About us


The Declaration for Good Off-Label Use Practice is supported by a coalition of European organisations that are dedicated to ensuring that high standards of patient care are upheld and that progress in medical research and innovation is achieved.

To date, the following European Associations have endorsed the declaration:


 European Federation of Neurological Associations (EFNA)

European Multiple Sclerosis Platform (EMSP)

European Medical Association (EMA)

European Brain Council (EBC)

European Alliance for Access to Safe Medicines (EAASM)

European Alliance of Restless Legs Syndrome (EARLS)

European Myalgic Encephalomyelitis Alliance (EMEA)

European Parkinson`s Disease Association (EPDA)

Associazione Italiana Miastenia e Malattie Immunodegenerative (AIM)

European Association of Myasthenia Gravis Patients’ Associations (EuMGA)

The Encephalitis Society

ANMAR Onlus Associazione Nazionale Malati Reumatici

Società Italiana Nefrologia (SIN)

 

 

 




The signatories would like to thank Professor Marc Dooms, for developing this declaration, committing his time to its promotion and allowing the signatories to make it publicly available.

The declaration on Good Off-Label Use Practice has been written by Marc in full independency and no financial support has been paid to him for his work on the off-label use of medicines.

The signatories would also like to thank Professor Guy Goodwin, TM van der Zanden and Prof.dr. SN. de Wildt for their important contributions to the declaration.

This initiative has been financed with an unconditional grant from The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Europe’s principal trade body for small-to-medium sized innovative companies working in the field of pharmaceuticals.

EUCOPE is committed to the principles contained within the declaration and dedicated to upholding the highest standards of care in the interest of the patients. For these reasons, while the editorial and scientific oversight has always been the sole responsibility of Professor Dooms and the other authors, EUCOPE has facilitated the distribution of this declaration among European stakeholders and transparently called for its endorsement. No compensation was paid to the author by EUCOPE or its members.

 

Professor Marc Dooms is a Senior Orphan Drug Pharmacist at the University Hospitals in Leuven. He is compounding/ dispensing pharmacist in First in Men Randomized Clinical Trials. Marc has been a member of the Belgian Order of Pharmaceutical Sciences and the Flemish Society of Hospital Pharmacists (VZA) since 1975 and the Belgian representative to the European Union of Experts in Rare Diseases and has worked closely with Orphanet, the European Society of Clinical Pharmacy, and the American Society of Health Care Pharmacists, among others, since 2000.

Professor Guy Goodwin is a NIHR Senior Investigator. From 1996 until 2015 he was WA Handley Professor of Psychiatry and Head of the Department of Psychiatry at Oxford. Professor Goodwin’s interests are in the treatment of bipolar disorder, and the application of neuroscience in understanding the neurobiology of mood disorders, with a focus on developing new treatments. The views expressed are those of the author and not necessarily those of the UK’s NHS, NIHR or Department of Health.

TM van der Zanden, Bsc, PhD, Erasmus MC Sophia Children’s Hospital, Rotterdam, The Netherlands; Department of Pharmacology and Toxicology, Radboud University, Nijmegen, The Netherlands. Program manager of the Dutch Paediatric Formulary (www. kinderformularium.nl). The views expressed are those of the author.

Prof. dr. SN. de Wildt, paediatric intensivist, clinical pharmacologist, department of Intensive Care and Paediatric Surgery, Erasmus MC Sophia Children’s Hospital, Rotterdam, The Netherlands; Department of Pharmacology and Toxicology, Radboud University, Nijmegen, The Netherlands. Director of the Dutch Paediatric Pharmacotherapy Expertise Network NKFK, chair of editorial board of the Dutch Paediatric Formulary (www.kinderformularium.nl). The views expressed are those of the author.

Launching the GOLUP

The GOLUP Declaration was officially launched in September 2016 in the European Parliament. Following the event, the criteria were reworked to take into account some of the concerns expressed by stakeholders, in particular the paediatric community. The new, improved declaration allows for more flexibility for doctors and patients without compromising on the key principle of ensuring patient safety.  

Building on the momentum

In July 2017, the European Brain Council hosted a roundtable on “Ensuring the safe prescription of medicines off-label in Europe: what role for the European Union?”. Over 30 leading healthcare and policy stakeholders attended, discussing how to best address the existing challenges with off-label use. The event provided an opportunity to debate the European Commission’s study on off-label use released in February 2017. A call to the European Commission and the European Medicines Agency for the adoption of EU guidelines came out strongly from the event. An updated version of the declaration was also presented, finding wide support among stakeholders in the room.

The Declaration for Good Off-Label Use is open to any National and European organisation which supports its principles and objectives.

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To gather further information on becoming a signatory of the declaration please emails us at :

info@braincouncil.eu

EFNA

European Federation of Neurological Associations

EMSP

European Multiple Sclerosis Platform

EMA

European Medical Association

EBC

European Brain Council

EAASM

European Alliance for Access to Safe Medicines