COVID-19 is not transmitted by food or food packaging, says WHO

There is ‘no evidence’ that the SARS-CoV-2 virus can be transmitted in food or on food packaging, said the World Health Organization on Thursday.

WHO’s Executive Director of Health Emergencies Mike Ryan made the comments in response to reports that a dozen frozen chicken wings imported into China’s southern city of Shenzhen tested positive for COVID-19, sparking concern that contaminated food could spur outbreaks of the coronavirus.

So far, China has already tested a “few hundred thousand” food samples for COVID-19, but only ten have tested positive for COVID-19, said the WHO on Thursday. And even though viral genetic material can be found on some surfaces, like packaged food, there is still no evidence that the coronavirus can be transmitted through food, emphasized the Organization.

In early July, China suspended imports of Ecuadorian shrimp for fear that the products could spawn COVID-19 outbreaks, after reports from the port cities of Xiamen and Dalian. And on Wednesday, the virus was identified on frozen shrimp packaging from Ecuador, during a routine inspection by officials in eastern China’s Anhui Province, according to Reuters. But so far, no human cases of coronavirus have been linked to the contaminated food.

“There is no evidence [that] food or the food chain is participating in transmission of this virus”, said Ryan on Thursday, at a regular press briefing. “People should not fear food or food packaging or processing or delivery of food…Our food, from a COVID-19 perspective, is safe.”

WHO Guidance Says Food-borne Transmission “Highly Unlikely” & Virus Can Be Killed By Cooking

It is “highly unlikely” that COVID-19 can be contracted from food or food packaging, states the WHO and the Food and Agriculture Organization of the UN (FAO), in their joint scientific guidance on food safety from early April. 

“We know that the virus can remain on surfaces for some time, but the virus can be inactivated on your hands if you wash your hands”, added WHO’s Technical Lead for COVID-19 Maria Van Kerkhove. “We have no examples of where this virus has been transmitted as a foodborne…viruses can be killed if the meat is cooked.”

Thus, sanitizing food preparation surfaces and cooking meals thoroughly can effectively kill most viruses.

“Coronaviruses cannot multiply in food; they need an animal or human host to multiply,” according to the WHO’s guidance on food safety. “There is no evidence to date of viruses that cause respiratory illnesses being transmitted via food or food packaging.”

Rather, the main drivers of COVID-19 transmission are respiratory droplets or aerosolized particles released from coughing and sneezing, or contact with contaminated surfaces.

Image Credits: Wikimedia Commons: Flixtey.

A doctor explains contraceptives to a young girl at the Sukhbaatar District Health Center, Ulaanbaatar, Mongolia.

Funding for research into sexual and reproductive health issues, ranging from HIV/AIDs to pregnancy prevention, comes from only three major donors, and the global recession caused by COVID-19 may shrink the funding landscape further.

“There’s a clear gap in investment to research and develop new products to meet people’s needs in low-resource settings. With a few funders stepping in to fill this gap, there are missed opportunities to make a real impact on the lives of people in LMICs,” said Nick Chapman, CEO of Policy Cures Research, the group that produces the annual G-FINDER reports.

“Looking to the future, not only are unprecedented funding levels being funneled towards COVID-19, but an impending global recession will undoubtedly have an impact on future development funding commitments and available funding to address other global health issues, like SRH,” added Chapman, in a press release.

The new G-FINDER Sexual & Reproductive Health report released Thursday also found that in 2018, US $1.4 billion of the US $1.7 billion invested in the area went towards HIV/AIDS research, dwarfing the paltry US $71 million that went towards all other sexually transmitted infection research worldwide.

“Strong global advocacy” and “sustained investment” have helped HIV/AIDS stay high on funders’ radars, said Maya Goldstein, lead author on the report.

But issues such as human papillomavirus (HPV) and HPV-related cervical cancer, the fourth most common cancer in the world, received just $52m in R&D funding in 2018. Maternal killers such as postpartum haemorrhage (PPH) and pre-eclampsia, a dangerous hypertensive disorder in pregnancy, received only US $4.4 million and US $12 million respectively in 2018.

The United States National Institutes for Health (NIH), the Bill and Melinda Gates Foundation, and the pharmaceutical industry represent the most significant donors to sexual and reproductive health research. The US NIH funded about two-thirds of the US $1.7 billion total investment.

“There’s a clear need and opportunity for more private and public sector investors to contribute,” said Goldstein. “The magnitude of [the top funders’] investments compared with others signals perhaps too heavy a reliance on a few organisations to support SRH innovation.”

 

 

Image Credits: UNFPA/Andrew Cullen.

Vaping, or the use of electronic nicotine delivery devices that vaporize nicotine-infused liquid, is linked to a dramatically higher risk of getting infected by COVID-19 in teens and young adults, according to a new study by Stanford University researchers.

The study, published in The Journal of Adolescent Health just ahead of International Youth Day on Wednesday, found that teens and young adults who vaped were five times more likely to be diagnosed with COVID-19.

Those who vaped and smoked traditional combustible cigarettes were seven times more likely to receive a positive COVID-19 diagnosis.

“Young people may believe their age protects them from contracting the virus or that they will not experience symptoms of COVID-19, but the data show this isn’t true among those who vape,” said the study’s lead author, Stanford researcher Shivani Mathur Gaiha, in a press release.

“This study tells us pretty clearly that youth who are using vapes or are dual-using [e-cigarettes and cigarettes] are at elevated risk, and it’s not just a small increase in risk; it’s a big one.”

The study analyzed self-reported data from 4,351 people between the ages of 13-24 across the United States. It found that those who had used e-cigarettes or conventional cigarettes in the past were also more likely to experience symptoms of COVID-19, and seek testing. 

The researchers found no relationship between only smoking traditional cigarettes and COVID-19 infection in this study. However, senior author Bonnie Halpern-Felsher, a professor of pediatrics at Stanford, said this may be due to the fact that few teens and young adults exclusively smoke combustible cigarettes in the United States.

“We need the FDA to hurry up and regulate these products. And we need to tell everyone: If you are a vaper, you are putting yourself at risk for COVID-19 and other lung disease,” said Halpern-Felsher.

Image Credits: Flickr: Mike Mozart.

Russia’s speedy approval of a COVID-19 vaccine on Tuesday has drawn widespread criticism from Health Ministers, researchers, and even a Russian pharma industry group. 

However, it has also spurred interest and offers to collaborate on testing the new vaccine in other countries, including from quarters as farflung as Israel and the Philippines.

The Russian COVID-19 vaccine, dubbed Sputnik V, is the first in the world to receive national regulatory approval; it was approved for public use even ahead of its Phase III trial. Additionally, results from earlier clinical trials have not yet been released to the public or the World Health Organization, sparking concerns from many experts that the country is jumping the gun in a bid to showcase Russia’s scientific prowess.

“It is not about being first, it is about having an effective, a tried and with that a safe vaccine,” German Health Minister Jens Spahn told the radio station Deutschlandfunk on Wednesday. “The problem is that we know very little because the Russian authorities are not being transparent. To have trust in such a vaccine I believe it is important to do the necessary testing even in times of pandemic and to make everything public.

“We know that as of now that there has been no Phase 3 testing, so no clinical trials with a broad spectrum of people. And with that it can also be dangerous to start too early.”

Jeremy Farrar, director of The Wellcome Trust, tweeted, “It is wrong to release any vaccine without robust assessment [of] safety & efficacy. This vaccine [has] not been robustly assessed & should not be released outside clinical trials.”  Rapid  release of Russia’s vaccine before testing was completed could jeopardize public trust in vaccines in general, he suggested. 

But the World Health Organization refrained from openly joining the chorus of criticism. A WHO spokeperson told Health Policy Watch that WHO experts were “in touch” with the Russian vaccine’s development team, and stressed that vaccine research protocols should be followed.

“Accelerating vaccine research should be done following established processes through every step of development, to ensure that any vaccines that eventually go into production are both safe and effective,” said the spokesperson.

Russia’s own Association of Clinical Trials Organizations has expressed concerns about the speedy approval, calling the vaccine a “Pandora’s box.”

“The rules for conducting clinical trials are written in blood. They can’t be violated,” ACTO Executive Director Svetlana Zavidova told Bloomberg News. “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”

Developed by Russia’s Gamelaya Institute, and funded by the Russian Direct Investment Fund, some 67 people were administered the vaccine in small Phase I and Phase II trials, including President Vladimir Putin’s own daughter, although no results or data have been released or shared with the World Health Organization, the latter a protocol followed by other vaccine developers. 

Russia has announced that healthcare workers will be among the first to receive the vaccine, starting in October 2020. However, a Russian Ministry of Health spokesperson told Science Insider that the current registration would not allow the vaccine to be used more broadly until January 2021, presumably after larger clinical trials have been conducted.  

Growing Interest From Other Countries In Testing Russia’s Vaccine

Despite the chorus of criticism, policymakers and experts in some quarters were taking a more positive approach, expressing interest in using or testing the Russian vaccine.

President of The Philippines, Phillippe Duterte told media outlets that he “trusted” the Russian vaccine, and offered to have himself  “publicly injected” to alleviate Filipinos’ fears.

Colorized electron micrograph of SARS-CoV-2 (yellow) attacking a dying cell (red)

The Russian vaccine was also stirring scientific interest in Israel, which has a 1 million strong Russian emigrant community.  

Zeev Rotstein, head of Jerusalem’s Hebrew University’s Hadassah Medical Center said that Haddassah, one of the country’s top hospitals, would collaborate in testing the Russian coronavirus vaccine candidate.

“We are playing a part in conducting safety and efficacy studies,” Rotstein said in an interview with The Jerusalem Post.  He noted that Hadassah, which has a worldwide network, would work in  collaboration with its new branch in Skolkovo, Moscow.  Hadassah became the first foreign medical center to open a clinic in Russia in 2018, at the Moscow International Medical Cluster. 

Israel, which is considered a biomedical powerhouse, should not be so quick to dismiss the Russian coronavirus vaccine, Rotstein underlined, saying that the country should not only  be betting on the success of US vaccine candidates.  In June, Israel signed a pre-order agreement wiht Moderna, the Boston-based firm that just embarked on Phase III trials of a COVID-19 vaccine candidate. 

 “I strongly recommend the authorities in Israel not focus only on the American companies that are manufacturing vaccines and not neglect the ability of Russian scientists,” Rotstein said. “I would have recommended that the foreign minister be in contact with the foreign minister of Russia in order… to not exclude the possibility that the vaccine be allocated to Israel too.

“There are a lot of accusations regarding Russian technology and science,” he added.  “But if you remember, the fact that they called it Sputnik V is to say to the world, ‘Remember who was first in space.’ Russia could be very advanced.”

He was referring to the Russian satellite Sputnik, the first to be launched into orbit in 1957, beating the United States in the early phases of the space race.   

In another interview with Israel’s Radio 103FM, Rotstein suggested that the vaccine was also being administered to a small number of patients at Hadassah via a compassionate use program, though it was unclear how that compassionate use would apply to a vaccine. 

“We expect to hear more information from the mayor of Moscow in a very short period of time,” Rotstein said. “We are in direct contact with our people in Moscow and we are getting information as it is available.”

Israel’s Health Minister Yuli Edelstein, himself a Russian emigrant, was a little more cautious.  He told a press conference on Tuesday that Israel was interested in holding discussions with Russia about its vaccine but only “if we are convinced that it is a serious product then we will try to enter into negotiations 

“We are following vigilantly every report, no matter what country,” Edelstein said. “We have already discussed the reports from the research center in Russia about the vaccine development.

COVID-19 Vaccine Race Takes On Space-Race Era Competition

The naming of Russia’s Sputnik 5 vaccine is yet another reflection of the way in which countries are racing helter-skelter to develop and procure potential vaccines on behalf of their own nations – first and foremost – with far less thought about the need for global solidarity of the kind that WHO has said it critical to beating the pandemic. 

While Russia pursues Sputnik 5, the United States is heavily invested in the COVID-19 vaccine candidate of the Boston-based Moderna, which entered Phase 3 clinical trials in late July after publishing early phase trial results and receiving a large dose of financial support from BARDA, a branch of the US Department of Health and Human Services (HHS).

On Tuesday, HHS ordered 100 million doses of Moderna’s investigational COVID-19 vaccine to be manufactured even as a massive 30,000 person Phase 3 trials was only getting underway. The doses will only be made available if the vaccine is proven to be safe and effective in the Phase 3 trial. 

The procurement contracts have been awarded to Moderna as part of Operation Warp Speed, a US government initiative to deliver 300 million doses of a safe effective vaccine to citizens by January 2021. The US Congress has allocated more than US $10 billion for the initiative. 

On Wednesay, Anthony Farci, director for the National Institute of Allergies and Infectious Diseases (NIAID) which has also invested heavily in the Moderna candidate, expressed “serious doubts” that the Russian vaccine had already been proven to be safe and effective. 

And like the race to space several decades ago, whether or not Sputnik V may already be in orbit, it remains to be seen which vaccine candidate – American, Russian, British – will be the first to land on the moon. 

Image Credits: Coronavirus from US NIH, Sputnik Rendition from Flickr: Kordite – adaptation by G Ren/HP-Watch, NIAID.

More than US $100 billion will be required just to scale-up manufacturing and ensure worldwide distribution of a coronavirus vaccine, said WHO Director-General Dr Tedros Adhanom Ghebreyesus in prepared remarks at a WHO press conference on Monday.

He said that the World Health Organization’s ACT Accelerator consortium has received only 10% of the funding that would be required for scale up and production of a new vaccine, as well as new COVID-19 treatments and diagnostics. 

However, Seth Berkley, CEO of Gavi, The Vaccine Alliance cited a much more modest requirement in an interview with Heidi News last week, republished today by Health Policy Watch. 

In his interview, Berkley said that a new COVID-19 vaccine could be produced and distributed for under $US 50 per dose. The vaccine arm of the ACT Accelerator is thus looking to raise US $2 billion to help secure 2 billion doses of the vaccine for low-income countries that cannot afford to purchase the vaccine themselves, as well as some stock for higher income countries that bet on the wrong vaccine candidate. 

According to Gavi’s documents on the vaccine investment case, some US $18.1 billion would be required to fund the final development, production, and deployment of all 2 billion doses.  

“But here’s the thing,” added Berkley, “the pandemic is costing the world $375 billion a month in lost GDP. If you look at the overall costs, the vaccine bill could be as high as $75 billion. That means that an effective vaccine that would help the economy recover would pay for itself in five or six days.”

GAVI is co-leading the vaccines pillar of the Act Accelerator with WHO and the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI). 

According to the latest update on the ACT Accelerator investments, about US $3.4 billion of the US $31.3 billion required has been pledged to the accelerator overall – or 10% of the requirements for drugs, diagnostics and vaccines. 

WHO, when queried about the discrepancy in data about vaccine investment requirements, did not reply.

The Challenge Will Be Delivering A Vaccine To Those In Need

Whatever the figure might be, it’s clear that the bigger challenge may be not in the vaccine’s development – but in delivery. 

“I believe that we will get COVID-19 vaccines that are both safe and effective, the challenge is going to be scaling up the production, paying for all of that, and preparing national systems to deliver this,” said WHO Health Emergencies Executive Director Mike Ryan. 

“Having an effective vaccine is only part of the answer… You have to have enough vaccine, you have to get enough people access,” he added. 

Some US $3.2 billion from the ACT Accelerator will be required to build up supply chains to safely deliver a vaccine in low and lower-middle income countries, according to the investment case. Upper-middle income countries and high-income countries are expected to cover the costs of distribution through their own national health budgets.

“This [US$ 100 billion] sounds like a lot of money and it is. But it’s small in comparison to the 10 trillion dollars that have already been invested by G20 countries in fiscal stimulus to deal with the consequences of the pandemic so far,” said Dr Tedros.

Dr Seth Berkley (left, during the Ebola outbreak) has led the Vaccination Alliance (Gavi) since 2011. | Gavi / Frédérique Tissandie

To facilitate equitable access to COVID-19 tests, treatments, and vaccines, WHO launched the COVID-19 Access Accelerator (ACT) in April. COVAX is the vaccine component of this initiative. It is led by WHO, the Oslo-based Coalition for Epidemic Preparedness Innovations (CEPI) and the Geneva-based Gavi, the Vaccine Alliance (GAVI). Heidi.news spoke with Gavi’s Executive Director, Seth Berkley, to discuss the challenges of what could be the most massive immunization campaign ever conducted.

Why it’s important. A vaccine is probably the only way to halt a pandemic that, according to WHO’s latest data, has led to more than 20 million reported cases and 750,000 deaths. More than 200 vaccine candidates are in development, of which three have entered the final phase of clinical trials. But potential demand by some 7.8 billion people is running headlong into what could be a precariously limited vaccine supply. Will rich countries preemptively snatch up available vaccines, as suggested by the behavior of the United States and some European countries, including Switzerland, which have pre-ordered millions of doses? And what if one of these countries is betting everything on the wrong candidate? These are some of the big questions now on the table.

Heidi.news: A recent article published in Science stated that “vaccine nationalism” threatens the global plan to distribute future COVID-19 vaccines equitably. Do you share the same concern?

Seth Berkley: Yes, we do. That’s why we’re building the COVAX mechanism. We have had the experience of the “swine” flu in 2009. So a small group of rich countries bought the entire stockpile of vaccines with only a few donations here and there. This could happen again. We may end up in a situation where about 30 countries have all the vaccines and 170 countries do not have access, at least initially. We know that vaccines will be a limited commodity for the next 12 to 18 months. The challenge is to stop the pandemic. It has to be seen as a global public health issue. People need to understand that in a pandemic situation we are only safe if others are safe. With an infection spreading at the speed of light, this solidarity is the condition for the economy, trade, exchanges, to resume.

HN: The United States and Europe are ordering hundreds of millions of doses of potentially effective vaccines in advance. Does that mean that we will not have the equitable access that you are advocating?

SB: Advance orders are a necessary mechanism for vaccine manufacturers to make the investment possible. Normally we have a global production capacity of about 1.5 billion vaccines that we need to continue to produce. That means huge investments for the new COVID-19 vaccines, which may require two doses. And, we don’t know which of these vaccines will be effective. In any case, we do know that there will not be enough vaccines, to begin with. So we need an equitable, but also effective, way to distribute it globally. This means first vaccinating the groups of people most at risk, namely health workers, who make up 3% of the world’s population, and the elderly (17%). And we need to do this at the global level, which is what COVAX is all about.

Seth Berkley announces the launch of the COVAX facility at a 4 June 2020 virtual event

HN: How does it work?

SB: The COVID-19 vaccine global access facility (COVAX Facility) consists of two parts. The COVAX Advance Market Commitment (AMC) is modeled on what Gavi usually does for other vaccines in developing countries. It is intended to enable the purchase and delivery of vaccines for developing countries based on funds from donors in rich countries. The AMC will provide guarantees to manufacturers to create sufficient global production capacity before vaccines are licensed. It will then purchase vaccines and help deliver them to 92 countries, representing half of the world’s population.

The second mechanism is the financing of vaccines for upper-middle and high-income countries. It is a pooled fund set up by contributing countries to guarantee them doses of various vaccines. There will probably be between 12 and 15 vaccines selected. This fund functions as insurance by providing access to a wide range of vaccines, including those for which there have been no specific pre-orders. Therefore, if the candidate in which a country has invested fails, it will still have access to other vaccines for about 20% of its population.

The advantage of such a global program is that it allows production capacities to be optimized.

“Health care workers should be the first to be vaccinated.”

HN: How did you choose which people to vaccinate first?

SB: Health care workers should be the first to be vaccinated. Not only are they the most at risk, but they are essential to the proper functioning of the healthcare system. Older people are a challenge because we know they develop a weaker immune response than younger people. In addition, there are fewer elderly people in developing countries and there is little experience in vaccinating this segment of the population. Vaccine adjuvants can be used to better treat the elderly, but their effectiveness also remains to be demonstrated. Finally, we need to ensure vaccines for minority groups who are most at risk and dense urban areas in developing countries.

Healthcare workers should be vaccinated first, says Berkeley

HN: Do you think the cost of vaccines could be a barrier?

SB: We don’t know the final price, mainly because of the unknown manufacturing and dosage. But COVID-19 vaccines are likely to be cheap. With a single-digit price, maybe double-digit for some, but under $50 a dose. Most people will be able to afford these prices. But here’s the thing: the pandemic is costing the world $375 billion a month in lost GDP. If you look at the overall costs, the vaccine bill could be as high as $75 billion. That means that an effective vaccine that would help the economy recover would pay for itself in five or six days.`

Two billion dollars for two billion doses

HN: How much funding are you looking for?

SB: The goal is to raise $2 billion to have 2 billion doses available by the end of 2021. That’s 950 million doses for COVAX AMC, 950 million doses for high- and upper-middle-income countries, and 100 million doses for humanitarian and emergency situations, to prevent some outbreaks from getting out of control. The vaccine portfolio will be actively managed and adjusted.

HN: How many countries have signed up to date?

SB: As far as COVAX is concerned, 78 countries have declared their interest in this mechanism. Some of them publicly, such as Switzerland, the European Union, South Korea, Argentina, Brazil, and Canada. Together, they represent 1.6 billion people. These countries now have until the end of August to conclude legally binding agreements. As far as the AMC is concerned, we have raised almost $600 million. This allowed our board to formally approve the mechanism on July 30.

HN: Are you sure that one of these vaccines will be effective?

SB: Between Gavi, CEPI, and the Gates Foundation, we have already identified 16 or 17 eligible vaccines. But the truth is that we do not yet know if they will be effective and safe. Preliminary data is promising. Antibodies against the spike protein, which allows the virus to enter cells, are being produced. But we don’t know how effective these antibodies will be in neutralizing the coronavirus. And there are still many questions about the right dosage, the manufacturing, among others.

HN: Are you concerned that the anti-vaccine movement will derail the public health objective of vaccination?

SB: This is a concern that exists only in the developed world. And it doesn’t help to have political leaders who don’t follow science-based recommendations. But at the end of the day, there are only a small number of people who are anti-vaccine. Probably the same number of people who would get vaccinated at all costs. The challenge is to convince everyone in between.

HN: As an epidemiologist and director of one of the world’s leading vaccination organizations, how are you coping with the pandemic period?

SB: It’s a very difficult time. I wouldn’t say I’m working 24/7, but 20 hours a day, seven days a week is probably close to reality. Our work at Gavi is critical, so we’re motivated. We had our funding summit recently. Normally, I would have had to travel all over the world for that. This time we did it online via video conferences with 42 heads of state. They committed $11 billion to our next programme.

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Seth Berkley and GAVI

Founder of the Global AIDS Vaccine Initiative (IAVI), Seth Berkley co-leads the COVAX initiative to provide equitable and effective access to future COVID-19 vaccines. Trained in medicine at Harvard and in epidemiology at the Center for Disease Control (CDC), Berkeley has been Executive Director of Gavi, the Vaccine Alliance (GAVI), since 2011. Over the past two decades, GAVI, a private-public partnership, has facilitated vaccination of more than 760 million children in developing countries, preventing more than 13 million unnecessary deaths. During the COVID-19 pandemic, Gavi provided medical equipment to health workers and supported screening initiatives.

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Health Policy Watch is partnering with Geneva Solutions, a new non-profit journalistic platform dedicated to covering Genève internationale. In the midst of the Coronavirus pandemic, a special news stream is published at heidi.news/geneva-solutions, providing insights into how the institutions and people in Geneva are responding to this crisis. The full Geneva Solutions platform and its daily newsletter will launch 24 August. Follow @genevasolutions on Twitter for the latest news updates.

Image Credits: Gavi / Frédérique Tissandie, Government ZA.

Photo Credit: Jon Osborne

A World Health Organization spokesperson on Friday said that the Organization is not well-positioned to make specific recommendations about when, where, and how travelers should be tested or quarantined for COVID-19 as countries reopen aviation, deferring the policy question to national governments.

“Some of it is really dependent on what your national authorities ask of you. WHO provides guidance to governments, but then the governments will have their own recommendations as to when you should be tested or retested, how soon before travel you need to have taken your test, etc. So some of those [questions] are not really on our plate to be able to answer,” WHO spokesperson Nyka Alexander said at live-streamed WHO Q&A on international travel.

Instead, the agency recommended travelers keep abreast of quarantine and testing policies in their countries of origin and destination countries.

“The limitations or the restrictions are changing every day because of the evolution of the outbreak,” said Carmen Dolea, head of the WHO International Health Regulations Secretariat. “People that decide to travel need to be to keep themselves abreast of all these changes… so they can plan their accordingly.”

In the early months of the global health emergency, senior WHO officials, including Drector General Dr Tedros Adhanom Ghebreyesus and Emergencies Executive Director Mike Ryn repeatedly advised countries against imposting any travel restrictions at all.  But as the virus spread across the planet, most countries took unilateral action, locking down all but essential aviation.

Now, the patchwork of traveler quarantine and testing policies emerging across countries as skies reopen has still left many people confused and sometimes in a lurch, as countries abruptly change policies without notice.  However, in the last meeting of WHO’s COVID-19 emergency committee, experts abstained from issuing any specific recommendations about how to safely resume aviation, saying only that countries should periodically review restrictions to ensure that they are well founded.

In July, the European Union sought to devise a coherent regional approach, opening travel between all countries of the EU region and compiling a “safe list” of other nations, like Canada and New Zealand, which have low levels of infection and whose nationals can also freely enter the EU.  Travelers from countries on the so-called  “green list”, which is being updated regularly,  are not required to undergo additional COVID-19 testing before or after arrival, nor are they required to quarantine.

However, as the summer wore on, it became apparent that even a spot on the safe list isn’t enough to guarantee ease of travel, as different countries that were part of the zone began to steer their own course anyway.

On July 26th, United Kingdom citizens vacationing in Spain had their return plans abruptly changed after the UK removed Spain from its “safe” country list – meanting that UK citizens returning from holidays in Spain would have to quarantine at home for two weeks upon landing.

Different Approaches To Traveler Quarantine And Testing

Other countries, such as France, are now requiring travelers from countries outside the safe list to arrive with proof of a negative COVID-19 test taken 2-3 days before arrival, take a test upon entry into France, or undergo a mandatory 2 week quarantine.

Germany has required all travelers from risk areas with more than 50 per 100,000 infections to quarantine for two weeks upon arrival, unless they have a signed doctors note indicating they have tested negative for COVID-19 in the 48 hours before landing. Germany has also announced they will be requiring travelers from risk areas to take mandatory COVID-19 tests upon arrival in the near future.

The United Kingdom has continued with its blanket two week mandatory quarantine for travelers from non-safe countries, despite pressure from the airline industry to move towards a traveler testing approach.

Heathrow Airport Chief Executive Officer John Halloway-Kane said in a letter to the UK Prime Minister that the havoc caused by the Spain flip-flop reiterates the need for the UK to embrace passenger testing.

Halloway-Kane wants the UK to take a “test upon arrival” approach. Passengers would be required to take a coronavirus test on arrival, quarantine for 8 days and then take a second test to determine whether they picked up an infection during flight.

That would at least reduce the amount of time that returning travelers have to quarantine.  But in the currently volatile atmosphere, even adding passenger testing to the equation may not diminish the changeability of travel policies. Countries make their safe entry lists based on the epidemiological situation in the country of origin. If a spike in cases in the country of origin occurs, the entry requirements for travelers can still change quickly, as was the case recently with Spain.

As a result, many governments are simply recommending that their citizens avoid traveling altogether unless it is essential. And if they do, they need to keep up with changing travel requirements as much as possible. Switzerland recommends travelers contact a country’s embassy on the day of travel to determine whether entry is still possible.

WHO also is recommending that people avoid non-essential travel, particularly for people with pre existing conditions or above the age of 65.  In a radical departure from its earlier resistance to the public wearing of face masks, WHO has now become an enthusiastic proponent of the use of masks, particularly in closed environments like planes, trains and buses, as well as stores.

And, in fact, the Organization kicked off a new #WearAMask challenge on social media channels Friday.

The campaign, designed to promote wider public use of the masks in settings where COVID-19 is a risk, asks people to promote photos of their own reusable cloth masks. Such masks should be made of three-layers of fabric, including a knit or woven cotton inner layer, a polypropolene filter layer, and a water-resistant polyester or polyester-cotton blend outer layer for optimal efficacy, and can be easily made at home.

 

Image Credits: Flickr: Jon Osborne.

In the unprecedented race to develop a COVID-19 vaccine, the World Health Organization says that there are no “cutting corners” in testing the safety and efficacy of a new vaccine candidate.

Vaccine development has moved at an unprecedented pace. In six months, some 26 candidates are already undergoing human testing, while 139 more are in preclinical trials, according to WHO’s COVID-19 vaccine tracker. Russia recently announced its intention to approve a Russian vaccine by August 10, although they have not released any safety and efficacy data to the public nor to WHO.

Following the Russian announcement, more concerns have been exprssed that vaccine developers may be making compromises in safety and efficacy studies for speed.

Six other vaccine candidates, not including the Russian vaccine candidate,  are already in Phase III clinical tests, the last stage of mass testing in humans according to WHO’s tracker. This crucial phase of testing helps determine whether the vaccine candidate can truly protect against COVID-19 infection, COVID-19 disease, or severe illness.

But a senior WHO official expressed confidence on Thursday that safety corners are not being cut, despite the speed at which R&D is taking place. Results from preliminary trials of all other six vaccine candidates, not including the Russian one, have been submitted to WHO’s vaccine tracker and are being monitored by the organization.

“This is about accelerating the process of development, putting the risk on the financial side of the equation, not on the safety side of the equation, and ensuring that there’s enough [vaccine] production to meet the needs around the world,” said WHO Health Emergencies Executive Director Mike Ryan at the Apsen Security Conference.

But even after a vaccine is approved and deployed widely, Ryan said, scientists will continue monitoring safety and efficacy signals.

“We will still have to remain cautious as we scale up the number of people vaccinated. Rare side effects…only become apparent when you vaccinate lots and lots of people. So there will still be a need for a monitoring phase, even when we start to vaccinate a population level,” said Ryan.

“There are no cutting corners here,” he warned.

Many Unknowns With Russia’s Vaccine Candidate

Ryan’s comments come a week after Russia announced its intention to approve a vaccine candidate developed by the Moscow-based Gamaleya Institute, by August 10th, and begin mass immunizations by October 2020, according to CNN. Russia has the fourth highest number of coronavirus cases in the world, reporting over 870,000 cumulative cases.

Meanwhile, in a race that has taken on some of the feeling of a Cold War-era rivalry, the United States has said it expects a vaccine only to be approved at the earliest by the end of 2020 or beginning of 2021. The United States’ epidemic has dwarfed other countries’ outbreaks with more than 4.8 million cumulative cases reported.

China, the original epicentre of the world’s outbreak, has already approved a vaccine candidate for military use, although experts remain concerned about the efficacy of the vaccine, and Phase III tests are still ongoing.

Cumulative cases of COVID-19 as of 6:37PM CET 6 Aug 2020. Numbers change rapidly.

“It’s another Sputnik moment,” Kirill Dmitriev, head of Russia’s sovereign wealth fund, the financier behind the Russian vaccine, told CNN. Dmitriev was referring to the Soviet Union’s first ever successful satellite launch, ahead of the United States’ launch in the infamous ‘Space Race’ of the 20th century. “Americans were surprised when they heard Sputnik’s beeping. It’s the same with this vaccine. Russia will have got there first.”

But Russia’s vaccine is not one of the six that WHO has been monitoring in clinical trials. And the Organization has said that so far, they have not received any information on the effectiveness and safety of the vaccine from Russia’s trials. Critics have been concerned that the vaccine has not yet undergone enough testing to verify its safety and effectiveness.

Human Challenge Studies Can Be Justified, But May Not Be Required For Testing COVID-19 Vaccines

Speaking at the Aspen event, Ryan also said that human challenge studies, in which individuals in a vaccine trial are purposely inoculated with the virus to test a vaccine candidate’s efficacy, are not necessarily required in the context of COVID-19.

Normal final phase clinical trials draw their conclusions by enrolling massive numbers of people, under the assumption that enough participants will be naturally exposed to the infectious agent to test the vaccine’s efficacy. The large sample size allows scientists to tease out conclusions that could be missed in smaller trials; but these trials can take more time to carry out.

As a result, some experts, including a Harvard bioethicist, have proposed that carefully designed, smaller human challenge studies may be the fastest way to test a vaccine candidate’s efficacy.

Ryan said that a WHO committee is considering the implications of human challenge studies, examining parameters to conduct them in a safe and ethical manner.

“Obviously, we do not fully understand the long term consequences of natural infection, even in younger adults, and we will have to be very careful for instituting human challenge studies,” he said. “They will have to be very carefully assessed for their ethics and the potential health effects. But there are certainly circumstances in which such trials can be justified.”

However, he added that since COVID-19 has become so widespread, larger-scale trials of the traditional kind can be completed within a relatively short time-frame.

“[Human challenge studies are] usually done when there’s very low level of human disease, and therefore it’s difficult to demonstrate efficacy,” explained Ryan. “In this case we have disease, all over the world so we should be able to demonstrate efficacy of the vaccine in the traditional way by large-scale population based trials.”

 

Image Credits: Johns Hopkins CSSE.

Existing smog tower stands in the Lajpat Nagar neighborhood of south-east Delhi.

Environmentalists and scientists have called out the recent Indian Supreme Court decision directing the government to install “smog towers” in Delhi as an injudicious move that will lead to a waste of public money.

The opposition escalated after the Court on Tuesday, ordered the government to begin installing the smog towers within the next week.

Critics compare the use of the expensive and untested technology, that claims to suck up air pollutants produced by vehicles, industry and other sources, with the installation of outdoor air-conditioners to cool down global warming.

“Assuming that we can vacuum away our outdoor air pollution problem is not only a waste of tax-payers money, but also highly unscientific. If there is one lesson to learn from the COVID lockdowns, then it is the fact that we can clean our air and our act only by controlling the emissions from all the sources,” says Sarath Guttikunda, director of Urban Emissions, an air pollution information, research and analysis repository.

Even assuming 100% efficiency at all times, any outdoor smog tower can purify only 0.00007233796% of the total volume of air in the city’s 6,400 square kilometer airshed every hour, through which some 5.76 billion cubic meters of air pass every hour, contends Guttikunda.  In comparison, preventing emissions at sources such as a cement or coal-fired plant would prevent nearly 100% of emissions. He also notes that the technology was tested and failed during the 2010 Commonwealth Games in Delhi.

Smog Towers Are Cost-Ineffective Technologies
Smog obscures buildings in the distance in Gurgaon Cyber City, in Delhi

Due to the sharp limits of the technology, smog towers are ultimately far less cost-effective, in comparison to actually reducing emissions at source. At present air pollution levels, Delhi would need at least 2.5 million such smog towers to clean its air, according to one analysis carried out by Council on Energy, Environment and Water (CEEW). The city requires more sustainable solutions, as citizens in the capital inhaled dangerously toxic air for 241 days in 2019, the analysis adds.

“In no way should such unproven technologies be encouraged,’ says Tanushree Ganguly, a programme associate at CEEW, adding that money being spent on these smog towers could be used for proven measures, such as: ensuring coal power plants that generate significant air pollution comply with emission norms, ensuring a clean and reliable mass transit system, and improving waste management, to halt incineration.

“In addition to rejecting the smog tower as a solution, we should demand for evidence of its impact (or lack of it) through all our writings on this subject. We could ask for evidence on the Lajpat Nagar smog tower’s impact, the smog guns that are being used. If these are indeed solutions, then where is the evidence of the impact? Where is the data, the clear metrics to assess performance?” asks Ganguly.

“Limited resources available for air pollution action should be used for reducing emissions at source rather than testing technologies that are unproven to be effective,’ adds urban air quality scientist Pallavi Pant.

Smog Towers Haven’t Worked in China
Smog (left) obscures view of Tiananmen Square (right) in Beijing, China.

Other critics point to China, which has long experimented with smog towers many times larger than the smog tower currently in use in Delhi at Lajpat Nagar, without any documented success.

“Smog towers just end up as visible showpieces which are easier to sell as solutions to gullible ordinary citizens. When public money is scarce, especially during a pandemic, this is surely no time to experiment with untested technologies. To tackle air pollution, curbing emissions must be the top priority.” says Mihir Shah, strategic communications lead, CEEW.

“The general theme of these studies is that there are slight to modest AQ benefits in the very close vicinity of these very large towers. That is rather damning when taken in the broader perspective: a colossal misallocation of resources that will never scale,” says Joshua Apte, who holds a joint appointment at the University of California at Berkeley’s School of Public Health and Civil/Environmental engineering department.

While slamming the misallocation of resources, environmentalists also are wondering what led to the sudden enthusiasm among decision-makers for the smog towers. They say that the move will merely delay what are urgently needed measures, such as the stricter enforcement of existing laws, greater focus on renewables, less dependance on fossil fuels and more focus on health harm caused by dirty air.

“When the bucket is overflowing and your house is flooded, you don’t go looking for a mop, you turn off the tap. The only solution to pollution is to stop pumping pollutants in the air. Smog towers are a criminal waste of money and anyone with basic common sense can see that,” says Brikesh Singh of the Clean Air Collective, an unbranded collective of over 100 think-tanks, researchers and activist groups.

‘It is necessary to have enough proof to show that smog towers are an effective solution for air pollution before they start them installing them across the country,” says Meghna Amin, campaigner at Jhatkaa. Jhatkaa, an Indian NGO that builds grassroots citizen power, has been running a campaign against smog towers since March 2020, giving the science and rationale behind it.

“We are unable to understand why the government and the courts are repeatedly rejecting the opinions of environmentalists and experts who have clearly stated that smog towers are ineffective in outdoor settings. The only effective way to tackle PM2.5 is to eradicate it at its source. Any other solution is just a waste of tax payers money,” Amin adds.

Supreme Court Has Played Activist Role in Smog Tower Installation

The Court’s original order on the towers was issued in January, after two months in which Delhi reached some of the highest winter air pollution levels ever recorded, prompting public outcry. With government failing to effectively mount policies, the court began to play a more activist role in the desperate quest for solutions to clean the city’s toxic air.

The Court asked the central and Delhi governments to set up a panel to explore the feasibility of various emergency measures. Smog towers was one of the recommendations made at the time – although the panel, whose members were never publicly identified, only recommended setting up a ‘pilot” to ‘see how it fares.’  A joint proposal by the Indian Institute of Technology-Bombay, IIT- Delhi and the University of Minnesota, which had been pending with the Central Pollution Control Board, was then pulled out of the drawers.

As soon as talk of installation of smog towers became public, our air pollution advocacy non-profit Care for Air wrote an open letter to the Supreme Court, requesting it to not promote “band-aid fixes” like smog towers and other outdoor air-purifiers to deal with north India’s debilitating winter smog. At the same time, campaigning for Delhi state’s Legislative Assembly elections was getting into high gear, and the main political parties and their candidates were promising to clean the city’s polluted air.  For the first time that pollution came up as a poll agenda, following a  parliamentary debate on the subject, also a first.

While skies cleared visibly in the spring during the COVID-19 pandemic lockdown, the smog season of late fall and winter is now looming. Late fall and early winter are times when urban emissions from sources such as heating increase substantially, while weather conditions leave pollutants lingering in the city’s air. Crop burning in neighboring regions adds to the toxic mix.  Last year the pollution darkened the city’s skies for weeks on end, with 24-hour air pollution levels 10-20 times above WHO air quality recommendations.

On July 21, the Court ordered the national government, as well as Delhi state authorities, to accelerate its actions to install smog towers in Delhi.  Last week, the Court gave the government one week for the project – to be funded by public money – to begin.  On Tuesday, the government informed the Court that it had finally entered into an agreement with IIT-B, to supervise a project to install smog towers in Delhi.

The Supreme Court of India

While the Court moves may be seen by some as a valiant attempt to make some progress on cleaning Delhi’s toxic air ahead of the next crisis, analysts say the Court has overlooked the science that says that the technology only works within enclosed spaces, and has failed in other countries.

The Court, however, has largely ignored the outcry, calling out the Ministry of Environment, Forest and Climate Change and the Delhi government, over and over, giving them fresh deadlines to comply with its direction on installing smog towers in the capital city.

“We are shocked at the attitude of the respondents with respect to installation of smog towers, which were supposed to be installed within three months and for which an agreement was to be entered into and the order was passed on 13 January after obtaining the requisite reports,” the Court said in July.

In a hearing on 29 July, when IIT-Bombay displayed reservations about going ahead with the project in Delhi, a furious Supreme Court Justice Arun Mishra sternly rebuked the engineering institution, saying the court would “punish” it for withdrawing from a government project. Justice Misra even threatened contempt proceedings, saying “I can’t tolerate this nonsense.”

Environmentalists retweeted this exchange, questioning why the court was pressing this so urgently when science doesn’t back smog towers being of any use in reducing outdoor air pollution.

Air Pollution Finally a National, Political Issue
Smog in Delhi

On the more positive side, the debate has also helped thrust air pollution into the forefront of national debate – even at a time when Delhi skies have been unusually clean and blue, due to the COVID-19 imposed lockdown that reduced the city’s noxious fumes from sources such as traffic, industry and construction.

Air pollution kills nearly seven million people worldwide each year, according to the WHO’s estimates. Some 91% of those premature deaths occur 4 in low- and middle-income countries, and the greatest number in the WHO South-East Asia and Western Pacific regions.

Delhi is among the most polluted cities in the world. In May 2014, the WHO’s list of cities suffering high air pollution levels had identified New Delhi as the worst in its 1,600-city worldwide database.

Increasingly aware of the health damage that air pollution is wreaking, voters across the city and social classes have begun to demand clean air as a social and human right. But the mounting political pressure has also led to quick fix solutions, such as the smog towers. Others include “smog guns” and “vacuum cleaners” to clean outdoor air.

However, as Randeep Guleria, director of the All India Institute of Medical Sciences, New Delhi, recently said, such technologies belittle the problem on the one hand and on the other, raise false hopes among those affected by air pollution.

Existing Tower Doesn’t Work
Smog towers have not been able to reduce levels of PM2.5 particles within their vicinity.

In early January, the Gautam Gambhir Foundation installed a ‘smog tower’ in Lajpat Nagar, costing ₹7 lakh (US $9300), according to media reports. Global air pollution experts say it is not helping reduce pollution by even marginal amounts – even in its immediate vicinity.

Five experts, including scientists associated with Care for Air, visited the tower within the first three weeks of its inauguration on January 3 and found that PM2.5 some distance away from the tower was lower than PM2.5 close to the tower.

“I did a video shoot near the tower for 3 hours. There was absolutely no reduction in PM levels next to this smog tower and within a 150m radius on 3 different angles,” says Barun Aggarwal, CEO of clean air consultancy firm Breathe Easy Consultants, who visited the site on January 10 with his industry calibrated DustTrak monitor- an instrument used to accurately measure particulate matter concentrations. “I saw a man standing there with a local handheld meter taking readings. I found out he works for the company that made the tower, but he seemed completely clueless about how to take readings.”, says Aggarwal.

Things were worse three days later, on January 13, when atmospheric scientists and researchers Bhargav Krishna and Apte visited the tower. Its inbuilt monitor measured PM at 636, as photographed and tweeted by Krishna and Apte. Their photos and tweets also showed that some of the filters were already damaged and air wasn’t reaching the bottom outlets. On January 31, when Tanushree Ganguly who works on air pollution section at the Council on Energy, Environment and Water, visited the tower, it wasn’t working.

Similarly, China’s giant smog-sucking tower installed in 2016 was found to be inefficient by the China Forum of Environmental Journalists after a 50-day trial. Smog-free towers called WAYU, developed and installed by IIT and National Environmental Engineering Research Institute (NEERI) in Delhi in 2018, ended up as dustbins due to their ineffectiveness.

Smog Towers Give False Sense Of Complacency

Ultimately, observers say, installations such as smog towers provide the public with a false sense of complacency and assurance. At this point in a national pandemic where winter 2020 could lead to high levels of air pollution that compounds the impacts of the mounting incidence of respiratory infections from COVID-19, we need strong actions that yield a real and significant reduction in PM2.5 levels.

Already in February, Finance minister Nirmala Sitharaman allocated ₹4,400 crore (US$ 600 million) towards clean air in this year’s national budget, as per the recommendations of the 15th Finance Commission. The national finance commission is also considering the creation of longer-term performance based grants for India’s cities and local authorities over the coming five years. These funds should be targeted towards reducing emissions at source through improved industrial filters, faster transition to renewable energy, improved public transportation and the shutdown of old thermal power plants that do not meet emission standards – rather than expensive and unproven smog towers.

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Jyoti Pande Lavakare is the co-founder of Care for Air India. She is an independent journalist focusing on environmental health issues, and a former financial and business reporter for Dow Jones Newswires, The Business Standard and India Ink. her first book, “Breathing Here is Injurious To Your Health” is due to be published by Hachette in 2020.

Image Credits: Care for Air India, Flickr: Ninara, Flickr: James Riker, Wikimedia Commons: Legaleagle86, Flickr: Ninara, Jyoti Pande Lavakare.

Parents hold their child, who suffers from spinal muscular atrophy.

European legislation on drugs for rare diseases is “far from perfect”, but it is not a ‘failure’ given the amount of private sector investment it has attracted in the past two decades, says Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe, a non-profit alliance of some 930 rare disease patient organisations across 72 countries, in an interview with Health Policy Watch. 

He was responding to a report published in The BMJ last week by a Dutch group of investigative journalists that said European orphan drug regulations have “failed” to incentivize R&D for rare diseases. The report also said the regulations, which offer new orphan drugs ten years of “market exclusivity”, had created a ‘corporate cash machine’ allowing biopharmaceuticals to reap ‘billions’ in profits. 

The investigative report largely based on an interim European Commission review, also notes that two thirds of orphan drugs have been developed for diseases that are already treatable – implying that most orphan drug investment is redundant.

Cam, however, said the report’s conclusions are simplistic, ignoring the big achievements that have been made since the regulations were put in place two decades ago.

“Twenty years ago, pulmonary arterial hypertension used to be fatal. Today, 7 treatments are approved in Europe, largely because of EU and US orphan drug regulations. The life of patients has changed,” he said. 

He said that the deeper problem is the lack of collaborative action among European member states on the orphan drug front, particularly in post-marketing research into the long-term benefits of newly approved drugs, which can further define their long-term value – and thus market price potential.  

The investigative report also claims that only 18-24 of the 142 orphan drugs that had been approved between 1999 and 2017 were developed as a result of the EU Orphan Regulation. However, there is “no data” to back up this “opinion”, said Le Cam.

Le Cam also added that 50% of orphan products in the EU market (65) can be sold as generic treatments because their ten-year period of market exclusivity has run out – according to an internal analysis by EURORDIS, which has not been published.

The Investigative Desk’s Analysis Is ‘Rigorous’, But Some Interpretations Are Misleading  

Although The BMJ analysis is rigorous, some of its interpretations are misleading because they suggest that rare disease R&D is redundant, among other issues, said Le Cam.

“Over time, the [EU orphan drug] regulation seems to have become less effective in directing research to areas where there are no treatments….95% of rare diseases remain still without a treatment”, said the interim version of the European Commission review.

Yann Le Cam, CEO of EURORDIS – Rare Diseases Europe

However, that ignores the fact that new treatments which have been approved often target the most prevalent diseases, said Le Cam. And rare disease prevalence can differ by a factor of 3,000. For instance, cystic fibrosis affects about 30,000 people in Europe, while some rare immune-deficiencies only affect 10 newborns a year.

“When you look at the numbers, it’s true that 95% of rare diseases are not treatable. What’s usually not mentioned is that two-thirds of orphan drugs developed so far treat the 400 most prevalent diseases. Deriving estimates from data can offer useful starting points, but they can also be misleading.”

The 95% figure is also an underestimate of the real unmet medical needs, as “very few” existing treatments are curative. For most rare diseases – such as hemophilia, cystic fibrosis, or seizure disorders – people are still living with a “dreadful disease”.

Finally, he notes that the conclusions of the BMJ investigative report are largely based on an interim version of the European Commission review,to be published in final form only later this summer. Until then, the underlying data upon which the report was based isn’t really available.  

“The BMJ article doesn’t provide any analysis or rational ground to claim that EU Orphan Regulations failed. They refer to a report by the European Commission which is not yet published, hence we don’t know how this number was derived. This is not a fact or a demonstrated analysis, it is a mere opinion,” he said. 

Rare diseases are defined as ones that affect less than 5 in every 10,000 people. It is estimated that at least 30 million people in the EU are affected by a rare disease.

European Incentives Have Provided Value – However Market Exclusivity Invites Misuse Of The Rules

Ellen ‘t Hoen, Director of Medicines, Law & Policy and a long-standing advocate of strong medicines access policies, offers a rather nuanced view of The BMJ report’s conclusions – and on Europe’s incentive schemes. 

“The number of orphan drugs registered has risen sharply in 20 years thanks to European incentive schemes. However, the market exclusivity for 10 years leads to high prices and invites ‘drug pirates’ to misuse the rules,” she told Health Policy Watch, referring to a recent article she co-authored and published in the Dutch medical journal.

“I recognise that there is a need for incentives to develop orphan drugs – but the current regulation is in need of urgent revision,” she added, pointing to a Briefing Document by Medicines, Law & Policy published last year, which concluded that while the EU regulations had been abused, its ‘incentives have undoubtedly contributed to a huge increase in the level of engagement of pharmaceutical firms with orphan diseases, which has led to many new orphan medicinal products being introduced to the European market’.

Now, however, “the time has come to critically evaluate the EU Orphan Drug Regulation for effectiveness and to develop new innovation models for diseases for which the pharmaceutical industry is not showing interest,” said ‘t Hoen. “The European Commission and the Member States urgently need to take measures to stop improper use of the Orphan Medicinal Products Regulation.” 

She said she was awaiting the full report by the European Commission to see what remedies it recommends. 

“The [European] Commission commissioned a study of the orphan drug regulation and has it at its disposal – for some time now but has not made the study public. Word on the street is that it is forthcoming. This study is carried out by Technopolis and addresses the effectiveness of the regulation. It will be important to know the conclusions and recommendations made by the researchers. The study is part of the pharmaceutical incentives review the Council asked for in 2016.”

Importantly, EU Regulation needs to have a “corrective mechanism for misbehaviour”, emphasized Hoen, who received a royal prize for her work on access to medicines a few months ago. 

Among the recommendations made by her NGO a year ago, would be the introduction of a so-called ‘‘sufficiency test’, which would shorten the ten year period of market exclusivity if sufficient return on investment is proven for a given orphan drug.

According to recent data, a ten-year period of market exclusivity has been granted in 99.96% of orphan drugs in the EU based on the so-called ‘prevalence threshold’, which assumes that investment in diseases affecting less than five in ten thousand people is not profitable. This assumption is needing ‘urgent revision’, said ‘t Hoen.

European Collaboration To Drive Down Prices Of Orphan Drugs  

Child with Williams syndrome in Russia

Le Cam agrees that in some cases, a ten-year period of market exclusivity or more is excessive given the rewards the drugs may bring.

But he stresses that more European collaboration not only on R&D but also with respect to price negotiations, would help improve access and lower prices of many orphan drugs, referring to the findings of a 2018 EURODIS analysis.

If Member States were to collaborate more closely on post-marketing R&D, they would be better positioned to negotiate drug prices, as well as agreements to ensure access to drugs in smaller countries and specific demographic groups. 

He explains that in the case of many orphan drugs, treatments are “stabilizing” rather than “curative”. And given the small numbers of patients involved, post-market evaluation of the real value of new rare disease treatments is critical. It can also ensure that treatments cater to the broad range of clinical symptoms reported by patients with rare diseases – a highly heterogeneous group. 

“Today, data collected in the region is not robust enough to allow different treatments to be compared between each other and to determine which product is the most suitable for which age, in which situation, in which combination and which regimen”, said Le Cam. “Pooling data across Europe with the same research questions and protocols would be good science and better use of your money.”

“We can blame the private sector as this report does, but we also need to blame member states for their fragmented approach to generating evidence on orphan drugs after they’re approved. As a result, we still don’t know the real-life value of treatments in patients and are unable to adjust prices accordingly.”

Given that some patients fail to respond to specific treatments, having several drugs for the same disease up our sleeves is crucial – and it can also drive down their price due to competition. Developing such data would also enable orphan drugs to be priced more fairly, as their cost would reflect their ‘real-life value in patients’.

Le Cam also added that European member states tend to negotiate orphan drug prices on an individual basis rather than on a regional level, leaving smaller nations – such as Denmark, Belgium of the Netherlands – standing in the queue for “years” until they gain access, although the same treatment may be available in a larger country right next door.

In 2017, about a quarter of Europeans with a rare disease said their treatment had not been available in their country over the previous year, according to a EURORDIS survey co-funded by the EU.

A Structured & Collaborative Approach To Price Negotiations 

In 2018, EURORDIS urged member states to jointly negotiate a ‘European Transactional Price’ for orphan drugs to account for the fact that preliminary treatments are still ‘‘approximates” rather than ‘curative’ treatments. The Paris-based NGO also called on countries to collaboratively generate robust value assessments for orphan drugs – thus empowering the region to renegotiate the Transactional Price in a way that it reflects the value of the treatment provided. 

The mechanisms proposed by EURORDIS would reduce fragmentation of the European market and allow patients to have immediate access to lifesaving drugs while reducing prices, Le Cam says.

“Offering immediate access to patients and predictability of revenue will attract private sector investment, while also reducing prices and expanding getting access to patients.”

The industry is ready to compromise prices in return for better access to patients and market predictability, he said. However, Member States have acted as the main bottleneck in past decades, and must collaborate for better price negotiation and access.

Today, collaboration is limited to a handful of initiatives, but “the intent is there”. These include the so-called ‘BeNeLuxA’ initiative from 2015, where Belgium, the Netherlands, Luxembourg, Austria, and Ireland came together to kick start negotiations for medicines, including orphan drugs.

More recently in 2017, other member states – Malta, Romania, Greece, Cyprus, Italy, Spain, Portugal and Ireland – agreed to jointly negotiate orphan drug prices in the Valletta Declaration, which covers some 160 million Europeans, or about 32% of the EU’s population.

In 2017, ten European Member States signed the Valletta Declaration to improve access to medicines, including orphan drugs

The General Consensus – ‘Urgent’ Action Is Needed

Despite lively debates over The BMJ investigative report, there seems to be a growing  consensus that both the European Commission and Member States need to take urgent measures to improve access to patients with rare diseases.

The debates over medicines access and pricing raised by COVID-19 may even help accelerate action on the rare disease front as well. 

Says Le Cam: “European Member States have never been able to put their act together because there was a lack of support from the European Commission that didn’t want to put their finger in supporting Member States to collaborate on price negotiation and access. Now, this is changing completely with COVID-19.” 

Image Credits: EURORDIS – Rare Diseases Europe, EURORDIS – Rare Diseases Europe, EURORDIS – Rare Diseases Europe, Valletta Technical Commitee.