Saturday, 17 October 2026

Transfer Pricing in the Pharmaceutical Industry: New Challenges in Light of Evolving Regulations

Transfer pricing has long been a key area of focus for pharmaceutical companies, but an increasingly demanding regulatory environment is creating new compliance challenges.

Transfer Pricing in the Pharmaceutical Industry: New Challenges in Light of Evolving Regulations


Unique transfer pricing challenges in the pharmaceutical industry

 

Determining arm’s-length pricing for transactions between related parties is particularly complex in this sector due to research and development activities, intellectual property and licensing arrangements, manufacturing and contract manufacturing models, as well as international distribution structures.


Transfer Pricing Gets More Complex: New Segmentation Requirements


One of the most significant changes under the transfer pricing rules that become mandatory from 2026 is the tightening of segmentation requirements. Companies will be expected to track revenues, costs, and profits attributable to individual related-party transactions with a level of detail sufficient to support comparability analyses and transfer pricing positions.


For pharmaceutical businesses, this can be especially challenging. A single entity often performs multiple functions simultaneously, such as sales and marketing activities, clinical or R&D services, manufacturing and packaging operations, the distribution of licensed products, or acting as a regional shared service center. Because these activities involve different functions, risks, and expected returns, they cannot automatically be treated as a single profit pool for transfer pricing purposes. The new regulations clearly move toward a transaction-level or activity-level approach.


Benchmarking Difficulties in the Pharmaceutical Sector


An additional challenge arises from the global nature of the pharmaceutical industry. Multinational groups frequently carry out similar transactions across several jurisdictions, while significant differences may exist in product portfolios, business models, functional profiles, competitive environments, and economic conditions. These factors must be considered when establishing transfer prices and assessing comparability, and appropriate adjustments may be required where necessary.


The Transfer Pricing Team at LeitnerLeitner can serve as a trusted partner in this area. Our professionals have extensive experience in both transfer pricing advisory projects and tax authority audits across multiple jurisdictions. Rather than producing transfer pricing documentation as a routine exercise, we take a holistic approach, reviewing clients’ overall transfer pricing framework and highlighting the broader accounting, tax, and business implications that may arise.


Segmentation, Benchmarking, and Documentation: Three Components of One Transfer Pricing Process


In practice, many companies still focus primarily on business operations throughout the year and address transfer pricing compliance only during the year-end closing process. However, this approach is becoming increasingly risky. The key components of a transfer pricing framework are closely interconnected: pricing policies, segmented financial tracking, benchmarking analyses, and transfer pricing documentation all form part of the same process.


If these tasks are postponed until the end of the financial year, companies often discover too late that the necessary information is not available at the required level of detail, that cost allocations rely on retrospective estimates, or that existing systems cannot reliably separate the results of individual transactions. Such shortcomings can become particularly problematic during a tax audit.


The Way Forward: Embedding Transfer Pricing into Daily Operations


The most effective approach is to integrate transfer pricing into day-to-day business processes rather than treating it as a standalone compliance exercise. Related-party pricing should ideally be established at the outset of transactions and supported by appropriate benchmarking analyses. Likewise, segmentation principles should be built into accounting and controlling processes, while cost allocation methodologies should be properly documented and consistently applied.


Under such a framework, transfer pricing documentation becomes the natural outcome of a well-designed process rather than a year-end fire drill. This not only reduces compliance risks but also improves the quality of documentation, the reliability of benchmarking analyses, and the consistency of reporting provided to tax authorities.


Given the complexity of pharmaceutical business models and multinational corporate structures, transfer pricing compliance requires considerable expertise. For this reason, many companies may benefit from engaging experienced advisors to support part or all of their transfer pricing obligations.


Transfer Pricing Remains a Perennial Issue in the Pharmaceutical Industry – New Challenges In Light of the New Regulations