In August 2021, Oregon Senate Bill 763 was signed into state law, mandating that no person may engage in business as a pharmaceutical representative in the state without obtaining license from the Department of Consumer and Business Services (DCBS). DCBS is implementing SB 763 in a two-prong approach. The first, a temporary rule finalized on December 20, implements the licensure requirement, outlines the application procedure, and requires applicants to commit to obtaining 15 hours of continuing education in 2022. Concurrently, DCBS is debating a proposed permanent rule, anticipated for finalization in May 2022, governing long-term implementation of SB 763.
Who has to obtain a license?
The law requires licensure of “pharmaceutical representatives,” defined as an individual who “markets or promotes pharmaceutical products to health care providers” (HCPs) for 15 or more days per year. In public debates on the proposed rules, DCBS stated it did not view this definition to include medical science liaisons (MSLs) or market access personnel. In response to industry requests for clarification, DCBS is considering further clarifying the scope of the licensure requirement in the permanent rule.
What are the requirements to obtain or maintain licensure?
- Submit an application for licensure along with a $750 fee. Tutorials on the application process are available online here, and applications must be submitted via the NIPR website online here.
- Licensees applying before July 2022 must commit to obtaining 15 hours of continuing education credits in 2022. These continuing education credits must be provided by entities registered as education providers with the National Insurance Producer Registry (NIPR) and cannot be provided by a licensee’s employer. For this initial year, DCBS has indicated it will accept credits for courses approved under Chicago’s similar ordinance. After July 2022, applicants will have to comply with the continuing education requirements to be implemented under the permanent rule.
- Beginning in 2023, and to be further implemented in the permanent rule, licensees will have to submit annual reports of the following information:
(1) a list of HCPs in Oregon who the licensee contacted;
(2) the number of times each HCP was contacted;
(3) the location/duration of the contacts;
(4) which pharmaceutical products the licensee promoted;
(5) whether any samples, materials, or gifts were provided (and, if so, the monetary value); and
(6) whether and how the licensee otherwise compensated the HCP for contact with the licensee.
Lesser requirements laid out in the temporary rule include that licensees must carry a copy (electronic can suffice) of their license, and that licensees’ titles cannot be misleading or cause an HCP to think the representative is an HCP themself.
Are there penalties available under the law?
Licensees who engage in prohibited conduct under the law may be subject to license revocation or suspension and/or a civil penalty not less than $1,000 or more than $3,000 for each day during which a violation continues. Prohibited conduct under the law includes engaging as a pharmaceutical representative in the state of Oregon for 15 or more days without a license, engaging in deceptive or misleading marketing of a pharmaceutical product, or failure to timely report information required under the law.
We will continue to monitor the revision and finalization of the rules implementing Oregon SB 763, and keep you apprised of any changes. If you have any questions about the Oregon state rules or on reporting requirements more generally, please contact one of the Hogan Lovells lawyers listed in this alert or with whom you usually work.
Authored by Ron Wisor and Laura Hunter