Innovative Medicines Review
The UK Department of Health and the Department for Business, Innovation and Skills announced on 20 November that it will launch an initiative called the 'Innovative Medicines Review' to consider how to speed up patient access to cost-effective and innovative medicines, devices and diagnostics.
In its press release the Government acknowledges that it takes on average over a decade and £1billion to develop a new drug. However, it claims that a fresh approach, made possible by developments in genomics and digital technology, could significantly reduce the time it takes to develop new medicines, devices and diagnostics.
The 'Innovative Medicines and MedTech Review' is intended to examine:
- how access to innovative products for NHS patients could be accelerated by new approaches to the development of medicines, diagnostic and devices, based on precision medicine and emerging technologies;
- how more collaborative work between companies and regulatory and evaluation bodies can bring about quicker assessment of innovative products, using better data;
- how charities and patient groups can play a greater role so that NHS patients can get access to cutting-edge treatments;
- what more can be done to promote the rapid adoption of important medical innovations into clinical practice.
The Innovative Medicines Review is the latest initiative forming part of the Government's Strategy for UK Life Sciences (PDF).
NHS England 5 Year Forward View
NHS England has published their 5 Year Forward View. There are implications for the medical technology industry in the vision laid out, some explicit, some implicit. The Forward View also provides opportunities for continued partnership with the biopharmaceutical industry. As such the Forward View has been welcomed by the ABHI and ABPI.
MHRA 'One stop shop' on regenerative medicine
The MHRA has launched a 'one stop shop' that will provide regulatory advice for those working in the life sciences industry on regenerative medicines.
The MHRA states that the service will, for the first time, provide a single point of access to regulatory advice from the four regulatory bodies that work in the sector. It is intended that the service will help businesses and other organisations to quickly and easily navigate the different regulators, allowing better access to the right advice.
Venture capital in the Autumn Statement
The Chancellor's Autumn Statement of 3 December contains the following items relating to venture capital:
- The Government announced that, where a gain realised on or after 3 December 2014 would be eligible for Entrepreneurs' Relief but is instead deferred into investments which qualify for either EIS or Social Investment Tax Relief, the gain will remain eligible for Entrepreneurs' Relief when it is realised. The position for investments qualifying under SEIS is different, where a partial exemption from tax may apply for gains reinvested in SEIS qualifying companies.
- All community energy generation undertaken by qualifying organisations will be eligible for SITR from the date of expansion of the relief, at which point it will no longer be eligible for EIS, SEIS and VCT reliefs. All other companies which benefit substantially from subsidies for the generation of renewable energy will not be able to benefit from EIS, SEIS and VCT reliefs from April 2015.
The Government announced that it will make tax-advantaged venture capital schemes easier to use by launching a new digital process in 2016 for EIS, SEIS and SITR and a new format of VCT return.
Taylor Wessing contributed several observations and suggestions to the consultation on the UPC 17th draft Rules of Procedure that took place in Trier, Germany on 26 November 2014.