EU impact on life sciences: more market access but more red tape

Being part of a European Union-wide regulatory framework gives UK bioscience firms easy access to a huge market, but sometimes brings with it excessive regulation, costs and overly conservative rules against the use of new science, particularly genetically modified organisms, a report by MPs has found.

EU Regulation of the Life Sciences, produced by the House of Commons Science and Technology Committee and released today, paints a picture of a system that is attractive to businesses but sometimes frustrating for ministers and scientists.

Under EU rules, life sciences research and the approval of new treatments is harmonised across the union in a single regulatory framework.

Representatives of the biomedical industry said that being part of this system made it more attractive for companies to invest in the UK.

Steve Bates, chief executive of the BioIndustry Association, told the inquiry that “you can see the benefits from working in a harmonised scheme that gives you access to a very large market – 27 per cent of the global market rather than 3 per cent of the market if it was the UK alone”.

In a similar vein, evidence from the Association of Medical Research Charities (AMRC) said that belonging to the harmonised framework “plays an important part in the UK’s attractiveness for inward investment and research by the life sciences industry”.

But the report also notes that these EU-wide rules had sometimes led to excessive regulation, with the Wellcome Trust identifying an “increased burden on academic researchers and a drop in clinical trials conducted in the UK and the EU”.

However, the AMRC argued that this was because the UK had implemented the rules in a more “stringent” way than other EU states.

There were also concerns about the cost of complying with the EU framework. Evidence from the Cell and Gene Therapy Catapult Centre said that the EU’s centralised system “can be an extremely costly (financial and resource) and lengthy process”.

The committee accused the EU of having “wilfully misused” the precautionary principal – a rule that when there is no clear scientific consensus on the environmental impact of a new technology, it should be avoided – to block the use of new scientific advances, particularly genetically modified organisms.

It heard from the life sciences minister, George Freeman, who said that the EU had not approved the commercialisation of a blight-resistant GM potato “despite the absence of any scientific evidence of harm to human health or biodiversity”.

The report backs Mr Freeman’s call for “an enlightened regulatory system on the side of innovation” and urges member states to adopt a “far more scientifically robust application of the precautionary principal”.

david.matthews@tesglobal.com