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1024698
unstar this property registered interest false more like this
star this property date less than 2018-12-13more like thisremove minimum value filter
star this property answering body
Department of Health and Social Care more like this
star this property answering dept id 17 more like this
unstar this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
unstar this property hansard heading Orphan 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 and Social Care, whether he is taking steps to introduce a revised definition for ultra-orphan medicine. more like this
star this property tabling member constituency Linlithgow and East Falkirk more like this
star this property tabling member printed
Martyn Day remove filter
star this property uin 202090 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 2018-12-20more like thismore than 2018-12-20
star this property 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
star this property answering member constituency Thurrock more like this
star this property answering member printed Jackie Doyle-Price more like this
star this property question first answered
less than 2018-12-20T17:10:46.507Zmore like thismore than 2018-12-20T17:10:46.507Z
star this property answering member
4065
star this property label Biography information for Dame Jackie Doyle-Price remove filter
star this property tabling member
4488
unstar this property label Biography information for Martyn Day more like this
1024700
unstar this property registered interest false more like this
star this property date less than 2018-12-13more like thisremove minimum value filter
star this property answering body
Department of Health and Social Care more like this
star this property answering dept id 17 more like this
unstar this property answering dept short name Health and Social Care more like this
star this property answering dept sort name Health and Social Care more like this
unstar this property hansard heading Rare Diseases: 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 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
star this property tabling member constituency Linlithgow and East Falkirk more like this
star this property tabling member printed
Martyn Day remove filter
star this property uin 202091 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 2018-12-20more like thismore than 2018-12-20
star this property 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>
star this property answering member constituency Thurrock more like this
star this property answering member printed Jackie Doyle-Price more like this
star this property question first answered
less than 2018-12-20T17:07:43.307Zmore like thismore than 2018-12-20T17:07:43.307Z
star this property answering member
4065
star this property label Biography information for Dame Jackie Doyle-Price remove filter
star this property tabling member
4488
unstar this property label Biography information for Martyn Day more like this