Here is a brief overview on the legislative procedures in place in the European Union (EU). There are currently two types of EU legislative procedures outlined in the Treaty of Lisbon:
- Ordinary legislative procedure;
- Special legislative procedures.
Understanding how the EU legislative process works and which stakeholders are involved is key in developing strategies to better advocate for patients’ rights at EU level.
Ordinary Legislative Procedure
The European Commission submits a legislative proposal to the European Parliament and the Council
- The “right of initiative” lies with the European Commission. It is responsible for submitting most legislative proposals. However, Parliament and Council may ask the Commission to submit proposals and in a few well-defined cases other institutions may come up with proposals as well.
- The Commission’s proposal is the result of an extensive consultation process.
- The Commission’s proposal is usually adopted by the College of Commissioners and is published in the Official Journal of the European Union.
- The Commission submits its legislative proposal also to all EU national Parliaments at the same time it submits it to the European Parliament and the Council.
First reading in the European Parliament
- The President of the European Parliament refers the proposal to a parliamentary committee, which appoints a rapporteur who is responsible for drawing up a draft report containing amendments to the proposed text. The committee votes on this report and any amendments tabled by other members.
- The European Parliament then discusses and votes on the legislative proposal in plenary on the basis of the committee report and amendments. The result is the Parliament’s position.
- Parliament can:
- reject the proposal as a whole
- approve the proposal without amendments
- approve it subject to amendments
- If Parliament does not adopt the legislative resolution, the proposal is referred back to the committee responsible.
- Once Parliament has concluded its 1st reading the Commission may adopt a ‘modified proposal’ incorporating a number of Parliament’s amendments. The legislative text is then sent to the Council.
First reading in the Council
- Preparatory work in Council runs in parallel with the 1st reading in Parliament, but Council may only formally conduct its 1st reading based on Parliament’s position. Council can: accept the EP position, in which case the legislative act is adopted; or adopt changes to Parliament’s position, leading to a Council’s 1st reading position, which is sent to Parliament for a 2nd reading.
- Council decisions are prepared within specific working parties made up of representatives of the member states and chaired by the representative of the country holding the six-monthly rotating presidency, assisted by the Council’s secretariat. The working parties report to the Committee of Permanent Representatives, which prepares every Council decision taken at ministerial level.
For more information about the ordinary legislative procedure, consult the European Parliament Website.
Special legislative procedures
In special legislative procedures, the Council of the EU is, in practice, the sole legislator. The European Parliament is simply associated with the procedure. Its role is thus limited to consultation or approval depending on the case.
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.
