The Spanish Brain Council (SBC), in cooperation with the European Brain Council (EBC), will hold the workshop “Declaración sobre buenas prácticas del uso fuera de guía de medicamentos en España” on 25th April in Madrid.

Organized against the backdrop of the Good Off-Label Use Practice (GOLUP) campaign, this workshop aims to raise awareness of the 5 principles laid down in the GOLUP-declaration and facilitate an exchange of views amongst policy-makers and healthcare stakeholder on issues related to off-label use in Spain. The forthcoming event in Madrid is the second national workshop organized in the context of EBC’s advocacy work on off-label use of medicines.

The European Commission’s “Study on off-label use of medicinal products in the European Union” released in February 2017 indicated that the use of medicines off-label is a widespread phenomenon across Europe. Off-label use of medicines, i.e. the practice of using a medicine outside its authorised indication, for another patient group or in a different dose, can offer solutions in areas of unmet medical needs but also presents challenges related to therapeutic innovation, patient safety and professional liability.

In view of this and in order to provide further clarify on when medicinal products can be safely prescribed off-label, EBC as well as 12 other organizations have endorsed the GOLUP-declaration. This document calls on regulators to adopt guidelines on the practice of off-label use and includes 5 criteria aimed at enhancing patient safety.

The forthcoming workshop in Madrid will bring together a wide range of brain researchers, scientists, policy-makers and healthcare professionals in order to address some of the challenges presented by off-label use in Spain. Speakers include:

• Frédéric Destrebecq – European Brain Council / Consejo Europeo del Cerebro
• Cesar Hernandez Garcia – Spanish Agency of Medicines and Medical Devices / Agencia Española de Medicamentos y Productos Sanitarios
• Alba Ancochea Díaz – Spanish Federation of Rare Diseases / Federación Española de Enfermedades Raras
• José Ramón Ara Callizo – Spanish Society of Neurology / Sociedad Española de Neurología
• Celso Arango López – European College of Neuropsychopharmacology
• Javier Pardo Moreno – Rey Juan Carlos Hospital
• Marina Díaz Marsá – Foundation for Neurodegenerative Diseases Investigation
• Representative from Farmaindustria (TBC)
• Representative from the Ministry of Health (TBC)

Should you be interested in attending this workshop, please do not hesitate to reach out to us (policy@braincouncil.eu or +32 (0)2 513 27 57).