of the Essential Medicines List, on the other hand, said that the Committee had postponed inclusion of the these two breast cancer drugs pending further analysis, because the “large overall survival benefit” of pertuzumab found in one trial of women with metastasized cancers had not been seen in other trials, and for TDM1, alternative options are available on the list.

Dr Nicola Magrini, Secretary of the Essential Medicines List Expert Committee, noted that the new list is growing “rapidly and convincingly” with respect to cancer treatments – and health systems will face serious challenges just in responding to the new cancer drugs that have already been added to the list.

The WHO Expert Committee has also proposed a larger scientific and technical group meeting next year, together with countries and civil society, to discuss current challenges in providing cancer treatments and programs that meet the “expected EML [Essential Medicines List] standards, which are pretty high now,” he said.

New High-Priced Cancer Drugs

Indeed, efficacy is not the only issue involved in the debate over cancer drugs. Another key factor is pricing. As the Executive Summary notes, some of the cancer drugs chosen for inclusion are “high-priced cancer medicines.”

Love of KEI said that some of the rejected cancer drugs also would have introduced competition to drive down prices. He noted that the decision to exclude enzalutamide for treatment of prostate cancer ignores the pricing benefits that its inclusion would generate through competition with abiraterone, a drug that was accepted, but that carries a very high price.

Love said that exclusion of enzalutamide also could undermine efforts such as those by students at UCLA to convince the university to drop a patent suit in India against production of generic versions of the patented drug, marketed as Xtandi. Generic production would dramatically lower the price of enzalutamide, which currently costs around US$ 5,000 a month in India.

Love also noted that since enzalutamide is a monotherapy with smaller active ingredient (API) requirements than abiraterone, it would eventually become much cheaper to manufacture, making it a good option in terms of both efficacy and pricing in the long-term.

See below or here for details on the new cancer drugs added to the Essential Medicines List.

First All-Oral Drug for Sleeping Sickness

The latest Essential Medicines List also includes the first all-oral treatment for sleeping sickness, fexinidazole, an important milestone in the treatment of this neglected, and usually fatal, disease.

Registered by Sanofi and developed in clinical trials led by the Drug for Neglected Diseases initiative (DNDi), fexinidazole is used to treat the first and second stages of sleeping sickness, also known as Human African Trypanosomiasis, transmitted by the bite of a tsetse fly.

“65 million people, who live mainly in rural parts of East, West and Central Africa, are at risk of contracting sleeping sickness,” DNDi said in a statement.

Inclusion of the first all-oral drug in the Essential Medicines List “will spur governments in endemic countries to include fexinidazole in their treatment guidelines,” said Dr Nathalie Strub-Wourgaft, DNDi’s Director of Neglected Tropical Diseases, in the statement. “Inclusion of fexinidazole is also a further sign of WHO and Sanofi’s commitment to ensuring swift deployment of this paradigm-changing treatment.”

Insulin Analogues Not Included

During the WHO Expert Committee on the Selection and Use of Essential Medicines meeting in April of this year, debates were heated over how to address the rising cost of insulin, a life-saving essential medicine that has been available for nearly 100 years.

Some proposed for the inclusion of insulin analogues, an altered form of human insulin, to increase competition, but others strongly opposed this, noting that the high cost of insulin analogues – 8-11 times that of insulin – could actually drive insulin prices up.

The Committee ultimately decided not to include insulin analogues in the list, recognising “the need for a wider understanding of the complexities of access to insulin and the current insulin market,” and recommending that “WHO prioritize the coordination of a series of actions to address the issues of insulin access and affordability,” according to the Executive Summary.

“In the absence of other coordinated actions, the Committee considered that the inclusion of insulin analogues for adults on the EML [Essential Medicines List] would be inadequate to address the underlying issues of poor access and affordability of insulins,” it said.

The Committee’s decision was welcomed in a press release Wednesday by Health Action International (HAI), citing its recent study showing that analogue insulin can be as much as six times more expensive than human insulin, which is on the EML, and there is no independent evidence showing that the analogues are more cost-effective.

“A decision to include analogue insulins in the EML would increase pressure on national governments to purchase these far higher priced insulins. In low- and middle-income countries, where health systems budgets are already stretched; this would have disastrous consequences for people in need of insulin,” said Dr Margaret Ewen, co-lead of the HAI study in the statement, adding. “When the price of long-acting analogue insulin is lowered to an affordable level for governments and individuals, we would welcome a thorough evaluation on its value on the EML.”

Abortion Drug Moved to Core List, No Longer Requires Close Supervision

The drug combination mifepristone–misoprostol, used to end pregnancies that are less than 10 weeks along, was recommended by the Expert Committee to be moved from the complementary to the more select core list of medicines, and for the two drugs to be co-packaged.

The Committee further recommended the removal of the note accompanying the listing that the drug “Requires close medical supervision,” explaining in the Executive Summary that this is “based on the evidence presented that close medical supervision is not required for its safe and effective use.”

The Committee, however, noted that “its mandate did not extend to providing advice regarding the statement ‘Where permitted under national law and where culturally appropriate.’” So ultimately the decision to preserve the note was made by the WHO Director General.

Recommendations on Improving Access to and Affordability of Essential Medicines

In the Executive Summary, the Committee noted that throughout its April meeting to review and update the Essential Medicines List, issues of access to and affordability of the essential medicines was a core theme, particularly in the context of the rising cost of insulin and the high prices for the newly added cancer drugs. It further noted that this issue of affordability applies both to health systems and to patients.

While it acknowledged the “limited role of WHO in price setting at country level,” it “identified several different actions that could contribute to making some of the recently listed essential medicines more affordable at country level,” which include:

  • A wider adoption of biosimilars, which are the equivalent of less expensive generics for biologically-based drugs;
  • Expanding the remit of the Medicines Patent Pool, which negotiates with patent holders for licences of priority drugs to so as to make them available to low- and middle-income countries;
  • Expand the role of pooled procurement/tendering of drugs;
  • Use of patent flexibilities [available for health products], in the 1995 World Trade Organization (WTO) agreement on Trade Related Aspects of International Property Rights (TRIPS);
  • Other existing instruments, such as competition law;

Elaine Fletcher and David Branigan wrote this story.

Image Credits: WHO.

Nairobi, Kenya – The World Health Organization has commended efforts by the government of Uganda for keeping the deadly Ebola virus from spreading eastwards into the country from the Democratic Republic of the Congo (DRC), where a prolonged outbreak has claimed approximately 1,600 lives since last August.

The East African country has recorded only three confirmed cases of the disease since 11 June – when the first case was reported by WHO – linked to three people who had crossed the border into western Uganda from the DRC.

Another three suspected cases were being treated at a hospital near the DRC border, where health-workers have concentrated treatment facilities so as to contain the spread of the disease farther east in Uganda and the broader East Africa region.

Surveillance for ebola virus disease at the border between DR Congo and Uganda. Photo: WHO/Matt Taylor

The ability to check the spread of the highly contagious virus with a 68% fatality rate has so far been enabled by a good disease surveillance system managed by well-trained teams of health workers, according to Matshidiso Moeti, WHO Regional Director for Africa. Strong community-backed surveillance has also been critical, said Uganda’s Health Minister Jane Ruth Aceng.

“I commend Uganda for its quick response to the Ebola outbreak,” said Moeti to UN TV, when she toured western Uganda near the DRC border late last month (25-26 June). “I spoke with health authorities who told me how the training they had received in detecting the disease” enabled them to be “on high alert for patients with any signs of infection. They were able to move swiftly when the first Ebola cases arrived in their health facility,” she said, according to a WHO news release.

Uganda and the DR Congo share a porous 900 kilometre border – running through fertile and mineral-rich jungles. The rough terrain makes control over civilian crossing challenging. And on the DRC side, armed militias that oppose the DRC central government operate with relative impunity, particularly in the areas of Kivu. Nearby, Rwanda and Burundi also share a significant border with DRC, making Ebola surveillance by neighbouring countries even more important for the broader region.

Rapid Health Sector Mobilization & Ring Vaccination Strategy

Since the outbreak was declared in Uganda in early June, 1,063 ‘high risk individuals’ have been vaccinated Moeti said, adding that vaccination of contacts and contacts of contacts, a strategy known as ‘ring vaccination’, has shown good results in the DRC, and previously in other countries of West Africa.

The ring vaccination strategy has also contributed to the fact that there have been no new cases of Ebola in Uganda since 12 June, the latest WHO situation report noted.

Uganda has trained more than 9,000 of its health workers in detecting symptoms of Ebola, and has vaccinated nearly 5,000 workers against the disease.

Additionally more than 100 people who had contacts with people confirmed to have Ebola in Uganda are being monitored to enable a quick response if symptoms of the illness develop.

Community Leadership Key to Surveillance

With support from WHO and partners, another 16,000 community leaders and volunteers have been trained in remote border areas to help with disease surveillance; provide medical attention to potential patients; and alert authorities of suspected cases of infections, according to the WHO release.

The local teams, it said, serve as the “eyes and ears” of local and national emergency response systems supporting “surveillance, infection prevention and control, patient care, cross-border activities and coordination with communities.”

As a result of such community cooperation, all high-risk districts in the west of Uganda are able to screen people, identify suspect cases and trace the contacts of potential patients whenever needed, Uganda’s Health Minister Aceng said. “As of now we remain in a high alert, we will continue with our risk communication and sensitizing the population,” she said in a video of her visit to the field with Moeti.

She added that due to these efforts, there were no further known cases of Ebola transmission in Uganda presently, but monitoring efforts will continue until the pathogen was completely brought under control in the DRC.

In DRC, Community Mistrust & Unrest Continue to Fuel Ebola 

The 4 July situation report issued by the WHO indicated that in DRC, the epicentre of the outbreak, there were 285 new confirmed cases of Ebola during the 12 June – 2 July period, marking a trend of decreasing cases since the height of the epidemic in mid-April. A total of 2,369 cases have so far been recorded, with 2,275 confirmed cases resulting in 1,598 deaths, since the outbreak began in August of last year.

Source: WHO

The eastern DRC city of Butembo in DRC’s North Kivu region has borne the brunt of the outbreak, made worse by conflict and political instability that has seen health workers unable to reach patients, and in some cases lose their lives.

Teams of responders in the city of one million inhabitants have often faced community mistrust, fuelled by misinformation spread by politicians in the general elections that took place in late 2018.

Over the past six months, armed groups active in the area attacked health workers while looting and destroying Ebola treatment centres, during which frontline responders and security forces protecting them lost their lives, according to WHO reports.

WHO and Congolese authorities have been conducting awareness-raising activities for teams working in treatment and vaccination sites, aimed at helping to build community support and trust to ensure the safety of responders.

Unlike in the earlier outbreak in West Africa, the WHO and agencies involved in the current campaign have been relying heavily on vaccinations of people who have come into contact with victims, focusing on first and second degree contacts, demonstrating some success in containing the spread of the virus.

Despite this progress, the international NGO Médecins Sans Frontières (MSF/Doctors Without Borders) in its latest update lamented that attacks on health personnel have continued to date, which, coupled with inter-communal violence, contributed to the failure to end the outbreak – now more than ten months strong.

“Vaccination of contacts, contacts of contacts and frontline workers in Butembo and Katwa (the epicentre of the outbreak) is sometimes temporarily suspended because of threats to the safety of vaccination teams,” the organisation said.

However, it added that as a frontline entity involved in combating the disease, it now has the facilities, skills and scientific capacity to better manage the current outbreak, as compared to previous ones.

“We have new tools and improvements in the medical management of this epidemic, compared to previous Ebola epidemics, such as new developmental treatments; a vaccine that has given indications of being effective; Ebola treatment centres are more open and accessible for the families of patients; and provision of a higher level of supportive care,” it noted.

In Uganda, MSF declared that it will collaborate with health authorities “to improve the hygiene and infection prevention and control measures in Kagando and Bwera hospitals, where the confirmed Ebola cases were first admitted,” and would also “support the safe provision of care for medical needs unrelated to Ebola in these facilities, should the need arise.”

Image Credits: WHO/Matt Taylor, WHO.

[Republished from The Lancet]

Richard Horton, Editor-in-Chief of The Lancet, examines the issues around the pending appointment of a new executive director for UNAIDS, as well as the candidates for the post, following the May resignation of executive director Michel Sidibé. The selection process has fueled questions about who may now be best positioned to lead UNAIDS following a sexual harassment scandal that cast a shadow over the agency and its leadership – with some critics questioning whether it should continue as a separate institution altogether. Horton has led The Lancet since 1995, and has established the journal as a leading voice on cutting-edge health policy issues, ranging from antimicrobial resistance (AMR) to obesity and climate change. He is a recent recipient of the Roux Prize.

Richard Horton, Editor-in-Chief, The Lancet. Photo: ILO/A.Lwin

Who is best qualified to lead an organisation—UNAIDS—that has not only suffered severe reputational loss, but also faces threats to its continuing existence? UNAIDS is a jointly sponsored UN programme that has, in its own words, “led and inspired global, regional, national, and local leadership, innovation, and partnership to ultimately consign HIV to history”. But some observers believe this glorious history is just that—history. Rob Yates was recently appointed head of Chatham House’s Centre on Global Health Security. He wrote on Twitter last week that a new Executive Director of UNAIDS should have the “courage and ability to wind up the organisation and integrate it into @WHO”. Kul Gautam, a former Deputy Executive Director of UNICEF, argued that “now it’s time to question [UNAIDS] continuation”. Anthony Costello, most recently a Director at WHO, commented, “No one questions the need for a strong and distinct body for the HIV response. It’s whether UNAIDS would function better under the democratic accountability of the World Health Assembly which might have prevented its shameful recent history”. Laurie Garrett, a Pulitzer-Prize winning writer on global health, noted that those selecting the next Executive Director “MUST define clearly why the world needs UNAIDS & how it should fit in the global health landscape.” Is it time to choose a leader who will close down UNAIDS? Maybe one day. But not now. Predictions about the end of AIDS have been badly misjudged. According to the Global Burden of Disease Study, there were almost 1 million deaths from AIDS in 2017. Those deaths occur throughout the lifecourse, but the toll is especially severe among 15–49-year-olds (676 100 deaths). There are almost 37 million people worldwide living with HIV. And the incidence remains shockingly high—1·9 million people newly infected every year. Although the number of AIDS-related deaths is projected to fall, even by 2040 those deaths will still be unacceptably high (742 million, with a worst-case scenario of 2·3 million deaths). The AIDS epidemic is at a critical moment. Decelerating the political response by extinguishing UNAIDS now would be a catastrophic error.

Photo: UNAIDS/Sydelle Willow Smith

There are five candidates: Salim Abdool Karim (an infectious diseases epidemiologist and Director of the Centre for the AIDS Programme of Research in South Africa); Sani Aliyu (physician, infectious diseases expert, and Director-General of Nigeria’s National Agency for the Control of AIDS); Chris Beyrer (physician, HIV specialist, former President of the International AIDS Society, and Professor of Public Health and Human Rights at Johns Hopkins Bloomberg School of Public Health); Winnie Byanyima (engineer, politician, diplomat, and now Executive Director of Oxfam International); and Bernard Haufiku (physician and Namibia’s former Minister of Health and Social Services). Each candidate has strengths. Aliyu spearheaded Nigeria’s AIDS response under difficult political circumstances. Haufiku has ministerial experience. Byanyima knows how to run a complex global organisation. Karim is a highly respected HIV scientist whose work has transformed clinical practice. And Beyrer, whose partner died of AIDS in 1991, successfully uses human-rights approaches to protect and advance the health of marginalised communities in Asia, Africa, Latin America, Russia, and the US. There are disappointments. Only one woman? No forum for public debate and scrutiny? Appointment not election?

The next Executive Director of UNAIDS must fulfil five criteria. First, s/he must have the personal integrity to restore trust and credibility to a damaged organisation—and to give governments confidence to invest in the AIDS response. Second, s/he must have proven scientific understanding of the AIDS epidemic in order to be able to use evidence as a platform for political advocacy. Third, s/he must have demonstrable ability to represent and engage with civil society. Fourth, s/he must be able to point to their commitment to key vulnerable populations. And finally, s/he must be able to show transformational leadership of a large organisation. The Programme Coordinating Board of UNAIDS met in Geneva last week and “commended the strong competencies of all short-listed candidates”. After interviews, a Committee of Cosponsoring Organisations will deliver no more than three names to the UN Secretary-General, António Guterres. It is no exaggeration to say that his choice may determine the future fate of the AIDS epidemic.

Salim Abdool Karim, Director of the Centre for the AIDS Programme of Research in South Africa. Photo: Rajesh Jantilal/AFP/Getty Images
Sani Aliyu, Director-General of Nigeria’s National Agency for the Control of AIDS. Photo: Sani Aliyu
Chris Beyrer, Professor of Public Health and Human Rights at Johns Hopkins Bloomberg School of Public Health. Photo: Rajesh Jantilal/AFP/Getty Images
Winnie Byanyima, Executive Director of Oxfam International. Photo: Franke Tsang/South China Morning Post/Getty Images
Bernard Haufiku, Namibia’s former Minister of Health and Social Services. Photo: UN Photo/Rick Bajornas

 

 

 

 

 

 

 

 

 

Republished with permission from The Lancet: https://doi.org/10.1016/S0140-6736(19)31563-6. Click here, for more information about Richard Horton and The Lancet.

Image Credits: UNAIDS/Sydelle Willow Smith, ILO/A.Lwin, Rajesh Jantilal/AFP/Getty Images, Sani Aliyu, Franke Tsang/South China Morning Post/Getty Images, UN Photo/Rick Bajornas.

Only a month after a hotly-contested World Health Assembly resolution touched off a debate around “price transparency” as a way to improve access to medicines, a new controversy over how to stimulate access has emerged in another UN Forum, the Human Rights Council.

This time the debate is around ways to “delink” incentives for the research and development of new medicines from patent systems that “reward” companies or institutions investing in the drug’s development with a legal monopoly over sales of the end-product for years to come.

The sensitive “delinkage” issue is part of a draft Human Rights Council (HRC) resolution on “Access to medicines and vaccines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” under consideration at this month’s session in Geneva.

Human Right Council. Photo: UN/Jean-Marc Ferré

“Delinkage” has become a mantra for many civil society and patient advocacy groups, as well as some governments, which perceive exclusive patent rights as a key driver in rising drug prices, limiting access to new treatments. The term broadly refers to alternative incentives or rewards that reduce reliance on patents as a means of financing R&D, yielding products that are cheaper and more readily available.

The draft HRC resolution on medicines access, due for its final review on 11 July, is backed by a core group of countries including Brazil, China, Egypt, India, Indonesia, Senegal, South Africa and Thailand. Representatives of that group point out that the recently contested delinkage paragraph was part of an already-approved 2016 version of the same resolution, and is merely being reaffirmed again in this year’s updated draft, which now has 27 co-sponsors in all.

“The Human Rights Council brings this resolution up every three years, because it is viewed as worthy in this context, to have a human rights perspective on access to medicines,” said Brazil’s representative Clara Solon in a public HRC consultation Tuesday.

The text calls upon countries “to continue to collaborate, as appropriate, on models and approaches that support the delinkage of the cost of new research and development from the prices of medicines, vaccines and diagnostics for diseases that predominantly affect developing countries, including emerging and neglected tropical diseases, so as to ensure their sustained accessibility, affordability and availability and to ensure access to treatment for all those in need.”

Two other paragraphs [8,9] ”encourage” governments, international organizations, NGOs, researchers and the private sector to pursue alternative R&D incentives, in terms such as the following:

  • “improved existing and alternative frameworks to adequately reward innovation, pricing and affordability of health products;” and
  • “to redouble efforts to achieve a continuous supply of quality, safe, effective and affordable health products through research and development that meets public health needs, for the efficient application and management of intellectual property standards, to carry out evidence-based selection of health products and seek fair and affordable pricing.”

Delinkage Supporters and Critics

Support for “delinkage” principles has been growing over the past decade, led by figures ranging from US Presidential hopeful Bernie Sanders to Nobel Prize winning economist Joseph Stiglitz and Bernard Pecoul of the Geneva-based Drugs for Neglected Disease Initiative. Countries supporting the idea have included India, The Netherlands, and the Group of 77, representing some 134 developing nations. Some private sector voices, notably former GlaxoSmithKline CEO, Sir Andrew Witty, have also expressed support for innovative ways to fund R&D.

The advocates assert that the current R&D system, based around granting exclusive patent rights for new drugs, is breaking down. Newly patented drugs that are coming onto the market are increasingly priced in a range that stretches the budgets of high-income countries, while leaving middle- and low-income countries out of the loop altogether.

The problem is particularly acute for drugs treating non-communicable diseases such as cancer, where new therapies can carry a $US 100,000+ annual price tag. And particularly if public funds or tax breaks are invested in drug R&D, then rewards other than exclusive patent monopolies should be considered for the final drug products, advocates assert.

“Access will always be unequal without the delinkage of R&D costs from the prices of drugs, vaccines, cell and gene therapies, diagnostic tests and other health technologies and services,” remarked Thiru Balasubramanian, of Knowledge Ecology International (KEI), in an interview. One of the groups that participated in last week’s HRC consultations, KEI has been a flagbearer of the delinkage concept.

At the same time some key developed countries, including Switzerland, Japan, Australia, and the European Union representative at the HRC, contend that existing patent systems remain the backbone stimulating R&D investments, and that the HRC resolution treads too far into territory outside of its traditional domain. They have asked for deletions or major changes in the paragraphs that reference “delinkage” as well as references to alternative R&D incentives.

“Delinkage is stated too broadly. As supporters of the global IP system [for medicine patents], we want to make sure that it keeps performing, while finding solutions in areas where it is not working. But we are very worried about taking a one-size-fits-all approach,” Nora Kronig, head of International Affairs at the Swiss Federal Office of Public Health, told Health Policy Watch.

“Looking at access to medicines broadly, there are a lot of elements that come into the chain. For instance, if you don’t have robust regulatory systems people can’t get medicines either. It is also untrue to talk about market failure with respect to the whole access to medicines issue,” she added.

While critics are increasingly adamant that the current system is cracking, “saying that that there is a global market failure on access to medicines generally is not accurate,” argues Kronig. “We are fully open to discuss possibilities where things are not working to find solutions to improve access to medical products, but what we are very worried about is to undermine a largely functional system to offset unquestioned distortions in sub-sectors of the markets for medicines.”

Informal Consultations on the Draft Resolution

At Tuesday’s informal consultations on the draft, other countries expressed concerns that the Human Rights Council may be duplicating work already being carried out by the World Health Organization and the World Health Assembly body of WHO member states.

“We share concerns about how we are use these very overstretched platforms,” said Canada’s delegate. “While still recognizing there is a role for human rights, … we would like to refrain from re-negotiating thoughts and technical issues that are already being discussed in other fora such as WHO and WHA.”

The final text of the HRC draft resolution, obtained by Health Policy Watch, reflects slight modifications in the disputed paragraphs, although terms like “delinkage” remain along with reference to alternative incentives for drug R&D.

Besides the core group, other co-sponsors of the resolution, so far, include HRC members from: Bangladesh, Iraq, Peru, Philippines, Qatar, Saudi Arabia, Tunisia, and Uruguay. UN member states and observers that are not officially members of the HRC can still co-sponsor HRC resolutions, and such supporters include: Algeria, Bolivia, Ecuador, Eswatini, Ethiopia, Haiti, Kuwait, Mongolia, Turkey, the United Arab Emirates and Palestine.

Talks with other countries will continue up until next Thursday, when the final resolution is formally reviewed by the HRC. But the essence of the three contested paragraphs would not change or be removed, core sponsors affirmed.

“The resolution has one paragraph mentioning de-linkage, and some European countries don’t like this,” said one delegate, who asked not to be named.

“But the resolution is not about delinkage, it touches on many aspects of access to medicine, including delinkage and alternative frameworks [for R&D], but we also talk about rights to health, health literacy, many other issues. It is very broad text.”

“We are not planning to make more changes in the text, but we will work very hard to add more cosponsors as well as to try to avoid public objections to the final text,” the delegate added. “But if it comes to it, we will have a vote.”

Image Credits: UN Photo / Jean-Marc Ferré, CDDEP.

The European Commission and European Union medicines regulatory agencies sent an open letter to all sponsors of EU-based clinical trials to remind them of their obligation to publish the results of the trials – both positive and negative – in a public database.

The open letter by the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reminded sponsors that according to a 2012 EC guideline, clinical trial summary results are required to be published in the EU Clinical Trials Database, EudraCT, and that publishing these results is their direct responsibility.

“Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health,” the EMA said in a press release.

“In addition, for those medicines which are placed on the market or used in further clinical trials, it allows patients and healthcare professionals, or any other citizen, to find out more information about medicines they might be taking or prescribing,” it said.

The letter noted that out of the 27,093 completed clinical trials in the EudraCT database, 68.2 percent are in compliance with the EU publication rules and 31.8 percent have missing results, which the letter identified as “an encouraging trend.”

However, it added that “there is still significant progress to be made,” citing that reporting compliance for non-commercial sponsors is low at 23.6 percent, compared to that of commercial sponsors at 77.2 percent.

The letter particularly encouraged academic and other non-commercial sponsors “to post the results of their trials in EudraCT in order to maximise their valuable contribution to meet public health needs and to advance clinical research especially where commercial interest is weaker.”

“Underreporting in general and selective reporting of trials with positive outcome may lead to potentially avoidable redundancies in the conduct of clinical trials and compromise the economic and scientific efficiency of clinical research,” it warned. “In addition, unreported clinical trials with unfavourable outcome can have negative public health implications.”

Image Credits: European Medicines Agency.

The Global Antibiotic Research & Development Partnership (GARDP) has announced its new “5 BY 25” strategy to mobilise global stakeholders to raise the €500 million needed to develop and deliver five new antibiotic treatments by 2025, to help tackle antimicrobial resistance (AMR).

Drug-resistant infections already cause at least 700,000 deaths globally each year, and affect people in countries across income levels; addressing the growing threat of AMR will be key to achieving universal health coverage (UHC) and the Sustainable Development Goals (SDGs), a GARDP press release explained.

“We are in a race against time to develop new antibiotics and make them accessible to the millions of people who need them. GARDP’s remarkable progress over the last three years in building strong partnerships and a talented team positions it well to meet this ambitious new goal,” said GARDP’s Chair of the Board, Professor Ramanan Laxminarayan, quoted in the release.

“WHO strongly welcomes the progress of GARDP to date and its new ambitious ‘5 BY 25’ goal which complements WHO’s Global Action Plan on AMR. We call on all key actors to support and collaborate with GARDP in line with the UN Interagency Coordination Group on AMR,” said Dr Hanan H. Balkhy, Assistant Director-General for AMR Division at WHO, in the release.

This “5 BY 25” strategy is part of GARDP’s new business plan, which was recently approved by the GARDP Board and will be launched at the World Health Summit in October. The strategy is detailed in a recent webinar by Dr Manica Balasegaram, GARDP Executive Director.

Calling on the support of member states, philanthropic and other global organisations, GARDP aims to develop five new treatments that will focus on the priority pathogens identified by the World Health Organization, along with current unmet needs for diseases and key populations. GARDP aims to achieve this by “developing assets in late stage clinical development and ensuring access,” the GARDP website explains.

The five categories of WHO priority pathogens include:

  • Carbapenem-resistant (CRAB): A. baumannii
  • Carbapenem-resistant (CRE): Enterobacteriaceae
  • Sexually transmitted infections
  • Children (paediatric antibiotics)
  • Neonatal sepsis

“Alarming levels of resistance are now reported in countries of all income levels, with the result that hundreds of thousands of newborns are dying of untreatable sepsis, and patients are suffering from gonorrhoea and serious bacterial infections that do not respond to any available antibiotics,” the release said. “While AMR has the highest burden in low to middle income countries, high income countries are also greatly affected.”

Image Credits: GARDP.