The aim of the Swedish conference is to find ways of cooperating systematically across Europe on the collection and sharing of data on the effectiveness of drugs. A better understanding of how well drug treatments work in everyday clinical use would benefit patients, pharmaceutical companies, government agencies and society as a whole.
Among the potential benefits of European collaboration on the follow-up of drug effectiveness, we envision:
- More rational use of medicinal products and other healthcare resources.
- Spin-off effects from the provision of joint EU information on side-effects, IT support, cross-border healthcare, etc.
- Earlier and safer access by patients to new drugs, and more regular, structured contact with the healthcare professionals responsible for their treatment.
- A stronger position for Europe as an area in which the pharmaceutical industry would be interested in setting up research and development activities.
Examples of cooperation areas of particular interest include biologic agents for chronic inflammatory diseases, cancer drugs, and orphan medicinal products where individual countries often have too few patients to sustain comprehensive assessment programmes.
Among the desired outcomes of the conference is an agreement by the participants to start a pilot project on collective gathering of data on drug effectiveness. We hope to jointly develop a model for systematic and structured follow-up for initial testing on an orphan drug. Following evaluation of the project, other drugs might also be considered.
July 2010 Update on the Swedish EU Presidency Assessing Drug Effectiveness Project (SPADE)
At a meeting in Brussels in April 2010 an Oversight Committee was constituted to oversee and govern the project. Representatives of the European Commission/DG Sanco, EMA, National Competent Authorities, Patient Organisations, EFPIA, EuroBio were invited to the meeting. The Committee outlined a working plan with the overall aims to:
- Explore methodological challenges relating to multinational collection and sharing of data relevant to the assessment of drug effectiveness.
- Identify solutions used by existing clinical networks to meet these challenges and thereby, facilitate the development of working procedures and datasets that may be useful for patient care and agency assessment as well as for research and industry needs at the national and European level.
In line with this an MPA working group has elaborated a questionnaire which has been sent out to three selected clinical networks representing chronic myeloic leukemia, cryopirin-associated fevers in children an multiple sclerosis. The results will be compiled and discussed with the Oversight Committee before being presented to a broader public. Results are expected during autumn 2010.