Crop protection rules could widen Europe’s farming gap

Proposed EU data protection changes could weaken incentives to renew crop protection products, as Europe’s farm output lags competitors

EU crop output grew an average of only 0.1% a year between 2011 and 2023, while UK output stood still.

The pesticide industry in Europe has warned the loss of crop protection products could accelerate, due to proposed changes in the EU’s regulatory data protection (RDP) rules.

Already in the EU, the number of authorised active ingredients for crop protection has fallen from more than 1,000 in the early 2000s, to 420.

Now, EU proposals on data protection threaten the period of exclusivity pharmaceutical companies have over their clinical trial and pre-clinical data. These companies rely on the regulatory data protection
window, the set number of years during which generic or biosimilar developers are prevented from relying on the originator’s proprietary trial data to gain approval for a competing product.

To assess the potential impact on investments in Europe, CropLife Europe, representing pharmaceutical companies, said it commissioned analysis of 180 active ingredients approaching renewal from 2030 onwards.

CropLife Europe said all 180 active ingredients could be affected, if the business case for generating their renewal data is weakened, particularly where other market participants may benefit from those regulatory data without contributing to their cost.

And 86 face the most immediate risk of the economic incentive to invest in their renewal coming under greater pressure, because they support management of uncommon pests, commercially vulnerable but agriculturally important uses, specialist crops, or professional turf and amenity management.

CropLife Europe explained: “Keeping safe crop protection solutions on the market is not a one-off event. 

"Renewing an active substance requires companies to generate continuous, rigorous scientific evidence. This can cost between €5m and €20m per active substance, plus up to €2m for product-level renewals. RDP ensures companies investing in this required safety research have a fair opportunity to recover their costs.”

But the European Commission’s proposal to create a single EU-wide starting date for RDP clashes with authorisations of active ingredients occurring at different speeds across multiple member states.

CropLife Europe warned: “A rigid single start date risks drastically shortening effective protection periods, in practice."

“If regulatory changes unintentionally erode incentives to fund required safety studies, who will invest in the science needed to give farmers the tools they rely on?” asked Olivier de Matos, director general of CropLife.

“The priority should be to simplify the rules without undermining their intended purpose,” he said.

Meanwhile, the Bayer pharmaceutical company said the loss of crop protection products was one of the reasons the EU and UK were losing ground to major competing exporter regions.

EU crop output grew an average of only 0.1% a year between 2011 and 2023, while UK output stood still. But output grew 1% in the USA, 3.3% in Brazil, and by an average globally of 2%.

The EU and the UK could slip further behind, unless their farmers get quicker access to new seed, crop protection, and digital tools, according to Bayer.

“The EU and the UK are confronted with a widening resilience gap. To counter that, agriculture must be understood as a critical strategic sector for Europe’s autonomy and competitiveness,” said Frank Terhorst, head of strategy and sustainability for Bayer’s Crop Science Division.

“It is critical to embrace innovation as an opportunity rather than a risk to be managed. Europe has the capabilities to lead, but we need to ensure that enough solutions are available to farmers and that innovation can reach the field faster."