Berlin – BAH General Manager Dr. Hubertus Cranz: “A lot of shadows, little light, that’s the assessment of the Commission’s proposal in a nutshell. Unfortunately, welcome administrative simplifications are being nullified by new requirements. Particularly problematic is the possibility of revoking or refusing the authorization of a medicinal product if the environmental risk assessment is not considered sufficient. Innovative medicines cannot be available as a result; Established medicines disappear from the market or are difficult to access.”
In addition, there are stricter obligations regarding the ability to deliver medicines and the reporting of bottlenecks. However, these will not increase the security of supply. This requires comprehensive solutions and a change in remuneration structures. The proposals to change the protection periods for intellectual property are also problematic.
The entry into the electronic leaflet is pleasing. A printed form should no longer be mandatory in all EU member states as soon as possible. It is also important that minor product adjustments can be made unbureaucratically in the future.
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The Federal Association of Drug Manufacturers (BAH) has the largest number of members in the drug industry in Germany. It represents the interests of around 400 member companies that employ around 80,000 people in Germany. The companies organized in the BAH make a significant contribution to securing the supply of pharmaceuticals in Germany. They provide almost 80 percent of the over-the-counter medicines sold in pharmacies and almost two thirds of the prescription medicines, as well as a large part of the material medical products for patients. Under www.bah-bonn.de there is more information about the BAH.