TIF has developed a close collaboration with professional societies which focus on research and treatment of diseases or groups of diseases, or focus on public health issues that are relevant to the care of haemoglobinopathies’ patients.
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:
There are 3 main institutions involved in EU legislation:
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.
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:
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:
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
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
The Association of Southeast Asian Nations (ASEAN) is an important regional body which was established in 1967 in Bangkok, Thailand, with the signing of the ASEAN Declaration (Bangkok Declaration) by the Founding Fathers of ASEAN, namely Indonesia, Malaysia, Philippines, Singapore and Thailand. Brunei Darussalam joined in, in 1984, followed by Viet Nam in 1995, Lao PDR and Myanmar in 1997, and finally Cambodia in 1999, making up what is today the ten Member States of ASEAN.
As dictated by the ASEAN Declaration, ASEAN focus on:
HOW TIF WORKS WITH THE ASEAN
TIF has worked diligently to strengthen relations with ASEAN Secretariat and ASEAN member states, particularly in the context of efforts to ensure the worldwide implementation of WHO resolutions EB118.R1 on thalassaemia and other haemoglobinpathies and WHA59.R20 on sickle cell anaemia, adopted in 2006.
This close monitoring and communication with the ASEAN Secretariat has gained pace in 2013, as TIF has received an official Invitation to present its Report on thalassaemia in the course of ASEAN’s Senior Officials’ Meeting on Health Development (SOMHD) in August 2013.
More information on ASEAN can be found at their official website.