Publication date: January 07, 2026
The European Union has launched a comprehensive regulatory framework for biotechnology and support for businesses in this field. It is estimated that approximately 80 percent of active pharmaceutical ingredients are imported, particularly from countries such as China and India. The European economy cannot afford this current state of affairs if it is to remain competitive, stable, and attractive to investors. For this reason, the so-called Biotech Act, which is intended to regulate the field and industry of biotechnology, as well as research conducted on it, in such a way as to solve the current problems occurring therein.
First of all, it should be pointed out that the legislative form in which Biotech Act is to be issued is planned as a regulation, which will not need to be adopted by individual member state parliaments, but will apply directly after an appropriate transition period (if one is provided). Currently, the new normative act is scheduled for adoption in the second quarter of 2026, so changes will be implemented quickly, according to these assumptions.
The definition of biotechnology that is to apply within the scope of this regulation is to cover all its zones, i.e. white biotechnology – industrial, green-food (agri-food), red – medical and therapeutic, blue – marine, and therefore it will cover this discipline in its entirety without exceptions.
Although the EU points out that in 2022 alone, as a side effect of the creation of new biotechnology-related jobs, another 650,000 new jobs were created, it recognizes certain current and serious problems with the competitiveness of its economy. The main current challenges that comprehensive regulation aims to address include the inability to utilize a very good and qualified research base for development. Due to the complex procedures for awarding research grants to scientists working on the development of this discipline and for obtaining financial support by micro, small, and medium-sized enterprises, there is a very high tendency to emigrate abroad to countries where these procedures are easier to complete. Regarding the lack of investment support, data has emerged indicating that in the US, 52% of investments go to biotech industry, while in the European Union only 2%. Another problem is the certain state of “regulation dispersion” in this field, meaning the lack of a single normative act that regulates every procedural issue that may arise in the field of biotechnology. Biotech Act aims to address this very obstacle. One of the last problems mentioned by the European Commission is the lack of realization of the potential of artificial intelligence (AI/ML)-based models in the biotechnology industry. Furthermore, Biotech Act is expected to significantly impact the operation of the food industry and the use of biotechnology in food processing and treatment, including the field of novel food. It will simplify the procedure for introducing new food products to the market for the first time, the financing procedure, and access to investment support for startups, as well as introduce new compliance requirements for the creation of food and other products.
The European Union emphasizes that bioproduction and biotechnology are pillars of the competitiveness and strength of its economy, and even a kind of pillar.
The regulation in question will contain general provisions containing definitions for the application of the Act and will also outline a specific objective for implementing the measures provided for therein. The inclusion of such provisions (especially in the recitals) will likely facilitate the interpretation of the regulation’s specific provisions. The draft addresses several key issues: improving the functioning of the internal market by creating a foundation for increasing the competitiveness of the economy in the field of biotechnology, enabling more effective and rapid implementation of research in this field in production and marketing, and tempering this desire and goal with appropriate requirements regarding professional ethics, the protection of human and animal life and health, morality, and high standards of good industrial practice. The general objectives also address the introduction of innovations into the internal market, new biomedical engineering and biotechnology products, the use of new technologies in industry to improve it, and the use of its products in the daily lives of EU citizens.
The organizational plans also include the creation of a special commission composed of members of member state governments. Its task will be to act as an intermediary between EU bodies and biotechnology stakeholders (both scientific and business), ensuring the effective implementation of new ideas and research as quickly and efficiently as possible. This is intended to increase pro-competitive activity and thus lead to faster development of the internal market. A support network for smaller entrepreneurs, start-ups, and researchers, as well as a procedure for obtaining support, are also planned.
According to the project’s assumptions, a special investment program will also be introduced in cooperation with the European Investment Bank Group and other partners. Entities operating in regulated sectors will be able to receive funding for their operations in accordance with the regulations on financial support and assistance.
In addition, an extension of the SPC (Supplementary Protection Certificate) for 12 months covering medical products and those created using biotechnology, as well as Advanced Therapy Medical Products are planned. This is intended to support the continued support for patients provided by these products and the activities of companies involved in their production.
The project includes a strategy for implementing artificial intelligence policy in the biotechnology industry, in line with the recommendations of the European Medicines Agency. Other provisions that contribute to the overall biotechnology regulatory landscape include the implementation of Directive 2001/83/EC on interactions and combinations between medicinal products and medical devices and on regulatory sandboxes, and the creation of an EU regulatory sandbox for early-stage health biotechnology products that fall outside the existing health regulatory framework.
At the very end of the proposed Biotech Act regulation are provisions to prevent the misuse of biotechnology products. They provide mechanisms for monitoring, reporting, and tracking suspicious transactions related to biotechnology products that raise concerns, as well as enforcement mechanisms to ensure legal compliance with EU regulations.