Why Europe’s drug shortages might worsen

By Maggie Fick and Natalie Grover

LONDON (Reuters) – When Ignacy Bioska-Rieg heard there was a scarcity of amoxicillin in Spain, he shortly added modifications to his drug firm’s manufacturing unit to spice up manufacturing of the favored antibiotic. However a number of additional shifts have been so far as he might go.

As a lot as he would have favored to considerably improve provide, Bioska-Rieg mentioned he couldn’t justify investing thousands and thousands of euros in new manufacturing traces except he was paid extra for generic medication to cowl sharply rising prices.

However, like many European nations, Spain set the worth producers paid for pediatric amoxicillin when the generic model of the drug first launched within the nation 20 years in the past, and it has not often budged since.

“It is a non-commercial,” mentioned Biosca-Rig, chief govt of Spanish drugmaker Reig Joffre.

“We wished to reply, however we had an issue,” he mentioned. “Prices go up, costs keep the identical.”

With many nations all over the world reporting antibiotic shortages as respiratory infections return with a vengeance after the pandemic restrictions are lifted, the issue is especially acute in Europe.

With generic costs underneath management, many European drugmakers have mentioned they’re reluctant to extend capability at a time when Ukraine’s struggle has raised costs for all the pieces from vitality for factories to cardboard for packaging to aluminum for bottle caps – suggesting extra shortages are on the playing cards. .

In line with 13 European producers and 6 generic drug business associations and commerce teams that spoke to Reuters, many firms are struggling to make sufficient cash to justify making the antibiotic – not to mention ramping up manufacturing.

“We can not afford to maintain this worth cap when all our manufacturing, logistics and regulatory compliance prices are doubling or extra,” mentioned Adrian van den Hoeven, director basic of foyer group Medicines in Europe, which represents generic drug makers. area.

The story continues

The corporate declined to reveal margins for particular generics to Reuters for aggressive causes.

Value of low cost generics

Earlier than launching tenders, many European governments examine generic drug costs with different markets within the area, or comparable medication, to set a reference worth, which serves as a benchmark in negotiations with suppliers.

They sometimes award contracts to producers who supply the bottom costs, placing extra downward stress on costs in subsequent tenders, drugmakers say.

Generic medicines now account for round 70% of all medicines allotted in Europe, however solely 29% of the cash nationwide well being our bodies spend on medicines, in response to Medicines for Medicines in Europe.

European generic drug makers say tender procedures and managed costs have led to a aggressive backside and European companies are being undercut by suppliers from Asia.

Over the previous decade, this has pressured some European firms to both lower output or to fabricate generics and lively pharmaceutical components (APIs) in India and China, the place prices are a lot decrease.

Business executives now say the one method to revive manufacturing in Europe is an overhaul of pricing plans, to keep away from future shortages and stop the continent changing into extra depending on Asia for important medication.

“There’s a rising consciousness that we might need to pay extra to make sure that our provide of those medication is secure and that we aren’t depending on different areas for our personal well being and nationwide safety,” mentioned Rena Conti, a drug pricing skilled and professor within the division. Markets, Public Coverage and Regulation at Boston College’s Questrom Faculty of Enterprise.

Brussels, we now have an issue

The European Medicines Company (EMA) and EU lawmakers have acknowledged there’s a drawback.

The EMA and European Fee have met repeatedly with drugmakers and commerce teams since shortages have been first reported in October, however no main motion has but been introduced, all events concerned mentioned.

EMA Chief Medical Officer Stephen Thurstrup advised Reuters final month that it was pretty uncommon for therefore many nations to report shortages of the identical product, however forecast demand would drop because the climate warmed.

Within the interim, various medication can be utilized the place amoxicillin is unavailable, Thurstrup mentioned.

A number of affected person teams warned final month, nonetheless, that substitutions at the moment are lowering the availability of different medication.

The European Fee is scheduled to desk amendments to the bloc’s pharmaceutical legal guidelines in March.

It’s proposing measures together with producers holding bigger reserve provides and offering early warning of shortages, however executives need Brussels to again their requires the federal government to alter the tendering and pricing system.

“The principle long-term drawback isn’t the price of manufacturing, it’s the construction of the general European market, which as a producer doesn’t enable us to regulate costs flexibly to replicate modifications in enter prices, particularly within the case of important medication,” mentioned Giovanni Barbella, head of generics at Swiss pharmaceutical big Novartis. World Provide Chain Head at Sandoz.

In Spain, the worth of pediatric amoxicillin in 2003 was set at 98 cents ($1.05) for 60 ml. In 2013, it grew to become priced at 40ml however has not modified since then. Half a field or bottle of generic medication bought in Spain prices lower than 1.60 euros, in response to the nation’s Generic Manufacturing Affiliation.

In Germany, Europe’s greatest generics market, the common quantity obtained by producers has fallen by 66% over the previous decade, in response to drug pricing skilled Melissa Barber in Britain, in response to the German generic drug affiliation Professional Generic.

Most European nations don’t have any mechanism to evaluate costs, hyperlink them to inflation or justify will increase as a result of APIs have turn into scarce, mentioned Elizabeth Stampa, a member of the advisory board of Spanish pharmaceutical firm Medicem.

“It is extraordinarily troublesome to maintain the identical merchandise that you simply launch 10 years later aggressive,” mentioned Stampa, who was beforehand chief govt of Medichem.

No extra energy

Some nations are promising to take motion.

Germany’s parliament will think about authorized modifications to its tendering course of for generic medication this yr, whereas Spain’s well being ministry advised Reuters final month that the federal government was contemplating modifications to its pricing system that would result in briefly larger costs for medication akin to amoxicillin.

Executives and commerce teams additionally mentioned they have been typically unaware when there was a threat of shortages as a result of there was no central EU system monitoring the availability of generic medicines wanted in every nation, as is the case with patented medicines.

“You get what you pay for. By making worth the figuring out consider tenders, you might be sending a message that security of provide, high quality and environmental requirements are much less essential,” mentioned Thomas Kueny, director basic of the Worldwide Federation of Pharmaceutical Producers and Worldwide Federation of Pharmaceutical Producers. affiliation

Years of worth stress on producers have pressured many smaller firms out of enterprise, and just a few generic producers serve most of Europe for medication akin to amoxicillin.

5 firms – Britain’s GSK, Sandoz, American drug firm Viatris, India’s Aurobindo and France’s Servier – have about 60% of the amoxicillin market in Europe, in response to market researcher IQVIA.

In Germany, for instance, Sandoz has a 70% market share for the drug amoxicillin, Professional Generica mentioned.

When shortages grew to become obvious, some firms elevated manufacturing, however not sufficient to fulfill quick demand.

“European capability is diminished and in the intervening time there is no such thing as a spare capability to reply to this scarcity,” mentioned Rex Clements, chief govt of Dutch API maker Centrient Prescribed drugs.

Sandoz advised Reuters that by including extra shifts at its Austrian manufacturing unit, it goals to extend manufacturing of amoxicillin by a double-digit proportion this yr in comparison with 2022, and an expanded facility may even come on stream in 2024.

GSK has employed new employees and added modifications to its amoxicillin crops in Britain and France, a spokesman mentioned.

However firms with smaller market shares akin to Israel’s Teva, which has 5% of the amoxicillin market within the area, are restricted, in response to Medicines Europe.

“There isn’t any means we are able to improve our capability to fill the hole available in the market,” mentioned Eric Tysier, Teva’s head of presidency affairs in Europe. “It isn’t potential.”

($1 = 0.9348 Euro)

(Reporting by Maggie Fick and Natalie Grover in London; Further reporting by Emilio Parodi in Milan, Emma Pinedo González in Madrid, Renee Maltezou and Eleftherios Papadimas in Athens, Jakob Grönholt-Pedersen and Ludwig Berger in Copenhagen; and Franking Burger in Mining Franking; David Clarke)