Industry Leaders Speak at Pharma & Life Sciences Conference; MHRA Challenges, VPAS Management, Skills Gaps and Industry Premises Debated

This year the conference was held in association with EMIG (Ethical Medicines Industry Group). The event brought together industry experts and thought leaders from the life sciences sector to address the challenges posed by the post-Brexit and COVID landscape.

Paul Gershlick, VWV's Partner and Head of the Pharmaceuticals and Life Sciences sector and Chair of PING, said: "After the last three very positive PING Conferences, this year was a reality check. The MHRA issues and VPAS in particular are presenting big challenges for pharma in the UK. However, if these are addressed, the future still looks very bright for life sciences in the UK, with leading academia, a single healthcare system as a testbed for innovations and a globally recognised industry - particularly in exciting future areas such as cell and gene therapies and AI."

The Conference featured four thought-provoking sessions on topical themes including the MHRA in transition, the future of VPAS/VPAG, skill shortages and the challenge of finding industry suitable premises.

The MHRA is in Transition - What can Industry Do?

The first session of the afternoon focused on the regulatory shortages and delays with the applications to the MHRA after Brexit, which are threatening the viability of product launches in the UK. Improving patient health and access to effective medicines remains the mission of the MHRA, as the Agency works through the post-Brexit challenges.

Key takeaways:

• The MHRA is taking steps to reduce the delays in licensing products. These steps include boosting recruitment and training of assessors, improving the expertise of existing assessors, prioritising applications, and publishing performance data.
• The MHRA appoints Head of AI: The MHRA has appointed a new Head of AI to improve efficiency and explore the use of AI for assessment. AI could be used to identify potential risks, automate some of the assessment process, or improve the overall efficiency of the process.
• The MHRA is working on an international recognition framework that would allow it to recognise decisions of regulators from other countries. This would reduce the duplication of work and make the licensing process more efficient.

Speakers were Dr Shirley Hopper, Deputy Director, Innovative Medicines, HQA at the MHRA; and Dianne Lee, Chair, Hertfordshire LEP Life Sciences Industry Panel, and CEO, DLRC

Summing up her views on the pressing issues faced by the MHRA, Dianne said: "From a regulatory perspective there are some clear challenges that our agency, MHRA, has been facing very much like the rest of business. Changes in the way people want to work, and ‘the great resignation’ has impacted all employers. However, as the Agency works through these challenges and negotiates the UK position outside the EU, I believe there are some great opportunities that will have a positive impact on UK business. In turn this will assist life sciences companies in Hertfordshire to navigate the global regulatory maze that is drug/device development."

Can Pharma Continue to Supply Profitably in the UK under VPAS / VPAG?

VPAS has been one of the most talked about topics in the pharma industry this year. VPAS is a voluntary scheme within the pharma industry to assist the DHSC regulate the amount spent on branded medicines by the NHS. In 2019, the percentage reimbursement was 9.6%, but this figure has surged up to 26.5% for 2023, leading to widespread criticism by the industry.

Key takeaways:

• To bring a new active substance to the NHS, a supplier must receive NICE approval for cost effectiveness resulting in up to 80% discount on marketed price, before further possible reductions to receive NHSE’s approval for affordability, and only then to be subjected to the VPAS rebate on top of that.
• Rather than being based on a particular supplier’s growth and margin, VPAS is based on the growth in industry’s spend overall. This means that a supplier showing 2% annual growth could be subject to a 26.5% levy payment. It also affects suppliers with the same percentage, whether they were on slim margins or much bigger. One proposal is for the most severely affected businesses could be taken out of the scheme and put into a separate scheme altogether.
• For VPAS not to act as a barrier to external investment, a fixed, single figure percentage rebate should be applied to all in-scope medicines, providing certainty and ensuring medicines are not sold at a loss. This would encourage investment from the US due to the high esteem that the UK’s medical regulatory bodies are held in.

Speakers for this session were Leslie Galloway, Chair, Ethical Medicines Interest Group (EMIG); and Richard Williams, Principal, RFW Associates

Leslie Galloway, Chair of EMIG was in conversation with VPAS expert Richard Williams of RFW Consultancy on the voluntary pricing scheme and its potential impact on the industry. The discussion focused on the burden of the unbudgeted 26.5% tax in 2023 and its potential consequences for pharma companies operating in the UK, as well as looking at what could happen in the next five year deal.

Describing how key an issue VPAS is to pharma, Richard Williams emphasised: "The 2024 VPAS is the most important issue facing the branded pharmaceutical industry. Pharma cannot continue with rebates of 26.5% and Government hasn’t the budget to materially reduce them. Who blinks first?".

“You Just Can’t Get the Staff”... or Can You?

The third session of the afternoon focused on the perception that there are skills shortages in the pharmaceuticals and life sciences industry, presenting significant challenges for businesses.

Key takeaways:

• The new skilled visa worker process includes tradeable points that can be reduced for those with STEM degrees or PhDs. The digital transformation of the process is set to significantly reduce turnaround times. The Home Office is in conversation with the Department of Health and Social Care about adding roles such as lab technicians to the shortage occupation list. Businesses wanting to see further jobs added to the shortage occupation list should partake in the calls for evidence in the first instance.
• The life sciences sector currently needs around 25,000 workers with at least a BSc, a figure that is predicted to rise soon to 39,000. This signifies a shift from a skills to a knowledge economy. 13.5% of current UK students are undertaking STEM degrees, suggesting that there is a greater pipeline of qualified candidates. SITEC and the University of Hertfordshire are providing practical and industry-focused skills to have students ready for the world of work.
• Only 820 industrial placements were provided to students in 2022. Industry partners can do more to engage with colleges and higher education to ensure graduates are entering the job market with the requisite skills. This might be by providing work experience, but would also include working with universities to develop programmes to meet the needs of the industry.

Speakers were Adam Lee, Work Services - Operations Lead, Visa, Status and Information Services, The Home Office; Prof Darragh Murnane, Professor of Pharmaceutics & Associate Dean for Business and Enterprise, University of Hertfordshire; Dr Kate Asante, Director of Business Development & Engagement, University of Hertfordshire; and Kit Davies, CEO and Principal at SITEC, at the North Hertfordshire College; session led by VWV Employment Law Partner, Bob Fahy

Kit Davies, CEO and Principal at SITEC, at the North Hertfordshire College, noted that he was "delighted to have spoken at the PING conference and shared the amazing work that is happening at North Hertfordshire College around Skills and Apprenticeship developments in the Life Science sector. Exciting times are ahead, made possible through education and industry collaboration and partnership working."

Dr Kate Asante, Director of Business Development & Engagement at the University of Hertfordshire commented: "The University of Hertfordshire is a passionate educator of life sciences, partnering with post-16 colleges, employers, professional and regulatory bodies to develop industry-relevant curriculum to meet crucial skills gaps. Through that collaboration, our 4,000 life sciences students are work-ready and able to respond to real-world needs."

Where Are the Hidden Gems to Locate?

The final session of the day focused on the apparent shortage of space for the industry in the UK. The issue is not necessarily a lack of space, but rather finding the right kind of space in the right location. Where the business is in the commercialisation process will determine the type of space that it needs. It may require research and development, scale up, or large scale GMP compliant manufacturing space.

Key takeaways:

• The space is out there and within the Golden Triangle and in other locations in the country, but the developers are currently catering for the immediate demand rather than taking a long term view on how space needs evolve as a pharmaceutical business develops.
• To compete with the very established markets, such as Boston in the US, the UK needs to take a long term and national approach to develop the right kind of space.
• Universities and hospitals can act as anchors within the industry, both for recruiting talent and accessing the cutting edge developments. Having a variety of businesses in different stages of their journey on the same site helps grow the culture and appeal of working in the sector in any given location.

Speakers were Rob Burborough, Partner, 3PM; Sally Bedwell, Senior Business Development Manager - Northern Home Counties, Morgan Sindall; Dr Ivana Poparic, Head of Cluster Development, MedCity; Miranda Knaggs, Corporate Development Director, Pioneer Group; Dr Ashley Brewer, CEO, Science Creates Incubators; and Prof Gino Martini, CEO, Precision Health Technologies Accelerator; session led by VWV Commercial Property Associate, Aanika Shah.

Hertfordshire Overview

The success of the PING Conference would not have been possible without the generous support and sponsorship from the Hertfordshire LEP and the University of Hertfordshire. Their commitment to fostering innovation and growth in the life sciences sector has been instrumental in making this conference a resounding success.

Paul Witcombe, Life Sciences and Advanced Manufacturing Lead at the Hertfordshire LEP, commented: "Once again the Hertfordshire LEP is delighted to support the PING conference – a place where Life Sciences businesses come together in Hertfordshire to share ideas on key issues. This year, Navigating Stormy Waters addressed topics resulting from the UK leaving the EU and challenges since the global pandemic as government and industry feels its way to a different future. While these issues are much broader than our county boundaries, the huge impact affects us all."

For more information about the Pharmaceutical Industry Network Group (PING) and Pharmaceuticals and Life Sciences Law, please contact Paul Gershlick on 07795 570 072, or complete the form below.