Cell and gene therapy regulatory, pricing, and reimbursement framework: With a focus on South Korea and the EU

被引:6
|
作者
Lee, SungKyung [1 ]
Lee, Jong Hyuk [2 ]
机构
[1] Korea Inst Ind Econ & Trade KIET, Ctr Growth Engine Ind, Sejong, South Korea
[2] Chung Ang Univ, Coll Pharm, Seoul, South Korea
关键词
cell and gene therapy; regulation; reimbursement; industrial policy; pricing; regulatory harmonization; innovative medicine; patient accessibility; EUROPE;
D O I
10.3389/fpubh.2023.1109873
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Ever since relevant bioengineering technologies have sufficiently matured to the platformizable commercialization stage, a slew of money has flocked to the cell and gene therapy market over the last few years, resulting in an abundance of clinical studies in the field. Newer modalities have brought up a string of regulatory and legislative tasks, such as developing guidelines and legislative rules to systematically regulate newer pharmaceutical products. Accordingly, another layer of legislation and guidelines tailored for cell and gene therapies has been introduced and is expected to evolve on par with technological progress. Furthermore, authorities have shifted to pricing and reimbursement policies that can share risks for cost and outcome among stakeholders altogether, such as developers and the government, while expanding the accessibility of patients to innovative cell and gene therapies. This review attempts to capture the salient regulatory features of the cell and gene therapy market in the context of South Korea and the European Union and points out where two sovereign entities currently stand on each policy element and how each tackles regulatory challenges. We can observe the converging trend where regulatory, pricing and reimbursement rules of adjoining countries in the supranational union or member countries of a consortium are getting more aligned. Evidently, concerted efforts to share regulatory science knowledge and embrace reference pricing have played their parts. The authors argue that policy priorities should be placed on initiatives to harmonize with other medical authorities to better the rights of patients and clear out the uncertainties of developers, ultimately to share and advance regulatory science and layout forward-looking policies at opportune times.
引用
收藏
页数:16
相关论文
共 50 条
  • [1] PRICING AND REIMBURSEMENT FRAMEWORKS IN CHINA, JAPAN AND SOUTH KOREA WITH FOCUS ON KEY REIMBURSEMENT DRIVERS
    Singh, B.
    Sehgal, M.
    [J]. VALUE IN HEALTH, 2018, 21 : S53 - S53
  • [2] Reimbursement and pricing of regenerative medicine in South Korea: key factors for achieving reimbursement
    Cho, Eun
    Yoo, Seung-Lai
    Kang, Youngju
    Lee, Jong Hyuk
    [J]. REGENERATIVE MEDICINE, 2020, 15 (04) : 1551 - 1560
  • [3] Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea
    Choi, Minjoung
    Han, Euiri
    Lee, Sunmi
    Kim, Taegyun
    Shin, Won
    [J]. REGULATORY ASPECTS OF GENE THERAPY AND CELL THERAPY PRODUCTS: A GLOBAL PERSPECTIVE, 2015, 871 : 163 - 179
  • [4] Historical overview of regulatory framework development on pricing and reimbursement of medicines in Bulgaria
    Vassileva, Maria
    Kamusheva, Maria
    Manova, Manoela
    Savova, Alexandra
    Tachkov, Konstantin
    Petrova, Guenka
    [J]. EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH, 2019, 19 (06) : 733 - 742
  • [5] Pricing and Reimbursement Pathways of New Orphan Drugs in South Korea: A Longitudinal Comparison
    Lee, Jong Hyuk
    [J]. HEALTHCARE, 2021, 9 (03)
  • [6] CURRENT CHALLENGES AND POTENTIAL SOLUTION FOR PRICING REGULATORY AND REIMBURSEMENT FRAMEWORK OF INNOVATIVE DRUGS IN EGYPT
    ElMordy, B.
    Fouad, S.
    Elsisi, G. H.
    Elmahdawy, M. D.
    [J]. VALUE IN HEALTH, 2018, 21 : S174 - S174
  • [7] REGULATORY FRAMEWORK FOR DEVELOPING CELL & GENE THERAPY PRODUCTS IN INDIA
    Pandit, K. R.
    Nisar, A.
    [J]. CYTOTHERAPY, 2024, 26 (06) : S186 - S186
  • [8] OVERVIEW OF GENE THERAPY PRICING POLICIES AND REIMBURSEMENT MODELS IN THE EU-5 (GERMANY, UK, FRANCE, ITALY AND SPAIN)
    Sopena, L.
    English, B.
    Munetsi, R.
    [J]. VALUE IN HEALTH, 2020, 23 : S418 - S418
  • [9] Pricing and reimbursement policy for new orphan drugs in South Korea: focused on patient accessibility and budget impact
    Lee, Jong Hyuk
    Yoo, Seung-Lai
    [J]. EXPERT OPINION ON ORPHAN DRUGS, 2022, 10 (01): : 23 - 28
  • [10] PRICING AND REIMBURSEMENT, AND MARKET ACCESS OF THERAPEUTIC MATERIALS (MEDICAL DEVICES/DIAGNOSTICS/BIOMARKERS) IN SOUTH KOREA.
    Seo, M.
    [J]. VALUE IN HEALTH, 2019, 22 : S677 - S677