Publication date: November 12, 2025
DEFINITIONS
Biotechnology is the application of science and technology to living organisms, their parts, and models, in order to improve the properties of living and non-living materials, applied scientific research, products, and services. This definition was developed by the Organisation for Economic Co-operation and Development (OECD). Another definition was provided by the UN Convention on Biological Diversity: biotechnology refers to any technological solution that uses biological systems, living organisms, or their derivatives to produce or modify products or processes. Biotechnology has been identified as one of the areas most likely to contribute to the development of the global economy in the coming years, as it does not pose a direct threat to humans or the environment; on the contrary, its use and development aim to increasingly improve resource utilization while maintaining sustainable development and environmental protection policies. Biotechnology is a field with enormous potential, as its development creates a significant number of new jobs, and development in this area will bring results that will improve the operation of many economic sectors, reducing costs and increasing profits. It has been recognized as a critical technology from the perspective of economic security.
Biotechnology is primarily divided into medical and non-medical biotechnology. Medical biotechnology primarily focuses on the development of innovative treatment strategies for various diseases, the production of drugs, vaccines, and medical devices, as well as preventive care. This development allows for the reduction of treatment costs, which until recently were a significant limitation for patients unable to take care of their health due to lack of funds or the unavailability of appropriate resources. Various solutions developed using these methods are already in use, starting from the very beginning, with the invention of synthetic insulin in the 1980s, which significantly reduced the costs generated by insulin imports, leading to a significant drop in its price. Certain factors, such as mealtimes, are irrelevant in the administration of this type of insulin, as it works faster. Biotechnology is also used to improve and create innovative vaccines – one such example of such a large-scale application of this technology was the creation of a vaccine during the COVID-19 pandemic. The vaccines were developed using mRNA technology in a short period of time, in response to the specific conditions of the pandemic. Medical biotechnology also encompasses genetic engineering, including gene therapy. It encompasses not only scientific research but also the practical application of modern solutions – in hospitals and clinics where patients often wait without any hope of treatment.
Medical biotechnology is also referred to as red biotech. A further division concerns non-medical biotechnology – that is, biotechnology used in any sector other than medicine. This is the focus of most Polish and EU regulations on biotechnology, although a clear shift in this regard is visible. Non-medical biotechnology is divided into many specific branches. One of the basic ones is white Biotech, which deals with industrial processes and the use of microorganisms to produce chemicals, biofuels, and other materials in a way that reduces energy consumption and waste production, is used in the cosmetics and clothing industries, as well as in the creation of various chemicals. Green biotech, also known as agrobiotechnology, is used in agriculture, producing fertilizers, biopesticides, and creating new plant varieties with improved properties, resistant to diseases and pests, with the goal of reducing world hunger. Blue biotech is concerned with the use and research of water resources for industrial purposes. Yellow biotech is used in sustainable food production, to improve its quality, and according to some interpretations it also deals with insects (as a distinction from red biotech dealing with animals and from green biotech, dealing with plants). Grey biotech is mainly about environmental protection, including ways to preserve biodiversity and remove pollution. The others are: brown biotech – used in developing biodiversity in desert areas; Purple biotech – a field dealing with legal regulations regarding biotechnology, social reception and issues related to patent law; gold Biotech – bioinformatics and computer technology, nanobiotechnology, and database development; black (or dark) biotech – encompasses bioterrorism and biological weapons. This division is not perfect – it is imprecise and inconsistent, as it is not free from discrepancies between the works of various authors. However, it is constantly being developed, and these terms have become widely used.
TECHNOLOGIES IN PRACTICE
Medical biotechnology is developing various methods and technologies that push the boundaries of what we have known in saving human lives. One such technology is CAR-T therapy – an innovative treatment for people with acute lymphoblastic leukemia and lymphoma. Its use is limited due to the small number of centers that meet the requirements for facilities using this technology, and it is also very expensive (at least half a million PLN is required to treat a single patient). Cancer-destroying cells (T lymphocytes) are collected from the patient, then refined and multiplied in the laboratory. Afterwards, they are administered intravenously to the patient once, remaining in the body as a living medicine – created individually for each patient. Since 2021, a program run by the Medical Research Agency has been operating in Poland, under which patients can obtain reimbursement for this expensive therapy. However, resources are limited, and reimbursement is only available to patients with advanced stages of a very specific type of leukemia, primarily those under 25 years of age. Biotechnology has made it possible to create therapeutic mRNA, synthetically produced to deliver specific types of protein to the body for therapeutic purposes. This relationship has been exploited in the development of a vaccine against COVID-19. Currently, this technology is primarily used in vaccine development, but there are very few cases in which a vaccine alone is sufficient. It is necessary to develop technology that allows for the delivery of molecules in other ways, not just intravenously or intramuscularly. There is a huge demand for funding for this type of research. Another biotechnological method used in medicine is CRISPR – Clustered Regularly Interspaced Short Palindromic Repeats. This method allows for precise modifications to DNA. It utilizes the Cas9 system, an enzyme that can cut and modify DNA fragments at specific locations. This therapy is useful in the treatment of genetic diseases, cancers, and for prevention. These methods are constantly being developed, but adequate funding for research focusing on them is lacking. Their effectiveness depends, among other things, on safety, which is another challenge in their development – ensuring appropriate conditions is expensive. So-called biopharmaceuticals are being produced – drugs produced using genetic engineering techniques, which are proteins with therapeutic properties, utilizing bacteria, fungi, plants, and mammals. Biopharmaceuticals have been considered safe and well-tolerated for many years. However, they must follow a similar path as traditional drugs – undergoing a series of tests and trials before being approved for sale. They offer a solution in the treatment of many diseases for which traditional therapies have been ineffective – primarily in oncology.
ETHICAL PROBLEMS
Biotechnology is primarily used in the form of GMOs – genetically modified organisms. Genetic engineering is used to obtain plants (and less frequently, animals) with desired traits. This is highly controversial, but since the dawn of time, genetic modifications have been the basis for plant cultivation, reproduction, and crossbreeding. These efforts support the fight against hunger by focusing on larger-scale food production without compromising quality. Medical biotechnology, in particular, is fraught with controversy and extensive ethical dilemmas. Currently, it is used only for therapeutic purposes, but there are many voices in society that believe it is close to crossing the line into practices that violate ethical principles, bordering on eugenics, and are used to “improve” the human genome.
On the other hand, the availability and cost of such advanced therapies poses an ethical challenge. A significant portion of these therapies are available only to the wealthiest or most determined individuals. For the rest of the patients, there is no hope, as funding for such expensive therapies is incredibly difficult to obtain. The previously mentioned ABM program actively supports leukemia patients, but funding remains limited, and there is no way to provide support for all patients. Priority is given to patients in the very advanced stages of the disease, especially those with the most severe forms, as well as to children and adolescents – yet even in this area, government support is limited. Access to complex therapies is also crucial, as people with rare diseases have the same right to treatment as those with common diseases. However, more efforts are being made to develop therapies for more necessary diseases, prioritizing the health of as many people as possible, which is the essence of pharmacoeconomics. Appropriate funding would partially pave the way for research into more niche therapies.
COMPETITION IN THE BIOTECHNOLOGY MARKET
Biotechnology is a particularly dynamic and fast-growing economic sector. The European Union included it in its 2020 development plan as an area requiring special support, with enormous potential. Red biotech companies are characterized by intense competition and rapid growth. The COVID-19 pandemic has demonstrated how dynamic this market is and how much financial resources it can absorb. In these unusual circumstances, a vaccine was developed that significantly reduced the number of cases and accelerated the end of the pandemic that devastated the global economy. The main players in the COVID-19 vaccine market were the American companies. The United States leads in terms of market share in medical biotechnology, with the largest number of companies being established there, and procedures for introducing biological plant protection products, for example, are significantly more streamlined compared to those in Europe. However, the EU market has enormous potential for development in this field. Many specialists and scientists with valuable knowledge for biotechnology development are working and developing in Europe. However, there is a negative phenomenon of these specialists emigrating to places where obtaining grants or other types of funding for research in this field is much easier. The European Union remains second in the ranking of the largest markets for biotechnology, but these proportions are very unfavorable – the United States is the clear leader, holding approximately 60% of the market, with the European market accounting for only a dozen or so percent. Right behind Europe is China, whose growth is much more dynamic and will soon become the second largest biotechnology industry after the United States. The biotechnology industry is the foundation of security, economic stability, and the production of all kinds of goods, as demonstrated by the recently raging pandemic. Therefore, the European Union has decided to take consistent and concrete actions to improve its position in order to increase independence and security within the community. Individual European countries, such as the Netherlands and Germany, have their share of the biotechnology market, but these actions alone are not significant in a global perspective. To build a significant position, European countries must take joint actions within the EU market.
POLISH AND INTERNATIONAL BIOTECHNOLOGY REGULATIONS
• Act on Genetically Modified Microorganisms and Organisms
The Act on Genetically Modified Microorganisms and Organisms of June 22, 2001, addresses the previously discussed GMOs. Its regulations primarily address the safety of introducing genetically modified organisms to the market, particularly in agriculture and industry—food, materials, and cosmetics production. Among other things, the Act establishes a Register of Genetic Engineering Facilities and contains administrative provisions.
• Pharmaceutical Law Act
The Pharmaceutical Law Act of 6 September 2001 contains regulations on the authorisation of the use of various types of products, stipulating that a marketing authorisation is not required for medicinal products used exclusively for scientific research by entities related to science and higher education, as well as medicinal products used by manufacturers of investigational products used exclusively for clinical trials and intermediate products manufactured for further use in the manufacturing process.
• Industrial Property Law Act
The Industrial Property Law of June 30, 2000, regulates intellectual property protection related to the patenting of inventions that are biotechnological achievements. The Act defines a biotechnological invention as a new invention, involving an inventive step and suitable for industrial application, and applies to a product consisting of or containing biological material, or a method by which biological material is produced, processed, or used. It also specifies the types of biotechnological inventions, the definition of an unethical invention, and regulations governing the entire patenting process.
• Act on Laboratory Medicine
The Laboratory Medicine Act of September 15, 2022, specifies the conditions for practicing the profession of laboratory diagnostician and performing activities related to laboratory medicine. It defines laboratory medicine as a field of medicine whose task is to determine the composition and biological, chemical, and physical parameters of biological materials. A laboratory diagnostician is a person with a university degree in, among other fields, biotechnology or medical biotechnology and a master’s degree in engineering.
• UN Convention on Biological Diversity
Among the most important international agreements in the field of biotechnology, which provided the basis for subsequent regulation of this matter, is the Convention on Biological Diversity, adopted during the Earth Summit on June 5, 1992, and ratified by Poland in 1995. This was a consensus among all 196 state parties. Highly developed countries in the North sought to exploit natural resources located, among others, in the South to utilize the naturally occurring genetic resources found there. They maintained that natural resources were a public good and should have the opportunity to utilize them. Developing countries, which did not have a significant share in biotechnology, demanded that other countries benefit from the use of their resources.
Previous regulations have addressed the topic of biotechnology, and medical biotechnology in particular, only in a fragmentary way. The current regulations mainly concern white Biotech, biotechnology used in industry, is still in the spotlight. However, there is a lack of comprehensive regulations governing this topic on a broader scale. There is a need to regulate this issue to ensure safety in biotechnology. This will create greater scope for development in this field of science, as it will be easier to overcome barriers existing due to financial or safety reasons. National, internal regulations are needed, as well as EU regulations. To build a significant position in the biotechnology market, European countries must undertake joint efforts to develop legislation and finance biotechnology projects.
LEGISLATIVE ACTIONS OF THE EUROPEAN UNION FOR THE DEVELOPMENT OF BIOTECHNOLOGY
Biotechnology has been identified as one of the ten pillars of critical technologies for European economic security due to its cross-cutting nature. Biotechnology is also one of the priority technologies in the EU’s 2024 regulation on the Strategic Technology Platform for Europe (STEP). The European market offers enormous potential for the development of this sector, along with its human resources and research achievements. However, it currently lacks the appropriate regulations and conditions that would revolutionize and drive rapid development in this field. Biotechnology companies require financial support and broader opportunities to operate in the European market. At the same time, initiatives such as IPCEI MED4Cure are emerging – a project to support research and development projects covering all key stages of the pharmaceutical value chain, from the collection and testing of cells, tissues, and other samples to sustainable technologies for the production of breakthrough therapies. The development of biotechnology is an investment in the EU’s independence and autonomy from the US and China, in internal and external security, and in improving quality of life and well-being, particularly in the areas of nutrition and healthcare.
Communication from the European Commission
In March 2024, the European Commission issued a communication entitled “Building a Future in Harmony with Nature: Stimulating the Development of Biotechnology and Bioproduction in the EU” to other EU bodies, outlining the problem of stagnation in the European biotechnology market. It identified barriers to development and outlined the general directions for solutions that must be implemented to stimulate the development of biotechnology in Europe. It described examples of biotechnological methods that have been adapted and yielded significant results, and outlined potential cases in which the use of these methods could lead to the development of innovative solutions. It announced the simplification of formal procedures, which is intended to contribute to the streamlining of the adoption of new methods in industry, medicine, pharmacology, and beyond. The communication emphasized the importance of centralizing a system of financial subsidies for specialized biotechnology activities to support investments at every stage of their development and operation, particularly during the scale-up phase, when project development is associated with the highest risk and requires broad investment horizons. This is intended to prevent specialists and highly qualified personnel from leaving the European Union in the hope of better prospects for developing initiatives in other countries. An industrial innovation accelerator for biotechnology and synthetic biology (EU IBISBA) was established, creating conditions conducive to achieving full operational efficiency of European research infrastructure. The use of artificial intelligence to advance data analysis, reducing costs and increasing automation was also announced. Biotechnology is intended to align with and support sustainable development policies by reducing carbon footprints and protecting the environment. The creation of so-called regulatory sandboxes was announced, legal structures that allow businesses to operate in a safe testing environment to experiment with a given project or service under relaxed conditions – this is intended to further streamline the development of initiatives in the biotechnology sector.
Strategy for Life Sciences
In July 2025, the EU Life Science Strategy was adopted, an EU development plan for health -related sectors, including biotechnology. It is a framework plan for 2025-2029, constituting a set of recommendations for the development of sciences such as biotechnology, pharmacy, and bioinformatics. This document is explicitly designed to pave the way for future comprehensive regulation, a regulation called the Biotech Act. It imposes no obligations on member states; it merely creates an institutional framework. Despite its lack of binding force, the European Commission received 794 comments and recommendations during the consultation process. Increased efforts in the field of biotechnology have already been implemented, including the establishment of the GenAI4EU initiative, which allocates approximately €500 million to stimulate the use of generative artificial intelligence, including in the EU’s biotechnology industrial system. The strategy also aims to stimulate the development of biotechnology in Central and Eastern European countries, including Poland. Due to the lack of a well-developed subsidy system for biotechnology research and the limited regulations in this area, Polish deep-tech initiatives are left without the necessary resources for development and without prospects. New European initiatives are intended to facilitate access to competitions, which provide an opportunity to develop and promote solutions developed in our part of Europe.
EU Biotech Act
In July 2024, it was announced that work was planned on creating a regulatory act on biotechnology, which was to enter into force in 2025 and is intended to “lead biotechnology from the laboratory to the factory, and then to the market.” This regulation is intended to simplify legal regulations governing the biotechnology sector, which hinder the operations and development of corporations – the current fragmentation of regulations hinders the EU’s international competitiveness in biotech. Legal certainty and predictability are essential in this matter, as this is what investors expect. The regulation is to include a plan for financing startups emerging in this industry, while maintaining high ethical standards. This legislative model is based on the creation of comprehensive regulatory acts that will comprehensively regulate an innovative field that requires rapid, well-thought-out, and loophole-free regulation – a trend also evident in the revolutionary AI Act.
However, the European Commission’s 2025 work programme did not include the introduction of a regulation on biotechnology. It was announced that this act would not be introduced until the second half of 2026 due to the project’s complexity, the heated debate surrounding its content, and the unclear framework within which the legislation would proceed.
Opinions and consultations
Individual EU member states have developed biotechnology sectors, but they have not achieved significant success as standalone players. Denmark, France, Germany, Spain, Italy, and Belgium lead the European biotech market, each in a specific field, including pharmaceuticals, industry, and environmental protection. France is currently the fastest-growing country in the EU in terms of biotechnology, focusing on food and agriculture. Emerging players such as Austria, Slovenia, Lithuania, and Estonia are increasingly involved in developing their biotech sectors, including niche technologies, while Malta and Cyprus are focusing primarily on marine biotechnology. Due to the need to adapt EU regulations to the needs of member states, despite the early stages of work on the act, some have expressed their views on their expectations regarding the regulatory framework. Germany supports the concept of a comprehensive regulation that would encompass the entire field of biotechnology, without excluding any of its elements. The country participated in the work on this act even before Denmark assumed the EU Council Presidency. France advocates limiting regulation to the energy and agri-food sectors. Denmark also advocates a comprehensive approach, arguing that limiting it to red biotech alone would be counterproductive and potentially counterproductive. Italy has emphasized the importance of biotechnology for its economy, and although medical and marine biotechnology are most important to it, it advocates for comprehensive regulation. However, countries agree on the need to regulate biotechnology efficiently, as this is another area in the race between the US and China, a field in which we do not want to be left behind.
EuropaBio, one of the most active organizations representing the European biotechnology industry, advocates for a cross-sectoral regulatory framework that would strengthen Europe’s competitiveness as a player in the biotechnology market. Generally speaking, stakeholders express concerns that regulation will be limited to only certain areas within the broader biotechnology umbrella, preferring a holistic approach.
Biotech Act is also intended to mitigate public sentiment surrounding GMOs in food and agriculture, but not exclusively. Its goal is to calm media panic and disinformation in this context, promoting awareness and acceptance. Effective public communication could emphasize that biotechnology is already a part of everyday life, with many products based on biotechnological processes or components—and that it brings tangible results not only in health care but also in areas such as soil protection, energy, fertilizers, and combating water pollution.
The European Union is currently conducting a public consultation on the proposed regulation. The consultation is aimed at citizens, innovators, entrepreneurs, industry representatives, financial institutions, investors/venture capitalists, researchers/research organizations, civil society (including consumer, patient, and environmental organizations), other users of biotechnology (e.g., farmers and foresters), trade unions, national and regional authorities, and all other interested parties. The consultation period was from 4 August to 10 November 2025. Adoption by the Commission is planned for the third quarter of 2026.
SUMMARY
The European Union’s actions, as well as individual actions by member states, are bringing Europe closer to re-entering the global biotechnology market. This is crucial from the perspective of security, cybersecurity, and autonomy. The COVID-19 pandemic and the outbreak of war in Ukraine have demonstrated how we should ensure the efficiency and stability of the system at many economic levels and in many areas, particularly in the areas of public health and economic self-sufficiency. Biotechnology is a field used increasingly widely, in every sphere of life, so we need clear and comprehensive regulations that will make various initiatives more transparent. The trend toward developing biotechnology will help achieve a stable position, not only in times of prosperity but also in times of crisis.