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155948
star this property registered interest false more like this
star this property date less than 2014-11-17more like thismore than 2014-11-17
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Prescription Drugs more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health, what steps his Department is taking to encourage flexibility in the licensing process for potential new treatments for rare conditions. more like this
star this property tabling member constituency Crawley more like this
star this property tabling member printed
Henry Smith remove filter
star this property uin 214491 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2014-11-24more like thismore than 2014-11-24
star this property answer text <p>Most new medicines for rare conditions are licensed by the European Commission.</p><p> </p><p>The European Union offers a range of incentives to encourage the development of these medicines in order to address unmet clinical need. These incentives include a period of 10 years market exclusivity, the provision of Protocol Assistance (scientific advice specifically tailored for orphan medicinal products) and fee reductions and waivers for regulatory procedures.</p><p> </p><p> </p><p> </p><p>Through the Medicines and Healthcare products Regulatory Agency (MHRA), the United Kingdom takes an active role in the decision making process at the European Medicines Agency’s Committee on Orphan Medicinal Products, ensuring applications for Orphan Drug designation of potential drug candidates for rare diseases are appropriately recognised, encouraging companies to develop their products further and recommending use of existing flexibilities such as conditional authorisation, authorisation under exceptional circumstances and accelerated assessment. The UK is actively involved in the European Medicines Agency’s adaptive licensing pilot that is exploring further use of these flexibilities. The MHRA has an Innovation Office that can offer advice and assistance to developers of drugs for rare diseases, including on the use of flexibilities.</p><p> </p><p><strong> </strong></p><p> </p><p>In addition, in the UK, the Early Access to Medicines Scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.</p><p> </p><p> </p><p> </p><p>We are also commissioning an external review of the pathways for the development, assessment, and adoption of innovative medicines and medical technology. This review will consider how to speed up access for NHS patients to cost-effective new diagnostics, medicines and devices.</p><p> </p><p><strong> </strong></p><p> </p><p><strong> </strong></p><p> </p>
star this property answering member constituency Mid Norfolk remove filter
star this property answering member printed George Freeman more like this
star this property question first answered
less than 2014-11-24T17:23:13.99Zmore like thismore than 2014-11-24T17:23:13.99Z
star this property answering member
4020
star this property label Biography information for George Freeman more like this
star this property tabling member
3960
unstar this property label Biography information for Henry Smith more like this
155953
star this property registered interest false more like this
star this property date less than 2014-11-17more like thismore than 2014-11-17
star this property answering body
Department of Health more like this
star this property answering dept id 17 more like this
star this property answering dept short name Health more like this
star this property answering dept sort name Health more like this
star this property hansard heading Drugs: Licensing more like this
star this property house id 1 more like this
star this property legislature
25259
star this property pref label House of Commons more like this
star this property question text To ask the Secretary of State for Health, if he will set targets and goals for speeding up the use of off-patent drugs outside their licensed indications, where evidence supports that use. more like this
star this property tabling member constituency Crawley more like this
star this property tabling member printed
Henry Smith remove filter
star this property uin 214424 more like this
star this property answer
answer
star this property is ministerial correction false more like this
star this property date of answer less than 2014-11-24more like thismore than 2014-11-24
star this property answer text <p>We have no plans to set such targets or goals.</p><p> </p><p> </p><p> </p><p>Off-patent drugs are those whose patent period has expired and they are widely used in the National Health Service now. Drugs can also be prescribed ‘off-label’ outside of their licensed indication(s) to individual patients where doctors consider it is clinically appropriate to do so. Prescribing decisions are rightly a matter for clinicians in discussion with their patients.</p><p> </p><p> </p><p> </p><p>We are in the process of setting up a round-table discussion with key stakeholders, including NHS England and the National Institute for Health and Care Excellence to explore opportunities for supporting appropriate use of off-label drugs outside their licensed indications where the evidence supports this.</p><p> </p> more like this
star this property answering member constituency Mid Norfolk remove filter
star this property answering member printed George Freeman more like this
star this property question first answered
less than 2014-11-24T17:35:43.843Zmore like thismore than 2014-11-24T17:35:43.843Z
star this property answering member
4020
star this property label Biography information for George Freeman more like this
star this property tabling member
3960
unstar this property label Biography information for Henry Smith more like this