Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the potential impact of his Department's proposed reforms to the Medicines and Healthcare Products Regulatory Agency on the incentives for international pharmaceutical companies to approach the UK for regulatory approval of their products in the first instance.
Answered by Will Quince
There are no proposed reforms to the Medicines and Healthcare products Regulatory Agency (MHRA), therefore no assessment can be made on that basis. However, as set out in the Life Sciences Vision the MHRA is recognised as a global leader and plays a fundamental role in shaping global standards. As an independent sovereign regulator MHRA is able to act with agility to allow safe and timely market access for vaccines, medicines, and technologies to safeguard the health of the United Kingdom population.
Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what his Department's planned timescale is for making the (a) Certifications, (b) Continuous Benefit Risk Assessment integrating Real World Evidence, (c) Enhanced Patient Engagement and (d) Novel Methodology and Innovative Clinical Trial Design tools available for Innovation Passport holders.
Answered by Will Quince
The Innovative Licensing and Access Pathway (ILAP) was launched in January 2021, and has seen strong interest from both small and large companies in a variety of therapeutic settings. Companies who successfully gain an Innovation Passport designation are able to apply for the next step which is the Target Development Profile (TDP).
The TDP interaction provides an opportunity for platform discussions with the ILAP partners on the Company’s development programme and the resulting roadmap may make reference and or recommendation for use of one or more of the tools of the ILAP toolkit. Time scales for the delivery of these tools is subject to agreement with the ILAP partners, the stage of development of the product and availability of partner resources.
Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent steps his Department has taken to improve outcomes for bowel cancer patients.
Answered by Helen Whately - Minister of State (Department of Health and Social Care)
NHS England have been working with Cancer Alliances to facilitate the prioritisation and implementation of treatment-focussed recommendations from clinical audits and Getting It Right First Time reports that will make the biggest impact in terms of improving survival outcomes and reducing inequalities. This work was piloted in 2022/23 in lung cancer, and in 2023/24 this work is now expanding to cover three new tumour sites where there is an existing clinical audit: prostate, breast, and bowel.
Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent discussions he has had with (a) the BioIndustry Association and (b) other biotech industry representatives on the Government's proposed reforms to the Medicines and Healthcare products Regulatory Agency.
Answered by Will Quince
The Government has no proposed or planned reforms of the Medicines and Healthcare products Regulatory Agency.
Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential impact of the proposed reforms of the Medicines and Healthcare products Regulatory Agency on the retention of (a) staff and (b) skills at the agency.
Answered by Will Quince
The Government has no proposed or planned reforms of the Medicines and Healthcare products Regulatory Agency.
Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the potential impact of the UK’s withdrawal from the European Medicines Agency on the Medicines and Healthcare Products Regulatory Agency.
Answered by Will Quince
Since leaving the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) has become an independent sovereign regulator. As set out in the Life Sciences Vision, MHRA is recognised as a global leader, playing a fundamental role in shaping global standards, acting with agility to allow safe and timely market access for vaccines, medicines, and technologies. MHRA received transitional funding from the Government from 2018 to 2020 and is primarily funded through fees, and also receives grant in aid funding from the Government. The Department receives regular updates on the performance and capacity of the MHRA through established mechanisms including quarterly and annual accountability reviews.
Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps his Department is taking to replace the loss of European Union (a) resources and (b) staff at the Medicines and Healthcare Products Regulatory Agency.
Answered by Will Quince
Since leaving the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) has become an independent sovereign regulator. As set out in the Life Sciences Vision, MHRA is recognised as a global leader, playing a fundamental role in shaping global standards, acting with agility to allow safe and timely market access for vaccines, medicines, and technologies. MHRA received transitional funding from the Government from 2018 to 2020 and is primarily funded through fees, and also receives grant in aid funding from the Government. The Department receives regular updates on the performance and capacity of the MHRA through established mechanisms including quarterly and annual accountability reviews.
Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what discussions he has had with the Office of National Statistics on the funding of the Covid-19 Infection Survey beyond March 2023.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Discussions are ongoing on the future funding of the COVID-19 Infection Survey beyond March 2023, we are considering all options.