It’s by focusing on quality that Panacea aims to grow its share of the burgeoning pharmacovigilance market. It’s a promising tactic given the understanding by pharmaceutical companies that putting price before all else is not the optimum route given the ever more stringent global regulatory and safety demands.
Established in the Isle of Man in 2008, Panacea works with pharmaceutical companies to ensure their drugs comply with safety and reporting standards.
Pharmacovigilance is the process of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications to ensure that drugs on the market are safe for patients and to identify new hazards associated with the medication.
It was the thalidomide tragedy in 1961 - when thousands of congenitally deformed infants were born as the result of being exposed in utero to an unsafe medicine prescribed to pregnant women to combat morning sickness - that sparked the first systematic international efforts to address drug safety issues and the ultimate emergence of the practice and science of pharmacovigilance.
However, it was only with the proliferation of generic pharmaceutical companies and generic product licences in the mid 2000s that pharmacovigilance truly came to the fore as an outsourced solution.
Initially pharmacovigilance was once seen as a necessary evil, a grudge purchase - this frustration resulted in the general adoption of a ‘cheap is best’ philosophy. Consequently pharmacovigilance companies in countries with low wages attracted a large share of the international market.
However, there is a growing realisation within the pharmaceutical industry that pharmacovigilance delivers real benefits to a business and ‘buys’ a level of security. An ever increasing numbers of companies are now willing to pay what it takes to ensure best quality.
“There has been an acceptance within the industry that cheap is not necessarily best when it comes to pharmacovigilance,” explains Stuart Colligon, the founder of Douglas-headquartered Panacea. “Quality is now seen as key - and our service is very much quality first.”
Another source of new business is the rise in pharmaceutical companies dissolving in-house pharmacovigilance operations in favour of outsourcing the service.
Panacea, which also has staff based in the UK, is expanding its pharmacovigilance services beyond the pharmaceutical industry to include veterinary, cosmetics, foodstuffs and medical devices.
“Although human medicines will continue to be our primary focus we are diversifying into other areas of product safety and pharmaceutical regulatory affairs,” says Mr Colligon, noting that safety and reporting standards are being ratcheted up within the cosmetics industry.
Working from secure, dedicated offices in the Island’s capital, Panacea is responsible for marketing authorisations in every EU country and beyond but is currently concentrating on expanding its customer base in the United Kingdom and Ireland.
It has experience of inspections from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the Irish Medicines Board (IMB), and the Food and Drug Administration (FDA) in the United States.
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.
Panacea is flexible and responsive to clients’ needs, handling everything from one-off projects to continuous relationship over several years.
Two senior members of its management team have postgraduate qualifications in pharmacovigilance, while other employees are currently studying for the same qualification.
“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.”
Tel: +44 (0)1624 672777