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16 November 2017updated 08 Sep 2021 2:40pm

Small pharma companies are fighting to innovate

SMEs are facing major challenges in the pharmaceutical industry.    

By Emma Chaffin

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.

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. We eagerly await the Autumn Budget, and other announcements, for signs of support. 

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

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