Compulsory vaccination for care home staff

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The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 will come into force on 11 November 2021 and will make COVID vaccination compulsory for care home staff. Here we examine some of the key questions you may have.

What do the regulations say and why have they been introduced?

Given the higher risk COVID poses to residents of care homes, who are generally elderly or vulnerable (or both), when compared to the general population, the government decided to make the COVID vaccine mandatory for anyone working in a care home. It’s not a decision without controversy and it has been acknowledged that requiring anyone to undergo a vaccine as a condition of keeping their job is a highly unusual step. However, the government’s line on this – which will sound familiar – is that the pandemic is an exceptional situation and that unusual steps are needed to tackle the crisis.

What if an individual can’t have the jab for a medical reason?

The regulations anticipate this scenario and make it clear that where someone can’t have the jab for a medical reason, they will still be allowed to attend work, provided they can provide evidence of their medical exemption or, in the short term, self-certify their exemption. The actual numbers falling within this exemption will be low.

Do the regulations just apply to frontline care workers?

No, the rules apply to anyone working inside a care home.  There are some specific exemptions (see below) but otherwise, the rules apply to all staff regardless of the role they carry out and regardless of whether they actually have any direct contact with residents during their day-to-day work.

What about families visiting relatives in care homes?

The regulations contain a fairly lengthy list of exemptions that apply, the most significant one being that people visiting residents do not have to be fully vaccinated.  This includes friends as well as family members. This gives rise to a slightly bizarre scenario whereby an individual turning up to work at a care home without being fully vaccinated would have to be turned away, but the same person attending in their capacity as a friend or relative would be allowed in!

Whilst there are various other exemptions that could apply, in practice these will only apply in a limited number of scenarios.

What are the timescales on this?

The deadline for care home workers to be fully vaccinated is 11 November. Anyone not fully vaccinated by that date is strictly forbidden from entering the care home unless one of the exemptions applies. This means that workers will need to have received their first jab by 16 September in order to get the second jab in time for the deadline.

Anyone who is willing to get the jab but misses the deadline could ask their employer to try and bridge the gap (e.g. with holiday and/or unpaid leave) but this is only likely to be a feasible option where the delay is relatively short.

What if somebody won’t have the jab?

Unless the employer can relocate them to a building without any residents (e.g. a separate head office) the likelihood is that they will be dismissed. Such dismissals are likely to be fair provided a proper consultation process has been followed by the employer.

So is this good news or bad news for care home operators?

It depends on your viewpoint. On the plus side, it provides certainty for operators who were otherwise stuck in a bit of a quandary when dealing with employees refusing to get the COVID vaccine. However, it is likely to lead to operators having to dismiss employees that they would otherwise want to keep, and many operators are already struggling with severe staffing shortages.

Watch our importance of employee well-being in the workplace and practical issues for employers to consider webinar

In this joint webinar with Brewin Dolphin, we will look at factors to consider in order to promote good health and wellbeing in the workplace which can boost employee engagement and organisational performance.

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Matt’s expertise cover all areas of Employment law. He has considerable experience of advising clients on complex employment litigation, senior hires and exits, large-scale redundancy exercises and complicated TUPE issues.

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From guidance on the Coronavirus Job Retention Scheme and support with largescale redundancies, to working from home and policies and other workplace issues, our team of experts are on hand to work with your HR teams to help with any issue, large or small.

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Blog

2021: a year of potential

Keeping positive can be a challenge during a pandemic, but it’s vital that businesses look ahead to the future and the opportunities that 2021 holds.

Although the economy is flirting with a second recession and some sectors are struggling under nationwide restrictions, the area of mergers and acquisitions is looking promising.

An ideal opening

For businesses that are well-prepared and unafraid to take the leap, the current economic situation means there are plenty of M&A opportunities available.

If the deal market continues to move, British businesses will remain attractive to overseas investors. Making strategic or opportunistic acquisitions while prices stay low, could even accelerate growth plans.

Which sectors are performing well?

Certain sectors that lend themselves to our current climate, such as pharmaceuticals, technology, PPE and MedTech, have all been performing well over the last year, even with the uncertainty caused by Brexit.

Due to this uncertainty, some international buyers may be waiting to see what the post-Brexit landscape looks like before making a move, but many others are still showing an interest in UK acquisitions.

Read our 2021 predictions for the education and construction sectors.

Strategising for the future

Whilst the present remains unstable, it might be difficult to think about future strategies, but it is important to do so.

Industries hit hardest by the pandemic should continue to use the financial support available to them, including the furlough scheme, CBILS and Future Fund. However, they must keep on top of any changes to the current schemes and be aware of when they are set to end.

For those facing less challenges, they should consider whether they are in a position to expand and invest. Many companies are in need of a buyer or strategic partner, and with valuations being difficult to carry out accurately at present, a host of potential investment opportunities have been opened up.

With the changes to Capital Gains Tax (CGT) still looking likely, a short-term deal rush may be on the horizon. As such, businesses and business owners should also be assessing whether they can take advantage of this.

In any market there are always investment opportunities to be had. So, although it may be some time before confidence returns, there’s much to be gained from businesses taking a positive approach to 2021 and readying themselves for growth. 

Contact us

2021 holds plenty of unknowns, but it is also a year for potential and there are many reasons to remain positive. If you have any questions or concerns about issues that may be affecting your business, get in touch and the relevant team will aim to reply to your query within two hours.

From inspirational SHMA Talks to informative webinars, we also have lots of educational and entertaining content for life and business. Visit SHMA® ON DEMAND.

Our free legal helpline offers bespoke guidance on a range of subjects, from employment and general business matters through to director’s responsibilities, insolvency, restructuring, funding and disputes. We also have a team of experts on hand for any queries on family and private matters too. Available from 10am-12pm Monday to Friday, call 0800 689 4064.

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Shakespeare Martineau advises Dr Martens family founders in multi-billion pound float

Northamptonshire-turned-global shoe brand Dr Martens has launched at the top of the range valuation of 370p per share, equating to a £3.7 billion market cap.

Advising the family founders of the household-name brand is the corporate team at Shakespeare Martineau who also advised the Griggs family on the company’s original sale in 2014 to private equity giant Permira for £300m – at the time of sale, the family retained a 10% stake in the business.

“This has been an incredibly successful float and indicates the interest and value in such as well-established and popular brand, as shown by the IPO offer being eight times oversubscribed and within the first hours of the trading the share price jumping in value.   The successful float is a culmination of the success and hard work of the Griggs family and later the management backed by Permira.

“We have a long-standing relationship with the Griggs family and are pleased to have supported them in this incredible brand’s journey.”

Starting as a modest work-wear boot in 1901, Dr Martens have evolved into an iconic fashion staple – known for its ‘rebellious self-expression’ – having sold more than 11 million pairs of boots in more than 60 countries worldwide.

Stephen Griggs said: “We’re very proud of our family’s brand and how by working with the right people it has transformed into a global icon.

“We’ve got a long-standing relationship with the Shakespeare Martineau team – they have always been as invested in our success as we are.”

Contact us

From inspirational SHMA Talks to informative webinars, we also have lots of educational and entertaining content for life and business. Visit SHMA® ON DEMAND.

Our free legal helpline offers bespoke guidance on a range of subjects, from employment and general business matters through to director’s responsibilities, insolvency, restructuring, funding and disputes. We also have a team of experts on hand for any queries on family and private matters too. Available from 10am-12pm Monday to Friday, call 0800 689 4064.

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Client

Coloplast A/S v Salts Healthcare Ltd

Patents Court finds medical device patent obvious over five items of prior art & CGK.

Shakespeare Martineau LLP acted for Salts Healthcare Ltd, the successful defendant in the below proceedings.

On 18 January 2021, Nicholas Caddick Q.C. sitting as Deputy High Court Judge, handed down his judgment in Coloplast A/S v Salts Healthcare Ltd. This judgment follows an eight day trial that took place in hybrid form over late September and the beginning of October 2020. 

Coloplast alleged infringement of its patent EP (UK) 2 854 723. Salts denied infringement and counterclaimed for revocation on the bases of lack of novelty, lack of inventive step/obviousness, insufficiency, AgrEvo obviousness and added matter. 

In parallel proceedings at the European Patent Office “EPO”, the Opposition Division “OD” had found earlier in October 2019 that the patent lacked novelty over one of the items of prior art relied on by Salts in the UK proceedings. This decision is under appeal to the EPO Technical Board of Appeal TBA, expected to be heard later in 2021. The EPO proceedings however are based on different claim sets, and so the Court accepted it needed to consider the case afresh. 

In short, the Court found the patent invalid for lack of inventive step, but that had it been valid, it would have been infringed. 

The case concerns ostomy bags, which are connected to a stoma created surgically, in order to collect human waste from the stoma, usually after surgery to address issues in the digestive tract. As with many medical device cases, the market for them is valuable, and this commercial significance sits alongside important issues around patient sensitivity. 

The case involved many issues typical to patent litigation, and to that extent there was no “new” point of law at stake. What is unusual about the judgment though is that the patent was found invalid over all six cited items of prior art, being three prior publications and two prior uses, as well as the Common General Knowledge. AgrEvo obviousness was relied on also by Salts, but the judge found this added nothing more to the obviousness findings he had already made. This finding underlines the fact that although AgrEvo might be thought to be a sufficiency issue because it concerns lack of technical contribution, the UK courts tend to interpret it as an obviousness argument. As a matter of general interest, the UK approach to AgrEvo was summarised by Floyd LJ in Generics (UK) v Yeda Research & Development 2014 in the Court of Appeal but the judge did not deal with this in any detail, saying that it added nothing to his finding of conventional obviousness. 

The case is also illustrative of the interplay between timings of parallel UK and EPO proceedings. Salts had earlier sought a stay of the UK proceedings pending the OD decision, which the Court had refused. But as things turned out, the OD did find the patent invalid and the appeal to the TBA will likely come on before any appeal to the UK Court of Appeal, should permission be granted. 

From a procedural point of view, this was a substantive patent trial conducted in “hybrid” form, much of it online. Whilst not ideal, with for example some witness cross examination taking place by video link in a different time zone, it was a good example of how successfully the UK Courts have been able to adapt to the current circumstances induced by the COVID-19 pandemic.  

For further information on this case or any patent enquiry please contact Nicholas Briggs or another member of the IP team in your local office. 

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Deal

Midlands dealmakers advise on £33 million sale of Addmaster to Swedish company Polygiene

Staffordshire company Addmaster, one of the UK’s leading suppliers of antibacterial additives, has been sold to Swedish company Polygiene for £33 million, with the support of Midlands-based Shakespeare Martineau and Bracebridge Corporate Finance.

Addmaster supplies performance-enhancing additives for the plastic, paper, textiles, paints and coatings industry.  The acquisition brings together Addmaster’s expertise in antimicrobial technologies on hard surfaces with Polygiene’s long-standing reputation in odour control and antiviral solutions for textiles.

Addmaster’s Biomaster technology, designed to prevent bacteria and viruses growing, has been in high demand and has been adopted in a diverse range of applications. In a recent development, the technology has also completed extensive testing and has been found to be effective on both porous and non-porous substrates against SARS-CoV-2, the virus that causes Covid-19. This means that Biomaster can give up to 99% protection just four hours after it has been added to products, preventing any bacteria or virus growing on everyday items.

Addmaster founder, Paul Morris said: “This is a fantastic deal for our business and gives us the financial backing and global resources we need to maximise the potential of our products, including the world-leading antimicrobial protection offered by Biomaster.

Paul added: “I’m hugely grateful to the support of Shakespeare Martineau and Bracebridge Corporate Finance who have been with us every step of the way.

Andy Moore, managing director at Bracebridge Corporate Finance commented: “We have worked with Addmaster over the last 3 years and have seen the business go from strength to strength. The sale to Polygiene is the result of many years’ hard work from Paul and his team. We advised the shareholders on the sale, project managing and negotiating the deal with Polygiene, working closely with Shakespeare Martineau on the legal aspects.

Duncan James said: “We are delighted to have worked with Addmaster and its shareholders to achieve an outstanding result for the business. The deal is a superb example of a Midlands business being advised by Midlands advisors on an international transaction.

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Deal

Corporate team advises on global medtech joint venture

Our corporate team has supported medical equipment businesses Scientific Magnetics and Tecmag – part of Avingtrans – with their upcoming merger with Magnetica.

The merger will mark the fifteenth deal we’ve supported and completed on for Avingtrans in 13 years.

Magnetica, an Australian medtech and engineering company specialising in next-generation MRI technologies, plans to merge with Scientific Magnetics – a UK-based business that designs, manufactures, tests and installs bespoke superconducting magnet systems – and its US subsidiary Tecmag, which manufactures instrumentation for NMR, NQR and MRI markets.

Contracts have now exchanged, but completion of the merger is conditional upon Magnetica’s shareholder approval at a general meeting on January 29.

Subject to completion, Avingtrans, which owns a majority stake in Scientific Magnetics, will become the majority shareholder in the combined business, which will continue to be known as Magnetica.

The combined business will form a key part of Avingtrans’ Medical and Industrial Imaging division moving forward. Scientific Magnetics and Tecmag will become wholly owned subsidiaries of Magnetica.

In addition to the deal, Avingtrans, which designs, manufactures and supplies critical components, modules, systems and associated services to the energy, medical and industrial sectors, will also be investing in the newly formed business, to fund new MRI product development and commercialisation activities.

Keith Spedding, partner and business transaction and growth specialist led the deal. He said: “We’re seeing a lot of activity in the medtech market. It’s a fast moving, innovative industry with its products and services growing in demand. This merger is an excellent fit for all involved and will create a powerhouse of potential as they look to increase accessibility to high quality medical imaging around the world.

“Working with Avingtrans plc for more than a decade has been an exciting journey – we’ve seen them grow rapidly and we have been able to support this growth with our international, corporate and medtech expertise.”

Steve McQuillan, CEO of Avingtrans, said: “The team at Shakespeare Martineau have played a crucial part in our growth success over the years – they understand our business, they understand our sector and help us take a bigger picture view of the market.

“We believe this merger offers real potential to accelerate the planned move up the value chain in what is a highly specialised and integrated, international medical-imaging market.”

Contact us

For further information please contact Keith Spedding or another member of the corporate team.

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News

App founded by NHS surgeon secures million pound seed investment

MediShout, the app for frontline hospital staff to resolve facilities and equipment issues, has closed a £1 million seed round from Venture Capital fund Episode 1, supported by law firm Shakespeare Martineau.

The app, founded by London-based NHS surgeon Ash Kalraiya, connects staff, equipment suppliers and service maintenance teams. It enables frontline staff to report and resolve operational issues directly and easily using the app. By using data and AI, MediShout predicts and prioritises issues in the hospital’s facilities and equipment to ensure that patients can receive the best possible care.

Ash Kalraiya said: “As a surgeon, I have all too often been delayed by items like lightbulbs in the theatre being broken, faulty equipment or not having the right stock when I need it. We founded MediShout to stop such frustrating issues from getting in the way of patient care. Our ultimate vision is to use AI and digital technologies to transform our hospitals into smart-buildings that run smoothly.”

The app is already being used by six hospitals and several equipment suppliers, and with this new round of funding, the team plans to expand to over 20 hospitals in 18 months.

Experts in medtech and entrepreneurial start-up businesses, Shakespeare Martineau, supported Medishout with the transaction – advising on the investment process and terms from inception.

Ash added: “The Shakespeare Martineau team not only provide us with legal advice, but they have really helped guide our business performance while supporting us through some difficult negotiations. They have been an amazing source of personal support through tricky times, especially the pandemic, which I will be eternally grateful for.”

Partner and project lead Roger Harcourt said: “It has been a privilege to help Ash and his team on their journey.  The Medishout system they’ve developed can deliver major efficiency gains to healthcare and other operations where the efficient deployment of resources is absolutely crucial and is now gaining significant traction in the market.

“Bringing Episode 1 on board recently was another major step toward achieving their ambitious growth goals.  We look forward to continuing to support Medishout as it goes from strength to strength.”

During Covid-19, frontline staff are more reliant than ever on functioning equipment, logistics and infrastructure to treat patients. MediShout has already helped improve PPE allocation during the peak of Covid-19.

Carina Namih, Partner at Episode 1 Ventures adds: “Hospital facilities have been left behind by digital innovation for too long. As doctors and product designers, this team really understands how technology and AI can help frontline hospital staff be more effective. We are hugely excited by the positive impact that MediShout will have.”

How can we help?

Our expert lawyers are ready to help you with a wide range of legal services, use the search below or call us on: 0330 024 0333

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Guides & Advice

CCGs, GPs and LPAs: It’s time to work together

CCGs, GPs and LPAs: It’s time to work together

Even without COVID-19, a huge number of primary care providers have been running at full capacity for years. Pressure to meet care and quality targets is only going to increase as the population grows and underfunding and frequent financial penalties will make this even harder.

COVID-19 has had devastating effects on the healthcare sector, and primary care providers now have the chance to seek increased financial contributions from developers. Collaboration between Clinical Commissioning Groups (CCGs), GPs and Local Planning Authorities (LPAs) will be key to securing the future of the UK’s healthcare service.

Funding for expansion

A new residential development will inevitably impact primary care providers as a wave of new patients appear. Often, the only solution is to expand, increasing capacity and lessening the pressure on the service. However, this costs money that many GP surgeries or healthcare providers simply may not have, and therefore contributions towards this burden should be something that the developers plan to support right from the start.

Factors such as the number of homes and the development population should be considered, and the funding the care provider is entitled to then based on this.

Community infrastructure levy (CIL) regulations

Initially, CIL regulations had pooling restrictions that limited the funding that care providers could receive to just five agreements. Recent planning reforms mean this is no longer the case, allowing providers to seek provision from as many agreements as needed, where the development is set to affect their services.

It is vital that care providers take action to secure any opportunity for funding that is presented to them.

Engaging with the planning process

Monitoring for new developments should become part of normal business for CCGs and GPs. When one does appear, they should engage with the planning process early on and respond to applications as and when they come in.

Primary care providers should also engage with policy at a local level, ensuring that it supports the financial requests they may consider submitting as new developments arise. Proactive engagement is essential.

Prioritising administration

The day-to-day care of patients will always be healthcare’s main priority, but that doesn’t mean administration can be forgotten. Unless primary care providers have adequate resourcing, it will be difficult to make the most of these funding opportunities. Employing consultants could be one way to stay on top of policy changes and applications to make sure they can be actioned efficiently.

Now more than ever, collaboration between LPAs, housing developers and care providers is necessary. The services that the healthcare sector offers are vital, and we need to ensure that it has the funding it needs to withstand any - and all - future challenges.

Read more about our healthcare expertise.

Contact us

For guidance and support on how we can help you to secure the future of the UK’s healthcare service, contact Paul Wakefield in our legal planning team.

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Avicenna was founded in 1992. Since then, its membership base has grown considerably to over 1,000 independent pharmacists. It now has an active position in the sector and offers supply and support services to all of its members. As well as this, it operates a chain of 21 retail pharmacies, largely based in the south-east of England.

Throughout the acquisition, our corporate team advised on a variety of legal areas, ensuring the process went as smoothly as possible.

Keith Spedding, partner in our corporate team, commented:

“Juno has more than 100 years’ experience in the pharmacy sector, making this acquisition a wise move for Avicenna. The pharmacy sector is constantly growing, and Avicenna has put itself in a strong position to take advantage of that. We wish all of the team the very best for the future.”

Ian Gray, chairman of Avicenna, said:

“This acquisition is a great opportunity for Avicenna, and we’ve been overwhelmed by the positive response from our shareholders. I’d like to thank Shakespeare Martineau for their hard work and support during the course of the acquisition. I look forward to starting our journey with Juno and am certain that we’ll continue to go from strength to strength as part of its offering.”

Find out more about our corporate team.

At the initial hearing, the EMA failed to convince the High Court that a Brexit ‘frustration’ argument should be invoked to allow their 25-year lease at Canary Wharf to be broken. However, the EMA chose to appeal this decision and the Court of Appeal will hear their case.

Julian Joseph, our real estate partner, had this to say:

“The doctrine of frustration is difficult to invoke, and the EMA’s attempt to use this as a reason to break its £500m lease early was certainly bold. Although originally rejected, the news that the organisation has been granted permission to appeal means the battle is to continue.

“The 25-year lease is unusually long, but the Judge ruled that even with the company’s move to the Netherlands approaching, there was not enough evidence to terminate the lease using the frustration route. Every aspect of the frustration claim was explored, creating a 95-page long ruling.

“Disposal provisions, were the EMA to move to Amsterdam, were agreed upon by the parties at the creation of the contract. These comprised the options permitting the EMA to assign the lease or to sublet the premises, and if that wasn’t possible, they would have to retain the premises and pay the rent. The judge was clear that this agreement must be followed.

“To avoid these issues, it is vital for organisations to consider whether the terms and the durations of leases will be suitable for them in the future as well as now, including in difficult trading conditions.

“If EMA were to have succeeded in invoking the Brexit ‘frustration’ argument to terminate their lease, many other companies would have attempted the same. For now, this has been avoided, but if the appeal is successful, it could cause huge waves in an already volatile property market.”

Contrastingly, there are a lot of people desperate for affordable and suitable accommodation. Intergenerational living could be the answer to both problems.

Our partner in the social housing team, Gary Ekpenyoung, discusses the intergenerational living model and the benefits it holds:

Homeshare is an intergenerational living model that has established itself as an alternative to residential care and home visits. An agreement is made between an older person and another party, that gives the latter rent-free accommodation as long as the former is provided with companionship and support.

Loneliness, and the mental health issues associated with it, puts a large amount of strain on the NHS. The Homeshare approach could lessen this strain, through reducing loneliness and isolation, and allowing people to stay out of residential care for longer.

There is also no need for concerns surrounding the generational gap, as an interviewing and vetting process matches people based on personality, so that the relationship is mutually beneficial.

Almost 500 UK households are now embracing intergenerational living, but the Tenant Fees Act 2019, which received Royal Assent on 12 February 2019 could potentially cause a few hurdles. The legislation stops lettings agents charging excessive fees to their tenants, a positive goal, but one that could put Homeshare agreements in danger, as money is exchanged to cover admin and matching costs. This could lead to income drying up for Homeshare UK – part of Shared Lives Plus – the network managers for Homeshare.

Thankfully, Homeshare has secured Government support and recent amendments to the Tenant Fees Act have limited the impact of the Act on Homeshare schemes.

The combination of an aging population and ever-increasing rental costs has brought the value of Homeshare to the forefront. Intergenerational living is a solution to a multi-generational problem.

Dignity and respect are core principles at Belmont Healthcare. The business provides high-quality care to those who are most vulnerable, and specialises in looking after people with dementia and Parkinsons.

Haslington Lodge is a semi-purpose-built home that supports residents with constant care of a non-nursing nature. It has 46 bedrooms, many of which are en-suite.

To ensure comfort and a supportive environment, the units have a family-feel. Residents are encouraged to relax in communal spaces and take part in group activities.

Shakespeare Martineau advised on all legal aspects of the acquisition, including undertaking due diligence, negotiating acquisition documents and liaising with funders.

Over the last year, Belmont Healthcare has acquired two care homes, with Haslington Lodge being the second. March 2018 saw the business take over Edendale Lodge, a home in Crowhurst, East Sussex.

Roger Harcourt, head of healthcare at the firm, said: “The acquisition of Haslington Lodge is great news for Belmont. Each home that is added to the Belmont brand allows the business to broaden the reach of its excellent care services. The critical mass achieved through the purchase will help to continue this expansion. Belmont are dedicated to providing high-quality care for the elderly, and this is where its success stems from.

“The past year has allowed us to form a solid bond with Belmont and this deal highlights their skill at acquiring and integrating new businesses with great success.”

Adam Hutchison, managing director at Belmont Healthcare, said: “Haslington Lodge is an exciting addition to our family of care homes. We hope that we can nurture the home and its staff so that it becomes a model care home that others look to as an example of high-quality support.”

The NHS has been promised an extra £20bn annually and as revolutionary technologies such as virtual and augmented reality tools and digital health management platforms become part of the mainstream medical landscape, improvements to health services could be monumental.

This is not just the case when considering patient outcomes, but also in increasing preventative measures, widening patient’s access to services and relieving pressure on increasingly overwhelmed providers. However, when looking to fill gaps in the market and deliver these innovations, entrepreneurial individuals and companies must understand the challenges they may face and how to navigate them successfully.

Attract investment

Med-tech entrepreneurs can face many barriers on the road to market, but perhaps none more arduous than attracting investment. Even with a terrific central idea in place, investors are often incredibly scrupulous and can be difficult to win over. This can be a difficult problem to navigate, as even just demonstrating the efficacy of a product or service can cost a high price, so without the necessary funding, good ideas are essentially dead in the water. Therefore, it is important that healthcare innovators produce a detailed breakdown for potential investors, explaining not only the idea itself, but also their step-by-step intentions, detailing the exact route to the end product or service. It is also important to highlight how said route will be profitable; investors need to know that you can speak their language and intend on returning financial gains.

All reasonable ideas should be on the table at this point. By seeking support in this arena, innovators may conclude that the best route to commercialisation will involve licensing their idea to a larger business with specialist resources already in place. Alternatively, they may decide that investors in other territories such as the US may be more freely able to fund their projects. In the increasingly globalised healthcare technologies market, the world really can be the innovator’s oyster.

Learn from your failures

While it might seem somewhat contradictory, to truly succeed in the world of med-tech innovation, entrepreneurs will often need to fail first. It is often easy to fixate too intensely on the original concept; failure is the only sure-fire way to learn adaptability, and the capability to iterate both ideas and distribution strategies. By adopting a ‘fail fast’ attitude, innovators can learn to make adjustments quickly, speeding up the timeline to market.

Sometimes it is even worth failing at an ideas stage, if the product or device in development isn’t properly solving a problem. A technological innovation can be effective and novel, but if it doesn’t solve a significant problem in the market or in the practice and application of healthcare, then it is unlikely to be particularly viable or attractive prospect for investors. In an instance such as this failure can often help entrepreneurs to see the bigger picture and appreciate the importance of fully understanding the market and the customer user experience.

Protect your innovations

If entrepreneurs do go down the route of licensing when attempting to commercialise their product, it is important that the agreement is carefully scrutinised. A well-drafted licence agreement will help to balance risk and reward between parties and will therefore help the entrepreneur realise value through a royalty stream. However, it is similarly important that any agreements also ensure the integrity of any intellectual property (IP).

This should be the case with any innovation under any circumstance and isn’t always the simplest of tasks. However, rushing to patent might not always be the best course of action when attempting to protect a new technology, so specialist advice should always be sought when grappling with IP. Other forms of protection may also involve the use of confidentiality and non-disclosure agreements, so any med-tech innovators should make sure they’re well-versed in the application of these legal contracts.

What now?

If entrepreneurs remain pragmatic when looking to commercialise a new innovation, and employ a structured approach, huge opportunities are available to not only create a viable business venture, but also to revolutionise the healthcare sector to everyone’s benefit. For more information, or to discuss any of these issues further, please contact Roger Harcourt, partner and head of healthcare.

The changes enable the NHS to hire medical practitioners and nurses from outside of the EU without being restricted by Government enforced caps on migrant worker numbers.

What are the current rules?

Under current immigration rules, the Government caps the number of non-EU skilled workers coming into the UK under the Tier 2 general category at 20,700 a year, with variable monthly quotas in place to ensure this limit is not exceeded.

Businesses who wish to recruit non-EU skilled workers must not only have a Tier 2 sponsor licence, but are also required to apply for a ‘Restricted Certificate of Sponsorship’ for each vacancy they wish to open to workers coming from outside of the EU. However, when these monthly restrictions are met, employers who have not been able to recruit are then required to re-apply for the Certificates in the next month, and in some cases have to re-advertise.

Prior to December 2017, this quota had only been exceeded once. But as demand for non-EU labour has seen an unprecedented increase, this quota has now been filled consecutively over the last six months. From December 2017 to April 2018, over 8,000 of the nearly 17,000 requests for Restricted Certificates of Sponsorship have been refused.

What’s more, analysis shows this demand is not likely to fall anytime soon, particularly as we enter the summer months and businesses look to recruit graduates to commence contracts in September.

Why does this particularly affect the NHS?

With a large shortage of skills in the UK healthcare sector, the NHS is heavily reliant on migrant labour to fill vacancies for trained doctors and nurses. As the number of skilled migrants from the EU looking to work in the UK has declined for a variety of reasons, including the impact of the EU referendum, the NHS has increasingly had to look to recruit outside of the EU.

The current cap on recruitment of skilled overseas workers has exacerbated this skills shortage, leading to the British Medical Association declaring the rules unsuitable for the NHS and ultimately “threatening patient care and safety”.

What are the announced changes and what do they mean for the sector?

The latest announcements have sought to address these issues and enable the NHS and the healthcare sector as a whole to recruit workers more effectively.

From 6 July 2018, medical practitioners and nurses are to be removed from the ‘Restricted Certificates of Sponsorship’ process. While restrictions on advertising will still be in place, these roles will no longer be subject to a monthly cap on the number of workers they can recruit from outside of the EU.

Further, the 700 certificates previously allocated to medical practitioners and nurses will now become available for other skilled professionals. This will enable increased recruitment of non-EU skilled labour in other industries outside of the healthcare sector.

Whilst these changes have been seen as a welcome positive step for the NHS in the short-term, concerns over recruitment in the sector in the long-term remain. With the Migration Advisory Committee (MAC) warning that the impact of Brexit on the number of skilled migrant workers in the UK is not expected until September 2018, only time will tell.