Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada: Meeting #3

Meeting Objectives:

1. Open dialogue with key stakeholders
2. Review patient and advocacy positions
3. Discuss evidence gathered to date

Participants

Panel Members	Secretariat	Observers
Dr. Penny Ballem (Chair) Dr. Francine Décary Dr. Patrick Robert (Special Advisor) Dr. Merlyn Sayers (Special Advisor)	Dr. Marie-Anik Gagné Connie Berry Dr. Vicky Hogan Dr. Chris Gravel Robyn Cummings Stacey Spicer	Kyle Norrie for Liz-Anne Gillham-Eisen, Director, HPFB Abby Hoffman, Assistant Deputy Minister [Oct 23: for part only] [various presenters as noted below]

Item

Welcome and introductions

Dr. Ballem reviewed the meeting objectives, and summarized the stakeholder outreach activities already undertaken and planned.

1. Approval of Agenda

Decision: The Panel endorsed the meeting agenda.

2. Endorsement of Record of Decisions of September 12, 2017 meeting

3. Discussion

Panel members discussed their observations and questions arising from the written submissions, and potential lines of inquiry related to the presentations to follow.  Questions about the current regulatory framework were addressed.  Dr. Décary explained that Héma-Québec was unable to provide some of the requested data because the Québec structure intentionally separates roles and responsibilities across different institutions.

Action:

• Assemble data available to compare demographic profiles of the Canadian and US populations, including socio-economic differences by geographic region.
• Provide copy of Ontario Voluntary Blood Donations Act, 2014 (provided October 24)

Guest presentations and discussions (See attachment #3)

4. Canadian Blood Services presentation

Dr. Graham Sher, Jean-Paul Bédard, and Mathias Haun presented on behalf of Canadian Blood Services (CBS). They responded to questions from Panel members on a number of points, resulting in exchanges of views on:

• The degree to which Canadian immune globulin (Ig) utilization rates reflect appropriate use,  why there are significant international differences in utilization rates, and what Ig control measures are available;
• Evidence related to whether Ig practice patterns may change due to emerging new alternative products or new Ig indications, need to better understand international differences in treating immune thrombocytopenic purpura (ITP);
• Self-sufficiency targets in different jurisdictions and what they represent;
• Frequency of plasma donation in compensated and uncompensated systems;
• Rationale for the CBS position related to private sector partnerships;
• CBS’ ability to maintain whole blood supplies in the context of private sector plasma collection, and CBS strategies to mitigate any negative impact.

Actions:

• CBS to provide further information on legislative protections for voluntary blood/plasma donations in other jurisdictions (e.g. France, UK)
• Secretariat to review pre-/post-implementation data re Ig utilization rates in provinces and territories where some control / review measures have been used (AB, ON, BC). Review QC Traceline data / summaries available from INESS and INSPQ.
• [See Day 2 #2 below for Action items related to ITP.]

5. Héma-Québec presentation

Dr. Marc Germain presented on behalf of Héma-Québec (H-Q). He responded to questions from Panel members on a number of points, resulting in exchanges of views on:

• Decision-making roles and responsibilities within the Québec blood system, including roles in Ig utilization oversight;
• History of H-Q's decisions on and approach to plasma self-sufficiency;
• H-Q's emphasis on fixed stand-alone plasma collection centres while blood collections are primarily from mobile clinics, and lessons learned from its experiences to date;
• Rationale for its >30% plasma self-sufficiency target and its prospects for achieving it.

6. Canadian Plasma Resources presentation

Dr. Barzin Bahardoust and Jim Pimblett presented on behalf of Canadian Plasma Resources (CPR). They responded to questions from Panel members on a number of points, resulting in exchanges of views on

• CPR's current and planned operations in Canada including targets, timelines, and contingencies;
• CPR's past discussions with CBS / H-Q, and CPR data on any overlap between plasma and blood donors;
• CPR's perspective on the Canadian and global contexts for plasma and blood collections.

7. Open discussion on the day's presentations and discussions

Panel members discussed key points from the presentations heard that will inform the Panel’s findings on supply and demand factors, relevant global and domestic contextual issues, cost and efficiency considerations, the role of the regulatory framework, and the relative urgency and likelihood of risks occurring.

Action:

• Secretariat to assemble available data on the relative cost of products produced by contract fractionation vs. finished commercial product, and elements of those costs.

8. Adjourned – day # 1.

1. Overnight thoughts or observations

The Chair led a discussion in regard to the emerging vision for the layout and high level content of the report; the need for graphics to ease communication of complex issues was identified.

2. Summary of Statements Submitted from Patient and Stakeholder Groups

Panel members discussed the submissions received from patient and stakeholder groups and the approach to the roundtable teleconferences scheduled for October 27 and 31, 2017.

3. Discussion

Panel members discussed the mini-reports prepared by the secretariat.  The Panel determined that in some areas sufficient foundation to frame their opinions had been provided, while additional information was requested on some topics.  Discussion was also held on topics emerging from other meeting discussions and materials, including:

• Evolving global context for contract fractionation;
• International Plasma and Fractionation Association (IPFA) concept of strategic independence;
• Government roles in responding to product shortage situations;
• Evidence of the safety record for plasma-derived products.

Action:

• Secretariat to assemble evidence on other countries' contract fractionation arrangements, focusing on usual comparators as well as Norway, Sweden and Poland.
• Secretariat to arrange telephone interview for Chair with Australian blood operator.
• Secretariat to deconstruct the table on other countries' proportions of un/compensated plasma into paid pheresis plasma, unpaid pheresis plasma (as in Italy and France), and (unpaid) recovered plasma.
• Secretariat to identify / review select Ig clinical guidelines for ITP and available utilization data, including the UK (National Institute for Health and Care Excellence - NICE) and Quebec (INESS – for neurology).
• Secretariat to review details of inclusion of platelet growth factors on PT formularies (where applicable), i.e. whether listed for ITP or for other diseases. Also, identify any post-market efficacy studies on treatment of ITP with platelet growth factors. Secretariat to review whether US FDA or other US government oversight body has authority or accountability to monitor product security of supply, and if so what federal levers exist to react to emerging shortage risks.

Guest presentations and discussions

4. Therapure Biopharma Inc. presentation

Blaine Forshage and Mark Krause presented on behalf of Therapure.  They responded to questions from Panel members on a number of points, resulting in exchanges of views on:

• Therapure’s current and planned operations in Canada including targets, timelines, and contingencies;
• Commercial approaches to sourcing plasma, and their perspective on the Canadian context;
• The prospect for their new technology to significantly increase the yield of Ig within the medium term, and their business and economic models;
• Therapure’s past discussions with CBS / H-Q and level of interest in Canadian collaborations.

After the Therapure presenters left, the Panel discussion included comment on challenges of managing a ‘hybrid’ (both blood and plasma) donor pool, such as information technology and inventory management issues.

Action:

• Dr. Sayers to contact Sacramento and/or other US operators of such hybrid systems to obtain further information on benefits and challenges of integrated blood and plasma collections.

5. Prometic presentation

Bill Bees presented on behalf of Prometic.  He responded to questions from Panel members on a number of points, resulting in exchanges of views on:

• Prometic’s current and planned operations in Canada including targets, timelines, and contingencies;
• Experience in and evolution of donor payment in Winnipeg, their approach to sourcing plasma and their perspective on the current Canadian context;
• The prospect for their new technology to significantly increase the yield of Ig within the medium term, and their business and economic models;
• The prospect of expanded uses for their plasminogen product, potentially overtaking Ig as a driver
• Prometic’s past discussions with CBS / H-Q and level of interest in Canadian collaborations.

After the final presenters left, the Panel held an extended discussion to summarize and synthesize its views of and conclusions about the written and oral submissions received.  Key factors and findings were identified and a draft logic flow for the report was developed. The draft will evolve as further evidence is received.

Action:

• Secretariat to incorporate discussion details into an initial report outline for review by the Chair.
• Secretariat to validate trade agreement interpretation with Health Canada legal counsel.

6. Updates

N/A

7. Roundtable

N/A

8. Next meeting: December 7 & 8 in Ottawa

Confirmed

9. Adjournment