Having been highlighted again last weekend by Prime Minister Theresa May as being among the industries of key concern in the Government’s battle to achieve the best deal for the UK, the likely impact of Brexit on the Pharmaceutical industry and Life Sciences industry will be the topic under discussion at our next roundtable event on 20th March.
With the UK being one of the world’s leading innovators and exporters of pharmaceuticals and medical devices, our Life Sciences sector contributed £30.4 billion to the economy and supported 482,000 jobs in 2015. As most major players in the sector operate globally, Brexit will inevitably cause major disruption across EU drug supply chains. Pharmaceutical companies nationwide are currently working out how to unravel decades of EU integration - UK-based businesses hold the market authorisations or licences for over 2,000 medicines in the EU.
One of the key challenges facing the pharma sector is uncertainty about future funding. Over the last 40 years, companies have tended to co-operate internationally and work together on major projects, supported by EU funding. In fact, Europe has failed to invest in the sector compared to other global regions and the Association of the British Pharmaceutical Society (ABPI) is also concerned that the lack of investment in the NHS may encourage drugs companies to abandon the UK. Additionally, some UK universities are worried that they will miss out on new opportunities to participate in EU funded projects due to uncertainty around Brexit.
Of equal concern is the issue of regulation. For heavily regulated industries like pharmaceuticals and medical devices, the fact that EU law is incorporated into the UK’s legal framework has far reaching consequences, providing opportunities as well as challenges. The Government has announced that it intends to repeal the European Communities Act and transfer the body of existing EU law into UK law, with decisions to be addressed in the future about which legislation will remain. Organisations like ABPI are already working with regulators and Government on all relevant aspects of this. It is also likely that Brexit will result in increased costs to protect intellectual property rights (the industry’s most valuable asset) as, rather than using the EU wide registered rights currently available, separate UK registered rights will be required for trademarks and registered designs.
What’s more, as UK-based businesses increasingly explore export beyond European markets, the risk of IP theft will also rise. As pharmaceutical companies spend billions on R&D every year to develop patented drugs and devices; their IP can be an attractive target for criminal activity. The need for stringent IP protection is particularly acute in emerging markets where regulatory oversight may not be as robustly enforced as in developed countries and, thus, can threaten or delay R&D. With global competition becoming fiercer, the need to protect new cures, drugs and devices has to be a top business priority.
The impact of General Data Protection Regulation (GDPR) will also be felt in the sector. While the digitisation of health care data and advances in enabling technologies have improved Life Sciences’ R&D and operational efficiency, these improvements also bring increased cyber risks, both from malicious attacks and also from the obligations of new data protection legislation. Sensitive intellectual property, personally identifiable information and protected health information will need to be safeguarded throughout the product cycle. Businesses must ensure they understand the requirements of GDPR which comes into effect on 25th May 2018 and will replace existing data protection laws throughout the UK and the EU.
Another continuing area of concern is skills shortages as the UK becomes a less attractive and accessible environment for overseas professionals. There is a very real fear that we will lose the ability to win top talent internationally. There is no doubt that if we are to retain our flourishing Life Sciences sector, we need to develop and retain employees with critical business and technology skill sets.
All of these issues will be considered by our panel of experts at our roundtable on 20th March:
- Jo Pisani, partner for PwC Strategy and UK pharma and Life Sciences consulting, will discuss the changing pharmaceutical global/UK landscape, highlighting key threats and opportunities
- Scott McDonald, director of member series at Lhasa Ltd, will explore competitive advantage through collaboration
- Andrew Swift, CEO of Fera Science Ltd, will share a post Brexit view on European funding and governance
- Sue Streatfield, legal director in the Intellectual Property team at Clarion, will give an insight into her experience of working with many international pharmaceutical businesses and the support she has provided
Taking place on Tuesday 20th March at our offices (Elizabeth House, 13-19 Queen Street, Leeds), the event will start at 11.30am with registration, followed by lunch and discussion at 12.00pm until 2.00pm.
The event is open to pharmaceutical and Life Sciences businesses only. To apply for a place, or if you have any questions regarding the event, please contact Laura Courbet on 0113 336 3348 or via email at email@example.com
Disclaimer: Anything posted on this blog is for general information only and is not intended to provide legal advice on any general or specific matter. Please refer to our terms and conditions for further information. Please contact the author of the blog if you would like to discuss the issues raised.