{
  "url": "https://openlegislation.uk/access-to-medical-treatments-innovation-act-2016/section-3",
  "json_url": "https://openlegislation.uk/access-to-medical-treatments-innovation-act-2016/section-3.json",
  "legislation": "ukpga/2016/9",
  "legislation_title": "Access to Medical Treatments (Innovation) Act 2016",
  "legislation_url": "https://openlegislation.uk/access-to-medical-treatments-innovation-act-2016",
  "path": "section/3",
  "kind": "section",
  "number": "3",
  "heading": "Section 2: supplementary",
  "text": "(1) In section 2, “doctor” means a registered medical practitioner.\n(2) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—\n(a) the off-label use of an authorised medicinal product, and\n(b) the use of a medicinal product in respect of which no UK marketing authorisation is in force.\n(3) In subsection (2)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—\n(a) for a purpose other than one for which its use is specified,\n(b) in relation to a person who is not within a description of persons for whom its use is specified, or\n(c) in any other way in which its use is not specified.\n(4) In this section—\n(a) “authorised medicinal product” means a medicinal product in respect of which a UK marketing authorisation is in force;\n(b) “ UK marketing authorisation” and “medicinal product” have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);\n(c) “specified”, in relation to a medicinal product, means specified in its UK marketing authorisation.\n(5) References in section 2 to medical treatment include references to treatment carried out for the purposes of medical research (but nothing in section 2 is to be read as affecting the regulation of medical research).\n(6) Nothing in section 2 applies in relation to treatment which is carried out solely for cosmetic purposes.",
  "extent": null,
  "status": "prospective",
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in s. 3(2)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in s. 3(4)(a) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Word in s. 3(4)(b) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Word in s. 3(4)(c) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 8 para. 2; 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukpga/2016/9/section/3",
    "retrieved_at": "2026-10-29T09:06:24.649095+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}