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Volumn 12, Issue 1, 2012, Pages 23-29

Access to orphan drugs in Europe: Current and future issues

Author keywords

European Union; market access; marketing authorization; orphan drugs; price and reimbursement; regulation

Indexed keywords

ORPHAN DRUG;

EID: 84856487084     PISSN: 14737167     EISSN: 17448379     Source Type: Journal    
DOI: 10.1586/erp.11.95     Document Type: Review
Times cited : (49)

References (14)
  • 1
    • 84856425256 scopus 로고    scopus 로고
    • European Commission: Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
    • 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 Communities L18/1-L18/5 (2000).
    • (2000) Official Journal of the European Communities
  • 2
    • 62949147825 scopus 로고    scopus 로고
    • European Medicines Agency: fee reductions for designated orphan medicinal products. EMA/960144/2011, London, UK
    • European Medicines Agency: fee reductions for designated orphan medicinal products. EMA/960144/2011. European Medicines Agency, London, UK (2011).
    • (2011) European Medicines Agency
  • 3
    • 84856437793 scopus 로고    scopus 로고
    • 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
    • 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 Communities C242/8-C242/11 (2008).
    • (2008) Official Journal of the European Communities
  • 5
    • 84856461461 scopus 로고
    • 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
    • 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 Communities L142/11-L142/13 (1989).
    • (1989) Official Journal of the European Communities
  • 6
    • 84856495426 scopus 로고    scopus 로고
    • Study on orphan drugs: Phase 1: Overview of the conditions for marketing orphan drugs in Europe
    • Alcimed
    • Alcimed. Study on orphan drugs: Phase 1: overview of the conditions for marketing orphan drugs in Europe. Koning Boudewijnstichting 2006, 18-23 (2010).
    • (2010) Koning Boudewijnstichting , vol.2006 , pp. 18-23
  • 7
    • 84856425257 scopus 로고    scopus 로고
    • Quantitative analysis of the influence of disease and product characteristics on orphan drug prices in Europe
    • Atlanta, GA, USA, 15-19 May
    • Aballéa S, Toumi M, Vataire AL, Millier A, Lamure M. Quantitative analysis of the influence of disease and product characteristics on orphan drug prices in Europe. Presented at: 15th ISPOR International Meeting. Atlanta, GA, USA, 15-19 May 2010.
    • (2010) 15th ISPOR International Meeting
    • Aballéa, S.1    Toumi, M.2    Vataire, A.L.3    Millier, A.4    Lamure, M.5
  • 10
    • 79958849417 scopus 로고    scopus 로고
    • Pricing and reimbursement of orphan drugs: The need for more transparency
    • Simoens S. Pricing and reimbursement of orphan drugs: the need for more transparency. Orphanet. J. Rare Dis. 6, 42 (2011).
    • (2011) Orphanet. J. Rare Dis. , pp. 642
    • Simoens, S.1
  • 11
    • 84856461175 scopus 로고    scopus 로고
    • 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
    • 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 Communities L136/1-L136/33 (2004).
    • (2004) Official Journal of the European Communities
  • 12
  • 13
    • 33747050446 scopus 로고    scopus 로고
    • Are rare diseases still orphans or happily adopted? The challenges of developing and using orphan medicinal products
    • DOI 10.1111/j.1365-2125.2006.02654.x
    • Dear JW, Lilitkarntakul P, Webb DJ. Are rare diseases still orphans or happily adopted? The challenges of developing and using orphan medicinal products. Br. J. Clin. Pharmacol. 62, 264-271 (2006). (Pubitemid 44215525)
    • (2006) British Journal of Clinical Pharmacology , vol.62 , Issue.3 , pp. 264-271
    • Dear, J.W.1    Lilitkarntakul, P.2    Webb, D.J.3


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