Source: EURLEX
Language: en
Format: md

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| European flag | Official Journal  of the European Union | EN  C series |

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|  | C/2024/6026 | 23.10.2024 |

Opinion of the European Economic and Social Committee

Communication from the Commission to the European parliament, the Council, the European Economic and Social Committee and the Committee of the Regions

Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU

(COM(2024) 137)

(C/2024/6026)

Rapporteur:

Florian MARIN

Co-rapporteur:

Antonello PEZZINI

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| Advisor | Giannino Cesare BERNABEI (for the Cat.1 co-rapporteur) |
| Referral | 29.5.2024 |
| Legal basis | Article 304 of the Treaty on the Functioning of the European Union |
| Section responsible | Consultative Commission on Industrial Change |
| Adopted in section | 6.6.2024 |
| Adopted at plenary session | 10.7.2024 |
| Plenary session No | 589 |
| Outcome of vote  (for/against/abstentions) | 200/0/2 |

1.   Conclusions and recommendations

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|  | 1.1. | The EESC welcomes the Commission proposal on the important opportunities provided by biotechnology and biomanufacturing but feels that a more specific approach is needed. The EESC is disappointed that the EU does not yet have a bioeconomy strategy or a biotechnology act, deeming that there is an urgent need for such legislation given the global situation. |

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|  | 1.2. | The EESC proposes that the EU bioeconomy strategy should be based on an integrated sectoral approach with specific targets, including a research agenda for the next 10 years, a list of skills and a clear role for civil society. |

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|  | 1.3. | An ethical code for EU companies and products placed on the EU market should be considered and promoted globally. The ethical aspects should be constantly monitored, with the involvement of civil society and due regard for human rights and dignity and privacy. Biotechnology and biomanufacturing should give priority to the sanctity of life rather than market interests. |

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|  | 1.4. | Dedicated measures are needed to develop competencies and consolidate synergies between biotechnology skills requirements and biomanufacturing needs. These measures should be based on social dialogue and collective bargaining in order to avoid brain drain and stabilise the workforce. |

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|  | 1.5. | The EESC suggests that the development of biotechnology and biomanufacturing in the EU should include:  |  |  | | --- | --- | | — | sectoral indicators and their cross-cutting impact on the various sectors; |  |  |  | | --- | --- | | — | public-private partnerships to bolster national, European and international cooperation; |  |  |  | | --- | --- | | — | a cross-sectoral research system combining multisectoral research processes; |  |  |  | | --- | --- | | — | a database listing potential investors and companies that have products in the authorisation phase, with ongoing clinical tests and a clear relation with ESAP; |  |  |  | | --- | --- | | — | faster and less bureaucratic authorisation processes, permits and licences for biotech industrial capabilities in line with the ethical aspects; |  |  |  | | --- | --- | | — | investments to consolidate the link between artificial intelligence (AI) and biotechnology, especially as regards using new classes of molecules; |  |  |  | | --- | --- | | — | a perfect synergy with the SDGs and the proposed Blue Deal; |  |  |  | | --- | --- | | — | dedicated and harmonised European and global standards; |  |  |  | | --- | --- | | — | support for SMEs to become more involved in the sector; |  |  |  | | --- | --- | | — | transparency and real-time data provided partly with the help of AI; |  |  |  | | --- | --- | | — | measures to increase public support, trust and education concerning biotech products; |  |  |  | | --- | --- | | — | a clear contribution to the consolidation of the well-being economy and the well-being society; |  |  |  | | --- | --- | | — | more clarity between national and shared competencies. | |

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|  | 1.6. | The EESC suggests that biotechnology and biomanufacturing in the EU should be financed with due regard for the following issues:  |  |  | | --- | --- | | — | a synergies-based approach to the Recovery and Resilience Facility (RRF), Strategic Technologies for Europe Platform (STEP) and the European Investment Bank (EIB) and cohesion policy that is based on common indicators, a common database and a single access point for financing; |  |  |  | | --- | --- | | — | redirecting part of the money yielded by environmental taxes to financing green biotechnology products; |  |  |  | | --- | --- | | — | using a variety and combination of financial sources and funds such as loans, venture capital and public funds; |  |  |  | | --- | --- | | — | strengthening the EU Biotech Hub and helping to attract capital. | |

2.   General comments

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|  | 2.1. | Industrial biotechnology exploits the extraordinary properties of microorganisms and enzymes, including their diversity, efficiency and individual natures, to create products in sectors such as the chemistry, food and feed, pulp and paper, plastics, textiles, automotive, medicine and electronics sectors and, most importantly, in the energy sector. It is also used in other manufacturing processes, with more environmentally friendly biological processes operating at low temperature and pressure levels, consuming less energy, emitting fewer greenhouse gases and using renewable agricultural products as raw materials. |

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|  | 2.2. | Europe has a global market share of 12 % in this area, with the global biotechnology industry dominated by the US, with a market share of around 60 %. The biotechnology industry’s contribution to the GDP was EUR 31 billion in 2018, creating over 200 000 direct jobs and 625 700 indirect jobs. |

3.   Multifunctionality, trends and challenges of biotechnology and biomanufacturing

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|  | 3.1. | The EESC is disappointed that the EU bioeconomy strategy is set to be launched at the end of 2025 and that only general future intentions have been published, while the US has already launched a dedicated and specific package for biotechnology and biomanufacturing. The US [(1)](#ntr1-C_202406026EN.000101-E0001) has defined an industrial strategy for biotechnology and biomanufacturing, setting objectives in five areas: climate; food and agriculture; supply chains; health; and transversality. China has identified biotechnology as a key sector in its strategy. India, which is experiencing strong growth in the biotechnology sector, has presented a biotechnology strategy as part of its ‘Make in India’ campaign, and the United Kingdom, with its ‘life science strategy’, intends to give a new boost to its biotechnology sector. |

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|  | 3.2. | The EESC flags up the imperative need for a biotechnology act in the near future as the EU needs to go further in facilitating the development of the biotechnology industry. The anticipated EU bioeconomy strategy should include an industrial pathway to address in a consolidated manner all challenges at stake for this industry (notably decarbonisation, digitalisation, water efficiency), taking the sector specificities into account. As stated in EESC opinion ‘Industrial and technological approaches and best practices supporting a water resilient society’ [(2)](#ntr2-C_202406026EN.000101-E0002), the industrial pathways should include a human dimension roadmap, to take into account the skills needed and ensure quality job. The pathway should be complemented by a research agenda for the next 10 years, a list of needed skills, dedicated actions for building public acceptance, dedicated financial resources and a clear role for civil society, and should integrate standards and diplomacy as well. It should strongly correlate with other strategies from areas interlinked with biotechnology and with the Blue Deal. |

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|  | 3.3. | The single market is still not running smoothly, with EU legislation being implemented in different ways at national level in the Member States. The EESC believes that special EU rules for this industry are needed in order to exploit the advantages of the single market. More should be done to ensure more clarity when it comes to national and shared competences. The synergical involvement of civil society, universities, Member States and other stakeholders is crucial for the future of the biotechnology in the EU. |

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|  | 3.4. | Personalised medicine, precision medicine, biogas capture and sequencing genomes of new microbial species are examples of clear avenues for developing biotechnology in the EU (while closely monitoring patient rights). Nanobiotechnology is expected to expand greatly due to increasing technological progress in the field of nanotechnology. The EESC points out that a common approach of the ethics is needed in the EU alongside with common, faster and less bureaucratic authorisation processes of permits and licences for biotech industrial capacities. |

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|  | 3.5. | The EESC is concerned about the dominant positions situations which might appear and this could affect the EU competitivity and the loyal competition. A possible dominant market positions over farming and food production held by a small number of companies, and a reduction in the genetic diversity of agricultural products, could negatively affect small farmers, poverty and access to healthy food. Patents on plants and animals are still to be rejected. The existing Community Plant Variety Rights System can ensure an appropriate open source framework for future biotech-based breeding. Maintaining coherence between current and future strategies and policies on one hand, and the development of biotechnology and biomanufacturing on the other should be a constant concern especially for the next EU Commission. |

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|  | 3.6. | Public tenders, public investments, national orientation budgetary quotas, dedicated labels and territorial distribution of supply chains should be used to support the development of the biotechnology industry. |

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|  | 3.7. | The EESC considers that clear and precise indicators of the size of European biotechnology and its cross-cutting impact on the various sectors involved are essential. Concrete sectorial targets are needed for the future of biotechnology and biomanufacturing, taking into account the additional sectors which are influenced. |

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|  | 3.8. | The EESC believes that it is more important to focus on which products are being developed and their impacts on society, and not necessarily on the metrics of the companies, since industrial biotechnology is a key enabler in the transition towards a more sustainable and competitive circular bioeconomy. Biotechnology’s contribution to the well-being economy and to the well-being of society, as well as the benefits it generates for all, should not be neglected. |

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|  | 3.9. | The EESC believes that significant investments are needed to consolidate the link between AI and biotechnology, especially for using new classes of molecules which are not accessible at the moment. AI should be used to consolidate the link between biotechnology and biomanufacturing, and data infrastructure should be built in this regard. |

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|  | 3.10. | AI is an instrument which can contribute to providing much-needed real-time data. Instruments for tracking the development phase of biotech assets, as well as more transparency in the industry, are needed. AI applied to the biobased industry allows companies to automate a wide range of processes, helping them simplify and expand their operations. Image analysis using AI can allow us to analyse microbiomes, select phenotypes and develop rapid diagnostics in a wide range of applications. The use of AI enables healthcare solutions that facilitate the development of personalised treatments. |

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|  | 3.11. | Increasing public support, trust and education and avoiding fake news about biotech products are needed to consolidate the biotechnologies that products require. Involving civil society in the risk assessment, promoting a positive culture based on biosecurity and biosafety alongside with transparent business models and facilitating access to data are important for helping consumers to understand biotechnologies and thus accept them. A perfect synergy with the SDGs should be ensured. |

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|  | 3.12. | The EESC considers that it is important to ensure timely delivered technical standards through a European standardisation system that supports the functioning of a single biotechnology market, with relevant harmonised standards that facilitate new and advanced bioproduction solutions in a safe manner. Dedicated and harmonised international standards for biotech products should be developed and implemented globally, taking into account the characteristics of such products. The international judicial system should take these situations into account. A link between diplomacy and biotechnology should be further consolidated. |

4.   Investment and financing

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|  | 4.1. | The EESC believes it necessary to strengthen the EU’s competitive position through financial reference frameworks for investments in biotechnology and bioproduction, including access to risk capital in Europe and a fast lane for SMEs. The capital markets union is still not delivering enough, with the capital market’s contribution to biotechnology expected to remain low in the future. Listing the same products in over 10 different European stock markets is proving to be a red-tape-heavy challenge. The EU capital market remains fragmented. |

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|  | 4.2. | The financial system should be compelled to deliver more for the biotechnology and biomanufacturing industry, taking into account the EU economy’s exposure to the banking system. Innovative approaches such as venture debts, which are loans to early-stage companies, are an important tool for assisting firms heavily involved in research to continue to invest in research and development and market expansion. |

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|  | 4.3. | Recognising the importance of biotechnology for the sustainable future of the EU under STEP [(3)](#ntr3-C_202406026EN.000101-E0003) is not enough to win the global competition race. A synergic and complementary approach between the RRF, STEP, the EIB and cohesion policy that is based on common indicators, a common database and the efficient management of the different thematic objectives should be taken into account to increase efficiency in financing biotechnology and biomanufacturing. Having a single access point for financing the biotechnology and biomanufacturing industry is important. |

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|  | 4.4. | Consideration should be given to the option of redirecting funds collected via environmental taxes to finance biotechnology green products. Using a diverse and complementary variety of financial sources and funds such as loans, venture capital and public funds should be a priority. |

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|  | 4.5. | The EU is facing numerous challenges in developing the market, including raising the significant amounts of capital needed, unpredictability (especially in terms of costs), operational complexity and a lack of skills in and money for the labour force. The dependence on investors or venture capitalists should be carefully managed, taking into account the need to approach all the market niches and not prioritise profits. This is particularly important in the rare disease sector. Reducing the dependence of SMEs on large companies in this industry is imperative. |

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|  | 4.6. | Dedicated campaigns for attracting more private investments should be considered. The perception that a bioproduct is successful if it is accepted on the US market should be changed through campaigns. Objective, transparent and consumer-friendly information campaigns on the potential, benefits and risks of bioproduct developments should be a constant concern. Risk culture should be improved and risk assessment procedures created for biotech products to attract more investments. |

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|  | 4.7. | An adapted tax system and subsidies alongside innovative financial support should be dedicated to consolidating biotechnology and biomanufacturing in the EU. It is essential to take into account the economic complementarity between various Member States in order to involve the Member States that can help consolidate biomanufacturing capacity in the EU and increase its strategic autonomy. Biotechnology should be included under the EU Green Taxonomy. |

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|  | 4.8. | Steps should be taken to develop both a dedicated platform for biotech companies included in the EU Biotech Hub to find potential investors and capital, and a yearly EU event to match the needs of investors with the biotechnology and biomanufacturing industry. There is also a need to develop a database listing potential investors, and another listing companies that have products in the authorisation phase, with ongoing clinical tests and a clear relation with the European Single Access Point. A European database is needed to ensure that large, high-quality, easily accessible and secure biological datasets can lead to new biotechnological discoveries. |

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|  | 4.9. | Asymmetric access to information poses significant barriers to SMEs in terms of accessing capital from the capital market and banking sector. An adapted and strong regulated market is needed to prevent market distortions and ensure that investors will have an adapted profit, as they help generate an overall economic benefit for society. Cross-cutting efforts are needed to boost international cooperation and the internationalisation of SMEs. |

5.   Research and innovation

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|  | 5.1. | The EESC considers that more should be done to adopt an agile regulatory process for biotechnological products. It should be able to absorb and process the progress of innovation through the market and aim to ensure the transparency and effectiveness of products placed on the market in a safe and efficient way. Account here must be taken of the fact that the EU has a powerful research system and is a global leader in delivering high-quality scientific articles, but is lagging in turning research into commercial products. |

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|  | 5.2. | The EESC calls on the Commission to motivate the Member States to include biotechnology and biomanufacturing in their smart specialisation strategies. The EU biotech research system should be product oriented. A systemic cross-sectoral intervention and combining multisectoral research process is highly needed. An adapted regulatory framework would address every phase of biotech product production and distribution, from research and phase 1 of testing to market distribution. |

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|  | 5.3. | The EU’s research infrastructure needs to be organised in an integrated and supportive way. More clusters with strong academic and SME involvement, and more start-ups from various sectors interconnected with the biotech industry should be consolidated and well-financed. Investments in capacity building, in scaling infrastructures and in support infrastructure (such as clusters, incubators and industrial infrastructure) are important. |

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|  | 5.4. | Europe has long been recognised as a leader in biotechnology research and innovation. However, turning this into industrial application and manufacturing at scale is proceeding at a slower pace in the EU than it is in other countries. The EESC believes that instruments such as unitary patents and regimes for supplementary protection certificates should be better promoted at Member State level to protect them and innovation as much as possible, and eliminate the risks of these being transferred to third countries, such as the US. The intellectual property framework protecting EU patents needs to be revised. |

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|  | 5.5. | The EESC believes that public-private partnerships (national, European and international) are a key component of investments and are needed to stimulate progress in all sectors of biotechnology and biomanufacturing, to support adequate physical and IT infrastructures, to conduct research activities and to achieve fundamental developments, ensuring connections between researchers and end users and bringing discoveries to the market quickly. Robust production capacities are clearly needed for the future, and the main elements needed to scale up can be found in the EU. The EESC calls for partnerships and interdisciplinary and collaborative models to be encouraged, and a specific strategic and legislative framework to be delivered in this regard. |

6.   Jobs and skills

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|  | 6.1. | The EESC is disappointed that no actions have been proposed for skills and human resources in the Commission’s proposal. The future of biotechnology and biomanufacturing must involve retaining skills and attracting more talent in the EU, which should be given the same importance as protecting patents and innovation. Brain drain is real and weakens the EU’s competitiveness, especially in the east, where brain drain is creating problems in an ageing society. Attracting expert outside the EU for developing the sector should be a preoccupation. |

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|  | 6.2. | The biotech industry is heterogeneous and fragmented. Exchanges, networking, mutual learning, awareness raising and promoting education and skills should pave the way for the interconnectivity needed between various innovation ecosystems at EU level. Assuring high-quality working conditions, social dialogue and collective bargaining are important for stabilising the workforce. Investments in training qualified human resources with a permanent support process for current and future bioproduct developments is crucial for the competitiveness of the industry. Biotechnology is a sector which can raise an interest for more youth involvement. The EESC is considering that strengthening the role of universities in this regard is important. |

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|  | 6.3. | Innovation in the biotechnology sector requires a dedicated, integrated and highly flexible instrument to create and protect the synergy between biotechnology skills requirements and biomanufacturing needs. The multiplication effect in the biotechnology industry is important, given that one direct job created has the potential to create a further three indirect jobs. |

7.   Ethical aspects

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|  | 7.1. | The human race has never been more powerful and vulnerable at the same time. The EESC considers that the role of civil society in protecting an ethical future for European society is crucial. Science in fields such as biotechnology is not enough and must be supplemented by politics and the right policies to ensure a fair future for our society. Biotechnology should be used to eliminate poverty, food inequality and food scarcity, and not to control or to gain more power. |

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|  | 7.2. | The EESC calls on the Commission to develop an ethical code for EU companies and for products placed on the EU market and promoted globally, to protect people from possible technology misuse and to respect human dignity and rights. Ethical aspects of biotechnology should be regularly monitored with the full involvement of civil society. The EESC believes that biotechnology should be developed in a way that prioritises the sanctity of life, and not the market, overtreatment or undertreatment. |

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|  | 7.3. | In order to increase acceptance in society, the implications of genetic resources on human rights, on human dignity and on the privacy of individuals need to be addressed. Societal values should be integrated across all domains, and public health improved. The EESC suggests that the fundamental values recognised by the European Union in the Charter of Fundamental Rights must be taken into account in biotechnology developments. Protecting democracy and our democratic values should be a priority. |

Brussels, 10 July 2024.

The President

of the European Economic and Social Committee

Oliver RÖPKE

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ELI: http://data.europa.eu/eli/C/2024/6026/oj

ISSN 1977-091X (electronic edition)

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