{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T07:41:34Z","timestamp":1792395694879,"version":"4.4.0"},"reference-count":15,"publisher":"Cambridge University Press (CUP)","license":[{"start":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T00:00:00Z","timestamp":1792368000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/www.cambridge.org\/core\/terms"}],"funder":[{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Law. Med. Ethics"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Words can have inherently multiple meanings; therefore, semantics can directly impact policies and behaviours. In regulatory practice, semantics refers to the specific, actionable meaning behind terminology, and attention to semantics can help ensure that legal frameworks are interpreted accurately. Refining semantics is not a purely theoretical exercise, but a subtle yet powerful element that has the potential to make the regulatory system more efficient in setting priorities and more reliable in meeting societal expectations and needs. When their intended purpose does not align with their true meaning, labels widely used in pharmaceutical regulation such as \u201cbreakthrough,\u201d \u201corphans,\u201d or \u201cunmet medical need\u201d risks undermining the clarity and precision essential to a sound regulatory framework. In addition, differences in definitions, scopes, eligibility criteria, and incentives can obstruct the efficient convergence of efforts in drug development and access. As pharmaceutical investments and clinical research increasingly transcend borders, the adoption of consistent terminology and regulatory definitions becomes crucial. This alignment can enhance cooperation among investors, governments, regulators, researchers, health care practitioners, and patients.<\/jats:p>","DOI":"10.1017\/jme.2026.10293","type":"journal-article","created":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T07:00:26Z","timestamp":1792393226000},"page":"1-3","source":"Crossref","is-referenced-by-count":0,"title":["The Impact of Semantics in Medicines Regulation"],"prefix":"10.1017","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2616-994X","authenticated-orcid":false,"given":"Enrico","family":"Costa","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04b6nzv94","id-type":"ROR","asserted-by":"publisher"}],"name":"Brigham and Women\u2019s Hospital and Harvard Medical School"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron S.","family":"Kesselheim","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04b6nzv94","id-type":"ROR","asserted-by":"publisher"}],"name":"Brigham and Women\u2019s Hospital and Harvard Medical School"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2026,10,19]]},"reference":[{"key":"S1073110526102939_r3","unstructured":"3. News, \u201cDeal on Comprehensive Reform of EU Pharmaceutical Legislation,\u201d European Parliament, https:\/\/www.europarl.europa.eu\/news\/en\/press-room\/20251209IPR32110\/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation (last visited September 3, 2026)."},{"key":"S1073110526102939_r12","unstructured":"12. Costa, Ross , and Kesselheim, , \u201cOrphan Designation for Drugs Approved in the United States and European Union: A\u00a0Comparative Analysis.\u201d"},{"key":"S1073110526102939_r11","doi-asserted-by":"publisher","DOI":"10.1016\/j.isci.2022.104698"},{"key":"S1073110526102939_r1","unstructured":"1. Public Health, \u201cReform of EU Pharmaceutical Legislation,\u201d European Commission, https:\/\/health.ec.europa.eu\/medicinal-products\/reform-eu-pharmaceutical-legislation_en (last visited September 3, 2026)."},{"key":"S1073110526102939_r7","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2015.16984"},{"key":"S1073110526102939_r6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMhpr1713338"},{"key":"S1073110526102939_r15","doi-asserted-by":"publisher","DOI":"10.1016\/j.drudis.2025.104462"},{"key":"S1073110526102939_r8","doi-asserted-by":"publisher","DOI":"10.1093\/shm\/hkx098"},{"key":"S1073110526102939_r9","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.70349"},{"key":"S1073110526102939_r5","volume-title":"Effectiveness and Efficiency: Random Reflections on Health Services: Report on Randomised Controlled Trials (RCTs)","author":"Cochrane"},{"key":"S1073110526102939_r2","unstructured":"2. Public Health, \u201cReform of EU Pharmaceutical Legislation\u201d; Legislative TrainSchedule, \u201cRevision of the EU Pharmaceutical Legislation,\u201d European Parliament, https:\/\/www.europarl.europa.eu\/legislative-train\/theme-promoting-our-european-way-of-life\/file-revision-of-the-pharmaceutical-legislation (last visited September 3, 2026)."},{"key":"S1073110526102939_r13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2019.07.007"},{"key":"S1073110526102939_r10","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2022-073242"},{"key":"S1073110526102939_r4","first-page":"132","article-title":"Les Lois Intellectuelles du Langage Fragment de S\u00e9mantique","volume":"17","author":"Br\u00e9al","year":"1883","journal-title":"Annuaire de l\u2019Association Pour l\u2019encouragement Des \u00c9tudes Grecques En France"},{"key":"S1073110526102939_r14","article-title":"Unmet Medical Needs Definition and Incentives: Stakeholders Perspectives on the Reform of the EU Pharmaceutical Llegislation","volume":"11","author":"Wens","year":"2024","journal-title":"Frontiers in Medicine"}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110526102939","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T07:00:28Z","timestamp":1792393228000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110526102939\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,19]]},"references-count":15,"alternative-id":["S1073110526102939"],"URL":"https:\/\/doi.org\/10.1017\/jme.2026.10293","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,19]]}}}