PROMOTING GOOD PRACTICE
FOR THE OFF-LABEL
Some European Union Member States are imposing prescribing guidelines that effectively promote off-label use for the sole purpose of reducing healthcare spending. We are concerned that this trend is creating unnecessary and avoidable risks for patients and often puts healthcare professionals in the position of being liable for a decision that they have not taken in full autonomy, and is potentially disrespecting the medical needs of the patients.
These criteria, drawn together by an independent expert, stem from decades of research and clinical practice and serve to provide a clear framework on when and how the off-label use of medicinal products could safely take place.
They do not aim to limit off-label use, but seek to promote a harmonised approach for its occurrence in order to maintain the highest levels of patient safety and minimise adverse events.
A clear, Europe-wide approach on the issue is becoming increasingly urgent to preserve the European regulatory framework and ensure the safety of patients.
We thus call on the European Medicines Agency and other national regulatory bodies to adopt strict guidelines to support healthcare practioners to take their decision on the basis of the medical need of their patients and ensure economic benefit does not prevail over public health.
The Declaration on Good Off-Label Use Practices is open to any national and European organisation which supports its principles and objectives.
Patient safety and informed consent:
The importance of good off-label use practices
The purpose of this event is to allow an exchange of ideas and experience among stakeholders and local actors, to understand which paths to take in individual Member States and to allow a continuous exchange of ideas and information on the off-label use of medicines.
17th June 2021
National Workshop on Off-label Use of Medicines Declaración sobre buenas prácticas del uso fuera de guía de medicamentos en España – 25th April 2018
Good Off-Label Use Practice (GOLUP) National Roundtable – Italy On 13th December 2017, the European Brain Council (EBC) participated in a roundtable on the use of off-label medicines in Rome, Italy. This was the first of a series of national roundtables to be organised by the Good Off-Label Use Practice (GOLUP) coalition.
EBC Hosts Roundtable on Off-Label Use of Medicines On the 10th of July, the European Brain Council (EBC) hosted an extremely insightful roundtable on “Ensuring the safe prescription of medicines off-label in Europe: what role for the European Union?”.
Professor Marc Dooms presents the GOLUP declaration at the ECRD
On 10th-12th May 2018, EURORDIS hosted the ninth European Conference on Rare Diseases & Orphan Products (ECRD) in Vienna, welcoming almost 1000 participants from more than 50 countries.
Off-label use of medicines: The need for good practice guidelines – the International Journal of Risk and Safety in Medicine
Article written by Dooms and Killick in which they present a set of guidelines for best practice in off-label use rooted in the need to ensure patient safety above all other concerns.
“EU needs guidelines on off-label us of medicines” argues MEP Piernicola Pedicini Since the European Parliament requested better guidance on the widespread off-label use of medicine, very little has been done, writes Piernicola Pedicini
Our response to the European Commission’s study on off-label use in the EU