Predlog konceptualnega modela za vstop zdravil sirot na trg
DOI:
https://doi.org/10.32015/JIBM.2024.16.2.1Ključne besede:
trženjski model, tržna strategija, redke bolezni, zdravilo, vrednotenje zdravstvenih tehnologij, zdravilo sirota, utemeljena teorijaPovzetek
Pravica do zdravja je tesno povezana s telesnim in duševnim blagostanjem vseh posameznikov ter je nujen pogoj za uresničevanje dodatnih človekovih pravic, vključno z uresničevanjem ustreznega življenjskega standarda. Redke bolezni so bolezni, ki prizadenejo zelo majhen del prebivalstva in imajo zaradi redkosti njihovega pojavljanja posebno mesto. Pogosto gre za kronična, napredujoča ali življenjsko nevarna zdravstvena stanja. Nekatera od njih se lahko zdravijo z zdravili, ki jih imenujemo zdravila sirote. Farmacevtska industrija zdravila sirote ne razvije zaradi ekonomskih razlogov, temveč da zadosti potrebam javnega zdravja. Pred prihodom na trg je treba ovrednotiti novo zdravljenje, za kar uporabljamo vrednotenje zdravstvenih tehnologij, s katerim ocenimo relativno učinkovitost novih zdravil, medicinskih pripomočkov in drugih zdravstvenih tehnologij. Vstop zdravila sirote na trg zahteva aktivno (so)delovanje vseh deležnikov: imetnikov dovoljenja za promet z zdravilom, pristojnih organov, medicinske stroke in organizacij bolnikov. Z uporabo kvalitativne metodologije in konstruktivistične utemeljene teorije smo razvili model vstopa zdravil sirot na trg, ki je prilagojen nišnemu trgu in upošteva ključne kategorije.
Literatura
Aaker, D. A., and Weinberg, C. B. (1975). Interactive marketing models. Journal of Marketing, 39(43), pp. 16–23.
Abozaid, G. M., Kerr, K., McKnight, A., and Al-Omar, H. A. (2022). Criteria to define rare diseases in orphan drugs: a systematic review protocol. BMJ Open, 12(7), e062126. https://doi.org/10.1136/bmjopen-2022-062126
Althobaiti, H., Seoane-Vazquez, E., Brown, L. M., Fleming, M. L., and Rodríguez-Monguió, R. (2023). Disentangling the cost of orphan drugs marketed in the United States. Multidisciplinary Digital Publishing Institute, 11(4), pp. 558–558. https://doi.org/10.3390/healthcare11040558
Anamul, H., and Alam, Z. (2012). Business analysis of pharmaceutical firms in Bangladesh: Problems in prospects. Journal of Business in Technology (Dhaka), 6(1), pp. 61-77.
Bergen, M., Dutta, S., and Walker, O. C. (1992). Agency relationships in marketing: A review of the implications and applications of agency and related theories. Journal of Marketing, 56(3), pp. 1–24. https://doi.org/10.1177/002224299205600301
Borden, N. H. (1964). The concept of the marketing mix. Journal of Advertising Research, 4(1), pp. 2–7.
Boulden, J. B., and Buffa, E. S. (1970). Corporate models: online real-time systems. Harvard Business Review, 48(4), pp. 65–83.
Brody, H. (2007). Hooked: Ethics, the medical profession, and the pharmaceutical industry. Lanham, MD: Rowman & Littlefield.
Brody, H., and Light, D. W. (2011). The inverse benefit law: how drug marketing undermines patient safety and public health. American Journal of Public Health, 101(3), pp. 399–404.
Charmaz, K. (2014). Constructing grounded theory: A practical guide through qualitative analysis (2nd ed.). London: Sage.
den Exter, A. (2017). The right to healthcare under European law. Diametros, 51, pp. 173-195.
Denzin, N. K., and Lincoln, Y. S. (Ed.). (2005). The handbook of qualitative research (3rd ed.). Thousand Oaks, CA: Sage Publications.
Easterby-Smith, M., Thorpe, R., and Lowe, A. (2005). Raziskovanje v managementu. Koper: Fakulteta za management.
EMA. (2020). Legal framework: orphan designation. Available at: https://www.ema.europa.eu/en/human-regulatory/overview/orphan-designation/legal-framework-orphan-designation (Accessed: April 19, 2021).
EURORDIS. (2007). Survey of the delay in diagnosis for 8 rare diseases in Europe (´EurordisCare2`). Available at: https://www.eurordis.org/sites/default/files/publications/Fact_Sheet_Eurordiscare2.pdf (Accessed: March 8, 2021).
Glaser, B. G., and Strauss, A. L. (1967). The discovery of grounded theory: Strategies for qualitative research. Chicago: Aldine.
Gobburu, J. V. S., and Lesko, L. J. (2009). Quantitative disease, drug, and trial models. Annual Reviews, 49(1), pp. 291–301. https://doi.org/10.1146/annurev.pharmtox.011008.145613
Groft, S. C., Posada, M., and Taruscio, D. (2021). Progress, challenges, and global approaches to rare diseases. Wiley-Blackwell, 110(10), pp. 2711–2716. https://doi.org/10.1111/apa.15974
Jamshed, S. (2014). Qualitative research method-interviewing and observation. Journal of basic and clinical pharmacy 5, pp. 87-88. DOI: 10.4103/0976-0105.141942.
JAZMP. (2021). Homepage. Available at: https://www.jazmp.si/humana-zdravila/farmakovigilanca/ (Accessed: April 19, 2021).
Kehayov, A. (2016). Modern approach in exercising the right to health care. Journal of Medical in Dental Practice, 3, pp. 484–487. https://doi.org/10.18044/Medinform.201632.484
Kesič, D. (2004). Model tržnega prilagajanja farmacevtskih družb iz tranzicijskih držav v procesu globalizacije trga (Doktorska disertacija). Ekonomska fakulteta, Maribor.
Kotler, P., and Keller, K. L. (2016). Marketing management. New Jersey: Pearson Education Limited.
Kronberger, N., and Wagner, W. (2000). Keywords in context: Statistical analysis of text features. v M. W. Bauer in G. Gaskell (Ed.), Qualitative researching with text, image, and sound (pp. 300-317). London: Sage.
Legard, R., Keegan, J., and Ward, K. (2003). In-depth interviews. In J. Ritchie in J. Lewis (Ed.), Qualitative research practice: A guide for social science students and researchers (pp. 139–169). London: Sage Publications.
Lublóy, Á. (2014). Factors affecting the uptake of new medicines: a systematic literature review. BioMed Central, 14(1). https://doi.org/10.1186/1472-6963-14-469
McCarthy, E. J. (1960). Basic marketing: A managerial approach. Homewood, IL: Richard D. Irwin Inc.
McIntyre, S. H. (1982). An experimental study of the impact of judgement-based marketing models. Management Science, 28(1), pp. 17–32.
Montgomery, D. B., and Weinberg, C. B. (1973). Modelling marketing phenomena: A managerial perspective. Journal of Contemporary Business, 2(4), pp. 17–43.
Morgan, H. (2022). Conducting a qualitative document analysis. The Qualitative Report, 27(1), 64-77. https://doi.org/10.46743/2160-3715/2022.5044
Riffenburgh, R. H., and Gillen, D. L. (2020). Statistics in medicine (4th ed.). San Diego, CA: Academic Press.
Ryan, G. W., and Bernard, R. H. (2003). Techniques to identify themes. Field Methods, 15, 85–109. http://dx.doi.org/10.1177/1525822X02239569
Sheiner, L. B., and Steimer, J. L. (2000). Pharmacokinetic/pharmacodynamic modeling in drug development. Annual Reviews, 40(1), 67–95. https://doi.org/10.1146/annurev.pharmtox.40.1.67
Shieh, G. (2010). On the misconception of multicollinearity in detection of moderating effects: Multicollinearity is not always detrimental. Multivariate Behavioral Research, 45(3), pp. 483–507. https://doi.org/10.1080/00273171.2010.483393
Strauss, A. L., and Corbin, J. (1998). The basics of qualitative analysis: Grounded theory procedures and techniques (2nd ed.). Thousand Oaks, CA: Sage.
European Parliament and Council (2000). Regulation (EC) No 141/2000 on orphan medicinal products. Official Journal of the EU, No. L 018.Vukasović, T. (2012). Trženje – od temeljev trženja do strateškega tržnega načrtovanja. Koper: Založba Univerze na Primorskem.
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