Germany facing pharmaceutical crisis: AMNOG urgently needs new solutions!

Germany facing pharmaceutical crisis: AMNOG urgently needs new solutions!

The pharmaceutical industry plays a key role in medical progress and healthcare - this is not new, but in times of increasing challenges it is becoming increasingly clear. Current developments, such as the revision of the EU pharmaceutical legislation and the implementation of the EU benefit assessment (EU HTA), are bringing the supply of pharmaceuticals into focus. According to an article by Doctors newspaper These changes are necessary to facilitate access to medicines in Europe and strengthen competitiveness.

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 in view of the current political framework, which has been further exacerbated by the GKV Financial Stabilization Act. The complexity of price negotiations, combined with rigid pressure and combination discounts, leads to a confusing situation for patients and providers.

Approaches to solutions and necessary adjustments

More flexibility is required in AMNOG. In order to meet growing demands, evidence-based price negotiations are necessary that are also geared towards small patient groups and ethical challenges. Suggestions for further development include taking into account relevant care needs and using the best available evidence in difficult therapy situations. A constructive dialogue between the actors in the health system is essential in order to find a sustainable solution.

The interlinking of national and European processes could help here. As the vfa reports, the EU HTA is intended to enable harmonization of methods for assessing health technologies in order to increase efficiency and avoid duplication of work. Europe could thus achieve a more uniform use of the results from the European assessment in AMNOG.

The global context of drug supply

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

An increasingly globalized market not only requires a good hand in regulation, but also tireless cooperation from all those involved. The focus is on cooperation and regular dialogue meetings in order to optimize the interaction between numerous actors. These measures are intended to place the supply of pharmaceuticals in Germany and Europe on a solid foundation that promotes both innovation and accessibility.

In conclusion, it can be said that it is urgently necessary to create clear rules and framework conditions to ensure a fair and safe supply system. The challenges are great, but with a coordinated approach and a committed dialogue between the various actors, we can make the supply of medicines fit for the future.