Reacción a "The European Commission presents its proposal on the Critical Medicines Act to guarantee supply and reduce external dependence"

Possible effect of the CMA

“To be honest, I welcome any initiative that addresses the resilience of supply routes for pharmaceuticals. The problem, however, is that there are many players and many rules that have to be adhered to in the production of pharmaceuticals. But let's stick to the production of a drug: basically, everything starts with petroleum and its products from refining, and then the journey to becoming a drug is a long one and involves many chemical processes. Let's look at the example of paracetamol, the active ingredient in fever-relieving syrup, which the French president claims a pharmaceutical company in France will be able to supply the entire European market with from this year. There are only a few production steps to make paracetamol, but all the intermediate products are toxic, which is why their handling is strictly regulated by the so-called REACH regulation for the protection of our environment and, of course, human health. This makes their production in Europe almost impossible. So it is not surprising that the French manufacturer of paracetamol has a joint venture with a Chinese company that supplies the last intermediate product, and then only the very last and uncritical step of production is carried out in France.”

“This describes the problem: we have very strict environmental legislation in Europe that protects us and the environment from hazardous chemicals. That is why we buy almost everything, that is, the so-called fine chemicals, in China. This cannot be easily changed because, for example, the chemical industry in Germany has closed down important manufacturing branches for environmental reasons. This topic is hardly discussed in the CMA. I would be pleased if sufficient money were spent on keeping existing production in Europe or, as the case may be, on reconditioning production plants that still exist so that they can continue to be used. A good example is the production of penicillins in Austria, where the Austrian government has spent many millions to enable a generics company to optimize its production, which is then reasonably competitive with production in China. This is how it should continue.”

Incentives for pharmaceutical companies to produce in the EU

“It is right to try to reduce bureaucratic and regulatory hurdles and to obviously want to promote scientific contributions – i.e. new manufacturing methods. It is also right to try to help each other more in Europe to avoid bottlenecks at the individual production steps. But ultimately, as far as fine chemicals are concerned, there is still the almost insurmountable dependency on China. It remains to be seen whether the financial support for the production of the 270 essential drugs in the EU will be sufficient. At least a start has been made.”

Adjustment of drug prices

“For many reasons, production in the EU will not be as cheap as in China. Currently, the profit margin for the production of drugs – and this is only about generics – is so low that no manufacturer will set up a new production facility. In other words, the prices of drugs will have to rise, despite EU funding. But that alone is not enough. European manufacturers also need to be sure that their drugs will be accepted by health insurance companies. Without that, no one will set up a new production facility in Europe; nor will anyone invest large sums in optimizing old facilities.”

Profitability of EU production

“I don't think that it is possible to make production in the EU profitable. Ultimately, the EU must be willing to pay more for the production of medicines in order to provide patients with a sufficient supply of safe medicines. At least the will to do so has been expressed.”