Availability of medicines for rare diseases in EU Countries

Pharmaceuticals Policy and Law

Volumn 11, Issue 1-2, 2009, Pages 101-109

  Trama, Annalisa ^a   Pierannunzio, Daniela ^a   Loizzo, Alberto ^a   Taruscio, Domenica ^a   Ceci, A ^a  

^a ISTITUTO SUPERIORE DI SANITÀ   (Italy)

Author keywords

Accessibility; Availability; Orphan medicinal product; TEDDY

Indexed keywords

EID: 85013584809     PISSN: 13892827     EISSN: 2210495X     Source Type: Journal    
DOI: 10.3233/PPL-2009-0215     Document Type: Article

References (11)

1. Alcimed, Study on Orphan drugs, Overview of the conditions for marketing orphan drugs in Europe. Available at URL: http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/pricestudy/final final report part 1 web.pdf, Accessed 20 November 2008.
2. Commission of the European Communities. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on rare diseases: Europe’s challenges, COM(2008) 679 final (11.11.2008) Available at URL: http://ec.europa.eu/health/ph threats/non com/rare 10 en.htm. Accessed 21 November 2008
3. European Medicines Agency (EMEA). Human medicines - Orphan medicinal products. Available at URL: http://www.emea.europa.eu/htms/human/orphans/intro.htm. Accessed 20 November 2008.
4. European Medicines Agency (EMEA), List of orphan-designated authorised medicines, EMEA/563575/2008 (6 November 2008).
5. European Organisation for Rare Diseases (Eurordis), Survey of orphan drugs availability in Europe, 2002, Available at URL: http://www.eurordis.org, Accessed 20 November 2008.
6. European Organisation for Rare Diseases (Eurordis), Survey of orphan drugs availability in Europe, 2004. Available at URL: http://www.eurordis.org, Accessed 20 November 2008.
7. European Organisation for Rare Diseases (Eurordis), Survey of orphan drugs availability in Europe, 2007, Available at URL: http://www.eurordis.org, Accessed 20 November 2008.
8. European Organisation for Rare Diseases (Eurordis), Round Table of Companies "Do rare diseases patients have real access to orphan drugs in Europe?", July 9th, 2007 - Barcelona, Spain.
9. European Parliament and Council Regulation 141/2000/EC, 16 December 1999 on Orphan Medicinal Products, Official Journal of the European Communities L18 (22.01.2000), 1-5.
10. Council of the European Communities. Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal I products for human use and their inclusion in the scope of national health insurance systems, Official Journal of the European Communities L40 (11.2.1989), 8.
11. F. Meyer, Timely and equitable access to orphan medicines across Member States, The European HAS workshop November 2006, Paris in report of the 4th European Conference on rare diseases, Patients at the heart of rare diseases policy development, Lisbon, 2007, 141-143.