Rare Cancers Act 2026
<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1"><num>1</num><heading>Review of law on marketing authorisations</heading><subsection eId="section-1-1"><num>(1)</num><intro><p>The Secretary of State must—</p></intro><level class="para1" eId="section-1-1-a"><num>(a)</num><content><p>carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer, and</p></content></level><level class="para1" eId="section-1-1-b"><num>(b)</num><content><p>prepare and publish a report setting out the conclusions of the review.</p></content></level></subsection><subsection eId="section-1-2"><num>(2)</num><content><p>In carrying out the review the Secretary of State must, in particular, consider regulatory approaches in other countries.</p></content></subsection><subsection eId="section-1-3"><num>(3)</num><content><p>The report must be published before the end of the period of three years beginning with the day on which this Act is passed.</p></content></subsection><subsection eId="section-1-4"><num>(4)</num><content><p>The Secretary of State must lay a copy of the report before Parliament.</p></content></subsection><subsection eId="section-1-5"><num>(5)</num><intro><p>In this section—</p></intro><hcontainer name="definition"><content><p>“<term refersTo="#term-human-medicines-regulations" eId="term-human-medicines-regulations">Human Medicines Regulations</term>” means the Human Medicines Regulations 2012 (<ref eId="c00001" href="http://www.legislation.gov.uk/id/uksi/2012/1916">S.I. 2012/1916</ref>);</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-marketing-authorisation" eId="term-marketing-authorisation">marketing authorisation</term>” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021;</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-medicinal-product" eId="term-medicinal-product">medicinal product</term>” has the meaning given by regulation 2 of the Human Medicines Regulations;</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-orphan-medicinal-product" eId="term-orphan-medicinal-product">orphan medicinal product</term>” means a medicinal product in relation to which the orphan criteria set out in regulation 50G(2) of the Human Medicines Regulations are met.</p></content></hcontainer></subsection></section>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-1"><num>(1)</num><intro><p>The Secretary of State must—</p></intro><level class="para1" eId="section-1-1-a"><num>(a)</num><content><p>carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer, and</p></content></level><level class="para1" eId="section-1-1-b"><num>(b)</num><content><p>prepare and publish a report setting out the conclusions of the review.</p></content></level></subsection>
<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-1-1-a"><num>(a)</num><content><p>carry out a review of the law relating to marketing authorisations for orphan medicinal products that are for the diagnosis, prevention or treatment of cancer, and</p></content></level>
<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-1-1-b"><num>(b)</num><content><p>prepare and publish a report setting out the conclusions of the review.</p></content></level>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-2"><num>(2)</num><content><p>In carrying out the review the Secretary of State must, in particular, consider regulatory approaches in other countries.</p></content></subsection>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-3"><num>(3)</num><content><p>The report must be published before the end of the period of three years beginning with the day on which this Act is passed.</p></content></subsection>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-4"><num>(4)</num><content><p>The Secretary of State must lay a copy of the report before Parliament.</p></content></subsection>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-1-5"><num>(5)</num><intro><p>In this section—</p></intro><hcontainer name="definition"><content><p>“<term refersTo="#term-human-medicines-regulations" eId="term-human-medicines-regulations">Human Medicines Regulations</term>” means the Human Medicines Regulations 2012 (<ref eId="c00001" href="http://www.legislation.gov.uk/id/uksi/2012/1916">S.I. 2012/1916</ref>);</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-marketing-authorisation" eId="term-marketing-authorisation">marketing authorisation</term>” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021;</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-medicinal-product" eId="term-medicinal-product">medicinal product</term>” has the meaning given by regulation 2 of the Human Medicines Regulations;</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-orphan-medicinal-product" eId="term-orphan-medicinal-product">orphan medicinal product</term>” means a medicinal product in relation to which the orphan criteria set out in regulation 50G(2) of the Human Medicines Regulations are met.</p></content></hcontainer></subsection>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-human-medicines-regulations" eId="term-human-medicines-regulations">Human Medicines Regulations</term>” means the Human Medicines Regulations 2012 (<ref eId="c00001" href="http://www.legislation.gov.uk/id/uksi/2012/1916">S.I. 2012/1916</ref>);</p></content></hcontainer>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-human-medicines-regulations" eId="term-human-medicines-regulations">Human Medicines Regulations</term>” means the Human Medicines Regulations 2012 (<ref eId="c00001" href="http://www.legislation.gov.uk/id/uksi/2012/1916">S.I. 2012/1916</ref>);</p></content></hcontainer>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-marketing-authorisation" eId="term-marketing-authorisation">marketing authorisation</term>” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021;</p></content></hcontainer>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-marketing-authorisation" eId="term-marketing-authorisation">marketing authorisation</term>” has the meaning given by section 9 of the Medicines and Medical Devices Act 2021;</p></content></hcontainer>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-medicinal-product" eId="term-medicinal-product">medicinal product</term>” has the meaning given by regulation 2 of the Human Medicines Regulations;</p></content></hcontainer>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-medicinal-product" eId="term-medicinal-product">medicinal product</term>” has the meaning given by regulation 2 of the Human Medicines Regulations;</p></content></hcontainer>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-orphan-medicinal-product" eId="term-orphan-medicinal-product">orphan medicinal product</term>” means a medicinal product in relation to which the orphan criteria set out in regulation 50G(2) of the Human Medicines Regulations are met.</p></content></hcontainer>
<hcontainer xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" name="definition"><content><p>“<term refersTo="#term-orphan-medicinal-product" eId="term-orphan-medicinal-product">orphan medicinal product</term>” means a medicinal product in relation to which the orphan criteria set out in regulation 50G(2) of the Human Medicines Regulations are met.</p></content></hcontainer>
<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-2"><num>2</num><heading>Secretary of State’s duties as to research</heading><intro><p>In <ref eId="c00002" href="https://www.legislation.gov.uk/ukpga/2006/41/section/1E">section 1E</ref> of the <ref eId="c00003" href="https://www.legislation.gov.uk/ukpga/2006/41/contents">National Health Service Act 2006</ref> (Secretary of State’s duty to facilitate research etc)—</p></intro><level class="para1" eId="section-2-a"><num>(a)</num><content><p>the existing text becomes subsection (1);</p></content></level><level class="para1" eId="section-2-b"><num>(b)</num><content><p><mod>after that subsection insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><subsection><num>(2)</num><content><p>The research that the Secretary must facilitate or otherwise promote under subsection (1)(a) includes research into cancers that in the opinion of the Secretary of State are rare cancers.</p></content></subsection><subsection><num>(3)</num><intro><p>In discharging the duty under subsection (1)(a) in relation to those cancers, the Secretary of State must, in particular, ensure that there are such arrangements in place as the Secretary of State considers appropriate to—</p></intro><level class="para1"><num>(a)</num><content><p>enable potential participants in clinical trials to be identified and contacted, and</p></content></level><level class="para1"><num>(b)</num><intro><p>ensure that a person (to be known as “<term refersTo="#term-the-national-specialty-lead-for-rare-cancers">the National Specialty Lead for Rare Cancers</term>”) is appointed with a job description that includes promoting and facilitating research into rare cancers by—</p></intro><level class="para2"><num>(i)</num><content><p>providing advice in relation to the design and planning of research, and</p></content></level><level class="para2"><num>(ii)</num><content><p>facilitating collaboration between interested persons.</p></content></level></level></subsection><subsection><num>(4)</num><content><p>In this section “<term refersTo="#term-rare-cancer">rare cancer</term>” means a cancer that affects not more than 1 in 2000 people in the United Kingdom.</p></content></subsection></quotedStructure></mod></p></content></level></section>
<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" class="para1" eId="section-2-a"><num>(a)</num><content><p>the existing text becomes subsection (1);</p></content></level>
<level xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" class="para1" eId="section-2-b"><num>(b)</num><content><p><mod>after that subsection insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><subsection><num>(2)</num><content><p>The research that the Secretary must facilitate or otherwise promote under subsection (1)(a) includes research into cancers that in the opinion of the Secretary of State are rare cancers.</p></content></subsection><subsection><num>(3)</num><intro><p>In discharging the duty under subsection (1)(a) in relation to those cancers, the Secretary of State must, in particular, ensure that there are such arrangements in place as the Secretary of State considers appropriate to—</p></intro><level class="para1"><num>(a)</num><content><p>enable potential participants in clinical trials to be identified and contacted, and</p></content></level><level class="para1"><num>(b)</num><intro><p>ensure that a person (to be known as “<term refersTo="#term-the-national-specialty-lead-for-rare-cancers">the National Specialty Lead for Rare Cancers</term>”) is appointed with a job description that includes promoting and facilitating research into rare cancers by—</p></intro><level class="para2"><num>(i)</num><content><p>providing advice in relation to the design and planning of research, and</p></content></level><level class="para2"><num>(ii)</num><content><p>facilitating collaboration between interested persons.</p></content></level></level></subsection><subsection><num>(4)</num><content><p>In this section “<term refersTo="#term-rare-cancer">rare cancer</term>” means a cancer that affects not more than 1 in 2000 people in the United Kingdom.</p></content></subsection></quotedStructure></mod></p></content></level>
<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-3"><num>3</num><heading>Disclosure of information for research purposes</heading><subsection eId="section-3-1"><num>(1)</num><content><p><ref eId="c00004" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">Section 261</ref> of the <ref eId="c00005" href="https://www.legislation.gov.uk/ukpga/2012/7/contents">Health and Social Care Act 2012</ref> (power of NHS England to disclose information obtained in connection with information systems) is amended as follows.</p></content></subsection><subsection eId="section-3-2"><num>(2)</num><content><p><mod>In <ref eId="c00006" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">subsection (5)</ref>, after <ref eId="c00007" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">paragraph (d)</ref> insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><level class="para1" eId="d25e270"><num>(da)</num><content><p>the disclosure is made for the purpose of facilitating the carrying out of relevant clinical trials (whether or not in the United Kingdom) by enabling potential participants in those trials to be identified and contacted,</p></content></level></quotedStructure><inline name="appendText">.</inline></mod></p></content></subsection><subsection eId="section-3-3"><num>(3)</num><content><p><mod>After <ref eId="c00008" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">subsection (5)</ref> insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><subsection><num>(5A)</num><intro><p>In subsection (5)<ref href="#d25e270">(da)</ref> “<term refersTo="#term-relevant-clinical-trials">relevant clinical trials</term>” means clinical trials in connection with the research and development of orphan medicinal products for the diagnosis, prevention or treatment of cancers that in the opinion of NHS England are rare cancers; and for this purpose—</p></intro><hcontainer name="definition"><content><p>“<term refersTo="#term-orphan-medicinal-product">orphan medicinal product</term>” means a medicinal product in relation to which the orphan criteria set out in <ref eId="c00009" href="https://www.legislation.gov.uk/uksi/2012/1916/regulation/50G">regulation 50G</ref><ref eId="c00010" href="https://www.legislation.gov.uk/uksi/2012/1916/regulation/50G">(2)</ref> of the <ref eId="c00011" href="https://www.legislation.gov.uk/uksi/2012/1916/contents">Human Medicines Regulations 2012</ref> (<ref eId="c00012" href="http://www.legislation.gov.uk/id/uksi/2012/1916">S.I. 2012/1916</ref>) are met;</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-rare-cancer">rare cancer</term>” means a cancer that affects not more than 1 in 2000 people in the United Kingdom.</p></content></hcontainer></subsection></quotedStructure></mod></p></content></subsection><subsection eId="section-3-4"><num>(4)</num><content><p><mod>After <ref eId="c00013" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">subsection (6)</ref> insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><subsection eId="d25e336"><num>(6A)</num><content><p>A power conferred by this section to process information does not authorise the processing of information which would contravene the data protection legislation (but the power is to be taken into account in determining whether the processing would contravene that legislation).</p></content></subsection><subsection><num>(6B)</num><content><p>In subsection <ref href="#d25e336">(6A)</ref> “<term refersTo="#term-the-data-protection-legislation">the data protection legislation</term>” and “<term refersTo="#term-processing">processing</term>” have the same meanings as in the <ref eId="c00014" href="https://www.legislation.gov.uk/ukpga/2018/12/contents">Data Protection Act 2018</ref> (see section 3 of that Act).</p></content></subsection></quotedStructure></mod></p></content></subsection></section>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-3-1"><num>(1)</num><content><p><ref eId="c00004" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">Section 261</ref> of the <ref eId="c00005" href="https://www.legislation.gov.uk/ukpga/2012/7/contents">Health and Social Care Act 2012</ref> (power of NHS England to disclose information obtained in connection with information systems) is amended as follows.</p></content></subsection>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-3-2"><num>(2)</num><content><p><mod>In <ref eId="c00006" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">subsection (5)</ref>, after <ref eId="c00007" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">paragraph (d)</ref> insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><level class="para1" eId="d25e270"><num>(da)</num><content><p>the disclosure is made for the purpose of facilitating the carrying out of relevant clinical trials (whether or not in the United Kingdom) by enabling potential participants in those trials to be identified and contacted,</p></content></level></quotedStructure><inline name="appendText">.</inline></mod></p></content></subsection>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-3-3"><num>(3)</num><content><p><mod>After <ref eId="c00008" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">subsection (5)</ref> insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><subsection><num>(5A)</num><intro><p>In subsection (5)<ref href="#d25e270">(da)</ref> “<term refersTo="#term-relevant-clinical-trials">relevant clinical trials</term>” means clinical trials in connection with the research and development of orphan medicinal products for the diagnosis, prevention or treatment of cancers that in the opinion of NHS England are rare cancers; and for this purpose—</p></intro><hcontainer name="definition"><content><p>“<term refersTo="#term-orphan-medicinal-product">orphan medicinal product</term>” means a medicinal product in relation to which the orphan criteria set out in <ref eId="c00009" href="https://www.legislation.gov.uk/uksi/2012/1916/regulation/50G">regulation 50G</ref><ref eId="c00010" href="https://www.legislation.gov.uk/uksi/2012/1916/regulation/50G">(2)</ref> of the <ref eId="c00011" href="https://www.legislation.gov.uk/uksi/2012/1916/contents">Human Medicines Regulations 2012</ref> (<ref eId="c00012" href="http://www.legislation.gov.uk/id/uksi/2012/1916">S.I. 2012/1916</ref>) are met;</p></content></hcontainer><hcontainer name="definition"><content><p>“<term refersTo="#term-rare-cancer">rare cancer</term>” means a cancer that affects not more than 1 in 2000 people in the United Kingdom.</p></content></hcontainer></subsection></quotedStructure></mod></p></content></subsection>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" xmlns:uk="https://www.legislation.gov.uk/namespaces/UK-AKN" xmlns:ukl="http://www.legislation.gov.uk/namespaces/legislation" eId="section-3-4"><num>(4)</num><content><p><mod>After <ref eId="c00013" href="https://www.legislation.gov.uk/ukpga/2012/7/section/261">subsection (6)</ref> insert—<quotedStructure startQuote="“" endQuote="”" uk:context="body" uk:docName="ukpga" ukl:TargetClass="primary" ukl:TargetSubClass="unknown" ukl:Context="main" ukl:Format="double"><subsection eId="d25e336"><num>(6A)</num><content><p>A power conferred by this section to process information does not authorise the processing of information which would contravene the data protection legislation (but the power is to be taken into account in determining whether the processing would contravene that legislation).</p></content></subsection><subsection><num>(6B)</num><content><p>In subsection <ref href="#d25e336">(6A)</ref> “<term refersTo="#term-the-data-protection-legislation">the data protection legislation</term>” and “<term refersTo="#term-processing">processing</term>” have the same meanings as in the <ref eId="c00014" href="https://www.legislation.gov.uk/ukpga/2018/12/contents">Data Protection Act 2018</ref> (see section 3 of that Act).</p></content></subsection></quotedStructure></mod></p></content></subsection>
<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-4"><num>4</num><heading>Extent</heading><subsection eId="section-4-1"><num>(1)</num><content><p><ref href="#section-2">Sections 2</ref> and <ref href="#section-3">3</ref> extend to England and Wales only.</p></content></subsection><subsection eId="section-4-2"><num>(2)</num><content><p>The remainder of this Act extends to England and Wales, Scotland and Northern Ireland.</p></content></subsection></section>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-4-1"><num>(1)</num><content><p><ref href="#section-2">Sections 2</ref> and <ref href="#section-3">3</ref> extend to England and Wales only.</p></content></subsection>
<subsection xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-4-2"><num>(2)</num><content><p>The remainder of this Act extends to England and Wales, Scotland and Northern Ireland.</p></content></subsection>
<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-5"><num>5</num><heading>Commencement</heading><content><p>This Act comes into force at the end of the period of two months beginning with the day on which it is passed.</p></content></section>
<section xmlns="http://docs.oasis-open.org/legaldocml/ns/akn/3.0" eId="section-6"><num>6</num><heading>Short title</heading><content><p>This Act may be cited as the Rare Cancers Act 2026.</p></content></section>