{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T22:43:54Z","timestamp":1781649834289,"version":"3.54.5"},"reference-count":58,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T00:00:00Z","timestamp":1748217600000},"content-version":"vor","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Wound Repair Regeneration"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The late 1980s saw the emergence of experimental therapies based on human cell and tissue products (HCTPs) within academic and hospital settings, several of them wound healing related. In 2008, the European Commission introduced the Regulation on advanced therapy medicinal products (ATMPs), defining many of these HCTPs as ATMPs, and more specifically as somatic cell therapy medicinal products (sCTMPs) or tissue\u2010engineered products (TEPs). In 2013, we predicted that the ATMP regulation would adversely impact Member States' health care systems and would threaten the sustainability of many HCTPs provided by public health institutions. To assess the current ATMP state of play and investigate whether these predictions ultimately came true, we consulted relevant scientific and trade literature and official competent authority reports and surveyed the former Belgian HCTP producers. We found that the ATMP Regulation produced 19 authorised ATMPs, with 16 of them (84.2%) belonging to the gene therapy medicinal product (GTMP) class and only 3 HCTPs (15.8%), 2 TEPs and 1 sCTMP. List prices varied according to the ATMP class, with public health insurances struggling to reimburse ATMPs, especially the exuberantly priced GTMPs. This led to marketing authorization withdrawals, and crowd funding approaches and lotteries to determine who would receive lifesaving treatments. A hospital exemption (HE) scheme was enacted to protect ATMPs not intended for commercial exploitation. Whilst limited financial resources generally hampered HE utilisation by public actors, stringent regulatory policies made it virtually impossible in Belgium, resulting in meaningful HCTPs no longer being available to surgeons and their patients.<\/jats:p>","DOI":"10.1111\/wrr.70039","type":"journal-article","created":{"date-parts":[[2025,5,26]],"date-time":"2025-05-26T05:05:22Z","timestamp":1748235922000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Current State\u2010Of\u2010Play of the\n                    <scp>EU<\/scp>\n                    Advanced Therapy Medicinal Product (\n                    <scp>ATMP<\/scp>\n                    ) Field, With an Emphasis on Belgian Human Cell and Tissue Products"],"prefix":"10.1111","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5995-8350","authenticated-orcid":false,"given":"Gilbert","family":"Verbeken","sequence":"first","affiliation":[{"name":"Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital  Brussel Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lieke","family":"Convents","sequence":"additional","affiliation":[{"name":"Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital  Brussel Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Delmotte","sequence":"additional","affiliation":[{"name":"Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital  Brussel Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Pierre","family":"Draye","sequence":"additional","affiliation":[{"name":"Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital  Brussel Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serge","family":"Jennes","sequence":"additional","affiliation":[{"name":"Burn Wound Centre Grand H\u00f4pital de Charleroi  Gilly Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Vanderkelen","sequence":"additional","affiliation":[{"name":"Burn Wound Centre Queen Astrid Military Hospital  Brussel Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Griet","family":"Nijs","sequence":"additional","affiliation":[{"name":"Centre for Gene Therapy and Regenerative Medicine University Hospital Antwerp  Edegem Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Lewalle","sequence":"additional","affiliation":[{"name":"Haematology Department HUB\u2010Institute Jules Bordet  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1730-8357","authenticated-orcid":false,"given":"Etienne","family":"Baudoux","sequence":"additional","affiliation":[{"name":"Laboratory of Cell and Gene Therapy CHU Li\u00e8ge  Li\u00e8ge Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivier","family":"Cornu","sequence":"additional","affiliation":[{"name":"Musculoskeletal Tissue and Cell Therapy Unit University Hospital Saint\u2010Luc, UCLouvain  Brussels Belgium"},{"name":"Neuro\u2010Musculoskeletal Laboratory (NMSK) Institute of Experimental and Clinical Research (IREC), UCLouvain  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ineke","family":"Vanlaere","sequence":"additional","affiliation":[{"name":"Belgian Association for Tissue and Cell Banks (BVWB\u2010ABBT)  Edegem Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Pierlot","sequence":"additional","affiliation":[{"name":"Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital  Brussel Belgium"},{"name":"Burn Wound Centre Queen Astrid Military Hospital  Brussel Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Rose","sequence":"additional","affiliation":[{"name":"Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital  Brussel Belgium"},{"name":"Burn Wound Centre Queen Astrid Military Hospital  Brussel Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Paul","family":"Pirnay","sequence":"additional","affiliation":[{"name":"Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital  Brussel 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KCE Report 396 \u201cAcademic Development of ATMPs in Belgium: An Exploratory Study of the Legal & Strategic Options \u201daccessed March 25 2025 https:\/\/kce.fgov.be\/sites\/default\/files\/2025\u201001\/KCE_396_Development_ATMPS_Belgium_Report.pdf."},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.omtm.2019.01.010"},{"key":"e_1_2_8_20_1","doi-asserted-by":"crossref","unstructured":"M.Paterlini \u201cStem\u2010Cell Therapy Company Saved by Public Funds \u201d2023Nature Italy accessed January 20 2025 https:\/\/www.nature.com\/articles\/d43978\u2010023\u201000183\u20109.","DOI":"10.1038\/d43978-023-00183-9"},{"key":"e_1_2_8_21_1","unstructured":"M. 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