PEAH News Flash 383

News Flash Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

News Flash 383

 

Chronicle of a Pandemic Foretold – Learning From the COVID-19 Failure—Before the Next Outbreak Arrives 

WHO: Coronavirus disease (COVID-2019) situation reports 

Mixed outcomes at the ‘COVID-19 World Health Assembly’ 

WHO Director-General’s closing remarks at the World Health Assembly 

A strong call for COVID-19 treatments and vaccines to be global public goods – World Health Assembly 

Governments strike a deal on COVID-19 review, equal treatment access 

WHA: COVID-19 Resolution 

The Medicines Patent Pool welcomes the adoption of a landmark resolution at the 73rd World Health Assembly 

US missing, China takes leader spotlight at WHA 

China Announces US$ 2 Billion COVID-19 Initiative; US Assails China’s Pandemic Response; WHO Decries Global “Amnesia” About Epidemic Lessons 

US President Donald Trump Comes Out Punching Against WHO COVID-19 Response – Threatens Permanent Defunding In 30 Days 

US to back away from WHO move on Covid-19 drug patents 

WHA 73. United States of America Explanation of Position “COVID-19 Response” Resolution 

WHO to agree deal over future coronavirus inquiry 

WHO’s independent body recommends review to draw lessons from pandemic 

US and UK ‘lead push against global patent pool for Covid-19 drugs’ 

Realising the True Value of Integrated Care: Beyond COVID-19 

Cashing in on the pandemic: how lawyers are preparing to sue states over COVID-19 response measures 

Opinion: What does it take to stock a nation with medical supplies? 

What African Nations Are Teaching the West About Fighting the Coronavirus 

Health inequity during the COVID-19 pandemic: a cry for ethical global leadership  

Africa Needs a DOVE Fund: Or Should We Starve So We Can Pay our Debts? 

Coronavirus: World Bank warns 60m at risk of ‘extreme poverty’ 

Under cover of coronavirus, the world’s bad guys are wreaking havoc 

How COVID-19 Will Likely Affect Spending, And Why Many Other Analyses May Be Wrong 

Double epidemic could crash Latin America health systems 

New EU migration pact set for start of summer 

‘HIV, Universal Health Coverage, and the future of the global health architecture: A civil society discussion paper on key trends and principles for evolution’

Financing Biologic Product in Canada by Malek Ayoub

Diseases Are Neglected by the Pharmaceutical Industry by Luciana M.N. Lopes and Alan Rossi Silva 

To Restore Forests, First Start With a Seed 

 

 

 

Financing Biologic Product in Canada

...Because the reference biologic has already been developed, the corresponding biosimilar doesn’t require the same level of intensive research and development. As a result, biosimilars are priced competitively in some cases costing more than a third less. It has been estimated that biosimilars have the potential to generate about $740 million in savings per year for Canadian healthcare systems by 2021...

By Malek Ayoub

HTA | Market Access, Pricing & Reimbursement | Market Research, UK

Financing Biologic Product in Canada

 

 

Biologic product VS Biosimilar drug

·       Biologic product

It is a drug (medicines) made from living cells through highly complex manufacturing processes, and they are used to prevent, treat, diagnose, or cure a variety of serious and chronic illnesses including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. They must be handled and administered under carefully monitored conditions. Biologic drugs are generally larger and more complex than chemically produced pharmaceutical drugs.

·       Biosimilar product

 It is a similar product to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is known as a reference product and approved based on a showing that it is “highly similar” to an FDA approved biological product. Additionally, it may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product. Important to mention that the use of the biosimilar products is more cost effective because they offer therapeutic equivalence with original biological medicines for a cheaper costs.

Reference biologic drug

A biologic drug authorized on the basis of a complete quality, non-clinical, and clinical data package, to which a biosimilar is compared to demonstrate similarity.

Specification

A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance, drug product or materials at other stages of its manufacture should conform to be considered acceptable for its intended use.

Conformance to specification means that the drug substance and drug product, when tested according to the listed analytical procedures, will meet the acceptance Specifications are critical quality standards that are proposed and justified   by the manufacturer and approved by regulatory authorities as conditions of approval.

Biologic drugs in Canada

Health Canada works to maximize the safety and effectiveness of biologics, including vaccines and biotechnology products, as well as, radiopharmaceuticals in the Canadian marketplace and health system. Before a biologic can be considered for approval, sufficient scientific evidence must be collected to show that it is safe, efficacious and of suitable quality. Biologics differ from other drugs for human use in that they must include more detailed chemistry and manufacturing information in addition to the information required for other drugs. This is necessary to help ensure the purity and quality of the product, for example to help ensure that it is not contaminated by an undesired microorganism or by another biologic.

As part of the New Drug Submission process, biologic manufacturers must also supply Product Specific Facility Information that outlines the method of manufacture of the biologic in significant detail, since slight variations can result in a different final product. Further, an inspection of the manufacturing facility, known as an On-Site Evaluation (OSE), is completed to assess the production process and facility since these aspects also have a significant impact on the safety and efficacy of the product. If there is sufficient evidence to support safety, efficacy or quality claims for a New Drug Submission (NDS) or a Supplement to a New Drug Submission (S/NDS), the product is issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN) indicating that the biologic is approved for sale in Canada.

Biologics are then monitored by being placed on a lot release schedule tailored to their potential risk, manufacturing, testing and inspection history to date. With higher risk biologics, each lot is tested before being released for sale in Canada. Moderate risk biologics are periodically tested at the discretion of Health Canada while manufacturers of low risk biologics usually only need to contact Health Canada regarding lots being sold or for providing certification of complete and satisfactory testing. Products are carefully scrutinized before they are placed in any level of the lot release process, and at any time the testing regime for a biologic may be altered.

Health Canada, in collaboration with the Public Health Agency of Canada, also monitors biologic adverse events, investigates complaints and problem reports, maintains post approval surveillance, and manages recalls, as required.

HTA in Canada

For over 40 years, Canada has had a publicly funded, national health-care system designed to ensure residents receive “reasonable access” to “medically necessary” health-care services, regardless of their ability to pay. However, unlike many of its European counterparts, Canada’s system is a decentralized one, comprised of 13 separate provincial and territorial health insurance plans. Guided by common values and responsible for meeting basic standards of coverage, these plans determine how best to organize, manage, and deliver health care within their jurisdictions. Decisions regarding which new technologies to include in the basket of publicly funded services, therefore, rest with individual provinces and territories, and the role of the federal government remains primarily limited to premarket approval and, in the case of patented pharmaceuticals, price regulation. It has, however, retained responsibility for providing services to limited populations, such as veterans, the military, first nations, and inmates.

Canada’s history in health technology assessment (HTA), a field developed to support purchasing or coverage decisions, reflects the decentralized nature of the country’s health-care system. Its roots predominantly exist at the provincial level, with the establishment of the Conseil d’evaluation des technologies de la sante (CETS) which now called the Agence des technologies et des modes intervention en sante (AETMIS). At around the same time, a joint committee representing the federal, provincial, and territorial ministries of health identified HTA as one of its key priorities and announced the creation of a national, independent HTA body called the Canadian Coordinating Office of Health Technology Assessment (renamed the Canadian Agency for Drugs and Technologies in Health (CADTH) in 2006). Funded by the provincial, territorial, and federal governments, its mandate is to provide impartial, evidence-based information on the clinical and economic implications of drugs and other health technologies (including devices, procedures, and systems) to the 13 public insurance plans. Since then, HTA has played an increasingly important role in technology coverage policy in Canada.

With the demand for assessments exceeding resources available to the national HTA agency and the types of requests broadening to include context specific questions framed from perspectives other than that of society, the past 20 years have seen the emergence of local HTA initiatives in hospitals, regional health authorities, and provinces across the country. Now more than ever, decision-makers at all levels of government are investing in “institutionalized” HTA, creating a landscape shaped by a combination of ongoing national and local efforts.

Regulatory framework for Biosimilars in Canada

The following statements outline the fundamental concepts and principles of the regulatory framework for biosimilar in Canada: 

  • The sponsor is responsible for providing the necessary evidence to support all aspects of a biosimilar
  • A biosimilar sponsor is eligible to apply for the indication(s) and condition(s) of use that are held by the reference biologic drug authorized in
  • Biosimilars are new drugs subject to the Food and Drugs Act and Part C of the Food and Drug Regulations. The concepts and the scientific and regulatory principles within the existing regulatory frameworks for biologic, pharmaceutical, and generic pharmaceutical drugs are used as the basis for the regulatory framework for biosimilar.
  • The basis for accepting a reduced non-clinical and clinical data package for a biosimilar hinges  on demonstrated similarity between the biosimilar and the suitable reference biologic drug. A final determination of similarity will be based on the entire submission, including data derived from comparative structural, functional, non- clinical and clinical
  • Biosimilars are not “generic biologics” and many characteristics associated with the authorization process and marketed uses for generic pharmaceutical drugs do not apply. Authorization of a biosimilar is not a declaration of pharmaceutical equivalence, bioequivalence or clinical equivalence to the reference biologic
  • A biosimilar submission involves a comparison to another product. Hence all biosimilar are subject to the laws, and patent and intellectual property principles outlined within the Food and Drug Regulations Patented Medicines Regulations, and the Patent Act.
  • As a biosimilar is authorized using a reduced non-clinical and clinical package, it should not be used as a reference biologic drug for another biosimilar submission.

How the Biosimilars are regulated by Health-Canada? 

  • Biosimilars are regulated as new drugs under the Food and Drugs Act and the Food and Drug Regulations. Health Canada’s Biologics and Genetic Therapies Directorate (BGTD) regulates biosimilars in collaboration with the Regulatory Operations and Regions Branch (RORB) and the Marketed Health Products Directorate (MHPD). Health Canada has developed a robust, science-based regulatory framework for biosimilars that reflects many approaches adopted by other major drug regulatory agencies. Health Canada’s guidance document Information and Submission Requirements for Biosimilar Biologic Drugs communicates the regulatory framework for biosimilars and is intended to help manufacturers comply with the laws and regulations governing the authorization of biosimilars in Canada. Health Canada’s rigorous standards for authorization mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar as any other biologic

Reimbursement and pricing approval process in Canada

Pricing approval for brand pharmaceuticals in Canada is regulated by the federal government, through the Patented Medicine Prices Review Board (PMPRB). It acts in a regulatory capacity, to ensure that prices charged by patentees for patented medicines sold in Canada are not excessive. The price of non-patented drugs, such as generics, is not regulated by the PMPRB. Every strength of each dosage form of each patented medicine   sold in Canada, patentees are required to file price and sales information twice a year for price regulation purposes.

The reimbursement process in Canada is governed by a combination of federal, provincial and private plans. Through the publically-funded Medicare system, all Canadians and residents have free access to coverage for drugs, procedures, and physician services provided in hospitals.

Hospital drug formularies are under provincial purview. Outside the hospital setting, drugs are reimbursed to the majority of Canadians by private health insurance plans, either to employees and their families through employer group insurance, or to other persons and their families on an individual basis. Some vulnerable groups, such as seniors, welfare recipients, and native persons, are covered by specific provincial, territorial, or federal plans. Most plans involve co-payments and deductibles so that patients contribute to the costs of reimbursed medicines.

Importance of Biologics and Biosimilars

As originator biologic medicine patents expire, more biosimilars will come to market, which in turn will create more treatment options for patients and their doctors. Unlike generic pharmaceuticals, biosimilars are not exact copies of their originator biologic medicine. Since biosimilars and originator biologic medicines are not identical treatments, doctors can choose what’s best for their patients based on their needs. Experts have anticipated that a 20% to 30% price reduction from the reference biologic would create a viable biosimilar through increased patient access. This has the potential to impact what a patient pays out- of-pocket (OOP). Reductions in list price will impact patients in benefit design, such as high- deductible plans and co-insurance, where OOP costs are determined by a percentage of a medication’s list price instead of fixed co-payments.

As biosimilar are often used to treat long term diseases, like diabetes, multiple sclerosis, their use would clearly contribute to reducing the funding gap in the Canadian health system. Moreover, the use of biosimilar due to the competition what creates, not just allow access to a wider range of patients to certain therapies, but provides incentives for originator companies to invest more in developing a new biological medicines and therapies, which could result in cost saving for the future health system and deliver a more cost effective choices.

The current situation and challenges

Canadians are spending more on prescription drugs now than a few decades ago, the rate of growth of prescription drug spending has been getting incrementally smaller in recent years, the Canadian Institute for Health Information (CIHI) reported that public and private spending on prescription drugs grew less than a percentage point between 2013 and 2014, the smallest increase since spending was first tracked 40 years ago. Analysts attribute that development to the fact that drug patents have been expiring, paving the way for cheaper generic versions. But analysts also say it’s too soon to pop the cork on the champagne  bottle.

Because the biologic products developed out of living organisms, they are more expensive than conventional drugs and data shows they constitute 14 percent of drug spending in Canada at a cost of $3 billion per year. Between 2008 and 2013, public drug program spending on one class of biologics (anti-TNF drugs) used to treat rheumatoid arthritis and Crohn’s disease increased by $233.8 million in Canada.

The future perspective

By knowing that the biosimilars can differ slightly in structure from their reference biologic products, but demonstrate no clinically meaningful differences and provide a safe treatment option for patients. A growing number of health care providers in Canada started pointing to a possible solution to the high cost drugs.

Because the reference biologic has already been developed, the corresponding biosimilar doesn’t require the same level of intensive research and development. As a result, biosimilars are priced competitively in some cases costing more than a third less. It has been estimated that biosimilars have the potential to generate about $740 million in savings per year for Canadian healthcare systems by 2021.

Dr. Arthur Karasik, President of the Ontario Rheumatology Association, says he is “cautiously optimistic” about the future of biosimilars. He predicts the use of biosimilars will increase as they get positive results in additional clinical trials. Karasik adds that the majority of patients have little knowledge about biosimilars and he emphasizes the importance of educating them to gain more information and knowledge. As a result of inventing more and more biosimilars and making them available in the market, less money will be spent on prescription drugs, and the saved money could be spent in other areas of health care, making the entire system more sustainable.

Recommendations

Stakeholders have recommended that Health Canada should review data that support therapeutic interchangeability (switching prescription from the biologic to biosimilar drug), after conducting researches and clinical studies that prove the equivalence of the impact of these drugs. In case of a biosimilar is approved clinically comparable version of the reference product, biosimilar product should be considered as interchangeable. With this, payers would be able to save significantly more money.

The World Health Organization (WHO) collaborates closely with International Non- proprietary Name (INN) experts and national nomenclature committees to select a single name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical. To avoid confusion, which could jeopardize the safety of patients, trade- marks should neither be derived from INNs nor contain common stems used in INNs. Therefore, Canadian biosimilars should use the same INN as their reference product that serve as important indicator to physicians and pharmacists that the active substances of both products are comparable.

 

References

Diseases Are Neglected by the Pharmaceutical Industry

‘The concern about access, so far, has not yet been incorporated into research for treatments or vaccines for COVID-19, despite significant pressure from civil society’.

 The several years of indifference to the reality of people affected by neglected diseases seem to have created one of the greatest obstacles to the coronavirus pandemic control. By accepting that new health technologies were determined by Big Pharma's economic interest at the expense of millions of people’s lives, we’ve naturalized our lives pricing and the understanding of health as a commodity - and an expensive one! So now we are forced to ask ourselves: when the coronavirus vaccine comes out, will my family and I have access to it? Will we and our health systems be able to buy the drug?

image credit: Centers for Disease Control and Prevention (CDC)

By Luciana M. N. Lopes and Alan Rossi Silva*

 Translated by Luciana M. N. Lopes and Alan Rossi Silva

Originally published at Le Monde Diplomatique Brasil

 

Diseases Are Neglected by the Pharmaceutical Industry

 

Another day. Many thoughts I can’t avoid. Do I need to be isolated? Is my family at risk? Will I have any sequelae? Will I lose my job? If so, how’d we live? Will I run out of food? If I go to a hospital, will they look after me? Will someone look down on me on the streets? What if someone gives me some drug? Hasn’t anyone invented a better medicine that can fix one thing without ruining another one? What about this vaccine that hasn’t come out? When is it being launched?

Fear. Anxiety. Anguish. The wait. Many people living with neglected diseases have been dealing with for a long period of time – sometimes for a lifetime, feelings the whole world got to share in recent weeks.

According to the World Health Organization (WHO), every year, around 1.5 billion people (20% of the world population) in more than 140 countries need interventions against Neglected Tropical Diseases (NTDs). We’ve heard of several of them: leishmaniasis, leprosy (Hansen’s disease), Chagas disease, schistosomiasis, among others, which disproportionately affect populations and regions in social vulnerability. These diseases are so called by not being of great interest to the pharmaceutical industry that does not see sufficient economic return to spur its commercial interest for Research and Development (R&D).

Imagine that: you wake up, make a coffee and open the newspaper. A headline pops up: ‘research and development of COVID-19 vaccine is canceled due to lack of economic interest’. It’s true that this scenario seems difficult to imagine. After all, researchers, governments, companies, nonprofits and several other actors are in a race against time to make new technologies available that could change history and the story of the coronavirus pandemic. According to the Milken Institute mapping, there are more than 90 development studies for treatments and more than 50 for vaccines. Every day, a flood of news has been published on the subject, and apparently, we’re getting closer to a solution for this new disease.

Quickness

A quick launch of a vaccine or a proper treatment against COVID-19 would make all our lives easier, but especially lives of people like Nancy Dominga: ‘I’m between my life and my job. And between my life and my job, I’ll pick my life and I’ll stay at home’. She is in a risk group for COVID-19 because she has heart issues – sequela of a disease that hasn’t been controlled in many parts of the world, despite being around for 111 years: Chagas disease.

Like COVID-19, many NTDs affect entire families. Nancy lost four beloved ones to Chagas disease, which kills around 14,000 people a year in Latin America. There are between 6 and 7 million infected people in the region, but less than 10% of them are diagnosed and less than 1% receive treatment at the appropriate time. There is no vaccine. And both available drugs are over 50 years old, have efficacy limited to early stages of the disease and show relevant adverse effects.

We’re all worried about our grandparents, parents, uncles, aunts, friends and colleagues who are in a risk group for COVID-19. We want society to get mobilized and provide social and economic conditions so our loved ones can stay at home and have no need to expose themselves to be at risk of infection. So, can you imagine knowing that someone you love is in a risk group precisely because she or he was exposed to society’s indifference?

This abandonment is historical. There are diseases that are still important today, such as leprosy (there were more than 200 thousand new cases in the world only in 2018), that have caused suffering for – literally – millennia. As if the anguish of waiting for an effective, safe and quality treatment that never comes was not enough, these neglected people often additionally suffer from the prejudice of an ill-informed society.

Neglected diseases

And it was thinking of it that, in 2016, the Brazilian Social Forum to Confront Neglected and Infectious Diseases was created as a collective of movements, organizations and individuals that fight in defense of the right to health of people and communities affected by and/or living with infectious and neglected diseases. Eloan Pinheiro, former director of the Institute of Drug Technology (Farmanguinhos) in Brazil and one of the founders of the Forum, points to the initiative as an important space to share knowledge, combat discrimination and fight for public policies that can change the reality of these people.

She warns us that the struggle for NTDs drugs and for their cure is crucial but not enough: new people will get infected if deeper causes of these diseases, such as poverty and lack of adequate housing, are not addressed. When referring specifically to the need for new NTDs drugs, Eloan invites us to think outside the box: ‘It’s not enough to just have the drugs, it’s necessary to fight for a financial fund to study new products, diagnostic kits and vaccines, using even local knowledge of medicinal plants. It’s necessary to dare leave the traditional Big Pharma product development scheme’.

We need indeed to seek different paths – especially because we’re dealing here with diseases and people which are invisible to our traditional social structures. COVID-19, on the other hand, ‘has a very different profile from neglected diseases regarding its visibility, its presence on the public agenda and the attention it gets of the media’, says Francisco Viegas, the Latin America Advocacy Advisor for a non-profit drug R&D organization for NTDs: the Drugs for Neglected Diseases Initiative – DNDi. Francisco also points out that the fact that COVID-19 reaches rich Countries and ‘in addition to a large market horizont for new health tools, arouses the interest of multiple actors in searching for solutions’.

While in 2018, according to the G-Finder Report, the global funding for basic research and product development for NTDs from 262 entities reached a record amount of US$ 4.05 billion, Johnson & Johnson and the US government alone have pledged to co-invest more than US$ 1 billion in a COVID-19 vaccine R&D. If, on the one hand, knowing that there are several actors – including Big Pharma – in search of technologies for COVID-19 brings some relief, on the other hand, it turns on a warning light: if there’s economic interest in saving my life, how much does it cost?

Access

Having worked for 15 years with a R&D model alternative to the one traditionally adopted by the pharmaceutical industry, Francisco highlights that ‘DNDi considers that its innovative treatments must reach all countries and patients who need them, that’s why we work with the notion of ‘public good’. It means that they ideally have no patent protection and have price affordability guarantees’. Despite the fact that a great number of studies against the new coronavirus has adopted collaborative approaches in order to speed up investigations – just as DNDi usually does -, Francisco warns us: ‘the concern about access, so far, has not yet been incorporated into research for treatments or vaccines for COVID-19, despite significant pressure from civil society’.

The several years of indifference to the reality of people affected by neglected diseases seem to finally collect their debt. All this time we’ve tolerated an unfair incentive system for health innovation may have created one of the greatest obstacles to the coronavirus pandemic control.

By accepting that new health technologies were determined by Big Pharma’s economic interest at the expense of millions of people’s lives, we’ve naturalized our lives pricing and the understanding of health as a commodity – and an expensive one! So now we are forced to ask ourselves: when the coronavirus vaccine comes out, will my family and I have access to it? Will we and our health systems be able to buy the drug?

The good news is that the COVID-19 pandemic, exactly by collecting our debts from the past, is also giving us the opportunity to stop, think, catch up on our obligations and put our house in order. Giving visibility to the reality of people affected by NTDs during the current crisis doesn’t mean to establish a hierarchy among the diseases. It’s quite the opposite. It’s the strong statement that we won’t be able to overcome this challenge if we continue to accept a system that ignores the suffering of millions of people as if they were less valuable and their needs were less urgent.

Epidemics and diseases, regardless of our will, will continue to emerge. What we can change is how we look at those affected by all of them and how we face them. It’s precisely at this moment when humanity is called to fight an invisible enemy that we have the unique opportunity to notice the silenced reality of those who have waited, for a long time, to be seen.

 

 

————————————————-

*Luciana M. N. Lopes is a PhD student in Public Health at the Federal University of Minas Gerais (UFMG) and Alan Rossi Silva is a PhD student in Law at the State University of Rio de Janeiro (UERJ), in Brazil. They represent the Universities Allied for Essential Medicines (UAEM), a student-driven organization in defense of universal access to medicines and a fair biomedical innovation system.

PEAH News Flash 382

News Flash Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

News Flash 382

 

WHO Member States Agree On Draft Resolution For COVID-19 Response – Overriding US Objections to ‘Equitable Access’ 

MSF at the 73rd World Health Assembly 

Bernie Sanders, Ilhan Omar, Carlos Menem, Yanis Varoufakis & Richard Durbin and 300 other lawmakers call for a cancellation of developing world’s’ debt – Washington Post

Will donors finally agree on fair rules for reporting debt relief as ODA? 

How sustainable are the SDGs? We need more development, not post-development 

Why Some National Health Care Systems Do Better than Others 

NEW deadline for GHW6 case studies – Nov 30 

Life Expectancy Increased, But COVID-19 Threatens Gains 

The Digital Migration: Lessons About Open Science Arising from the COVID19 Crisis 

G2H2 Civil society meeting ahead of WHA73 Friday, 15 May 2020, 15.00-17.30 hrs CEST. A World Health Assembly in times of a dual crisis: Covid-19 and the collapse of multilateralism as we have known it 

IS SPACE CLOSING FOR CIVIL SOCIETY IN GLOBAL HEALTH? 19 May 2020, 16:00 – 17:30 73rd World Health Assembly Week 

Coronavirus disease (COVID-2019) situation reports 

Postscript – The World at Risk: Covid-19, Global Sustainability and 1 HOPE by George Lueddeke 

Back to Basics – Lessons Learnt from COVID-19 Pandemic by Meenakumari Natarajan 

Reflections on the COVID-19 Crisis: Smart Lockdown by Muhammad Usman Khan

Universities announce a One Health Center 

Covid-19 in Greece 

Covid-19 pandemic and refugees, asylum seekers and migrants in Greece: a public-health necessity to prioritize their comprehensive care 

In The Fight Against COVID-19, It’s Not Too Late to Fix America’s Public Health System 

As Gates Foundation Keeps Up COVID-19 Fight, Here are 3 Things to Know

Protecting Women’s Reproductive Health During the Pandemic 

The COVID Pandemic and the WHO: Need for Reflection and Global Solidarity 

Low-paid workers more likely to die from Covid-19 than higher earners 

COVID-19 MUST NOT JEOPARDISE THE FIGHT AGAINST MAJOR KILLER DISEASES 

Maintaining and prioritizing HIV prevention services in the time of Covid-19 

The potential impact of the Covid-19 on tuberculosis in high burden countries 

Unicef: 6,000 children could die every day due to impact of coronavirus 

Cascade of continuous HIV care for MSM in five countries  of the EECA region   

Does the use of low-dose antibiotics in livestock put human health at risk? 

Catching fog and other creative solutions for clean water access 

Brazil deploys thousands of troops to protect Amazon’s trees 

Deadly humidity events accelerating – study 

 

 

 

 

Reflections on the COVID-19 Crisis: Smart Lockdown

The critical discussion of weak immune systems and chronic illnesses catching up to us in an acute infection should be at the heart of the public health discourse at these COVID-19 pandemic times. The lack of promotive and preventive dimensions of public health will continue to deliver such crises in the future and even when those crises emerge we should remember that lockdown is not a real policy option. A lockdown makes sense if we are caught off guard and we are biding time to create policy solutions. Quarantine and selective isolation are the key public health interventions, not lockdown
Country Officer at Institute for Health Metrics and Evaluation
Lahore, Pakistan

Reflections on the COVID-19 Crisis: Smart Lockdown

 

 

The various strategies laid out by experts in Pakistan are focused on a tiered approach whereby neighborhoods will be locked down and the extent of lockdown will be determined by the number of cases identified. These strategies miss the mark on one very important aspect: Locking down neighborhoods can create concentrated pockets of infection given that social distancing and hand hygiene cannot be enforced at such a micro-level. Additionally, 40% of the country does not have access to water and soap at home. These proposed ‘smart’ lockdown will, therefore, increase the probability of transmission of the virus to the most vulnerable population (elderly who are at home and those with chronic illnesses).

The issue of identifying what constitutes a neighborhood notwithstanding, let’s say a pooled test identifies a certain neighborhood where the infection is present. Further testing reveals the need for a lockdown- you lock down the area for 14 days but due to poor understanding of social distancing and hygiene- the virus keeps spreading in that neighborhood. You do a follow-up test after 14 days. You don’t find a positive test. The probability of this follow up test being a false negative is somewhere in the range of 0.25 to 0.30 (some have pegged it even higher). This might be due to poor viral load (early phase of infection) or low sensitivity of the kit. Either way, the uncertainty around opening this neighborhood is immense. So, are we going to continue to shut down these neighborhoods over and over again? Given the amount of deprivation that most of these neighborhoods face- we face a catch 22: data shows that deprived population is at a higher risk of dying from COVID-19 and simultaneously they face the health threats that emerge from poverty (which is the biggest precursor to poor health) as well as diseases of despair. So what is the point of the lockdown if it is not crunching the virus and is increasing the health burden due to forgone healthcare and income?

Through seroprevalence testing, we know that the actual prevalence of the disease is on an order of magnitude 30 to 85 times higher than reported cases in the west. Although antibody testing has its limitations given its specificity and sensitivity, these can be accounted for through rigorous methodology as well as through adding appropriate weights in the statistical analysis. The concerns around the accuracy of the test also abound when it comes to the RT-PCR test being used to identify people infected with SARS-CoV-2 but we have circumvented that problem through repeat testing and testing at different points during the incubation and disease phase. Furthermore, the antibody doesn’t capture those who fought off the virus without an antibody response, which means the prevalence may even be higher, it is still offering key insights. This higher prevalence is good news as it shows that we had grossly overestimated the fatality rate. Given our population density and strong person to person network- it would be fairly safe to assume that the prevalence is much higher than cases reported. This should also be obvious given our limited testing capacity. Lockdowns are effective because they create the necessary social distance required to reduce transmission and that too if implemented in the earliest phase of the epidemic. It is very difficult to ensure with accuracy the exact time when a viral epidemic of respiratory infection has started in a region. Positive tests are not the same thing as the incidence of the disease so what testing reveals is not the epidemic curve but rather (crudely speaking) number of tests done. By the time the first death was reported in NY- it had already been a month since the virus was in circulation.

The critical discussion of weak immune systems and chronic illnesses catching up to us in an acute infection should be at the heart of the public health discourse right now. The lack of promotive and preventive dimensions of public health will continue to deliver such crises in the future and even when those crises emerge we should remember that lockdown is not a real policy option. A lockdown makes sense if we are caught off guard and we are biding time to create policy solutions. Quarantine and selective isolation are the key public health interventions, not lockdown.

The virus has to complete its cycle- you can spread the deaths by flattening the curve but you can’t avoid them via lockdown. The way you can partially avoid them is through herd immunity that is achieved by exposing healthy individuals to the virus. Yes, some healthy individuals will have negative outcomes- but unfortunately, some healthy individuals will always have negative outcomes. We have to assess this risk against the day to the day background risk of life. The COVID-19 death risk in people <65 years old is equivalent to the death risk from driving between 13 and 101 miles per day for 11 countries and 6 US states. The younger you are the lesser the risk. Those who say that there is no evidence for herd immunity confuse what WHO has stated. The absence of evidence is being read as evidence of absence. We have enough precedent in terms of fighting off coronaviruses and other viruses to reasonably assume that herd immunity is the most likely outcome. If herd immunity is not possible then a permanent lockdown till we die of some other ailment is in order – as the implication is that vaccines would also be ineffective.

Based on the best data available we need to:

· Revisit pandemic models that were developed in a situation of limited data and critically identify their shortcomings instead of continuing to follow their results. Find updated international models to serve as a proxy for local policymaking

· Isolate those facing the highest risk (elderly, those with chronic conditions and immuno-compromised)

· Identify areas that can promote super-spreading of disease (mosques, bus stops) and institute social distancing mechanisms there. We need smart usage of law enforcement and our limited public health infrastructure.

· If the government wants to pursue a test, trace, isolate (not lockdown) strategy- the quality of the test has to be improved and the time for processing of the test has to be reduced drastically to isolate before further transmission.

· Isolation SOP’s (Standard Operating Procedures) need to be developed for the layman and should be tested before implementation.

· Roll back the lockdown by opening the society to the least at-risk population. The stronger the immune systems of those being exposed to virus the lesser the probability of transmission and the lesser the intensity of the illness. In this vein, keeping the schools closed is counterintuitive. Keeping the schools closed seems to be a political decision rather than a technical one.

· Start a nationwide educational campaign on public health spanning issues such as building a stronger immune system, social distancing measures, and hygiene.

· Start an educational campaign on the strategic and safe use of masks that avoids cross-contamination. Though there is mixed evidence on the efficacy of masks- they can be (if cross-contamination and a false sense of security can be avoided) a constant reminder to stay vigilant.

· Concomitantly, establish clean water units and start a countrywide soap dispensing campaign

· Poor immune system and spread of much of the infectious diseases in Pakistan can be attributed to poor sanitation. Improvement of sanitation facilities will make the population resilient towards infectious diseases and greatly reduce the overall burden of diseases in the country. Much of the increase in life expectancy over the last 100 years is attributed to non-medical public health interventions such as hygiene and improved sanitation.

Back to Basics – Lessons Learnt from COVID-19 Pandemic

In the current pandemic scenario, public health experts need to look at the establishment of animal health care and the strengthening of an ecosystem where human and animal will live congruently to protect human health. This integrated, holistic and harmonious approach to protecting human health is referred to as one world one health, a name coined by the wildlife conservation society. A better understanding of the ecosystem is needed to protect public health

By Dr. Meenakumari Natarajan, MPH.Ph.D

Health Economist, Epidemiologist

Scientist-C-National Institute of Epidemiology (NIE-ICMR), Chennai – India

 Back to Basics 

Lessons Learnt from COVID-19 Pandemic

 

In this postmodern world, matching pace with the world’s growth and securing a place for oneself, our complicated life is burdened with the fear of new, sometimes anonymous diseases which are growing drastically, and it is a major concern for research. One such disease is COVID-19. The world is becoming small, national borders are diminishing by recent developments in all sectors. More people travel or trade across the global. Our ecosystem also includes forest, sea and space. With all these changes it is becoming easier for diseases have jumped from animals to human.

The viruses find ways to jump from species to species. Jumping from one species to species is a good survival strategy for viruses like swine flu virus, HIV, now coronavirus.  COVID-19 is a relatively new virus. It has only recently jumped to human which is part of the reason. Viruses need hosts and that jumping among hosts is good for viruses but often not so good for hosts. In recent days scientists have made amazing and wonderful progress in tracing the origin of COVID-19: found bats were indeed involved. (Kock, Karesh et al. 2020)

At present mankind is facing many challenges, which will require globally integrated solutions. The spread of infectious diseases that jumped from animals to human was mainly by the interface in the ecosystem which they live. In the preindustrial phase, birth and death rate were similar, the world was balanced fluctuated conferring to natural events like droughts and disease. Unfortunately, the invention of new techniques and procedures caused the death rate to decline further resulting in a population explosion. Millions of animals were hunted to feed billions of people. It is important to note, that the present evidence that exponential growth of population, urbanization, modernization of the farming system all made encroachment of forest and closer interaction of wildlife thereby exposing humans and domestic animals to new pathogens.

In this scenario, public health experts need to look at the establishment of animal health care and the strengthening of an ecosystem where human and animal will live congruently to protect human health. This integrated, holistic and harmonious approach to protecting human health is referred to as one world one health, a name coined by the wildlife conservation society. A better understanding of the ecosystem is needed to protect public health.

World history is plagued with wars, boycotts, violence, and pandemics; however, death and health are shaken by uncontrolled pandemics such as COVID-19. Many countries have done enormous effort to contain COVID-19 such as early diagnosis, contact tracing, contact isolation, quarantine, social distancing, temporary hospital construction, financial support to citizens, closing the national borders, cutting off transportation intra and international etc.. This increases many additional issues such as global economic loss, Economic recession, economic slowdown and supply chain cut off. At present we do not have any clear-cut structure or strategy to confront a future global pandemic and economic crisis. (Pan, Ojcius et al. 2020).

Now the world is moving towards health promotion, disease prevention and it cannot be achieved by alone. It requires support from other sectors such as education, agriculture, industries etc. It requires cooperation and partnership across the disciplines. It is time for the world to review their pandemic plans to address pandemic preparedness in their business plans Many countries have started, tested and updated their plans to reduce the negative impact of a pandemic on the industry, economy, education, ecosystem and health. (Chakraborty and Maity 2020)

However, in line with the ideas of harmonious life with the ecosystem, it can be concluded that this is time for us to Revisit, Revise, Restructure, Reform, and Rebuild ourselves to counteract future crisis.

 

References

  1. Chakraborty, I. and P. Maity (2020). “COVID-19 outbreak: Migration, effects on society, global environment and prevention.” Sci Total Environ 728: 138882.
  2. Kock, R. A., W. B. Karesh, F. Veas, T. P. Velavan, D. Simons, L. E. G. Mboera, O. Dar, L. B. Arruda and A. Zumla (2020). “2019-nCoV in context: lessons learned?” Lancet Planet Health 4(3): e87-e88.
  3. Pan, X., D. M. Ojcius, T. Gao, Z. Li, C. Pan and C. Pan (2020). “Lessons learned from the 2019-nCoV epidemic on prevention of future infectious diseases.” Microbes Infect 22(2): 86-91.

 

PEAH News Flash 381

News Flash Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

News Flash 381

 

Webinar registration: The COVID Pandemic and the WHO: Need for Reflection and Global Solidarity, May 8, 2020 

Weekly COVID-19 Pandemic Briefing – The Geopolitics of the Coronavirus 

 WHO: Coronavirus disease (COVID-2019) situation reports 

‘Finding The Balance’ In Saving Lives & Livelihoods From COVID-19 – Charting Ways Forward In Africa 

WHO: EU draft for WHA on “COVID-19 Response” lacks clarity 

What does the EU’s pledging event on May 4th, to fight COVID-19 actually mean for global health? 

Is ODA up to the challenges posed by the coronavirus pandemic? 

The Economic Impact of COVID-19 around the World: Projections of Economic Growth Falling Further, Food Insecurity, and A Round-Up of Other Recent Analysis 

Interactive: An analysis of COVID-19 funding in West and Central Africa 

Urgent steps are needed to define how COVID-19 medical tools can really be “global public goods” 

Needed: a pandemic patent pool 

March-In Rights And Compulsory Licensing—Safety Nets For Access To A COVID-19 Vaccine 

Public health must be strengthened for a healthy post-COVID world 

Il silenzio degli innocenti 

The One Health Initiative: The Collaboration Between Human and Animal Medicine 

Staying Sane during COVID-1: Mental health resources for ourselves, others, and the world 

The COVID-19 Pandemic And Rural Hospitals—Adding Insult To Injury 

Global Humanitarian Response Plan COVID-19: Information update (1 May 2020) 

Yes, COVID-19. But what about other infectious diseases? 

Microbe that blocks malaria identified in mosquitoes 

Economic evaluation of short treatment for multidrug-resistant tuberculosis, Ethiopia and South Africa: the STREAM trial 

TB and Covid-19 Interactive maps 

UN response to Haiti cholera epidemic lambasted by its own rights monitors 

Reducing antibiotic use in livestock, China 

Sudan criminalises female genital mutilation (FGM) 

Record child displacement figures due to conflict and violence in 2019: UNICEF 

A Global “Hunger Pandemic” is Coming. Who’s Giving to Keep People Alive?

‘Big push’ on food security as COVID-19 response enters second phase 

Food insecurity in West Africa could leave 43 million at risk as coronavirus hits 

EU weighs options for gas grid in zero carbon world 

Energy firms rally behind green stimulus call 

Billions Could Live in Extreme Heat Zones Within Decades, Study Finds 

 

 

 

Postscript – The World at Risk: Covid-19, Global Sustainability and 1 HOPE

Postscript piece here by George Lueddeke is just an addition - an update to an article by him first posted on PEAH in March this year. Publishing it further to the article may be of help to reinforce proactivity and awareness governments and policymakers desperately need in preparation for post-Covid-19. Given the devastating worldwide effects of the pandemics, no wonder, indeed, global and national leaders are urged to collaborate and adopt sustainability values and measures without delay to save the world from itself.

Comments on the article and postscript are welcomed – glueddeke@aol.com

By George Lueddeke PhD, MEd, Dipl. AVES (Hon.)

Chair, One Health Education Task Force and the international One Health for One Planet Education initiative (1 HOPE) 

(One Health Commission and the One Health Initiative)

POSTSCRIPT

The World at Risk

Covid-19, Global Sustainability and 1 HOPE

The article published on 25 March 2020 reported data that totally underestimated the devastating global effects of Covid-19. Since that time the pandemic has forced more than 30 million Americans alone to lose their jobs, far exceeding the 25 million job losses worldwide predicted by the United Nations. Indeed, projections are now that close to 200 million people could end up without work globally – ten times the March prediction with over 80% of the global workforce of 3.3 billion people having had their workplace fully or partly closed. Business is in freefall with several countries (e.g., France, Italy) already in recession and GDP possibly collapsing by as much as 12 percent across the Euro area as shoppers stay indoors. The possibility of a global depression similar to the 1930s is very real. While the coronavirus antiviral drug remdesivir looks promising, many scientists agree that it may not be a “game-changer” for most patients, and the hunt is on for a long-term solution to the global crisis. Over 100 clinical labs are conducting intensive research – most collaboratively- to develop a vaccine that would provide protection for billions of people with Oxford University and Imperial College leading the way in the UK.

The impact of Covid-19 has been devastating with the total number of cases across the world now moving toward 4 million (May 3) and most of the more than 254,000 deaths in the US (c. 66, 000), followed by Spain (c. 25,000), Italy (29,000) and the UK (c. 30,000). On a cautiously  more positive note, in some  countries the cases  may have peaked in April and governments have begun to ease restrictions on social distancing as concerns remain over  the psychological effects of those (especially the elderly and young) forced to remain indoors and away from family and friends.

Covid-19 was not unexpected as key reports in the US (e.g., independent Commission on a Global Health Risk Framework for the Future [GHRF], 2016; Harvard’s Global Health Institute report, Global Monitoring of Disease Outbreak Preparedness: Preventing the next Pandemic, 2019) all  reached similar conclusions as the GHRF:  “a flu pandemic could kill millions, cost trillions, and derail the global economy.”  In the UK the possibility of a pandemic was considered a “level five” threat-war-gamed in October 2016. Notably, the Global Preparedness Monitoring Board in 2019 also alerted governments to scale up “research and development for new vaccines and medicines.” Its chair, Dr Gro Harlem Brundtland, formerly Prime Minister of Norway and Director-General of the World Health Organization, lamented that world leaders’ response to an impending crisis was “a cycle of panic and neglect.”

The questions on everyone’s mind are ‘when will the pandemic be over?’ and ‘what changes will need to be put in place to create a new “normal,”?’ –  one that mitigates the probability of a pandemic reoccurrence, and other possibly future crises.  As someone recently said, the “old normal” was never “normal,”  not when we have regions and countries, for example, Africa and India – with over 1 billion people each – excluded as permanent members of the United Nations Security Council (UNSC), the UN’s most powerful body that  has ‘primary responsibility for the maintenance of international peace and security’ but seems to be in a state of  Covid-19 ‘paralysis,’  when we are driving species to extinction at about 1000 times baseline rates, while decreasing vertebrate animals by more than  50% in the past two generations. And, definitely not when social injustices and inequities are allowed to continue  (e.g., the Syrian conflict – creating ‘one of the worst humanitarian crises of our time’ with millions killed or forced to flee their homes now facing Covid-19,  and, globally, 4.5 billion out of c 7.8 billion without safe sanitation). Can we really continue on a planet where annual funding for conflicts and wars (c. US $13 trillion) is prioritised over peace (c. US $ 6 billion) with on-going attempts to reduce even this amount?  And, can we simply ignore the latest metaphorical re-setting of the Atomic Clock (threats to humanity – e.g., nuclear weapons, climate change, pandemics) by the members of the Bulletin of the Atomic Scientists, from 2 minutes to midnight in 2018 to 100 seconds in January 2020?

In terms of responding to the question on the length of the pandemic raised in the previous paragraph no one really knows the answers and will largely depend on how well people follow government guidelines on keeping safe. Unfortunately, many of the most vulnerable living in the poorest conditions will not have any guidelines to follow and will be at greatest risk to themselves and their families and indeed the world. Their plight will need to become a top global priority as we strive to build  a new “normal” and the adoption of  a global new mindset – re-orienting society  from its main concern for itself and separate from and superior to nature (anthropocentrism or humancentrism) – the root causes of most global problems today!- to one that respects and protects the sanctity of all life and the sustainability of the planet (ecocentrism). Transdisciplinary education (holistic learning!) – across all formal and non-formal levels – that demonstrates a much greater concern for the future – remains our best hope for transforming society in the longer run.

In the immediate, the sage advice offered by Angel Gurria, OECD Secretary General, is well worth noting as governments plan for a new “normal”.  In a piece entitled “Tackling the coronavirus (Covid-19) crisis together: Contributing to a global effort,”  he  contends  that in the post-COVID world

“…governments have a unique chance for a green and inclusive recovery that they must seize – a recovery that not only provides income and jobs, but also has broader well-being goals at its core, integrates strong climate and biodiversity action, and builds resilience. Stimulus packages need to be aligned with ambitious policies to tackle climate change and environmental damage. Only such an approach can deliver win-win-win policies for people, planet and prosperity.”

Applying lessons from previous crises, the Secretary General’s recommended strategies include the need to

  • align ‘the short-term emergency responses to the achievement of long-term economic, social and environmental objectives and international obligations (the Paris Climate Agreement, the SDGs)’;
  • prevent ‘lock-in of high-emissions activities’ while focusing  ‘support on the most vulnerable countries’; and
  • ensure the systematic integration of ‘environmental and equity considerations into the economic recovery.’

His concluding comment that ‘Protecting the planet is the most important inter-generational responsibility we have today’ is one that must be taken very seriously by all decision-makers.   Significant steps in this direction would be reversing decades of undervaluing and underfunding (5%: 95% ratios) public health measures at the expense of treatment and increasingly unaffordable cures. Extending the meaning and responsibilities of public health to embrace not only human health and well-being but also all species is another critical advance.  In this regard, bringing human and veterinary medicine more closely together (education, research, practice) would not only reduce costs but most importantly also lead to building our capacity for ensuring the sustainability of life on earth. Over 70% of all emerging diseases today are of animal [zoonotic] origin. Covid-19  is the most recent and likely one of the most devastating pandemics  in the past century, and  to save the world from itself,  global and national leaders – regardless of  political persuasion or ideological leanings – are urged to collaborate and adopt sustainability values and measures without delay.

In the final analysis, will any of our differences or divisions that we have created matter on a planet potentially devoid of life?

 

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Comments on the article and postscript are welcomed – glueddeke@aol.com