The European Union EU is an economic and political entity and confederation comprised of 28 member states, which are located in the European region. EU policies aim to ensure the free movement of people, goods, services, and capital, enact legislation in justice and home affairs, and maintain common policies on trade, agriculture, fisheries and regional development.
The EU has a unique institutional set-up involving the following institutions:
The EU’s broad priorities are set by the European Council, which brings together national and EU-level leaders
Directly elected from member States, MEPs represent European citizens in the European Parliament
The interests of the EU as a whole are promoted by the European Commission, whose members are appointed by national governments of Member states
Governments defend their own countries’ national interests in the Council of the European Union.
There are 3 main institutions involved in EU legislation:
The European Parliament, which represents the EU’s citizens and is directly elected by them;
The Council of the European Union , which represents the governments of the individual member countries. The Presidency of the Council is shared by the member states on a rotating basis.
The European Commission, which represents the interests of the Union as a whole.
Legislation is produced by a process of co-decision which was introduced by the Maastricht Treaty (1992), extended and ratified by the Lisbon Treaty (2009). During this process, these three institutions produce the policies and laws that apply throughout the EU. In effect, the Commission proposes new laws, and the Parliament and Council adopt them. The Commission and the Member States then implement them, and the Commission ensures that the laws are enforced.
HOW TIF WORKS IN THE EU
TIF maintains a close relationship with all the legislative bodies of the EU, holding meetings with key officials in the Commission and with Members of the European Parliament and frequently communicates with the Commissioner for Health and Consumers. Furthermore, TIF actively participates in the legislative process, providing the patient perspective in consultations on new legislation and revision of existing regulations and directives. To read more on TIF’s involvement in EU policies, please click here.
More information about the European Union can be found at its official website.
EUROPEAN MEDICINES AGENCY (EMA)
The European Medicines Agency (EMA) is a body of the EU responsible for the regulation of medicinal products within the EU. In the case where a European marketing authorisation is granted, it is valid throughout the EU and EEA-EFTA states (Iceland, Liechtenstein and Norway). Moreover, in view of the continuing globalisation of the pharmaceutical sector, the EMA works to build closer ties with partner organisations around the world, including the WHO and the regulatory authorities of non-European countries.
The EMA works hard, constantly monitoring the safety of medicines through a pharmacovigilance network and taking appropriate actions if adverse drug reactions are reported. Furthermore, the EMA stimulates innovation and research in the pharmaceutical sector, providing scientific advice and other assistance to companies for the development of new medicines in addition to publishing guidelines on quality-, safety- and efficacy-testing requirements.
Indeed, the EMA is divided into four main units and one unit for administration, which reflect its functions and services. These units are:
- Human Medicines Development and Evaluation Unit is responsible for all activities related to medicines for human use, from the development stage to final approval, with special emphasis on safety and efficacy.
- Patient Health Protection Unit promotes pharmacovigilance and risk management, reviewing the benefit and risk of each approved product.
- The Veterinary Medicines Unit is responsible for the authorisation of veterinary products.
- Information and Communications Technology Unit provides high quality and advanced infrastructure solutions to support services.
Under each unit, several scientific committees conduct the main scientific work and are comprised of members of all EU and EEA-EFTA states in addition to other stakeholders. Patient representatives from eligible organisations are able to participate in the following committees:
- Committee for Medicinal Products for Human Use (CHMP)
- Committee for Orphan Medicinal Products (COMP)
- Paediatric Committee (PDCO)
- Committee for Medicinal Products for Veterinary Use (CVMP)
- Committee on Herbal Medicinal Products (HMPC)
- Committee for Advanced Therapies (CAT)
- Pharmacovigilance Risk Assessment Committee (PRAC)
HOW TIF WORKS WITH THE EMA
In promoting closer ties with patient organisations, EMA has set up a Patients & Consumers’ Working Party (PCWP) in order to ensure that the voices of all stakeholders are heard. TIF participates in the PCWP, attending meetings and actively becoming involved in consultations.
More information on the European Medicines Agency can be found at their official website
EUROPEAN COMMITTEE OF EXPERTS ON RARE DISEASES (EUCERD)
The European Committee of Experts on Rare Diseases (EUCERD) was formally established in 2009 by the European Commission as the committee charged with aiding the preparation and implementation of Community activities in the field of rare diseases. To do this, the Committee must cooperate and consult with specialised bodies in Member States, relevant European authorities in the fields of research and public health and other relevant stakeholders acting in the field of rare diseases. The EUCERD fosters the exchange of relevant experience, policies and practices between these parties. Most importantly the EUCERD is responsible for the development of guidelines and recommendations to ensure the smooth implementation of the European Council Recommendation (2009/C151/02) on an action in the field of rare diseases.
HOW TIF WORKS WITH THE EUCERD
TIF participates as a patient organization on this Committee, as thalassaemia is considered to be a rare disease in Europe, as per the EU definition where a rare disease is one that affects 1 in 2000 citizens. For more information on rare diseases click here and for EUCERD reports, click here.
More information on the EUCERD can be found at their official website