11th Workshop, Paris: “Improving Access to Orphan Drugs for all Patients affected by Rare Diseases in Europe: EU Assessment of Clinical Added-Value of Orphan Drugs (CAVOD)”

11th Workshop of the Eurordis Round Table of Companies:

“Improving Access to Orphan Drugs for all Patients affected by Rare Diseases in Europe: EU Assessment of Clinical Added-Value of Orphan Drugs (CAVOD)”


December 11th, 2009

Paris, France

Following the outcomes of the EU Pharmaceutical Forum in 2008, Yann Le Cam speaking to workshoppersthe Commission Communication on Rare Diseases (November 2008) and the EU Council Recommendations on Rare Diseases (June 2009), this meeting provided the opportunity for all stakeholders to discuss the EURORDIS and the EBE(EFPIA)/ EuropaBio proposals on how to move towards the practical implementation of an effective and realistic procedure for the evaluation of the clinical added-value of newly authorized orphan medicinal products (CAVOD). During this meeting, an agreement was reached on the nature and specific objectives of the CAVOD report, as well as on the possibility of setting up a Working Party in charge of the CAVOD report at the European Medicines Agency level.

Participants: 63

Key feature: first time that all the actors concerned by HTA in Europe were together to discuss a new innovative approach for Orphan Medicinal Products that could benefit all parties.


Concept Paper


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La voix des patients atteints de maladies rares en EuropeEURORDIS Donnant la voix, à l'international, aux personnes vivant avec une maladie rare, Rare Diseases International est une initiative d'EURORDISRare Disease International Pour rapprocher patients, familles et experts sur un forum modéré multilingue, où partager leurs expériences. RareConnect est une initiative d'EURORDIS RareConnect Le programme Rare Barometer est une initiative d’EURORDIS qui vise à réaliser des sondages pour transformer les expériences des patients de maladie rare en faits et chiffres à communiquer aux décideurs politiques.Rare Barometer Campagne internationale de sensibilisation organisée chaque année le dernier jour de février, la Journée Internationale des Maladies Rares est une initiative d'EURORDISRare Disease Day Participez au plus grand événement réunissant tous les acteurs des maladies rares en Europe lors de Conférence européenne bisannuelle sur les maladies rares et les médicaments orphelins (European Conference on Rare Diseases and Orphan Products, ou ECRD). L'ECRD est une initiative d'EURORDISEuropean Conference on Rare Diseases