Why could Europe’s drug shortages get worse? | – #Europes #drug #shortages #worse
LONDON, Feb 8 (Reuters) – When Ignasi Biosca-Reig heard there was a shortage of amoxicillin in Spain, he moved quickly to increase production of the popular antibiotic. medicine added shifts in his company’s factories. But a few extra turns was as far as he could go.
Although Biosca-Reig wanted to significantly increase supplies, overall to cover the sharply increased costs medicine said that it could not justify investing millions of euros in new production lines if it was not paid more for.
However, many Europe countries, to manufacturers in Spain child price paid for amoxicillin It set the price when the generic version of the drug was first launched in the country two decades ago, and it has struggled since then.
Spanish medicine “It’s a non-business,” said Biosca-Reig, chief executive of producer Reig Jofre ( RJFE.MC ).
“We wanted to react, but we had a problem,” he said. “Costs increase, price remains the same.”
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While many countries around the world are reporting antibiotic shortages as respiratory infections return with a vengeance after pandemic restrictions are lifted, the problem is particularly acute in Europe.
With generic prices regulated, many European drugmakers have said they are reluctant to expand capacity at a time when the war in Ukraine has driven up the cost of everything from energy for factories to packaging cardboard to aluminum for bottle caps. cards.
13 who spoke to Reuters Europe According to the manufacturer and six generic drug industry associations and trade groups, many firms struggle to make enough money to justify producing the antibiotic — let alone increase production.
“This is limited when all of our manufacturing, logistics and compliance costs are up by double digits or more prices we can’t keep it,” said a representative of generic drug manufacturers Europe Adrian van den Hoven, CEO of lobby group Medicines. region.
Companies Reuters spoke to declined to disclose margins for specific generics, citing competitive reasons.
PRICE OF CHEAP GENERICS
Before tendering, many European governments set a reference price that serves as a benchmark in negotiations with suppliers, comparing the price of a generic drug with other markets in the region or with similar drugs at home.
Drug manufacturers say that they are usually the lowest price offer they sign contracts with manufacturers that do, which results in further downward pressure on prices in subsequent tenders.
According to Medicines Europe, generic medicines now account for around 70% of all medicines dispensed in Europe, but national only 29% of what health agencies spend on drugs.
European generic drug manufacturers say that the tender system and regulated prices has spurred a race to the bottom, with European firms being undercut by suppliers from Asia.
Over the past decade, this has forced some European companies to either cut production or move production of generics and active pharmaceutical ingredients (APIs) to India and China, where costs are lower.
Industry leaders now say an overhaul of pricing schemes is the only way to revive production in Europe to both prevent future shortages and prevent the continent from becoming even more dependent on Asia for essential drugs.
Department of medicine prices “There is a growing awareness that we may have to pay more to ensure that our supply of these drugs is secure and not dependent on other regions,” said Rena Conti, an expert on in markets, public policy and law from Boston University’s Questrom School of Business.
BRUSSELS, WE HAVE A PROBLEM
The European Medicines Agency (EMA) and EU lawmakers acknowledge the problem.
The EMA and the European Commission have met repeatedly with drugmakers and trade groups since the shortages were first reported in October, but all parties said no major action had yet been announced.
Steffen Thirstrup, the EMA’s chief medical officer, told Reuters last month that it was unusual to see multiple countries reporting shortages of the same products, but predicted that demand would ease as warmer weather approaches.
Thirstrup said that in the interim, alternative drugs can be used where amoxicillin is not available.
A number of last month sick groups warned that substitutes are now crowding out supplies of other drugs.
The European Commission plans to amend the bloc’s pharmaceutical law in March.
Measures requiring manufacturers to hold larger inventories and provide early warning of shortages offer does, but executives want Brussels to also back calls for governments to change their tendering and pricing systems.
“The main long-term issue is not the cost of production, it’s the overall European market framework, which as a manufacturer, especially to reflect changes in the input costs of key medicines prices it doesn’t allow for flexible adjustment,” said Giovanni Barbella, head of global supply chain at Sandoz, the generic unit of Swiss pharmaceutical giant Novartis ( NOVN.S ).
in Spain child cost of amoxicillin 2098 cents ($1.05) for 60 ml in 03 USA dollar) was determined at the level. In 2013, it was the price of 40 ml, but it has not changed since then. Half of the generic drugs sold in Spain cost less than 1.60 euros per box or bottle, the country’s generics manufacturers’ union said.
According to drug pricing expert Melissa Barber, antibiotic generic prices in Britain are on par with Spain, while in Germany, Europe’s largest generics market, the average amount manufacturers receive has fallen by 66% over the past decade. Pro Generika said.
Elisabeth Stampa, a member of the advisory board of the Spanish pharmaceutical company Medichem, said that in most European countries, it is necessary to revise the prices, inflation There is no mechanism to link to or justify growth due to the lack of APIs.
Stampa, formerly CEO of Medichem, said, “10 “It’s very difficult to keep the same products you market year after year competitive,” he said.
NO SPARE HOLDER
Some countries are promising to take action.
Germany’s parliament is due to consider legal changes to its tendering system for generic drugs this year, while Spain’s health ministry told Reuters last month that the government was considering changes to its pricing system that could result in temporarily paying higher prices for drugs such as amoxicillin.
Executives and trade groups also said they are often unaware when there is a risk of shortages because there is no central EU system that monitors the supply of key generic medicines in each country, as is the case with patented medicines.
“You get what you pay for,” said Thomas Kueny, CEO of the International Federation of Pharmaceutical Manufacturers. “By making price the deciding factor in tenders, you send the message that security of supply, quality and environmental standards are less important,” he said. Associations.
Years of price pressures on manufacturers have forced many smaller firms out of business, and only a handful of generic manufacturers serve much of Europe for drugs like amoxicillin.
Five companies — Britain’s GSK ( GSK.L ), Sandoz, U.S. drugmaker Viatris ( VTRS.O ), India’s Aurobindo ( ARBN.NS ) and France’s Servier — hold about 60% of the amoxicillin market in Europe, according to a market researcher. IQVIA.
In Germany, for example, Sandoz has a 70% market share for amoxicillin drugs, Pro Generika says.
When shortages were discovered, some companies increased production, but not enough to meet immediate demand.
“There is a reduction in European capacity, and at this point in time, there is no spare capacity to really meet those shortages,” said Rex Clements, chief executive of Dutch API maker Centrient Pharmaceuticals.
Sandoz told Reuters it aims to increase amoxicillin production by double-digit percent this year compared to 2022 by adding extra shifts at the Austrian plant, and an expanded facility will also start operating in 2024.
GSK also Britain and amoxicillin factories in France hired new workers and added shifts.
But companies with smaller market shares, such as Israel’s Teva ( TEVA.TA ), which has 5% of the region’s amoxicillin market, are limited, according to Medicines for Europe.
“There is no need to increase our capacity to fill the market gap way there is none,” said Erick Tyssier, Teva’s head of government affairs in Europe. “It’s just not possible.”
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Reporting by Maggie Fick and Natalie Grover in London; Additional by Emilio Parodi in Milan, Emma Pinedo González in Madrid, Renee Maltezou and Eleftherios Papadimas in Athens, Jacob Gronholt-Pedersen in Copenhagen and Ludwig Burger in Frankfurt report; Edited by Josephine Mason and David Clarke
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2023-02-08 10:18:06
Source – reuters
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