European policies on orphan diseases and drugs stimulate drug development, but could be improved

Drugs and Therapy Perspectives

Volumn 27, Issue 5, 2011, Pages 24-26

[No Author Info available]

Author keywords

Health policy; Orphan drugs

Indexed keywords

BOSENTAN; DASATINIB; IMATINIB; ORPHAN DRUG; SILDENAFIL; SORAFENIB;

ARTICLE; COST EFFECTIVENESS ANALYSIS; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG SAFETY; ECONOMIC ASPECT; ERECTILE DYSFUNCTION; ETHICS; EUROPE; HEALTH CARE POLICY; HUMAN; PREVALENCE; PULMONARY HYPERTENSION; RARE DISEASE; REGISTER;

EID: 79954488011     PISSN: 11720360     EISSN: 11791977     Source Type: Journal    
DOI: 10.2165/11601550-000000000-00000     Document Type: Article

References (10)

1. European Commission. European Commission Regulation (EC) no. 141/2000 of the European Parliament and the Council of 16 December 1999 on orphan medicinal products. Official Journal of the European Communities 2000; L 18/1 [online]. Available from URL: http://ec.europa.eu/health/files/eudralex/vol-1/reg-2000- 141/reg-2000-141-en.pdf [Accessed 2011 Mar 31]
2. Annual report of the European Medicines Agency 2007. London: European Medicines Agency, 2008
3. Denis A, Simoens S, Fostier C, et al. Health technology assessment policy governing orphan diseases and orphan medicines. Brussels: Belgian Health Care Knowledge Centre, 2009
4. Denis A, Mergaert L, Fostier C, et al. Issues surrounding orphan disease and orphan drug policies in Europe. Appl Health Econ Health Policy 2010; 8 (5): 343-50
5. Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical trials in small populations. London: European Medicines Agency, 2006 Jul 27
6. Cook JP, Vernon JA, Manning R. Pharmaceutical risk-sharing agreements. Pharmacoeconomics 2008; 26 (7): 551-6 (Pubitemid 351871550)
7. Drummond M, Evans B, LeLorier J, et al. Evidence and values: requirements for public reimbursement of drugs for rare diseases: a case study in oncology. Can J Clin Pharmacol 2009; 16: e273-81
8. Gericke CA, Riesberg A, Busse R. Ethical issues in funding orphan drug research and development. J Med Ethics 2005; 31: 164-8 (Pubitemid 40378689)
9. Orofino J, Soto J, Casado MA, et al. Global spending on orphan drugs in France, Germany, the UK, Italy and Spain during 2007. Appl Health Econ Health Policy 2010; 8 (5): 301-15
10. McCabe C, Tsuchiya A, Claxton K, et al. Orphan drugs revisited. QJM 2006; 99: 341-5