Orphanet: O lekach sierocych

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

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 :

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