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Agreements with Healthcare Professionals – Compliance Considerations

Pharmaceutical companies are subject to regulations related to their interactions with Healthcare Professionals (HCPs), which include requirements for transparency, anti-bribery, and codes of conduct, as well as compliance programs. These regulations are particularly important when it comes to agreements with HCPs, which are common in the pharmaceutical industry and may include consulting arrangements, speaking engagements, research collaborations, or other types of professional services.

To ensure compliance, companies must structure these agreements to avoid conflicts of interest and not influence prescribing decisions. In addition, companies must disclose any value transferred to HCPs, as required by regulations in many countries, which are typically made publicly available on a government database.

Here are some key considerations when entering into agreements with HCPs:

Legitimate Services: Any agreement with a healthcare professional must be based on legitimate services provided by the healthcare professional. The services should be necessary and provide value to the company. The agreement should clearly outline the scope of services, the deliverables, and the compensation.

Fair Market Value: The compensation provided to the healthcare professional must be at fair market value for the services provided. The company should have a process in place to determine fair market value and document the rationale for the compensation offered.

Compliance with Anti-Kickback Statute: Any payments or other benefits provided to HCPs must not be in exchange for the referral of patients or the purchase of healthcare products. These payments must be structured to comply with the Anti-Kickback Statute and other applicable local laws and regulations.

Transparency: Any payments or other transfers of value to HCPs must be disclosed to the appropriate authorities and made publicly available where required. Companies must have processes in place to track and report these payments accurately.

Independent Medical Judgment: Any agreement with a healthcare professional must not interfere with the healthcare professional’s independent medical judgment. The agreement should contain a clause stating that the healthcare professional will make decisions based on the best interests of patients.

Written Agreements: Any agreement with a healthcare professional should be in writing and clearly outline the terms and conditions of the agreement. The agreement should also include a termination clause that allows either party to terminate the agreement for cause or without cause.

Summary

Pharmaceutical companies need to be diligent in ensuring that their interactions with HCPs, including HCP agreements, are transparent, ethical, and compliant with all applicable international and country-level laws and regulations. They must ensure that services provided are legitimate, compensation is at fair market value, and agreements do not interfere with HCPs’ independent medical judgment. Additionally, companies need to have processes in place to track and report any payments or transfers of value to HCPs. Failure to comply with these regulations can result in significant legal and financial penalties, as well as damage to the company’s reputation.

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