For the purposes of this rule, the following definitions apply:
(a) DSM means the latest published edition of
Diagnostic and Statistical Manual of Mental Disorders.
(b) ICD means the most recent revision of the
International Classification of Diseases published by the United
Nations-sponsored World Health Organization that provides codes, up to six
characters long, to classify diseases and a variety of signs, symptoms,
abnormal findings, complaints, social circumstances, and external causes of
injury or disease.
Peer-reviewed published scientific study means that a study has been cited by
the Cochrane Review, the Institute of Medicine, or PubMed Central.
(d) Petitioner means an individual who has
filed a petition in accordance with ORS 475C.913 and this rule.
(e) State Public Health Officer (SPHO) means
the individual appointed by the Director of the Authority in accordance with
ORS 431.045, or his or her designee.
The Authority shall accept a written
petition from any person requesting that a particular disease or condition be
included among the diseases and conditions that qualify as a debilitating
medical condition under ORS 475C.777.
petition may only request a single disease or condition be added as a
debilitating medical condition. A separate petition must be submitted for each
disease or condition proposed to be added as a debilitating medical condition.
A petition must be submitted
by mail using a form prescribed by the Authority and must include, along with
the form, the following in an electronic format (e.g. compact disc (CD) or
(A) A specific description of
the disease or condition proposed to be added and its characteristics,
including the applicable ICD code or the specific diagnosis as described in the
(B) A general explanation of
how or why the petitioner believes marijuana would mitigate the symptoms or
effects of the disease or condition that is the subject of the petition; and
(C) At least one peer-reviewed
published scientific study showing the efficacy in humans for use of medical
marijuana for the disease or condition that is the subject of the petition.
(c) A petitioner may
also include with the information required to be submitted in subsection (2)(b)
of this rule letters of support from physicians or other licensed health care
professionals knowledgeable about the disease or condition proposed to be
added, and any other information the petitioner believes the SPHO should review
in considering the petition.
a petitioner submits a petition to add the same or a substantially equivalent
disease or condition that was the subject of a petition that was denied by the
SPHO within the last five years from the date a new petition is submitted, a
petitioner must submit at least one peer-reviewed published scientific study
that was published since the date the SPHO denied the previous petition for the
same or substantially equivalent disease or condition.
(e) A petition may not contain individually
identifiable health information as that is defined in ORS 433.443 unless any
individual identified in relation to health information submits an
Authorization for Use and Disclosure of Information on a form prescribed by the
Authority. A petition that contains individually identifiable health
information that is submitted without the required authorization must be
returned to the petitioner as incomplete.
(f) A petition that does not contain all the
information required by section (2) of this rule shall be returned to the
petitioner as incomplete. A petition returned as incomplete is not considered a
denial for purposes of subsection (2)(d) of this rule.
If the petitioner has submitted a
petition with all the information required in section (2) of this rule, the
(a) Assign a petition number to
(b) Notify the
petitioner by certified mail that the petition has been accepted;
(c) Post a notice, a copy of the petition and
materials submitted by the petitioner on the Authority's website announcing
that the petition has been accepted and is under consideration, and solicit
information from individuals or organizations concerning experts in cannabis
therapeutics and scientific studies, including but not limited to peer-reviewed
published scientific studies;
Notify the Oregon Cannabis Commission (OCC) by electronic mail that the
petition is under consideration, and request from the OCC recommendations
regarding relevant experts and information pertinent to the petition;
Conduct an investigation that
may, as the SPHO determines necessary, include:
(A) Consulting with one or more experts in
cannabis therapeutics and one or more experts on the disease or condition that
is the subject of the petition;
Requesting a literature review and a summary of peer-reviewed published
scientific studies related to the use of marijuana for the disease or condition
that is the subject of the petition, from neutral persons knowledgeable about
conducting such reviews; and
Gathering any other information the SPHO believes relevant to making a decision
on the petition.
Hold a public hearing at a time and place determined by the SPHO. At the public
hearing the petitioner shall have the opportunity to address the SPHO in person
or by telephone. Written comments shall be accepted by the SPHO for one week
following the close of the public hearing.
Following the investigation identified in
subsection (3)(e) of this rule and the close of the public comment period
specified in subsection (3)(f) of this rule, the SPHO must issue a Notice of
Intent to either approve or deny the petition.
The SPHO must issue a Notice of Intent to
Approve the petition if, based on the evidence presented to and considered by
the SPHO, the SPHO finds that:
is efficacious for the disease or condition that is the subject of the petition
or marijuana may mitigate the symptoms or effects of the disease or condition
that is the subject of the petition; and
(B) Any risk of physical or mental harm from
using marijuana for the disease or condition that is the subject of the
petition is outweighed by the physical or mental benefit of using marijuana for
that disease or condition.
(b) The SPHO must issue a Notice of Intent to
Deny the petition if the SPHO determines that the evidence presented to and
considered by the SPHO does not meet the standards established in subsection
(4)(a) of this rule.
(c) The Notice
of Intent must be in writing and must describe all evidence and information
upon which the decision of the SPHO is based, including the identity and
credentials of all experts relied upon.
(d) If the Authority issues a Notice of
Intent to Deny the petitioner is entitled to a contested case hearing as
provided under ORS chapter 183. The petitioner has 30 days to request a
(5) At a
contested case hearing, the petitioner has the burden of proving the decision
of the SPHO was without a reasonable basis in fact.
(6) The SPHO must issue a final order within
180 days of receipt of a complete petition.
(7) A petitioner may withdraw his or her
petition without prejudice at any time prior to the public hearing specified in
subsection (3)(f) of this rule. A petition withdrawn after the public hearing
specified in subsection (3)(f) of this rule shall be deemed denied for purposes
of this rule.
Or. Admin. R. 333-008-0090
OHD 3-1999, f. & cert.
ef. 4-29-99; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 6-2002, f. & cert.
ef. 3-25-02; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f.
12-19-07, cert. ef. 1-1-08; PH 18-2012, f. 12-26-12, cert. ef. 1-1-13;
29-2017, amend filed 12/22/2017, effective
123-2018, minor correction filed 04/27/2018, effective
69-2022, minor correction filed 05/11/2022, effective
Statutory/Other Authority: ORS 475C.913 & 475C.919
Statutes/Other Implemented: ORS