Above, participants at the EHC February 2019 Round Table in which representatives from the German NMO presented on the new German legislative proposal. 

Germany passes a new law that moves the distribution of haemophilia products from treatment centres to pharmacies

A legislative proposal could have harmed haemophilia care in Germany, but thanks to the work of the national patient organisation and other stakeholders, the legislation was amended to address patients’ concerns.

At the end of last year, the German Ministry of Health proposed a new law affecting the distribution of haemophilia treatment products. So far, all products are distributed by the haemophilia centres directly to the patients. In future, patients will get them from regular pharmacies.

When the German Haemophilia Association, DHG, heard about the Ministry’s plans last year, we were very concerned. We feared that the new law would destroy a well-established system and lead to numerous problems, such as:

  • the erosion of haemophilia treatment centres,
  • a decrease in quality of treatment, and
  • a threat to treatment safety, traceability and documentation.

In our eyes, the draft was developed too quickly without considering all consequences.

So, we started our campaign. We also asked the EHC for help and received a great ‘letter of support,’ which was very useful for us. In February 2019, we had the opportunity to give a presentation about the proposed law at the EHC Round Table held in the European Parliament in Brussels under the auspices of Member of European Parliament (MEP) Mrs Gesine Meissner (Germany/ ALDE). After the Round Table, we decided together to send a request to all NMOs of the EHC. The goal was to get a better understanding of how the other European countries distribute factor concentrates. We got replies from many different countries which were very helpful.

At the same time, we were able to establish contacts with the relevant health politicians of all German political parties. Additionally, we asked our members to contact their respective Members of Parliament (MPs). To support them in doing so, we sent out sample letters. Soon we noticed that we managed to make haemophilia a topic of discussion in Berlin, Germany’s federal legislative capital. During the readings of the proposed law in the German federal parliament, many different politicians addressed the topic of haemophilia.

In April, there was a public hearing, and the DHG was invited as an expert to give testimony. We were also asked to provide a written statement. In May, we organised a Round Table in Germany with doctors, representatives of health insurances and pharmacists to discuss concrete proposals and find adequate solutions. Simultaneously, the Ministry of Health, together with two MPs, organised an ‘expert meeting’ about haemophilia to which we were also invited. In summary, we were in a lively exchange with many politicians and had profound discussions with all relevant stakeholders during the legislative process.

In June, the law was passed by the parliament as well as by the Federal Council. As we had anticipated in the weeks prior, we were not able to prevent the change of the distribution channel from haemophilia centres to pharmacies. However, we are happy that our objections were taken seriously and that the draft law was amended to take some important details into account. The amendments that were incorporated in the final legislation strengthen the role of the haemophilia centres and oblige pharmacies to report to the prescribing doctors, which closes the potential gap in documentation which we had originally feared.

This new law, regarding the distribution channel of haemophilia products, will come into effect in August 2020. In the upcoming months, all stakeholders will prepare for the change. We will carefully monitor the process and look out for potential problems. But after all, we are confident that it will be possible to find workable solutions.

We want to thank all of you who provided us with information about the distribution system in your respective countries. We appreciate it very much that so many of you were willing to help. Last but not least, we wish to thank the EHC team for their helpful support!

Dr Anna Griesheimer
Deutsche Hämophilie Gesellschaft