Hostname: page-component-84b7d79bbc-5lx2p Total loading time: 0 Render date: 2024-07-30T09:46:29.240Z Has data issue: false hasContentIssue false

DEVELOPMENT OF HEALTH TECHNOLOGY ASSESSMENT IN ROMANIA

Published online by Cambridge University Press:  24 April 2017

Silvia Gabriela Scintee
Affiliation:
Scoala Nationala de Sanatate Publica Management si Perfectionare in Domeniul Sanitarsscintee@snspms.ro
Marius Ciutan
Affiliation:
Scoala Nationala de Sanatate Publica Management si Perfectionare in Domeniul Sanitar

Abstract

Objectives: The aim of this study was to describe and analyze the introduction of health technology (HTA) in Romania.

Methods: Based on a review of the literature and legislative documents and personal experiences and observations, the authors describe, evaluate, and explain the background and evolution of the HTA system.

Results: Initiatives to introduce HTA in Romania date from the early 1990s, but real steps were taken only in 2012 when the European Union Directive 2011/24/ on the application of patients’ rights in cross-border health care had to be passed into Romanian law.

The main developments consist of: the establishment of a national competent authority, the development of a methodology for the rapid assessment of drugs, setting HTA as the main tool for compiling the list of medicines to be covered by the NHIF, and capacity building initiatives. One early result of HTA implementation was an updated list of reimbursed drugs, allowing Romanian patients access to new, innovative medicines.

Conclusions: In Romania, HTA become an issue for all stakeholders: decision makers are interested in cost-containment, patients in obtaining the best care, and producers in receiving acceptable reimbursement remains on the health policy agenda. Further steps are envisaged, especially for international collaboration, which is considered an important factor for HTA development in Romania.

Type
Theme Submissions
Copyright
Copyright © Cambridge University Press 2017 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Scîntee, G, Trăistaru, T. Implementing primary health care reform in Romania: An experiment in eight districts. In: Feachem, Z, Hensher, M, Rose, L, eds. Implementing health sector reform in Central Asia. Papers from an EDI Health Policy Seminar held in Ashgabat, Turkmenistan, June 1996. Washington DC: IBRD/WB. 1999:131-36.Google Scholar
2. Vlădescu, C, Scîntee, G, Olsavszky, V, Allin, S, Mladovsky, P, Romania: Health system review. Health Syst Transit. 2008;10:1-172.Google Scholar
3. Institutul Național de Statistică [National Institute of Statistics]. Sistemul conturilor de sănătate în România 2013 [The National Health Accounts. Romania 2013]. Bucharest: INS; 2015 Google Scholar
4. National Institute of Statistics. Romanian Statistical Yearbook 2015. Bucharest. 2016.Google Scholar
5. Vlădescu, C, Scîntee, SG, Olsavszky, V, Hernández-Quevedo, C, Sagan, A. Romania: Health system review. Health Syst Transit, 2016;18:1-170.Google Scholar
6. OECD (2014). Health at a Glance: Europe 2014. Paris, OECD. https://doi.org/10.1787/health_glance_eur-2014-en (accessed October 4, 2016)Google Scholar
7. Evidence, Ciutan M. - Foundation for the development of medical science. Manage Health. 2008;12:1.Google Scholar
8. Radu, CP, Chiriac, ND, Pravat, MA. The Development of the Romanian Scorecard HTA System. Value Health Reg Issues. 2016;10:41-47 CrossRefGoogle ScholarPubMed
9. Ministry of Health Order no. 861/2014 for the approval of HTA criteria, documentation to be submitted by applicants, methodological instruments used in the assessment process concerning inclusion, extension of indications, non-inclusion or exclusion of medicines in/from the List of INNs of medicines from which the insured persons benefit, as well as INNs of medicines granted in national health programmes, and the means of challenge, Official Gazette, no. 557 of 29 July 2014.Google Scholar
10. Morega, D. Transparency Directive and Romania's Health Insurance System, Journal of the International Institute for Law and Medicine. Yorkhill Law Publishing; 2015:25-42 Google Scholar
11. National Agency for Medicines and Medical Devices, 2014 Activity report. http://www.anm.ro/anmdm/_/RAPORT%20ACTIVITATE/Raport%20ANMDM%202014%20dupa%20CA.pdf (accessed October 4, 2016).Google Scholar
12. Ministry of Health Order no. 703/2015 for the amendment and supplementation of the appendix to Minister of Health's Order no. 75/2009 for the approval of the Norms on the pricing of medicines for human use and for the amendment of Ministry of Health Order no. 245/2012 for the approval of prices of medicines for human use included in the National Catalogue of Medicines for Human Use Authorized for Marketing in Romania. Official Gazette, Part I, no. 396 of 05.06.2015.Google Scholar
13. Ruiz, F, Lopert, R, Chalkidou, K. Technical assistance in reviewing the content and listing processes for the Romanian Basic Package of Health Services and Technologies. Final report and Recommendations: Next Steps. NICE International; 2012.Google Scholar