References
- European Commission: Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products. Official Journal of the European CommunitiesL18/1–L18/5 (2000).
- European Medicines Agency: fee reductions for designated orphan medicinal products. EMA/960144/2011. European Medicines Agency, London, UK (2011).
- European Commission: guideline on aspects of the application of Article 8(2) of Regulation (EC) No. 141/2000: review of the period of market exclusivity of orphan medicinal products. Official Journal of the European CommunitiesC242/8–C242/11 (2008).
- EURORDIS position paper: why research on rare diseases? EURORDIS, Paris, France (2010).
- European Commission: Council Directive 89/341/EEC of 3 May 1989 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. Official Journal of the European CommunitiesL142/11–L142/13 (1989).
- Alcimed. Study on orphan drugs: Phase 1: overview of the conditions for marketing orphan drugs in Europe. Koning Boudewijnstichting2006, 18–23 (2010).
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- European Commission: Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004. laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Official Journal of the European CommunitiesL136/1–L136/33 (2004).
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Websites
- EMA’s rare disease (orphan) designations database. www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/orphan_search.jsp&murl=menus/medicines/medicines.jsp&mid=WC0b01ac058001d12b&jsenabled=true (Accessed 11 August 2011)
- European Commission: inventory of community and member states’ incentive measures to aid the research, marketing, development and availability of orphan medicinal products. Revision 2005. http://ec.europa.eu/health/files/orphanmp/doc/inventory_2006_08_en.pdf
- Orphanet website. www.orpha.net/consor/cgi-bin/Education_AboutOrphanDrugs.php?lng=EN (Accessed 6 November 2011)
- NICE. Appraising orphan drugs (2006). www.nice.org.uk/niceMedia/pdf/smt/120705item4.pdf
- Datamonitor. Orphan drug strategies, a route to unlocking new commercial opportunities. Datamonitor, London, UK (2009). www.datamonitor.com/store/Product/orphan_drug_strategies_a_route_to_unlocking_new_commercial_opportunities?productid=DMHC2548
- Project for the 2011 health insurance funding act: articles examination. Report no. 88 (2010–2011) by M. Alain Vasselle for the commission of social affairs, 3 November 2010. www.senat.fr/rap/l10-088-7/l10-088-74.html#toc35
- Framework agreement between the French economic committee and the pharmaceutical industry. 7 October 2010. www.sante.gouv.fr/IMG/pdf/Accord_cadre_en_vigueur.pdf
- OECD Health Data 2011. http://stats.oecd.org/Index.aspx?DataSetCode=SHA (Accessed 6 November 2011)