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1010186

registered interest
date	19/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	National Institute for Health and Care Excellence: Fees and Charges
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to his Department’s consultation entitled NICE recommendations: charging and appeal panels which closed on 14 September 2018, what assessment his Department has made of the potential effect on the sustainability of the smallest businesses of (a) charging for NICE appraisals and (b) charging for NICE appraisals at a discounted rate.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	192827
answer	answer is ministerial correction date of answer 22/11/2018 answer text <p>The Government recently consulted on draft amendments to regulations that would enable the National Institute for Health and Care Excellence (NICE) to charge companies for the cost of developing technology appraisal and highly specialised technology evaluation recommendations relating to their products and to allow NICE to recruit appeal panel members representing the National Health Service from the devolved administrations.</p><p> </p><p>The consultation included a draft Impact Assessment and sought views on allowing NICE to charge small companies less and permit small companies to pay in instalments. The charging model in the consultation document proposed a 25% discount for small companies. The Government is currently analysing the responses and will publish its response in due course.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 192828 question first answered 22/11/2018 15:08:39 answering member 4067 label Biography information for Steve Brine
tabling member	4061 label Biography information for Bill Esterson

1010187

registered interest
date	19/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	National Institute for Health and Care Excellence: Fees and Charges
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to his Department’s consultation entitled NICE recommendations: charging and appeal panels which closed on 14 September 2018, what discussions his Department has had with NICE on exempting the smallest companies from the proposed appraisal charges.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	192828
answer	answer is ministerial correction date of answer 22/11/2018 answer text <p>The Government recently consulted on draft amendments to regulations that would enable the National Institute for Health and Care Excellence (NICE) to charge companies for the cost of developing technology appraisal and highly specialised technology evaluation recommendations relating to their products and to allow NICE to recruit appeal panel members representing the National Health Service from the devolved administrations.</p><p> </p><p>The consultation included a draft Impact Assessment and sought views on allowing NICE to charge small companies less and permit small companies to pay in instalments. The charging model in the consultation document proposed a 25% discount for small companies. The Government is currently analysing the responses and will publish its response in due course.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 192827 question first answered 22/11/2018 15:08:39 answering member 4067 label Biography information for Steve Brine
tabling member	4061 label Biography information for Bill Esterson

1010188

registered interest
date	19/11/2018
answering body	Department of Health and Social Care
answering dept id	17
answering dept short name	Health and Social Care
answering dept sort name	Health and Social Care
hansard heading	SecurMed: Fees and Charges
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, with reference to the European Medicines Verification Organisation’s report, NMVO’s Fee Models Status, published on 21 August 2018, what discussions his Department has had with the UK's National Medicines Verification Organisation on reducing the entrance fees for small companies in line with those of other European countries.
tabling member constituency	Sefton Central
tabling member printed	Bill Esterson
uin	192829
answer	answer is ministerial correction date of answer 22/11/2018 answer text <p>SecurMed, the not-for-profit company set up by stakeholders in the United Kingdom medicines supply chain, is responsible for setting the fee model and level of fees as the UK’s National Medicines Verification Organisation (NMVO). In their supervisory capacity, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department’s aim is to ensure that SecurMed is complying with the regulation in a fair and proportionate way. As part of that role, the MHRA and the Department have been involved in discussions with SecurMed to challenge and seek to influence the pricing model to ensure that the UK’s fee structure is fair and proportionate.</p><p> </p><p>The European Commission has confirmed that the fee model being used by SecurMed is in line with the majority of other member states NMVO’s across the European Union. It is based on the number of users and cost per connection where larger organisations, which are more likely to have multiple marketing authorisations, pay more. An annual fee waiver scheme exists for micro Marketing Authorisation Holders which is designed to support start-ups and help ensure there is not a barrier to market entry.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 22/11/2018 17:48:40 answering member 4065 label Biography information for Dame Jackie Doyle-Price
tabling member	4061 label Biography information for Bill Esterson