PROMOTING GOOD PRACTICE

 

FOR THE OFF-LABEL

 

USE OF MEDICINES:

A harmonised European approach to prioritise patient safety


WHAT IS OFF-LABEL USE

arrow-yellow-bottom

Before being placed on the market, medicines obtain an authorisation and a label for the indication for which they are tested. This testing follows very rigorous regulatory standards and procedures to demonstrate scientifically that the medicine is efficacious and of high quality but also minimises as much as possible risks to patient safety.

Off-label use is the practice of using a medicine outside its authorised indication. It plays an important part in some medical areas, since it can be of benefit to patients when no other treatment option is available, such as it is often the case in rare diseases or in the case of child and adolescent care.



WHAT SHOULD YOU KNOW ABOUT OFF-LABEL USE?

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 need of the patients.



WHAT IS GOOD PRACTICE?

We believe that off-label use of medicinal products should only occur if the following criteria are met:

  • Presence of a severe, life-impairing  or life-threatening condition;
  • Absence of authorised treatment  or repeated treatment failure;
  • Absence of alternative treatments authorised for the condition;
  • The off-label use is supported by strong evidence  in scientific literature;
  • The patient has been educated and has given his  or her informed consent;
  • Presence of established reporting routes for  adverse events and linked to off-label use.

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 the 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.


CALL TO ACTION!

We believe health professionals 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.

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 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.

Endorse the Declaration on Good Off-Label Use Practice

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

Download the declaration

Share your experience

We are interested in knowing
your experience with off-label use.
If you are interested in sharing it,




FOLLOW THE CAMPAIGN

arrow-yellow-bottom

 EVENTS


31Aug

Second Event!

Wednesday, Brussels Parliament

NEWS


20
Jul

Second post!

Ut enim benefici liberalesque sumus, non ut exigamus gratiam (neque enim beneficium faeneramur sed natura...

Read More
03
Jul

First post!

Ut enim benefici liberalesque sumus, non ut exigamus gratiam (neque enim beneficium faeneramur sed natura...

Read More

A clear, Europe-wide approach on the issue is becoming  increasingly urgent to preserve the European regulatory  framework and ensure the safety of patients

FIND OUT MORE  ABOUT OUR PROPOSAL

WHAT IS GOOD PRACTICE?

The signatories of this declaration believe that off-label use of medicinal products should only occur if the following criteria are met:

  • Presence of a severe, life-impairing  or life-threatening condition;
  • Absence of authorised treatment  or repeated treatment failure;
  • Absence of alternative treatments authorised for the condition;
  • The off-label use is supported by strong evidence  in scientific literature;
  • The patient has been educated and has given his  or her informed consent;
  • Presence of established reporting routes for  adverse events and linked to off-label use.

These criteria, independently identified by Professor Marc Dooms, 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 purport to limit the off-label use, but intend to provide a harmonised approach for its occurrence in order to maintain the highest levels of patient safety and minimise any adverse events.


CALL TO ACTION!

We believe health professionals 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.



Who we are

The Declaration on Good Off-Label Use Practices is open to any national and European organisation which supports its principles and objectives. Current signatories include: 

 

We thus call on the European Medicines Agency 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.