Regulatory in Thoughts from the Centre
- Select a blog category
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.
According to Forbes, annual global sales of counterfeit drugs were estimated to have reached approximately $200 billion in 2011.
Pharmaceutical companies face a very real and immediate challenge to achieve sustainable Research and Development (R&D) models and produce affordable treatments. The rising cost of drug development, highlighted in Deloitte’s return on pharmaceutical innovation research, is a key part of this challenge which could be addressed through transforming the way clinical trials are conducted.
The Internet has not only changed the way people communicate, it has become a powerful and important resource for health information.
According to the Federation of Indian Chambers of Commerce and Industry (FICCI), globally, India ranks third for pharma manufacturing volume and 14th in terms of value.