How does the FDA review the quality of drug imports

Importing medicinal products without Swissmedic is dangerous

The National Council no longer considers controls of generics by Swissmedic to be necessary and also calls for uncontrolled parallel imports even for the pharmaceutical market. This system change is problematic for several reasons.

The expenditures for pharmaceuticals are the only ones in the health care system that are regularly checked and continuously reduced. This means that around a billion francs are saved annually compared to 2012. Nevertheless, a majority in the National Council expects further savings by making uncontrolled imports possible for the entire pharmaceutical market or at least a substantial part of it.

Medicines approved in the European Economic Area (EEA) can already be imported into Switzerland in parallel within the framework of a simplified procedure and regardless of the existence of a patent. However, since Switzerland is not part of the European Union (EU) drug control and monitoring system, the Swiss licensing authority Swissmedic can only guarantee drug safety if products imported at the same time are registered with it.

Supply endangered

The National Council no longer considers this control to be necessary in the future, at least for generics. In addition, he is now calling for an uncontrolled parallel import for the entire pharmaceutical market with a further push. These changes would have serious effects on patient and supply security in Switzerland. On the one hand, patients rightly expect that the package inserts and product names are understandable, otherwise there is a risk of incorrect therapy.

On the other hand, Swissmedic could no longer intervene or initiate a product recall should safety or quality problems arise. This is because she would not receive the relevant information at all and because there would no longer be a registered license holder in Switzerland who would have to carry out the recall and pay for any damage.

Parallel imports lead to a multiplication of the players in the distribution chain and thus make the traceability of drugs more difficult, which will open the door to counterfeiting. In Switzerland, thanks to national approval and close controls, practically no counterfeits have been found in the official sales channels. In addition, this system change would weaken the security of supply. Due to the dependency on middlemen, the planning for warehousing in Switzerland would be lost. When it comes to deliveries, preference would be given to those countries that are currently offering the highest price. In this way, no crisis-resistant storage can be ensured.

Patients get nothing

As a result, the patients go away empty-handed. This is because parallel traders usually buy in a country with low prices and move the drugs to countries where the authorities have ordered a higher rate. These retailers reap the profits, while there are hardly any savings in the healthcare sector itself, while significantly more delivery bottlenecks are becoming the rule, as the example of Europe shows.

If one considers the considerable consequences of such a thoughtless system change, it is not understandable why the National Council wants to accept this. The savings for the Swiss healthcare system would be minimal, but the risks would be enormous. This would not only undermine the security of medicines and supplies, but would also call into question Swissmedic's position as an independent licensing authority, thereby weakening Switzerland as a location for research and innovation. In the interests of an orderly supply of safe and proven medicines to Switzerland in the future, it is to be hoped that the Council of States will come to a different decision here.

Stephan Mumenthaler is Director of Science Industries.