Launched in 2008, Panacea has gained an enviable reputation in pharmacovigilance, offering a true level of security both for drugs companies and their customers
By Mike Cowley
When Stuart Colligon launched his company Panacea in Douglas on the Isle of Man back in 2008, it was a time when his chosen sector was – as he recalls – “about as popular as the poll tax” which clearly indicates the regard in which it was held as this had resulted in riots in the UK.
For pharmacovigilance, the process of collecting, monitoring, researching and evaluating the adverse effects of medications, was then viewed as a necessary evil, effectively a grudge purchase by his potential clients in the booming generic drugs marketplace.
And having previously worked in business development in the pharmaceutical industry internationally, Stuart Colligon had identified this as a niche market with considerable commercial potential. He chose the Isle of Man not only because he was living there at the time but because the government were helpful and there was an established Manx life science cluster.
Here was a market that he was aware had exploded with the proliferation of generic pharmaceutical companies and generic product licenses in the early 2000s as a result of a raft of medicinal product patents expiring after 20 years of protection (based on a 15-year patent timeline and a further five-year special protection certificate) which saw the originators have to give up their market monopoly of the drugs on which they had spent multi-million pounds to develop.
Even over-the-counter drugs such as hay fever remedies that once sold for £4 were now available at a quarter of the price. So everyone appeared to be happy – the users, the health service because it drove costs down and certainly the generic license holders. However, the same did not hold true for the companies who had spent years researching and developing the original products, only to lose market share to rival commercial operations who reverse engineered the products. That is why many of the original developers have in fact now included the generic route in their portfolios themselves.
While a few of the giants like Pfizer fought back by patenting both the colour (blue) and the shape(diamond) of their blockbuster pill Viagra, even they eventually lost dominance in what was eventually the pharmaceutical equivalent of the gold rush.
However there still remained real concern over the potential for another Thalidomide disaster which took place in 1961 when thousands of congenitally deformed infants were born as the result of being exposed in utero to the medicine when it was prescribed to pregnant women to combat morning sickness. That in turn sparked the first systematic international efforts to address drug safety issues and the ultimate emergence of the practice and science of pharmacovigilance.
When the generics boom started at the turn of the century, the problem, though, was that this concern appeared to be confined to the regulatory authorities rather than the generic drug companies themselves, who seemed convinced they could rely on the safety track records – often over two decades – of the products they were licensing. But they still had to comply when powerful bodies such as the EMA in Europe, the MHRA in the UK and the FDA in the States acted to ensure that mandatory pharmacovigilance was properly applied by the generics players.
So initially in their collective frustration they saw the answer lay in ‘buying cheap’ and consequently pharmacovigilance companies either willing to provide a ‘bare minimum’ service, or in countries with low wages reaped the financial rewards.
However, the sector did not escape without incident and with the threat of product recalls and potentially being closed down hanging over them if safety standards were not met, eventually companies experienced a change of heart amid a growing realisation that here was a situation that needed to be taken seriously – and that pharmacovigilance offered a true level of security, both for their businesses and their customers.
In recent years, this has seen an increasing number of companies willing to pay for quality. “There has been an acceptance within the industry that cheap is not necessarily best when it comes to pharmacovigilance. Quality is now seen as key – and our service is very much quality first,” insists Stuart Colligon.
Just how important pharmacovigilance is for the end user of drugs was illustrated when Panacea became the first company in the world to spot significant problems with an antiseptic solution used on the skin. It discovered the appropriate remedial action when it found cases in which the product caused burns to premature babies when used at times of catheter insertion and is why Panacea today finds itself in the top five pharmacovigilance companies operating in the UK and Europe.
Working from secure, dedicated offices in the island’s capital, Panacea is responsible for monitoring the safety of medicines with marketing authorisations in every EU country and beyond and does so from its Isle of Man HQ and United Kingdom offices. From here it is currently concentrating on expanding its customer base across the EU.
It has experience of successful inspections from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the Irish Medicines Board (IMB), and the Food and Drug Agency (FDA).
The company has extensive disaster recovery plans in place which involve real-time off-site backup of all its operations and data. This means that in the event of an emergency all its critical pharmacovigilance processes can continue uninterrupted and its clients’ critical data is protected at all times.
Two senior members of its management team have postgraduate qualifications in pharmacovigilance, while other employees are currently studying for the same. As part of the requirement to work in the EU pharmaceutical industry, it is necessary that a company has experts living within the EU. And as the Isle of Man is not a member, they currently reside in the UK itself. Now, with Brexit looming, Panacea is already making contingency plans to recruit additional experts in other parts of the EU.
This is all part of Panacea’s ongoing strategy to ensure that they are at the leading edge of pharmacovigilance.
“We have a dedicated quality management function which ensures that all our work – at every level – is checked, audited, and compared with best practice and complies with the highest and latest standards,” says Mr Colligon.
“We invest significantly in training. Each member of staff has modular training that is tailored to their role within Panacea and is modified if their responsibilities change. Training is updated on an annual basis or earlier, as necessary. I am deeply proud of the people that we have in Panacea; they are exceptional and this, ultimately, is what enables us to deliver such a high level of service to customers.”
Panacea’s professionalism also seems to have won fans in high places.
A recent conference on pharmacovigilance saw an attack on the quality of the service available to companies from one of the delegates.
This brought a quick response from a panel representative who singled out Panacea as an example of the high quality that is now available to generic drug companies today.
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Swift action a life saver for client
When a leading UK generic pharmaceutical firm with more than 100 drug products learned they were due for an inspection by the MHRA regulatory body, they called in Panacea to make a pre-inspection audit.
This proved fortunate for them as the Panacea inspection team found a situation so serious that if it had been allowed to carry on unnoticed could have resulted in the closure of the operation.
Normally a red alert would ensue if there was one “Critical Finding” in the internal processes but in this case multiple were found. In addition, there was also a large amount of “Major Findings” requiring prompt attention.
Having identified these, it is normal practice for the MHRA to give the offending company 90 days to correct the situation or face closure.
However, because of Panacea’s trusted reputation in the sector, this was extended to nine months and the company’s future was guaranteed.