Regulatory in Thoughts from the Centre
- Select a blog category
My Take: Highlights from the 2018 FT Conference panel discussion on the potential for a successful life sciences economy in the UK
By John Haughey, Deloitte Industry Leader, Life Sciences & Health Care
Earlier this month I had the pleasure of chairing a panel of life science experts at the Global Financial Times Pharmaceutical and Biotechnology conference.1 The conference brought together some of our industry’s leading minds to discuss the commercial conundrums of disease prevention, the transformational impact of advanced gene and cell therapies and the hope and hype of patient-centricity. The discussion topic for my panel was - ‘Big Bang? Industrial Strategy - Creating a Successful Life Sciences Economy’, and was focused on the UK’s Industrial Strategy and in particular the UK’s sector deal for life sciences.2 In this week’s blog I wanted to share some of my key takeaways from our animated and insightful discussion.
By Karen Taylor, Director, Centre for Health Solutions
Following our 2014 and 2017 Life Science and Health Care Predictions reports, ‘A bold future?’ and ‘The future awakens’, this week we launched our third predictions report, A bold future for Life Sciences Regulation: Predictions 2025. This year’s report presents an unashamedly optimistic view on what Life Sciences regulation might look like in 2025 if both life science companies and regulators were to work more collaboratively, embrace disruptive technologies, and acquire new skills and talent. We argue that this would improve not only the productivity of the regulators and industry but also provide patients with access to the latest medical innovation much sooner. We also imagine through a series of ‘portraits’ how a regulator, company and patient might behave in 2025. This week’s blog provides an overview of the four predictions presented in our future of regulation report and examples of the evidence today that enable us to predict a bold future for life sciences regulation in 2025.
Keep calm and carry on: How can the healthcare and life sciences industries weather the Brexit storm?
We have now had the best part of a week to absorb the momentous news that the UK has voted to leave the European Union. Much has been written about this seismic event and, following our blog in February this year, on what Brexit might mean for the healthcare and life sciences industries,i we thought we should use this week’s blog to update our views on the potential risks and opportunities for our life sciences and healthcare sectors.
The Conservatives' 2015 election manifesto committed to hold a referendum by 2017 on whether or not the UK should stay in or leave the European Union. Increasing unrest among Eurosceptic politicians and a narrowing of the polls on the likely outcome of the vote has led to the suggestion that the referendum could be held as early as June or September 2016. While all industries are speculating on the potential impact of an “out” vote, the global pharmaceutical industry faces some very specific concerns. This blog considers some of the main questions that the pharmaceutical industry is contemplating as part of the in/out debate.
This week we're delighted to feature a guest blog written by Fiona Maini and Sarah Chan who both work in Deloitte's Risk Advisory practice. The focus is on the new clinical trials regulation and what it means for Life Science companies.
This week the Kings Fund published its report 'The NHS under the coalition government'. This report examines the NHS’s performance between 2010 and 2015, based on routinely available data (inputs such as funding and staffing and outputs such as hospital admissions and A&E attendances). It also draws on surveys of patient and staff experience; data on access and waiting times targets; and measures of safety and quality of care. The report concludes with an analysis of NHS productivity and an assessment of its prospects in the next parliament and beyond.i
This week the Center for Health Solutions is delighted to bring you a guest blog from one of our regulatory compliance specialists in health care and life sciences:
Off-label prescribing is the prescription of a drug for an indication or for an age group, dose or form of administration for which it is not approved. Recently, it has become a thorny topic for the life sciences industry, regulators and healthcare payers, with high profile cases arising in France and Italy.
In one of our previous blogs we discussed the US Food and Drug Administration’s (FDA’s) introduction of the ‘breakthrough’ designation concept as a way of improving earlier access to medicines for patients with high unmet medical need. In this blog we’re focussing on the Early Access to Medicines Scheme (EAMS), a similar scheme launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2014.
In December 2012, the Deloitte Centre for Health Solutions’ report ‘Telecare and telehealth- a game changer for health and social care’ focussed on the costs and benefits of scaling up the adoption of traditional telecommunication technology. Given that the adoption of mobile technology in healthcare was still in its infancy we proposed returning to the use of mobile technology at a later date.