What does the future hold for biopharma regulation in the EU?

6 Feb 2018

Lorraine Nolan, chief executive of the HPRA. Image: Luke Maxwell

Lorraine Nolan, chief executive of the HPRA, believes if the EU is to stay on top of innovation, it has to become more flexible.

If the EU is one of the major biopharmaceutical hubs in the world, then Ireland is one of its vital components, having attracted 75 different companies to the country, with all of the 10 largest having an operation here, according to IDA Ireland.

The IDA figures also noted that this makes Ireland the seventh-largest exporter of medicinal and pharmaceutical products in the world, as of 2015.

But with all this success comes the challenge of regulating it, which is the role of the Health Products Regulatory Authority (HPRA), headquartered in the heart of Dublin.

Ahead of her appearance at this year’s BioPharma Ambition event on 21 and 22 February in The Printworks at Dublin Castle, the HPRA’s chief executive, Lorraine Nolan, spoke with Siliconrepublic.com about where biopharma regulation is right now, and where it’s going.

For starters, regulatory authorities across the EU are set for a major change this year with the introduction of new clinical trials regulation set to come into force in 2019.

The intention of the regulation, according to the European Medicines Agency, will be to make it mandatory for those conducting trials to follow a set of consistent rules in all member states. Crucially, it stipulates that all conduct and results will be made publicly available.

For Nolan, it will be a major boon to regulators such as the HPRA, bringing a considerable boost in efficiencies to the approval process.

Speaking specifically about the transparency element, she said it “provides a really big step change in terms of increasing the patient involvement, public involvement and public understanding of the processes for approvals of medicines”.

However, she added that there is still room for improvement for the EU when it comes to staying competitive with some of the other major regulators, such as the Food and Drug Administration in the US and the Pharmaceuticals and Medical Devices Agency in Japan, which are considered world leaders.

“On the innovation side, some of the challenges are that we have to keep pace,” she said. “The speed at which things can happen, both from a legislative viewpoint and a policy viewpoint, has to become more flexible and adaptable.”

‘So much we can get from big data’

Speaking as someone who has worked in the sector for 17 years, Nolan added that on the plus side for Europe, there has been a major change in attitude and even language within the EU over the past five or six years, in order to stay on top of the game from a regulatory standpoint.

Arguably driving this has been the adoption of new technologies such as the internet of things, which promises to provide a wealth of new information through connected health devices – something the HPRA knows it has to manage carefully.

“There is so much we can get from big data. The trick for us is to get it and use it in a way that it can be robust in informing regulatory decision-making, and there’s huge power to make better decisions as regulators,” she said.

Lorraine Nolan will be speaking as part of the Ambition for Medical and Biopharma Innovation’ panel at BioPharma Ambition on 21 February 2018.

Colm Gorey was a senior journalist with Silicon Republic