Taking stock: the European elections
In May 2019 the citizens of the European Union cast their vote and chose a new European Parliament. With the highest turnout in the last twenty years – slightly over 50% – these elections featured a general rebuff of traditional mainstream parties. A much-feared move to the right did not take place, yet new leading political forces will create new majorities and momentum to re-evaluate the “European idea.”
The traditional “grand coalition” between the Christian-Democrats (EPP) and the socialists (S&D) was dismantled. During the last decades, these two political families were the most dominant political groups in Brussels. Today, although the EPP and the S&D Groups remain the two largest, they no longer enjoy total dominance. Only with the liberal Renew Europe Group (formerly known as ALDE) or the Greens, both the winners of the elections, can majorities be formed. Renew Europe became the third biggest political force in the European Parliament, while the Greens have advanced to the fourth place. This new balance will undoubtedly influence the upcoming European agenda. Overall, the political landscape in Brussels has become more fragmented and finding political compromises on the EU level will be challenging.
Following the European elections, the European Council surprisingly nominated on 2nd July the incumbent German Minister of Defence, Mrs Ursula von der Leyen, to become the next President of the European Commission. The European Parliament confirmed her on 16 July.
Besides a longstanding political career, Mrs von der Leyen is a medical doctor by training and profession, focused on women’s health. Having someone with a medical background at the helm of the European Union brings renewed hope for advocacy groups, such as the EHC, that the European institutions will continue to promote and advance health-related policies and initiatives. Mrs von der Leyen has already started to build a work programme for the European Commission as well as a team of Commissioners to execute such a programme. She has called on the Member States to put forward their ‘best candidates.’ Mrs Stella Kyriakides, the Cypriot candidate, was appointed to lead the health portfolio. The appointed Commissioners will be interviewed by the European Parliament during the Commissioners’ hearings to take place on 1st and 2nd October.
What to expect from the 2019-2024 mandate?
There will be much work to be done in the 2019-2024 mandate by the new Commission and Parliament on ongoing and new files related to healthcare. Amongst others, there will be a joint evaluation of the Orphan Medicinal Products (OMP) Regulation and the Paediatrics Regulation. This assessment is expected to be finalised in the fall of 2019. The Proposal for Health Technology Assessment (HTA) Regulation awaits approval in the Council of the EU. Aimed at ensuring consistent, high-quality HTAs, the new HTA Regulation wants to improve access to new health technologies and avoid duplication of research. Negotiations are ongoing on Horizon Europe, the EU’s framework programme to support research and innovation. It is also forecasted that in 2021, the European Commission will re-evaluate the functioning of the European Reference Networks (ERN), the EU’s virtual networks of healthcare professionals spread across the Union to simplify discussion and knowledge-sharing on rare diseases and their treatments. This revision could entail opportunities for discussions on enhanced patient involvement in ERNs. Lastly, following years of assessment and evaluation, the Blood, Tissues and Cells Directive may also be re-opened for revision in this term.
Besides these legislative files, it is also expected that the Commission and Parliament will have to face other challenges such as access and affordability of medicines, medicines shortages and preparedness for Brexit.
A new political term brings fresh opportunities for working towards shaping future EU policies in the field of rare diseases. With a new balance of power and a new cohort of policymakers, it is a crucial time for building awareness around rare bleeding disorders.
The MEP Rare Bleeding Disorders Group: where to go next?
Since 2009, the EHC gathered committed supporters amongst Members of the European Parliament. In 2015, these supporters gathered in an informal group of MEPs supporting patients with rare bleeding disorders. The Group formalised in November 2017 to the MEP Rare Bleeding Disorders Group.
During the last two parliamentary terms, these MEPs helped the EHC in raising awareness about issues faced by the European bleeding disorders community through its Round Table of Stakeholders. These events are held three times a year and allow a variety of stakeholders involved in the provision of care for people with bleeding disorders to meet, analyse a topic and discuss solutions and a way forward. Topics discussed in the Round Tables included recently, for example, the future of comprehensive care, switching from standard therapies, and women and bleeding disorders. With so many innovative treatments for haemophilia under development, the topic of access and affordability of novel technologies has been frequently discussed during the Round Tables. The EHC is hoping to bring discussions on ‘Markets and Access’ again to the European Parliament on 3rd December for its next Round Table.
Although the European elections slimmed down the MEP Rare Bleeding Disorders Group to only one member, Dr Cristian-Silviu Buşoi (EPP, Romania), the EHC is confident that, thanks to its track record, it will be able to attract new MEPs to the cause of people with rare bleeding disorders in Europe. In particular, the EHC is looking for MEPs that will champion its activities including access to novel therapies, support for people with inhibitors, the development of young volunteers, recognition for women with bleeding disorders and the support of an ageing patient population, the first one of its kind.
The EHC is looking forward to renewing its collaboration with the European Parliament to advance the cause of people with rare bleeding disorders in Europe.
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.
