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Comparison of the various policies on orphan drugs worldwide
USA Japan Australia UE
Legal framework Orphan Drug Act (1983) Orphan Drug Regulation (1993) Orphan Drug Policy (1998) Regulation (CE) N°141/2000 (2000)
Admnistrative authorities involved FDA / OOPD (*) MHLW/OPSR (*) (Orphan Drug Division) TGA (*) EMEA / COMP (*)
Prevalence of the disease (per 10,000 individuals), justifying the orphan status 7,5 4 1,1 5
Estimation of the population affected, prevalence rate (per 10,000 individuals) 20 millions

7,3
No information No information 25-30 millions

6, 6-8
Marketing exclusivity 7 years 10 years 5 years (similar to other drugs) 10 years
Tax credit yes : 50% for clinical studies yes : 6% for any type of study + limited to 10% of the company's corporation tax no managed by the member states
Grants for research programmes of NIH and others governmental funds no 'FP6' + national measures
Reconsideration of applications for orphan designation No yes yes (every 12 months) yes (every 6 years)
Technical assistance for elaboration of the application file yes yes no yes
Accelerated marketing procedure yes yes yes yes (via the centralised procedure)
Sources: European Parliament 1999- STOA PUBLICATIONS- Orphan Drugs- PE
167 780/Fin.St.
Presentation of Prof Josep Torrent-Farnell (president of the COMP) at the 'Annual EuroMeeting 2001', Barcelona, 6-9 mars 2001.

(*) Abbreviations :

  • FDA: Food and Drug Administration
  • OOPD: Office of Orphan Products and Development
  • MHLW: Ministry of Health, Labour and Welfare
  • TGA: Therapeutic Good Administration
  • EMEA: European Agency for the Evaluation of Medicinal Products
  • COMP: Committee for Orphan Medicinal Products
  • NIH: National Health Institute

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