Germany against the pharmaceutical crisis: Amnog urgently needs new solutions!

Germany against the pharmaceutical crisis: Amnog urgently needs new solutions!

Pharmaceutical industry plays a key role in medical progress and health care - this is not new, but in times of increasing challenges it becomes increasingly clear. Current developments, such as the revision of the EU Pharma legislation and the implementation of the EU usage evaluation (EU HTA), focus on the supply of drugs. According to an article by Ärzte Zeitung , these changes are necessary to facilitate access to medicinal products in Europe strengthen.

In Germany, the AMNOG system, which has existed since 2011, has reached its limits. It can no longer fulfill its role as a value-based pricing instrument, especially with regard to the current political framework, which have been further tightened by the GKV Finance Stabilization Act. The complexity of the price negotiations, combined with rigid pressure and combination discounts, leads to a confusing situation for patients and providers.

approaches and necessary adjustments

More flexibility in the amnog is required. In order to meet the growing requirements, evidence -based price negotiations are necessary, which are also based on small patient groups and ethical challenges. Suggestions for further development include the consideration of relevant care needs and the use of the best available evidence in difficult therapy situations. A constructive dialogue between the actors in the health system is essential to find a sustainable solution.

The interlinking of national and European processes could help here. As the vfa , the EU-HTA should enable the methods to evaluate health technologies in order to increase efficiency and avoid duplication. Europe could thus come to a more uniform use of the results from the European evaluation in the amnog.

The global context of the pharmaceutical supply

The EU is the largest trading player in the field of medicines and medical devices at an international level. However, globalization leads to challenges, especially when it comes to the safety of the supply chains. The European Commission and the European Medicines Agency (EMA) therefore work closely with international regulatory authorities to set standards and to ensure the conformity of drugs. This also includes bilateral dialogues with countries such as the USA, India and China, as on the European Commission is explained in detail.

An increasingly globalized market not only requires a good knack in regulation, but also a tireless cooperation of everyone involved. Cooperations and regular dialogue meetings are in the foreground to optimize the interaction between numerous actors. With these measures, the supply of drugs in Germany and Europe is to be placed on a solid foundation that promotes both innovation and accessibility.

Finally, it can be stated: It is urgently needed to create clear rules and framework conditions in order to ensure a fair and safe supply system. The challenges are great, but with a coordinated approach and a dedicated dialogue between the various actors, we can make the pharmaceutical supply to the future.