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
Jim is aged 66 and has Haemophilia A with a high titer inhibitor which he developed at age 14.
Maria Elisa Mancuso (MD, PhD) is a Haematologist and works as a Senior Haematology Consultant at the Center for Thrombosis and Haemorrhagic Diseases of IRCCS Humanitas Research Hospital in Rozzano, Milan, Italy. She is Adjunct Clinical Professor at Humanitas University. She obtained a post-degree in Clinical and Experimental Haematology and a PhD in Clinical Methodology. She is involved in clinical research and has published several original articles in peer-reviewed journals a The Lancet, Blood, Journal of Thrombosis and Haemostasis, Haematologica, Thrombosis and Haemostasis, British Journal of Haematology and Haemophilia. She is reviewer for several peer-reviewed journals and member of the Editorial Board of JTH. She is a member of several scientific societies (ISTH, WFH, ASH, EAHAD, SISET, AICE) and was a medical member of the Inhibitor Working Group of the European Hemophilia Consortium. She is co-chair of the ADVANCE Study Group. She has acted also as co-chair of the Scientific and Standardization Subcommittee of ISTH on FVIII, FIX and rare bleeding disorders. She has been involved as principal and co-investigator in several clinical trials, and she takes care of both children and adults with hemophilia and other congenital bleeding disorders with a specific scientific interest in novel therapies, prophylaxis, inhibitors, and chronic hepatitis C.
As a patient with factor II deficiency, the diagnostic and treatment of rare bleeding disorders is a matter dear to my heart. My motivation to participate in the work of the ERIN committee is to improve both diagnostic and treatment for patients with rare bleeding disorders across Europe.
Economist and financial expert by profession, executive coach and trainer by passion and haemophilia advocate by every drop of my blood through my son (who has severe haemophilia A with inhibitors). Bringing a good decade of practical experience from the corporate insurance world, laser focus, growth mindset and resilience from my own experience, offering you anything I can just do, in hope that together we can make life more fulfilled for those impacted by bleeding disorders.
Amy Owen-Wyard is a Registered Mental Health Nurse. With experience working with children, young people, their families and adults with severe and enduring mental health conditions. Amy was also involved in a service improvement to provide a holistic care approach for those in general hospitals to support both their mental and physical health, whilst sharing her expertise and knowledge in mental health with the wider multidisciplinary team.
