Generic pesticides have traditionally played an essential role in the market, haven’t they? After the innovators are rewarded for their efforts in developing new technologies and enjoy exclusive market access through patents and protection periods, it’s time for the generic manufacturers to step in. Once the monopoly ends, competition drives down prices, providing more affordable options for farmers, many of whom face financial constraints. By offering cost-effective pest control solutions, generic pesticides help ensure farms can maintain both yield and quality, which is crucial for food security.

Biopesticides, regardless of the status of the Sustainable Use Regulation, are undeniably part of the future of crop protection. They are often seen as having a more favourable environmental profile compared to chemical pesticides, supporting sustainable agriculture and helping to manage resistance. Furthermore, as the portfolio of chemical pesticides continually reduces, through regulatory attrition, there is a growing demand for viable alternatives. Microbial biopesticides, however, tend to be expensive – not only due to complex production processes but also because storage and handling can be more challenging in some cases. This would seem to create an ideal opportunity for generic manufacturers to enter the market. So, where are they?

Finding a single generic microbial biopesticide for sale in the EU is surprisingly difficult. In fact, I have yet to come across one approved via Article 34 of Regulation (EC) 1107/2009 in any member state. What might be causing this absence? Could it be that the investment required to develop the necessary manufacturing and distribution infrastructure is outweighed by the regulatory uncertainty of success? If that’s the case, perhaps it’s time to reconsider the numbers. The EU biopesticide market is expected to be valued at $2 billion by 2025, with estimates predicting it will triple by the end of the decade. That’s a 10-15% compound annual growth rate (CAGR), making up around 10% of the total EU pesticide market.

But is it really that simple? The short answer is no. While the EU has made progress in simplifying the regulatory process for microbial pesticides and making it more fit for purpose, these changes aren’t likely to have an immediate impact on the market for generic products. Even if you identify a microbial strain with an expired patent and lapsed data protection, you still face challenges. Will the existing data meet current regulatory requirements? What about renewal? New data submitted by the original innovator could attract additional protection, with a duration that varies from one member state to another. Additionally, an innovator might reformulate their product, effectively removing the original reference product from the market, preventing generics from using it for their own submissions. To be fair, it’s also quite probable that the original formulation might under-perform compared with re-formulations, making it a non-starter. Combine this with significant delays in the renewal process and legal uncertainties around Article 34 in some member states, and the situation for generic manufacturers starts to look much riskier.

While it's not impossible to introduce a generic microbial pesticide to the market, it’s certainly not the straightforward process one might expect. Ironically, it may even be easier to submit an application for a new product under Article 33 than for a generic product under Article 34 – but that’s a thought for another time!