Good practice for the off-label use of medicines – Save the Date

An event on “Safeguarding patient safety and quality of care in Europe: Good practice for the off-label use of medicines” will be hosted by MEP Piernicola Pedicini in the European Parliament in Brussels on Tuesday 27 September 2016, between 10.00 and 12.00.

This meeting, which brings together a number of leading healthcare and policy stakeholders, aims to thoroughly examine the issue of off-label use of medicinal products and current trends in this area. On this occasion, the Declaration on Good Off-Label Use Practices will also be presented by its author, Professor Marc Dooms.

A number of organizations, including EFNA, are convinced that there is an urgent need for a clear approach on the issue at the European level. For this reason, we are one of the signatories of the Declaration, which provides a clear framework on when and how the off-label use of medicinal products could safely take place.

This proposal does not intend to limit the off-label use, but aims to provide a harmonized approach for its occurrence in order to maintain the highest levels of patient safety and minimize any adverse events. The criteria identified reaffirm that patient safety should always prevail over considerations of cost and physicians should be supported by the public bodies and authorities responsible for the approval and use of medicines whose role is to protect public health. Physicians need to be given the freedom to uphold their pledge towards their patients to act ethically and put the patient’s interest first.

You can find further details about the off-label use and the declaration here: website.

To register to the event, please fill in this form by Sunday 4 September 2016.

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