Franz Stadler is the author of the book “Medicines Monopoly”. Stadler knows his way around the field: he is a pharmacist, holds a doctorate in pharmacy and has operated a cytostatic laboratory near Munich for many years.
Germany has come through the corona pandemic well so far. Even so, your forecast is: “In the future, not every patient will get the best medicines at all times.” Why?
We have come through the pandemic well so far because, among other things, our health system has not yet been fully economized. There are, however, two opposing tendencies that are currently sawing stability. One is the financial pressure on the solidarity system, which ensures that the supply of medicines is increasingly centralized. The second is that many participants strive to get as much profit as possible from the system. For example, patent-protected drugs are becoming more and more expensive, the total expenditure for drugs continues to rise, even though billions of euros are saved in the so-called generic market for generic drugs. At some point this can mean that health insurances are no longer able to cover the costs of certain innovative drugs. With that we are getting closer to the American system. So we would have the best supply options – but only for those who can afford it.
In your book you call these and other developments in the health system “drug monopoly”. What does that mean?
Medication monopoly is the carefree, almost playful, greed-for-money handling of our drug supply. Everyone only sees the costs and benefits on their side. That is understandable from the point of view of the individual participants. But so the big picture, namely the health system, gets out of sight. And that is exactly what threatens our supply of medicines.
What role does drug production play in this?
In the production of active ingredients in the generic market, we now have a global focus on a few producers – that makes supply more central and efficient, but also more fragile. Around 80 percent of the active ingredients currently come from Asia, above all from India and China. If there are disruptions in production, this leads to worldwide delivery bottlenecks. However, this is not a new phenomenon. There were also delivery bottlenecks before the corona pandemic.
This is due, among other things, to the discount agreements that health insurers and active ingredient manufacturers conclude for imitation drugs. In principle, these discount contracts work like tenders, so only the cheapest provider is awarded the contract. This can of course save money. For the active ingredient manufacturers, however, they prefer to sell to the buyer who offers them the highest price – and that is not Germany. This in turn intensifies delivery bottlenecks that are already there.
What does outsourcing mean for the quality of these preparations?
The quality is harder to control. For example, the active ingredient manufacturers are currently submitting a so-called Cep certificate to the European Medicines Agency (EMA), which lists the production steps and possible impurities. During controls, only the specified impurities are checked. The valsartan scandal of 2018 shows, however, that impurities can also occur that are not listed in these certificates – in the case of valsartan with the carcinogenic N-nitrosodimethylamine. After that, many drugs containing valsartan had to be withdrawn from the market – and that has led to more than a hundred delivery bottlenecks worldwide. In my opinion, if you want to avoid this, you need a private foundation for drug safety that independently and thoroughly examines drugs for any contamination.