The burden of regulation may be preventing the development of disruptive innovation from basic research in life sciences. That will be the theme of the Laurence Crowley Lecture to be delivered by Prof Joyce Tait at the UCD Smurfit School on Monday.
In her lecture entitled Advanced Innovative Biotechnologies: a new approach to their regulation and governance, Prof Tait will explain how the current regulation of life sciences industries includes many examples where well-meaning decisions have unintentionally stopped fruitful lines of innovation and have needlessly delayed the introduction of societally useful innovations.
Prof Joyce believes that a new approach involving the creative use of standards in a more equitable relationship with regulatory systems could offer a solution.
“People have been saying for a long time that useful innovations in life sciences are being stopped because there is not enough profit potential to meet the regulations,” she says. “It’s not just the upfront cost, it’s the time that it adds to the process. It costs $2 billion (€1.72bn) and takes 15 years to develop a new drug.”
Only the major pharmaceutical companies can afford this and even then, only when the potential market for the new drug justifies the investment.
“If we could change the regulatory system it could make a huge difference to innovation,” she adds.
Tait and her team at Innogen in Edinburgh, an institute that explores the social and economic impact of innovation in life sciences and genomics, have been working with the British Standards Institute (BSI) for the past two years on a solution to this issue.
“One way to do it would be to adapt the system to cater for incremental and disruptive innovation in different ways, that would be a start.” she says. “We got a grant from the BSI because we showed that standards might be a way of achieving this. Standards are different to regulation, they are much more consensual. Regulators often make decisions without realising what their upstream impact might be.”
The change she is proposing is to utilise a standards-based system for the early part of the process with regulation taking over when the innovation is close to becoming a market reality. This would create a balance between allowing innovation to flourish in the basic research environment while ensuring that public safety was protected by regulation at the appropriate stage.
She offers an illustration of how this can work in practice. “You can’t really talk to regulators about changing the regulatory system.” she contends. “It’s just not in their vocabulary. But standards can be changed much more easily and small changes to them can have a huge impact. The US FDA some years ago changed the guidelines for the development of anti-microbials. This brought down the cost of development by 50 per cent and made a huge difference to company’s willingness to develop new products.”
Changes like this can have a fundamental impact on development economics as well. “Smaller companies can now take on the process even with much smaller profit margins,” she notes.
This is incremental innovation, however, and the eventual regulatory systems for the products when the reach the market is well established. “Where disruptive innovation is involved you probably don’t know what regulatory system is appropriate. In many cases that’s driven by industry. For example, when it came to GM crops there was a tussle between the agri-chemical sector and the plant sector as to which system of regulation was more appropriate. If you had developed them through the seed companies, you probably wouldn’t have insecticide resistant crops now.”
The framework she is advocating would mean that the regulatory system will have much less influence on the development process. “The problem we have is that we have plenty of research but not enough disruptive innovation is coming out of it,” Tait continues. “The way the system works at the moment, any SME in the life-sciences sector has to at some point in its existence sell the IP to a multinational company or be taken over by one because it can’t afford to bring the innovation to market.
“We need to bring down the cost of regulation and shorten the timescale to get to the point that SMEs can become big companies in their own right.”
Unfortunately, at least some of the signs from Europe are not hopeful that this is achievable. "Europe has just introduced a new regulation for diagnostic devices and it is already leading to companies going out of business because it is too bureaucratic."
She concludes by pointing to the gene-editing technologies which hold out so much promise in the agricultural sphere. “The way we have bred plants in the past has been for yield and resistance, but we could now use gene editing to edit the flavour back into them where it has been lost. If a small company is only making a minor change and is meeting standards and applying guidelines it shouldn’t have to go through the full regulatory process. This would lower costs greatly and help foster innovation.”
UCD Smurfit School will host the Laurence Crowley lecture with Prof Joyce Tait on Monday, November 6th, at 6pm. For event details and registration – smurfitschool.ie/leclectureseries