References
- Grootendorst P, Pierard E, Shim M. Life-expectancy gains from pharmaceutical drugs: a critical appraisal of the literature. Expert Rev. Pharmacoeconomics Outcomes Res.9(4), 353–364 (2009).
- Annemans L, Arickx F, Belle O et al. A call to make valuable innovative medicines available in the European Union. Background report for the ministerial conference ‘Innovation and solidarity on pharmaceuticals’. RIZIV, Brussels, Belgium (2010).
- Docteur E, Paris V. Improving health system efficiency: achieving better value for money. Presented at: Joint European Commission/OECD Conference. Brussels, Belgium, 17 September 2008.
- Eichler HG, Pignatti F, Flamion B, Leufkens H, Breckenridge A. A mounting dilemma: balancing early market access to new drugs against the need for comprehensive data on benefits and risks. Nature Rev. Drug Discov.7, 818–826 (2008).
- Denis A, Mergaert L, Fostier C, Cleemput I, Simoens S. A comparative study of European rare disease and orphan drug markets. Health Pol.97(2–3), 173–179 (2010).
Websites
- European Commission. Pharmaceutical Forum http://ec.europa.eu/pharmaforum
- European Commission. Regulation (EC) No. 469/2009 of the European Parliament and of the council of 6 May 2009 concerning the supplementary protection certificate for medicinal products www.deti.ie/science/ipr/pubcodver.pdf
- European Commission. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use http://openmedicineeu.blogactiv.eu/files/2011/02/MedicinesRegulations Consolidated2001-83EN-2004.pdf
- European Commission. Article 107 TFEU (ex Article 87 TEC): Notion of State Aid and Derogations www.stateaidlaw.eu/46_68_news_232.php
- European Commission. Innovative Medicines Initiative (IMI) Strategic Research Agenda. Creating Biomedical R&D Leadership for Europe to Benefit Patients and Society http://ec.europa.eu/research/fp6/pdf/innovative_medicines_sra_final_draft_en.pdf
- European Commission. Commission regulation (EC) no 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No. 726/2004 of the European Parliament and of the Council http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_507/reg_2006_507_en.pdf
- European Medicines Agency. CHMP Guideline on the scientific application and the practical arrangements necessary to implement Commission regulation (EC) No. 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use falling within the scope of Regulation (EC) No. 726/2004 www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004908.pdf
- European Commission. Commission Regulation (EC) No. 141/2000 of the European Parliament and the Council of 16 December 1999 on orphan medicinal products http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2000:018:0001:0005:en:PDF
- European Medicines Agency. CHMP Qualification of Novel Methodologies for Drug Development: Guidance to Applicants www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004201.pdf