September 12, 2022, is a landmark date for the advancement of the bioeconomy in the US: an executive order by the President of the United States links, for the first time, the advancement of biotechnology and biomanufacturing as a critical element of advancing the US economy. Georgia Lagoudas, Former White House Office of Science and Technology Policy and Chair of the Bioeconomy and Policy track of the SynbioBeta 2024 conference, recalls the drafting and gaining support for a national bioeconomy agenda. “All ingredients were in place to catalyze momentum,” she told me. “The maturation stage of biotechnology, particularly in non-medical applications, played an important role in making this effort possible.”

The United States has made impressive progress in the last few years with designing and implementing legislation, policies, and regulatory updates that aim to uphold the US's leadership position in biotechnology (see the policy tracker here). To develop local biomanufacturing in a coordinated way, the Department of Defense introduced BioMADE as one of its Manufacturing Innovation Institutes with the aim to generate and coordinate industrial-scale biomanufacturing in the US. The National Institute of Standards is taking an active interest in synthetic biology, developing standards and frameworks with the aim of facilitating innovation, market adoption of new technologies, and the safety of new products and services.

Perhaps the most highlighted policy actions around synthetic biology revolve around biosecurity. The US Congress appointed the National Security Commission on Emerging Biotechnology (NSCEB), chaired by Ginkgo’s CEO Jason Kelly, with the mission to examine the national security implications of emerging biotechnology. “When people think "biotech" plus "national security,” they usually think “biosecurity.” That’s a deeply important topic, but it’s not the core of our mission,” Caitlin Frazer, Executive Director of NSCEB, told me. “We’re looking at issues like how the military could use emerging biotechnology to fuel, feed, and heal our servicemembers, how we can use biotech to shore up vulnerable supply chains. How can we create economic opportunity in the U.S. through biomanufacturing? And, of course, how we protect against misuse of these powerful technologies by countries that don’t share our values.”

Frazer highlights the importance of the government working together with industry and academia to formulate effective policies. “Our latest gene synthesis security white paper outlines one such iterative governance approach model, a regulation strategy that engages stakeholders, implements and verifies security tests, and learns from itself,” Frazer noted. Lagoudas also commended the coordination between government agencies in creating a biotechnology framework.

The US is taking active steps in creating policies that won’t stifle biotech innovation but also ensure benefits for the US economy. However, establishing a green economy needs to be a global effort, and it’s worth examining how other countries view synthetic biology through the lens of policymaking.

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Putting Biotechnology and Biomanufacturing High On the National Agenda

Synthetic biology is set to revolutionize the way we perceive products, raw materials, and supply chains. Its full potential, however, can only be achieved if it is successfully integrated into national policies with effective initiatives, incentives, and regulatory frameworks that will enable the bioeconomy.

The UK was one of the first countries to recognize the importance of integrating synthetic biology into its national policy, and one of the pioneers is Paul Freemont, Professor at Imperial College London. “Together with Prof. Richard Kitney, we recognized in 2003 the emergence of synthetic biology/engineering biology as a new interdisciplinary research field. We succeeded in convincing the then UK science minister David Willetts of its importance, which led to the roadmap and large government investments into academic synbio research which has continued through to today,” Fremont told me. “ We also established in 2013 the first UK national translation and commercialization center for synbio, called SynbiCITE, and we have just celebrated ten years of success.”

The UK announced an ambitious plan to invest £2B ($2.6B) in engineering biology over the course of 10 years. The country was one of the first to publish a synthetic biology roadmap back in 2012 and has since implemented national strategies and numerous initiatives to promote synthetic biology research in various sectors.

The continental Europe, and in particular Scandinavia, has always been a hub for biotech innovation. And while the researchers and industry in the region are familiar with the advancements in synthetic biology, there is a reluctance to use the term in official bioeconomy documents. “In June 2022, the Swedish Government decided to appoint a Bioeconomy Strategy Inquiry with an assignment to propose a national strategy for the bioeconomy,” Lars Friberg, Climate Strategist at Sweden´s Innovation Agency—Vinnova, said. “[the strategy] does not talk about synthetic biology at all. This might be about to change, though.” According to Friberg, Vinnova is actively inquiring about how to advance Sweden’s synthetic biology capabilities and is looking at the strategies and policies implemented in other countries.

The European Union, in general, seems to be shying away from using the terms synthetic and engineering biology. According to Marit Hvithamar Rystrøm, Leading Senior Adviser, European Biosolutions Coalition, Denmark, this may be due to the different historical business strengths in biotechnology. “One way of differentiating the terms could be that synthetic biology or engineering biology is more connected to the lab space, whereas the term “biosolutions” mainly refers to the products and processes closest to the consumer,” she said. Denmark has a long tradition in biotechnology, and a lot of research innovation comes from private foundation funding, such as the Novo Nordisk Foundation.

Japan is an industrial powerhouse with world-leading companies in the automobile, food, electronics, and the chemical industry. Wataru Mizunashi, Director General of the Bioeconomy Unit, NEDO, believes that this is why Japan needs to develop a strong biomanufacturing capacity as well. “I believe that by combining our strengths in providing products with high functionality, high quality, and reasonable costs to our customers with synthetic biology, we can add even more environmental value,” he said, envisioning a seamless integration of bioengineered products into the highly developed specialized manufacturers. The Japanese Government has published the “Japan Bioeconomy Strategy 2019” and is updating it regularly, with the latest version expected in July 2024. “The Cabinet Office, the Ministry of Economy, Trade and Industry, the Ministry of Education, Culture, Sports, Science and Technology, and others, are working together to provide support for the realization of a bioeconomy,” Mizunashi added. 

Australia left its mark at the recent Synbiobeta 2024 conference. In a post reciting the Aussie Synbiobeta experience, Robert Speight, Director of the Advanced Engineering Biology Future Science Platform at CSIRO, admits that Australia was a bit late in embracing the synthetic biology hype but has made significant steps ever since. “Biotechnology is listed as a critical technology with synthetic biology as an example,” Speight told me. “CSIRO, universities, centers of excellence, Bioplatforms Australia, Biofoundries, investors, state governments and start-ups are coming together strongly to build a vision for the bioeconomy with synthetic biology at its heart.” CSIRO has published a roadmap and an ecosystem update on synthetic biology, focused on Australia's strengths and vibrant ecosystem. A country with lots of natural resources, particularly in the agriculture and energy sector, has a lot of potential to advance its bioeconomy even further. 

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Why and How Should Scientists Engage with Policymakers 

While the policymakers and politicians draft and implement policies, it is up to the scientists and entrepreneurs to bring the agenda to them and ask for action. “Sometimes academics forget that lobbying policymakers is an important activity if one wants to make things happen by providing the right evidence and acting as catalysts for policymakers,” Freemont emphasized. Having recently given expert testimony at the UK parliament, he stresses the value of providing expertise, evidence, and vision.

Lagoudas recalls that it took her some time to learn the proper politics and legislative lingo and advises scientists to avoid slipping into technical terminology and jargon when talking to politicians. “Explain that this is what biotech can do for the US, the world, and your constituency. Bring concrete examples, such as insulin, a biotech product that has been around for ages,” she said. 

Also, scientists should avoid the fallacy that they are talking to people with a limited understanding of the field. “Policymakers—especially those in Congress—are receptive to and excited about our message that the Age of Biology is here,” Frazer explained. “Some members of Congress come into office with deep technical backgrounds and may already speak the language of biotechnology.”

Hvithamar Rystrøm emphasized the need to communicate and see things from a policy point of view. “A lot of arguments resonate with politicians: that 8% of global CO2 emissions can be removed if existing innovative biological solutions (biosolutions) are implemented, and also that biosolutions offer an entirely different and sustainable food production in Europe and the rest of the world,” she added. “Simply replacing 10% of the world's animal protein with cultivated proteins could reduce CO2 emissions by 700 million tons and free up 900,000 km2 of agricultural land for nature restoration. Many biosolutions are based on plants that grow in Europe, making the value chain much more robust.”

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The Power of Global Collaboration

Ambitious initiatives and engaged politicians cannot, however, create global impact in isolation. This is why bioeconomy policies should factor in international collaboration and global outreach of outcomes. “The need for collaboration on developing synbio solutions that can rapidly scale to do meaningful carbon dioxide reduction is identified by Vinnova and others as an important area for international collaboration. This goes beyond pure science and research. There is a great need to also address the public awareness and acceptance for these novel technologies and also the need to reform and adjust regulatory frameworks and international regimes and treaties,” Friberg said. “Yet another field where we need international collaboration is on building business cases, standards, and finance models for these new synbio solutions.”

Fremont has participated in and initiated several global engagement actions promoting different aspects of synthetic biology, such as the Global Biofoundry Alliance, a recent global task force for technical standards and metrics for engineering biology, the Engineering Biology Research Consortium Policy and International Engagement Working Group, and the World Economic Forum Future Council for synthetic biology. “I can honestly say that there is an enormous appetite for global engagement and cooperation to advance synthetic biology and a global bioeconomy. Despite the current geopolitical environment, there is an increasing realization that the future of the planet is under threat through climate change and that synthetic biology provides one (not the only one) major technology that can help,” he noted.

The current geopolitical tensions have created apprehension that global partnerships may weaken in the fields of bioeconomy and combating climate change. Lagoudas, however, thinks that this is not the case. She explained that, due to the awareness created, the US approached its international partners to exchange know-how on how to fill talent and infrastructure gaps. In a sense, the realization that biotechnology and biomanufacturing are important for the US economy actually increased the appetite for international collaboration in this area. Frazer echoes the same sentiment: “We have drawn so much inspiration from our conversations with government officials, investors, researchers, and leaders from other countries. There are exciting scientific developments happening all over the world, and we want the U.S. and its friends and allies to benefit from each other’s strengths.”

Mizunashi already sees more practical areas of collaboration, both at a global and regional level. “It is easy to imagine cooperation in obtaining biomass, raw materials, and building supply chains… I believe that we should work together globally to visualize the environmental and economic value of bioproducts.”