ECCA Highlights Agricultural Competitiveness Impact of Data Protection Regulatory Confusion in Spain
The European Crop Care Association (ECCA), representing the post-patent plant protection industry in Europe, has highlighted regulatory confusion for Spanish farmers in accessing more affordable post-patent plant protection products (PPPs) and its impact on agricultural competitiveness.
Spain’s interpretation of data protection rules is causing regulatory confusion by conflating two distinct legal concepts – Article 59 and Article 63 – under Regulation (EC) No 1107/2009. Spanish authorities are blocking access to post-patent PPPs by interpreting Article 59 of Regulation (EC) No 1107/2009, which grants owners the temporary right to prevent a test or study report from being used for the benefit of another applicant, as if it were linked to Article 63, which instead concerns the confidentiality of genuinely sensitive business information.
Notably, this confusion restricts Spanish farmers’ access to more affordable post-patent plant protection products (PPPs), increasing production costs and lowering agricultural competitiveness.
“Amid the current regulatory confusion, Spain is effectively treating data protection as a basis for restricting access to regulatory information and delaying the authorisation of post-patent plant protection products, even where the legal period of protection may have expired,” said Paolo Marchesini, General Manager of ECCA. “This interpretation goes beyond the legislator’s original intent and creates unnecessary barriers – and costs – for farms across Europe. We cannot allow farmers’ hands to be tied behind their backs.”
“Since the founding of ECCA, our message has been simple: European farmers should not be treated differently depending on how individual Member States interpret the same legislation,” added Marchesini. “The [Food and Feed Safety Simplification] Omnibus provides a long-awaited opportunity to establish a harmonised regulatory framework for post-patent PPPs, removing intra-EU market barriers and ensuring fair and equal access to plant protection for all European farmers.”
The economic consequences for farmers in Spain and across Europe
Spain is one of Europe’s most important agricultural producers, with farmers growing a diverse range of crops including olives, grapes, citrus fruits, vegetables and cereals. It is the largest fruit and vegetable producer in Europe, accounting for around a quarter of total EU production, and is also the world’s largest producer of olive oil (European Commission, International Olive Council). At the same time, Spanish agriculture is increasingly exposed to climate-related challenges such as prolonged drought, rising temperatures and new pest pressures.
In this context, timely access to effective and competitively priced plant protection products is essential to maintaining productivity and safeguarding the competitiveness of one of Spain’s most important export sectors. Restricting access to post-patent PPPs reduces the availability of lower-cost alternatives and can leave farmers more dependent on higher-priced products, adding to existing pressures linked to food inflation, fertiliser costs, energy prices and wider geopolitical instability.
The economic consequences are also significant for the post-patent plant protection industry. Unclear or artificially prolonged data protection periods can increase the cost of preparing a product dossier by an average of approximately EUR 3.7 million. ECCA estimates that, for its members alone, around four such dossiers each year could be avoided, representing approximately EUR 14.8 million in unnecessary annual costs.
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