Access To Medical Treatments (Innovation) Bill — House of Commons, 2016-01-29
Topic: Health
John Simon Bercow (Conservative, Centre-right): With this it will be convenient to discuss the following: New clause 2—Identifying evidence on off-patent repurposed drugs and passing to relevant bodies— (1) The Secretary of State shall require the National Institute for Health Research to develop and introduce a mechanism for— (a) gathering and recording existing evidence on off-patent, repurposed drugs, including clinical trial evidence, and (b) passing this information to relevant bodies (2) The Secretary of State shall determine the relevant bodies under subsection (1) and may revise that determination from time to time New clause 3—Appraisal in new indications— (1) Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall direct the National Institute for Health and Care Excellence (NICE) to conduct an appraisal in relation to the drug in its new indication (2) An appraisal under subsection (2) should include a cost-effectiveness analysis New clause 4—National commissioning policy for off-patent new drugs— Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall require NHS England to produce and disseminate a national commissioning policy New clause 5—Accessibility of the licensing process— (1) The Secretary of State shall require the Medicines and Healthcare products Regulatory Agency to consult key stakeholders about steps to be taken to make the licensing process more accessible to organisations or individuals other than pharmaceutical companies (2) For the purposes of subsection (1), key stakeholders shall include, but not be limited to— (a) patient organisations, (b) medical research charities, (c) relevant academics, and (d) the British Generic Manufacturers Association New clause 6—British National Formulary: inclusion of off-patent drugs— The Secretary of State shall require NICE and the British National Formulary (BNF) to review their processes for registering off-label uses of repurposed drugs where there is strong evidence of their effectiveness Amendment 10, in clause 1, page 1, line 3, after "treatments" insert "(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)" Amendment 13, in clause 5, page 3, line 44, at end insert— "(1A) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)— (a) the off-label use of an authorised medicinal product, and (b) the use of a medicinal product in respect of which no marketing authorisation is in force (1B) In subsection (1A)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product— (a) for a purpose other than one for which its use is specified, (b) in relation to a person who is not within a description of persons for whom its use is specified, or (c) in any other way in which its use is not specified (1C) In this section— (a) ‘authorised medicinal product’ means a medicinal product in respect of which a marketing authorisation is in force; (b) ‘marketing authorisation’ and ‘medicinal product’ have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916); (c) ‘specified’, in relation to a medicinal product, means specified in its marketing authorisation."