This public call for expressions of interest relates to the appointment by the European Commission of members representing patients' organisations at the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA). Regulation (EC) No 141/2000 of the European Parliament and of the Council on orphan medicinal products ("the Regulation") lays down specific rules concerning the criteria and procedure for the designation of an orphan medicinal product. Central to the operation of this Regulation is the Committee for Orphan Medicinal Products (COMP) established as part of the EMEA.
For ease of reference, the provisions of the Regulation directly relating to the COMP are outlined in the Annex to this document. Of particular note, Article 4(3) of the Regulation provides for the composition of the COMP.
Article 4(3) lays down that the COMP shall include "three members nominated by the Commission to represent patients' organisations". The members of the Committee shall be appointed for a term of three years, which shall be renewable.
The COMP meets at the EMEA in London, UK. Travel and subsistence costs for members of the Committee will be met by the EMEA. The main working language of the Committee is English.
Call for expressions of interest - how and by when?Expressions of interest in being Commission appointees to represent patients' organisations should be notified to the European Commission by e-mail to This email address is being protected from spambots. You need JavaScript enabled to view it. by 13 March 2008. Expressions of interest should provide the following information: I. Name, job title and qualifications of proposed member. II. Representatives of which organisation(s). III. Presentation of the organisation(s) represented, including the organisation's legitimacy (i.e. statutes registered in a Member State of the European Economic Area (EEA)), mission and objectives, focus on orphan medicinal products, capability to represent patients, whether the governing body is elected, how accountability and transparency of funding and activities are ensured. IV. Experience of the proposed member including that relevant to the tasks of the COMP listed in Article 4(2) of the Regulation (see the Annex). V. Outline of any conflicts of interest with the pharmaceutical and medical device sector that could affect impartiality. VI. Motivation as to why the proposed member considers that he/she should be chosen as member of the COMP to represent patients' organisations in Europe. VII. Curriculum Vitae of the proposed member. Assessment criteria
Assessment of expressions will be based on: I. Whether the proposed member represents patients' organisations at a European level. II. Whether the proposed member has competencies and experience relevant to the tasks of the COMP listed in Article 4(2) of the Regulation. III. Ability and experience in representing organisations, and the characteristics of the organisation represented. Appointment process
Based on the assessment criteria listed above, the European Commission will draw up a list of appointees prior to the appointments being made.