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  1. Politics
1 December 2017updated 09 Sep 2021 6:18pm

The SME pharmaceutical perspective

With Brexit on the horizon, navigating the pharmaceutical industry is a challenge for smaller firms.  

By Emma Chaffin and Carl Sterritt

At Shield, we were very proud to launch our first product in the UK in 2016 just six years after we were established as a company. The UK launch was the first launch globally for Shield, which was initially for a narrow indication for a small group of patients. We are now looking to obtain a broad license which would mean our product would be available across Europe for a much larger number of patients. However, in the UK we will have to engage with multiple reimbursement processes before clinicians can prescribe for patients. 

Shield is an independent SME and the UK pharmaceutical industry, although full of opportunity, can be a difficult environment, particularly for a small company. Recruitment and retention is a huge challenge for pharmaceutical SMEs, and a great deal of manpower is required to navigate the complex innovation access landscape. The British healthcare system is, by nature, highly decentralised. This is firstly as a result of being divided into four different countries. Within that, in England alone, there are over 200 hospital formularies to allow new drugs into hospitals, and 90 area prescribing committees to allow GPs to prescribe therapies, all of which have separate application processes and varying budgets. 

Germany launched shortly after, which made for an interesting comparison. Unlike the UK, once the price and reimbursement was agreed at a national level, clinicians could prescribe the drug without further process. Within a year of launch, Germany has roughly three times the rate of patient access than the UK, despite the German launch coming three months later.

The UK spends just 9.9 per cent of its GDP on healthcare, with Italy being the only other G7 nation that spends less, and Britain lags in patient access to new drugs. The ABPI found that for every 100 patients in comparable countries that can access a new drug in its first year of launch, just 12 patients in the UK can do so. 

Shield would like to see faster adoption of innovative medicines and a simplified adoption process, with more support for SMEs. We have heard positive noises from government in recent months, most notably the Accelerated Access Review (AAR), led by the Office for Life Sciences, which is designed to speed up adoption of innovative medicines.

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Particularly encouraging is the commitment of £6m over the next three years to support SMEs in gathering the evidence required to develop and market innovative medicines. More generally, Shield welcomes the recommendation to remove the duplication of assessments, with an eye to establishing a standardised assessment that channels localised approval bodies into four key hubs . The current national health technology appraisal system adopted by independent agencies, such as NICE and the SMC (Scottish Medicine Consortium) are the most system supported methods of gaining reimbursement in the UK. However, unlike in Scotland, less than half of medicines are topic selected for a NICE appraisal, which has a significant impact on adoption of new medicines in England. 

In line with the Life Science Strategy recommendations 2017 made by the life science industry, Shield encourages the further implementation of recommendations made in the AAR, particularly increasing the SME tax break threshold to higher than £5m to foster a level playing field between SMEs and the pharmaceutical giants that dominate. 

Companies like Shield have so much to offer the life sciences sphere, but the challenges are great.

Emma Chaffin is general manager of Shield Therapeutics UK and Republic of Ireland.

Medical Innovation in the face of Brexit

Shield Therapeutics is a born and bred British company; we are UK-founded, UK-based with UK products. I started the company in 2010 with a simple mission: to develop therapies for patients that will significantly improve their lives. Shield develops drugs that are likely to be used in a secondary care environment, for patients with diseases that cause specific conditions. We launched our first product in 2016 in the UK and Germany.  

Despite our proud British roots, we are far from inward-looking, nor is the wider pharmaceutical industry. Healthcare innovation has no nationality – all the medical congresses and journals are international – so operating across borders is imperative, as is the need to engage with the varying national regulatory and commissioning environments. Between 2015-19 Shield will have invested around £100m across France, Germany, Italy, Spain and the United Kingdom (the EU5). Our own workforce represents this internationalism; we have employees who hail from Russia, the USA, France, Germany, Austria, Australia, and many more parts of the world.  

Brexit presents a number of question marks that could prove very unsettling for the UK life sciences industry, and particularly SMEs within it. A number of points require urgent clarification to prevent any pre-emptive movement away from the British market, and stave off doubt over companies’ future ability to invest in UK-based medical innovation. 

The European Medicines Agency (EMA), a network which authorises marketing across all EU member states, is currently based in London; a testament to Britain’s position as a leading medical force. If Brexit signifies a withdrawal from EU institutions it seems highly unlikely that the EMA can remain headquartered in London, and more generally that the UK can remain a member of the EMA at all. This could result in the UK becoming a secondary market; pharmaceutical companies will have to submit a separate application for the UK to the rest of the EU. This is currently the case for Switzerland, and results in a delay on patients gaining access to new medicines. Shield is eager to see productive negotiation with the EU that aims to prevent further complication of regulation, and retains alignment with the EMA. 

As an SME, it is already a struggle to compete with the big pharmaceutical companies for highly skilled workers, so any harm to the UK healthcare sector’s reputation as a great place to work will have an adverse effect on smaller companies. To this end, addressing the insecurity around free movement of people is imperative to the healthcare sector, as it is to all UK-based industries. 

EU funding plays a significant role in the research and development of new drugs; therefore, securing continued access to bodies like the European Investment Bank and European Investment Fund is imperative. Similarly, free trade agreements that are existent between EU and non-EU states need to remain accessible, and the movement of medicines and pharmaceutical supplies across borders should be frictionless to mitigate delays that could prove very costly.

Shield is British and proud, but we cannot guarantee that the UK will continue to be our home without certain assurances. Without these, operating out of the UK may well become too difficult to justify, especially as a smaller company. Either way, it will become clear very soon just what is feasible for Shield, and for much of the sector.

Carl Sterritt is the founder and chief executive of Shield Therapeutics.