The UK’s departure from the EU will have significant consequences on multiple aspects of manufacturing. This includes: regulatory approval, supply chain and manufacturing process for companies producing active substances and final goods in the UK.

The European Union very strict health and safety manufacturing rules and requirement on human and veterinary medicinal products.

Once the UK leaves the European Union – on 29 March or following a potential transition period – the United Kingdom and goods manufactured within the UK will be classified as a third-country and third-country manufactured product. Therefore, any medicinal/pharmaceutical product manufactured by UK marketing authorisation holders will have to follow EU rules on imported pharmaceutical goods.

The exclusive use of authorised manufacturers is lead by EU legislation. Good manufacturing practices for starting materials list detailed guidelines manufacturing must be in accordance with.

Written approval needed for UK medicinal exports to EU

Similarly, EU import of active substances for human use medicinal products must follow these guidelines.For example, active substances are accompanied by a written confirmation from a relevant competent authority in the exporting third country. This confirms the standards of good manufacturing practice and control of the plant are equivalent to those in the Union.

If the final manufacturing site of a product is located in the United Kingdom following Brexit, rules apply. The European Union legislation stipulates strict rules on the importation of medicinal products from third countries. Under EU legislation, importers of medicinal and other pharmaceutical goods must be in possession of manufacturing licenses granted by national competent authorities. This is under Article 40(3) of Directive 2001/83/EC and Article 44(3) of Directive 2001/82/EC. A number of conditions may grant third-part manufacturers licenses.. Conditions can include EU-licensed representatives and inspected goods-manufacturing processes.

Medicinal manufacturing processes must adapt to comply

According to EU-Brexit notices, for centrally authorised medicinal products, UK marketing authorisation holders must therefore need to specify an authorised importer established in the Union and submit the corresponding variation.

Moreover, to ensure continued validity, marketing authorisation term changes may need to be considered.

Furthermore, when importing medicinal and other pharmaceutical goods from a third-country into the EU, UK marketing authorisation holders are required to specify an EU-based site of batch control in order to facilitate full qualitative and quantitative tests, among others, on each production batch of at least all active substances as required by the national competent authority.

For further information on how to prepare and mitigate the impacts of Brexit on your business, consult:

The HPRA, European Commission or European Medicines Agency.

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Research advancements in regenerative medicine will transform the way patients are treated in Ireland according to Professor Daniel Kelly.

He envisions a future where hospitals will have 3D bioprinting systems. This would enable ‘off-the-shelf’ patient-specific biological implants to treat diseases such as osteoarthritis. This is a core area of research for his team.

Professor Kelly’s research includes the use of 3D bioprinting to generate anatomically accurate, biomimetic constructs. These can be used to regenerate both cartilage and bone in a diseased joint.

Industry partners collaboration is key to realising vision

Access to and working with industry partners is central to creating targeted advances in materials and process technologies in this space.

“Working with industry partners such as Johnson and Johnson means that we have the capability to translate our research into production. This helps with delivering new products and innovations,” Professor Kelly notes.

“This is essential for market differentiation in the Life Science sector, and also having real impact on patient outcomes.”

Medtech support helps innovate bioscaffolding

“Partnership, innovation and scientific collaboration is key,” according to Professor Fergal O’Brien, AMBER Deputy Director. O’Brien has successfully translated work from his lab in the Royal College of Surgeons in Ireland, through a spin-out medtech company. His work focuses on using collagen biomaterials to repair damaged bone and cartilage to human patients.. He is looking to the future.

“We want to expand into new and exciting areas of research. These includeuch as the development of electroconductive biomaterials for nerve repair,” he added.

“We’re looking at different lines of research to do this. One of which is to incorporate nanomaterials, such as graphene, into 3D bioscaffolds.”

Multi-disciplinary teams

Developing these next generation implants relies on working with industry partners but also between scientists and engineers working across disciplines.

“The success of this work relies on the ability to work across traditional subject and discipline boundaries to access a diversity of scientific expertise,” Professor O’Brien continues.

“Collaborating with other research groups opens up possibilities to generate new ideas and solutions. These will drive the future of healthcare.”

Both agree that being Principal Investigators within AMBER, the Science Foundation Ireland centre for Advanced Materials and Bioengineering Research, has been a key enabler for large scale engagements with industry, cross-discipline collaboration, and has opened up new avenues for research.

Commenting on the relationship between research and industry, Professor O’Brien notes: “A thriving research sector, which has been delivering impactful scientific research for many years has been central to the success of the medical technology and biopharmaceutical sector in Ireland.

“As scientists, we constantly look to the future to ask what’s next for healthcare, but also, how can we ensure our research is translated into patient benefit while ideally creating high value jobs in Ireland.

“Maintaining and nurturing this ecosystem is essential to sustaining continued economic growth in the life science sector.”

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Ireland is home to nine of the world’s top 10 medtech companies. It is a strategic base for the European market, worth €110 billion. The group now wants to make Ireland an international leader. This is down to innovative, patient-centred Irish medtech products and solutions tackling changing health needs.

Patient-centred medtech products and changing needs

Healthcare spending in the Organisation for Economic Co-operation and Development (OECD) grew an estimated 2.5% in 2017. That year saw an increased demand for services with ageing populations and the rise of chronic diseases. Hospitals account for 40% of health spending. Connected health is a way to support better care pathways and empowered patients as well as tackle rising costs. 

Leading a healthcare revolution

As we look to the future, we need to help small companies make it big, with medtech start-ups fuelling innovation and the burgeoning connected health scene in Ireland ready to start a healthcare revolution. Ireland is uniquely placed to become a global leader in this exciting space. Not only are we home to top medtech companies, but 10 of the world’s top 10 biopharma and ICT companies also have a base here. Irish medtech is an industry leader.

Helping small companies make it big

My top priority for this year is to drive policies and conditions to ensure entrepreneurship can thrive with as many as four out of five medtech businesses here being either start-ups or SMEs, with these businesses acting as the lifeblood of medtech innovation.

Globally, the top 30 medtech companies dominate the medtech market, accounting for 64% of the market with €226 billion in sales. For example, to make Ireland one of the top 10 start-up communities in the world, we’re urging the government to focus on three key areas: create a supportive tax environment, promote better funding avenues, and help develop research talent.

Priorities for growth in Irish medtech

Ireland is one of the best places in the world to do business. This is due to Ireland having a strong and stable business environment along with a rich pool of talent underpinned by dynamic programmes.

Now, we must do more to nurture entrepreneurship. Government must make our capital gains tax more competitive to help entrepreneurs take risks to succeed. We must support relief programmes to encourage investment. As well as ensure access to venture capital and seed funding for early stage start-ups.

To emphasise words, with the right business environment, the Irish medtech industry will drive growth. Thanks to this, it will also develop new ways to save and transform lives.

Source: Irish Medtech Association Chair and FIRE1 CEO Conor Hanley

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Ireland is a place where innovation, for instance innovative medicine, thrives and foreign direct investment finds a home. As soon as thirty years ago, just 5,200 worked in an industry characterised by basic manufacturing. At the present time, the originator pharmaceutical companies directly employ 30,000 people.

All the top 10 global pharmaceutical companies in fact operate in Ireland – the likes of GSK, Pfizer, AbbVie, Novartis, MSD and many more. They are part of Ireland’s enterprise ecosystem, with a huge impact in societal, economic and human health terms, putting us as part of a globally networked system of innovation

Over the past 10 years, the originator pharmaceutical industry has invested all in all €10 billion in manufacturing and research sites around the country. That represents close to the biggest wave of investment in new biotechnology facilities anywhere in the world. Between 2003 and 2018, the number of biotechnology manufacturing sites jumped from two to twenty.

However, these numbers are impressive – but they are no cause for complacency. Ireland must continue to pursue excellence in manufacturing and research, and adapt public policy to the promise of innovation in new medicines. If we do that, our industry will remain a reliable source of high-quality, well-paid jobs well into the future.

Investing smartly to meet the needs of our ageing population

As Ireland’s population ages and medical conditions grow more complex, healthcare will come under increasing pressure to deliver the same, or better, services. The task will be to invest smartly. How we plan for the adoption of bio-technology innovation into the health services must be coordinated centrally by the State. For that reason, we have called for the appointment of a Chief Innovation Officer at the Department of Health. 

We must be quicker at ensuring access to new medicines

Through innovation, we can develop therapies that, in the long run, will save the system money by reducing hospital stays. In the short term, these new innovative medicines – if they are made available efficiently to patients – will in short change people’s lives for the better. But, as things stand, Ireland is an outlier in Western Europe when it comes to the speed of availability of innovative medicines for patients.

Our ‘Manifesto for Better Health’ makes the case for a better environment for reimbursement and innovation. Ireland should be in the top seven countries in the EU-28 for speed of access to new medicines. Instead, it is among the slowest. This is an urgent challenge. 

Vaccines save 2.5 million children a year

Scientific advancements mean that we know more about illness than ever before. This knowledge is being translated into new ways of treating common conditions. Medical progress has led to a dramatic decline in death rates for diseases such as cancer, HIV, polio and measles. Hepatitis C has virtually been cured by innovative medicines. 

Today, if diagnosed early, leukaemia can be driven into remission with a once-daily treatment. Vaccines have rid the world of smallpox, driven polio to the brink of eradication, and virtually eliminated measles, diphtheria and rubella in many parts of the world. Vaccines save the lives of over 2.5 million children every year. This is the dividend of innovation. 

Transforming patient care

Promising medicines in development have the potential to transform care, helping patients live longer and with a better quality of life. In some cases, medicines could prevent further illness, reduce the need for other treatments or even offer a cure. 

To capture the value of innovation, we need better outcomes data. The structuring and use of data are among the most promising projects for the future of medical progress. Irish hospitals and healthcare professionals hold a huge volume of historical data. This data, properly mined and applied, could lead to the development of a predictive and preventative approach to medicine.

An exciting global wave of medical innovation is breaking around the world. Ireland should be ready to catch it. With the right policy moves matched to industry pioneers, we can have a leadership role in powering patient care through innovation. 

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Health Innovation Hub Ireland (HIHI) works across the health sector with industry. They are developing new healthcare technologies, products, and services that will ultimately help to create Irish jobs and exports.

One of the exciting things for us here working in the healthcare sector, is that Ireland is ideally placed to be a world leader in the provision of total connected health solutions. We have in fact a highly networked ecosystem. The industry expertise required to embrace the convergence between health and the Internet of Things (IoT), which is the future of healthcare globally.

From improved diagnostics to innovative prosthetics or profitable data management. The combined health and healthcare sector continues to show enormous growth potential. Many of the world’s top medical technology companies have invested significantly in Ireland. A number of exciting, research-based, indigenous companies are emerging and competing internationally. In fact, 50% of companies in the Irish medtech sector are indigenous.

Linking hospitals and primary academic partners

Furthermore the Irish government has identified the medical technology sector as one of the key drivers of industrial growth for the future. They provide a wide range of supports to encourage and foster this growth, not least Health Innovation Hub Ireland (HIHI). Connecting new products with people qualified to test them. Which are for example industry and clinical teams – through usability, pilot and validation studies. This supports the development of new healthcare technologies, in real-life clinical settings.

Organising our hospitals into hospital groups linked to a primary academic partner brings the right people together.

It means that companies are gaining invaluable sight and authoritative feedback about how their product works or indeed if it requires modification. This prior to commercialisation. Simultaneously, the health service accesses products and services that they may not ordinarily be able to use and ultimately, we benefit patient care.

Personalised healthcare

The move worldwide is towards personalised healthcare that empowers the patient, largely through connected health. There is unparalleled potential in this to reduce the burden on acute settings. Broadly speaking, this could mean there are fewer patients attending hospital and more care takes place in the community. This after all is the direction that we should be taking our health service in and HIHI can help with that.

Ireland has combined exports from our life sciences and ICT sectors of over €140 billion annually. The health service needs products to meet its particular needs and enterprise needs guidance from qualified users on developing products. We can positively leverage the strengths of enterprise to deliver innovation into our health system. This while creating an international reputation for Ireland as a leader in connected health development.

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The demand for talent can be met with flexible approaches to learning and continuous professional development (CPD). Lifelong learning is in fact one of any professional career. A growing and rapidly changing pharma sector needs to look both within and outside of the industry. This in order to develop and up-skill people.

To keep Ireland’s pharma workforce at the leading edge, qualifications that feature advanced manufacturing technology and data analytics topics are critical.

Pharmaceutical companies must work with industry and academic partners to develop education programmes. Moreover, these can be delivered full-time and part-time with online remote learning support. Equally, this flexibility will help those already in the industry to get to the next career level. It will also help people from outside the pharma industry transition into roles.

Qualifications must be relevant and up-to-date

To ensure that education and training are meeting the needs of the pharma industry, it’s critical to work with key industry stakeholders. This to develop programmes that prepare students for these high-tech jobs. Industry lecturers and insights from business can build academic programmes that align academic learning and practical applications.

Training in advanced manufacturing technologies and data science to future-proof our workforce and industry 

Advanced manufacturing technologies and data science are critical areas of focus for the world’s top pharma companies. However, to keep Ireland’s pharma workforce at the leading edge actions need to be taken. Courses and qualifications that feature technology and data analytics topics, as well as subjects such as Lean Six Sigma, are even more important now. Managers and leaders in the industry are starting to explore how they can prepare their people. In to leading the digital future of high-tech pharma manufacturing.

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The Biopharmachem sector shows no sign of slowing down. Recent investments – totalling some €10 billion in the last 10 years – are now starting to come into operation. Much of this investment has been in cutting edge biotech manufacture with industry leaders adding significant investments to their ever-growing portfolios.

It is no surprise that Ireland now has 10 out of the top 10 global biopharma players here. Ireland is considered only second to the USA as a hub for biotech manufacture.

There are a number of reasons for this impressive growth trajectory. Which sees the sector valued at over €65 billion in exports – that’s over half the goods exported from Ireland. These include:

• Competitive rates of taxation
• Strong record of regulatory compliance
• Location within the European Union
• Strong research base
• Excellent pool of talented and experienced people

It is worth considering the importance of Ireland’s talent pool. A highly regulated sector such as biopharma depends very much on having the right level of employee. This in terms of qualification, aptitude and experience. There is no doubt that Ireland continues to come up trumps in all these areas.

We must continue to invest in talent

However, in the mind of BioPharmaChem Ireland (BPCI) and its members, we can never lose sight of the need to continually invest in our talent pool. The BPCI Talent and Skills Group continues to champion this. This by working closely with the IDA, Skillnets and organisations such as NIBRT and Innopharma to ensure that the pipeline remains well fed.

In 2016, the Expert Group on Future Skills Needs conducted a comprehensive review for the sector, concluding that an additional 8,400 job opportunities would be created in biopharma by 2020. We are well on the way to meeting this. The sector currently employs well over 30,000 and this number is set to grow.

BPCI continues to work with the educational community to ensure enough graduates take up the study of STEM subjects.

Encouraging apprenticeships in biopharma

They have also championed the brand new, Laboratory Apprenticeship Programme. This designed to encourage school leavers and mature students to consider a non-traditional apprenticeship within the sector. In order to allow them to ‘earn as they learn’. The programme was launched in partnership with Tallaght Institute of Technology, supported by The Higher Educational Authority (HEA) and Solas last year. It opens up a vocational route into the sector, reflecting the German and Swiss models. In the view of BPCI, this will help greatly by expanding the existing talent pool.

BPCI also promotes the BioPharmaChem Skillnet, which supports ongoing training and skill development within the sector, allowing companies to refine and develop their existing skills bases.

There is no doubt that, as the sector continues to become more sophisticated – employing digitisation etc – opportunities will open up for entire new skill sets, such as information technology and software development. This will also offer excellent opportunities for local specialist service providers.

Local company, APC, is a great example of this. Based in Cherrywood, Dublin, APC provides contract development and manufacturing support to the sector. It has developed a particular expertise in continuous manufacturing – both small and large molecule – truly cutting-edge technology.

It is important not to ignore the contribution that Science Foundation Ireland (SFI) makes though its support for its centres. Centres such as The Synthesis and Solid State Pharmaceutical Centre (SSPC), Curam and The Alimentary Probiotic Centre (APC). These novel organisations bring industry together with the third level research community to help promote research in the sector. Of course, they also help to develop the kind of expertise required to drive the sector on to the next level.

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Elaine Daly

Partner and Head of Business Consulting, Grant Thornton

We are living in an age of increasing pharmaceutical innovation, which can solve some of the most complex medical needs of an ageing patient population.

Transformative patient care is achieved by advances in treatment that improve patient outcomes or quality of life. This through developing innovative, novel products that treat previously untreated illnesses (usually due to complexity) or by radically improving existing treatments.

Ireland provides in fact a world-class base for life sciences’ product development. All of the top ten most innovative pharmaceutical companies have operations in Ireland. Seven of these have facilities that are involved in the manufacture of medicinal products. Those can help treat or even cure complex medical needs in key treatment areas such as oncology, cardiology, rheumatology and diabetes.

Innovative medicines personalise patient care?

Innovative medicines can by all means have a transformative effect on a patient’s quality of life. Ireland is host to a multi-million euro study, “The Irish Personalised Approach to the Treatment of Haemophilia (iPATH)”. Which is jointly conducted by the Royal College of Surgeons in Ireland, Science Foundation Ireland and Shire in partnership with the Irish Haemophilia Society.

The study is developing innovative approaches to improving the treatment of haemophilia. This by looking at genomic differences in haemophilia patients, which as a result could potentially open the door to the personalisation of therapies. Novel products for haemophilia, such as extended half-life products, can reduce the annual amount of infusions needed by 59%. This can drastically increase the quality of life of the patient.

AI can improve efficiency in getting drugs to market

Artificial intelligence (AI) and machine learning present opportunities to improve both healthcare delivery and patient outcomes. According to the Financial Times in 2018, 15 life sciences companies added AI to their drug discovery processes. AI has the potential to reduce the inefficiency of drug development. Which can cost billions of euros and take many years to get a product to market. Any technique that can reduce costs and speed up development timelines will have a profound effect on patient care. It will also allow innovative therapies to reach the patient at a faster rate.

Additionally, there are significant opportunities for companies to leverage AI and machine learning techniques to analyse anonymised patient data to spot signs of disease that will enable the possibility of more targeted and personalised medicine. There is moreover an excellent opportunity to leverage the large concentration of life science and technology companies with operations in Ireland to capitalise on the new technological approaches to drug development and patient care.

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Health research impacts almost everyone. Be it through treating a life-altering disease. Or informing nutrition for the optimal diet. Equally dealing with the challenging problems of an ageing population.

Advances in science / technology means we’re rapidly moving from a “one size for all” healthcare to a “personalised” approach. These tailor to individual health and lifestyle needs. In Ireland, we are at the forefront of many of the research developments in this sector. Both in our academic institutions and in industry.

Who is using the personalised approach?

FutureNeuro, the SFI Research Centre for Chronic and Rare Neurological Diseases, is based at the Royal College of Surgeons Ireland. Led by Professor David Henshall, the team seeks a better understanding of brain diseases like epilepsy. As a result, both personalised and effective treatments are developed here.

They are tailored to the patient taking into account both individual genetic differences as well as those elicited through studying individual brain waves and responses to different treatments.

At CÚRAM, the SFI Research Centre for Medical Devices based at NUI Galway, is led by Professor Abhay Pandit. The teams explore and develop innovative personalised medical technologies. There is a particular focus on respiratory, neural, cardiovascular, musculoskeletal, renal and soft tissue disorders. Essentially, the overarching aim of CÚRAM is to provide affordable, transformative solutions for chronic diseases.

Likewise the cell-based research in regenerative medicine, led by Professor Fergal O’Brien of the SFI Amber Research Centre, addresses individual patient needs following trauma or arthritis. Professor Walter Kolch’s research group at the Conway Institute UCD are pioneering approaches to tailor personalised effective pharmaceutical treatments to individual cancer patients.

Wearable sensors in sports

A major area of growth is the development of wearable sensors to continuously monitor various parameters. These include blood pressure, heart rate, sweat, distance walked. Analysis of the large amounts of data these devices generate to provide tailored advice to the individual. Much of this occurs in the SFI Research Centre for Big Data Analytics – Insight. Several innovations have resulted in start-up companies. Most recently, in March 2019, Outdoor Sports announced a partnership with major US league soccer team, Colorado Rapids, to bring their technology to individual athlete testing and tracking.

In all of the above examples, there is extensive, and mutually beneficial, research collaboration and cooperation with companies both large and small. For example, J&J, Boston Scientific, Stryker, Astra Zeneca, Arch Therapeutics.

Funding for the personalised approach

In a new, all-inclusive, approach to funding competitive research, which will improve Irish society and the economy, including the health of people living in Ireland, SFI have launched Challenge Based Funding. Furthermore, to compete for the SFI Future Innovator Prize, multidisciplinary teams must identify economical and societal challenges and develop potential new solutions. Many of the competing teams have identified personalised health related challenges e.g. creation of personalised orthopaedic implants, treatment of rare diseases like epidermolysis bullosa (EB) through gene-editing, reducing the burden of chronic pain, and improving breast cancer diagnosis.

Given the rapid pace of scientific discovery and its application, and the ever-growing opportunities arising from the convergence of genetic analysis, sensors, ICT, big data analytics and artificial intelligence, the potential to develop better diagnostic tools and therapeutic interventions that are more effective because they are focused on the individual, has never been greater. It is important that researchers in Ireland from both academia and industry remain at the forefront of these exciting developments. This is so that all of us can benefit by leading healthier, longer and fulfilling lives.

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Lisa Rose discusses current threats from antibiotic-resistant bacteria – and the importance of the diagnostic laboratory in infection prevention and combatting AMR and other such threats.

“Bacteria are clever organisms!” says Rose. “They multiply very quickly, and naturally have ways of adapting and evolving in their environment. One of the ways they develop is resistance to antibiotics. They are able to multiply in the presence of antibiotics”. When bacteria that have developed resistance multiply, this can result in an infection that is not treatable by antibiotics. Thus, antibiotic resistance, or antimicrobial resistance (AMR), poses a major threat to public health. Infection prevention is vital

The diagnostic laboratory plays a key role in helping humans to be ‘clever’ in combatting these ‘clever bacteria’! “AMR poses a very particular challenge for those of us working in diagnostic microbiology laboratories,” says Rose. “On a daily basis we are trying to decipher extremely complex test results. We’re trying to detect novel and emerging resistant organisms. “I feel that laboratory scientists can play an essential role in the early detection of AMR.

Infection prevention and control

There’s an increasingly high level of expertise needed now for the complex challenges we’re facing. For this reason, we need faster tests, and laboratories have the ability to design these rapid tests and implement them. Furthermore, they have expertise to decipher the complex antibiotic profiles which determine the underlying resistance mechanisms. All of this helps clinicians in prescribing proper treatments and implementing infection prevention and control strategies. For example, “a challenge at the moment is the recent outbreak of CRE in a Dublin hospital, and the ongoing outbreak of CRE in other hospitals around the country. We also face a challenge with gonorrhoea, which is now regarded as a superbug. This is due to the fact that it has developed resistance to last line of defence antibiotics.

There’s been about a seven-fold increase in the development of gonorrhoea cases in Ireland, in the decade up to 2013. There is a need for a national bacterial STI reference laboratory to monitor the worrying trend of antibiotic resistance in gonorrhoea. “The laboratory plays a key role in the detection of resistant superbugs and infection prevention and control to stop the spread of bacteria. “Currently we have a wide range of tests, all of which follow national and international best practice. We utilise various methods for detecting AMR, some of which have been in existence for a number of years. Some are more complex and more novel, such as using molecular methods for the detection of the actual resistant gene.

Combatting AMR

“Increasingly we are relying on these more rapid gene tests, because we can get results in one or two hours. This can have a huge impact on patient care and preventing the spread of these resistant bacteria. If we can tell clinicians that in a particular hospital there is a resistance organism that could be transmitted to other patients, they know that they can isolate the patient with the infection immediately.” Diagnostic testing also helps guide treatment.

“When we know whether a bacterium is resistant to a particular antibiotic, that can guide the clinician in their course of treatment.” To illustrate the role of the laboratory in combatting AMR into the future, Rose says: “The new rapid diagnostic tests are an essential part of combatting AMR. Resources from the government are vital, to enable medical scientists to implement rapid diagnostic tests on a national basis and to facilitate surveillance scientists in detecting emerging resistance.”

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