The tussle between Germany’s research-based pharmaceutical industry and health insurers over discount contracts has taken on a new dimension, questioning the very interchangeability of medicines that contain the same active ingredient.

The discount contracts were set up as part of the health reform of 2003 and then expanded in further legislation in 2006 and 2007. They allow a health insurance fund to enter into a contract with a specific manufacturer who would then guarantee the provision of a particular drug at a competitive price. By introducing this mechanism, the federal government expected and still expects to save millions of Euros on pharmaceutical expenditure, as health insurance funds search around for the best deals.

The research-based pharmaceutical industry argues that there are drawbacks to the scheme, not least the threat to the existence of small-to-medium drug companies. Perhaps most significant for the patient, however, is the claim by the industry that the discount contracts could have a negative impact on patient safety.

The German pharmaceutical industry association, BPI, noted recently that doctors were being encouraged to substitute medicines that were not indicated for the same conditions but had the same active ingredient, purely because they were the subject of a discount contract. The fact that the medicine does not have the same indication clearly shows that the manufacturer had not intended it to be used in any manner other than that for which it had been designed. “Substitutability” with these products is therefore not an option, said the BPI.

But health insurers, backed by the health ministry, disagree. What’s more, Germany’s largest health insurer, the AOK, has now published two legal reports that back its stance on substitution. Commenting on his report, Professor Alexander Ehlers, a specialist pharmaceuticals lawyer at Munich University, noted that there was no legal requirement for the products to be identical. The second study is also a legal text by Professor Thorsten Kingreen from the University of Regensburg and focuses on pack sizes.

The reports are thorough and convincing. There is perhaps only one problem: both reports are a commentary on the legality of substitution under federal law. However, the pharmaceutical industry appears to be concerned not so much with the wording of the law, but rather with the science behind the substitution issue and therefore the patient safety aspect. With this in mind, it appears that the AOK – although its legal stance is undoubtedly secure – has missed the point of the argument. What’s more, it is irrelevant to what extent the law stands behind you, if a patient is adversely affected as a result of a spurious substitution.

Despite this glaringly obvious difference in approach to the substitution issue by the pharmaceutical industry and health insurers, one thing is for certain: with the general election around the corner and discount contracts seemingly saving at least some of the healthcare budget, no political party is likely to discard them.