The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London. It is the European Union body responsible for coordinating the existing scientific resources put at its disposal by member states for the evaluation, supervision and pharmacovigilance of medicinal products. The mission of EMEA is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health. The Agency provides the member states and the institutions of the EU with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products, in accordance with the provisions of EU legislation relating to medicinal products.

EMEA consists of five Committees:

  1. Committee for Medicinal Products for Human Use (CHMP)
  2. Committee for Medicinal Products for Veterinary Use (CVMP)
  3. Committee for Orphan Medicinal Products (COMP)
  4. Committee on Herbal Medicinal Products (HMPC)
  5. Paediatric Committee (PDCO)

TIF fulfils the EMEA criteria for collaborating patients’ organisations, and has since 2007 become involved in the work of the CHMP and COMP. As an expert organisation, TIF nominates so-called “expert patients” to participate in reviews of EMEA documents addressed to patients and consumers. The objective of the reviews is to evaluate the information for clarity and user-friendliness. The ultimate aim is to provide information in patient-friendly form in all key official documents, whenever a new medicine is approved for the market, or at the time of the renewal of its marketing authorisation.

TIF participates in expert patient initiative

The involvement of patients’ and consumers’ organisations in the activities of EMEA through its Committee for Medicinal Products for Human Use (CMPH) has grown significantly over the yeas, and EMEA is currently working to widen the participation of patients and consumers to other scientific committees in the future.

Patients can become involved in EMEA activities either as representatives of their organisation, or as “experts”. During the past year, expert patients have been involved in the review of package inserts (also known as Patient Information Leaflets, or PIL) at the time of renewal of the marketing authorisation, and in reviewing European Public Assessment Report (EPAR) summaries for newly authorised medicines. TIF is represented in this project by an expert patient and a member of staff.

After one year, results show a very high participation rate from patients’ and consumers’ organisations, and comments received from them have contributed to an increase in the quality of the documents. Following these positive results, EMEA is now looking to make the procedure a permanent part of evaluating package inserts and EPARs. The groundwork has also now been laid for extending the participation of patients and consumer organisations to the work of the Pharmacovigilance Working Party (PhVWP). We will be updating readers on these developments.

Important documents:

What is an orphan drug or an orphan medicinal product?

“Orphan drugs”, or in the EU “orphan medicinal products”, are medicines intended to treat diseases so rare that sponsors (companies) are reluctant to develop them under usual marketing conditions. The process from the discovery of a new molecule to its marketing is long (10 years on average), expensive and, since much work is done in formerly uncharted territory, very risky (of many molecules tested, none or only one may have a therapeutic effect). Under normal market conditions a company developing a drug intended to treat a rare disease may not recover the capital invested for its development. Industry and health authorities have jointly argued, first in the US and then at national and European levels (the European Commission) for the incentives required to stimulate the development of orphan drugs; these efforts led in 2000 to the European Parliament unanimously approving the EU Regulation on Orphan Medicinal Products (EC 141/2000).

The review of all marketing applications for orphan medicines is centralised through EMEA – the European Medicines Evaluation Agency) with the goal of making rapidly available, for rare diseases, medicines with a level of quality, efficacy and safety equivalent to that required for any other medicine.

Source: EPPOSI

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