Overview

Belgium is the fourth-largest exporter of pharmaceutical goods in the world, behind Germany, Switzerland, and the United States; a major pharma transportation and manufacturing hub; and an important market for innovative U.S. companies looking for opportunities in research and development (R&D), biotechnology, and clinical trials.

Belgium holds a strong global position in every essential aspect of the biopharmaceutical value chain – from research and development and clinical trials to production, logistics, and international trade. This is thanks to the country’s well-developed ecosystem for research and production, a strong regulatory and transportation infrastructure, a highly skilled workforce, and robust collaboration between its public authorities and research centers. Belgium’s pharmaceutical industry employs more than 30,000 people, and every year the industry spends $1.64 billion (€1.5 billion) on R&D – the equivalent to 40 percent of all private investment made in Belgium. As a result, Belgium is home to 29 of the world’s top-30 pharmaceutical companies including important subsidiaries of major U.S. companies such as Johnson and Johnson and Pfizer. 

The United States is its number-one trading partner for these medicinal and pharmaceutical products. According to Eurostat, in 2022, amongst the European Union (EU) Member States, Belgium had the second-highest dollar amount of medicinal and pharmaceutical product exports behind Germany. In the same year, Belgium was the EU’s largest importer of medicinal and pharmaceutical products, followed by Germany and the Netherlands (€18 billion). According to Eurostat, the main destination of Belgium’s extra-EU exports of medicinal and pharmaceutical products in 2022 was the United States, accounting for over 50 percent of Belgium’s exports, followed at a distance by Japan (22.8 percent), the United Kingdom (16.1 percent), China and Switzerland (both 4.5 percent), and Singapore (1.1 percent). Imports of these products to Belgium came mainly from the United States, accounting for over 43 percent of all Belgium imports of these products, then Switzerland (40.1 percent), United Kingdom (7.5 percent), Singapore (4.6 percent), China (2.9 percent), and Japan (1.3 percent).

Table: Belgium Market Size – Medicinal & Pharmaceutical Products

(Total market size = (total local production + imports) - exports)

Sources: Eurostat for Production and Trade data. U.S. Internal Revenue Service (IRS) for exchange rates. Statista for 2023 projected growth rate.

Notes:  Dutch and Belgian imports can be overestimated due to the so-called “Rotterdam-Antwerp Effect” which describes distortions in official trade statistics due to misreporting of commodities passing through major world ports in route to their destination. Production numbers are for “Manufacture of Chemicals & Chemical Products; Basic Pharmaceutical Products & Pharmaceutical Preparations”. Export and import numbers include Luxembourg. Indicated exchange rates are the IRS “Average Exchange Rates for Converting Foreign Currencies into U.S. Dollars”. he 2023 estimated exchange rate based on European Central Bank’s rate on August 8, 2023. 2023 projection based on an annual growth rate (CAGR 2023-2028) of 6.22% from Statista.

Sector Developments

Industry has raised concerns regarding Belgium’s reimbursement process. 

While Belgium plays a pioneering role in the development and production of innovative medicines, this does not necessarily translate into rapid availability of these innovations for patients. According to a study based on data collected by the European Sector Federation EFPIA, less than half of the medicines that received authorization between 2016 and 2019 were available to Belgian patients by 2020, in line with the European average, while only 38 percent of medicines for the treatment of rare diseases were reimbursed by 2020 in Belgium, well below the European average. Industry representatives have confirmed that the reimbursement process not only takes too long in Belgium, but that the willingness to pay for reimbursements is also lower compared to other European countries. With Belgium’s current budget reflecting a deficit of 4.7 percent for 2023, ranking the second highest in the Eurozone, the government is limited in its ability to increase the budget for reimbursements. Moreover, industry representatives relay that there is limited political support to increase the federal budget for reimbursements because the division of competences between the federal ministry of health – responsible for treatment of illness – and the regional ministries of health – responsible for preventative care – makes federal support for preventative health medications a cost rather than as a cost-saving measure. According to industry, the aggregation of health data could offer a solution to this problem and help companies and governments to assess the value of pharmaceutical products. 

Belgium is taking steps to facilitate access to health data and health related data.

Health data in Belgium is scattered across hospitals and health insurance funds that are reluctant to share their data as there is still a strong historical division and competition between the Catholic and Secular institutions. Industry representatives underscore that Belgium risks losing its competitive advantage to the Netherlands and Scandinavian countries where such a health register is available. To address this issue, in March 2023, Belgium’s Federal Chamber of Representatives adopted a law instituting the Healthcare Data Agency (HDA). The HDA is a new autonomous administrative agency within the Federal Public Service Public Health. The main purpose of the HDA is to facilitate the access to health data and health related data in a simplified and reliable manner and facilitate the re-use of such data. There is still much to be determined regarding the implementation of the law – most importantly ensuring compliance with the EU General Data Protection Regulation (GDPR).

New EU pharma reforms aim to improve access to medicines and cut down market exclusivity.

In April 2023, the European Commission’s (EC) unveiled long-anticipated pharma reform plans with a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections. Notably, this includes the reduction of regulatory data protection from eight years to six as well as a set of incentives. Companies would receive a patent extension of additional two years if their products are launched across all the EU’s member states. The incentive for launching new products across the EU comes at a time when disparity in access to medicines and broader health inequality across different EU member states continues to be highlighted. Industry representatives have expressed concern that this legislation could hamper Belgium’s current strong and favorable intellectual property regulation.

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.

In 2021, Belgium spent €5.2 billion on R&D, an increase of 35.1 percent compared to 2019. 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 on 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 300 life sciences companies with biotech activities.

In total, Belgium’s life sciences sector employs more than 30,000 people and the healthcare sector represents 80 percent of total biotech activity. It covers various areas:  the design and development of new drugs, the preparation of drugs for use, production, distribution, and marketing. Other companies are active in the so-called platform technologies, which support design and development, while others are active in the medical diagnostics sector. Finally, there are service companies that focus on bio-information technology and the protection of intellectual property rights for biotechnological discoveries.

Biotech companies in Belgium have access to more than 500,000 square feet of highly flexible infrastructure including eight universities, 19 research parks, 23 incubators, and numerous research institutes, academic hospitals, and clinical research organizations. In Flanders, the biotech sector and its research centers are concentrated in Ghent and Leuven.  One of the main drivers of research in Flanders is the uniquely structured Flanders Interuniversity Institute for Biotechnology (VIB), in which 1,000 scientists are engaged in both basic and applied research. Flanders’ Biovalley is situated around Ghent Harbor and focuses on biofuels and bio-enzymes. Wallonia has biotech centers in Liege, Mons, Ottignies, Charleroi, Namur, and Gembloux. BioWin is the Health Cluster of Wallonia, the regional reference for all stakeholders in health biotech and medtech research and innovation projects. Lifetech Brussels has established tailor-made services to facilitate the creation and development of biotech and healthcare companies. The Brussels Life Science Incubator (BLSI) promotes scientific research, specifically in life sciences and healthcare. Most of the projects supported are in e-health, medical devices, and biotechnology.

Clinical Trials: the number of clinical trial applications approved in Belgium has grown steadily.

Clinical trials increased from 506 in 2016 to 574 in 2021. 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 new 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.

On January 31 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  

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. The U.S. Commercial Service in Brussels can advise U.S. companies on finding local partners.  

Resources

• Belgium Ministry of Health
• Federal Public Service Public 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, contact Commercial Specialist Danny Dumon in Belgium at danny.dumon@trade.gov.