- January 22, 2025
The coming years may be quite a difficult time for manufacturers, who are obliged to supply the packaging of their medicinal products with further safety features. The aim of such actions is to limit the possibility of falsification in order to ensure unique codes or serialization.
In addition, manufacturers will also have to pay for the creation of an online database where information on all medicinal products is to be collected. And all of this thanks to the European Union directive.
This regulation applies to the sale of such products through an official sales network, but in our country, counterfeit medicinal products are distributed only outside the official network. Therefore, this regulation will in fact be directed against a problem that does not exist. It is also worth noting that generic medicinal products, which are the only ones manufactured by our domestic manufacturers, are not falsified.
The system to be introduced may cost our industry as much as €50 million, which makes it possible to predict that a large part of domestic manufacturers will not be able to cope with such costs. On the other hand, those who will bear the financial burden of such changes will stop developing. All this will have a negative impact, for example in the form of higher prices for generic medicines.
In addition, the distribution of medicinal products will be hindered as a system that identifies new safety features will have to be installed everywhere.
What can be done to avoid negative consequences?
First of all, the directive, or rather the possibility of amending it, should be examined. The solution could be to earmark the financial resources set out in it to disseminate information on the dangers of purchasing medicinal products outside the official sales network. Money can also be used to combat counterfeit medicines.
It is also a good idea to create a so-called white list of generic medicines, which would be excluded from regulation in this way. For example, only expensive innovative medicines could be covered.
Moreover, the costs of developing an IT system should not be borne by manufacturers. Public funding should be used for this purpose.
