Seed World

The Next European Regulatory Challenge for Seed Breeders

As the European Union has started to realise that the benefits of new genomic techniques (NGTs) to food security far outweigh the risks (especially as Farm2Fork will seriously impact European farm yields), there is now a more favourable regulatory environment for innovative seed breeding technologies. But do not think, for a moment, that this will mean smooth sailing for those bringing new seeds onto the market. Following the hoops laid out in the past for new agricultural technologies, we can expect a very expensive, and thus very exclusive, regulatory process.

One of the most attractive advantages of NGTs is the low cost of entry for innovators. Labs in developing countries can concentrate on solutions to local agricultural challenges rather than relying on big companies with deep research budgets chasing more lucrative markets for commodity seeds. But if activists are forced to accept a less restrictive regulatory regime for NGTs (which they still insist are GMOs), they will fight tooth and nail to make the regulatory hurdles as restrictive as possible (and thus more expensive).

David Zaruk

In 2005, I was the Product Stewardship Communications Manager at Cefic (European Chemical Industry Council), during the first reading of REACH in the European Parliament. The regulation threated to incur serious research costs on industry to meet the registration requirements. I noticed then that the big chemical companies were not too concerned about the costs while the SMEs were, and they very loudly voiced their fear they would go bankrupt (and more vulnerable to big companies scooping them up on the cheap).

Fast-forward two decades and Brussels has become even more regulatory-restrictive so we should ask how such high compliance costs will create barriers to enter markets for all but the biggest seed-breeding companies. Can a small biotech company afford to wait ten years and pay tens of millions of euros to comply with demands from agencies and governments? Will smaller seed breeders need to enter into agreements with bigger companies?

Then there is the challenge of keeping the seed on the market. During the time of the European Commission’s deliberations on the Sustainable Use of Pesticides Regulation, Phillips McDougall released a study showing that more than half of the research costs spent by pesticide companies was to keep existing products on the market. With Farm2Fork, I cannot expect costs to go down or opportunities to increase.

Useful Idiots

The irony of creating near impossible regulatory hurdles is that the activist NGOs have created a cost and time environment advantageous to big companies and only for seeds in lucrative cash crop markets rather than technologies that would help smallholders facing local challenges with smaller crop varieties. So, the NGOs are inadvertently promoting a type of agriculture they despise while disincentivising cutting-edge innovations from young, local researchers.

Every time I see a new NGO campaign, I look to see which big industry will profit from it. In the energy arena, companies like Gazprom overtly financed NGOs like Friends of the Earth to attack nuclear and promote the Nord Stream gas pipeline, while those demanding a faster fossil fuel transition are knowingly enabling another decade (at least) of dirty coal emissions. Governments just shrug and say they are giving the people (which people?) what they want.

Activists are often single-minded in their search for simple solutions to promote their ideologies. The Greenpeace Golden Rice debacle shows how easy it is for the well-fed to exploit the present regulatory system based on some privileged puritan ideology. The situation worsens when large companies work with these NGOs to advance their interests while claiming to be concerned about sustainability.

Steps to Improve the Innovative Environment

It would be nice if we could all agree that better (less) regulation on seed innovations is the best route forward but given the participatory, consensus nature of the European policy process, this is not going to happen. So how can Brussels create a regulatory environment that will not stifle NGT research or only help the largest companies in the most profitable seed markets?

Steps taken by the pharmaceutical registration process could be helpful. If there is a drug that shows promise in fighting a major disease (or pandemic), it can be fast-tracked for emergency use authorisation. When a new seed solution could help smallholders deal with serious threats to food supply (like banana wilt, cassava brown streak disease or cacao black pod rot…), should we force farmers to wait 20 years for some company to have a completed dossier? If there are clearly understood trial phases, like the drug development process, then only the most intransigent ideologues would interfere with emergency-use legislation for seed solutions during massive crop failures.

If the European Commission is bent on imposing stifling regulatory restrictions, then they should consider financially supporting SMEs trying to bring promising innovations to market. Leaving small organisations with no choice but to be acquired or to enter into unfavourable partnerships does not encourage innovation or competition. The European Commission needs to be accountable for the consequences of their actions.

Finally, companies should be outed by their peers for supporting NGOs who promote a climate of fear and regulatory restrictions.