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1024698
registered interest false more like this
date remove filter
answering body
Department of Health and Social Care more like this
answering dept id 17 more like this
answering dept short name Health and Social Care more like this
answering dept sort name Health and Social Care more like this
hansard heading Orphan Drugs more like this
house id 1 more like this
legislature
25259
pref label House of Commons more like this
question text To ask the Secretary of State for Health and Social Care, whether he is taking steps to introduce a revised definition for ultra-orphan medicine. more like this
tabling member constituency Linlithgow and East Falkirk more like this
tabling member printed
Martyn Day more like this
uin 202090 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2018-12-20more like thismore than 2018-12-20
answer text <p>Currently, rare diseases are defined as conditions affecting no more than five in 10,000 people in the European Union. The new European Clinical Trial Regulation (Regulation (EU) No 536/2014) will introduce an ‘ultra-rare’ condition and states that clinical trials for the development of orphan medicinal products and those of medicines affecting no more than one person in 50,000 in the EU (ultra-rare diseases) should be fostered, and in such areas, a rapid yet in-depth assessment is of particular importance. The new clinical trials regulation is expected to be implemented in the EU in late 2020. The Government has confirmed that United Kingdom law will remain aligned with the parts of the new EU clinical trials Regulation that are within the UK’s control.</p> more like this
answering member constituency Thurrock more like this
answering member printed Jackie Doyle-Price more like this
question first answered
less than 2018-12-20T17:10:46.507Zmore like thismore than 2018-12-20T17:10:46.507Z
answering member
4065
label Biography information for Dame Jackie Doyle-Price more like this
tabling member
4488
label Biography information for Martyn Day remove filter
1024700
registered interest false more like this
date remove filter
answering body
Department of Health and Social Care more like this
answering dept id 17 more like this
answering dept short name Health and Social Care more like this
answering dept sort name Health and Social Care more like this
hansard heading Rare Diseases: Drugs more like this
house id 1 more like this
legislature
25259
pref label House of Commons more like this
question text To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure that the UK remains a world leader for the treatment of rare diseases after the UK leaves the EU. more like this
tabling member constituency Linlithgow and East Falkirk more like this
tabling member printed
Martyn Day more like this
uin 202091 more like this
answer
answer
is ministerial correction false more like this
date of answer less than 2018-12-20more like thismore than 2018-12-20
answer text <p>The Government is committed to the safe and effective regulation of medicines in the United Kingdom; ensuring patients and the public have fast access to new, innovative medicines, including medicines for rare diseases.</p><p> </p><p>The agreement of an implementation period will ensure that access to medicines continues, and patient safety is maintained, in both the UK and European Union markets. Beyond that, the Political Declaration sets out a plan for a free trade area for goods, underpinned by deep regulatory co-operation, as well as a joint commitment to explore close cooperation with the European Medicines Agency.</p><p> </p><p>The Government also continues to prepare for the unlikely outcome that we leave the EU without any deal in March 2019. The Department has been engaging with all pharmaceutical companies that supply the United Kingdom with pharmacy or prescription-only medicines from, or via, the EU/European Economic Area, on their contingency plans in the event of a no deal EU Exit.</p><p> </p><p>Whatever the exit scenario, we will work to ensure that the UK will remain a world leader for the treatment of rare diseases after the UK leaves the EU, that UK patients are able to access the best and most innovative medicines including medicines for rare diseases and that their safety is protected. The UK life sciences industry has much to offer in creating, developing, trialing and commercialising medicines that will benefit UK patients and strengthen the ability of the UK to compete internationally.</p>
answering member constituency Thurrock more like this
answering member printed Jackie Doyle-Price more like this
question first answered
less than 2018-12-20T17:07:43.307Zmore like thismore than 2018-12-20T17:07:43.307Z
answering member
4065
label Biography information for Dame Jackie Doyle-Price more like this
tabling member
4488
label Biography information for Martyn Day remove filter