'Regulators: Get to the point', say experts at DIA Euromeeting
Kicking off the plenary discussion in Copenhagen, Denmark, Morten Østergaard underlined the general mood of the panel when he called for more integration and less complication in the way clinical trials are regulated.
He said: “More than ever we need the best brains working together across borders. Now innovation in the healthcare sector must be made available quickly and in a responsible manner.”
And though the panel – which included regulators, industry leaders and academics – disagreed on the specific steps needed to reform the drug discovery process, all backed Østergaard’s call to simplify matters.
Marc-Christoph Wagner, journalist and moderator of the discussion made the suggestion that in becoming more ethical, the regulators have now become “too ethical” to the detriment of progress.
Professor Hazel Biggs, co-director of HEAL (health ethics and law) and professor of health care law and bioethics at the University of Southampton, UK, caused controversy in her reply when she suggested that industry should be able to take more risks.
“High level of regulation means massive costs but if we were willing to take greater risks we would reduce that price,” she said.
“It builds in more bureaucracy and more cost that is unnecessary. We need to think about how far are prepared to permit people to take their own risks.”
Guido Rasi, executive director of the European Medicines Agency (EMA) retorted it is not the amount of regulation involved in clinical trials and the discovery process, but the fact governing bodies need to adapt to the rapid changes more quickly.
He said: “It’s not a matter of too much or too little. The process has to adapt to a changing environment. Sometimes we have to take the decision in an environment that we are somewhat blind in.”
Rasi also said the industry and patients are looking for a certainty that can only be brought about by change, adding: “It’s much more important than one more or one less rule in the game. Industry and the regulators need to change together to see a new business model.”
He stressed the EMA is not renouncing the need to find new drugs.
A three-manned race
Throughout the discussion it was clear that the patient has now become an equal stakeholder with industry and academia in their own care.
Speaking about the greatest challenges faced in the pharmaceutical sector today and how to solve them, Liselotte Højgaard of the department of clinical physiology nuclear medicine and PET, for the University of Copenhagen, Denmark, said the way forward is a collaboration between all three.
She said: “The answer is research in a collaborative effort. An interdisciplinary effort between all the payers – the doctors, the patients and industry.”
Rasi added: “We now have to define the roles that are in the process and what part each one plays. There are three stakeholders now.”
He called to industry to take action over this, warning: “If you do not define the roles properly, we (the regulators) don’t have the grounding to see if we can change our role within the process."
AstraZeneca chief David Brennan extended an olive branch when he said: “Let’s find a way to modify behaviour so regulators understand the outcome you’re searching for, and what they can do to help.
“Behaviour and outcome are two things that are opportunities, and changing that would make a massive difference.”
In the end innovation was the name of the game. Lars Rebien Sørensen, president and CEO of Novo Nordisk, summarised: “Innovation is above solving any other problems we have. We somehow need to develop the understanding that the need for innovation is the most pressing matter.”
