Healthcare is one of the most highly regulated industries in the world—and for good reason. Patient safety, ethical engagement, and regulatory integrity are non-negotiable. Yet for pharma, biotech, and healthcare organizations, staying ahead of increasingly complex and evolving regulations is a constant challenge. Global frameworks, digital transformation, and cross-border operations mean compliance requirements are continually shifting, and even small missteps can carry significant consequences.
At Eunomia, we navigate these challenges daily with our pharma clients. The encouraging news? With the right combination of clear governance, practical processes, and a strong compliance culture, adherence to regulations can move from being a burden to a strategic advantage. Below, we highlight ten of the most pressing healthcare compliance challenges and offer practical approaches to address them.
1. Promotional Compliance & Material Review
Pharma promotional materials—whether digital, print, or in-person presentations—are under intense regulatory scrutiny. Every claim must be accurate, balanced, and backed by data, while also complying with codes such as ABPI in the UK and EFPIA in Europe. With fast-moving marketing demands, review teams are often stretched, increasing the risk of delays or, worse, non-compliant content reaching the market.
The Solution
Establish a structured material review (copy approval) process with clear roles and timelines. Use practical checklists to ensure claims are substantiated and references are appropriate. Leverage digital approval tools to streamline workflows, track version history, and maintain audit-ready records—reducing both risk and review bottlenecks.
2. HCP Engagement & Fair Market Value
Engaging healthcare professionals (HCPs) is essential for research, education, and patient care, but it carries significant compliance risk. Payments, honoraria, consultancy fees, and travel support must all be proportionate, transparent, and compliant with codes like ABPI and EFPIA. Without robust controls, even well-intentioned engagements can be viewed as inducements or create reputational damage.
The Solution
Develop clear policies for HCP interactions, anchored in documented Fair Market Value (FMV) benchmarks. Standardise contracting and approval processes, and ensure all transfers of value are transparently reported. Regular audits and training help reinforce consistency and demonstrate compliance to regulators and the public.
3. Clinical Trial Transparency
Clinical trials generate vital data, but incomplete or delayed disclosure undermines trust and can trigger regulatory penalties. Pharma companies face obligations to publish trial results, adverse events, and financial relationships with HCPs/HCOs across multiple jurisdictions. The complexity of different reporting systems and timelines often leads to inconsistencies or gaps.
The Solution
Implement centralized systems to manage trial data and disclosures, ensuring accuracy and consistency across regions. Establish clear internal accountabilities for reporting, and audit documentation regularly. Align processes with EFPIA, FDA, Sunshine Act, and local codes to build a transparent, trusted compliance framework.
4. Third-Party Risk Management
Pharma companies rely heavily on third parties—CROs, distributors, suppliers, and consultants—to deliver critical services. Yet, if these partners fail to meet compliance standards, the liability still sits with the sponsoring company. Risks include bribery, off-label promotion, data mishandling, or weak pharmacovigilance practices, any of which can cause regulatory and reputational fallout.
The Solution
Adopt a structured due diligence process before onboarding, supported by ongoing monitoring of third-party activities. Include compliance clauses in contracts, require certifications where relevant, and use technology platforms to track high-risk engagements. Regular assessments and audits help ensure partners operate to the same standards you uphold internally.
5. Patient Organization & Advocacy Support
Collaborations with patient organizations are vital for education, support, and raising disease awareness. However, funding or partnerships that are not managed transparently can be perceived as undue influence or hidden promotion. Regulators and the public increasingly expect full disclosure of industry support, and inconsistent practices can erode credibility.
The Solution
Create clear policies for supporting patient organizations, with documented objectives that are aligned to genuine patient benefit. Ensure funding is proportionate, transparent, and publicly disclosed in line with EFPIA and local codes. Maintain written agreements that define scope, independence, and reporting obligations to safeguard trust.
6. Anti-Bribery &Anti Corruption Controls
With frequent interactions between pharma companies, HCPs, and government officials, even small lapses can raise red flags under anti-bribery and anti-corruption (ABAC) laws. Global frameworks like the UK Bribery Act and FCPA impose strict requirements, and violations—whether intentional or not—can result in heavy fines and reputational harm.
The Solution
Implement robust ABAC policies backed by clear approval workflows for high-risk activities such as sponsorships, grants, and donations. Keep transparent records of all transfers of value, and provide regular, role-specific training so employees understand what’s permitted. Proactive monitoring and audits help identify risks before they escalate.
7. Cross-Border Compliance
Global pharma companies operate across multiple markets, each with its own regulations and industry codes. What is compliant in one country may breach the rules in another, creating complexity and inconsistency. This is particularly challenging for activities like HCP engagement, promotional materials, and transparency reporting, where local nuances matter.
The Solution
Develop a global compliance framework that sets consistent standards while allowing for local adaptation. Engage in-country compliance experts to interpret national codes and ensure alignment. Centralize reporting where possible to improve oversight, while empowering local teams to manage specific requirements effectively.
8. Patient Safety & Pharmacovigilance
Ensuring patient safety through timely detection and reporting of adverse events is a core compliance obligation. However, capturing accurate information across global markets, multiple partners, and diverse reporting systems is complex. Missed or delayed reporting can put patients at risk and lead to severe regulatory penalties.
The Solution
Establish robust pharmacovigilance systems with clear processes for collecting, monitoring, and escalating safety data. Train all staff and third parties to recognize and report adverse events promptly. Integrate safety reporting into broader compliance platforms to ensure traceability and audit readiness.
9. Documentation & Record-Keeping
Incomplete or inconsistent records are a common compliance pitfall in healthcare. Regulators expect audit-ready documentation for promotional activities, HCP interactions, clinical trials, and third-party agreements. Gaps or errors can lead to fines, delayed approvals, or reputational damage.
The Solution
Implement clear record-keeping policies and standardize documentation practices across teams. Use digital tools to automate retention, version control, and audit trails. Regularly review records to ensure completeness and accuracy, making compliance verifiable and efficient.
10. Training & Culture
Even the most robust policies fail if employees don’t understand or follow them. In pharma, gaps in knowledge around codes, HCP engagement, or adverse event reporting can lead to unintentional violations and regulatory scrutiny. Building a culture where compliance is part of daily decision-making is often easier said than done.
The Solution
Deliver regular, role-specific training that goes beyond tick-box exercises. Use scenario-based learning, quick reference guides, and mobile-accessible resources to reinforce practical application. Encourage open communication and a “speak-up” culture to embed compliance into everyday behaviors.
Final Thoughts
Healthcare compliance is not just a regulatory requirement—it’s a cornerstone of trust, patient safety, and ethical business practice. By proactively addressing challenges from promotional review and HCP engagement to pharmacovigilance, third-party oversight, and cross-border rules, pharma organizations can reduce risk while strengthening credibility with regulators, partners, and patients. The key is balance: combine clear policies, practical processes, and a culture of awareness to make compliance part of everyday operations. When compliance is treated as a strategic advantage rather than a burden, organizations can navigate complex regulations confidently and build lasting trust in an increasingly scrutinized industry.
