In its first month heading the EU, Sweden gathers experts to harmonise procedures for assessing marketed orphan drugs
On 1 July, Sweden took over the Presidency of the European Union (EU), completing the 18-month troika started under France and continued via the Czech Republic. The country holding the EU Presidency acts as the driving force behind the EU’s legislative and political activities and works to broker compromises between the EU Member States. The most important task for the three-Presidency team is to establish a common 18-month programme for all three presidencies. Following on the momentum initiated by France and sustained by the Czech Republic, during which the historical adoption of the Council Recommendation on an Action in the Field of Rare Diseases was achieved in June of this year, Sweden, less than one month into its turn at the helm of the EU Council Presidency, organised a conference of experts to push the envelope further. On 28-29 July, Assessing Drug Effectiveness – Common Opportunities and Challenges for Europe gathered stakeholders from throughout Europe to discuss how to develop cooperation across Europe for the collection and sharing of data on drug effectiveness and safety following marketing authorisation. Speakers included Thomas Lönngren, Executive Director of the EMEA, along with representatives from government, industry, research, and patient organisations. A workshop specific to orphan drugs – an area for which cooperation is considered critical as most individual countries have too few patients and resources to sustain a comprehensive follow-up scheme – brought together a panel of experts including Ségolène Aymé (Orphanet, RDTF Task Force), Yann LeCam (EURORDIS), Kerstin Westermark (Committee for Orphan Medicinal Products), Andrea Rappagliosi (EFPIA Economic & Social Policy Committee), Ad R. Schuurman (Dutch Health Care Insurance Board, MEDEV), Josep Torrent-Farnell (Autonomous University of Barcelona), Stanislav Primoi (Agency for Medicinal Products and Medical Devices of the Republic of Slovenia) and Giulia Del Brenna (DG Enterprise). The conference moved forward the process of post-marketing assessment harmonisation via the decision to develop a pilot model “for structured follow-up for initial testing on an orphan drug” for which several candidate products were proposed by the workshop panellists. A meeting to take place in autumn will bring together stakeholders interested in participating in the pilot project. An informational booklet is available describing the issues surrounding sharing common assessment data in Europe. Consult the conference press release, agenda and speaker presentations