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Consultations

Please note that this table shows consultations from 1st January 2018. Please refer to our consultations archive for consultations before this date.

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Consultation titleDateClosing dateOpen?CountryOrganisationPriorityKey commentsLinks
The scope of qualifying expenditures for R&D Tax Credits2020-07-212020-10-13YUKHM Treasury

O

R&D tax credits are a core part of the government’s support for innovation. The tax credits support innovative businesses as they invest, driving growth and productivity across the UK.
Spring Budget 2020 announced that the government would consult on what costs companies can include in R&D tax credit claims, and whether these need to be updated to ensure the credits remain well-targeted and reflect modern R&D processes.
The government is interested in hearing from stakeholders as it considers whether to include R&D costs for data and for “cloud computing”.
Consultation
Distributing vaccines and treatments for COVID-19 and flu2020-08-282020-09-18YUKDHSC

O

We want your views on proposed changes to the Human Medicine Regulations to help with the safe and efficient distribution of a COVID-19 vaccine and expanded flu vaccine programme in the UK, along with treatments for COVID-19 and any other diseases that become pandemic.Consultation
Digital Transformation in the NHS Inquiry2020-07-282020-09-09YUKPublic Accounts Committee

O

Substantial investment is planned (£8 billion over five years) but costing exercises and assumptions are flawed and the plans are probably not deliverable for the money allocated. Current governance arrangements are confused, and a new digital unit NHSX set up in 2019 to lead transformation has not yet developed its plans and way of working.

The NAO concludes that there are major technical challenges to overcome around sharing data, and the NHS’s planned actions might make the problem worse. This all points to significant risks to achieving value for money.

The Committee will question officials from the Department for Health and Social Care and NHS England & Improvement, on how the NHS is renewing its efforts to transform patient services by making use of modern technology and systems.
Inquiry
Legislative Consent Memorandum for the Medicines and Medical Devices Bill2020-07-082020-09-04NWalesWelsh Parliament

O

Legislative Consent Memorandum for the Medicines and Medical Devices Bill

On 8 July 2020, Vaughan Gething, MS, Minister for Health and Social Services laid a Legislative Consent Memorandum for the Medicines and Medical Devices Bill currently before the UK Parliament.

A Legislative Consent Memorandum (LCM) is required when the consent of the Welsh Parliament is sought by the UK Government to legislate on an issue which could normally fall within the competence of the Senedd. The provisions within the legislative competence of the Senedd are contained in Clause 16 of the Bill and confer a delegated power on the Secretary of State for Health and Social Care to make regulations for a database of information in relation to medical devices to be established and managed by NHS Digital, which previously had no remit in relation to Wales.
Consultation
2025 UK Border Strategy Public Consultation2020-07-232020-08-28NUKUK Government

Y

This consultation seeks the views and expertise of stakeholders to help develop the 2025 UK Border Strategy and ensure that the government and industry are able to work in partnership together to deliver a world class border.

This consultation closes at 11:55pm on 28 August 2020.

The government’s ambition is to create the world’s most effective border by 2025, to ensure the UK becomes an even more attractive place to travel to and do business with. It will ensure the UK is better protected against crime, terrorism and environmental and biosecurity threats.
Consultation
Delivering Value Through Disinvestment2020-08-102020-08-28NWalesAWMSG

Y

We would welcome your comments on the draft paper entitled “Delivering Value Through Disinvestment: An exploration and analysis of appropriate disinvestment in medicine considered Low Value for Funding by NHS Wales”. This paper has been jointly written by the Swansea Centre for Health Economics at Swansea University, and the Centre for Health Economics and Medicines Evaluation at Bangor University. The aim of the paper is to formalise how items are considered for inclusion in the Low Value for Prescribing Initiative going forward, and it will form the basis of discussion at a forthcoming All Wales Medicines Strategy Group meeting.Consultation
Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials2020-03-252020-04-25NEuropeEMA

Y

We would like to inform you that the European Medicines Agency (EMA) has published a draft guidance with regards to the points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (https://www.ema.europa.eu/en/implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical-trials).

This guidance covers actions that sponsors of ongoing clinical trials impacted by the COVID-19 pandemic should take to help ensure the integrity of their studies and interpretation of the study results while safeguarding the safety of trial participants as a first priority.
Consultation
Have your say on the Medicines and Medical Devices Bill2020-03-042020-04-23NUKPublic Bill Committee

G

Do you have relevant expertise and experience or a special interest in the Medicines and Medical Devices Bill, which is currently passing through Parliament?

If so, you can submit your views in writing to the House of Commons Public Bill Committee which is going to consider this Bill.

The Public Bill Committee is now able to receive written evidence. The sooner you send in your submission, the more time the Committee will have to take it into consideration.

The Committee will meet for the first time on Tuesday 17 March 2020. It will stop receiving written evidence at the end of the Committee stage, which is expected to be not later than 5.00pm on Thursday 23 April 2020. However, please note that when the Committee concludes its consideration of the Bill it is no longer able to receive written evidence and it can conclude earlier than the expected deadline of 5.00pm on Thursday 23 April 2020. You are strongly advised to submit your written evidence as soon as possible.
Consultation
Consultation for use of AI in medical devices2019-11-202020-01-15NFranceHAS

Y

As more and more medical devices are assessed in France, and their technology advances, use of artificial intelligence (AI) is becoming prevalent, along with questions on how to reimburse such products.

The Haute Autorité de Santé (Health Authority – HAS) has announced its intention to establish evaluation criteria for products using connective and AI technology.
Consultation
MedTech Funding Mandate2019-11-052019-12-18NUK - EnglandNHS England

G

The MedTech Funding Mandate is a proposal to support getting innovative medical devices, diagnostics and digital products to patients faster.

If we implement this policy, NHS England and NHS Improvement will review NICE guidance on medical technologies each year to identify medical devices, diagnostics and digital products that have been thoroughly assessed and recommended by NICE as being effective and capable of saving money within the first year. We will highlight these in annual guidance and we will expect hospitals and commissioning organisations to comply with this guidance where appropriate. We will also provide additional support by providing examples of how NHS organisations have implemented the innovations and by removing other barriers to their uptake such as duplicative procurement processes.
Consultation
NICE Evidence Standards Framework for Digital Health Technologies (DHTs) – Phase 22019-10-012019-10-15NUK - EnglandNICE

O

A survey has been launched to help NICE discover stakeholders’ priority areas for a second phase of work on the evidence standards framework for digital health technologies.Consultation
EUnetHTA consultation on "Practical considerations when critically assessing economic evaluations"2019-08-192019-10-11NEUEuropean Network for Health Technology Assessment (EUnetHTA)

G

EUnetHTA has opened a public consultation on "Practical considerations when critically assessing economic evaluations", aimed at HTA assessors.Consultation
MHRA Consultation on engaging patients and the public2019-07-152019-10-07NUK - EnglandMHRA

O

The MHRA has launched a consultation into the best ways to engage and involve patients in the MHRA’s work, in order to develop a more systematic approach to engagement strategies.Consultation
HTAI Consultation on 2020-25 Strategic Plan2019-08-142019-09-29NUK - EnglandHealth Technology Assessment International

G

HTAI has launched a consultation regarding its short-term strategic goals, which will feed into its finalised plan due for publication in January 2020.Consultation
NICE Consultation on how it uses real world data statement of intent2019-06-132019-09-13NUK - EnglandNICE

G

NICE has announced that it will explore how it uses real world data in forming its guidance.

As part of this, it has put out a statement of intent for consultation.

NICE (National Institute of Health and Care Excellence) is now proposing to extend its use of real world data to include sources such as:

  • hospital records of operations

  • registries which collect data on how particular treatments are used

  • surveys of people using services

  • data collected on national trends, such as how many people have a condition


The statement of intent, published by NICE, describes what kind of evidence NICE currently uses to develop guidance, what broader types of data are available, when and why broader types of data should be considered, and also practical considerations associated with data analytics.

Consultation
MAP Response
NHS consultation on Transparency and openness in health and social care research2019-06-172019-09-06NUK - EnglandNHS Health Research Authority

O

The HRA is creating an overall vision, series of commitments and strategy to make health and social care research more transparent. To incorporate feedback from the public and research professionals into the final strategy, about how some of those commitments will work in practice and the measures that will be taken, the HRA is running an online survey and holding a series of open workshops across the UK, as well as contacting patient groups and Research Ethics Committees and the approvals staff who support them.Consultation
Quality requirements for medical devices in combination products2019-06-032019-08-31NEUEMA

G

EMA has released a draft guideline on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations, for a 3-month public consultation.Consultation
Health and Social Care Committee inquiry into NHS investment and the NHS Long Term Plan2010-07-092019-08-22NUK - EnglandHouse of Commons Health and Social Care Committee

Y

The Committee is to investigate how investment capital expenses, training, social care and public health (to be outlined in upcoming funding settlements) could best support NHS effectiveness, and the implementation of the objectives outlined in the Long Term Plan.Consultation
Public consultation by HAS on the assessment of efficiency2019-07-012019-08-09NFranceHAS

G

On 2011, HAS published a first version of the methodological guide, which explained the principles the HAS relies on to conduct or evaluate efficiency assessments, whether in the context of public health assessments carried out by HAS or, since 2013, as part of the efficiency evaluations issued by the CEESP – Commission Évaluation Économique et de Santé Publique (Economic and Public Health Evaluation Committee).Consultation
EMA Consultation on draft guideline2019-01-142019-07-31NEUEMA

O

Antimicrobial resistance is a global public health problem. Regulators in the European Union, the United States and Japan have had extensive discussions over the last few years to explore and agree how to align as much as possible their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. The revised guidance reflects the outcome of these discussions.

In addition, it offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need, in accordance with experience gained from previous regulatory decisions.

Specific advice has also been added with regards to the EU regulatory requirements to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhoea.
Consultation
NICE indicator process guide2019-04-162019-07-15NUK - EnglandNICE

G

The NICE indicator process guide describes the process NICE uses to develop indicators from NICE quality standards, NICE guidance and NICE accredited sources. NICE indicators are used in a range of national measurement frameworks including the CCG Outcomes Indicator Set (CCG OIS) the CCG Improvement and Assessment Framework (CCG IAF), NHS England’s General Practice Indicators (GPI) and the Quality and Outcomes Framework (QOF).Consultation
Regulatory Science to 20252018-12-192019-06-30NEUEMA

Y

EMA has published its draft ‘Regulatory Science to 2025’ strategy for a six-month public consultation. This is a proposed plan for advancing the Agency’s engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines.

Stakeholders are invited to send their comments via an online questionnaire by 30 June 2019.
Consultation
EUnetHTA public consultation on REQueST® tool and its Vision paper2019-05-062019-06-28NEUEUnetHTA

Y

The Vision paper summarises key learnings from the Joint Action 3 and provides recommendations for long-term delivery, use and sustainability of REQueST. The document also provides recommendations for a permanent HTA cooperation on post-launch evidence generation.Consultation
AHSN and NHSX Consultation on data-driven health technologies2019-05-092019-06-09NUKAcademic Health Science Networks and NHSX

Y

AHSN and NHSX have opened a consultation upon data-driven technologies in healthcare. This aims to progress the digital transformation envisioned in the NHS Long Term and entrusted to the NHSX.Consultation
Feedback on blended payment model2019-04-262019-05-31NUK - EnglandNHS Improvement

O

NHS Improvement is gathering feedback on the operation of its new blended payment model for emergency and mental health careConsultation
Nominations for High Cost Devices list2019-04-232019-05-31NUK - EnglandNHS England

G

Nominations for devices (and drugs) to be added to (or removed from) the High Cost Devices and Drugs Lists in the next iteration (2020/21) of the National TariffConsultation
Preventing abuse of the R&D tax relief for SMEs2019-03-282019-05-24NUKHMRC

Y

This consultation is upon proposals to cap the R&D tax relief scheme at three times the relevant company’s total PAYE and NICs liability for that year, which will be implemented from April 2020.Consultation
UPDATED DEFINITION OF HTA2019-03-202019-04-30NInternationalHTAi

Y

The joint task group is now issuing this call for input from the HTA community to build broad consensus on the updated definition of HTA. Please view the document here: Open Consultation on a Proposed Updated Definition of Health Technology Assessment.Consultation
Your views on access to rare disease medicines2019-04-032019-04-19NUKGenetic Alliance UK

G

Genetic Alliance UK are working on a policy project to improve access to medicines for rare diseases. This project is called Resetting the Model. To inform this project, we are launching a survey to find out the views of patients, carers, patient organisations and industry members on access to medicines for rare diseases.Survey
NHS England: Items which should not routinely be prescribed in primary care2018-11-282019-02-28NUK - EnglandNHS England

Y

Set out in the consultation document are proposals for an review and update of Items which should not routinely be prescribed in primary care: Guidance for CCGs, published in Nov 2017. The commissioning guidance, upon which we are consulting, will be addressed to CCGs to support them to fulfil their duties around appropriate use of prescribing resources. This will need to be taken into account by CCGs in adopting or amending their own local guidance to their clinicians in primary care. The aim of this consultation is to provide you with information about the proposed national guidance and to seek your views about the proposals.Consultation
National Tariff 2019/2020 statutory consultation2019-01-232019-02-21NUK - EnglandNHS Improvement

G

NHS Improvement is consulting on its proposals for the 2019/20 - find out more on MAP's National Tariff pageConsultation
Public Health Outcomes Framework2019-01-212019-02-17NUK - EnglandPHE

O

The Public Health Outcomes Framework (PHOF) was established in 2012 and its indicators are reviewed every 3 years. Public Health England (PHE) is planning to update the PHOF in the summer 2019, to ensure that it continues to be relevant and meets the needs of users.Consultation
Evidence standards framework for digital health technologies consultation2018-12-102019-01-07NUK - EnglandNICE

Y

This consultation is being conducted by NICE regarding their recently published evidence standards framework for digital health technologies. These standards aim to make it easier for innovators and commissioners to understand what good levels of evidence for digital healthcare technologies look like, while meeting the needs of the health and care system, patients, and users.Consultation
Public consultation on legislation on medicines for children and rare diseases launched2018-10-122019-01-04NEUEuropean Commission

Y

An evaluation is currently taking place of the legislation for medicines for special populations, including both children and rare diseases. This evaluation will assess the efficiency and effectiveness of the current European Union (EU) legislation following recent pharmaceutical developments, particularly recent incentives for research, development and marketing of children’s and rare disease medicines. The outcomes of the evaluation will help to shape the EU policy on medicines for these special populations.Consultation
Evaluation of the EU Orphan Regulation for the European Commission (DG SANTE)2018-09-202018-11-14NEUTechnopolis

O

Study was commissioned with the view to measure the efficiency, effectiveness, relevance, and EU added value of the EU Orphan Regulation as well as its coherence with other regulations. Expected by mid-2019, the study is meant to provide further information – in addition to the study reports of Copenhagen Economics on pharmaceutical incentives in Europe, and the 10-Year Report of the Paediatric Regulation – for the EU Commission to evaluate the existing regulatory framework and explore possible legislative changes.
The present survey is intended for companies involved in the development and/or marketing of medicines, which have, or may be eligible for, EU orphan designation and their representative trade associations
Survey
Engagement on proposed 2019/20 National Tariff2018-10-092018-10-29NUK - EnglandNHSI - NHSE

G

Stakeholder engagement exercise consulting on published proposals for the 2019/20 National Tariff.Consultation
Health and Social Care Select Committee inquiry into the impact of a no-deal Brexit on health and social care2018-09-182018-10-15NUKHealth and Social Care Select Committee

G

Health and Social Care Committee to consider impact of a "no deal Brexit" on health and social care system.

The Health and Social Care Committee will be holding an evidence session in October on the impact of a no-deal Brexit on health and social care.

The session will be an opportunity for the Committee to follow up its earlier reports, Brexit and health and social care: people and process and Brexit: medicines, medical devices and substances of human origin.
Enquiry
MAP Response
NHSE Consultation on long-term plans for the NHS in England2018-08-242018-09-30NUK - EnglandNHS England

G

Consultation on priorities for design and improvement of NHS services in England in order to guide the development of a strategic plan for the next ten years. Input is sought from both staff and any stakeholders who work with NHS services.Consultation
Statutory scheme to control costs of branded health service medicines2018-08-072018-09-18NUKDepartment of Health and Social Care

G

Consultation on reforms to the statutory regulations scheme for pharmaceutical price setting and rebate.

The proposals cover three areas: Changing the payment percentage; Including all biological medicinal products (including biosimilars) within the scope of health service medicines captured by the payment mechanism, price controls and information requirements; and
Changing the application of the payment system for sales of medicines supplied under a contract with a contracting authority based on a framework agreement or under a public contract.
Consultation
MAP Response
Developing NICE guidelines: the manual2018-04-032018-06-25NUKNICE

G

NICE guidelines make evidence‑based recommendations on a wide range of topics, from preventing and managing specific conditions, improving health, and managing medicines in different settings, to providing social care and support to adults and children.
ACO contracts2018-01-252018-04-19NUK - EnglandNHS England

G

The consultation will set out how the ACI contract fits within the NHS as a whole, address how the existing statutory duties of NHS commissioners and providers would be performed under it, and will set out how public accountability and patient choice would be preservedConsultation
Sharing data for the "NICE Technology Appraisals in the NHS in England"2018-02-052018-04-04NUK - EnglandNICE

G

This consultation seeks views from companies who produce medical technologies, and diagnostic products, about sharing their data with NHS Digital so that it can be published on the "NICE Technology Appraisals in the NHS in England" (Innovation Scorecard) publication.

The Scorecard is a quarterly publication that provides information on the uptake of NICE approved innovative medicines and medical technologies in the NHS in England. It is commissioned by the Department of Health and published by NHS Digital.

Making information available (via the Scorecard) about the availability of innovative products will help raise awareness of these products across NHS organisations, helping improve their access for patients.
Consultation
GOC launches Education Strategic Review concepts and principles consultation2017-12-122018-03-16NUKGeneral Optical Council (GOC)

O

The General Optical Council has opened a consultation on the concepts and principles that could
underpin optical education and training in the future, as part of its Education Strategic Review
Consultation
Sustainability and Transformation in the NHS inquiry2018-02-232018-02-27NUKNHS England

G

The Committee will ask representative from the Department of Health and Social Care, NHS England and NHS Improvement about how they will ensure to put the NHS on a sustainable financial footing in the future, whilst managing increasing demandConsultation
Consultation to simplify and strengthen arrangements for research in the NHS2017-12-012018-02-01NUK - EnglandNHS England

Y

A consultation has been launched to simplify and standardise the process for getting research projects up and running in the NHS.

Cuts to bureaucracy and faster access to new and innovative treatments, are at the heart of 12 actions also agreed by the NHS England Board to support research and its application in the NHS.
Consultation
Review of Brain/CNS Cancer Quality Performance Indicators Consultation2017-12-182018-01-26NUK - ScotlandScottish Government

Y

The Scottish Government has opened a consultation on why clinical and public engagement is crucial
to ensure wide inclusiveness of clinical colleagues across NHS Scotland and Revised Brain and
Central Nervous System Cancer QPIs
Consultation
Modernising radiotherapy services in England - Consultation on proposed service
specification
2017-10-182018-01-24NUK - EnglandNHS England

O

The development of the proposed service specification sits alongside NHS England’s £130 million investment in radiotherapy equipment, which was announced last year and is aimed at delivering the vision for radiotherapy services. The proposed specification sets out how modernised services should be organised across England so that patients can access sustainable, high-quality and safe treatment. It also describes the benefits of doing things differently, and why the changes are neededConsultation
AWMSG Five Year Strategy 2018-20232017-12-152018-01-19NUK - WalesAWMSG

G

AWMSG is committed to ensuring that patients in Wales have access to clinically
effective and cost-effective medicines that will improve their health outcomes. Over the
next five years AWMSG will aim to ensure that prescribing in Wales is consistent with
the optimal prescribing practices in the rest of the UK. The strategy for the next five years
(1 April 2018–31 March 2023) builds on the success of the previous strategy (2013–
2018).
Consultation
Regulatory fees for 2018/192017-10-262018-01-18NUK - EnglandCare Quality Commission

O

The Care Quality Commission has opened a consultation on calculating the fees that providers of
health and adult social care must pay in order to be registered
Consultation
Asthma (update): Topic engagement2017-12-152018-01-15NUKNICE

Y

The National Institute for Health and Care Excellence has opened a consultation on asthma treatment
as well as changes in the areas for improvement for asthma
Consultation
supplementary protection certificates (SPCs) and patent research exemptions2017-10-122018-01-04NEuropeEuropean Commission

O

The Single Market Strategy, adopted in October 2015, announced that the Commission will ‘consult, consider and propose further measures, as appropriate, to improve the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulated market authorisations’.Consultation

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