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European healthcare and its patients have been grappling with drug shortages for years, a challenge that slowly became a chronic disease before peaking last winter.
A triple whammy for respiratory infections hit Europe at the start of the cold season in 2022, with the European Centre for Disease Prevention and Control (ECDC) warning that many EU countries were recording higher-than-normal rates of respiratory infections due to the peak of respiratory infections. Circulation of 3 common winter viruses: influenza, respiratory syncytial virus, and Covid-19.
While not unusual at this time of year, the ECDC said the wave of pre-same respiratory illnesses inflamed large numbers of young people and coincided with a sharp rise in strep A throat infections affecting young people. Older children are dying from strep A infections after developing an invasive variant, which occurs when the bacteria enter the lungs or bloodstream.
As the number of infections skyrocketed, doctors, pharmacists and patients found themselves in a sticky situation, having to unload the drugs needed to treat those infections — life-saving antibiotics. Across the block, fitness officials began sounding the alarm when it became apparent that, given the rising number of infections, there simply weren’t enough antibiotics to go around.
Antibiotics are lifesaving. But we treat them as though they were T-shirts or trousers
Ilaria Passarini, secretary general of the European Union Pharmaceutical Group’s (PGEU) lobby for EU pharmacists, says that while the PGEU has been calling for a solution to the drug shortage for years, the situation last winter was much worse.
“More and more patients were coming to the pharmacy asking for antibiotics, which weren’t in the logo [or] in the prescribed formulation,” he says. “Many pharmacists have had to send their patients to the doctor to ask for an alternative. In many cases, this has led to wait times of several days or even weeks.
Amoxicillin, one of the most commonly used antibiotics, used to fight a broad range of bacteria – from the ones causing strep A and respiratory infections, to skin, blood or kidney infections – was among the worst-hit. Last December, France’s National Agency for Drug Safety (ANSM) warned that amoxicillin, especially in preparations for children, was among 277 drugs in short supply. As a stopgap solution, the agency later allowed French pharmacists to compound available preparations to make them easier for under-12s to ingest. Shortages were also reported in Spain, Italy, Germany, Austria and the United States. By mid-December, the EU’s drug regulator, the European Medicines Agency (EMA), launched an official investigation into what was causing shortages, as it confirmed that 25 out of 27 EU countries lacked critical drugs like amoxicillin and other vital antibiotics, as well as medications crucial for patients fighting cancer, diabetes, heart disease and other serious illnesses.
Passarini argues that, when national regulations allow, pharmacists can simply interfere by preparing drugs or providing alternatives, but this is not without consequences for those fighting the disease.
“Drug shortages can have a negative effect on people’s physical condition, either because the disease worsens or because of the side effects of less suitable remedies,” says Ancel·la Santos Quintano, head of fitness policy at the European customer lobby. BEUC. Es possible that alternative remedies are also more expensive or interact negatively with other medications that the patient may be taking. According to the French League Against Cancer, many oncologists say that substituting a cancer patient’s usual drugs can worsen the prognosis.
When shortages came to a head earlier this year, EU capitals rushed to adopt last-minute contingency plans, adding stockpiling. intensify efforts to control Europe’s ailing pharmaceutical supply chain. In July, the Commission said it was taking preventive measures to be “better prepared” for the upcoming winter season. These included incentivizing corporations to increase their production of “key antibiotics. “, strengthening the EMA’s capacity to search for and monitor shortages, and build a list of critical medicines for the EU.
The list, which is expected to be published by the end of the year, will identify medicines “for which continuity of source will need to be ensured,” an EMA spokesperson said, adding that it will be based on six existing national lists that all EU member states will assess.
We want to have a secure supply chain, especially for critical medicines
Passarini says it’s time for the government to take action on a challenge that has plagued them for years, leaving them at the mercy of patients’ frustration. “Pharmacists are the face of the challenge; “A lot of times they don’t know why a drug is rarely widely available,” he says. year since then. The scenario for hospital pharmacists is equally dire. In its 2023 survey, the European Association of Hospital Pharmacists (EAHP) said that 95% of hospital pharmacies in 36 European countries reported drug shortages last year, a factor they have struggled with since the organization began surveying its members in 2023-2013.
However, when it comes to antibiotics, the murky and complicated nature of globalized pharmaceutical supply chains means there is no quick and easy solution. Most EU-based players don’t have much on supply lines. An overwhelming majority have factories in India and China producing active pharmaceutical ingredients, or APIs, with which European pharmaceutical corporations then make antibiotics.
Thomas Porstner, a member of the board of directors of GIRP, the European Association of Pharmaceutical Wholesalers, says its members are also informed of shortages “in the very short term and without data on the causes. “The situation of antibiotic sources, he adds, remains “precarious”. .
According to Passarini, the concentration of manufacturing capacities in a small number of producers in China and India increases risks of supply shortcomings and is “one of the main causes behind shortages”.
For Ulrike Holzgrabe, a professor at the Institute of Pharmacy and Food Chemistry at the University of Würzburg in Germany, this means that they are life-saving medicines, antibiotics today are produced under the same conditions and are subject to the same pressures as any other product. . Formation
“Antibiotics save lives. But we treat them like t-shirts or pants,” he says. The back-and-forth gymnastics involved in shipping and repackaging the procedure of preparing a single package of pills, he adds, makes it even more complicated. act in the event of an upheaval in the supply chain. “There is no direct line between API production and an injectable capsule or tablet. “
Today, most antibiotics are generic unbranded drugs that EU countries have always tried to buy brand-name at the lowest price imaginable. While this eases Social Security budgets, it has ultimately led to a just-in-time antibiotic production line where brands are looking to ramp up production as much as possible and as cost-effectively as possible.
“Our production sites operate 24/7, so when demand increases, it’s tricky to ramp up production to meet it,” says Adrian van den Hoven, chief executive of Medicines for Europe, which represents generic drug manufacturers. around 85% of European antibiotics.
Antibiotics, he adds, are at “particular risk” of shortages because “they are incredibly complex to manufacture, their value is incredibly low, and the market is very consolidated. A recipe for disaster.
The shortage of medicines can have a negative effect on the health of populations
Ivan Lugovoi, an assistant professor of pharmaceutical supply chain control at the Kühne University of Logistics in Hamburg, who has conducted extensive studies on drug shortages in the U. S. , said that he has been working on the drug shortage in the U. S. According to the U. S. Department of Homeland Security, he says there are two foolproof tactics for them: “Either you have stock or you have [manufacturing] without using capacity. . . And this price tension doesn’t allow companies to conserve this spare capacity, because they want to be as efficient as possible. “
This race to the bottom in generic drug prices has many other counterproductive tactics. This creates unbalanced access to medicines within the EU’s only market, as companies either prioritise selling to the highest bidder or remove medicines from unprofitable markets altogether, punishing the bloc’s poorest capitals. Big Pharma has also been fined for hindering the commercialization of less expensive generic opportunities for their brand-name drugs.
The series of proposals put forward in Brussels since the beginning of the year aim to tackle what many in the pharmaceutical industry see as a stagnant medicines market.
An ambitious overhaul to overhaul the bloc’s main pharmaceutical law, unveiled this spring, is part of these efforts. Belgium, which will take over the presidency of the Council of the EU early next year, has said it will make pharmaceutical reform and drug shortages one of the main objectives of its presidency.
While welcomed by pharmacists and wholesalers, key proposals to require corporations to promptly notify product shortages or recalls have sparked fear among pharmaceutical executives, paving the way for intense and protracted negotiations to redefine regulations governing one of the EU’s major economic sectors. But as shortages continue to plague the bloc, officials in Brussels acknowledge the need to take swifter action. As the bloc prepares for the winter season, the Commission says the EMA will play a bigger role in monitoring the source and forecasting of diseases, as well as stepping up its coordinated reaction efforts. While existing knowledge suggests that the origin of antibiotics appears to be “broadly in line with demand”, the report warns that this forecast depends “on the fulfilment by the companies involved of their legal responsibility to supply certain sources and their capacity adaptation”.
In October, the Commission also followed up on a proposal led by Belgium, subsidised in May through 18 other EU capitals, for a Critical Medicines Act that, among other things, would allow EU countries to share stocks in the event of shortages (but as a measure of last resort). jointly procure antibiotics; identify “donation channels” with countries in the Global South that are emerging from the winter disease season; and, above all, to inspire the local production of antibiotic APIs, for which the EU “depends entirely on one country or a limited number of manufacturers”.
“The Covid-19 pandemic and the Russian military aggression against Ukraine exposed Europe’s supply chains dependencies and the risk that economic dependency could be weaponised,” Commission vice-president Margaritis Schinas said at the time, adding that ensuring access to medicines in the EU was “fundamental”.
The EU’s last large-scale factory producing API for antibiotics like amoxicillin and penicillin is in Kundl, Austria, and is run by Sandoz, the generics branch of Swiss pharmaceutical giant Novartis. Other antibiotic factories are located in Spain, Portugal, France, Italy and Romania but, over the last decade, the EU has gone from being a leading manufacturer of antibiotics to an import-dependent region for critical medications.
Public health experts, pharmacists and others agree that diversifying and making the pharmaceutical supply chain more transparent will make it more resilient to risks and that, while it may not be easy, getting the industry to boost domestic production of antibiotics more critical. and creating new ones to fight the development of antimicrobial resistance is part of the solution.
It would be better if we were a little more independent so that we could react more temporarily and wait for what is produced in India or China.
“We need to have a secure supply chain, especially for critical medicines,” Passarini says. “Reshoring is a way to do that but it comes with costs,” she adds, referring both to the environmental impacts of API production and to drug prices, adding that these should be “proportionate to the security we gain”.
While looser environmental regulations are one of the main reasons pharmaceutical corporations have moved their production to China and India in recent decades, Holzgrabe, a professor of pharmacy at the University of Würzburg, says the main determinant is economic: providing us with less expensive, but “uncontrolled” antibiotics over supplies.
“It would be better if we were a little more independent so that we could react more temporarily instead of waiting for what is produced in India or China,” he says. Efforts are already underway to stimulate local production of antibiotics in Europe. In 2020, Sandoz signed a €175 million agreement with the Austrian government for the production of antibiotics at its Kundl production site. In exchange for a public investment of about one-third of the agreement, Sandoz pledged to keep penicillin API production active for the next 10 years. The move follows the announcement that France’s largest pharmaceutical company, Sanofi, has announced its ambition to create a new European API production champion, EuroAPI. But last month, the so-called champion said that, amid continued downward pressure on prices, he wasn’t promoting enough.
Van den Hoven says many generic drug brands are willing to invest in local production of antibiotics but want adequate support, adding that EU countries are reviewing their drug purchasing policies and putting security of supply ahead of low prices.
Ultimately, many supply chain actors and health policy experts agree that there is a pressing need to more broadly reconsider the EU pharmaceutical market if Brussels wants to ensure that medicines are sufficient and affordable, adding life-saving antibiotics. lives.
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