The shortage of antibiotics in Europe made headlines late last year, with most manufacturers citing supply-chain issues and a rise in demand across the continent for medicines. However, a report by Reuters published on Wednesday (February 8), suggests that their problems might not be over just yet. The news agency spoke to 13 European manufacturers and six generic drug industry associations and trade groups and noted that many firms are struggling to make enough money to continue to justify making antibiotics.&nbsp;

What has happened so far?

In December, pharmacies across the United Kingdom and France reported they are running out of key antibiotics which came amid a surge of post-Covid winter infections like strep throat. Some of these medicines included amoxicillin (used to treat a number of respiratory infections) as well as the common painkiller paracetamol.&nbsp;

However, even at the time, the phenomenon was not unheard of as a similar situation took place during the COVID-19 pandemic while the recent one was also attributed to the ongoing conflict in Ukraine and supply chain issues. Additionally, it was also attributed to the fact that India and China produced at least 60 to 80 per cent of the world’s active pharmaceutical ingredients and with this kind of market concentration comes risks.&nbsp;

ALSO READ |&nbsp;<a href="https://www.wionews.com/world/doctors-show-concern-as-countries-across-europe-face-shortages-of-antibiotics-542094">Doctors show concern as countries across Europe face shortages of antibiotics</a>

As China was still facing Covid-related restrictions, even though they were later dropped, to some extent it delayed the European procurement of ingredients, packaging and other components needed to manufacture medicines. Additionally, since the Russian invasion of Ukraine and subsequent sanctions, Europe also faced a spike in energy costs which made energy-intensive production difficult to maintain.&nbsp;

According to a survey of 29 European countries including the EU members and Turkiye, Kosovo, Norway and North Macedonia, reported a shortage of some 600 medicines while 20 per cent reported a shortage of at least 200-300 drugs, as per Politico. Additionally, the survey conducted between mid-November and December 31, last year, also showed that three-quarters of those countries that responded witnessed worse shortages this winter when compared to 2021’s winter.&nbsp;

EMA decides antibiotic shortage not a “major event”

Since the beginning of the year, many reports regarding the antibiotic shortage in Europe continue to emerge as seasonal infections saw a surge after all COVID-19 restrictions ended and people went back to their daily lives. Experts attributed this rise in seasonal infections to our weaker immune systems not used to the germs we encounter in day-to-day life. This surge of infections also caught drugmakers off guard who were also largely unprepared for the rise in demand.&nbsp;

ALSO READ |&nbsp;<a href="https://www.wionews.com/world/antibiotics-shortage-is-getting-scary-is-it-really-significant-know-everything-about-it-542341">Antibiotics shortage is getting scary, is it really significant? Know everything about it</a>

On January 26, the drug regulator, European Medicines Agency (EMA) termed the antibiotic shortage on the continent not a “major event”. However, if the situation was to be categorised it would allow EMA to coordinate action with countries across Europe as well as increase the reporting obligations of manufacturers. Notably, the drug regulatory body’s decision accounted for shortages of certain widely used antibiotics, including amoxicillin.&nbsp;

The EMA did acknowledge that nearly all European countries are currently witnessing antibiotic shortages. Furthermore, reports suggest that drugmakers also cut output when the demand decreased at the height of the Covid pandemic. Prior to the release of the statement by EMA, a group of patient and consumer groups wrote to the regulatory body and said there was not enough action being taken to tackle the shortages.&nbsp;

Additionally, they also noted, the use of alternative antibiotics was affecting the supplies of other medicines and called for the EMA to declare the situation as a “major event”. They also acknowledged that although it would not solve the crisis immediately it would at least offer some regulator visibility into the extent to which the antibiotics shortage is affecting different countries across the continent, reported Reuters.&nbsp;

What are the drug manufacturers saying about the shortage this time around?

According to a report by Reuters, drug manufacturers are reluctant to increase production with prices of generics regulated at a time when the conflict in Ukraine has led to an increase in the cost of virtually everything including components like energy to run the factories, cardboard for packaging and even aluminium for bottle caps.&nbsp;

ALSO WATCH |&nbsp;<a href="https://www.wionews.com/videos/europe-hit-by-shortage-of-antibiotics-doctors-and-officials-express-concern-542051">Europe hit by shortage of antibiotics; doctors and officials express concern</a>

“We cannot keep this capped pricing when all of our production, logistics and regulatory compliance costs are increasing at double digits or more”, said the director general of lobby group Medicines for Europe, Adrian van den Hoven to Reuters. The group represents makers of generic drugs in the region and this reluctance suggests that the issue of antibiotic shortages is not going to be tackled any time soon or even worsen.&nbsp;

How is the cost of generic medicine decided?

According to Medicines for Europe, generic medicines account for nearly 70 per cent of all dispensed medicines in the continent but only 29 per cent of the money is spent on drugs by national health agencies. Prior to launching tenders, many European governments compare the price of generic medicines to other markets in the region or similar ones within the country which then becomes the reference price and also serves as a benchmark for negotiations with suppliers, as per Reuters. Therefore, the contract typically goes to those who offer the lowest price which, according to the drugmakers, puts pressure on prices in tenders that come after.&nbsp;

ALSO WATCH |&nbsp;<a href="https://www.wionews.com/videos/europe-uk-reports-shortage-in-supply-of-antibiotics-doctors-to-recommend-shorter-courses-542105">Europe: UK reports shortage in supply of antibiotics; doctors to recommend shorter courses</a>

Reportedly, over the past decade or so, this has led many European companies to either cut output or move the manufacturing of this type of medicine and active pharmaceutical ingredients (APIs) out of the continent. This includes countries like India and China where the costs are much lower and where the production is now concentrated.&nbsp;

The European generic medicine makers have attributed this tender system and regulated prices to their downfall while also saying that they are being undercut by suppliers from Asia. Therefore, industry experts have called for an overhaul of pricing schemes which could encourage production in Europe to both avoid future shortages and reduce dependency on Asian countries for essential medicines, reported Reuters.&nbsp;

(With inputs from agencies)&nbsp; 
 
&nbsp;

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The shortage of antibiotics in Europe made headlines late last year, with most manufacturers citing supply-chain issues and a rise in demand across the continent for medicines.

The shortage of antibiotics in Europe made headlines late last year, with most manufacturers citing supply-chain issues and a rise in demand across the continent for medicines. However, a report by Reuters published on Wednesday (February 8), suggests that their problems might not be over just yet. The news agency spoke to 13 European manufacturers and six generic drug industry associations and trade groups and noted that many firms are struggling to make enough money to continue to justify making antibiotics. What has happened so far? In December, pharmacies across the United Kingdom and France reported they are running out of key antibiotics which came amid a surge of post-Covid winter infections like strep throat. Some of these medicines included amoxicillin (used to treat a number of respiratory infections) as well as the common painkiller paracetamol. However, even at the time, the phenomenon was not unheard of as a similar situation took place during the COVID-19 pandemic while the recent one was also attributed to the ongoing conflict in Ukraine and supply chain issues. Additionally, it was also attributed to the fact that India and China produced at least 60 to 80 per cent of the world’s active pharmaceutical ingredients and with this kind of market concentration comes risks. ALSO READ | Doctors show concern as countries across Europe face shortages of antibiotics As China was still facing Covid-related restrictions, even though they were later dropped, to some extent it delayed the European procurement of ingredients, packaging and other components needed to manufacture medicines. Additionally, since the Russian invasion of Ukraine and subsequent sanctions, Europe also faced a spike in energy costs which made energy-intensive production difficult to maintain. According to a survey of 29 European countries including the EU members and Turkiye, Kosovo, Norway and North Macedonia, reported a shortage of some 600 medicines while 20 per cent reported a shortage of at least 200-300 drugs, as per Politico. Additionally, the survey conducted between mid-November and December 31, last year, also showed that three-quarters of those countries that responded witnessed worse shortages this winter when compared to 2021’s winter. EMA decides antibiotic shortage not a “major event” Since the beginning of the year, many reports regarding the antibiotic shortage in Europe continue to emerge as seasonal infections saw a surge after all COVID-19 restrictions ended and people went back to their daily lives. Experts attributed this rise in seasonal infections to our weaker immune systems not used to the germs we encounter in day-to-day life. This surge of infections also caught drugmakers off guard who were also largely unprepared for the rise in demand. ALSO READ | Antibiotics shortage is getting scary, is it really significant? Know everything about it On January 26, the drug regulator, European Medicines Agency (EMA) termed the antibiotic shortage on the continent not a “major event”. However, if the situation was to be categorised it would allow EMA to coordinate action with countries across Europe as well as increase the reporting obligations of manufacturers. Notably, the drug regulatory body’s decision accounted for shortages of certain widely used antibiotics, including amoxicillin. The EMA did acknowledge that nearly all European countries are currently witnessing antibiotic shortages. Furthermore, reports suggest that drugmakers also cut output when the demand decreased at the height of the Covid pandemic. Prior to the release of the statement by EMA, a group of patient and consumer groups wrote to the regulatory body and said there was not enough action being taken to tackle the shortages. Additionally, they also noted, the use of alternative antibiotics was affecting the supplies of other medicines and called for the EMA to declare the situation as a “major event”. They also acknowledged that although it would not solve the crisis immediately it would at least offer some regulator visibility into the extent to which the antibiotics shortage is affecting different countries across the continent, reported Reuters. What are the drug manufacturers saying about the shortage this time around? According to a report by Reuters, drug manufacturers are reluctant to increase production with prices of generics regulated at a time when the conflict in Ukraine has led to an increase in the cost of virtually everything including components like energy to run the factories, cardboard for packaging and even aluminium for bottle caps. ALSO WATCH | Europe hit by shortage of antibiotics; doctors and officials express concern “We cannot keep this capped pricing when all of our production, logistics and regulatory compliance costs are increasing at double digits or more”, said the director general of lobby group Medicines for Europe, Adrian van den Hoven to Reuters. The group represents makers of generic drugs in the region and this reluctance suggests that the issue of antibiotic shortages is not going to be tackled any time soon or even worsen. How is the cost of generic medicine decided? According to Medicines for Europe, generic medicines account for nearly 70 per cent of all dispensed medicines in the continent but only 29 per cent of the money is spent on drugs by national health agencies. Prior to launching tenders, many European governments compare the price of generic medicines to other markets in the region or similar ones within the country which then becomes the reference price and also serves as a benchmark for negotiations with suppliers, as per Reuters. Therefore, the contract typically goes to those who offer the lowest price which, according to the drugmakers, puts pressure on prices in tenders that come after. ALSO WATCH | Europe: UK reports shortage in supply of antibiotics; doctors to recommend shorter courses Reportedly, over the past decade or so, this has led many European companies to either cut output or move the manufacturing of this type of medicine and active pharmaceutical ingredients (APIs) out of the continent. This includes countries like India and China where the costs are much lower and where the production is now concentrated. The European generic medicine makers have attributed this tender system and regulated prices to their downfall while also saying that they are being undercut by suppliers from Asia. Therefore, industry experts have called for an overhaul of pricing schemes which could encourage production in Europe to both avoid future shortages and reduce dependency on Asian countries for essential medicines, reported Reuters. (With inputs from agencies) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

Explained: Is Europe’s antibiotic shortage going to get worse? Here’s what we know

If reports are to be believed, pharmaceutical giants such as Pfizer, AstraZeneca PLC, GlaxoSmithKline, Sanofi and Bristol Myers Squibb may be gearing up to increase the price of over 350 medicines in the US in early January.

If reports are to be believed, pharmaceutical giants such as Pfizer, AstraZeneca PLC, GlaxoSmithKline, Sanofi and Bristol Myers Squibb may be gearing up to increase the price of over 350 medicines in the US in early January. The rise in price has been anticipated following the passing of the Inflation Reduction Act (IRA) by the Biden administration. Under the act, the government will negotiate prices directly for some medicines. Medicines are extremely expensive in the USA, compared to other countries because the pharma companies are allowed to set prices without any interference from the government or any related agency. Read more: US: FDA approves most expensive drug ever, costs $3.5 million per dose However, IRA attempts to change the status quo and thus pharma companies are attempting to get ahead of the curve, according to healthcare research firm 3 Axis Advisors which made the prediction. The pharma companies are expected to swing hard at the beginning; meaning the launch prices of the medicines will be kept high so as to offset inflation and avoid unnecessary press by the annual price increases. "Drug makers have to take a harder look at calibrating those launch prices out of the gate...so they don't box themselves into the point where in the future, they can't price increase their way back into profitability," Antonio Ciaccia, president of 3 Axis was quoted as saying by Reuters. WATCH | Gravitas: FDA approves life-changing therapy for Diabetes × The price increase comes on the back of pharma giants raising the price of over 1,400 medicines in 2022. Pfizer has increased the price of 89 medicines while GSK has increased the price of 26 unique medicines. According to reports, the median medicine price increase hovered around 4.9 per cent while the average increase stood at 6.4 per cent. This is the highest increase in the price of medicines since 2015. While most pharmaceutical companies keep the price hike under 10 per cent, the frequent hikes throughout the year manage to take the price beyond the reach of the users. Read more: China looking at Indian market for approved Covid-19 drugs as demand increases (With inputs from agencies) WATCH WION LIVE HERE:

Pharma companies to increase price of at least 350 medicines in the US from next year: Report

Prevention is better than cure -- but when it comes to Covid, what happens when people can't get the vaccine, don't want it, or they're immune suppressed and it fails to stop infection?

The hunt is on for a coronavirus treatment that can be taken as a pill soon after a confirmed positive, halting the disease in its tracks so that cases that might have been severe end up being nothing more than a bad cold.

Several companies are working on so-called oral antivirals, which would mimic what the drug Tamiflu does for influenza.

"It's great that we have vaccine rollout that has been significant, but it certainly will not be taken by everybody in our population, and not everybody who takes the vaccine will have a full response to it," David Hirschwerk, an infectious diseases physician at Northwell Health in New York told AFP.

An easily storable and transportable pill would also offer practical advantages over existing treatments such as monoclonal antibodies, which are mainly injected by drips at hospital infusion centers.

Also read |&nbsp;<a href="https://www.wionews.com/science/vaccines-can-be-redesigned-to-avoid-blood-clots-german-scientists-claim-387671">Vaccines can be redesigned to avoid blood clots, German scientists claim</a>

Promising results

One of the frontrunners in these efforts is a twice-a-day drug called Molnupiravir, which is being developed by Merck in partnership with Ridgeback Biotherapeutics.

Early results from a Phase 2 trial showed that, among dozens of volunteers who tested positive at the start, none of those who received the drug had any detectable virus by day five; while a quarter of those who received a placebo did.

Also read |&nbsp;<a href="https://www.wionews.com/world/pioneering-operation-morocco-to-start-vaccinating-prisoners-against-covid-387651">'Pioneering operation': Morocco to start vaccinating prisoners against Covid</a>

The numbers are promising but too small to draw firm conclusions from, and the company is now enrolling for a Phase 3 trial involving 1,850 people with results expected by fall.

"Viruses are basically little machines and they need certain components to replicate themselves," Merck's chief scientific officer Daria Hazuda told AFP. Antivirals are designed to interfere with that process.

Molnupiravir belongs to a class of antiviral called "polymerase inhibitors," which work by targeting an enzyme that viruses need to copy their genetic material, and introducing mutations that leave them unable to replicate.

Because antibodies target a surface protein of the coronavirus that is continually evolving, antivirals are expected to be more variant-proof.

Early use

Currently, there's just one antiviral approved by the Food and Drug Administration to treat Covid, which is Remdesivir by Gilead Sciences.

Like Molnupiravir, it is a polymerase inhibitor, though their precise actions differ.

Remdesivir's biggest disadvantage is that it was developed as an intravenous drug and targeted at hospitalized Covid patients, among whom it was shown to modestly reduce recovery time.

But by the time Covid has progressed to severe, much of the harm to patients' health comes from their own immune systems going into overdrive and damaging their organs, rather than viral replication.&nbsp;

That's why the focus now is on oral formulations that can be taken within days of infection, and apart from Merck, there are a few other notable entrants.

Roche and Atea have begun a 1,400 patient trial to study their own oral polymerase inhibitor, AT-527.

"This drug has so far been shown to be very potent in vitro," Jean-Pierre Sommadossi, founder and CEO of Atea told AFP.

"I think that after the pandemic, you're going to have a phase which is going to be endemic," he predicted, with the company hoping to file for authorization by the end of the year and launch the drug by 2022.

Curing the cold?

Pfizer, which has developed one of pandemic's foremost vaccines, is also attracting significant attention for its oral drug PF-07321332, which has begun Phase 1 human trials in healthy patients.

Its timeline is a little behind the others, because the medicine, which belongs to a class called "protease inhibitors," was designed specifically against the SARS-CoV-2 virus, with work beginning in March 2020.

Protease enzymes act as molecular scissors that cut long protein chains into smaller pieces, that are then re-assembled as part of viral replication.

"Our investigational orally-administered protease inhibitor was designed to 'fit into' the protease (ie stick into the scissors) and 'block it' (i.e. keep the scissors from working)," Charlotte Allerton, head of medicine design for Pfizer, told AFP.

The company is hoping to expand to late stage studies by the middle of this year, she added.

All the drugmakers also plan to study their medicines for preventative use among close contacts of infected people.

The antivirals under development have demonstrated effectiveness in lab studies against other types of coronaviruses -- some of which cause serious diseases like SARS and MERs, while others cause the cold.

"If it is proven to be very safe and proven to be effective, then it can be used broadly, irrespective of the diagnosis, to treat and prevent multiple respiratory infections," said Hazuda of Merck's product.

Prevention is better than cure -- but when it comes to Covid, what happens when people can't get the vaccine, don't want it, or they're immune suppressed and it fails to stop infection?

Prevention is better than cure -- but when it comes to Covid, what happens when people can't get the vaccine, don't want it, or they're immune suppressed and it fails to stop infection? The hunt is on for a coronavirus treatment that can be taken as a pill soon after a confirmed positive, halting the disease in its tracks so that cases that might have been severe end up being nothing more than a bad cold. Several companies are working on so-called oral antivirals, which would mimic what the drug Tamiflu does for influenza. "It's great that we have vaccine rollout that has been significant, but it certainly will not be taken by everybody in our population, and not everybody who takes the vaccine will have a full response to it," David Hirschwerk, an infectious diseases physician at Northwell Health in New York told AFP. An easily storable and transportable pill would also offer practical advantages over existing treatments such as monoclonal antibodies, which are mainly injected by drips at hospital infusion centers. Also read | Vaccines can be redesigned to avoid blood clots, German scientists claim Promising results One of the frontrunners in these efforts is a twice-a-day drug called Molnupiravir, which is being developed by Merck in partnership with Ridgeback Biotherapeutics. Early results from a Phase 2 trial showed that, among dozens of volunteers who tested positive at the start, none of those who received the drug had any detectable virus by day five; while a quarter of those who received a placebo did. Also read | 'Pioneering operation': Morocco to start vaccinating prisoners against Covid The numbers are promising but too small to draw firm conclusions from, and the company is now enrolling for a Phase 3 trial involving 1,850 people with results expected by fall. "Viruses are basically little machines and they need certain components to replicate themselves," Merck's chief scientific officer Daria Hazuda told AFP. Antivirals are designed to interfere with that process. Molnupiravir belongs to a class of antiviral called "polymerase inhibitors," which work by targeting an enzyme that viruses need to copy their genetic material, and introducing mutations that leave them unable to replicate. Because antibodies target a surface protein of the coronavirus that is continually evolving, antivirals are expected to be more variant-proof. Early use Currently, there's just one antiviral approved by the Food and Drug Administration to treat Covid, which is Remdesivir by Gilead Sciences. Like Molnupiravir, it is a polymerase inhibitor, though their precise actions differ. Remdesivir's biggest disadvantage is that it was developed as an intravenous drug and targeted at hospitalized Covid patients, among whom it was shown to modestly reduce recovery time. But by the time Covid has progressed to severe, much of the harm to patients' health comes from their own immune systems going into overdrive and damaging their organs, rather than viral replication. That's why the focus now is on oral formulations that can be taken within days of infection, and apart from Merck, there are a few other notable entrants. Roche and Atea have begun a 1,400 patient trial to study their own oral polymerase inhibitor, AT-527. "This drug has so far been shown to be very potent in vitro," Jean-Pierre Sommadossi, founder and CEO of Atea told AFP. "I think that after the pandemic, you're going to have a phase which is going to be endemic," he predicted, with the company hoping to file for authorization by the end of the year and launch the drug by 2022. Curing the cold? Pfizer, which has developed one of pandemic's foremost vaccines, is also attracting significant attention for its oral drug PF-07321332, which has begun Phase 1 human trials in healthy patients. Its timeline is a little behind the others, because the medicine, which belongs to a class called "protease inhibitors," was designed specifically against the SARS-CoV-2 virus, with work beginning in March 2020. Protease enzymes act as molecular scissors that cut long protein chains into smaller pieces, that are then re-assembled as part of viral replication. "Our investigational orally-administered protease inhibitor was designed to 'fit into' the protease (ie stick into the scissors) and 'block it' (i.e. keep the scissors from working)," Charlotte Allerton, head of medicine design for Pfizer, told AFP. The company is hoping to expand to late stage studies by the middle of this year, she added. All the drugmakers also plan to study their medicines for preventative use among close contacts of infected people. The antivirals under development have demonstrated effectiveness in lab studies against other types of coronaviruses -- some of which cause serious diseases like SARS and MERs, while others cause the cold. "If it is proven to be very safe and proven to be effective, then it can be used broadly, irrespective of the diagnosis, to treat and prevent multiple respiratory infections," said Hazuda of Merck's product.

Seeking a pill to cure Covid: Drugmakers eye alternative to vaccines

Drugmakers&nbsp;on Thursday said US President Joe&nbsp;Biden's support for waiving&nbsp;patents of COVID-19&nbsp;vaccines could disrupt a fragile supply chain, and that, rich countries should instead share more generously with the developing world.

Biden&nbsp;on Wednesday threw his support behind waiving intellectual property rights for COVID-19&nbsp;vaccines, angering research-based pharmaceutical companies.

Also read |&nbsp;<a href="https://www.wionews.com/world/us-backs-india-led-fight-to-waive-covid-vaccines-patents-383092">US backs India-led fight to waive Covid vaccines patents</a>

If adopted by the World Trade Organisation, the proposal would invite new manufacturers that lack essential know-how and&nbsp;oversight from the inventors to crowd out established contractors, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said.

"I have heard many (vaccine&nbsp;makers) talking about 'our resources are stretched, our technicians are stretched'," IFPMA Director General Thomas Cueni told Reuters. He warned of a possible free for all if "sort of rogue companies" were allowed to become involved.

Vaccine&nbsp;developers echoed his comments that waiving intellectual property rights was not a solution.

"Patents are not the limiting factor for the production or supply of our&nbsp;vaccine. They would not increase the global production and supply of&nbsp;vaccine&nbsp;doses in the short and middle term," said Germany's BioNTech, which aims to supply up to three&nbsp;billion doses together with Pfizer this year.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/us-supports-global-waiver-of-intellectual-property-protection-for-covid-19-vaccines-383100/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

BioNTech said it took more than a decade to develop its&nbsp;vaccines manufacturing process and replicating it required experienced personnel and a meticulous technology transfer, among several other factors beyond&nbsp;patents.

Another German company CureVac, which hopes to release trial results on its messenger ribonucleic acid (mRNA)&nbsp;vaccine&nbsp;as early as this month, said&nbsp;patents were not to blame for supply bottlenecks.

"Since mRNA technology has emerged as the key technology in the fight against COVID-19, the world now needs the same raw materials in unfathomable amounts. The biggest problem is how to coordinate this," a spokeswoman said.

IFPMA's Cueni said the real bottlenecks were trade barriers, in particular the US Defense Production Act (DPA).

The DPA is a decades-old US law that prioritised procurement orders related to US national defence, but it has been widely used in non-military crises, such as natural disasters.

Cueni said the way to kickstart low-income countries' vaccination campaigns, was for rich countries to donate&nbsp;vaccine, rather than widen eligibility to young and healthy people at home.

Moderna, which on Thursday reported quarterly results, said waiving intellectual property rights would not help to increase the supply of its&nbsp;vaccines in 2021 and 2022.

The US drugmaker said last year it would not enforce its&nbsp;vaccine&nbsp;patents. CureVac said on Thursday it would also not enforce its&nbsp;patents during the pandemic and that it knew of no other developer that would.

Italy's ReiThera which is in late-stage tests on an experimental COVID-19&nbsp;vaccine was also critical of&nbsp;patent&nbsp;waivers.

"There is proprietary know-how that has to be transferred by the owner. And then there is the problem with process materials, which at the moment have delivery times of almost a year," ReiThera's chief of technology Stefano Colloca said.

In contrast to the industry reaction, the GAVI&nbsp;vaccine&nbsp;alliance, which co-leads the COVAX dose-sharing programme with the WHO and faces major supply constraints, welcomed&nbsp;Biden's support for waiving intellectual property rights.

Drugmakers on Thursday said US President Joe Biden's support for waiving patents of COVID-19 vaccines could disrupt a fragile supply chain, and that, rich countries should instead share more generously with the developing world.

Drugmakers on Thursday said US President Joe Biden's support for waiving patents of COVID-19 vaccines could disrupt a fragile supply chain, and that, rich countries should instead share more generously with the developing world. Biden on Wednesday threw his support behind waiving intellectual property rights for COVID-19 vaccines, angering research-based pharmaceutical companies. Also read | US backs India-led fight to waive Covid vaccines patents If adopted by the World Trade Organisation, the proposal would invite new manufacturers that lack essential know-how and oversight from the inventors to crowd out established contractors, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said. "I have heard many (vaccine makers) talking about 'our resources are stretched, our technicians are stretched'," IFPMA Director General Thomas Cueni told Reuters. He warned of a possible free for all if "sort of rogue companies" were allowed to become involved. Vaccine developers echoed his comments that waiving intellectual property rights was not a solution. "Patents are not the limiting factor for the production or supply of our vaccine. They would not increase the global production and supply of vaccine doses in the short and middle term," said Germany's BioNTech, which aims to supply up to three billion doses together with Pfizer this year. BioNTech said it took more than a decade to develop its vaccines manufacturing process and replicating it required experienced personnel and a meticulous technology transfer, among several other factors beyond patents. Another German company CureVac, which hopes to release trial results on its messenger ribonucleic acid (mRNA) vaccine as early as this month, said patents were not to blame for supply bottlenecks. "Since mRNA technology has emerged as the key technology in the fight against COVID-19, the world now needs the same raw materials in unfathomable amounts. The biggest problem is how to coordinate this," a spokeswoman said. IFPMA's Cueni said the real bottlenecks were trade barriers, in particular the US Defense Production Act (DPA). The DPA is a decades-old US law that prioritised procurement orders related to US national defence, but it has been widely used in non-military crises, such as natural disasters. Cueni said the way to kickstart low-income countries' vaccination campaigns, was for rich countries to donate vaccine, rather than widen eligibility to young and healthy people at home. Moderna, which on Thursday reported quarterly results, said waiving intellectual property rights would not help to increase the supply of its vaccines in 2021 and 2022. The US drugmaker said last year it would not enforce its vaccine patents. CureVac said on Thursday it would also not enforce its patents during the pandemic and that it knew of no other developer that would. Italy's ReiThera which is in late-stage tests on an experimental COVID-19 vaccine was also critical of patent waivers. "There is proprietary know-how that has to be transferred by the owner. And then there is the problem with process materials, which at the moment have delivery times of almost a year," ReiThera's chief of technology Stefano Colloca said. In contrast to the industry reaction, the GAVI vaccine alliance, which co-leads the COVAX dose-sharing programme with the WHO and faces major supply constraints, welcomed Biden's support for waiving intellectual property rights.

Drugmakers say Biden misguided over vaccine patent waiver

An Oklahoma judge on Monday ordered US health care giant Johnson &amp; Johnson to pay $572 million in damages for its role in fostering the <a href="https://www.wionews.com/world/johnson-johnsons-greed-helped-fuel-us-opioid-crisis-oklahoma-claims-at-trial-222378">state's opioid addiction crisis</a>.

In the first civil trial of a drugmaker over an epidemic that has caused hundreds of thousands of overdose deaths, Judge Thad Balkman said prosecutors had demonstrated that J&amp;J contributed to a "public nuisance" in its deceptive promotion of highly addictive prescription painkillers.

"Those actions compromised the health and safety of thousands of Oklahomans," he said.

According to the ruling, the company and its Janssen pharmaceuticals division will fund an "abatement plan" for care for addicts, families and communities ravaged by the crisis.

"The defendants Janssen and Johnson &amp; Johnson's misleading marketing and promotion of opioids created a nuisance," Balkman said.

Landmark case

J&amp;J was the first pharmaceutical company tried over the US opioid crisis, which fueled over 70,000 overdose deaths in 2017 alone.

But there are some 2,000 outstanding lawsuits against many drugmakers and distributors filed by state and local governments, many overwhelmed by the costs of an epidemic that has only slightly abated.

Most of those are being rolled into a case to go to trial in October in Ohio that will likely set the basis for potentially many billions of dollars in settlements across the country.

Prosecutors had sought $17 billion in damages against J&amp;J for an abatement program to be spread over 30 years.&nbsp;

But Balkman said the state had not made a strong case for the future costs of the crisis to it and the community beyond one year, and so limited his ruling to that.

J&amp;J's shares rose about two percent to $130 in after-market trade following the decision.

The company immediately said it would appeal the decision.

"Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome," said J&amp;J executive vice president Michael Ullmann.

"The unprecedented award for the state's 'abatement plan' has sweeping ramifications for many industries and bears no relation to the company's medicines or conduct."

Company downplayed addiction claims

J&amp;J argued that the law was being inappropriately applied and that its products had a very small role in the addiction epidemic in Oklahoma and nationally.

Balkman said J&amp;J had promoted its drugs by telling doctors and patients that pain was not being treated enough and that "there was a low risk of abuse and a low danger" in the drugs themselves.

"The defendants used the phrase 'pseudoaddiction' to convince doctors that patients who exhibited signs of addiction... were not actually suffering from addiction, but from the undertreatment of pain," he said in his decision.

He also said the company consciously downplayed risks it knew were present, pointing to the 2007 $600 million fine in a Virginia trial of Purdue Pharma, one of the leading prescription opioid makers, for misleading the health industry and the public about the highly addictive properties of its Oxycontin painkiller.

J&amp;J is the first drugmaker to go to trial and the case is seen as a bellwether for thousands of possible criminal and civil suits over the seeming uncontrolled distribution of highly addictive painkillers like oxycodone and hydrocodone, and J&amp;J's Nucynta and Duragesic, between 2000 and 2015.

Two other major drugmakers accused in the same suit, Purdue Pharma of the United States and Israel's Teva, settled with Oklahoma before the case went to trial.&nbsp;

Purdue, which produced the widely abused opioid Oxycontin, agreed to pay the state $270 million in March and Teva negotiated an $85 million settlement.

Dozens of local and state governments across the country have also already exacted settlements with opioid manufacturers and distributors to address their problems.

An Oklahoma judge on Monday ordered US health care giant Johnson & Johnson to pay $572 million in damages for its role in fostering the state's opioid addiction crisis.

An Oklahoma judge on Monday ordered US health care giant Johnson & Johnson to pay $572 million in damages for its role in fostering the state's opioid addiction crisis. In the first civil trial of a drugmaker over an epidemic that has caused hundreds of thousands of overdose deaths, Judge Thad Balkman said prosecutors had demonstrated that J&J contributed to a "public nuisance" in its deceptive promotion of highly addictive prescription painkillers. "Those actions compromised the health and safety of thousands of Oklahomans," he said. According to the ruling, the company and its Janssen pharmaceuticals division will fund an "abatement plan" for care for addicts, families and communities ravaged by the crisis. "The defendants Janssen and Johnson & Johnson's misleading marketing and promotion of opioids created a nuisance," Balkman said. Landmark case J&J was the first pharmaceutical company tried over the US opioid crisis, which fueled over 70,000 overdose deaths in 2017 alone. But there are some 2,000 outstanding lawsuits against many drugmakers and distributors filed by state and local governments, many overwhelmed by the costs of an epidemic that has only slightly abated. Most of those are being rolled into a case to go to trial in October in Ohio that will likely set the basis for potentially many billions of dollars in settlements across the country. Prosecutors had sought $17 billion in damages against J&J for an abatement program to be spread over 30 years. But Balkman said the state had not made a strong case for the future costs of the crisis to it and the community beyond one year, and so limited his ruling to that. J&J's shares rose about two percent to $130 in after-market trade following the decision. The company immediately said it would appeal the decision. "Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome," said J&J executive vice president Michael Ullmann. "The unprecedented award for the state's 'abatement plan' has sweeping ramifications for many industries and bears no relation to the company's medicines or conduct." Company downplayed addiction claims J&J argued that the law was being inappropriately applied and that its products had a very small role in the addiction epidemic in Oklahoma and nationally. Balkman said J&J had promoted its drugs by telling doctors and patients that pain was not being treated enough and that "there was a low risk of abuse and a low danger" in the drugs themselves. "The defendants used the phrase 'pseudoaddiction' to convince doctors that patients who exhibited signs of addiction... were not actually suffering from addiction, but from the undertreatment of pain," he said in his decision. He also said the company consciously downplayed risks it knew were present, pointing to the 2007 $600 million fine in a Virginia trial of Purdue Pharma, one of the leading prescription opioid makers, for misleading the health industry and the public about the highly addictive properties of its Oxycontin painkiller. J&J is the first drugmaker to go to trial and the case is seen as a bellwether for thousands of possible criminal and civil suits over the seeming uncontrolled distribution of highly addictive painkillers like oxycodone and hydrocodone, and J&J's Nucynta and Duragesic, between 2000 and 2015. Two other major drugmakers accused in the same suit, Purdue Pharma of the United States and Israel's Teva, settled with Oklahoma before the case went to trial. Purdue, which produced the widely abused opioid Oxycontin, agreed to pay the state $270 million in March and Teva negotiated an $85 million settlement. Dozens of local and state governments across the country have also already exacted settlements with opioid manufacturers and distributors to address their problems.

Johnson & Johnson ordered to pay $572 million for opioid addiction crisis

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