The UK has historically had a strong tradition in pharmaceutical production. James Christie, ABPI Project Director for Manufacturing, looks at initiatives aimed at strengthening the UK’s position in the fast-changing global manufacturing sector
When we think of UK manufacturing success stories, aerospace and the automotive industry tend to be foremost in people’s minds – names such as BAE Systems and Rolls Royce. The important role of medicines manufacturing in the UK is often overlooked, despite being one of the country’s leading manufacturing sectors. It continues to provide the greatest Gross Value Added (GVA) per employee of any UK manufacturing sector and has exports worth £24bn.
Maintaining this position in an increasingly competitive landscape, and meeting the emerging challenges of stratified and personalised medicines, will require the adoption of novel strategies to speed development times, cut costs and retain and develop medicines manufacturing in the UK. The demands on the sector for affordability and improved access to care will reshape the industry.
Last year, the Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) launched the Medicines Manufacturing Industry Partnership (MMIP) to ensure that the UK maintains its world-leading capabilities to innovate, develop and commercialise therapies for patients.
Working closely with key government organisations, including the Medicines and Healthcare products Regulatory Agency (MHRA), UK Trade and Investment (UKTI) and Innovate UK, the MMIP is examining the UK’s position in medicines manufacturing and identifying opportunities for improvement in a number of areas.
The UK has one of the most progressive and pragmatic regulatory environments in the world through the MHRA
The UK has a highly skilled life sciences workforce and one of the most progressive and pragmatic regulatory environments in the world through the MHRA. The scientific R&D base is world-class and it is a global leader in the application of manufacturing processing. Meanwhile, the gradual reduction of the headline rate of Corporation Tax coupled with the introduction of the Patent Box scheme and improvements in the R&D Tax Credits scheme have helped the UK compete with other global candidates for medicines manufacturing investment in the past decade.
Despite these key strengths, the UK has faced growing competition from overseas in the past few years. Not only must the UK ensure that its fiscal environment is as competitive as those in overseas countries, but the fiscal environment also needs to be transparent to off-shore companies, enhancing the country’s ability to attract investment from the off-shore medicines manufacturing sector.
With the loss of patent exclusivity on established and effective products, the fiscal environment will also play a role in retaining existing manufacturers in the UK as well as attracting new growth as biosimilars assume greater importance in the medicines manufacturing landscape.
The advent of stratified medicines requires manufacturers to produce smaller batches, have greater flexibility in supply chain demand and still address the cost pressures felt by the health end-user communities
The technology challenge: The advent of stratified or personalised medicines requires manufacturers to produce smaller batches, have greater flexibility in supply chain demand and still address the cost pressures felt by the health end-user communities. A number of technologies are entering mainstream manufacturing, such as modularity (modular construction), disposables technology and the adoption of continuous production systems. Each of these technologies offers benefits around flexibility, capacity, right-sizing, cost of goods and reduced lead times.
Operational excellence in adopting these technologies is a hard won skill and capabilities such as lean, agile and efficient manufacturing will require both effort and commitment.
Supply chain challenges: Single product supply chains designed for ‘blockbuster’ drugs do not meet the requirements of targeted medicines, which require a more demand-led model with flexibility, reduced lead times for product change-overs and a direct link to the needs of patients. Where there are multiple stakeholders – patient, manufacturer, clinician and therapy centre – the need for orchestration of the supply chain is critical.
An ageing workforce: As the industry’s workforce ages, a new pool of talented and educated people, including highly skilled graduates and industrial apprentices, is needed. Co-investment in these skills by the pharma manufacturing sector and government will be key. The MMIP wants the most favourable environment for medicines manufacture in the UK and is working with relevant stakeholders to overcome some of these challenges.
Technology and innovation: A range of funding opportunities and initiatives for high-value manufacturing already exist in the UK, including the Research Councils (in particular BBSRC and EPSRC), Advanced Manufacturing Supply Chain Initiative (AMSCI), the Catapult Centres, Innovate UK and the Health Knowledge Transfer Network.
A priority for MMIP is to ensure that existing infrastructure and capabilities are fully and efficiently utilised by industry. MMIP believes that by aligning funding, industry could more effectively navigate and draw on the public investments and funding mechanisms currently in place.
Targeted medicines will require companies that offer smaller batch sizes and more flexible manufacturing
Through a greater understanding of the inter-relationships of the supply chain and the use of new technologies, the UK intends to be a leader in supply chain innovation. Additional drives towards operational excellence by the sector will be needed if it is to meet the challenges of complex supply chains.
MMIP is supporting the digital revolution in medicines manufacturing through Big Data, and the digital design of drug products. MMIP has also made recommendations that have been included in two major new government investments: the National Formulation Centre to support product and process innovation in manufacturing (including pharmaceuticals) and the Cell Therapy Catapult Manufacturing Centre.
The Patent box has been instrumental in levelling the field for manufacturing
Patent box: The Patent box was introduced in 2009 to encourage pharma and biotech R&D in the UK and has been instrumental in levelling the field for manufacturing. Recent proposed reforms to the patent box will change the landscape for the pharmaceutical industry and MMIP will be interacting closely with the government to make sure that medicines manufacturers still have access to the appropriate fiscal incentives to ensure that the UK can remain a competitive environment.
Skills: The ABPI recently surveyed the pharma sector to identify the skills needed now and in the future. The survey results are being fed into the Science Industry Partnership (SIP) which is led by employers from the science industries and works with the UK government to develop a new skills system for industry.
The MMIP is working with the MHRA Innovation Office to publish a series of case studies giving practical insight to the support MHRA can offer industry. It has also worked with UKTI to develop messages that better articulate why the UK is an attractive proposition for medicines manufacturing businesses.
This is just the start of MMIP’s work to develop an ecosystem that not only supports the existing medicines manufacturing sector but also facilitates new growth and inward investment for the UK. The stronger the medicines manufacturing sector in the UK, the more effective we will be at bringing innovative therapies and treatments to patients.
The first case study released from the Innovation Office at the MHRA under the Medicines Manufacturing Industry Partnership (MMIP) concerns a new facility that ensures the continued supply of a critical cancer medicine using a new sterile manufacturing process. AstraZeneca accessed guidance and advice from MHRA to help it successfully navigate regulatory and scientific requirements in the development of an essential new facility in Macclesfield, Cheshire. This helped the company to develop the site quickly, cost effectively and ensured the production of vital cancer medicine here in the UK.
It was essential that we had a good understanding of the regulatory expectations very early on in the process to understand the impact on design, cost and timelines
John Parker, UK Quality Director at AstraZeneca, said: ‘MHRA was very supportive and collaborative in their approach with us. It was essential that we had a good understanding of the regulatory expectations very early on in the process to understand the impact on design, cost and timelines in proposing the business case for the Macclesfield location. I genuinely believe that having easy access to MHRA in this manner provides a real competitive advantage to UK-based companies.’
Chief Executive of the Medicines and Healthcare Products Regulatory Agency, Ian Hudson said: ‘This case study is our first evidence of showing how early discussion with the MHRA can help facilitate innovation in industry, within the UK. We encourage industry to involve us early on in their thinking, through our Innovation Office.
'Through offering scientific and regulatory advice to companies in the early stages of medical developments, we are able to support innovative technologies such as this one which could change the way medicines are developed.'
MHRA Director of Inspection, Enforcement and Standards Division, Gerald Heddell, said: ‘We at MHRA welcome early approaches from companies who need access to expert knowledge, guidance and experience of regulatory processes. As well as being a regulator, we also recognise the importance of supporting companies in their planning processes, in order to ensure positive outcomes for public health.’
The Medicines and Healthcare products Regulatory Agency (MHRA) has helped OxSonics take a big step towards developing a revolutionary generation of ultrasound devices which aim to enhance delivery of anticancer drugs deep into solid tumours. The Innovation Office at MHRA provided informal access to world-leading expertise. It is hoped that following clinical trials the approach will result in better health outcomes for people currently facing terminal illness.
As well as being a regulator, we are passionate about helping companies develop products that could benefit patients and improve public health
MHRA Director of Licensing, Dr Siu Ping Lam, said: ‘Our experts have the knowledge and experience to helpfully support SMEs to develop their innovative products. As well as being a regulator, we are passionate about helping companies develop products that could benefit patients and improve public health. Through the MHRA Innovation Office and scientific advice service, we are able to offer information and guidance to help companies, large and small, navigate scientific and regulatory requirements effectively.'
The Innovation Office helped in a number of ways: co-ordinating and facilitating an initial meeting to clarify the classification of the particles and the ultrasound hardware – this in turn ensured that OxSonics could work to the correct regulatory standards; providing advice on the scientific and regulatory aspects of the toxicology studies to help OxSonics take its development forward; and offering the opportunity to hold a scientific advice meeting to review the planned pre-clinical toxicology protocols that would need to be in place to gain approval to start clinical investigations.