OAR 836-200-0540
Information Claimed to be Trade Secret

Mentioned in

PhRMA Challenges Oregon Drug Pricing Transparency Laws

FDA Law Blog, February 2, 2020

“ OR DCBS regulations set forth exacting requirements for demonstrating that a designated trade secret is entitled to protection from disclosure…”
 
Bibliographic info

(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).

Source: Rule 836-200-0540 — Information Claimed to be Trade Secret, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=836-200-0540.

836‑200‑0000
Statutory Authority 836‑200‑0010
Assessments 836‑200‑0020
Filing Procedures 836‑200‑0030
Form 10 K and Other Financial Stability Filings 836‑200‑0040
Reimbursement Insurance Policy 836‑200‑0050
Registration Requirements Not Exclusive 836‑200‑0055
Annual Report 836‑200‑0060
Service on Registrant 836‑200‑0100
Notice, Collision Damage Waivers 836‑200‑0105
Statutory Authority 836‑200‑0110
Registration Procedures 836‑200‑0120
Warranty 836‑200‑0130
Reimbursement Insurance Policy 836‑200‑0140
Registration Requirements Not Exclusive 836‑200‑0200
License, Discount Medical Plan Organization 836‑200‑0210
Renewal of expired license 836‑200‑0215
One-time processing fee, cancelled application 836‑200‑0220
License Requirement Not Exclusive 836‑200‑0250
Purpose and Authority 836‑200‑0255
Registration of Contracting Entity 836‑200‑0300
Statement of Purpose 836‑200‑0305
Retainer Medical Practice Application for Certification 836‑200‑0310
Retainer Medical Practice Application for Renewal 836‑200‑0315
Disclosures 836‑200‑0401
Statement of Purpose 836‑200‑0406
Application Requirements for Pharmacy Benefit Manager 836‑200‑0411
Renewal of Pharmacy Benefit Registration 836‑200‑0416
Registration Requirements Not Exclusive 836‑200‑0421
Service on Registrant 836‑200‑0436
Submission of Complaints 836‑200‑0440
Market Conduct Requirements for Pharmacy Benefit Managers 836‑200‑0500
Purpose and Statutory Authority 836‑200‑0505
Definitions 836‑200‑0510
Account Generation Requirement 836‑200‑0515
Threshold for Reporting Drug Price Increase 836‑200‑0520
Threshold for Reporting New Specialty Drug 836‑200‑0525
Expectations of Reporting Manufacturers 836‑200‑0530
Form and Manner Requirements for Drug Pricing Reporting 836‑200‑0535
Additional Information Requests 836‑200‑0540
Information Claimed to be Trade Secret 836‑200‑0545
Public Disclosure of Prescription Drug Manufacturer Filings 836‑200‑0550
Consumer Notices to the Department 836‑200‑0555
Assessments Against Prescription Drug Manufacturers 836‑200‑0560
Civil Penalties
Last Updated

Jun. 8, 2021

Rule 836-200-0540’s source at or​.us