scholarly journals Earlier Patient Access – the UK Early Access to Medicines Scheme (EAMS)

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000009 ◽  
Author(s):  
Daniel J. O'Connor ◽  
Keith McDonald ◽  
Siu Ping Lam
Keyword(s):  
Access To Medicines ◽  
Public Consultation ◽  
Treatment Protocols ◽  
Government Response ◽  
Early Access ◽  
Scientific Opinion ◽  
Life Threatening ◽  
The Uk ◽  
Insight Into ◽  
Innovative Medicine

The Early Access to Medicines Scheme (EAMS) was launched in the UK in April 2014 following a public consultation and government response, which outlined the scope of a potential scheme. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for two pivotal milestone decisions in the EAMS process: the Promising Innovative Medicine (PIM) designation and the EAMS scientific opinion, described in an EAMS public assessment report and 3 EAMS treatment protocols. In the 3 years since its launch, hundreds of patients with life-threatening or seriously debilitating conditions have benefited from EAMS medicines in a variety of mainly oncology indications. This editorial describes some of the achievements of the scheme over the past 3 years and provides insight into how the scheme may evolve over the coming years.

Pathways to faster access to medicines

2018 ◽  
Vol 56 (8) ◽  
pp. 93-96 ◽  
Keyword(s):  
Treatment Options ◽  
Clinical Trial Data ◽  
Access To Medicines ◽  
Trial Data ◽  
European Medicines Agency ◽  
The European Union ◽  
Life Threatening ◽  
The Uk ◽  
New Treatments ◽  
The Impact

Before a medicine can be marketed in the UK, marketing authorisation approval is needed from the European Medicines Agency (EMA) or the Medicines and Healthcare products Regulatory Agency (MHRA). However, the time it takes to appraise a medicine is considered by some to delay access to new treatments for people with serious or life-threatening conditions who have no other treatment options. Also, the standard regulatory process may be less suitable for medicines for rare conditions in which it is difficult to gather a large amount of clinical trial data. Here we look at a range of new regulatory and access pathways that have been developed to respond to these challenges and consider some of their potential pitfalls. In a future article we will review the impact that the UK’s departure from the European Union (EU) will have on licensing processes.

scholarly journals Validity of the UK early access to medicines scheme criteria for Remdesivir use in patients with COVID-19 disease

2020 ◽  
Vol 81 (4) ◽  
pp. 647-679 ◽  
Author(s):  
Anna Daunt ◽  
Pablo N. Perez-Guzman ◽  
Felicity Liew ◽  
Katharina Hauck ◽  
Ceire E. Costelloe ◽  
...  
Keyword(s):  
Access To Medicines ◽  
Early Access ◽  
The Uk

scholarly journals Transition of Pharmaceutical Regulations: The New Regulatory Era after Brexit

2021 ◽  
pp. 804-817
Author(s):  
Trivedi Ankit ◽  
Deshpande Shrikalp ◽  
Zaveri Maitreyi ◽  
Jain Praveen Kumar ◽  
Kolhe Kiran
Keyword(s):  
Clinical Trials ◽  
Transition Period ◽  
Access To Medicines ◽  
Pharmaceutical Sector ◽  
Legal Representation ◽  
Early Access ◽  
Regulatory Changes ◽  
Life Threatening ◽  
Stakeholder Input ◽  
New Guidelines

Aims: The current research paper describes the regulatory changes in different pharmaceutical sectors, which are affected after the Brexit and build new guidelines that were derived from the Medicines and Healthcare Products Regulatory Agency (MHRA). Study Design: Retrospective and concurrent review were employed to get idea regarding the regulatory changes in various pharmaceutical sectors that took place after dissimilation of Europe and Britain. Place and Duration of Study: The present study was carried out at Amneal Pharmaceutical Ltd., from January 2021 to April 2021. Methodology: On January 1, 2021, the MHRA had published a library of new guidance that applied as the transition period came to an end. This guidance covers the various sectors of pharmaceuticals like Clinical trials, medical devices, Importing and Exporting of pharmaceuticals, Legislation, New licensing, Pharmacovigilance and Pediatrics, which are affected due to Brexit. Results: The MHRA laid out the future BRITAIN requirements for registering clinical trials, legal representation and importing Investigational Medicinal Products (IMPs) after the end of the Brexit, Pediatric Investigation Plan (PIP) must be included in an application for BRITAIN marketing authorization (MA). Change in Licensing procedure and the Innovative licensing and access Pathway (ILAP) provides opportunities for enhanced regulatory and other stakeholder input, including interactions with National Institute for Health and Care Excellence. Early Access to Medicines Scheme (NICE.EAMS) providing access to unlicensed, promising treatments to patients who have life threatening or rare disease indications. Conclusion: To ensure the new approach builds on our previous success and exploits the opportunities that arise from Brexit, the industrial strategy should adopt a sophisticated supply chain view to develop an empirical base for pragmatic, joined up policies to help pharmaceutical sector grow. These policies and support will drive the BRITAIN’s pharmaceutical sector in a Post-Brexit era.

scholarly journals Public governance, agility and pandemics: a case study of the UK response to COVID-19

2021 ◽  
pp. 002085232098340
Author(s):  
Paul Joyce
Keyword(s):  
Leadership Role ◽  
Public Confidence ◽  
Strategic Decisions ◽  
Public Governance ◽  
Local Initiative ◽  
Government Response ◽  
Local Resources ◽  
The Government ◽  
The One ◽  
The Uk

The UK government’s leaders initially believed that it was among the best-prepared governments for a pandemic. By June 2020, the outcome of the collision between the government’s initial confidence, on the one hand, and the aggressiveness and virulence of COVID-19, on the other, was evident. The UK had one of the worst COVID-19 mortality rates in the world. This article explores the UK government’s response to COVID-19 from a public administration and governance perspective. Using factual information and statistical data, it considers the government’s preparedness and strategic decisions, the delivery of the government response, and public confidence in the government. Points for practitioners Possible lessons for testing through application include: Use the precautionary principle to set planning assumptions in government strategies to create the possibility of government agility during a pandemic. Use central government’s leadership role to facilitate and enable local initiative and operational responses, as well as to take advantage of local resources and assets. Choose smart government responses that address tensions between the goal of saving lives and other government goals, and beware choices that are unsatisfactory compromises.

Specialist infantry and defence engagement

2020 ◽  
pp. bmjmilitary-2020-001455 ◽  
Author(s):  
Jonathan Blair Thomas Herron ◽  
K M Heil ◽  
D Reid
Keyword(s):  
Armed Forces ◽  
Short Term ◽  
The Future ◽  
Uk Government ◽  
The Uk ◽  
Insight Into

In 2015, the UK government published the National Strategic Defence and Security Review (SDSR) 2015, which laid out their vision for the future roles and structure of the UK Armed Forces. SDSR 2015 envisaged making broader use of the Armed Forces to support missions other than warfighting. One element of this would be to increase the scale and scope of defence engagement (DE) activities that the UK conducts overseas. DE activities traditionally involve the use of personnel and assets to help prevent conflict, build stability and gain influence with partner nations as part of a short-term training teams. This paper aimed to give an overview of the Specialist Infantry Group and its role in UK DE. It will explore the reasons why the SDSR 2015 recommended their formation as well as an insight into future tasks.

The RUMA Alliance targets: an overview

Livestock ◽  
2021 ◽  
Vol 26 (4) ◽  
pp. 176-179
Author(s):  
Chris Lloyd
Keyword(s):  
Task Force ◽  
Animal Health ◽  
Antibiotic Use ◽  
Codes Of Practice ◽  
The Government ◽  
The Uk ◽  
Ongoing Support ◽  
The Impact ◽  
Insight Into ◽  
Roll Out

The Responsible Use of Medicines in Agriculture Alliance (RUMA) was established to promote the highest standards of food safety, animal health and animal welfare in the British livestock industry. It has a current focus to deliver on the Government objective of identifying sector-specific targets for the reduction, refinement or replacement of antibiotics in animal agriculture. The creation and roll out of sector specific targets in 2017 through the RUMA Targets Task Force, has helped focus activity across the UK livestock sectors to achieve a 50% reduction in antibiotic use since 2014. This has been realised principally through voluntary multi-sector collaboration, cross sector initiatives, codes of practice, industry body support and farm assurance schemes. This article provides an overview of RUMA's work to date providing insight into the methods used to create the targets, why they are so important, the impact they are having and how ongoing support and robust data are vital components in achieving the latest set of targets.

scholarly journals A Case Study of a Negotiated Tender within a Small-to-Medium Construction Contractor: Modelling Project Cost Variance

Buildings ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 260
Author(s):  
James Ellis ◽  
David John Edwards ◽  
Wellington Didibhuku Thwala ◽  
Obuks Ejohwomu ◽  
Ernest Effah Ameyaw ◽  
...  
Keyword(s):  
Construction Industry ◽  
Study Data ◽  
Review Literature ◽  
Third Party ◽  
Open Book ◽  
Competitive Tendering ◽  
Construction Contractor ◽  
The Uk ◽  
Insight Into

This research explores the failure of competitively tendered projects in the UK construction industry to procure the most suited contractor(s) to conduct the works. Such work may have equal relevance for other developed nations globally. This research seeks to teach clients and their representatives that “lowest price” does not mean “best value”, by presenting a case study of a successfully negotiated tender undertaken by a small-to-medium enterprise (SME) contractor; SME studies are relatively scant in academic literature. By applying the “lessons learnt” principle, this study seeks to improve future practice through the development of a novel alternative procurement option (i.e., negotiation). A mixed philosophical stance combining interpretivism and pragmatism was used—interpretivism to critically review literature in order to form the basis of inductive research to discuss negotiation as a viable procurement route, and pragmatism to analyse perceptions of tendering and procurement. The methods used follow a three-stage waterfall process including: (1) literature review and pilot study; (2) quantitative analysis of case study data; and (3) qualitative data collection via a focus group. Our research underscores the need to advise clients and their representatives of the importance of understanding the scope of works allowed within a tender submission before discounting it based solely on price. In addition, we highlight the failings of competitive tendering, which results in increased costs and project duration once the works commence on site. These findings provide new contemporary insight into procurement and tendering in the construction industry, with emphasis on SME contractors, existing relationships, and open-book negotiation. This research illustrates the adverse effects of early cost estimates produced without first securing a true understanding of project buildability and programming. Our work concludes with a novel insight into an alternative procurement option that involves early SME contractor involvement in an open-book environment, without the need for a third-party cost control.

Agricultural Multifunctionality and Care Farming: Insight from the UK

2015 ◽  
Vol 4 (1) ◽  
pp. 74-86
Author(s):  
Paul Custance ◽  
Keith Walley ◽  
Gaynor Tate ◽  
Goksel Armagan
Keyword(s):  
Learning Material ◽  
Multifunctional Agriculture ◽  
Economic Support ◽  
International Audience ◽  
The Uk ◽  
Generic Points ◽  
Care Farming ◽  
Compare And Contrast ◽  
Insight Into

The purpose of the article is to provide insight into care farming and the role that it may play in agriltural multifunctionality. The paper outlines three case studies of care farming in the UK to compare and contrast the roles that such organizations may play in multifunctional agriculture. Although the work has the obvious limitation of being based on case-study care farms that are based in the UK, the findings are sufficiently generic to serve as valuable learning material for those interested in the subject and located anywhere in the world. The main finding from this study is that care farming can take many different forms but still contribute to agricultural multifunctionality. The study also confirms the important roles that economic support and favourable legislation play in successful care farming. The paper concludes that care farming is a legitimate form of agricultural multifunctionality but reminds those interested in setting up or promoting care farms of the need for a supportive economic and legislative environment. The paper provides contemporary insight into the concept of care farming as a form of agricultural multifunctionality. A number of generic points are made that should be of value to an international audience of academics researching in this area as well as students studying care farming and agricultural multifunctionality, farmers considering diversifying into care farming and politicians working to create a political and economic environment that may support care farms.

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