References
- OECD. Health at a Glance 2015: OECD Indicators, OECD Publishing, Paris. [Internet]. [ cited 2016 May 09]. Available from: 10.1787/health_glance-2015-en
- OECD. Health spending starts to rise but remains weak in Europe, says OECD. [Internet]. [ cited 2016 May 09]. Available from: http://www.oecd.org/newsroom/health-spending-starts-to-rise-but-remains-weak-in-europe.htm
- Carone G, Schwierz C, Xavier A. Cost-containment policies in public pharmaceutical spending in the EU. European commission, European Econmy. Economic papers 461. September 2012. [Internet]. [ cited 2016 May 09]. Available from: http://ec.europa.eu/economy_finance/publications/economic_paper/2012/pdf/ecp_461_en.pdf
- Vogler S, Zimmermann N, Leopold C, et al. Pharmaceutical policies in European countries in response to the global financial crisis. South Med Rev. 2011;4(2):1–13. DOI:10.5655/smr.v4i2.1004
- WHO (World Health Organization). Access to new medicines in Europe: technical review of policy initiatives and opportunities for collaboration and research. 2015. [Internet]. [ cited 2016 Aug 30]. Available from: http://apps.who.int/medicinedocs/documents/s21793en/s21793en.pdf
- European Commission. Investing In Health: Commission Staff Working Document, Social Investment Package. February 2013. [Internet]. [ cited 2016 May 09]. Available from: http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
- Joumard I, André C, Nicq C. Health Care Systems: Efficiency and Institutions, OECD Economics Department Working Papers, No. 769, OECD Publishing. 2010. [Internet]. [ cited 2016 May 09]. Available from: http://www.oecd-ilibrary.org/economics/health-care-systems_5kmfp51f5f9t-en
- Medeiros J, Schwierz C. Efficiency estimates of healthcare systems, European Economy, Economic Papers 549, June 2015. European Commission. [Internet]. [ cited 2016 May 09]. Available from: http://ec.europa.eu/economy_finance/publications/economic_paper/2015/pdf/ecp549_en.pdf
- Murteira S, Ghezaiel Z, Karray S, et al. Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature. J Market Access Health Policy. 2013;1:21131.
- Pantziarka P, Bouche G, Meheus L, et al. The repurposing drugs in oncology (ReDO) project. Ecancermedicalscience. 2014;8:442. DOI:10.3332/ecancer.2014.485
- Allarakhia M. Open-source approaches for the repurposing of existing or failed candidate drugs: learning from and applying the lessons across diseases. Drug Des Devel Ther. 2013;7:753–766. DOI:10.2147/DDDT.S46289
- National Institutes of Health (NIH) National Center for Advancing Translational Sciences (NCATS). About new therapeutic use. 2015. [Internet]. [ cited 2016 Aug 30]. Available from: http://www.ncats.nih.gov/ntu/about
- Commission Expert Group on Safe and Timely Access to Medicines for Patients (“STAMP”). Repurposing of established medicines/active substances. Agenda item 3. 10 March 2016. [Internet]. [ cited 2016 May 09]. Available from: http://ec.europa.eu/health/files/committee/stamp/2016-03_stamp4/3_repurposing_of_established_medicines_background_paper.pdf
- Medicines for Europe. What is value added medicines. [Internet]. [ cited 2016 Aug 30]. Available from: http://www.medicinesforeurope.com/value-added-medicines/did-you-know/
- Barei F, Le Pen C, Simoens S. The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation. Gabi Journal. 2013;2(1):13–19. DOI:10.5639/gabij.2013.0201.011
- Barei F, Ross M. The refinement of the super generic concept: semantic challenge for product re-innovation? Generics Biosimilars Initiative J (Gabi Journal). 2015;4(1):25–32. DOI:10.5639/gabij
- Daiichi-Sankyo. Daiichi Sankyo Launches New Generic Drugs Through its Daiichi Sankyo Espha Subsidiary. Press realease.18 June 2015. [Internet] [ cited 2016 May 09]. Available from: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006305.html
- Ciulu R. Diversification Strategy in the Pharmaceutical Industry. Available at SSRN 1283129. 2008 Oct 12. DOI:10.2139/ssrn.1283129
- Teva website. New Therapeutic Entities (NTEs). Internet]. [ cited 2016 May 09]. Available from: http://www.tevapharm.com/research_development/rd_integrated/new_therapeutic_entities/
- Stegemann S, Kopp S, Borchard G, et al. Developing and advancing dry powder inhalation towards enhanced therapeutics. Eur J Pharm Sci. 2013 Jan 23;48(1–2):181–194.
- Stegemann S, Klebovich I, Antal I, et al. Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products. Eur J Pharm Sci. 2011 Nov 20;44(4):447–454.
- Charles River Associates. Assessing the value of biopharmaceutical innovation in key therapy areas in middle-income countries. November 2013. [Internet]. [ cited 2016 Oct 09]. Available from: http://www.ifpma.org/wp-content/uploads/2016/01/value_of_innovation.pdf
- IFPMA. Incremental innovation: adapting to patient needs. 2013. [Internet]. [ cited 2016 Oct 09]. Available from: http://www.ifpma.org/wp-content/uploads/2016/01/IFPMA_Incremental_Innovation_Feb_2013_Low-Res.pdf
- Hult KJ. Incremental Innovation and Pharmaceutical Productivity. 2014. [Internet]. [ cited 2016 May 09]. Available from: http://home.uchicago.edu/~khult/jmp_draft.pdf
- Munos BH, Chin WW. How to revive breakthrough innovation in the pharmaceutical industry. Sci Transl Med. 2011 Jun 29;3(89):89cm16.
- Nussbaumer P, Klebl B. Professional translational research: a new hybrid paradigm in early drug discovery. Future Med Chem. 2015;7(14):1879–1889. DOI:10.4155/fmc.15.124
- European Medicines Agency (EMA). Generic/hybrid/biosimilar products. SmPC training presentation. 2013. [Internet]. [ cited 2016 May 09]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/01/WC500137031.pdf
- EUR-Lex. 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. [Internet]. [ cited 2016 May 09]. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32001L0083
- Wu H. Balancing a biologics pipeline portfolio. Drug Discovery World website. 2011. [Internet]. [ cited 2016 May 09]. Available from: http://www.ddw-online.com/drug-discovery/p142736-balancing-a-biologics-pipeline-portfolio-spring-11.html
- IMS Health. The Third Sector. A growing opportunity in the pharmaceutical market? 2014. [Internet]. [ cited 2016 May 09]. Available from: http://futurehealthinsights.co.uk/media/1029/03-the-third-sector-a-growing-opportunity-in-the-pharmaceutical-market.pdf
- Agrawal P. Advantages and challenges in drug re-profiling. J Pharmacovigil S. 2015;2:2.
- Holloway K, Van DL. The world medicines situation 2011, Rational use of medicines. World Health Organization. 2011. [Internet]. [ cited 2016 May 09]. Available from: http://www.who.int/medicines/areas/policy/world_medicines_situation/WMS_ch14_wRational.pdf
- European Centre for Disease Prevention and Control (ECDC). Antimicrobial resistance/Basic facts. [Internet]. [ cited 2016 May 09]. Available from: http://ecdc.europa.eu/en/healthtopics/antimicrobial_resistance/basic_facts/Pages/basic_facts.aspx
- WHO (World Health Organization). The evolving threat of antimicrobial resistance: options for action. 2012. [Internet]. [ cited 2016 May 09]. Available from: http://apps.who.int/iris/bitstream/10665/44812/1/9789241503181_eng.pdf
- European Commission. Antimicrobial resistance. Available from: Antimicrobial Resistance. Last updated: 02 may 2016. [Internet]. [ cited 2016 May 09]. Available from: http://ec.europa.eu/dgs/health_food-safety/amr/index_en.htm
- Sabaté E. Adherence to long-term therapies. Evidence for action. World Health Organization (WHO). 2003. [Internet]. [ cited 2016 May 09]. Available from: http://apps.who.int/iris/bitstream/10665/42682/1/9241545992.pdf
- Kelly M, McCarthy S, Sahm LJ Knowledge, attitudes and beliefs of patients and carers regarding medication adherence: a review of qualitative literature. Eur J Clin Pharmacol. 2014 Dec;70(12):1423–1431.
- Casali PG; Executive Committee of ESMO. The off-label use of drugs in oncology: a position paper by the European society for medical oncology (ESMO). Ann Oncol. 2007 Dec;18(12):1923–1925. DOI:10.1093/annonc/mdm517
- Corny J, Lebel D, Bailey B, et al. Unlicensed and off-label drug use in children before and after pediatric governmental initiatives. J Pediatr Pharmacol Ther. 2015 Jul-Aug;20(4):316–328.
- Hyman SE. Psychiatric drug development: diagnosing a crisis. Cerebrum. 2013 Mar-Apr;5.
- Insel TR, Voon V, Nye JS, et al. Innovative solutions to novel drug development in mental health. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 1):2438–2444. [ Epub 2013 Apr 3]. DOI:10.1016/j.neubiorev.2013.03.022
- MacEwan JP, Seabury S, Aigbogun MS, et al. Pharmaceutical innovation in the treatment of schizophrenia and mental disorders compared with other diseases. Innov Clin Neurosci. 2016;13(7–8):17–25.
- European Centre for Disease Prevention and Control (ECDC). Summary of the latest data on antibiotic resistance in the European Union. 2012. [Internet]. [ cited 2016 May 09]. Available from http://ecdc.europa.eu/en/eaad/Documents/antibiotics-resistance-EU-data-2012.pdf
- Renwick M, Simpkin V, Mossialos E. International and European Initiatives Targeting Innovation in Antibiotic Drug Discovery and Development. The need for a One Health – One Europe – One World Framework. A report for the 2016 Dutch Presidency of the European Union - Executive Summary. 2016. [Internet]. [ cited 2016 May 09]. Available from: http://english.eu2016.nl/binaries/eu2016-en/documents/publications/2016/02/10/factsheet-innovation-in-antibiotic-drugs/factsheet-innovation-in-antibiotic-drug-discovery-and-development.pdf
- Vidal website. Extencilline: arrêt de commercialisation et mise à disposition d’une spécialité importée. 12 February 2014. [Internet]. [ cited 2016 May 09]. Available from: https://www.vidal.fr/actualites/13600/extencilline_arret_de_commercialisation_et_mise_a_disposition_d_une_specialite_importee/
- Docbuzz.fr. Arrêt de l’Extencilline: La France n’a plus de traitement contre la Syphilis. 17 February 2014. [Internet]. [ cited 2016 May 09]. Available from: http://www.docbuzz.fr/2014/02/17/123-arret-de-lextencilline-la-france-na-plus-de-traitement-contre-la-syphilis
- Hofmarcher T, Jönsson B, Wilking N. Access to high quality oncology care across Europe. IHE Report. 2014:2. IHE: Lund. [Internet]. [ cited 2016 May 09]. Available from: http://www.ihe.se/access-to-high-quality-oncology.aspx
- Gori S, Di Maio M, Pinto C, et al. Disparity in the “time to patient access” to new anti-cancer drugs in Italian regions. Results of a survey conducted by the Italian society of medical oncology (AIOM). Tumori. 2011 Jul-Aug;97(4):442–448.
- National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal. 2013. [Internet]. [ cited 2016 May 09]. Available from: https://www.nice.org.uk/process/pmg9/chapter/1-foreword
- Ferrario A, Kanavos P. Managed entry agreements for pharmaceuticals: the European experience. EMiNet, Brussels, Belgium. 2013. [Internet]. [ cited 2016 May 09]. Available from: http://eprints.lse.ac.uk/50513/1/__Libfile_repository_Content_Ferrario,%20A_Ferrario_Managed_%20entry_%20agreements_2013_Ferrario_Managed_%20entry_%20agreements_2013.pdf
- Garrison L, Towse A. The drug budget silo mentality in Europe: an overview. Value Health. 2003;6(Suppl):S1–S9. DOI:10.1046/j.1524-4733.6.s1.1.x
- Garau M, Shah KK, Sharma P, et al. Is the link between health and wealth considered in decision making? Results from a qualitative study. Int J Technol Assess Health Care. 2015 Jan;31(6):449–456. DOI:10.1017/S0266462315000616
- French Healthcare Products Pricing Committee (CEPS). 2014/2015 Annual report. September 2015. [Internet]. [ cited 2016 May 09]. Available from: http://social-sante.gouv.fr/IMG/pdf/rapport_annuel_2014_version_anglaise.pdf
- AstraZeneca. Novel collaboration with Medical Research Council gives UK academia access to AstraZeneca compounds. February 2015. [Internet]. [ cited 2016 May 09]. Available from: https://www.astrazeneca.com/content/dam/az/Our-Science/Partnering/case-studies/Feb15-Medical_Research_Council_Collaboration_Case_Study_UK-External-Final.pdf
- Institut National du Cancer (INCa). Le programme AcSé. [Internet]. [ cited 2016 May 09]. Available from: http://www.e-cancer.fr/Professionnels-de-la-recherche/Recherche-clinique/Le-programme-AcSe
- Agence Nationale de Sécurité du Médicament et des Produits de Santé. ANSM. Temporary Recommendation for Use (RTUs). October 2012. [Internet]. [ cited 2016 May 09]. Available from: http://ansm.sante.fr/content/download/45542/590551/version/1/file/RTU-english.pdf