On Reforming U.S. Healthcare

...there is a novel straightforward way to reduce U.S. healthcare costs and increase choice at the same time: 

- Require all U.S. Federal & State government agency and employer payments for healthcare to go directly to the beneficiaries of those payments on a per person or per- family basis that is tax-free. 
- Permit insured persons to decide how and which insurer and providers to pay for healthcare.

Doing this alone will bend the cost curve downward, reduce the healthcare bureaucracy and enable folks to freely select their own doctors as so-called conservative thought claim to champion. For persons unable to handle this responsibility on their own, say, due to their medical or mental limitations, the government (e.g., Medicare/Medicaid) would be the decision-making backstop...

By Larry J. Pipes, Ph.D.

Management Strategist and Consulting Professional, Los Angeles, CA

On Reforming U.S. Healthcare

Healthcare is the largest industry in the world, and in the U.S. healthcare absorbs nearly 20% of annual GDP. In 1960, U.S. Healthcare’s take out of our GDP was 5.01%.¹ Today other developed countries with which the U.S. companies compete spend less than 13% of their GDP on healthcare. Just think for a moment how better off the U.S. economy would be if U.S. healthcare costs were in line with healthcare spending by other developed nations (i.e., it would mean more money for worker salaries, business investments and shareholder profits to say the least). By this measure the U.S. pays a premium of about 7% of GDP for healthcare. A contributing factor for increases in healthcare consumption by U.S. citizens is subsidies² by employers and government agencies that arrange/pay-for healthcare service for employees & beneficiaries of government programs. Among other things, these subsidies affect consumers’ consumption choices re healthcare.

Now nowhere in the world has healthcare ever been produced or operated under a free market competitive system, so let’s quickly dismiss notions of capitalism as a sole solution. In 1963, economists Kenneth Arrow who later won a Nobel Prize offered a simple explanation for why free markets won’t work in healthcare:

Huge information & power mismatch between the buyer and seller.

Although economic theory of competitive markets rightly implies that if a seller, say, wants to sell a particular TV, a buyer can accept, choose another brand or simply walk away. But if physicians order particulars medicines, procedures or operations, patients are far less likely to just walk away thinking about it.

Now there is a novel straightforward way to reduce U.S. healthcare costs and increase choice at the same time:

Require all U.S. Federal & State government agency and employer payments for healthcare to go directly to the beneficiaries of those payments on a per person or per- family basis that is tax-free.
Permit insured persons to decide how and which insurer and providers to pay for healthcare.

Doing this alone will bend the cost curve downward, reduce the healthcare bureaucracy and enable folks to freely select their own doctors as so-called conservative thought claim to champion. For persons unable to handle this responsibility on their own, say, due to their medical or mental limitations, the government (e.g., Medicare/Medicaid) would be the decision- making backstop.

This novel idea would require health care suppliers (insurers, providers and product manufacturers) to compete directly for consumers/customers/patients business. For example, life, auto, home insurance markets aren’t dependent on third-parties to direct or limit which insurer consumers can or must select. Third-party interventions into market decisions via subsidies to consumers usually increase prices for not the best reasons.

Letting folks decide how to spend their own money is the sort of freedom actual conservatives and liberals alike should abide — right? Now this idea is not to imply the U.S. should do away with Medicare, Medicaid and employer sponsored healthcare plans as those who work for these government agencies and human resource departments are not trivial actors in the whole scheme of things.

On the other hand, if Americans want the current healthcare system fixed, they have only to elect and unambiguously direct political representatives to do so forthwith. What threatens the health insurance of Americans is stubborn, intractable refusal by one party to make reasonable fixes or improvements to the Affordable Care Act (Obamacare). The nation would be better served if politicians abandoned repeal & replace screeches, and focused their time and attention to fixing/improving Obamacare, including:

Obamacare’s mandate that large-and medium-sized employers provide insurance to workers applies only to workers employed 30 or more hours a week. Repubs correctly criticized the design of this mandate. It should be corrected.
Some proposed replacing the 40% excise tax on high-cost health plans, the so-called Cadillac tax, with a requirement that people include the cost of employer-financed health insurance above certain thresholds in their personal taxable income. There is a reasonable compromise to be made re this.
19 states have been unwilling to extend Medicaid coverage, partly from a fear that the Fed government will cut payments and leave states holding the bag (like what McConnell’s has proposed doing). Congress should reassure states re this which would help all states regardless of the party in control of legislatures.
Politicians on both sides have decried the provision of Obamacare authorizing the creation of the Independent Payment Advisory Board, an un-elected group empowered to hold down growth of Medicare spending by proposing cost-reducing changes that would take effect unless both houses of Congress mustered majorities to block them. So, agree to change or eliminate it.

If Congress Republicans proposed these straightforward types of Obamacare repairs or fixes, Democrats would want something in return. For instance, Democrats may well seek to raise, rather than lower, assistance for those who currently face high out-of-pocket medical costs. Now these are the kinds of trade-offs Donald J. Trump, the supposed deal maker supreme, should proudly strike — right?

A major challenge for this generation of US politicians particularly on the right is understanding and accepting the true nature of our democracy and of our politics which involve marrying principle to a political process that means neither the majority nor the minority gets 100% of what they want — ever! For example, Slavery was one of the most divisive issues in U.S. history. Abraham Lincoln didn’t believe in slavery, but his 1^st priority as President was keeping the Union intact. Most of Lincoln’s Emancipation Proclamation deals with States and areas where emancipation didn’t apply because those folks were allied with the Union so they were allowed to keep their slaves. Wartime President Lincoln made this compromise around the greatest moral issue that the US faced because he understood that his job was to win the war and maintain the Union.

The U.S. made compromises to get past slavery — one of the most morally divisive issues we faced. Political compromise is the reason why major legislation benefiting the Country is passed by Congresses and signed into Law by Presidents. Those who do not understand and accept this principle of compromise are undeserving of serving in Congress or the Presidency.

References

¹ Healthcare was 5.01% of US GDP in 1960, 6.05% in 1970, 7.88% by 1980, 12.09% in 1990, 13.3% in 2000, 17,3% in 2010, 17.56% in 2015 and 17.73% in 2018 (over 4 times defense spending). https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsHistorical

² Supply-Side and Demand-Side Cost Sharing in Health Care, Randall P. Ellis and Thomas G. McGuire, American Economic Journal, 1993: https://www.aeaweb.org/articles?id=10.1257/jep.7.4.135

Health Care Reform in The United States: A Call to Action

A call to action for clinicians and all the rest of us, here's a brief book review for Dr. Marty Makaray's recently published book focusing on Health Care Reform in the United States.

On the same issue, PEAH is going to post a couple of companion articles by Larry Pipes:

- On Reforming U.S. Healthcare
 
- An Economic Prescription for U.S. Healthcare: On Combining Capitalism, Socialism and Sports Competition

By Susan M. Severance, MPH

Forward Channel LLC

sseverancepdx@gmail.com

Health Care Reform in The United States: A Call to Action

I have been sheltering in place at home along with Dr. Marty Makary’s recently published book, The Price We Pay – What Broke American Health Care – And How To Fix It. I got the book from the library, read it, and then COVID-19 hit. The library asked that we hold onto our borrowed books for now. I am glad for that because I have it handy here with me. Dr. Marty Makary is a surgeon with the great ability to write in plain language; this is a book for all to read.

I highly recommend Dr. Makary’s book as an enlightening read into understanding the complicated health care system in The United States. Dr. Makary addresses public health care in The United States and does not hold back. Some of what he uncovers seems criminal in nature and unbelievable in our society. The areas covered in the book include: public health fairs, treatment of unpaid medical bills, overtreatment, health insurance, medications and the pharmacy, and overwellness. Dr. Makary encourages all in The United States to action with specific direction – a disruption movement that all can be a part of.

In a similar call to action, I want to share 5 books with you about patient safety and The United States health care system. All are written by surgeons. I read these fairly recently. Here are the books:

Flatlined by Guy L. Clifton, 2009
Unaccountable by Marty Makary, 2012
Being Mortal by Atul Gawande, 2014
The Checklist Manifesto by Atul Gawande, 2009
Better by Atual Gawande, 2007

I have had an interest in patient safety since being the project coordinator for an evidence-based medicine report on The Effect of Healthcare Working Conditions on Patient Safety published in 2003. The work was performed at the Oregon Health & Science University and funded and published by The Agency for Healthcare Research and Quality part of The United States Department of Health and Human Services. This large report is in the public domain and you can find a summary here. A structured abstract is also available below:

Labour Migrants in Russia and their Needs

Labour migrants in Russia unfortunately still have lack of access to health services. They also face a lot of barriers to a normal life from government and society in common.  
Daniel Kashnitsky, a junior researcher at the Higher School of Economics on direction on labour migration and HIV positive migrants living in Russia, told AFEW International about migrants’ medical insurance, collaboration with Russian authorities and some hopes for the better future

By Chamid Sulchan

AFEW International intern

AFEW is dedicated to improving the health of key populations in society. With a focus on Eastern Europe and Central Asia, AFEW strives to promote health and increase access to prevention, treatment and care for major public health concerns such as HIV, TB, viral hepatitis, and sexual and reproductive health

Labour Migrants in Russia and their Needs

Which difficulties do labour migrants from Central Asia face in Russia?

It depends on a country where these migrants come from. People from Kazakhstan and Kyrgyzstan feel a bit better in Russia, because those countries are part of the Eurasian Economic Union. Citizens of those countries do not need to apply for a residence permit nor for the permit to work. They can just come and only need to have an official registration in the place where they live. To get this document might become a barrier for some people, because not all the landlords are ready to provide them with an official registration.

Also, some migrants are eligible to apply for the state medical insurance. Migrants from Belarus, Armenia, Kyrgyzstan and Kazakhstan have been eligible to have one since three years ago, however TB and HIV services are not included in this state medical insurance.

But there are countries, such as Uzbekistan and Tajikistan, who are not part of the Eurasian Economic Union. Migrants from there have to apply for work permits, and they have to reapply every year. They also have to pay a special tax every month, which is a really heavy burden considering the low wages. It’s a large part of their income, so it affects them enormously.

Also, migrants can face some other issues. For example, in the Russian Federal law number 38 there is a paragraph saying that if a foreign citizen is identified with HIV or TB he/she needs to be deported from the country. If one is identified with HIV and it is known by the migration authorities, they will include the migrant’s name in their database. Since deportation is quite expensive, migrants often remain in Russia undocumented. But if once you leave Russia, you will be banned to re-enter. There is a small part of undocumented migrants who had been caught and they are kept in those detention centres. Other migrants live in hiding and keep working, doing black jobs. Some of them get ART (antiretroviral therapy) in NGOs and private clinics, however a large part of them do not have access to health services, they just keep living as their CD4 level goes down, and some of them they just end up in the emergency care. Unfortunately, we cannot estimate the figures, because the undocumented migrants are not in the state statistics or the patient file data.

What are the factors that influence a lack of access to health services for labour migrants? Probably language barriers, or something else?

Speaking the same language is important of course, because talking about health and body is quite intimate. People prefer to not only speak in their native language, but also to speak to a person who understands them, their social determinants of health, the culture.

Some migrants from Central Asia explained me why they prefer to go to clinics where people of their culture work. One of the reasons was that migrant doctors better understand socio-economic circumstances of migrants’ experiences in Russia. For example, they tend not to prescribe expensive medicines, because they know that migrants cannot afford them. One of the biggest barriers is discrimination in clinics and state institutions. Migrants from Central Asia are often exposed to it.

Unfortunately, migrants can be a reason of rising HIV epidemic in their countries, don’t they?

True. The migration of Central Asia is predominantly male, 80% of the migrants from Central Asia are young males from 20 – 50 years old. They are mostly seasonal migrants. They go to Russia for 10-11 months a year, then they go back to their home country for one or two months. This is the only time when they get to see their wives, children, and other relatives. A lot of them have sexual intercourse in Russia (sometimes not safe), with sex workers, or just with female from their communities.

What have you and your organization done to address the issue of labour migrants having a lack of access to health services?

First of all, me and my colleagues created a regional expert group on migration health in our region. It’s an informal network of civil society experts. We are trying to collect arguments and convince policy makers to lift the residence ban for HIV positive foreign migrants in Russia. We are trying to bring evidence to decision-makers that the HIV residence ban only aggravates the epidemiologic situation. It creates negative consequences for the migrants as they can spread the virus even further to the community. It affects a lot of people as they spread it in their home country. We have been in dialogue with the Russian authorities about this, but it is a long process to create this enabling atmosphere and to actually make it happen.

So, it’s hard to collaborate with the Russian authorities, isn’t it?

Yes, because the Russian authorities are little sensitive now to what civil society is claiming. You need to have very strong argument, create a supportive environment and change the public opinion. We are working with the journalists. We helped to create lot of publications on migrants with HIV living in Russia. We work with civil society organizations and we train them. Our partner organizations have direct services for migrants, at least in Moscow, St. Petersburg. Yekaterinburg and Rostov-on-don and some other large Russian cities that attract them labour migrants.

Some limited services for migrants do exist where they can get tested for HIV, where they can have consultations. But it is difficult to provide sustainable provision of ART, and this is a large problem as most of the migrants cannot afford therapy.

Today the Russian government seems reluctant to introduce any serious changes. On one hand, the authorities understand that Russian economy would not survive without migrants. So, they try to keep migrants low profile. They do not encourage migrants to raise their voices, to create trade unions or other grassroots movements. Migrants do not have access to social entitlements, not only healthcare but to pension funds and other security funds.

What do you think should be done by the Russian government to improve the access to health services for migrants from Central Asia?

The first thing Russia needs to do, is to liberalize its HIV legislation. This is very important, because once HIV-positive migrants are not stuck in Russia, then they can travel back and forth, at least they can receive ART from their home country. Secondly, Russia needs to allocate funding for NGOs that work with the migrants, to test them and provide psychosocial support. Third, anyone who resides in Russia and contributes to the Russian economy, should get access to the Russian healthcare, including HIV and TB services. The healthcare needs to change and include all the people who actually live and work in Russia. There is a human right aspect here, but also an epidemiological aspect: if you don’t want the diseases to spread further, you need to provide basic access to services.

How do migrants from countries like Tajikistan, Uzbekistan get health insurance in Russia?

They don’t have access to state insurance. But one of the requirements when applying for a work permit, is to have bought a private healthcare insurance. They can buy it from one of the private insurance companies. And it is a very basic insurance scheme, that costs about 50 euros per year. It is meant to show the authorities that one is formally secured, but in fact it does not improve with access to health care. These minimal insurance packages provide almost nothing more than just free emergency care which is still provided free of charge to anyone physically residing in Russia. If you have broken your leg or if you have any other acute situation, you will receive emergency care as it is accessible to anyone in Russia. But if you need any further treatment, then you need to pay. And in most cases the basic private insurance will not help you. Of course, you can buy a more expensive one, that would include everything, but most of migrants cannot afford it.

Do you see an opportunity that the situation will be changed in the future?

Well, I stay positive because there are some developments in the region of East Europe and Central Asia such as, for example, Kyrgyzstan and Kazakhstan having accessed to the Eurasian Economic Union. It was a major breakthrough, when member countries signed a health insurance agreement to cover their citizens when they migrate within the Union. In terms of access to HIV and TB care, it really has remained unchanged for 25 years, because when they adopted these policies, Russia did not have this severe HIV growth that it has now, it was only starting back then.

Nowadays we try to tell the authorities: it is not that you have to pay for the migrants and their health insurance, but just start with decriminalizing them, liberate migrants from this constant fear of being deported, of residing in illegality and being constantly subject to rights violation. This is really important if Russia ultimately wants to be created decent life conditions for all people who live and work in the country.

PEAH News Flash 384

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 384

Europe’s moment: Repair and prepare for the next generation

Speech by President von der Leyen at the European Parliament Plenary on the EU Recovery package

Coronavirus disease (COVID-2019) situation reports

GLOBALIZATION PARADOX AND THE CORONAVIRUS PANDEMIC

Op-Ed: Why democracies do better at surviving pandemics

Centering The Needs Of Birthing People During The COVID-19 Pandemic

Reducing COVID-19 Deaths In Nursing Homes: Call To Action

Italy Experience with COVID-19 by Daniele Dionisio

How Prepared is Africa for the COVID-19 Pandemic Response? The Case of Ethiopia by Garumma Tolu Feyissa, Lemi Belay Tolu, Alex Ezeh

Covid-19 in Etiopia

Building sustainable health financing options for emergency response: Lessons from the COVID-19 response in Africa

COVID-19 in India: an epidemic in congested cities

Science points to causes of COVID-19

Making a vaccine accessible: A glossary of terms

AstraZeneca could supply potential coronavirus vaccine from September

La vera guerra è iniziata, la guerra dei vaccini

World Health Organisation suspends trial of hydroxychloroquine over safety fears

Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis

WHO launches foundation to expand its funding base

WHO Foundation Established to Support Critical Global Health Needs

MoU between WHO and the new WHO Foundation

Ten Actions To Boost Low & Middle Income Countries’ Productive Capacity For Medicines

AMR: The health crisis waiting to happen

JUSTICE AND REPARATION: THE STRUGGLE OF CHEVRON-AFFECTED COMMUNITIES IN COVID-19 TIMES

How companies are exploiting the COVID-19 pandemic pretending their marketing is ‘Humanitarian’

Protecting The Hidden Homeless During COVID-19 And Beyond

The right to food and nutrition during COVID-19

AFEW International released its annual report 2019 “Towards Changes”

First poverty, now pandemic threatens access to electricity

Famine risk for millions in second locust wave

How Prepared is Africa for the COVID-19 Pandemic Response? The Case of Ethiopia

Based on Ethiopia's ranking in three domains basic to the response to COVID-19 outbreak (epidemiologic situation, health care preparedness, public health capacity), this article recommends strict mitigation measures to be practiced

credit: WHO

By Garumma Tolu Feyissa (PhD),^1€Lemi Belay Tolu (MD),² Alex Ezeh (PhD)¹

¹Dornsife School of Public Health, Drexel University, Philadelphia, Pennsylvania, USA

²Family Planning Fellow, Department of Obstetrics and Gynecology, Saint Paul Hospital Millennium Medical College, Addis Ababa, Ethiopia

How Prepared is Africa for the COVID-19 Pandemic Response? The Case of Ethiopia

Introduction

The coronavirus disease 2019 (COVID-19) is an ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The outbreak was first identified in Wuhan, Hubei Province, China, in December 2019. The World Health Organization (WHO) recognized it as a pandemic on 11 March 2020. As of May 25, 2020, more than 5,525,299 cases of COVID-19 have been reported in over 200 countries, causing 347,114 deaths. As of May 25, 2020, Ethiopia has registered total of 655 confirmed COVID-19 cases.

How prepared is Ethiopia for pandemic response?

Preventepidemics.org has created ReadyScore to determine whether a country is prepared to find, stop, and prevent epidemics. The score is based on 19 criteria to determine the level of countries preparedness and capability to control outbreaks. Countries are classified into five: Better prepared (over 80%), work to do (40-80%), not ready (under 40%), in progress and unknown. Ethiopia ReadyScore is 52 %.

Ethiopia’s COVID-19 Response

Since the COVID-19 was reported, Ethiopia started screening passengers at Bole international airport. Public Health Institute (EPHI) started laboratory test for COVID-19 and dedicated Eka Kotebe Hospital for COVID-19. Hand washing, cough hygiene and physical distancing were highly advocated. Ethiopia closed all night bars, schools including universities and abandoned religious gatherings. Additionally, mandatory quarantining of passengers, testing suspected cases and contact tracing were done.

What measures should be taken to mitigate the pandemic

In addition to the measures taken so far, it would critical to follow the guideline prepared by Resolve to Save Lives to decide when to loosen or tighten physical distancing measures.

When and How to Close due to COVID-19 Spread

Decision to tighten physical distancing depends on three domains of decision: level of viral transmission, health care preparedness and public health capacity. Accordingly, strict mitigation measures are needed when one or more criteria in at least 2 of 3 domains are met (When to Tighten).

The current situation of Ethiopia in accordance to the three decision domains:

1. Ethiopia’s COVID-19 Epidemiologic situation

Ethiopia showed 11% growth in past 24-48 hours on April 16,2020. Physical distancing was less implemented in major cities including Addis Ababa. This will increase the likelihood of exposure through mass gathering or congregation of people. Mass screening asymptomatic cases is not being carried out because of the limited capacity and the likelihood of delayed detection of cases is high. According to EPHI report currently, about 20 contacts have been identified for each confirmed case, with this about one third of the population would be infected at the peak. From the domain of prevention strategy, reducing contacts by 50% through enforcing physical distancing averts 15 million infections that would have occurred at the peak at the national level.

2. Ethiopia’s COVID-19 health care preparedness

Though different repurposing activities are undergoing, Ethiopia has limited health care capacity especially of Intensive Care Unit (ICU). Ministry of Health (MOH) recently disclosed to media that Ethiopia has totally 450 mechanical ventilators in both private and government settings. The number of Covid-19 cases is increasing daily, there are more admissions and less discharges. Additionally, Ethiopia has limited personal protective equipment.

3. Ethiopia’s COVID-19 public health capacity

Ethiopia is having congested mandatory quarantine because of continued flying airlines, especially more cases coming from Dubai. Given the longstanding social bond in the community, it is not easy to fully implement physical distancing recommendations. In addition, it will not be an easy task for the majority who live on daily labor in this era of quarantine since the government does not have capacity to provide life sustaining supplies or cash to each. Though there is commitment from the side of the government, clear operational guideline is missing and there is also weakness in the enforcement of the mitigation measures on the ground.

What should be the next immediate pandemic adaptive response for Ethiopia?

Depending on Ethiopia’s situation on the three decision domains, we recommend strict mitigation measures to be practiced. Hence, we recommend that Ethiopian government to tighten the following actions urgently:

Mass communication and community mobilization.
Strict social distancing measures.
Sanitary measures.
Maximizing case tracing and detection.
Developing detailed operational guidelines on preventive measures across different business, organizational and community settings.
Measures for sustaining essential health services.
Proactive measures to sustain life during the lockdown.

When and How to Reopen After COVID-19

COVID-19 physical distancing measures can be loosened when all the criteria under three domains of decision: level of viral transmission, health care preparedness and public health capacity are met. Hence we recommend Ethiopia to strategically decide when and how to reopen according to When and How to Loosen.

———————————————

^€Correspondence to Garumma Tolu Feyissa E-mail: garummatolu@yahoo.com

Italy Experience with COVID-19

No doubt that Italy has delayed taking some drastic decisions along COVID outbreak and made some operational mistakes. Irrespective of this, Italy has, anyway, provided global policymakers with good practices to follow

by Daniele Dionisio

PEAH – Policies for Equitable Access to Health

Italy Experience with COVID-19

Italy was the first European country to halt all air traffic with China and declare a state of emergency on January 31^st, while even putting scanners in airports to check arrivals for fever. Unfortunately, it was too late since we are now aware that the virus had been circulating in Italy since early January, if not before.

Doctors dealing with pneumonia in January and until mid February were unaware it was the coronavirus, since the symptoms were so similar to influenza and the coronavirus was still believed to be largely confined to China. Even after Italy documented its February 21^st cluster cases, the unusual way COVID-19 could present itself wasn’t understood, with some patients rapidly declining to breathing insufficiency.

This comes as no surprise since Italy was the first European country facing the explosion of the COVID-19 crisis. In this context, it was the first country in Europe to impose restrictions when coronavirus cases began to surface in its northern regions in February.

By the beginning of March, the virus had spread to all regions of Italy, though with lesser extent and intensity in central and southern regions than in northern ones.

Confirmed cases per million residents in Italy by province (as of 21 May 2020 - source:Wikipedia)

Under these circumstances, Italy was the first country to implement a national quarantine as a result of the dizzying increase and spread of coronavirus cases (on 8 March, Italy confirmed an additional 1,492 cases and 133 deaths, taking it to a total of 7,375 cases and 366 deaths.).

On 9 March 2020, the government of Italy under Prime Minister Giuseppe Conte imposed a nationwide quarantine, restricting the movement of the population except for necessity, work, and health circumstances, in response to the growing pandemic of COVID-19 in the country. Additional lockdown restrictions mandated the temporary closure of non-essential shops and businesses.

Italian lockdown images (source:Wikipedia)

Italy nationwide lockdown (resulting in about 60 million people quarantined - Italian population)

Regardless strict observance of nationwide quarantine measures, hot epidemic days went on, and on 27 March Italy confirmed a new highest single-day death toll with 919 deaths, increasing the country’s total to 9,134. Overall, confirmed cases of infection rose to 86,498.

No doubt that Italy has delayed taking some drastic decisions along COVID outbreak and made some operational mistakes. Let me remember here that the outbreak came to light when a 38-year-old Italian tested positive in Codogno, a municipality in the province of Lodi (Lombardy region). On 14 February, he felt unwell and was prescribed treatments for influenza. On 16 February, as the man’s condition worsened, he went to Codogno Hospital, reporting respiratory problems. Initially there was no suspicion of COVID-19 and no additional precautionary measures were taken, so allowing the virus to spread undisturbed and infect a number of other patients and health workers, as a ripple effect.

While the fault mentioned above partly arises from being Italy the first European country to be ravaged by the epidemic, at least a couple of further gaps happened during epidemic most hot days in Lombardy:

-Firstly, because Lombardy’s intensive care units (ICUs) were already filling up within days of Italy’s first cases, many primary care physicians tried to treat and monitor patients at home. Some put them on supplemental oxygen, commonly used for home cases in Italy. That strategy proved deadly, and many died at home or soon after hospitalization, having waited too long to call an ambulance.

– Secondly, a 30 March regional decree, aimed at easing pressure on Lombardy’s ICUs, told nursing home directors to not hospitalize sick residents over 75 if they had other health problems. The decree said it was “opportune to treat them in the same facility to avoid further risks of decline in transport or during the wait in the emergency room.” The decree also entitled properly equipped nursing homes as suitable isolation places for COVID patients discharged from hospitals. As for the elderly at some nursing homes the decree amounted to a death warrant.

Notwithstanding the mistakes highlighted above, Italy has, anyway, provided global policymakers with good practices to follow. In this regard, as reported in ‘Forbes’ on April 14th, six good practices can be highlighted in Italy’s response to the Coronavirus. As per the authors terms, these practices would include:

1-Prioritize citizens´ health and well-being

‘This point concerns the priority given by the Italian Government and Italian institutions to citizens’ health and well-being’.

2-Emphasize transparent communication

‘Italian leading figures have preferred to convey clear messages about the extreme seriousness of the situation. In this context, Italian institutions have also done extra-work to control and neutralize the spread of false information, which can so easily run throughout social media’.

3-Focus on flexibility and taking an integrated approach

‘Meaning that Organizations that generally work in sectors and contexts that are very distant from each other, have integrated their operational capabilities to deliver important tools and machines to fight against COVID-19’.

‘For example, Italian Siare Engineering International Group, one of the four companies in the world producing lung ventilators, has integrated into its organization a team of military engineers in order to guarantee 24-hour production. There are several other similar examples in the country, including the operational integration between the Italian Civil Protection Department and local volunteers’ associations, and the cases of small factories producing protection masks and police forces distributing them, among others. Another example worth mentioning is the Italian fashion sector. Companies like Valentino, Calzedonia, Geox, and Prada have quickly moved to the production of masks and other material useful to help sanitary professionals and the population at large’.

‘It is interesting to note that the Italian reaction has been neither top-down nor bottom-up. It has instead proved to be an effort of spontaneous, reciprocal collaboration between actors of any kind and any level, who are willing to cooperate in new innovative ways’.

4-The rapid development of an effective emergency logistical system

‘Italy has very rapidly developed infrastructures (for example, the development of ad hoc “COVID hospitals” throughout the country) and emergency transportation systems. This complex effort also has involved the coordination between military and civil institutions, in particular for the carriage of people in extreme situations’.

5-An emphasis on professional responsibility

‘A systemic culture of professional responsibility in critical professions such as nurses, medical doctors, public servants, etc. has allowed the Italian system to increase the number of professionals fighting against COVID-19. As it was the case, during most hot epidemic days, for the Italian Civil Protection launch of a call requesting the help of 500 volunteer nurses. In less than 48 hours, it received over 9,500 applications’.

6-Urge a coordinated international response

‘During the first and second week of February, the Italian Minister of Public Health, Roberto Speranza, worked hard to organize the first extraordinary assembly between all health ministers of the European Union. During the meeting in Brussels on February 13th, the Italian Government expressed the need for all European countries to approach the COVID crisis in an integrated way and to take into serious consideration also the African situation’.

In conclusion, I would like to remark Italy’s clear strategic priorities wherein citizens’ health and right of information have been put at the top of the national agenda.

When it comes at today’s situation, Italian government began to relax lockdown measures earlier this month, when it allowed factories and parks to reopen on 4 May.

Italian cabinet’s announcement came shortly after the country, which was once the global epicentre of the pandemic, reported a further decline in its daily death toll.

While Italy reported more than 900 deaths on 27 March, its daily death toll is around or below one hundred now that the number of new cases keeps decreasing. In this connection, let’s have a look at the latest figures released by the National Civil Protection Department.

As of 25 May 2020, the total number of infected persons was 230,158; leading the total of still positive cases to 55,300 (resulting in a decrease of 1,294 cases compared to the day before).

The number of patients in intensive care unit was 541 recording a decrease of 12 patients compared to the day before.

8,185 people were hospitalized with symptoms, a decrease of 428 compared to the day before.

46,574 people, equal to 84% of all infected cases, were in isolation without symptoms or with mild symptoms.

92 new victims were reported, bringing the national death toll to 32,877. The total number of discharged patients who have recovered from the virus rose to 141,981, an increase of 1,502 people compared to the day before.

Therefore, and in aligment with current lockdown easing under government decision, shops and restaurants reopened from 18 May, providing social distancing is enforced.

Catholic churches started resumpting religious services and Mass on the same day under strict social distancing, with worshippers wearing face masks. Other faiths are also allowed to hold religious services.

Mr Conte announced that travel to and from Italy, and between the country’s regions would be allowed from 3 June, whereby travellers from EU countries will be able to enter Italy without going into a two-week quarantine.

Gyms, swimming pools and sports centres reopened on 25 May, while cinemas and theatres have to wait until 15 June.

In sum, the announced measures are a key step in the country’s efforts to restart its economy after more than two months of lockdown.

In this context, on May 13^th, the Italian government released a ‘relaunch decree’ containing financial measures worth 55 billion euros (59.6 billion U.S. dollars) to support the economy hard hit by the coronavirus pandemic. As part of the decree, the national health service has been allocated 3.25 billion euros, meaning a much higher figure than what our State usually invests in the national health service (SSN) in a whole year. Health service investment was specifically earmarked to regional network, stronger hospital network and health personnel recruitment. Some details:

Regional network
Major financial resources will be invested in reinforcing the regional network, as the more reliable bulwark to count on in epidemic curses like COVID pandemic. As per Health Minister Speranza terms “We are putting 9,600 nurses out on the field, with the figure of family nurse, and we are investing, in particular, in home services for fragile people, which will lift the percentage of people receiving care (in this way) from 4% to 6.7%.

Stronger hospital network
A big chunk of the financial resources will be used to strengthen the hospital network aiming to gain up to 11,109 places in intensive care, 115% more than we had before the COVID emergency. This grounds on the rationale that
“We don’t know what’s in store for us. The experts have spoken of the possibility of a second wave (of contagion). We must be ready”.

Recruitment
On the same wavelength, Minister Speranza also announced that another 240 million euros will be invested in the recruitment of new personnel and 190 will go on incentives for doctors, including by financing another 4,200 specialization bursaries.

Coherently with his mandate, Minister Speranza also told World Health Assembly last week that Covid-19 vaccine must be a global public good, a right for all.

At the close of this article, find  a couple of links below  to stay updated with day-by-day COVID-19 situation in Italy and national government relevant decisions:

http://www.salute.gov.it/portale/nuovocoronavirus/homeNuovoCoronavirus.jsp?lingua=english

http://www.protezionecivile.gov.it/home

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