Most new medicines for rare conditions are licensed by the European Commission.<\/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>
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\u2019s 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\u2019s 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>
<\/strong><\/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> 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> <\/strong><\/p> <\/p> <\/strong><\/p> <\/p>"}
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], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
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], "answer" : {"_about" : "http://data.parliament.uk/resources/155953/answer", "answerText" : {"_value" : " We have no plans to set such targets or goals.<\/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 \u2018off-label\u2019 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> 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>"}
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], "questionText" : "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.", "registeredInterest" : {"_value" : "false", "_datatype" : "boolean"}
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, {"_about" : "http://data.parliament.uk/resources/105961", "AnsweringBody" : [{"_value" : "Department of Health"}
], "answer" : {"_about" : "http://data.parliament.uk/resources/105961/answer", "answerText" : {"_value" : " A randomised controlled trial funded by Cancer Research UK, the Medical Research Council and National Health Service Research and Development took place in 14 United Kingdom and six Italian centres, and evaluated screening for bowel cancer using a single Bowel Scope Screening (flexible sigmoidoscopy) between 55 and 64 years of age, removing small polyps by Bowel Scope Screening and providing full colonoscopy for "high risk" polyps. The study concluded that Bowel Scope Screening is a safe and practical test and, when offered only once between ages 55 and 64 years, confers a substantial and long lasting benefit. The UK National Screening Committee reviewed the evidence, and in April 2011 concluded that screening for bowel cancer using Bowel Scope Screening meets the United Kingdom National Screening Committee criteria for a screening test. In England its implementation will be managed by National Health Service Cancer Screening Programmes.<\/p> <\/p> <\/p> <\/p>