Promotion of Prescription Medicines

The following are examples of key regulatory agencies and do not necessarily reflect all existing regulations.

1. FDA

The U.S. Food and Drug Administration regulates prescription drug promotion to ensure that advertisements are not false or misleading and that they provide a fair balance of information about the benefits and risks. Since the FDA is one of the leading regulatory bodies aiming to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, its policies and regulations are widely referenced by other codes and regulatory frameworks.

2. EMA

The European Medicines Agency regulates promotional activities similarly, with a strong focus on the accuracy of information and prohibiting the promotion of prescription-only medicines to the general public.

3. MHRA

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices, and blood components for transfusion in the UK. The MHRA is an executive agency, sponsored by the Department of Health and Social Care.

Data Privacy

The following are examples and do not necessarily reflect all existing regulations and requirements.

• The Health Insurance Portability and Accountability Act (HIPAA) in the U.S. sets national standards for the protection of individually identifiable health information.

• The General Data Protection Regulation (GDPR) provides comprehensive data protection and privacy rules in Europe, including for medical and health-related information.

Key Considerations

• Legitimacy of Intent: Data collection and processing must have a clear, lawful purpose, such as improving patient care or conducting legitimate medical research.
• Conflicts of Interest: Data privacy practices should avoid conflicts that could compromise the integrity or security of patient information.
• Proportionality: Data collection should be limited to what is necessary for the intended purpose.
• Transparency: Patients must be informed about how their data will be used, and consent must be obtained where required.
• Protection of data and subjects’ rights: Ensure that subjects have the right of access to their data, the right to rectification, the right to erasure, the right to restrict processing, the right to data portability, the right to object, and the right not to be subject to a decision based solely on automated processing. Companies should have procedures on breach notification and a privacy policy in place.

Anti-Bribery and Anti-Corruption Measures

The following are examples and do not necessarily reflect all existing regulations and requirements.

1. The Foreign Corrupt Practices Act (FCPA) in the U.S., prohibits bribery of foreign officials and mandates accurate record-keeping.
2. The UK Bribery Act includes provisions against bribery in both the public and private sectors, imposing strict penalties for violations.

Key Considerations

• Legitimacy of Intent: Interactions between Medical Affairs staff and HCPs and officials must be for legitimate purposes, such as scientific exchange or medical education, and not for influencing purchasing decisions.
• Conflicts of Interest: Relationships between pharmaceutical companies and HCPs must be managed to avoid any actual or perceived conflicts of interest. Ensure that hospitality or other benefits (sometimes referred to as inducements) do not create conflicts of interest.
• Proportionality: Any financial support or benefits provided must be reasonable and not excessive.
• Transparency: Full disclosure of all payments, sponsorships, and benefits to HCPs and institutions is required to avoid any perception of impropriety.

Specific Requirements for Medical Affairs

The following are examples and do not necessarily reflect all existing Medical Affairs requirements.

1. Continuing Medical Education (CME):

• The Accreditation Council for Continuing Medical Education (ACCME) sets standards for the independence of CME activities in the U.S., requiring that these are free from commercial bias.
• Good CME Practice (gCMEp) ensures that CME activities in Europe are independent, evidence-based, and designed to improve medical practice.
• Education activities that are not considered CME (e.g., HCPs providing educational content, unaccredited education programs, grants, sponsorships, patient education programs) are governed by the codes of practice and other regulations.

2. Scientific Exchange:
Medical Affairs teams are often involved in scientific exchange activities, which must be clearly differentiated from promotional activities and adhere to guidelines ensuring that they are nonpromotional, evidence-based, and conducted with scientific rigour.

3. Scientific Publications:
The International Committee of Medical Journal Editors (ICMJE) has established standards for the conduct, reporting, editing, and publication of scholarly work in medical journals. The ICMJE expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding aggregate clinical trial results.

4. Research Activities:
GxP is a collection of quality Good Practice guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during clinical development, manufacturing, storage, and distribution. GxP includes Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP).