Strict management of interactions between healthcare industries and healthcare professionals is crucial to ensure transparency, ethics, and regulatory compliance.
At Universal Medica Group, we support you in managing your Compliance and Anti-Gift Law (LEA) obligations, ensuring legal security for your operations and protecting your reputation with health authorities and the public.
The Anti-Gift Law (LEA): What Is It?
The LEA, formerly known as the DMOS law (anti-gift law), strictly governs relationships between healthcare companies and healthcare professionals (HCPs), as well as certain associations, learned societies, and training organizations.
Main Obligations Under the LEA:
- Declaration or prior authorization required for certain benefits (invitations, payments, donations, etc.)
- Submission of contracts and agreements to the appropriate authorities (Medical Councils, Regional Health Agencies, etc.)
- Transparent disclosure of conflicts of interest on the government platform Transparence-Santé
- Strict adherence to financial thresholds and conditions governing the granted benefits
Why Is This Crucial?
Failure to comply with the LEA can result in significant financial penalties, legal action, and serious reputational damage.
Looking for optimal compliance and transparency?
Get expert advice from UNIVERSAL MEDICA GROUP.
Our Expertise in Compliance and LEA Management
We support you at every step to ensure compliant interactions with healthcare professionals and protect your reputation.
Management of Declarations and Authorization Requests
- Identification of activities requiring prior declaration or authorization (events, agreements, contracts, etc.)
- Preparation and submission of authorization requests to competent authorities (Medical Councils, Regional Health Agencies, etc.)
- Drafting and reviewing contracts and agreements according to legal obligations
- Management of regulatory deadlines and validation tracking
Illustrative example: Our experts manage over 2,000 submissions annually, ensuring smooth and compliant processes for our clients.
Disclosure of Conflicts of Interest on the Transparence-Santé Platform
- Collection and verification of data to be reported
- Preparation and submission of biannual files (S1 and S2) as required by law
- Rigorous quality control of published information to avoid any errors that could damage your reputation
- Proactive handling of corrections and follow-up requests from authorities
Key Figures
records published each year
events reported
simplified events handled
Drafting and Compliance of Your Internal Procedures
- Development of procedures and standard operating processes in compliance with LEA regulations
- Support in implementing internal control processes to regulate commercial practices
- Ensuring team compliance through dedicated training sessions
Why is this important? Clear and well-defined procedures help prevent errors and ensure efficient management of LEA obligations.
Strategic Compliance Consulting and Support
- Assessment of internal practices and recommendations for compliance improvement
- Legal and strategic guidance on interactions with healthcare professionals
- Implementation of a risk management plan in case of non-compliance
- Support during audits or inspections conducted by health authorities
Our added value: Our experts provide actionable and tailored advice to shield your organization from compliance risks.
Training Teams on Compliance and LEA Challenges
- Training sessions on LEA-related obligations and transparency requirements
- Team awareness on best practices for interactions with healthcare professionals
Our EuroAcademy platform offers dedicated training modules to help your teams master LEA compliance requirements.
Why Choose Universal Medica Group for Your Compliance and LEA Management?
- Proven expertise in managing LEA and transparency reporting
- Specialists in compliance and healthcare regulatory affairs
- Tailored support adapted to your internal processes and operational challenges
- Proven tools and methodologies to ensure smooth and compliant management of your obligations
- A proactive approach to anticipate regulatory changes and prevent non-compliance
Universal Medica Group: Your Trusted Partner for Seamless Compliance
Compliance and Anti-Gift Law management is a strategic issue for healthcare industries.
With Universal Medica Group, benefit from expert and rigorous support to:
- Ensure compliance in your interactions with healthcare professionals
- Manage your regulatory obligations precisely and transparently
- Safeguard the trust of your partners and your reputation
Need assistance with Compliance and LEA management? Contact our experts today to explore our customized support solutions.
