Life Sciences

Healthcare and Life Sciences organizations operate in a highly regulated and rapidly evolving environment, shaped by changing business models, disruptive technologies, growing data volumes, and increasing ESG expectations. At the same time, they must demonstrate the value of their innovations while navigating complex regulatory and market challenges.

Our multidisciplinary team supports pharmaceutical, Biotech, MedTech, and Life Sciences service companies throughout their growth journey. In Belgium, more than 60 dedicated specialists across Audit, Tax & Legal, and Advisory combine deep industry expertise with a strong understanding of emerging trends and market developments.

We help organizations address key challenges, including funding, regulatory compliance, ESG strategy, operational and supply chain transformation, digitalization, transactions, and commercialization. Our Belgian team is backed by a global network of over 4,500 Life Sciences professionals, providing access to international experience and leading practices to help clients innovate, grow, and succeed in a constantly changing environment.

Koen Van Ende

Head of Life Sciences, Partner, Corporate Tax | Tax, Legal & Accountancy

KPMG in Belgium

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Challenges & trends

Shifts within the R&D ecosystem

Shifts within the Research & Development (R&D) ecosystem are driven by eroding margins and the pressure to de-risk R&D, the move towards personalized solutions, the shift from treatment to prevention and cure, as well as the wealth of new scientific and technological innovations.

Rapidly Changing Tax environment

International developments like the introduction of the global minimum tax may have a substantial impact on the group effective tax rate and will add an additional layer of complexity to tax compliance obligations. This changing environment drives Life Sciences groups to reconsider existing tax policies and take appropriate actions to safeguard an efficient and responsible tax setup.

Significant disruptions within the Supply Chain

The future of the supply chain in the Life Sciences sector is being disrupted to fit new business models, technologies, and regulatory shifts. Companies will see significant disruption as they shift towards customer-centric offerings with demand-driven, automated networks, underpinned by digital platforms and technologies.

Focus on personalized and patient centric solutions

The focus on niche patient pools and specialty disease drugs continues to increase while personalized and precision medicine is a reality. This impacts business models and how to operate across the value chain.

Complex regulatory requirements and compliance rules

The Life Sciences industry faces an ever-changing regulatory environment. Balancing the desire to innovate and to achieve business goals while being compliant and mitigating compliance risks are some of the most challenging tasks.

Disruptive technological innovations

The adoption of disruptive digital technologies to automate and to optimize the potential of data is critical given the pressure to look for performance and cost reduction opportunities. On the other hand, technology players enter the healthcare space at a growing pace.

The importance of ESG goals

Long-term sustainability has recently become part of everyone’s agenda, but expertise is crucial. Regulations like the EU’s Corporate Sustainability Reporting Directive (CSRD) come with its own implications and challenges for the Life Sciences industry. Key trends gaining saliency within this industry include diversity, equity and inclusion, access to medicine, pandemics, decarbonization, biodiversity, water management, and circular economy.

Key services in the Life Sciences sector

We have a core team of Life Sciences specialists in Belgium across Audit, Tax & Legal, and Advisory. We are strongly connected within Belgium and internationally, sharing regular insights on trends, drivers and key issues.

KPMG supports Life Sciences companies on their transformation journey, leveraging data and analytics for better decisions and agile operations. Services include finance transformation, improving financial performance, guiding through procurement and supply chain challenges, implementing enterprise-wide solutions, and establishing cybersecurity strategies.

Optimizing operations

Our team of experts assists Life Sciences companies in applying various existing incentives, including R&D tax incentives, in a combined, coherent, and sustainable manner. These incentives can significantly impact the company's overall financial position. Given the strict and formalistic approach taken by tax authorities when auditing (R&D) tax incentives, successful application depends on robust and coherent documentation, which our specialists can prepare.

Our Grants & Incentives Practice assists Life Sciences companies in securing funding for R&D, sustainable investments, and business transformation.

Tax incentives, grants & subsidies

When it comes to defining an IP strategy, the tax implications of certain decisions should be carefully considered, aligned with business operations, and supported by a robust governance model. The registration of intellectual property is also of key importance for access to certain tax incentives, including the choice of IP protection.

Our team can assist you with the setup of an appropriate and sustainable transfer pricing policy, which is aligned with both the strategic objectives of the group and the operational reality of the business model from a global perspective. Our team also has valuable experience in obtaining advance tax rulings to provide upfront certainty on the application and amount of tax incentives applied, as well as Advance Pricing Arrangements (APAs) for cross-border certainty on transfer pricing policies on key controlled transactions.

IP strategy & transfer pricing

We guide our Life Sciences clients through the ESG lifecycle: strategy design, operational systems setup, and non-financial reporting. ESG is pivotal for investors, customers, and regulators. Our team integrates sustainability into business strategy, leveraging specific expertise and experience tailored to the unique and diverse needs of the sector.

ESG topics

Life Sciences companies work with a variety of third parties such as CROs, CDMOs, distributors, advisors, and many more. Without a holistic, technology-enabled oversight program on third parties, those relationships can become a weak link. We support companies in understanding the organizational risks presented by third parties, assess whether they can effectively manage those risks as needed, and establish consistent third-party oversight and monitoring.

Managing risk and compliance

The search for next generation therapies, coupled with declining R&D returns, means companies seek to acquire innovation through external deals. At KPMG, we support valuation exercises and M&A transactions, and we have developed in-depth integration and carve-out expertise over the years within the Life Sciences industry.

Enabling successful portfolio optimization

To make the difference, the auditor’s judgments must be rooted in an in-depth understanding of each client’s industry value drivers, competitive positioning, and marketplace practice. Our audit teams have the knowledge, experience, and skills in the Life Sciences sector to go beyond audit and provide relevant insights to bring your finance team to the next level.

Audit

We advise Life Sciences clients on a broad spectrum of issues as well as through the following integrated solutions

We believe the future enterprise will be “Connected. Powered. Trusted. Elevated.” It is our definition of a digitally transformed organization. One that is connected, aligned, and engineered around the customer. One that is powered by modern technology and agile business practices. One that is trusted by all its stakeholders, from customers, employees and suppliers to investors and regulators. One that can elevate and is empowered to prioritize and deliver value confidently.

KPMG Connected Enterprise is our framework and approach for enabling customer-centric, end-to-end digital transformation that meets the wide variety of challenges the Biopharmaceutical, MedTech, Biotech, and Pharmaceutical service companies are facing. A future-ready, connected Life Sciences company will have the capabilities to quickly respond to new data and market signals. KPMG Connected Enterprise focuses every critical process, function, and relationship of a business on meeting customer expectations, creating business value and driving sustainable growth in a digital world. KPMG Connected Enterprise for Life Sciences is an insight-led, customer-centric, enterprise-wide approach to digital transformation.

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KPMG Powered Enterprise is an outcome-driven, functional transformation solution that combines deep business and industry knowledge, global and local delivery capability, and market-leading cloud technologies. It helps drive sustainable change, improving performance and providing lasting value for your business, while delivering on your business strategy. It is an integrated, market-leading solution that transforms business functions including marketing, sales & service, commerce, supply chain management, procurement, finance, human resources, IT, enterprise service management, cyber, and risk.

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The Trusted imperative embraces and represents the entire estate of KPMG firms’ capabilities in cybersecurity, risk, and regulation. It also asserts an enabling, multiplying role for Trusted thinking in digital acceleration and transformation. We believe trust is the ultimate business enabler: growth, performance, efficiency, and innovation are all fueled and facilitated by the confidence that people have in an enterprise.

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KPMG Elevate identifies and quantifies value-creation opportunities. We help businesses target and capture value using a data-driven approach – confidently helping to achieve measurable improvements to increase profitability and performance. We focus on what needs to change for an organization to become a successful, modern, high-performing business.

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Life Sciences insights

The latest need-to-know information on the Life Sciences sector.

Life Sciences

Koen Van Ende