IDEAS home Printed from https://ideas.repec.org/a/taf/applec/v48y2016i27p2562-2570.html
   My bibliography  Save this article

Financial and legislative aspects of drug development of orphan diseases on the European market -- a systematic review

Author

Listed:
  • Petra Maresova
  • Blanka Klimova
  • Kamil Kuca

Abstract

According to the European Commission, medical products for orphan diseases are those which affect fewer than five persons out of every 10 000. Producers are reluctant to develop these drugs under the common market conditions because the demand for these drugs does not guarantee return on investments into research and development of such products. Patients with orphan diseases, however, have the same rights for treatment as any other patient. To stimulate the research and development of drugs for orphan diseases, the governmental offices introduce various incentives for health and biotechnological industry. This started in the USA already in 1983 by passing a special law. Japan introduced this law in 1993 and Australia in 1997. Europe followed in 1999 by introducing common policy for all member states.The aim of this article is to specify current economic and legislative conditions in European countries and compare them with the legislation and approaches of the countries which started this initiative, i.e. USA, Japan, Australia or Singapore. In addition, the treatment costs of orphan diseases are specified and prospects of this field are evaluated.

Suggested Citation

  • Petra Maresova & Blanka Klimova & Kamil Kuca, 2016. "Financial and legislative aspects of drug development of orphan diseases on the European market -- a systematic review," Applied Economics, Taylor & Francis Journals, vol. 48(27), pages 2562-2570, June.
    • Handle: RePEc:taf:applec:v:48:y:2016:i:27:p:2562-2570
    DOI: 10.1080/00036846.2015.1125433
    as

    Download full text from publisher

    File URL: http://hdl.handle.net/10.1080/00036846.2015.1125433
    Download Restriction: Access to full text is restricted to subscribers.
    File URL: https://libkey.io/10.1080/00036846.2015.1125433?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Denise Doiron & Denzil G. Fiebig & Meliyanni Johar & Agne Suziedelyte, 2015. "Does self-assessed health measure health?," Applied Economics, Taylor & Francis Journals, vol. 47(2), pages 180-194, January.
    2. Moors, Ellen H.M. & Faber, Jan, 2007. "Orphan drugs: Unmet societal need for non-profitable privately supplied new products," Research Policy, Elsevier, vol. 36(3), pages 336-354, April.
    3. Nurhan Yenturk & Burc Ulengin & Ahmet Cimenoglu, 2009. "An analysis of the interaction among savings, investments and growth in Turkey," Applied Economics, Taylor & Francis Journals, vol. 41(6), pages 739-751.
    4. Wellman-Labadie, Olivier & Zhou, Youwen, 2010. "The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity?," Health Policy, Elsevier, vol. 95(2-3), pages 216-228, May.
    5. Afschin Gandjour, 2015. "A model to optimize investments in health technologies, quality of care and research," Applied Economics, Taylor & Francis Journals, vol. 47(20), pages 2031-2039, April.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Marialuisa Saviano & Sergio Barile & Francesco Caputo & Mattia Lettieri & Stefania Zanda, 2019. "From Rare to Neglected Diseases: A Sustainable and Inclusive Healthcare Perspective for Reframing the Orphan Drugs Issue," Sustainability, MDPI, vol. 11(5), pages 1-21, March.
    2. Belousova, Olga A. & Groen, Aard J. & Ouendag, Aniek M., 2020. "Opportunities and barriers for innovation and entrepreneurship in orphan drug development," Technological Forecasting and Social Change, Elsevier, vol. 161(C).

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Salas-Vega, Sebastian & Shearer, Emily & Mossialos, Elias, 2020. "Relationship between costs and clinical benefits of new cancer medicines in Australia, France, the UK, and the US," Social Science & Medicine, Elsevier, vol. 258(C).
    2. Maria Alessandra Antonelli & Giorgia Marini, 2023. "Good health with good institutions. An empirical analysis for italian regions," Public Finance Research Papers 61, Istituto di Economia e Finanza, DSGE, Sapienza University of Rome.
    3. Anthony Lepinteur, 2021. "The asymmetric experience of gains and losses in job security on health," Health Economics, John Wiley & Sons, Ltd., vol. 30(9), pages 2217-2229, September.
    4. Christian Bünnings, 2017. "Does new health information affect health behaviour? The effect of health events on smoking cessation," Applied Economics, Taylor & Francis Journals, vol. 49(10), pages 987-1000, February.
    5. Prakash, Kushneel & Munyanyi, Musharavati Ephraim, 2021. "Energy poverty and obesity," Energy Economics, Elsevier, vol. 101(C).
    6. Huong Thu Le & Ha Trong Nguyen, 2017. "Parental health and children's cognitive and noncognitive development: New evidence from the longitudinal survey of Australian children," Health Economics, John Wiley & Sons, Ltd., vol. 26(12), pages 1767-1788, December.
    7. Bérengère Davin & Xavier Joutard & Alain Paraponaris, 2019. "“If You Were Me”: Proxy Respondents’ Biases in Population Health Surveys," AMSE Working Papers 1905, Aix-Marseille School of Economics, France.
    8. Olga Bruyaka & Hanko Zeitzmann & Isabelle Chalamon & Richard Wokutch & Pooja Thakur, 2013. "Strategic Corporate Social Responsibility and Orphan Drug Development: Insights from the US and the EU Biopharmaceutical Industry," Journal of Business Ethics, Springer, vol. 117(1), pages 45-65, September.
    9. Kovacic, Matija & Orso, Cristina Elisa, 2022. "Trends in inequality of opportunity in health over the life cycle: The role of early-life conditions," Journal of Economic Behavior & Organization, Elsevier, vol. 201(C), pages 60-82.
    10. Philippe Gorry & Diego Useche, 2018. "Orphan Drug Designations as Valuable Intangible Assets for IPO Investors in Pharma-Biotech Companies," NBER Chapters, in: Economic Dimensions of Personalized and Precision Medicine, pages 305-334, National Bureau of Economic Research, Inc.
    11. Gutiérrez-Portilla, Paula & Maza, Adolfo & Villaverde, José, 2019. "A spatial approach to the FDI-growth nexus in Spain: Dealing with the headquarters effect," International Business Review, Elsevier, vol. 28(6), pages 1-1.
    12. Chor Foon Tang & Soo Y. Chua, 2012. "The savings-growth nexus for the Malaysian economy: a view through rolling sub-samples," Applied Economics, Taylor & Francis Journals, vol. 44(32), pages 4173-4185, November.
    13. Aaron S Kesselheim & Jessica A Myers & Daniel H Solomon & Wolfgang C Winkelmayer & Raisa Levin & Jerry Avorn, 2012. "The Prevalence and Cost of Unapproved Uses of Top-Selling Orphan Drugs," PLOS ONE, Public Library of Science, vol. 7(2), pages 1-7, February.
    14. Karlsson, Martin & Klohn, Florian & Rickayzen, Ben, 2018. "The role of heterogeneous parameters for the detection of selection in insurance contracts," Insurance: Mathematics and Economics, Elsevier, vol. 83(C), pages 110-121.
    15. Belousova, Olga A. & Groen, Aard J. & Ouendag, Aniek M., 2020. "Opportunities and barriers for innovation and entrepreneurship in orphan drug development," Technological Forecasting and Social Change, Elsevier, vol. 161(C).
    16. Prakash, Kushneel & Kumar, Sanjesh, 2021. "“Smoking your child’s job away”: Parental smoking during one’s childhood and the probability of being employed in adulthood," Journal of Business Research, Elsevier, vol. 136(C), pages 86-98.
    17. Debora Di Gioacchino & Emanuela Ghignoni & Laura Sabani, 2024. "Health Disparities in Europe: Insights from a Cluster Analysis of Healthcare Systems," Working Papers - Economics wp2024_08.rdf, Universita' degli Studi di Firenze, Dipartimento di Scienze per l'Economia e l'Impresa.
    18. David Pérez-Mesa & à ngel S. Marrero, 2024. "Adult health and inequality of opportunity in Spain," Working Papers 671, ECINEQ, Society for the Study of Economic Inequality.
    19. Beatty, Timothy K.M. & Ritter, Joseph A., 2018. "Measuring the Health Cost of Prolonged Unemployment: Evidence from the Great Recession," Miscellaneous Publications 280435, University of Minnesota, Department of Applied Economics.
    20. Michele Ubaldi & Matteo Picchio, 2024. "In the wrong place at the wrong time. The impact of mass shooting exposure on mental health," Working Papers 491, Universita' Politecnica delle Marche (I), Dipartimento di Scienze Economiche e Sociali.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:taf:applec:v:48:y:2016:i:27:p:2562-2570. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Chris Longhurst (email available below). General contact details of provider: http://www.tandfonline.com/RAEC20 .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.