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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Use the search bar to filter the table by type, country or date.
| Consultation title | Date | Closing date | Open? | Country | Organisation | Priority | Key comments | Links |
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| Guideline on registry-based studies | 2020-09-24 | 2020-12-31 | Y | Europe | EMA | G | The EMA Patient Registry Initiative and the Cross-Committee Task Force on Registries have explored ways to improve the use of patient registries in the context of benefit-risk evaluation of medicinal products. The guideline was developed based on the comments received on the discussion paper on ‘Methodological and operational considerations on the use of patient disease registries for regulatory purposes’, that went through a public consultation between November 2018 and June 2019, and a consultation of EMA Committees and Working parties | Consultation |
| NICE: Reviewing our methods for health technology evaluation | 2020-11-06 | 2020-12-18 | Y | UK - England | NICE | G | Rapid access to clinically and cost effective health technologies is vital to patients and their families, the NHS and the life sciences industry. As health technologies advance, so too do methods of evaluation. Reviewing our methods to remain cutting edge helps us to support the needs of the health and life sciences ecosystem. We are interested in hearing your thoughts about: our proposals, how we've taken the evidence and considerations into account, any potential effects and implications. | Consultation |
| NICE Centre for Health Technology Evaluation (CHTE) topic selection programme | 2020-10-09 | 2020-11-19 | Y | UK - England | NICE | G | We'd like your views on the proposals for the Centre for Health Technology Evaluation (CHTE) topic selection programme. Topic selection is the process for deciding which topics we produce guidance on. It's designed to support the guidance development process so that chosen topics protect patient safety and support provision of the best quality care. CHTE is responsible for developing guidance on: diagnostics; highly specialised technologies; interventional procedures; medical technologies; technology appraisals. Currently each guidance producing programme has a bespoke process to identify, select and route topics. Updating these processes gives us the opportunity to ensure good governance and oversight. | Consultation |
| MHRA draft guidance on the licensing of biosimilar products | 2020-10-07 | 2020-11-15 | Y | UK | MHRA | Y | We have drafted new guidance to help developers of similar biological products (also known as biosimilars) more clearly understand the requirements for biosimilar products in the UK. This guidance is based on the current EMA biosimilar guidance, with additional details about: UK reference products; the lack of requirement for in vivo studies in animals; the changes in the requirement for a comparative efficacy trial in most cases | Consultation |
| NHS England 2021/2022 national tariff | 2020-10-19 | 2020-11-02 | N | UK - England | NHS England | G | NHS England has opened a consultation on the future policies for the 2021/2022 national tariff. The consultation provides an opportunity to give your thoughts on potential policies for the 2021/2022 national tariff, and related financial architecture discussed at the tariff engagement workshops held between 19th and 30th October. | Consultation |
| The scope of qualifying expenditures for R&D Tax Credits | 2020-07-21 | 2020-10-13 | N | UK | HM 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 |
| Consultation on the guidelines for the reimbursement and price application of a medicine | 2020-09-16 | 2020-09-30 | N | Italy | AIFA | G | AIFA makes available for public consultation on its institutional website the document containing the information required by art. 2 of the Ministerial Decree of 2 August 2019 "Criteria and methods by which the Italian Medicines Agency determines, through negotiation, the prices of drugs reimbursed by the National Health Service" (GU n. 185 of 24 July 2020), for the forwarding of request for negotiation. | Consultation |
| Distributing vaccines and treatments for COVID-19 and flu | 2020-08-28 | 2020-09-18 | N | UK | DHSC | 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 Inquiry | 2020-07-28 | 2020-09-09 | N | UK | Public 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 |
| Consultation on the proposed 2021 ABPI Code of Practice | 2020-06-19 | 2020-09-08 | N | UK | ABPI | G | Pharmaceutical companies are requested to provide one consolidated response including the name of the company, which will be kept confidential. Responses from individuals working for a pharmaceutical company are also welcome. The proposals for the Code would result in the most significant structural change in nearly 30 years and would make a major impact on the way that people interact with the requirements. That is why we are keen for users of the Code to scrutinise the proposals in detail and consider how it will affect the way they work. | Consultation |
| Public consultation on European Medicines Agencies Network Strategy to 2025 | 2020-07-06 | 2020-09-04 | N | Europe | European Medicines Agency | Y | The purpose of this public consultation is to seek views from EMA’s and HMA's stakeholders, partners and the general public on the proposed joint European Medicines Agencies Network Strategy to 2025 and whether it meets stakeholders’ needs. By highlighting where stakeholders see the need as greatest, there is an opportunity to help shape the strategy for the coming years, 2021-2025. The views being sought on the proposed strategy refer both to the extent and nature of the broader strategic theme areas and goals. We also seek your views on whether the specific underlying objectives proposed are the most appropriate to achieve these goals. The strategy will be aligned with the broader Pharmaceutical Strategy for Europe. | Consultation |
| Legislative Consent Memorandum for the Medicines and Medical Devices Bill | 2020-07-08 | 2020-09-04 | N | Wales | Welsh 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 |
| Prescribing Dilemmas – A Guide for Prescribers (Consultation) | 2020-08-16 | 2020-09-03 | N | Wales | AWTTC | O | This document provides guidance for health professionals regarding prescribing duration, foodstuffs, complementary medicines and alternative therapies, common ailments, fertility treatment, erectile dysfunction, prescribing for self and family, visitors from overseas, travel and occupational health vaccines, prescribing situations not covered by the NHS including private care and private prescriptions, unlicensed medicines, and prescribing outside national guidance. | Consultation |
| 2025 UK Border Strategy Public Consultation | 2020-07-23 | 2020-08-28 | N | UK | UK 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 Disinvestment | 2020-08-10 | 2020-08-28 | N | Wales | AWMSG | 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 |
| Intellectual property action plan | 2020-07-10 | 2020-08-14 | N | Europe | European Commission | O | Intellectual property (IP) rights (patents/copyright/trademarks) enable EU businesses to protect their inventions & creations to better compete around the world. The EU needs to better protect & manage IP if it is to assume leadership in key industrial areas & improve resilience to health & economic crises, while moving towards a greener, more digital economy. This initiative aims to upgrade the IP system, promote its smarter use, ensure better enforcement & promote fair play globally for IP. | Consultation |
| Targeted stakeholder consultation on the pilot project ‘Market Launch Intentions of Centrally Authorised Products’ | 2020-06-25 | 2020-07-22 | N | Europe | European Commission | G | In order to increase availability of CAPs, an ad hoc working group was set-up under the Human Pharmaceutical Committee, bringing together the Commission, national competent authorities and the European Medicines Agency, to consider possible actions which could help improve a wider roll-out of CAPs. One of the agreed actions is a ‘pilot project’ to raise awareness on this issue and engage with prospective marketing authorisation holders through voluntary sharing of their marketing intentions for specific types of CAPs in the pre-authorisation phase, and to improve regulators’ knowledge on the mechanism behind delayed market launch. . Prospective marketing authorisation holders participating in this pilot will be invited to share this information on a confidential basis. | Consultation |
| PMPRB Draft Guidelines Consultation | 2020-06-19 | 2020-07-20 | N | Canada | PMPRB | G | The June 2020 Draft Guidelines are available for public comment until July 20, 2020. To submit your feedback, please visit the Submit Feedback section. All written submissions will be made available to the public on this website. The PMPRB will be hosting a series of webinars to discuss the June 2020 Draft Guidelines with stakeholders. To participate, please visit the Webinar Registration section. On November 21, 2019, the PMPRB published a first draft set of new Guidelines (the “November 2019 Draft Guidelines”) for consultation with stakeholders and the public. Extensive feedback was received and significant changes have been made in response to that feedback, as reflected in the June 2020 Draft Guidelines. The written submissions are available on the PMPRB website. | Consultation |
| Pharmaceutical Strategy - Timely patient access to affordable medicines | 2020-06-02 | 2020-07-07 | N | EU | European Commission | G | The strategy aims to ensure Europe’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts. It will address all levels of the value chain from research and development to authorisation and access of patients to medicines taking into account scientific and technological advances. Lessons learned from the COVID-19 pandemic around preparedness and supply chains will also be addressed. | Consultation |
| Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials | 2020-03-25 | 2020-04-25 | N | Europe | EMA | 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 Bill | 2020-03-04 | 2020-04-23 | N | UK | Public 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 |
| EMIG COVID-19 Survey | 2020-03-19 | 2020-03-26 | N | UK | EMIG | G | The evolving situation with coronavirus (COVID-19) is expected to have widespread international consequences and governments from around the world have announced various policies in an attempt to delay the spread of the virus. This global situation has the potential to profoundly disrupt the UK pharmaceutical sector and the availability of medical products for UK patients. In light of these concerns, EMIG is conducting a survey to understand the overall risk that exists to our Members’ businesses, employees and to UK patients. | Survey |
| ICER Releases Draft Evidence Report on Therapies for Cystic Fibrosis | 2020-02-20 | 2020-03-18 | N | USA | ICER | G | The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of treatments for cystic fibrosis. ICER's report focuses on elexacaftor/tezacaftor/ivacaftor (TrikaftaTM, Vertex). ICER also examined new data that has become available since its May 2018 review of three other cystic fibrosis treatments already approved by the FDA: tezacaftor/ivacaftor (Symdeko®, Vertex), lumacaftor/ivacaftor (Orkambi®, Vertex), and ivacaftor (Kalydeco®, Vertex).This preliminary draft marks the midpoint of ICER's eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER's final conclusions. | Draft Evidence Review |
| Branded medicines: statutory scheme | 2020-01-21 | 2020-02-17 | N | UK | DHSC | G | This consultation seeks views on proposed changes to the statutory scheme to control the costs of branded medicines. The consultation focuses specifically on proposed amendments to the payment percentages that are currently set out in the legislation for the statutory scheme. We propose adjusting the payment percentages for 2020 and 2021 to help ensure allowed growth in statutory scheme sales of branded medicines to the NHS is limited to the current rate of 1.1% per year. | Consultation |
| PMPRB Draft Guidelines Consultation | 2019-11-29 | 2020-01-31 | N | Canada | PMPRB | G | Canada’s Patented Medicine Prices Review Board (PMPRB) has launched a consultation on its new Guidelines including changes for both grandfathered and non-grandfathered medicines. The consultation follows the announcement of new Patented Medicines Regulations, coming into effect from 1st July 2020, which, as MAP reported in August, will alter conditions such as which countries Canada may use for international reference pricing (IRP). | Consultation |
| NHS England Commercial Framework draft | 2019-11-01 | 2020-01-10 | N | UK - England | NHS England | G | NHS England are consulting on its draft Commercial Framework which sets out additional commercial flexibilities available | Consultation MAP Response |
| Community pharmacy drug reimbursement | 2019-10-21 | 2019-12-13 | N | UK - Wales | Welsh Government | Y | The Welsh Government is holding a consultation on proposed changes to reimbursing community pharmacy contractors for drugs they dispense against NHS prescriptions. | Consultation |
| National conversation on rare diseases | 2019-10-11 | 2019-11-29 | N | UK | DHSC | G | The Department of Health and Social Care has begun its ‘national conversation’ on rare diseases by developing surveys to understand the main barriers facing the community. In July 2019 Baroness Blackwood, Parliamentary Under Secretary of State, announced the project aiming to find common themes to feed into an overarching framework. | Survey |
| NHS (Pharmaceutical Services) (Wales) Regulations 2020 | 2019-09-30 | 2019-11-25 | N | UK - Wales | Welsh Government | O | The Welsh Government is consulting upon the details of the draft NHS (Pharmaceutical Services) (Wales) Regulations 2020, which will revoke and replace the 2013 iteration. The 2020 Regulations will build upon the changes introduced in 2017, which aimed to transform the Community Pharmacy Contractual Framework to deliver more clinical services through community pharmacies. | Consultation |
| Supply and Demand of Medicines in Scotland | 2019-09-27 | 2019-11-22 | N | UK - Scotland | NHS Scotland | O | The Committee is seeking views on the management of the medicines budget, including the clinical and cost effectiveness of prescribing. We want to hear about purchasing, prescribing, dispensing and consumption of medicines. | Consultation |
| EUnetHTA consultation on "Practical considerations when critically assessing economic evaluations" | 2019-08-19 | 2019-10-11 | N | EU | European 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 public | 2019-07-15 | 2019-10-07 | N | UK - England | MHRA | 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 Plan | 2019-08-14 | 2019-09-29 | N | UK - England | Health 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 |
| Community pharmacy drug reimbursement reform | 2019-07-23 | 2019-09-17 | N | UK - England | Department of Health and Social Care (DHSC) | Y | The Department of Health and Social Care (DHSC) has launched a consultation regarding the ways that community pharmacy contractors are paid for drugs dispensed through NHS prescriptions. | Consultation |
| EUnetHTA Consultation on Process of Information Retrieval | 2019-08-07 | 2019-09-13 | N | EU | EUnetHTA | G | Consultation on the methodological guideline “Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness” | Consultation |
| NICE Consultation on how it uses real world data statement of intent | 2019-06-13 | 2019-09-13 | N | UK - England | NICE | 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:
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 |
| Consultation on proposed methods adaptations for assessments of potential cures and other transformative therapies | 2019-08-08 | 2019-09-06 | N | USA | ICER | G | The Institute for Clinical and Economic Review (ICER) is consulting on a draft set of proposed adaptations to its value framework to be applied in the assessment of potential cures and other treatments that qualify as “single or short-term transformative therapies,” or SSTs. | Consultation |
| NHS consultation on Transparency and openness in health and social care research | 2019-06-17 | 2019-09-06 | N | UK - England | NHS 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 |
| Health and Social Care Committee inquiry into NHS investment and the NHS Long Term Plan | 2010-07-09 | 2019-08-22 | N | UK - England | House 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 efficiency | 2019-07-01 | 2019-08-09 | N | France | HAS | 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). On the 11th of June 2019, the CEESP validated a second provisional version, updating the methodological guide. The purpose of the consultation is to open space for scientific exchanges on the methodological principles HAS uses to evaluate efficiency of a technology or a health program. | Consultation |
| EMA consultation: key principles for the electronic product information of EU medicines | 2019-01-31 | 2019-07-31 | N | EU | EMA | Y | The European Medicines Agency (EMA) has worked with the Heads of Medicines Agencies (HMA) and the European Commission (EC) to prepare a proposal for digitising product information for medicines marketed in the EU. The information consists of the package leaflet and Summary of Product Characteristics (SmPC), and converting them to an electronic format will enable the latest versions to be shared immediately across Europe. The EMA point to other limitations that the new format should also solve. | Consultation |
| EMA Consultation on draft guideline | 2019-01-14 | 2019-07-31 | N | EU | EMA | 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 guide | 2019-04-16 | 2019-07-15 | N | UK - England | NICE | 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 |
| HAS consultation on vaccine use | 2019-06-12 | 2019-07-10 | N | France | HAS | Y | The purpose of the drafted recommendation is to define actions that need to be taken in the absence of documentation or incomplete information on vaccination status. The recommendation was drafted with the support of a multidisciplinary group following a systematic review of the literature. | Consultation |
| AHSN and NHSX Consultation on data-driven health technologies | 2019-05-09 | 2019-07-03 | N | UK | Academic 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. | Survey |
| Regulatory Science to 2025 | 2018-12-19 | 2019-06-30 | N | EU | EMA | 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 paper | 2019-05-06 | 2019-06-28 | N | EU | EUnetHTA | Y | REQueST® (Registry Evaluation and Quality Standards Tool) is built upon the results of the PARENT joint actions with a view to help HTA organisations in guiding and evaluating registries for effective usage in HTA. 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 |
| OHE Consultation on Indication-Based Pricing (IBP) | 2019-05-10 | 2019-06-24 | N | UK | Office of Health Economics | Y | The OHE has opened a consultation on indication-based pricing, as it attempts to innovate drug reimbursement to bring practices into line with industry developments. | Consultation |
| Feedback on blended payment model | 2019-04-26 | 2019-05-31 | N | UK - England | NHS Improvement | O | NHS Improvement is gathering feedback on the operation of its new blended payment model for emergency and mental health care | Consultation |
| Nominations for High Cost Drugs list | 2019-04-23 | 2019-05-31 | N | UK - England | NHS England | G | Nominations for drugs (and devices) to be added to (or removed from) the High Cost Drugs and Devices Lists in the next iteration (2020/21) of the National Tariff | Consultation |
| Preventing abuse of the R&D tax relief for SMEs | 2019-03-28 | 2019-05-24 | N | UK | HMRC | 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 |
| NICE Consultation on proposed changes and additions to existing NICE menu indicators used in the QOF and new NICE indicators | 2019-04-17 | 2019-05-16 | N | UK - England | NICE | Y | This consultation presents amended and new indicators with a focus on personalised care, addressing over- and under-treatment, and ensuring the best outcomes for patients. New NICE indicators included are: proposed changes and additions to existing NICE menu QOF indicators in the QOF, new indicators for general practice and new indicators - local authority. | Consultation |
| UPDATED DEFINITION OF HTA | 2019-03-20 | 2019-04-30 | N | International | HTAi | 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 medicines | 2019-04-03 | 2019-04-19 | N | UK | Genetic 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 |
| Role of big data for evaluation and supervision of medicines in the EU | 2019-02-15 | 2019-04-15 | N | Europe | EMA / HMA | Y | Stakeholder and public consultation on the conclusions of the Februrary 2019 summary report on the HMA-EMA Joint Big Data Taskforce. | Consultation |
| OLS Survey on EAMS | 2019-02-18 | 2019-03-08 | N | UK | Office for Life Sciences | G | The Early Access to Medicines Scheme (EAMS) gives patients with life threatening or seriously debilitating conditions early access to new medicines that do not yet have a marketing authorisation, when there is a clear unmet medical need. Since the scheme launched in 2014, over 1,500 patients have benefited from EAMS, with 69 Promising Innovative Medicine (PIM) designations and 22 Scientific Opinions (SOs) being issued. The Office for Life Sciences (as part of the Department for Health and Social Care) is seeking to collect views from industry to assess i) overall awareness of the scheme, ii) how widely it is being used, iii) how it is perceived and iv) the priority potential areas for change. OLS have asked the ABPI, BIA and EMIG to circulate this survey to their members to obtain a wide-range of views. | Survey |
| Peer Approved Clinical System (PACS) Tier Two – 6-month review | 2019-02-19 | 2019-02-28 | N | UK - Scotland | Scottish Government | Y | Early reservations were raised by NHS Boards ahead of the launch of PACS Tier Two. The former Cabinet Secretary for Health and Sport was aware of these concerns held by the NHS in Scotland and noted that there would be reviews of the policy after 6 and 12 months. | MAP story |
| NHS England: Items which should not routinely be prescribed in primary care | 2018-11-28 | 2019-02-28 | N | UK - England | NHS 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 |
| 2019/20 National Tariff Payment System - Statutory Consultation | 2019-01-23 | 2019-02-21 | N | UK - England | NHS Improvement | G | NHS Improvement has opened the statutory consultation on proposals for changes to the National Tariff; this follows an informal consultation in the autumn | Consultation |
| Public Health Outcomes Framework | 2019-01-21 | 2019-02-17 | N | UK - England | PHE | 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 |
| EMA epilepsy consultation | 2018-09-17 | 2019-02-17 | N | Europe | EMA | 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 |
| ICER consultation on drug pricing in USA | 2019-01-17 | 2019-02-13 | N | USA | ICER | G | With guidance from a multi-stakeholder advisory group — comprising representatives from patient advocacy groups, pharmaceutical companies, and payers representing both Medicaid and the private market — ICER has developed a draft protocol for how it will conduct its UPI assessments. ICER proposes that its 2019 report will focus on up to 13 prescription drugs that experienced the most significant US price increases over the past 24 months, based primarily on which net price increases resulted in the largest overall budget impact for the US health system. ICER will review changes in the evidence base for each of these drugs and assess whether or not new clinical data exists that could suggest that the drugs could be significantly more beneficial for patients than what was previously understood. A public comment period is now open for the draft protocol, and ICER will consider all feedback when finalizing its methodology for this initiative. | Consultation |
| Consultation on transparency in engagement between the EMA and medicines producers prior to application for market authorisation | 2018-10-07 | 2019-01-31 | N | EU | European Ombudsman | Y | European Ombudsman inquiry into EMA processes for pre-submission engagement with companies. The Ombudsman is looking at the role of these in facilitating the development and availability of innovative medicines, and the risks to the objectivity around the authorisation process. | Consultation |
| Evidence standards framework for digital health technologies | 2018-12-10 | 2019-01-07 | N | UK - England | NICE | 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 launched | 2018-10-12 | 2019-01-04 | N | EU | European 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 | 2018-10-25 | 2018-12-31 | N | USA, but impact will be global | US 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 consultation | 2018-09-17 | 2018-12-16 | N | Europe | EMA | 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 services | 2018-10-12 | 2018-12-11 | N | UK | NHS 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) | 2018-09-20 | 2018-11-14 | N | EU | Technopolis | 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 consultation | 2018-10-04 | 2018-11-01 | N | UK | MHRA | 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 Practice | 2018-08-09 | 2018-10-31 | N | Europe | European 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 Tariff | 2018-10-09 | 2018-10-29 | N | UK - England | NHSI / NHSE | G | Stakeholder engagement exercise consulting on published proposals for the 2019/20 National Tariff. | Consultation |
| NICE: Drug allergy diagnosis and management consultation | 2018-10-03 | 2018-10-16 | N | UK - England | NICE | 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 care | 2018-09-18 | 2018-10-15 | N | UK | Health 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 |
| Consultation on ABPI Code of Practice | 2018-08-29 | 2018-10-10 | N | UK | PMCPA (ABPI) | G | Consultation on changes to the ABPI Code of Practice | Consultation |
| NHSE Consultation on long-term plans for the NHS in England | 2018-08-24 | 2018-09-30 | N | UK - England | NHS 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 |
| ANSM Consultation on paracetamol safety | 2018-08-20 | 2018-09-30 | N | France | ANSM | 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 |
| NHS England Consultation on evidence based interventions | 2018-07-04 | 2018-09-28 | N | UK - England | NHS England | G | Public consultation on the design principles of the evidence based intervention programme | Consultation |
| Statutory scheme to control costs of branded health service medicines | 2018-08-07 | 2018-09-18 | N | UK | Department 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 |
| NICE charging for Technology Appraisal (inc. HST) plus amendments to Appeal Panels | 2018-08-09 | 2018-09-14 | N | UK - England | NICE / 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 MAP Response |
| NHS England Consultation on GP contract reform | 2018-07-04 | 2018-08-31 | N | UK - England | NHS England | G | Proposed contract changes around payments for regional variations and digital implementations. | Consultation |
| HIQA Consultation on ePrescriptions | 2016-07-18 | 2018-08-31 | N | Republic of Ireland | HIQA | 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 Ireland | Consultation |
| Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry | 2018-06-29 | 2018-08-21 | N | Europe | EMA | 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 System | 2018-05-02 | 2018-08-03 | N | Europe | European 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) Report | 2018-02-26 | 2018-07-02 | N | UK - England | Department 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 manual | 2018-04-03 | 2018-06-25 | N | UK | NICE | 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 rights | 2018-04-06 | 2018-06-08 | N | UK - 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 2007 | 2018-03-14 | 2018-06-06 | N | UK - Scotland | Scottish 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 definition | 2018-02-06 | 2018-05-06 | N | Europe | European 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 contracts | 2018-01-25 | 2018-04-19 | N | UK - England | NHS 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 preserved | Consultation |
| Sharing data for the "NICE Technology Appraisals in the NHS in England" | 2018-02-05 | 2018-04-04 | N | UK - England | NICE | 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 consultation | 2017-12-12 | 2018-03-16 | N | UK | General 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 |
| Conditions for which over the counter (OTC) items should not routinely be prescribed in primary care: A consultation on guidance for CCGs | 2017-12-20 | 2018-03-14 | N | UK - England | NHS 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 MAP Response |
| Consultation on proposed changes to the technology appraisals programme - phase 2 | 2018-01-19 | 2018-03-01 | N | UK - England | NICE | 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 inquiry | 2018-02-23 | 2018-02-27 | N | UK | Public 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 demand | Consultation |
| Public release of clinical information | 2017-12-09 | 2018-02-22 | N | Canada | Health Canada | Y | Health Canada invites stakeholder's comments on how it carries out this proposal, including the:
| Consultation |
| PMPRB Guidelines Scoping Paper – High Level Overview of Potential New Framework | 2017-12-02 | 2018-02-15 | N | Canada | PMPRB | 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 parts | Consultation |
| Naming of Biologic Drugs | 2018-01-18 | 2018-02-09 | N | Canada | Health 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 NHS | 2017-12-01 | 2018-02-01 | N | UK - England | NHS 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 Consultation | 2017-12-18 | 2018-01-26 | N | UK - Scotland | Scottish 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 | 2017-10-18 | 2018-01-24 | N | UK - England | NHS 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 needed | Consultation |
| AWMSG Five Year Strategy 2018-2023 | 2017-12-15 | 2018-01-19 | N | UK - Wales | AWMSG | 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 disorders | 2017-12-15 | 2018-01-18 | N | UK | NICE | G | The National Institute for Health and Care Excellence has opened a consultation on Serious eye disorders. | Consultation |
| Regulatory fees for 2018/19 | 2017-10-26 | 2018-01-18 | N | UK - England | Care 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 engagement | 2017-12-15 | 2018-01-15 | N | UK | NICE | 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 diseases | 2017-12-11 | 2018-01-08 | N | Europe | European 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 exemptions | 2017-10-12 | 2018-01-04 | N | Europe | European 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 |
