Global compliance in life sciences: Managing diverging risks, regulations and expectations

At a recent industry conference, Baker Tilly moderated a discussion with life sciences compliance leaders on one of the sector's most pressing challenges: how to build and maintain effective global compliance programs in an increasingly fragmented regulatory environment.

The conversation explored the realities of operating across regions with dramatically different regulatory expectations, cultural norms, enforcement environments, and emerging technology risks. Several key themes emerged throughout the discussion, including the importance of establishing strong ethical foundations, balancing global governance with local flexibility, managing growing data privacy obligations and preparing for the rapid adoption of artificial intelligence (AI).

A global industry operating under different rules

One of the most common themes throughout the discussion was that global compliance cannot rely on a single regulatory playbook. Significant differences exist in how regions approach core compliance topics, including promotional practices, medical affairs, sanctions, exports, third-party oversight and data privacy.

Even familiar compliance concepts do not translate cleanly across jurisdictions. Medical Affairs was identified as a particularly nuanced challenge in Europe, while Korea was highlighted for its highly intensive regulatory environment. Japan's healthcare landscape presents another unique model, where hybrid Medical Science Liaison (MSL) and sales roles create distinctions not commonly seen elsewhere.

Different regions also prioritize different risks. What may be considered high-risk activity in North America or Europe may receive far less scrutiny in Latin America or parts of APAC. These differences create a difficult reality for multinational organizations: Regulatory frameworks vary widely, but organizations are still expected to uphold consistent ethical standards globally.

Building a global ethical foundation

Despite the fragmentation in regulations, the importance of establishing a strong ethical foundation that applies across the enterprise remained a recurring theme. A common recommendation was to take a top-down approach by defining global ethical standards first and then operationalizing those standards regionally.

Global governance, however, cannot exist in isolation. Compliance leaders must maintain visibility into local realities and engage directly with regional teams. Being physically present or actively engaged with countries and business units was described as critical to understanding how regulations are interpreted and enforced on the ground.

This balance between centralized oversight and local flexibility was a central theme throughout the discussion.

Risk-based compliance requires regional context

At the global level, many organizations are taking a structured approach to compliance oversight that begins with assessing enterprise risk alongside executive leadership. Once those risks are identified, organizations can determine their tolerance and decide where additional controls or resources are necessary.

From there, global standards are developed to address enterprise-wide risks, while regional teams are responsible for addressing local nuances. The U.S. Department of Justice's Evaluation of Corporate Compliance Programs guidance was highlighted as a useful framework because it allows organizations to maintain consistency while still enabling regions to manage their own risks.

The discussion also emphasized the importance of using data to understand where specific regions may require additional support or oversight. Rather than training employees on every individual regulation globally, many organizations instead establish broad compliance principles centrally and rely on regional teams to implement and localize training requirements.

Third-party risk management was another major focus. Organizations must ensure employees and business partners understand the regional regulations that govern external relationships.

Data privacy: A global challenge with local interpretations

Data privacy emerged as one of the most complex topics facing global compliance teams. While organizations often treat data privacy as a single compliance category, motivations and expectations vary significantly by region.

In the European Union, privacy is often viewed as a fundamental right. In countries such as Russia, China and Germany, privacy frameworks may be more heavily influenced by anti-spying concerns and national security considerations. This creates operational complexity for organizations attempting to deploy global platforms or enterprise systems.

Organizations continue facing the challenge of complying with different privacy requirements across jurisdictions. The discussion also highlighted the practical difficulties associated with applying consistent privacy standards globally.

Some organizations choose to use GDPR as the baseline standard globally and then "walk down" protections where local regulations permit more flexibility. However, even that approach can become operationally burdensome because GDPR interpretations themselves vary across jurisdictions.

The discussion highlighted an ongoing tension within compliance organizations: while risk assessments may sometimes classify data privacy risks as relatively low, companies continue dedicating significant resources to privacy governance due to regulatory uncertainty and reputational concerns.

AI governance is moving faster than compliance programs

Artificial intelligence was consistently identified as one of the most significant emerging risks facing the life sciences industry. Organizations are still in the early stages of understanding how to govern AI effectively, particularly at a global scale.

Many organizations have limited visibility into how other regions are handling AI while also facing pressure to adopt emerging technologies quickly. At the same time, organizations are actively encouraging AI adoption while attempting to establish governance structures around it.

Governance committees, review processes and application oversight mechanisms are becoming more common, but the pace of AI development is creating substantial pressure on compliance teams. The discussion highlighted concerns surrounding data privacy, data inputs, outputs, algorithmic decision-making, and downstream usage of AI-generated information.

Some organizations may eventually require dedicated AI compliance officers as AI governance becomes more specialized. The conversation also underscored the growing importance of data quality and technical capabilities within compliance functions.

As organizations expand AI usage, data integrity and visibility become foundational requirements. If AI is going to be used effectively and responsibly, data quality is more important than ever.

Enforcement trends continue to diverge globally

The discussion also examined uneven regulatory enforcement trends across regions. Social media oversight was highlighted as a clear example.

In the UK, the Prescription Medicines Code of Practice Authority (PMCPA) was described as aggressively enforcing standards related to online interactions and promotional activity. Meanwhile, recent U.S. enforcement actions and regulatory letters related to social media suggest that enforcement priorities often shift alongside political and regulatory climates.

Monitoring enforcement trends globally is becoming increasingly important because regulatory priorities in one region frequently influence enforcement activity elsewhere. This creates additional complexity for multinational organizations attempting to standardize monitoring and oversight programs.

Balancing global standardization with regional autonomy

One of the most practical discussions centered around global systems, governance structures, and organizational resistance. Historically, many regions operated independently with their own processes and technologies.

Today, global compliance organizations are increasingly attempting to integrate regions into unified systems and governance frameworks. However, this often creates friction. Regional teams, particularly in APAC and Europe, may argue that their regulations are too specialized or complex for centralized governance models.

Cost considerations also play a significant role. Regional leaders may question why they should adopt expensive global platforms when local solutions are available at lower cost.

These concerns are legitimate and highlight the importance of balancing visibility with flexibility. Organizations must determine how much oversight is truly necessary while still allowing regions to manage their own operational realities.

Successful global programs depend heavily on collaboration and relationship-building. Executive sponsorship also remains essential. Organizations pursuing compliance transformation initiatives must clearly articulate the business value and consequences associated with those efforts.

The future of global compliance: More divergence ahead

When considering how global compliance programs may evolve over the next three years, one theme emerged consistently: organizations should expect greater fragmentation rather than increased harmonization.

Growing nationalism, weakening multilateral cooperation, and the emergence of competing regulatory frameworks may create environments where shared processes become more difficult to maintain.

This divergence is already visible in how different regions are responding to emerging risks, particularly AI. Some jurisdictions are moving aggressively to regulate new technologies, while others remain comparatively permissive.

Geopolitical tensions and concerns around data access and surveillance could further harden international boundaries. This may require organizations to rethink how they structure global compliance operations, manage vendors, and govern cross-border data.

Organizations may also need to rebuild certain internal capabilities rather than relying as heavily on shared global services.

What makes a strong regional compliance partner?

The discussion concluded with a focus on the relationship between global compliance teams and regional partners. Effective regional leaders play a critical role in helping global teams understand operational realities.

Regional teams should actively communicate local risks, regulatory challenges, and practical limitations. At the same time, global organizations should avoid overreaching and allow regions appropriate flexibility within broader ethical frameworks.

One example discussed was promotional risk. Promotional compliance may represent a high-risk area in North America and Europe, while being considered lower risk in Latin America or certain APAC markets. That does not mean lower-risk regions operate without standards. Rather, they may focus more heavily on maintaining ethical principles than managing extensive regulatory exposure.

Ultimately, successful global compliance programs depend on partnership, transparency, and adaptability. Global teams need visibility and assurance mechanisms. Regional teams need flexibility and representation. The organizations most likely to succeed will be those capable of balancing both.

Final takeaway

The life sciences industry is entering a period where global compliance programs must operate against a backdrop of increasing geopolitical fragmentation, rapidly evolving technology risks, and diverging regulatory expectations.

While organizations continue striving for harmonization, one message was clear throughout the discussion: rigid standardization is unlikely to succeed on its own. Instead, effective compliance programs will require strong ethical foundations, data-driven risk management, regional engagement and the agility to adapt as global frameworks continue to evolve.