Nordic Life Science 1
“There are a lot of initiatives that have been la
unched in different regions in different countries. These are good initiatives locally, but they do not collaborate in the most optimal way, and sometimes they even duplicate what’s being done in other regions.” FRÉDÉRIC DRUCK I n contrast, Druck says, the US chose a marketfocused approach, where hiring the best people and raising private capital helped build businesses that aimed to bring products to market as fast as possible. In Asia “they started from scratch”, as Druck puts it. Singapore, Taiwan, and China built up their biotech industries based on national strategic plans. China’s current national five-year plan includes strengthening the biopharma industry and bringing Chinese innovation to the global market. Moll points out that the US has paid the lion’s share for global research and development during recent decades, which has earned them better availability of medicines and greater inward investment. According to Moll, EU spending on pharmaceuticals has remained relatively flat for two decades – it’s around 1% of GDP in the EU, compared to 2% in the US and 1.8% in China. “In the past two decades, Europe as a region has lost a quarter of its global pharmaceutical research and development investments and around half of its global share of clinical trials to other regions of the world. Meanwhile, clinical trials in China have surged and the country recently became the leader in the discovery of new active substances – the building blocks of new medicines,” she says. “Countries like the US and China are implementing proinnovation policies and ambitious plans to ensure that they have the world’s best ecosystems for life sciences, because they understand the importance of innovation, health security, and the economic value of this industry,” she adds. One example is clinical trials – where a multinational trial application takes on average 113 days to get approved in the EU, but only 60 days in the US and China, according to the European Commission. Ultimately, it impacts timeto-market, patient access, and returns on investment. A fragmented Europe After three decades of building scientific excellence, Europe now finds itself in a landscape marked by fragmentation, Druck says. Regional clusters and national initiatives have 54 | NORDICLIFESCIENCE.ORG multiplied across the continent, often in parallel rather than in concert. The result is a patchwork of efforts that operate in silos. “There are a lot of initiatives that have been launched in different regions in different countries. These are good initiatives locally, but they do not collaborate in the most optimal way, and sometimes they even duplicate what’s being done in other regions,” he says. T his structural fragmentation is not limited to clusters and innovation program. It extends deep into the regulatory environment. Druck notes that the accumulation of EU-level and national rules has created dense regulations that are especially burdensome for smaller companies. He stresses that biotech SMEs must navigate highly specialized industry regulations, which slow down their ability to move from research to clinical development. The complexity and overlap, he argues, directly affect Europe’s competitiveness by delaying the first critical steps toward market access. Moll echoes this systemic challenge from a policy perspective. She argues that Europe’s innovation potential is undermined by the lack of coherence across its many national markets. “Europe needs to improve its entire ecosystem – from basic research all the way to market access,” she says, and continues: “27 individual Member States' markets require coherence, including for things like support for new biotechs, research funding, clinical trials, and market-access policies.” Innovation follows the money Europe’s financial environment has become one of the defining constraints on the continent’s ability to compete in life sciences. Venture capital has tightened, public funding has thinned, and the gap between what early-stage companies need and what Europe can provide continues to widen. EUROPE // STRATEGY