European Union; market access; marketing authorization; orphan drugs; price and reimbursement; regulation
Indexed keywords
ORPHAN DRUG;
CLINICAL PROTOCOL;
COST BENEFIT ANALYSIS;
COST EFFECTIVENESS ANALYSIS;
DRUG APPROVAL;
DRUG COST;
DRUG LEGISLATION;
DRUG MANUFACTURE;
DRUG MARKETING;
DRUG PROGRAM;
DRUG RESEARCH;
EUROPE;
EUROPEAN UNION;
FUNDING;
GOVERNMENT REGULATION;
HEALTH CARE ACCESS;
HUMAN;
PATIENT CARE;
POSTMARKETING SURVEILLANCE;
PRESCRIPTION;
RESOURCE ALLOCATION;
REVIEW;
DRUG COSTS;
DRUG DESIGN;
DRUG INDUSTRY;
EUROPE;
EUROPEAN UNION;
HEALTH SERVICES ACCESSIBILITY;
HUMANS;
INSURANCE, HEALTH, REIMBURSEMENT;
INSURANCE, PHARMACEUTICAL SERVICES;
ORPHAN DRUG PRODUCTION;
RARE DISEASES;
REIMBURSEMENT MECHANISMS;
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).
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).
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).
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).
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.
Le Cam Y. Inventory of access and prices of orphan drugs across Europe: a collaborative work between national alliances on rare diseases & EURORDIS. EURORDIS, Paris, France (2010).
Drugs for rare diseases: Influence of orphan designation status on price
Picavet E, Dooms M, Cassiman D, Simoens S. Drugs for rare diseases: influence of orphan designation status on price. Appl. Health Econ. Health Policy 9(4), 275-279 (2011).
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).
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)