The latest decision concerning Supplementary Protection Certificates (SPCs) was handed down by the CJEU in the Abraxis Bioscience case (C-443/17) on 21 March. The BIA’s IP Advisory Committee (IPAC) provided informal views on behalf of the sector to the UK Intellectual Protection Office (IPO) regarding this case, to inform the UK Government’s representations to the CJEU. Andrew Hutchinson of Simmons & Simmons and a member of IPAC has provided the following analysis for BIA members.
Delivering the deal negotiated with the EU is the Government’s priority. However, preparing for any outcome is recommended and many UK-based pharmaceutical firms would be affected by a ‘No Deal’ Exit from the EU. Here are the top five tips on preparation for no-deal.
The World Health Organisation is today convening its first expert advisory committee on developing global standards for the governance and oversight of human genome editing. The aim of the two-day meeting, in Geneva, is to examine the scientific, ethical, social and legal challenges of gene-editing and create guidelines and standards for it.
The meeting follows a call last week by some 16 leading scientists from 7 countries: USA; China; Canada; France; Germany; Italy and New Zealand for a global moratorium on heritable genome editing.
N-Site is a unique knowledge portal which provides expert insight and expertise for organisations, professionals and academics in the life sciences sector. This resource is now free to all subscribers, reflecting our intention for this resource to be used by as many as possible, and offers over 85 Guidance Notes from FTI Consulting, Gill Jennings & Every and Taylor Wessing on the key issues affecting companies in the sector.
I attended and participated in the inaugural WuXi Healthcare Forum in Shanghai in March 2019, enabling me to gain a better insight into some of the key trends occurring in innovative life science in China today. Here are a few thoughts that I came away with.
In the last two years China has made a concerted attempt to, and has delivered, fundamental changes to key aspects of its human healthcare market as part of a broader Government push to improve healthcare for the nation and become a leader in biotechnology. They fall into four areas regulation, reimbursement, talent and capital.
I spent last week at the inaugural WuXi Healthcare Forum in Shanghai, and it proved to be a hugely insightful week, with over 2000 global leaders gathered. I spoke on a panel entitled ‘New Era, Golden Opportunities’ where leaders from China and the UK explored how key stakeholders are redefining the innovation narrative – opening up a new era of opportunities and connecting the global life sciences ecosystem. I also attended the British Consulate-General/BioIndustry Association official reception hosted by John Edwards, HM Consul General in Shanghai and Kevin Holland, Minister Counsellor of Life Sciences and Healthcare at the British Embassy in Beijing. You can read a blog on my thoughts from the forum and the other life sciences developments in China here. The UK’s China life sciences tea
Fantastic member news came out this morning – Nighstar Therapeutics (who feature in our Cell and Gene Therapies Explainer) have reached an agreement to be acquired by Biogen Switzerland Holdings for $877 million. Nightstar was founded and built by BIA member Syncona Ltd, an industry leader focussed on building and funding global life science leaders. This valuation represents a 4.5X multiple on Syncona’s initial investment in Nightstar and is a resounding endorsement of Syncona’s business model, demonstrating the fantastic returns obtainable through long-term commitment to companies. You can read more about this great news here.
When Brexit seemingly takes up an ever-increasing amount of time and resources, it’s important (and perhaps even – dare I say it – refreshing) to remember there are other matters of great concern for the life sciences sector.
One of those matters is this year’s Spending Review (SR)– the process by which the Government decides how much each government department will spend within a given period. This has a major impact on our sector as public funding bodies, such as UK Research and Innovation (UKRI), its Councils and the National Institute for Health Research (NIHR), are funded through government departments.
I hope this week that you have been heartened by the news that the first child has been given pioneering CAR-T cancer therapy on the NHS. We also saw announced the death of Dr Stewart Adams, the 95 year old Boots scientist who pioneered the painkiller ibuprofen in the East Midlands in the late 1950s and early 1960s (by curing his own hangover, no less). As Professor Kevin Shakesheff, from the University of Nottingham, said "He is remembered for his successes in creating one of the most important painkillers in the world but, as with many inspirational people, he had to bounce back from failures in earlier clinical trials before he and his team created ibuprofen.
"Epidemic"; "crisis"; "timebomb"; these are the dramatic terms used to describe the impact opioids continue to have on society. Evolving issues are sparking increasing concern for those involved in the development, manufacture and supply of prescription drugs, including their insurers.