Virtual workshop on good practices for the off-label use of medicines in Sweden and Norway

The use of medicines off-label plays an important role in various areas of medicine as it allows patients to be treated in cases where an authorised drug is not available for a specific therapeutic indication, population or method of administration. Despite its importance, off-label prescription lacks a clear and uniform approach at European level. As elsewhere in Europe, physicians in the Nordics prescribe medicines off-label to treat conditions where there are no approved products on the market. However there is a lack of an aligned strategy among agencies and decision makers when it comes to dealing this matter, with different health care regions in the countries taking different approaches.

To maintain the highest levels of patient safety and minimise any adverse events, while not limiting the access to medications off-label when there is an unmet medical need, a number of organisations put forward the Declaration on Good Off-Label Use Practice (so called GOLUP) as a basis for discussion across Europe. Following a launch event in Brussels, workshops have been held in Rome and Madrid to present the GOLUP and discuss it with local stakeholders and decisionmakers.

Speakers:

• Maria Prigorowsky, Head of Public Affairs, Hjärnfonden, The Swedish Brain Foundation
• Lise Johnson, Chair of the board, MSforbundet, The Norwegian MS Association
• Frédéric Destrebecq, Executive Director, The European Brain Council
• Synnöve Lindemalm, Paediatrician and Clinical Pharmacologist, Karolinska University Hospital and representative of ePed (an evidence-based database for the Swedish pediatric population)
• Elisabeth Gulowsen Celius, Senior Neurologist at Oslo University Hospital and Professor at Institute of Health and Society, University of Oslo
• Thony Björk, Medicines expert, SPF Seniorerna, The Swedish Association for Senior Citizens
• Dag Larsson, Senior policy expert, Läkemedelsindustriföreningen, Trade association for the research based pharmaceutical industry in Sweden
• Line Walen, Senior Policy Advisor, Legemiddelindustrien, Trade association for the pharmaceutical industry in Norway
• Jenni Nordborg, National Coordinator and Director of the Office for Life Sciences, Government Offices of Sweden

Speakers will provide their remarks in English, followed by a Q&A session where the audience will have the option to intervene in Swedish/Norwegian.

This event is sponsored by the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Europe’s trade body for small to medium-sized innovative companies working in the field of pharmaceuticals and medical technologies.

For any enquiries, please contact:

Giuditta.Caramori@fticonsulting.com and Zachary.Burnside@fticonsulting.com