Regulatory Predictability Needed for an Industry Committed to Innovation

Howard Minigh
Howard Minigh, President and CEO of CropLife International

The crop protection industry helps millions of farmers grow their crops every year. From Asia to Africa and from Europe to the Americas, plant scientists are developing crop protection products to advance sustainable and productive agriculture to ensure global food security. We are a solutions-driven industry, but the challenges keep on coming.
The world’s population is growing by 80 million people every year and if nothing changes, by 2050 we will need our finite resources to meet the demands of two billion more people. Making the food security challenge even more difficult, farmers are growing food crops that must compete with 30,000 species of weeds, 3,000 species of nematodes, and 10,000 species of plant-eating insects — all of which are invading new geographies with a changing climate.
The crop protection industry continues to invest heavily in cutting-edge innovations to help farmers to meet these challenges. But innovation doesn’t come cheap and it is not easy. The cost of bringing a new crop protection product to market is $286 million — up more than 50% since the turn of the century — as product candidates meet an increasingly high performance bar for safety and efficacy. It now takes more than 11 years of research and development — three years longer than in 2000 — to bring a crop protection product to market and the average number of new molecules screened in order to discover one new crop protection product has increased from 52,000 in 1995 to 152,000 today.
Given the huge commitment required to bring new innovations to market, our industry needs predictable and risk-based regulations alongside robust intellectual property rights for companies to have the confidence to continue to invest in solutions. However, the increased politicization of regulatory decisions in Europe and around the globe is eroding that confidence.
One example is the EU’s proposed regulation on chemicals that could impact the human endocrine system — known as endocrine disruptors. The criteria for endocrine disruptors have been debated in the EU for several years, contributing to uncertainty over the final regulatory standard. The fear is that politics will trump science, and regulations will be based on inherent hazard rather than real risk of products. This unscientific approach, inconsistent with other global regulatory standards, could lead to delays in market access, trade disruptions and ultimately act as another disincentive to innovate.

“A further dent to industry’s confidence to innovate is from
the growing number of legal challenges calling for full disclosure
of data on crop protection products.”

The International Agency for Research on Cancer (IARC) provides another example of how science can be pushed aside by opportunist attacks on industry. IARC’s mandate is to identify potential cancer hazards — it does not assess actual risk. Nevertheless, IARC monographs have been used by industry critics to create confusion among regulators around the world. Any resulting knee-jerk regulatory decisions undermine our industry’s incentive to invest in new products.

A further dent to industry’s confidence to innovate is from the growing number of legal challenges calling for full disclosure of data on crop protection products. The protection of Confidential Business Data, such as product composition and manufacturing processes, is vital for any industry to ensure inventors are rewarded for their investments and encouraged to continue research and development. This must not be compromised to satisfy a minority of powerful activists.
The plant science industry currently ranks in the top four global sectors for the most investment in developing new products, and rightly so — over the next 40 years the agriculture industry will need to expand food production to meet the needs of more than 9 billion people. Achieving this will require a continuous pipeline of new technologies to help farmers increase crop productivity, and for that to happen, we must insist on a predictable, science-based regulatory environment and strong data protection.

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