As the life sciences industry sector is one of the most regulated industries in the world, FRA Life Sciences provides a broad set of services to help companies identify global compliance risk as well as develop practical, yet effective, solutions for operating under increasing scrutiny. Our expertise will help mitigate global compliance risk across multiple functional areas, including sales and marketing, medical affairs, research & development and instill any necessary change in a company’s compliance culture.
Global Compliance Program Strategy and Design
FRA Life Sciences has extensive experience working with both early and late stage companies in developing and/or expanding their global compliance programs. We understand that compliance touches all parts of the organization and work to have a dialogue to ensure buy-in with any changes a new program will have across the company. Some examples of our compliance program service offerings include:
- Compliance Program Framework Development and Expansion
FRA Life Sciences is an expert at advising start-up biotech and medical technology companies that are often staffed with business and science professionals during its early stage of development on how to develop an effective compliance program. We work hard with our clients to provide solutions to the following questions:
- How many people do we need and where should they be geographically located?
- What are the defined roles and responsibilities for our compliance resources?
- What type of background and expertise is required to fill open positions within the framework?
- What does a compliance program look like from an organizational structure perspective?
- How do we maximize functional efficiency and effectiveness while remaining within established budgets?
- What are the baseline elements of an effective compliance program and how do we implement them?
We also have vast amounts of experience working with mature life science companies who are looking to expand their compliance function globally. We can help companies identify regional/local laws and regulations which will guide the strategic approach for global expansion.
- Policy and Procedure Development
The creation and periodic updating of governance documents is an essential element of an effective compliance program. In addition, it is becoming more important to have these documents harmonized and located in a centralized repository which is easily accessible. We are experts at working with life sciences companies to develop documentation which addresses relevant external regulations, guidelines and laws. In addition, we can help with document retention solutions and the change management required to gain buy-in from key stakeholders across the organization.
- Regulatory Updates
In an ever-evolving industry, Life Science compliance professionals understand that regulations are in constant flux and cross geographic regions and functional areas. FRA Life Sciences advises our clients on when regulatory changes occur and can help conduct readiness assessments, provide strategic plans and update necessary documents and processes to ensure compliance with new or updated guidelines and laws across the globe.
Compliance Risk Assessments, Audits and Monitoring
FRA Life Sciences is highly experienced in the design and execution of effective risk assessments, audits and monitoring activities. Changing global regulatory requirements has led to difficulty managing compliance risk; however, an effective approach for identifying the risk is to conduct annual risk assessments, audits and monitoring exercises. These in turn will inform your training program, investigations function and remediation strategy.
Areas of focus for detecting and responding to potential non-compliant behavior include anti-bribery and corruption, FCPA, promotional practices, medical affairs activities, research and development, spend transparency and financial relationships with healthcare practitioners.
Specifically, FRA Life Sciences has extensive experience working with life science companies to fulfill their oversight obligations, as outlined below:
Risk Assessments – a high level assessment of compliance parameters across multiple risk areas allows companies to identify relative levels of risk. Adding in magnitude parameters enhances the assessment to provide perspective related to prioritization.
Compliance Audits – includes an assessment of what is actually occurring on a day-to-day basis versus what is supposed to be occurring based on internal and external guidelines, regulations and controls. Audit methodologies tend to include interviews of key stakeholders, transaction testing, systems reviews and policy and procedure review.
Compliance Monitoring – includes both transactional based monitoring as well as live field force monitoring through attendance at speaker programs, ridealongs, advisory boards, CME programs and other events. We have vast amounts of experience designing, managing and executing monitoring programs in the US and abroad.
Pre- and Post- Acquisition Due Diligence – as companies grow through product development or acquisitions, effective prioritization and allocation of resources are critical to maintaining a successful compliance program. FRA Life Sciences has vast amounts of expertise in conducting due diligence of targeted or recently acquired organizations to assess the level of risk that would be acquired as well. We have worked with a number of companies with the integration of policies, procedures, practices and resources between the two companies.
Anti-Bribery and Corruption/FCPA and Investigations
In addition to extensive experience aiding life sciences companies with their due diligence procedures, FRA boasts particular capabilities in conducing internal investigations, responding to government inquiries and testing compliance programs related to the US Foreign Corrupt Practices Act, the UK Bribery Act, and other anti-corruption laws. FRA Life Sciences has huge amounts of experience in a number of related areas, including:
- Data collection, mining, management, processing, hosting, analysis and transportation
- Forensic accounting, audits, reconciliations and due diligence reviews – including overseas subsidiaries, marketing agents, freight forwarders and joint venture partners
- Interviews – assisting external and in-house counsel with issue analysis, email review, interview planning and execution
- Profitability, benefit and disgorgement calculation and analysis
- Pricing reviews
Global Spend Transparency Assessments and Solutions
The expanding global regulations and industry codes related to disclosing transfers of value between life science companies and Healthcare Professionals and Organizations/Institutions (HCP/O/Is) are evolving rapidly. There are many considerations related to the constant changes to the regulations and codes, which are only compounded when scaling solutions globally. For example, considerations related to variations in requirements and interpretations, legal and compliance frameworks, technology solutions and processes, and overall culture of those responsible for reporting as well as those responsible for capturing the data.
FRA Life Sciences has assisted life sciences companies with all aspects of Spend Disclosure, Transparency, and Aggregate Spend matters related to addressing state and federal Sunshine Act requirements to large global spend transparency solutions. Our approach is strategic and customized to to each company’s systems, processes, structure and culture.
Our approach to Spend Transparency encompasses the entire lifecycle, including the following services:
- Define and assess elements of international Spend Transparency requirements, including scope, time line, penalties, and country-specific considerations
- Identify relevant spend activities, systems, and resources for each global affiliate
- Assess the current state and the company’s readiness to meet global and local requirements
- Develop a practical, actionable and prioritized strategic roadmap for addressing any identified gaps through actions necessary to prepare for compliance
- Implement certain actions on the developed roadmap through the coordinated efforts of global teams which can include legal, IT, finance, R&D, commercial operations and compliance
- Complete vendor assessment of available technology resources to fulfill gaps and needs
- Implement and project manage spend transparency solutions
- Develop and implement a change management and communications framework
- Develop and implement Spend Transparency data analytic, dashboarding and visualization tool
Corporate Integrity Agreement (CIA)/Independent Review Organization (IRO)
FRA Life Sciences has significant experience providing CIA related services for life sciences companies, with a proven track record of working cooperatively with both our clients and the OIG to accomplish the goals of the CIA. We are very familiar with the ever-changing regulatory environment, government enforcement initiatives and the complex set of laws and regulations that govern life science organizations.
This deep knowledge enables us to effectively assist organizations through the provision of the following services:
- IRO Services – FRA Life Sciences resources have worked and led numerous IRO engagements for companies operating under a CIA and has developed and implemented a large number of IRO work plans for conducting the requisite systems and transactional reviews related to the processes, policies and practices encompassed in the CIAs. IRO engagements can be intrusive and time consuming; we understand the importance of constant communication with our client to ensure efficiency and cooperative understanding of our approach and outcomes. We can conduct these types of engagements as an actual IRO or can do a Mock IRO to ensure readiness prior to the IRO conducting their assessment.
- CIA Advisory Services – FRA Life Sciences brings vast experience in the compliance and legal space, providing us with insight and credibility when assisting clients with discussions with the OIG when negotiating their CIAs. Working with clients and external counsel, we can identify the key areas of interest for regulators and harmonize them with the overall CIA negotiation strategy. In addition, we works with our clients to conduct readiness assessments for complying with their CIA requirements. We take a look at this readiness from a resource, systems and documentation perspective to ensure our client is able to address the requirements related to covered persons, certifications, policies and procedures, monitoring requirements, training programs and certifications.
Fair Market Value (FMV)
Government regulators are currently shifting focus to kickbacks and fraudulent payments from life sciences companies to the healthcare community. In the US, these regulators are looking towards the Anti-Kickback Statute and FCPA as the standards for ensuring members of the healthcare community are remaining independent in the treatment of patients and that life sciences companies are not having undue influence over items such as prescribing habits. Global scrutiny around spend transparency is another regulation/guideline which affects the monetary and contractual arrangements between life sciences companies and the medical community.
The establishment of fair market value rates for payments to HCPs and healthcare organizations is one control that ensures that erroneous payments are not made which may represent a conflict of interest, or may jeopardize the independence of the medical community. These rates must be based on a reasonable methodology, taking into account things such as compensation surveys, travel, HCP expertise and KOL status, specialty area and geographic area.
FRA Life Sciences is experienced in working with clients to address all FMV needs. Our services include the following:
- FMV Methodology development and documentation
- FMV Rate Development
- KOL Scoring and Tiering
- Change Management to gain buy in from the business and customers