Belgium Country Commercial Guide
Learn about the market conditions, opportunities, regulations, and business conditions in belgium, prepared by at U.S. Embassies worldwide by Commerce Department, State Department and other U.S. agencies’ professionals
Select Country Guide
Biopharmaceuticals
Last published date:

Overview

Belgium plays a leading role in the global biopharmaceutical sector: it is a major manufacturing, logistics and export hub, with strong R&D infrastructure, a skilled workforce, and a significant presence of top global pharma companies. According to recent industry analyses, Belgium ranked fourth worldwide in pharmaceutical exports in 2023 and is among the highest-exporting countries in the EU. In 2022 Belgium was the second-largest exporter to outside EU destinations of medicinal & pharmaceutical goods ($64.5 billion). The United States is one of Belgium’s top trading partners for pharmaceuticals; recent figures suggest the U.S. share of Belgian pharma exports is close to ~20 %. While exact numbers for sector employment and R&D investment vary by source, the Belgian pharma-biotech ecosystem remains robust, hosting dozens of global pharma firms and benefiting from strong public-private collaboration. Because Belgium’s port, logistics and regulatory environment support exports and production, the country remains highly attractive to U.S. and other international biotech and pharma companies seeking manufacturing or R&D partnerships in Europe.

Sector Developments

Industry has raised concerns regarding Belgium’s reimbursement process. While Belgium remains a major player in the development and production of innovative medicines, that strength does not translate into equally rapid patient access. For example, Belgium’s average waiting time from marketing authorization to reimbursed availability is 534 days, placing it behind many European peers. Reimbursement of orphan (rare disease) medicines also remains incomplete: a study found that of 151 orphan drugs in the European pipeline, only 86 were fully reimbursed in Belgium. In 2022 Belgium reimbursed 95 new medicines of which only 12 were orphan medicines. Recognizing these delays, the Belgian government has launched reform efforts — from January 2026 a new “Early & Fast Equitable Access” procedure will allow some therapies to be reimbursed even before full European authorization. The existing reimbursement pathway remains multi-step (including pricing and CRM decisions) and Belgium’s health-budget constraints continue to loom, reinforcing concerns about the pace and extent of access. On a positive note, the number of medicine shortage notifications decreased in 2024, signaling some improvement in product availability.

Belgium established the Health Data Agency to access to health data and health related data. 
The establishment of the Health Data Agency (HDA) is a significant step toward realizing the European Commission’s 2019-2024 political priority “A Europe for the Digital Age” within the health space in Belgium. The EU’s Digital Strategy provides for the creation of a European health data space (EHDS) to promote targeted research, diagnosis and treatment. To address this issue, in 2023 Belgium’s Parliament adopted a law instituting the Healthcare Data Agency (HDA). The HDA is an autonomous administrative agency within the Federal Public Service Public Health. The main purpose of the HDA is to facilitate access to health data and health related data in a simplified and reliable manner and facilitate the re-use of such data. The HDA’s operational framework is purposefully designed to align with the EHDS and future initiatives, ensuring ongoing compliance with European legal requirements. Operating from an inter-federal standpoint, the HDA collaborates with the Belgian health(care) ecosystem to foster cross-region and cross-border collaboration.  

Doing Business in Belgium’s Pharmaceuticals Sector 

As with all EU Member States, Belgium supports and implements the EU legal framework for regulating medicinal products for human use through its own set of national laws. Belgium’s Federal Agency for Medicines and Health Products (FAMHP) is responsible for safeguarding the quality, safety and efficacy of medicines and pharmaceuticals for human and veterinary use, medical devices, and raw materials used for preparing and manufacturing medicines. The Minister of Economic Affairs – with advice from the Pricing Committee for Medicinal Products of the Federal Public Service for Economic Affairs – is responsible for price regulation, including the approval of both prices and price increases for medicinal products. The Federal Minister of Social Affairs – in consultation with the Commission for Reimbursement of Medicines – decides on the reimbursement of medicines covered by public health insurance. At the EU level, the main regulatory authority is the European Medicines Agency (EMA) which protects and promotes human and animal health by evaluating and monitoring medicines within the EU and the European Economic Area (EEA).

Leading Sub-sectors

R&D: Belgium is by far the country with the highest biopharmaceutical R&D expenditures per inhabitant in Europe. Belgium scores well above other European countries even based on absolute numbers, with only Germany spending more. In 2022, Belgium’s biopharmaceutical sector invested $6.56 billion in R&D. While U.S. companies are attracted to Belgium for their R&D activities by the highly skilled and knowledgeable workforce, successful industry clusters and good collaboration between public and private actors, fiscal incentives are another important factor. To this end, the Belgian government has introduced several R&D tax incentives aiming to encourage companies to invest in top talent and/or innovation.
•    Partial withholding tax exemption for researchers: This allows companies to benefit from a partial exemption up to 80 percent from the wage withholding tax due to the salaries of qualified researchers.
•    Innovation income deduction: Under the Innovation Income Deduction (IID) regime, qualifying intellectual property (IP) income is eligible for a tax deduction up to 85 percent. The IID applies to a broad range of IP rights and allows for the carry-forward of unused deductions.
•    R&D investment deduction / tax credit: Companies can choose between an increased investment deduction and a tax credit for the acquisition or development of qualifying patents and environmentally friendly R&D investments.

Biotechnology: Belgium has more than 400 life sciences companies with biotech activities. 
Belgium is a prominent hub for biotechnology in Europe, offering a robust ecosystem that presents significant opportunities for U.S. biotech companies. The country’s strategic location, advanced infrastructure, and supportive policies make it an attractive destination for investment and collaboration in the life sciences sector.
Flanders is home to over 400 companies and research institutes in medical biotech, medtech, digital health, agtech, and industrial biotech. Biovia, the health innovation cluster for Flanders, connects these entities and supports them through funding, education, and networking opportunities. Wallonia features several science parks and competitiveness clusters focusing on biotechnology, ICT, and green tech. The region has attracted significant foreign investment and talent, bolstered by government support and a collaborative ecosystem of universities, research centers, and businesses.

Infrastructure and Innovation Support

VIB Bio-Incubators: Located in Ghent and Leuven, these incubators provide specialized infrastructure for biotech startups, including laboratory facilities and office spaces. They also offer access to a network of researchers and industry professionals, fostering innovation and collaboration; VIB.BE
EU Biotech Campus: Situated in Gosselies, Wallonia, this multi-operator training hub focuses on bio fabrication and bioproduction, providing state-of-the-art facilities and training programs to develop talent in biotechnology and biopharmacy.

Belgium’s biotech clusters offer numerous opportunities for U.S. companies to engage in strategic partnerships. Collaborations can focus on areas such as oncology, neurology, regenerative medicine, and infectious and autoimmune diseases. Flanders and Wallonia’s clusters provide access to a network of biotech pioneers, contract research organizations (CROs), contract manufacturing organizations (CMOs), and clinical trial experts, facilitating the advancement of breakthroughs in these fields.

Clinical Trials: the number of clinical trial applications approved in Belgium has grown steadily.
The Federal Agency for Medicines and Health Products (FAMHP) reports to have processed 622 clinical trial applications. In terms of the number of clinical trials set up per inhabitant, Belgium has remained within Europe’s top three countries over the past ten years. The clinical trials carried out in Belgium cover nearly all therapeutic areas. Belgium’s specific expertise in oncology is notable: over 30 percent of the authorized applications for clinical trials are intended to test new cancer treatments. Other trials address central nervous system disorders, digestive diseases, and cardiovascular conditions.  

Some of the key factors behind Belgium’s success as a clinical trials destination are the strong presence of the biopharmaceutical industry, the quality of the country’s infrastructure – including its research centers and over 70 hospitals – and the level of expertise of researchers and authorities, including the Federal Agency for Medicines and Health Products (FAMHP). In addition, Belgium offers a favorable regulatory environment, having introduced a new clinical trials law in 2018 to ensure the practical implementation of the EU Clinical Trials Regulation in Belgium. 

Under the law, Belgium has continued to implement its ultra-fast approval procedures for clinical trials, particularly for phase 1 trials – a procedure that takes barely 15 days. In 2022, the new regulation for clinical trials (Clinical Trials Regulation, CTR), Regulation 536/2014, came into force with the aim of simplifying the administration for applications for clinical trials of medicinal products for human use and harmonizing legislation within the European Union. Further information can be found on Belgium’s Federal Agency for Medicines and Health Products website: https://www.famhp.be/en/human_use/medicines/medicines/research_development/clinical_trials

Opportunities through strategic partnerships, business environment and access to EU markets 
Belgium’s biotech clusters offer numerous opportunities for U.S. companies to engage in strategic partnerships. Collaborations can focus on areas such as oncology, neurology, regenerative medicine, and infectious and autoimmune diseases. Flanders and Wallonia’s clusters provide access to a network of biotech pioneers, contract research organizations (CROs), contract manufacturing organizations (CMOs), and clinical trial experts, facilitating the advancement of breakthroughs in these fields. 

Belgium offers a favorable business environment for foreign investors, including U.S. biotech companies. The government provides various incentives, such as tax credits for research and development activities, grants for innovation projects, and support for infrastructure development. These incentives aim to attract and retain foreign investment in the biotech sector.

Establishing a presence in Belgium allows U.S. biotech companies to access the broader European market. Belgium’s central location in Europe provides logistical advantages, and its membership in the European Union ensures compliance with EU regulations, facilitating market entry across member states.

Belgium’s dynamic biotech ecosystem, characterized by world-class research institutions, state-of-the-art infrastructure, and a collaborative environment, offers compelling opportunities for U.S. biotech companies. Engaging with Belgium’s biotech clusters can lead to fruitful partnerships, access to innovation, and expansion into European markets.

Opportunities abound for innovative U.S. companies looking to partner with leading Belgian companies and institutions in R&D, biotechnology, and clinical trials. Although U.S. exporters are not required to appoint a local agent or distributor to sell to Belgian companies or the Belgian government, it is strongly recommended that companies consider partnering with a local company for the purposes of monitoring business opportunities, navigating import and standard testing regulations, and identifying public sector sales and contract opportunities. 

Resources

•    Belgium Ministry of Health 
•    The Federal Agency for Medicines and Health Products 
•    Belgian National Institute for Health and Disability Insurance
•    Belgian Health Data Agency
•    Sciensano (a research institute and the national public health institute of Belgium)
•    Pharma.be (the general association of the Belgium’s and Flanders’ pharmaceutical industry)
•    Flanders.bio (a dedicated networking organization for the life sciences sector in Flanders)
•    Essenscia (the federation for chemicals, plastics, and life sciences in Belgium)
•    FeBelGen (an industry association representing generic drug companies) 
•    Medaxes (an industry association representing companies that focuses on the accessibility of generic and biosimilar medicines, as well as other off-patent medicines, and self-care products)

For more information or assistance please contact the U.S. Commercial Service office close to you to discuss your international projects for Belgium. 

×

Global Business Navigator Chatbot Beta

Welcome to the Global Business Navigator, an artificial intelligence (AI) Chatbot from the International Trade Administration (ITA). This tool, currently in beta version testing, is designed to provide general information on the exporting process and the resources available to assist new and experienced U.S. exporters. The Chatbot, developed using Microsoft’s Azure AI services, is trained on ITA’s export-related content and aims to quickly get users the information they need. The Chatbot is intended to make the benefits of exporting more accessible by understanding non-expert language, idiomatic expressions, and foreign languages.

Limitations

As a beta product, the Chatbot is currently being tested and its responses may occasionally produce inaccurate or incomplete information. The Chatbot is trained to decline out of scope or inappropriate requests. The Chatbot’s knowledge is limited to the public information on the Export Solutions web pages of Trade.gov, which covers a wide range of topics on exporting. While it cannot provide responses specific to a company’s product or a specific foreign market, its reference pages will guide you to other relevant government resources and market research. Always double-check the Chatbot’s responses using the provided references or by visiting the Export Solutions web pages on Trade.gov. Do not use its responses as legal or professional advice. Inaccurate advice from the Chatbot would not be a defense to violating any export rules or regulations.

Privacy

The Chatbot does not collect information about users and does not use the contents of users’ chat history to learn new information. All feedback is anonymous. Please do not enter personally identifiable information (PII), sensitive, or proprietary information into the Chatbot. Your conversations will not be connected to other interactions or accounts with ITA. Conversations with the Chatbot may be reviewed to help ITA improve the tool and address harmful, illegal, or otherwise inappropriate questions.

Translation

The Chatbot supports a wide range of languages. Because the Chatbot is trained in English and responses are translated, you should verify the translation. For example, the Chatbot may have difficulty with acronyms, abbreviations, and nuances in a language other than English.

Privacy Program | Information Quality Guidelines | Accessibility