| 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. |
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(*) 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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