Increasing regulations and cutbacks in healthcare funding are causing the United Kingdom’s pharmaceutical industry to look to emerging markets for growth. However, regulatory compliance issues are also problematic in those territories, according to a recent study from Maetrics, a full-service life science consulting firm.
Spending cuts and increased requirements for pharmacovigilance at home are causing pharmaceutical firms to look abroad. With the National Health Service forecasting a potential £30bn funding gap by 2020, more than half of surveyed businesses (57%) confirmed that healthcare spending by governments will be a major challenge in 2015. In addition, that same percentage said keeping up with escalating regulatory demands are primary concerns for the coming year.
Increased demands for pharmaceuticals are drawing companies into emerging markets, though more than half of respondents said they had concerns about regulatory compliance in those territories. In addition, some 43% expressed concern about finding qualified staff for such ventures.
“Emerging market expansion offers an appealing solution for businesses that are feeling under pressure in mature markets, but ensuring compliance with different regulations is going to be tough,” said Peter Rose, managing director at Maetrics.
Additional key findings include:
- 36% of pharma respondents view the need for increased testing in pediatric medicines as a challenge for 2015.
- 20% are concerned about the 2015-2020 change in prescribing patterns – from standard pharma to products of biological origin – and the implementation of the Falsified Medicines Directive.
- A majority report inadequate investment in compliance at their firms, citing either lack of resources (68%), time (67%) or budget (65%).
- 61% report difficulties with implementing regulations to their specific environment.
- 60% say that regulations are hard to interpret and change too often.
“Having a strong quality and compliance team, whether internally or externally through a consulting partner, is more important now than ever before,” Rose continued. “It’s clear that the key to fully leveraging the opportunities in emerging markets is confidence in interpreting and implementing regulations.”
The study, conducted by leading business analyst MindMetre, surveyed more than 50 compliance and quality management professionals from four life sciences sectors, including pharmaceutical, medical device, biotechnology and nutrition – with participants from both large corporations and small to medium enterprises (SMEs) – to determine the industry outlook, examine growth drivers and provide insight into planning and buying behaviours.