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EMA

 Dear Mr Zdechovsky,

 Thank you for your email. The European Medicines Agency (EMA) engages with patients and consumer representatives through a network of organisations.

 To ensure that we engage fairly with the right organisations we have established a system of ‘eligibility’. This is to ensure that selected organisations genuinely represent the interest of EU patients and consumes.

 To become an EMA eligible organisation, eligibility criteria must be met, as defined here: Criteria to be fulfilled by patient, consumer and healthcare professional organisations involved in European Medicines Agency (EMA) activities

 The criteria includes a definition of patient and consumer organisation as follows:

  1. a)      Patients’ organisations are defined as not-for-profit organisations which are patient focused, and where patients and/or carers (the latter when patients are unable to represent themselves) represent a majority of members in governing bodies. These could be:
  • General umbrella organisations (e.g. representing either European organisations and/or national umbrella organisations), or
  • European disease specific organisations (i.e. representing national organisations or individual patients on acute and/or chronic diseases).
  1. b)      Consumers’ organisations are defined as not-for-profit organisations which defend and promote the general interests of European consumers – citizens as purchasers or users of goods and services

 Any organisation can apply to become an EMA eligible organisation. Interested organisations are invited to complete an application form which is available on EMA’s website, together with the relevant background documentation, which is assessed to determine if the criteria are met.

 More details on how these criteria are assessed can be found here: Assessment of patient, consumer and healthcare professional organisations‘ compliance with EMA eligibility criteria

 Eligibility is reviewed annually and all EMA ‘eligible’ patient/consumer organisations are listed on our website here.

 We hope this is helpful and answer your question, but please don’t hesitate to come back to us should you have any additional questions.

 With kind regards,

 Melanie Carr

Head of Stakeholders and Communication Division

 European Medicines Agency