Investing in healthy societies by boosting biotech competitiveness

The start of the new EU mandate presents a revived opportunity to establish a favourable and forward-looking regulatory ecosystem; one that incentivises the development of innovative treatments for European citizens and places healthier, longer lives and prosperity at its core. Biotechnology plays a crucial role in this ambition, developing life-changing medicines and offering solutions for previously untreatable conditions. However, without changes to the regulatory framework, and with the global landscape for innovation rapidly evolving, Europe risks losing competitiveness, missing out on global investment, and slowing the pace of research and development needed to deliver scientific breakthroughs and advance societal health. A new EFPIA report, for example, shows that Europe’s share of clinical trials has gone from 22% in 2013 to 12% in 2023.[1] With the promising agenda signaled by the upcoming Biotech Act, now is the time to unleash the full potential of biotechnology in the EU.

More than 40 years ago, Amgen was one of the early pioneers in establishing the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. With over 27,000 employees and our medicines available in approximately 100 countries, Amgen has helped millions of patients around the world fight the toughest diseases, including cancer, heart disease, osteoporosis, inflammation, and rare diseases.[2] Innovation is at the heart of what we do: Our ground-breaking BiTE® (Bispecific T-cell Engager) technology is a case in point. The BiTE technology was developed in Europe, in Amgen´s Research site in Munich, Germany. It leverages the immune system to fight difficult-to-treat cancers, with the potential to benefit patients with historically poor outcomes.[3] Having a strong Intellectual property (IP) framework, a streamlined and cohesive regulatory environment, and risk-based rules that support innovation are what allowed Amgen to deliver this and other life-changing solutions and grow from a start-up to the global biotechnology leader it is today.[4]  

Where innovation happens matters, and looking ahead, we are at a pivotal moment for the EU to improve access to medicines and ensure it remains an attractive place to invest in pharmaceutical research and manufacturing.

Fostering EU biotech innovation for global competitiveness

In Europe, the biotech sector is a key driver of economic growth and global competitiveness. As part of the pharmaceutical industry, it contributes to manufacturing value, drives exports and holds geostrategic importance in the face of health threats, as demonstrated by its instrumental role in Europe’s recovery, especially during the COVID-19 pandemic.[5] In addition, and as echoed by Mario Draghi in his recent report on European Competitiveness, biotech innovation creates high-skilled jobs and advances cutting-edge research, while also playing a vital role in developing therapies that improve and save lives.

However, Europe is facing mounting regulatory hurdles, rising R&D and manufacturing costs, and competition from rapidly growing markets like China, Brazil, and India.[6] Despite Europe’s rich history in life-sciences R&D, the fragmented regulatory framework for clinical trials, especially for combined (drug-diagnostic) medicines, is causing delays in patient access to clinical research and dissuading investments.  Unless changes to boost innovation are made, Europe will become reliant on other regions' medical innovations and supplies, and patients will have to wait longer for the latest advances in treatments. 

We now have an opportunity to reverse this trend and for Europe to see biotech and innovation as an investment in its economic and health future instead of a short-term cost.

Supporting innovation through a predictable and stable regulatory framework  

For innovative therapies to reach more patients as quickly as possible, we need a regulatory framework that is fit for purpose. It has to provide predictability and needs to be cohesive, rewarding innovators for taking risks while ensuring a secure and agile supply chain to provide continuous access for patients.

Intellectual property and regulatory incentives are the backbone of the biopharmaceutical innovation ecosystem. With the stability and predictability needed to attract investment and drive the development of new medicines, the EU’s IP and incentives system has been, so far, successful in delivering innovation and is working as intended, on promoting investments in EU economies. This is why ensuring that Europe maintains a supportive environment for biopharmaceutical innovation, such as in the EU General Pharma Legislation, is key to sustaining a healthy pipeline of treatments that address unmet medical needs.[7] Reliable and efficient medicines supply chains are also fundamental to securing access to established, life-altering medicines.  While current regulations by the EU and individual member states are designed to monitor quality and prevent shortages, they impose strict and inflexible requirements and bureaucracy that hinder the industry´s ability to swiftly respond to patients’ needs. We need a framework that enables industry to respond to changing market demands to avoid bottlenecks.

EU should seize momentum for competitiveness edge

It is clear that Europe stands at a pivotal moment in shaping the future of its healthcare and innovation landscape. To remain competitive and foster progress, the EU must move to a predictable framework that promotes innovation, strengthens the startup ecosystem, and attracts global investment in R&D for strategic autonomy.

Within this context, the revision of the General Pharmaceutical Legislation represents an opportunity to modernize and streamline the regulatory framework in line with breakthroughs in science, and in support of progress and innovation. However, as we look to the future, it is also the upcoming Biotech Act that holds the potential to steer Europe toward success by spurring innovation and making it a more attractive place for companies to develop the next generation of therapies and contribute to healthier societies.

Amgen remains committed to championing pro-patient, and pro-innovation initiatives and helping the EU and its Member States reestablish itself as a hub for cutting-edge medical advancements, ultimately benefiting patients and healthcare systems across the continent.