Information Claimed to be Trade Secret
(1) To request exemption from the disclosures required under OAR 836-200-0545 (Public Disclosure of Prescription Drug Manufacturer Filings), reporting manufacturers must clearly indicate any information provided to the department that they assert to be conditionally exempt from disclosure under ORS 192.345 (Public records conditionally exempt from disclosure) as a trade secret, in the following fashion:(a) Each line and informational element in every filed document that is claimed to be a trade secret must be clearly marked by the manufacturer;(b) Each filing that contains information claimed as trade secret by the manufacturer must include, in accordance with standards set forth on the department’s website and for each piece of information claimed as trade secret, a succinct written explanation of why the information is exempt from disclosure that demonstrates all of the following:(A) The information is not patented;(B) The information is known only to certain individuals within the manufacturer’s organization and used in a business the organization conducts;(C) The information has actual or potential commercial value;(D) The information gives the manufacturer an opportunity to obtain a business advantage over competitors who do not know or use it; and(E) The public interest does not require disclosure of the information.(c) If the manufacturer asserts that disclosure of any information provided in a report is affirmatively prohibited by state or federal law, the manufacturer must clearly indicate the relevant information and explain the basis of this assertion, including citations of the applicable state and federal laws.(2) The burden of proof to establish that information in a filing is conditionally exempt from disclosure as a trade secret is on the manufacturer submitting the filing. The department shall review the manufacturer’s explanations and determine exemptions from the disclosures required under OAR 836-200-0545 (Public Disclosure of Prescription Drug Manufacturer Filings) on a case-by-case basis.(3) If the department determines that any information claimed as trade secret by a reporting manufacturer must be disclosed, the department shall notify the manufacturer and provide a written explanation of the department’s determination. Within 15 days after receiving this notification, a manufacturer may submit a letter to the director to appeal the department’s determination and request reconsideration. The letter must explain the grounds for the request.(4) The director or the director’s designee will review appeals provided under subsection (3) of this section and issue a determination within 15 days, or within a time period necessary to obtain legal review, of receiving an appeal letter. If the director’s determination would result in the release of information claimed as trade secret by the manufacturer, the department shall notify the manufacturer of the director’s decision at least 21 days in advance of disclosing the information as provided under OAR 836-200-0545 (Public Disclosure of Prescription Drug Manufacturer Filings).(5) If the department exempts information provided by a manufacturer under OAR 836-200-0515 (Threshold for Reporting Drug Price Increase) to 836-200-0535 (Additional Information Requests) from disclosure under 836-200-0545 (Public Disclosure of Prescription Drug Manufacturer Filings), the department shall post an explanation of the basis of the exemption to its website along with a general description of the nature of the information exempted.(6) A person may petition the Attorney General, as provided in ORS 192.411 (Petition to review denial of right to inspect state public record), to review a decision by the department to exempt information from disclosure under this section. The department shall include an explanation of the right to petition for Attorney General review in the explanation posted under subsection (5).