Pharmacovigilance Must Not Be Overlooked As Brexit Looms
Executive Summary
Industry and regulators have insisted that effective pharmacovigilance in Europe must not fall by the wayside as they grapple with preparations for the UK’s imminent departure from the EU.
“Brexit is not in the interest of patient safety.” This statement, voiced by Wendy Huisman, succinctly captured the mood of the room at Medicines for Europe’s 2019 Pharmacovigilance conference held in London, UK, last week.
Huisman – senior pharmacovigilance consultant at Vigifit, and former qualified person responsible for pharmacovigilance (QPPV) for the EU at Teva, as well as the former chair of Medicines for Europe’s pharmacovigilance working group – was far from the only person to speak out on the subject, with industry and regulators alike forming a consensus that the UK’s imminent departure from the EU is unlikely to make pharmacovigilance any smoother for healthcare stakeholders in Europe.
However, all agreed it was essential that a strong emphasis continue to be placed on effective pharmacovigilance to prevent it from being overshadowed as industry grapples with preparations for Brexit, as the planned 29 March 2019 departure date looms.
‘Business As Usual’ Despite ‘Challenging Times’
Sabine Straus, chair of the pharmacovigilance risk assessment committee (PRAC) within the European Medicines Agency (EMA), acknowledged that “for everybody at the moment, Brexit is the most important thing in our minds”. However, she maintained that throughout the Brexit process EU pharmacovigilance systems would continue in “business as usual” mode.
“These are very challenging times,” Straus admitted, not least due to the EMA’s relocation from London to Amsterdam as a direct result of the Brexit process – a move which has resulted in staff losses and certain agency activities being dropped or minimised. However, she insisted, assurances had been received that “everything is in excellent working order” to prepare for Brexit.
“There will be some hiccups,” Straus conceded, but the EMA was aware of the issues involved and would prepare as much as possible to overcome them, she said. Meanwhile, she indicated, companies must also do their part to make the Brexit process as smooth as possible.
“What we would all like to have right now is a little more certainty” – Susana Almeida, Medicines for Europe
From industry’s perspective, said Susana Almeida – Medicines for Europe’s clinical development and safety director – the biggest challenge in preparing for the separation of the UK and EU was the continuing high level of uncertainty over the exact form that Brexit would take, and the timeframes involved given the various possible permutations.
Companies were cognizant of the need to prepare for a ‘worst-case scenario’, and the potential need to act upon it, Almeida said. But she indicated that there was a “fine balance” to be struck between companies needing to be prepared and not wanting to make significant structural changes unless absolutely necessary.
“What we would all like to have right now is a little more certainty,” she summarised.
Nevertheless, Almeida remained confident that pharmacovigilance concerns would not be drowned out amid all of the other regulatory considerations swirling around Brexit. While it was not a “sexy” subject, she conceded, it had not been overlooked.
But the action needed by industry to address the various pharmacovigilance concerns related to Brexit would ultimately depend on the specific path chosen for the UK’s departure, Almeida emphasized. “Until that is clear, we cannot be specific.”
Digital Technology Offers Data Opportunities
Insisting that efficient pharmacovigilance was “paramount for the safe use of medicines”, Adrian van den Hoven, director general of Medicines for Europe, observed that “industry and regulators have a shared responsibility to ensure that this system remains effective and efficient”.
“We commend the regulatory community on the close cooperation to achieve results for patients who rely on medicines,” he said, suggesting that “we need to accelerate the use of structured data to streamline and focus pharmacovigilance systems on patient needs”.
Pointing to the opportunities offered by ‘big data’, Almeida acknowledged that industry needed more sophisticated tools to turn this into information that it could use.
While some companies were further along than others in being prepared for this, she observed that things were moving fast in this area, and predicted that “in one or two years, we will see that a lot has changed”, suggesting that there would be a quick transformation in terms of industry’s ability to capture and interpret large digital data sets.
This would include finding the most efficient ways of reducing ‘background noise’ and identifying data that is relevant, she said, suggesting that ensuring good data was being used to make decisions was “one of the challenges we have right now”.
“Digital technologies offer the promise of more pharmacovigilance data from different sources, provided we can improve the capacity of the EMA pharmacovigilance system to better filter essential and non-essential information sent to companies for review,” Medicines for Europe stated. “The EMA-industry dialogue should step up its efforts to streamline the functioning of the system.”
“As we move into an increasingly patient-centered future, simplification and improved communication should be at the heart of our pharmacovigilance strategy.”