Regulatory Compliance Checklist for Pharmaceutical Industry in Sweden
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As the pharmaceutical industry continues to evolve, it’s essential for companies operating in Sweden to stay up-to-date with regulatory requirements. In this article, we’ll provide an overview of the key regulations and guidelines that pharmaceutical companies must adhere to when interacting with healthcare professionals (HCPs) in Sweden.
Relevant Statutory Law
While there is no specific law regulating interactions between pharmaceutical companies and HCPs in Sweden, general rules on anti-bribery are outlined in the Swedish Penal Code. Additionally, the non-profit organization, Swedish Anti-Corruption Institute (IMM), has issued a self-regulation code to prevent corruption in business.
Industry Codes of Conduct
Members of the trade association Läkemedelsindustriföreningen (LIF) must adhere to the Ethical Rules for the Pharmaceutical Industry. These rules provide guidelines on ethical behavior and interactions with HCPs, including restrictions on event locations, venues, accommodation, travel, meals, and more.
Key Guidelines
- Event locations: Choose reasonable venues that align with the purpose of the meeting.
- Accommodation: Prohibited for HCPs practicing in Sweden attending events. May be provided to HCPs engaged as consultants if required for their consultancy assignment.
- Travel: Economy class air travel should be selected unless there are justified exceptions.
- Meals and Refreshments: A moderate meal may be provided in connection with the meeting, but no more specific rules apply.
- Family Members: Under the Ethical Rules for the Pharmaceutical Industry, family members may not be invited to events or paid for unless invited in their own righteous capacity.
Competent Authorities
The Compliance Officer of LIF, the Swedish Pharmaceutical Industry’s Information Examiner Committee (IGN), and the Information Practices Committee (NBL) are responsible for enforcing compliance with industry codes of conduct. Public prosecutors may also be involved in matters related to anti-bribery.
Event Locations
- Avoiding winter sport locations during ski season and major international events is recommended.
- No meals are allowed at online events, and certain rules regarding invitations to online events that are advertised openly apply.
Conclusion
By understanding these regulatory requirements, pharmaceutical companies operating in Sweden can ensure compliance and maintain ethical relationships with HCPs.