Are the drug expiration dates a total scam

In the downward spiral of generics

"Blockbuster" - this is what the pharmaceutical industry calls high-turnover drugs that generate sales of more than one billion euros per year. The term was even adopted by Hollywood. Both areas are about profits, with drugs in the billions. But: Medicines are not only a source of revenue, they are also protected by patents. There is no such thing as competition that could lower the price - at least during the period when patent protection was guaranteed worldwide. This expires after 20 years, then cheap imitation products - so-called generics - lead to a massive drop in prices.

Much to the chagrin of the industry, which then has to accept massive losses. For some years now, generics have even been pushing the industry to the limit. Since all players in the market have concentrated on blockbusters, patent loss is currently taking place.

Good for the budget

"In the meantime, 89 percent of the prescribed products are patent-free and generic-capable," says Bernd Leiter, spokesman for the Austrian generics association and managing director of the generics supplier Stada. That brings a lot to the health insurers. "The savings through price reductions such as patent expiries and solidarity contributions amounted to around 1.3 billion euros for the period from 2009 to 2011," says Jan Oliver Huber, General Secretary of the Pharmig industry association.

Because local doctors are instructed by the health insurances to prescribe economically, which means nothing else than to choose the cheapest medication. Theoretically, this can also mean that a chronically ill person has to take a product A and then a product B. Aside from the confusion for patients, the much more difficult question is whether the two products are actually the same or just similar.

"For the approval of generics, a detailed bioequivalence study must be carried out, which is just as strict as the clinical test for original products. It is precisely determined whether the drug has exactly the same effect in the human body as the original," says Dagmar Holst, Deputy Medical Director of the Viennese regional health insurance fund and medical director of the field of treatment economics.

But differences

Such departments have existed at the health insurers for six months. Their job is to dispel myths about how generic drugs work. "It's about advice, information and communication," explains Holst and admits when it comes to the mode of action: "There can of course be differences in auxiliary materials such as colors, but they must not have any influence on the therapeutic effect." However, if a patient reacts differently or if it is difficult to switch, as is the case with certain types of cancer or mental illness, where the patient's adherence to therapy is important, a doctor can of course also prescribe the original product. According to Holst, the rule is that a doctor is obliged to use the cheapest for comparable drugs. But if it works differently for a patient, it is not comparable.

In fact, the discussion is theoretical, because in Austria the health insurances are not trying to replace original products with cheaper generics, but rather to lower the price of the original products with generics. In other words: a cheaper original is always better than an equally expensive generic. "There is a fixed tiered pricing structure," says Holst, "the first generic that comes onto the market has to be 48 percent cheaper than the original, the second 15 percent cheaper than the first, and the third ten percent cheaper than the second. As soon as the third generic is on the market, the original product has to go down to its price, otherwise it will not be reimbursed. "

Potential for improvement

The consequence of this policy is that the official proportion of generics in Austria is lower than in other countries. "Only 38 percent of the total dose units are generic," says Leiter. Holst contradicts: "In the second quarter of 2012 the proportion was 51 percent of all prescriptions." That is the important number. However, Leiter is convinced that pharmaceutical expenditure in Austria for 2011 could have been 256 million euros lower if generics had been used wherever it would have been possible. On average, original products are 55 percent more expensive than generics. However, even from the point of view of the generics association, raising the full potential is not realistic. Pharmig General Secretary Huber recognizes the potential for savings through generics, but sees their use as "no panacea for restructuring the health budget".

However, Leiter also sees an advantage in generics: They are the engine for innovation. "The laboratories of the original manufacturers report successes. 2012 brought new product launches. Although high-revenue product patents would expire by 2015, original manufacturers can still compensate for the patent expiries with new products Schriebl-Rümmele, DER STANDARD, February 18, 2013)