Generic manufacturers want to take more drugs off the market

Berlin Fever juices, important antibiotics, even anti-cancer drugs are always hard to come by in pharmacies. More than 400 drugs are currently on the list of the Federal Institute for Drugs and Medical Devices (BfArM) for drugs that are not in stock.

A survey of its member companies by the Pro Generika industry association now shows that the situation is likely to remain tense in the future. It is exclusively available to the Handelsblatt.

Ten companies took part in the survey, which produce a total of around two-thirds of the patent-free medicines required in Germany, so-called generics. “This gives us a very broad insight into the assessment of the situation,” said the industry association. All are based in Germany. Generics account for the largest share of medicines sold.

30 percent of the companies surveyed stated that they would eliminate between 10 and 50 percent of their drugs from the portfolio in the next twelve months. 70 percent said they will stop offering up to 10 percent.

According to the companies, the active ingredients in antibiotics, the opioid oxycodone, the antidepressant venlafaxine, the heart drug ivabradine, the cholesterol-lowering drug colestyramine, the blood pressure-lowering drug bisoprolol and metoclopramide, which reduces nausea after surgery, are particularly affected.

Generic manufacturers complain about earnings in the cent range

In general, product groups with a small number of patients and low fixed amounts are affected, it said. 20 percent of the companies surveyed said that between 50 and 80 percent of their drugs are likely to become uneconomical. 40 percent said between ten and 50 percent, again 40 percent said up to ten percent.

Karl Lauterbach

As the core of the reform, Lauterbach wants to have a list of medicines drawn up, especially for the treatment of children up to the age of twelve.

(Photo: Reuters)

“We assume that every tenth product will disappear from the market due to inefficiency,” said Bork Bretthauer, head of Pro Generika. “Due to high inflation and the simultaneous impossibility of increasing their prices, our companies are currently having to review their product portfolios.”

According to the manufacturers, the yields are often in the cent range. In addition, many providers have disappeared from the market in recent years, which has exacerbated the supply situation with medicines. There have been bottlenecks for years. But the shortage became particularly clear in the autumn and winter months, when fever juices for children were difficult to obtain in pharmacies. This was also due to a violent wave of infections and unusually high demand.

There is little hope in the industry that the draft law by Health Minister Karl Lauterbach (SPD), which became public this week, against delivery bottlenecks will change the situation. On the contrary: “The situation will continue to worsen,” said Bretthauer. “Because he only takes on one percent of generics – and even that rather sluggishly and almost half-heartedly.”

Early warning system and new rules for supplies planned

Specifically, Lauterbach wants to partially undermine the fixed amounts – for example for children’s medicines such as fever juices – and reform the discount agreements. According to the draft bill from the Ministry of Health, surcharges of 50 percent on certain medicines should be possible in the future. This should entitle statutory health insurance companies to make more expensive purchases.

We assume that every tenth product will disappear from the market due to inefficiency. Bork Bretthauer, head of Pro Generika

In addition, an early warning system to identify impending supply bottlenecks and new rules for inventories as a safety buffer are planned. In order to absorb short-term disruptions in the supply chain or short-term, larger additional requirements, “an obligation to keep stocks for several months” will be introduced, according to the draft.

According to this, health insurance companies and the pharmaceutical industry should generally agree on a “continuous, supply-related stockpiling” of certain medicines in discount agreements – in Germany or the EU and for a quantity that is delivered on average in three months.

Lauterbach had already presented key points in December as to how the shortage of medicines, especially for children, can be remedied. According to Lauterbach, the aim of the paper was also to bring part of the drug production back to Germany and Europe, even if this entailed price increases.

>> Read here: Concerns about drug shortages: “The situation has never been so serious”

One of the reasons for the supply problems is that the health insurance companies have so far been urging you to choose the cheapest provider when buying generics. This led to dependence on a few, cheaper suppliers in Asia.

price pressure

50

percent premium

According to a draft from the Ministry of Health, it should be possible in the future to use certain medications.

Lauterbach therefore wants to create a list of medicines, especially for the treatment of children up to the age of twelve, as the core of the reform. For these, the federal government can lift the price fixing of the health insurance companies, so that the price can then be increased by up to 50 percent from the last applicable fixed amount.

Cancer drug tamoxifen soon to be in short supply again?

How complicated the supply situation is, however, is not only evident in the case of pediatric medicines. The breast cancer drug tamoxifen, for example, was no longer available almost a year ago. There is no alternative for the more than 100,000 patients. It took months for the situation to improve – and is now coming to a head again.

>> Read here: Expert opinion warns of the consequences of the Lauterbach law for investors

After several manufacturers have phased out production in recent years, only two of them remain. With a market share of 80 percent, the pharmaceutical manufacturer Hexal is the largest supplier. If it has problems, it is difficult to compensate for the failure with another manufacturer. Especially since Hexal Tamoxifen is not produced in Asia, but already in Germany.

“We have had to increase our production significantly in recent years because suppliers have left the market,” says Hexal boss Thomas Wiegold to the Handelsblatt. In 2019 there were 160,000 packs, now it is 400,000 per year. “We can use it to meet demand, but with the current costs we can’t keep up production forever,” he says.

“The prices have not been adjusted for years, but production has become much more expensive.” Providers receive eight cents for a pill, the price has not changed even after the bottleneck last year.

More: Funds decide on measures against drug shortages.

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