Johan Vanhemelrijck

Last month, the council of ministers published its support ofthe commission’s mid-term policy review of the EU’s life scienceand biotechnology strategy. This stated that Europe must takeadvantage of the technology by addressing the regulatoryenvironment and improving access to capital.

While describing this as an “important step towards building thebio-economy”, Europe’s biotech sector remains concerned that thetechnology’s full potential will not be properly exploited untilEurope places science, and not public opinion, at the heart of itsdecision-making process.

“According to the treaty of Rome, politicians have to take thedecisions,” says Europabio secretary general Johan Vanhemelrijck.“EMEA (European medicines agency) and EFSA (European food safetyagency) were set up to investigate and provide risk assessments onproducts, and then politicians vote on the opinion. They tell usthat their voting is science based - it is – but it is alsoinfluenced by public opinion.”

Europe, says Vanhemelrijck, is the only region in the world thatactually votes on the science. He argues that this is a majorweakness - politicians can vote positively or negatively on anopinion without having to really justify their decision – incontrast to other regions of the world. Vanhemelrijck argues thatoutside influences have had a significant impact on the fact thatEuropean politicians have consistently voted against scientificevidence supporting the approval of genetically modified (GM)products.

“If safety criteria for a product is fulfilled in the US, thenit is illegal for the authorities not to put the product onmarket,” says Vanhemelrijck. “So if I am an anti-GM pressure group,and I see that one region votes on the science, while in another itwould be illegal not to put a product on the market if it meets thenecessary safety criteria - where would my efforts go? Where wouldI put fear? Where would I seed doubt? Seeding a sense of doubt tocultivate a no vote would not help in US. But it would inEurope.”

This situation, says Vanhemelrijck, has spiralled out ofcontrol. Once authorisation is delayed, because politicians refuseto vote on positive scientific results, suspicion is created withinthe public sphere that there is a problem.

“This is despite the fact that 10 million farmers worldwidecultivate 100 million hectares. This is the total agricultural landof Europe. Around 60 to 70 per cent of animals around the worldhave eaten GMOs. There has been no documented case of harm toanimal, human or environmental health - and by documented I meanscientifically documented. There has never in history been such amajor technology introduced on such a scale that has had no sideeffects like this one.”

Vanhemelrijck points out that problems of authorisation arealmost exclusively limited to products that end up in the foodchain. European politicians, he says, will happily vote in favourof biotech medicines and veterinary products that receive positivescientific opinions, but yield and growth enhancers in animalhusbandry for example, will get a negative vote after a positivescientific opinion.

“Why? Because it is not seen as being politically important toexploit animals more than nature would allow you to. So we handicapthe farmers, who we pay anyway through subsidies. When it comes toGMOs, there is no political gain for a lot of countries to vote infavour of a scientific opinion.”

There are other instances where improvements at the Europeanlevel could enable the biotech sector to fulfil its potential. “Agood example is clinical trials,” says Vanhemelrijck. “In Europethere is a directive, to which member states have added differentelements. This means that, as a company, if you want to conduct aclinical trial across several countries, you will be confrontedevery time with a different set of administrative burdens. You willtherefore probably have to eliminate some of these countries fromyour trials as you will want to preserve the protocol of yourtrial, otherwise your trial will not be valid.”

The potential is there though. There are about the same numberof biotech companies in Europe as there are in the US – thoughfurther examination reveals that EU companies typically employaround half of those in US, and invest around a third of their UScounterparts in R&D. In addition, they have access to about asixth of the capital available to American biotech firms. ButVanhemelrijck claims that large traditional companies are beginningto include biotechnology within normal production processes, andthat a new market is emerging whereby pioneering SMEs are becomingservice providers to major firms involved in anything from enzymesto textiles.

“Biotechnology is here,” says Vanhemelrijck. “It is a politicalfact that politicians can no longer deny. The overall feeling forbiotech - except for GM - is positive.

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