Pennsylvania Department of Health announces Phase 2 of Medical Marijuana Program

On March 22, 2018, the Pennsylvania Department of Health’s (DOH) Office of Medical Marijuana held a conference call with reporters to share an overview of the next phase of the Medical Marijuana Program.

DOH Director of Communications April Hutcheson stated that currently all twelve of the grower/processors who received permits during Phase 1 of the program have been approved to begin operations with 25,573 patients registered to participate in the program. Hutcheson also highlighted the following statistics:

•         9,020 patient certifications have been issued

•         7,000 of those 9,020 patients have purchased medical marijuana identification cards

•         6,683 patients have received medical marijuana from a dispensary in Pennsylvania

•         866 physicians have been registered to participate in the program

•         473 of the physicians registered have been approved

Hutcheson also noted that at this time all Pennsylvania dispensaries have medical marijuana products for sale. Most significantly, she said DOH is set to begin Phase 2 of medical marijuana permit applications for grower/processors and dispensaries with two distinct application processes.

According to DOH Director John Collins, during Phase 2 of the commercial segment there will be 13 additional grower/processor permits and 23 additional dispensary permits available. Director Collins explained there will be up to two grower/processors permitted in each of the Commonwealth’s six regions with the 13th permit made available to the highest scorer. In terms of the dispensaries, Collins said there will be nine permits available in Region 1, three permits available in Region 2, three permits available in Region 3, two permits available in Region 4, four permits available in Region 5 and two available in Region 6. He noted that 27 dispensary permits were issued during Phase 1, equaling a total of 50 dispensary permits once Phase 2 is completed; which is the maximum number provided in the statute. Collins said the same timeline will apply to both grower/processors and dispensaries. He indicated the applications will be available online at www.medicalmarijuana.pa.gov on April 5 with a deadline to submit of May 17.

Collins also explained the process for Clinical Registrant (“CR”) applications and said there are up to eight permits available. He noted that a CR is the permittee and holds both a grower/processor permit and a dispensary permit. The CR must establish a relationship with an Academic Clinical Research Center (“ACRC”) in Pennsylvania that must be affiliated with an acute care hospital or urgent care hospital licensed in Pennsylvania. Collins pointed out that the ACRC must first apply to be approved for the program beginning on April 5 with a deadline of May 3. On May 24, DOH will make available the application to be an approved clinical registrant. Collins said the deadline for that application to be submitted as well as the form establishing a relationship with an approved ACRC is July 12.

Questions were taken from the media.  Here is a summary:

What is the difference between a Clinical Registrant and an ACRC?

Hutcheson said an ACRC is a medical school with an acute care hospital attached to it and the medical school must apply to DOH to become a certified ACRC. A clinical registrant is the entity that would hold a grower/processor and dispensary permit and would have a direct relationship with the ACRC to conduct clinical research relating to medical marijuana, she explained.

Are any of the permit holders from Phase 1 exempt from applying in Phase 2?

Collins said the statute limits a permittee to hold just one grower/processor permit. On the dispensary side, he said, a current permit holder may apply in Phase 2 because the statute allows for up to five primary permits to be held by a permittee.

When will all the Phase 1 dispensaries be up and running?

Collins said there were 27 primary permits for dispensaries issued in Phase 1 with 13 of those currently capable of dispensing medical marijuana. He said nine are in receipt of inventory and actively dispensing. Others are in the process of receiving final inspections by DOH before they can be deemed operational, he noted.

How many growers are currently dispensing or supplying dispensaries and can each dispensary permittee have three locations?

Collins said all 12 grower/processors have been deemed operational and are currently growing medical marijuana for processing into approved products. Regarding dispensaries, he said each dispensary can have three locations equaling a total of 150 in the commercial market. He did note that there will be 48 additional dispensaries on the research side.

What type of research will the clinical registrants be doing?

Collins said DOH has not received any research synopses yet, but that there seems to be a high interest in pain management research, especially in light of the opioid crisis.

What is the review process for clinical registrants and ACRCs?

Collins said during the review process DOH will determine if the ACRC meets the requirements in the regulation and that the process would take about a week. For the Clinical Registrants, he said the process will ensure they meet the obligations to be able to apply and that they have a contractual relationship with an approved ACRC.

How long should it take the growers approved in phase two to be operational?

Collins said from the time applications were available until the time someone began growing was approximately nine months to a year in Phase 1 and he expects a similar outcome in Phase 2.

Is there any possibility that leaf (marijuana flower) will be introduced to this program at any time?

Hutcheson said the Medical Marijuana Advisory Board has been looking into that and is meeting on April 9 to vote on final recommendations to the Secretary of Health.

Is there a limit on the number of ACRCs?

Collins said “theoretically there is no limit,” but they must be accredited by either the Liaison Committee of Medical Education or the Commission on Osteopathic College Accreditation and have a relationship with an acute care hospital.

 

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Peter S. Murphy

Member - Wilmington