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Consultations

Please note that this table shows consultations from 1st October 2016. Please refer to our consultations archive for consultations before this date.

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Consultation titleDateClosing dateOpen?CountryOrganisationPriorityKey commentsLinks
NHS England: Items which should not routinely be prescribed in primary care2018-11-282019-02-28YUK - 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
EMA epilepsy consultation2018-09-172019-02-17YEuropeEMA

Y

The present document is a third revision of the existing guideline. It should be considered as general guidance on the development of medicinal products for the treatment of epileptic disorders and should be read in conjunction with other EMA and ICH guidelines, which may apply to these conditions and patient populations.Consultation
Public consultation on legislation on medicines for children and rare diseases launched2018-10-122019-01-04YEUEuropean 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
Consultation on proposed IPI international reference pricing model for the US 2018-10-252018-12-31YUSA, but impact will be globalUS Dept. of Health and Human Services (HHS) / Centers for Medicare & Medicaid Services (CMS)

G

This is the US Government's consultation on Administration proposals to benchmark US drug prices to other developed countries, particularly Europe.Consultation
EMA neonatal consultation2018-09-172018-12-16YEuropeEMA

Y

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates. Consultation
Draft Specification for Sarcoma services2018-10-122018-12-11YUKNHS England

O

NHS England has launched a consultation to seek views on proposed changes to Sarcoma Cancer Services.Consultation
Evaluation of the EU Orphan Regulation for the European Commission (DG SANTE)2018-09-202018-11-14NEUTechnopolis

G

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
MHRA No Deal Brexit consultation2018-10-042018-11-01NUKMHRA

G

The MHRA is conducting a consultation on how legislation and regulatory processes would have to be modified in the event of a no deal Brexit. The overall approach, as detailed in the Government’s notice to stakeholders on 23rd August, is that new marketing authorisations would be submitted separately to both the MHRA for UK markets and the EMA for European markets. Existing EU marketing authorisations will be automatically converted into UK ones. The MHRA would be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.

The consultation includes optional sections on Medicines, Clinical Trials, Medical Devices, Fees and the National Institute for Biological Standards and Control. Each section details the proposed changes, and allows respondents to indicate whether they support the proposals and provide comments.

The ABPI and BIA have submitted a joint response to this consultation, which can be found here.
Consultation
Consultation on ATMPs Good Clinical Practice2018-08-092018-10-31NEuropeEuropean Commission

G

Taking account the advances and experience in the field the Commission services have developed a new draft Guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products with the European Medicines Agency and the expert group of the competent authorities of the Member States. The Guidelines will adapt good clinical practice requirements (“GCPs”) to ATMPs. It will be a document that focuses on ATMP specificities only and which applies in addition to the GCP Guidelines of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The Directorate General for Health and Food Safety wants to give an opportunity for concerned stakeholders to express their views on the GCP requirements that should apply to ATMPs.Consultation
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
NICE: Drug allergy diagnosis and management consultation2018-10-032018-10-16NUK - EnglandNICE

O

NICE has announced a consultation to update the clinical guidelines on drug allergy diagnosis and management (CG183). The consultation runs from Wednesday 3 October to 5pm on Tuesday 16 October 2018.

NICE clinical guidelines are recommendations, based on the available evidence, for the treatment of patients by healthcare and other professionals.
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
Consultation on ABPI Code of Practice2018-08-292018-10-10NUKPMCPA (ABPI)

G

Consultation on changes to the ABPI Code of Practice Consultation
ANSM Consultation on paracetamol safety2018-08-202018-09-30NFranceANSM

O

Paracetamol is a safe and effective medicine under normal conditions of use.

But in case of misuse, especially overdose by combining several products containing paracetamol and / or by non-compliance with their dosage, paracetamol can cause serious damage to the liver in some irreversible cases. The misuse of paracetamol is the leading cause of liver transplantation of drug origin in France.

The ANSM invites anyone who wishes to participate, until 30 September 2018 , in the public consultation "Hepatic risk linked to paracetamol overdose: setting up a warning message on the boxes (packaging)".
Consultation
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
NHS England Consultation on evidence based interventions2018-07-042018-09-28NUK - EnglandNHS England

G

Public consultation on the design principles of the evidence based intervention programmeConsultation
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
NICE charging for Technology Appraisal (inc. HST) plus amendments to Appeal Panels 2018-08-092018-09-14NUK - EnglandNICE / DHSC

G

DHSE seeks comments on proposals to charges for NICE technology appraisals including HST from April 2019. It would also allow NICE Appeals Panels to recruit members from healthcare bodies across the UK, rather than just England.Consultation
HIQA Consultation on ePrescriptions2016-07-182018-08-31NRepublic of IrelandHIQA

O

The consultation process will take place over a six-week period. In this way, the public, service users and service providers will have the opportunity to provide feedback and become involved in the future of ePrescribing in IrelandConsultation
NHS England Consultation on GP contract reform2018-07-042018-08-31NUK - EnglandNHS England

G

Proposed contract changes around payments for regional variations and digital implementations.Consultation
Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry2018-06-292018-08-21NEuropeEMA

Y

EBMT requested qualification of the cellular therapy module of the EBMT Registry as suitable for performing pharmacoepidemiological studies for regulatory purposes, concerning CAR-T cell therapy for haematological malignancies.Consultation
Study supporting the Evaluation of the European Medicines Agency Fee System2018-05-022018-08-03NEuropeEuropean Commission

G

The consultation aims to elicit information, views and concerns of all groups having an interest in the EMA fee system and its implementation.Consultation
Cost-Effectiveness Methodology for Vaccination Programmes and Procurement (CEMIPP) Report2018-02-262018-07-02NUK - EnglandDepartment of Health

G

The consultation includes a recommendation that the cost-effectiveness threshold for immunisation programmes should be lowered to £15,000 per QALY to bring it into line with evidence estimating healthcare opportunity costs and the DHSC’s methodology for impact assessments and there is an attempt to make a connection with evaluation of medicines.Consultation
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.Consultation
Personal health budgets and integrated personal budgets: extending legal rights2018-04-062018-06-08NUK - England Department of Health and Social Care

G

The Department of Health and Social Care has opened a consultation seeking views on giving more people the right to have personal health budgets and integrated personal budgets Consultation
Update of The Licensing (Procedure) (Scotland) Regulations 20072018-03-142018-06-06NUK - ScotlandScottish Government

Y

The Procedure Regulations came into force on 1st February 2008 and have not been updated since issue. They provide for various procedural matters under the Licensing (Scotland) Act 2005. This consultation is seeking views, in particular, regarding the sections of these Regulations which relate to the public notification process. The consultation includes 4 open questions relating to the procedure regulations.Consultation
Public consultation on the review of the SME definition2018-02-062018-05-06NEuropeEuropean Commission

Y

The SME definition as provided in Recommendation 2003/361/EC is the structural tool to identify enterprises that are confronted with market failures and particular challenges due to their size, and therefore are allowed to receive preferential treatment in public support.

It is a widely used tool in EU policies such as competition (state aid), structural funds, research and innovation (Horizon 2020). Moreover, the SME definition is relevant for some European administrative exemptions and reduced fees, such as for Regulation on registration, evaluation, authorisation and restriction of chemicals (REACH).

The Commission is currently preparing for an evaluation and possible revision of some aspects of the SME definition. This public consultation is part of this process and will allow any interested actor to provide feedback on the evaluation and impact assessment of the SME definition.
Consultation
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"2018-02-05 2018-04-04NUK - 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 ReviewConsultation
Conditions for which over the counter (OTC) items should not routinely be prescribed in primary care: A consultation on guidance for CCGs2017-12-202018-03-14NUK - EnglandNHS England

Y

NHS England is launching a public consultation on reducing prescribing of over-the-counter medicines for 33 minor, short-term health concerns.

The changes look to free-up up to £136 million to expand other treatments for major conditions.
Consultation
Consultation on proposed changes to the technology appraisals programme - phase 22018-01-192018-03-01NUK - EnglandNICE

G

In October 2017 we consulted on amendments to our technology appraisal process. The aim of the proposals was to enable more topics to be processed through the current four appraisal committees.

We have now updated our guide to the processes of technology appraisals in line with these amendments. The draft guide is now open for consultation.
Consultation
Sustainability and Transformation in the NHS inquiry2018-02-232018-02-27NUKPublic Accounts Committee

Y

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
Public release of clinical information2017-12-092018-02-22NCanadaHealth Canada

Y

Health Canada invites stakeholder's comments on how it carries out this proposal, including the:
  • regulatory approach
  • scope of clinical information that would be publicly available following a final regulatory decision
  • clinical information that has ongoing commercial value and could be withheld from public release
Consultation
PMPRB Guidelines Scoping Paper – High Level Overview of Potential New Framework2017-12-022018-02-15NCanadaPMPRB

G

While the details of the framework remain to be worked out through consultation, its basic structure can be described as a risk-based approach to pricing review that is broken down into five main partsConsultation
Naming of Biologic Drugs2018-01-182018-02-09NCanadaHealth Canada

Y

Health Canada and the Institute for Safe Medication Practices Canada (ISMP Canada) are seeking input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada.

The objective of the consultation will be to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication-use process, including prescribing, dispensing, and adverse drug reaction reporting.
Consultation
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 QPIsConsultation
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
Serious eye disorders2017-12-152018-01-18NUKNICE

G

The National Institute for Health and Care Excellence has opened a consultation on Serious eye disorders.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 registeredConsultation
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
Evaluation of the legislation on medicines for children and rare diseases2017-12-112018-01-08NEuropeEuropean Commission

Y

the EU Commission intends to conduct some activities by the end of their mandate, in order to complement the already-completed or ongoing studies on Supplementary Patent Certificates (SPCs). Stakeholders are given the possibility to submit feedback on the roadmap by 8 January 2018.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
Regulating medical associate professions in the UK2017-10-122017-12-22NUKDepartment of Health

O

The Department of Health has opened a consultation seeking views on the regulation of medical
associate professions (MAPs) in the UK
Consultation
Will British citizens still get free healthcare in the EU after Brexit?2017-09-082017-11-24NUKUK Government

G

The inquiry will focus on the reciprocal healthcare implications of Brexit for UK citizens travelling, living and/or working in the rest of the EU, and for EU citizens travelling, living and/or working in the UK, in both the short and medium term.Consultation
Consultation on proposed changes to the technology appraisals programme2017-10-092017-11-16NUKNICE

G

NICE is proposing amendments to the TA process to enable more topics to be processed through the current 4 appraisal committees. Increasing demand means that the current appraisal process will be unable to cope with the number of appraisals the Institute will be asked to undertake, within the next two years.

The proposed adjustments retain the familiar elements of the current single technology appraisals (STA), while aligning them more efficiently.
Consultation
Information about health service products: proposed requirements2017-08-232017-11-14NUKUK Government

G

The proposed regulations cover medicines, medical supplies and other related products that are used in the NHS.

The main requirements include:

  • manufacturers, importers and wholesalers to provide quarterly information about sales and purchases of generic medicines and special medicinal products

  • those involved in the supply chain to record, keep and provide on request information related to sales and purchases of health service medicine, medical supplies and other related products

  • marketing authorisation holders, manufacturers and importers to tell government about any discontinuation and supply shortages of medicines
Consultation
Consultation on Pharmacotherapy for Smoking Cessation2017-10-202017-11-10NUK - WalesAWMSG

Y

The All Wales Medicines Strategy Group has opened a consultation on pharmacotherapyConsultation
Five year strategy consultation to achieve “healthcare that fits the needs and circumstances of patients and avoids wasteful care”2017-10-182017-11-10NUK - WalesAWMSG

Y

“Healthcare that fits the needs and circumstances of patients and avoids wasteful care”. This will only be achieved by working in partnership with many organisations within NHS Wales, and also outside Wales, to deliver a medicines’ strategy in Wales which promotes safe and effective prescribing practices. The recommendations in this strategy are aligned to these principles to ensure healthcare fits the needs and circumstances of patients and actively avoids wasteful care that is not beneficial to patients.Consultation
Expanding performance assessments of providers regulated by CQC2017-09-112017-11-07NUKDepartment of Health

O

This consultation is targeted at providers of health and social care services registered with the Care Quality Commission (CQC). It seeks your views as to whether it is appropriate for the CQC to extend performance assessment and ratings to all the providers and activities that would be prescribed by this new approach.Consultation
Brexit and the implications for UK business inquiry2017-09-202017-11-07NUKBEIS

G

The Business, Energy and Industrial Strategy Committee has today launched an inquiry on the implications of leaving the European Union for British business. The Committee aims to establish how the interests of different sectors should best be pursued both in the negotiating process and post-Brexit and attempts to examine a range of issues relating to market access, non-tariff barriers, regulation, skills, R&D, trade opportunities and transitional arrangements. Consultation
Cardiovascular disease: risk assessment and reduction, including lipid modification2017-10-192017-11-03NUK - EnglandNICE

G

The National Institute for Health and Care Excellence has opened a consultation on clinical guidance
for CG181 which has been checked by NICE for the need for update
Consultation
Accountable care models contract: proposed changes to regulations2017-09-112017-11-02NUKDepartment of Health

Y

The development of the ACO contract has identified a number of required changes to regulation, predominantly to ensure that current rules continue to apply to the new contract, and those organisations using it, but also in some cases creating additional flexibilities, for example for GPs who wish to enter into ACO arrangements without terminating their existing contracts.

This consultation seeks views on the proposed changes.
Consultation
General Osteopathic Council: Revised Osteopathic Practice Standards2017-08-012017-10-31NUKGeneral Osteopathic Council

O

The General Osteopathic Council has opened a consultation on Osteopathic Practice Standards in practiceConsultation
Brexit – medicines, medical devices and substances of human origin inquiry2017-09-212017-10-26NUKUK Health Committee

Y

New regulatory arrangements must be put in place from 29 March 2019 to guarantee the safe and effective supply of medicines, medical devices, medical products and substances of human origin in the UK. Patients, the NHS and the UK's life science industry need certainty about what the UK's regulatory arrangements will be after Brexit and a smooth transition towards them. There are also major implications for the future of medical research and development. The Health Committee invites submissions on the options available to the UK Government, including the respective opportunities, risks and trade-offs involvedConsultation
NHS continuing healthcare funding2017-10-202017-10-24NUKPublic Accounts Committee

G

The House of Commons Public Accounts Committee has launched an inquiry into NHS continuing
healthcare funding (CHC) and how NHS England’s efficiency plan is affecting the spending of CCGs
and the delivery of CHC
Consultation
Items which should not be routinely prescribed in primary care: A Consultation on guidance for CCGs2017-07-212017-10-21NUK - EnglandNHS England

G

NHS England have opened a consultation on the items that should not be prescribed in primary care. Last year 1.1 billion prescription items were dispensed in primary care at a cost of £9.2billion. In England there is considerable variation in what is being prescribed and to whom, with some patients receiving medicines that are ineffective or in some cases dangerous, for which there are other more effective, safer and/or cheaper alternatives. NHS England has partnered with NHS Clinical Commissioners to support Clinical Commissioning Groups (CCGs) in delivering a nationally co-ordinated approach to the development of commissioning guidance in this area to ensure consistency and address unwarranted variation.Consultation
Medicines management: managing the use of medicines in community settings for people
receiving social care: Topic engagement
2017-07-052017-10-17NUK - EnglandNICE

Y

The National Institute for Health and Care Excellence has opened a consultation asking for 5 key
areas for quality improvement in this area
Consultation
Statutory scheme to control cost of branded medicines: consultation2017-08-232017-10-17NUKUK Government

G

The aim is to achieve alignment with the current voluntary pharmaceutical price regulation scheme (PPRS), agreed in 2014.

The main proposals in the consultation are:
  • the introduction of a payment system similar to that in the 2014 PPRS
  • changes to the provisions on maximum prices, including removing the requirement for a 15% price cut
  • changes to the information requirements placed on companies
Consultation
Healthcare white paper consultation2017-08-112017-10-15NUKChartered Institute of Ergonomics and Human Factors

O

The Chartered Institute of Ergonomics and Human Factors has opened a consultation on its white
paper on health and social care
Consultation
Generic Drug Equivalence and Related Terminology2017-06-302017-10-13NCanadaHealth Canada

Y

Consultation regarding possible changes to the Food and Drug Regulations relating to establishing pharmaceutical equivalence between a proposed generic drug product and a Canadian reference product (CRP)Consultation
Genomics and genome editing in the NHS2017-09-142017-10-13NUKUK Government

O

This inquiry examines the Chief Medical Officer's (Dame Sally Davies) call in her latest annual report, ‘Generation Genome’, for mainstreaming genomic medicine in the NHS within 5 years.

The Committee is now inviting written evidence.

This includes observations on how any barriers to greater integration of genomic therapies in the NHS could be overcome, and how such barriers may differ across the devolved nations.
Consultation
Services Fit for the Future in Wales2017-06-282017-09-29NUK - WalesWelsh Government

Y

The Welsh Government has opened a consultation on a wide range of proposals to improve NHS
services, including strengthening leadership in NHS organizations and introducing new duties of
quality and openness
Consultation
Suspected neurological conditions: Draft guidance consultation2017-08-072017-09-19NUKNICE

O

The National Institute for Health and Care Excellence has opened a consultation on draft guidance for suspected neurological conditionsConsultation
Continuing Healthcare in Northern Ireland: Introducing a Transparent and Fair System2017-06-192017-09-15NUK - Northern IrelandDepartment of Health Northern Ireland

Y

The Department of Health is seeking views on proposals to reform the continuing healthcare policy in Northern Ireland. The consultation document is aimed at the general public, individuals and their families, clinicians and other stakeholders.Consultation
EMA consultation on the Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol2017-05-232017-08-22NEUEMA

Y

  • To outline the practical arrangements for notification of serious breaches; it does not include guidance related to urgent safety measures or other reporting obligations related to subject safety

  • To provide advice on what should and what should not be classified as a serious breach and what must be reported

  • To outline possible actions that may be taken by the EU/EEA Member States concerned (MSC) in response to notifications of serious breaches
Consultation
Review of Clinical Trial Access Quality Performance Indicator in Scotland2017-07-032017-08-18NUK - ScotlandScottish Government

Y

The Scottish Government has opened a consultation seeking views on the acceptability of the Quality
Performance Indicators
Consultation
Revising CADTH Common Drug Review Recommendations in the CADTH Therapeutic Review Process2017-06-302017-08-15NCanadaHealth Canada

G

CADTH is seeking stakeholder feedback on a revised therapeutic review process that would incorporate revisions to existing Canadian Drug Expert Committee (CDEC) recommendations issued through the CADTH Common Drug Review (CDR) processConsultation
CQC seeks views on next phase of regulation2017-06-122017-08-08NUKCQC

Y

The Care Quality Commission has opened a consultation on a further set of proposals to help shape
the next phase of regulation for health and social care across the country
Consultation
Consultation on Specialised Services clinical commissioning policy - Immediate Antiretroviral therapy2017-07-072017-08-06NUKNHS England

O

NHS England has opened a consultation on a clinical commissioning policy for Immediate Antiretroviral therapy for treatment of HIV-1 in adults and adolescentsConsultation
Flu vaccination: increasing uptake2017-06-272017-08-04NUKNICE

O

NICE have opened up their draft consultation for comments from stakeholders on how to increase the uptake of flu vaccinesConsultation
Revision of the guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population2017-05-042017-07-31NEUEMA

Y

The paediatric pharmacokinetics guideline needs revision to implement new knowledge and to reflect the experience gained since the Paediatric Regulation came into force in 2007.Consultation
Review of Health and Social Care2017-03-202017-07-11NUK - WalesWelsh Government

O

The Welsh Government has opened a survey as part of its review into health and social careConsultation
Post-implementation Review of the Human Medicines Regulations 2012 (MLX 391)2017-06-152017-07-06NUKUK Government

Y

Reviewing the impact of the 2012 Regulations, including:
  • the Pharmacovigilance Directive (Directive 2010/84/EU (amending Directive 2001/83/EC) (Section 1 of the questionnaire)

  • cross Border Prescriptions (Section 2 of the questionnaire)

  • the repeal of Section 10(7) of the Medicines Act 1968 on Pharmacy wholesale dealing (Section 3 of the questionnaire)
  • Consultation
    Recognition and Treatment2017-05-232017-07-03NUKUK - Northern Ireland

    O

    The Northern Ireland Department of Health has opened a NICE consultation on the recognition and treatment of eating disordersConsultation
    Intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by high spinal cord injuries: Interventional procedure consultation2017-05-302017-06-23NUKNICE

    O

    The National Institute for Health and Care Excellence has opened a consultation on the safety and efficacy of this procedureConsultation
    NICE: Sinusitis (acute): antimicrobial prescribing2017-05-262017-06-23NUKNICE

    O

    The National Institute for Health and Care Excellence has opened a consultation on antimicrobial prescribing for sinusitis
    Consultation
    NICE: Type 2 diabetes prevention. Standing committee C update: Addendum consultation2017-05-242017-06-23NUKNICE

    O

    The National Institute for Health and Care Excellence has opened a consultation on the draft addendum for Type 2 diabetes preventionConsultation
    Draft guideline on cystic fibrosis: diagnosis and management2017-05-042017-06-18NUKNICE

    Y

    This draft guideline and its supporting evidence are now out for consultation.Consultation
    Rapid Resolution and Redress Scheme for Severe Birth Injury2017-03-022017-05-26NUKDepartment of Health

    O

    The Department of Health has opened a consultation on the Rapid Resolution and Redress Scheme (RRR)Consultation
    Genomics for precision medicine strategy2017-04-122017-05-24NUK - WalesWelsh Government

    O

    Consulting on:
    • working with patients and the public in genomics
    • the provision of clinical and laboratory genetics services in Wales
    • plans to improve the health and healthcare provision for the people of Wales
    Consultation
    Sustainable access to innovative therapies2017-03-132017-05-01NEUOECD

    G

    To identify issues with the current system, to understand which topics are of most importance to stakeholders, to find out if there are any major differences in stakeholder views and canvass new ideasConsultation
    Q&A on implementation of risk based prevention of cross contamination in production and ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP/CVMP/
    SWP/169430/2012)
    2017-01-112017-04-30NEUEuropean Medicines Agency

    O

    Comments are invited on a question and answer document on health based exposure limits.Consultation
    Inquiry into Blood Cancer Care in the NHS2017-03-152017-04-27NUKAll-Party Parliamentary Group on Blood Cancer

    O

    The All Party Parliamentary Group on Blood Cancer has opened an inquiry into the treatment of blood cancer in the NHSConsultation
    Infected Blood Support: Special Category 2017-03-062017-04-17NUKDepartment of Health

    O

    The Department of Health has opened a consultation seeking views on the appeals mechanism that offers financial assistance for those with chronic hepatitis C infectionConsultation
    Industrial Strategy Green Paper2017-01-232017-04-17NUKDepartment for Business, Energy, Innovation and Skills

    Y

    Includes pillars around investing in science, research and innovation; improving procurement; cultivating world-leading sectors (including one on life sciences)Consultation
    Equality Scheme for the Department of Health 20172017-01-132017-04-10NUK - Northern IrelandDepartment of Health Northern Ireland

    O

    The Department of Health Northern Ireland is reviewing its approach to the Equality Scheme. It includes reference to medicines optimisation and the safe use of medicines and devices in Northern Ireland.Consultation
    Strategy for pharmacopoeial public quality standards for biological medicines2017-01-092017-04-10NUK - EnglandMHRA

    O

    Relevant to biosimilars, ATMP medicinesConsultation
    Individual Funding Request (IFR) Policy2017-01-252017-04-07NUK - Northern IrelandDepartment of Health Northern Ireland

    G

    Proposals change exceptionality criteria and include measures to increase clinical input in IFRsConsultation
    Chronic Kidney Disease (QS Update)2017-03-032017-03-28NUKNICE

    O

    The National Institute for Health and Care Excellence has opened a consultation on chronic kidney diseaseConsultation
    NHS Governance – Creating a Culture of Improvement2017-02-152017-03-15NUK - ScotlandScottish Parliament

    O

    The Committee is looking to explore the culture of the NHS and the way this impacts on patients. The inquiry aims to ascertaining how well NHSScotland’s policies and systems are operating to deliver good governance and create a culture of improvement.

    The Committee’s work will consider three main strands to NHS Governance: staff, clinical and corporate governance.
    Consultation

    Response
    Integration Authorities Consultation with Stakeholders2017-02-132017-03-08NUK - ScotlandScottish Parliament Health and Sport Committee

    O

    The Committee will examine Integration Authorities’ (IAs) approach to engagement with stakeholders and whether or not IAs are doing enough to involve patients, carers, the third sector and other stakeholders over the design and future of health and social care in their local area.Consultation

    Response
    Consultation on improving how patients and the public can help develop NICE guidance and standards2016-01-022017-02-28NUK - EnglandNICE

    Y

    Outlines steps that NICE will take to improve involvement of lay people in the development of its guidance. A key factor will be ensuring engagement at an earlier stage, facilitated by a larger pool of lay experts to choose from.Consultation
    Changes to DH accounting guidance for NHS bodies: 2017 to 20182017-01-262017-02-24NUK - EnglandDepartment of Health

    O

    The Group Accounting Manual (GAM) sets out mandatory accounting guidance for all DH group and NHS bodies in completing annual accountsConsultation

    Response
    Commission report on the paediatric regulation - consultation document2016-11-142017-02-20NEUEuropean Commission

    O

    Considers how the Paediatrics Regulation has had an impact on paediatric research, including the level of paediatric medicines available, clinical trials, waivers and deferralsConsultation
    Work, health and disability: improving lives2016-11-022017-02-17NUK - EnglandDepartment of Health, Department for Work and Pensions

    O

    Includes reference to the need for timely treatment to ensure people with long-term conditions are able to stay in work. Recognition of the need for employment to be a health outcomeConsultation
    Industrial Strategy Consultation2017-01-052017-02-16NUKLabour Party

    O

    Of interest in terms of overarching strategy around research and investmentConsultation
    Consultation on the New National Health and Social Care Standards2016-10-282017-01-22NUK - ScotlandScottish Government

    O

    Consultation looks at standards of care and treatment that people accessing NHS and social care services in Scotland can expect. There do not appear to be specific references to choice in treatmentConsultation
    Health and Social Care Transformation – Consultation on Criteria for Reconfiguring Health and Social Care Services2016-11-112017-01-20NUK - Northern IrelandDepartment of Health Northern Ireland

    O

    The consultation focuses on the need for certain services to be delivered at one or two hospitals to ensure that standards and outcomes delivered are high.Consultation
    Consultation on Draft of The Continuing Care (Scotland) Amendment Order 20172016-12-192017-01-20NUK - ScotlandScottish Government

    O

    Sets out details about continuing care in Scotland and plans to increase the higher age limit for persons eligible for continuing care form 18 to 19Consultation
    Public consultation on strengthening EU cooperation on Health Technology Assessment (HTA)2016-10-212017-01-20NEUEuropean Commission

    Y

    Consultation considers how far joint work across Europe on HTA should be increased and whether this should be mandatory or voluntary.Consultation
    Commissioning Policies for the Funding of Treatment Outside of Clinical Commissioning Policy2016-10-132017-01-15NUK - EnglandNHS England

    G

    Consultation on core policies within NHS England. Intended to provide clarity in arrangements, the proposals are relatively vague and suggest that a restrictive approach will be taken. Given their potential impact, a response is required.Consultation
    Consultation on changes to technology appraisals and highly specialised technologies2016-10-132017-01-13NUK - EnglandNICE / NHS England

    G

    Proposed changes in relation to a budget impact threshold, streamlined process and the use of cost per QALY for highly specialised technology assessments. These may have a significant impact on access policies so response is required.Consultation
    2017/2019 National Tariff2016-10-312016-12-06NUK - EnglandNHS England / NHS Improvement

    G

    The main objective for the 2017 to 2019 national tariff is to support providers of NHS care and commissioners to deliver sustainable, high quality care.

    In response to feedback from the NHS, we're proposing to set the tariff for two years: 2017/18 and 2018/19. We believe that setting a two-year tariff will give the sector greater certainty against which to plan and make the investment decisions necessary to deliver transformation to the service.
    Consultation

    Response
    Managing Common Infections2016-11-012016-11-28NUK - EnglandNICE

    O

    The National Institute for Health and Care Excellence has opened a consultation on the management of common infections.Consultation
    NICE Consultation on Managing Medicines at Home2016-10-172016-11-11NUK - EnglandNICE

    O

    The draft guideline which is being published for public consultation says health and social care staff should support people to take direct responsibility for their own medicines wherever possible, with help from family or carers if needed.

    To ensure staff are able to effectively carry out their roles, the guideline says home care providers should ensure they receive adequate training in medicines’ support. Home care workers should also be told when and how to seek help and advice.
    Consultation

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