生物公司在欧盟面临的七大挑战及应对方法
2024 年 1 十一月 当考虑在欧盟推出生物产品时，一个障碍立即浮现在脑海中——该地区的监管体系。
In February of this year, EU growers protested in the streets about many grievances—including the increasing restrictions of the Green Deal and growers’ shrinking toolbox to combat pests and weeds. The EU growers’ limited choice of biological products is impacted by the EU’s backlogged registrations application process.
Mark Trimmer，总裁兼创始合伙人 DunhamTrimmer says, “We see a very small share for microbial products in Europe. It’s mainly dominated by pheromones, plant extracts, PGRs, and other mineral-type products that are used on a broad scale. And that’s really a response to the regulatory system. It just takes forever to get a microbial product on the market, especially if it’s a new species not previously approved as a biocontrol agent. If it’s something that has been registered in the past — a Bt, for example — that can enter the market a little bit more easily, but it still takes a very long time.”
对于大多数试图进入市场的初创生物公司来说，“漫长的时间”往往意味着缓慢而昂贵的死亡。虽然生物防治产品还有很长的路要走，但欧盟对生物刺激素的监管已经有所改善，法规 (EU) 2019/1009 将生物刺激素纳入肥料类别。
Lawrence Middler, Biologicals Senior Analyst for AgbioInvestor says the biostimulants market is showing promise as growers look for ways to deal with abiotic stress. “Biostimulants could have a good opportunity over the coming years, also being boosted by sustainability targets to reduce fertilizer usage,” says Middler.
Biostimulants currently doing well are Corteva’s BlueN (Methylobacterium symbioticum strain Sb23) and Syngenta’s ISABION (Amino acids / C / N), CBC’s Plantech (amino acids / C (Organic) / N (Organic) products all have a significant place in the market according to AgbioInvestor.
随着欧盟继续禁止杀菌剂（如代森锰锌）和杀虫剂（如新烟碱）等产品，米德乐表示，“欧盟也在齐心协力控制紧急豁免（减损）的使用，这进一步强调了产品针对有害生物的必要性，一个很好的例子就是茎跳甲。”
七大挑战，七大对策
In addition to the EU’s regulatory challenges, launching a biological product faces several challenges. As in any good strategy, finding a counter to an obstacle is the way through. Thomas Laurent, CEO of Micropep and Middler give the following points to consider.
CHALLENGE 1: Fragmented Agricultural Market: The EU’s agricultural sector is highly fragmented, and farming practices vary widely from country to country.
“公司必须开发定制解决方案，以满足当地需求并遵守不同的农业标准，”劳伦特说。“每个国家可能需要独特的产品调整来适应其耕作方法和条件。”
CHALLENGE 2: Farmer Training and Education: EU growers use biologicals often in an integrated pest management (IPM) program, which can be more complicated farming practices.
“培训农民正确使用这些产品至关重要，”劳伦特提道。“生物制剂需要仔细注意使用时间、土壤和天气条件、剂量以及与其他产品的联合使用。农民需要了解生物制剂的复杂性以及它们与他们习惯使用的更简单、高效的化学品有何不同。培训必须采用农艺方法，有明确的参数并定期跟踪气象条件。”
CHALLENGE 3: Sustainability and Environmental Focus: With the Green Deal, the EU government and consumers are demanding sustainable practices.
“公司必须展示其生物制品除了功效之外，还具有环境效益，”劳伦特说道。“因此，强调生物制品如何支持可持续发展并有助于减少化学品使用非常重要，这能引起欧洲种植者的共鸣。”
CHALLENGE 4: Cost and Scalability: The EU’s small-scale, local farmers are as cost-conscious as large-scale U.S. farmers.
“生物制品的生产通常比化学替代品更昂贵，找到效率和可负担性之间的平衡对于成功至关重要，”劳伦特说。
CHALLENGE 5: Formulation and Stability: Biological molecules are often created with a restrictive shelf-life.
“确保产品在各种条件下稳定且始终如一地运行是公司必须应对的挑战，尤其是考虑到欧洲对产品质量和可持续性的严格要求，”劳伦特说。
CHALLENGE 6: Fierce Competition: Established markets such as France, Spain, and Italy, the product and company landscape is highly competitive.
“Bringing a new product to those markets will rely on companies having a laser focus on filling gaps in the market, satisfying a number of factors such as lowering costs, efficacy, resistance management, product substitution and input efficiencies,” says Middler. “[These markets have] an appetite for wider product adoption, especially in row crops, and governmental sustainability targets should stimulate the market in the medium to longer term.”
CHALLENGE 7: Application Incentives: Some European countries, like France, have strict application limits for chemicals.
“这可以激励农民采用生物制剂，因为它们不包含在这些应用指数中，”劳伦特说。“突出这一优势可以成为一个有价值的卖点。”
对生物制品实施 CAP
共同农业政策 (CAP) 为环保型农业实践提供更广泛的支持，鼓励采用生物防治和其他生物制品。欧盟农民通过 CAP 计划获得使用生物制品的间接财政支持。
CAP 提供各种补贴和补助来激励可持续农业，其中包括作为 IPM 一部分的生物解决方案和其他环保方法。对于希望采用更环保做法的农民来说，这种资金支持使向生物制剂过渡更具吸引力。
However, if the EU decides to reduce the CAP budget, this could lead to a decrease in farm income and profitability, putting additional pressure on farmers to maintain operations. In such a scenario, the value of crop output could fall, and the financial attractiveness of using biologicals might diminish unless more targeted support is introduced.
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