Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada - Terms of Reference

Context

Many Canadians depend on products manufactured from human plasma to treat a range of health conditions (“human plasma products”). Most of the plasma product supply used in Canada is purchased from US commercial manufacturers. In contrast, Canada’s blood supply (individual blood components for transfusion in hospitals) is 100% self-sufficient through voluntary blood donation operations managed by Canadian Blood Services and Héma-Québec.

At present, there is a strong global demand for immune globulin (Ig) human plasma products, which seems to be driving expansion of commercial plasma collection into new markets, including Canada.  In this context, the primary Canadian blood operator has raised concerns that:

• Increasingly competitive global Ig market conditions may detrimentally affect the security and sustainability of the Canadian Ig product supply; and
• New/expanded Canadian plasma collection operations may draw donors away from the voluntary blood donor pool to the extent that the security and sustainability of the Canadian blood supply may be detrimentally affected.

The federal government is initiating this Expert Panel on Immune Globulin Product Supply and Related Impacts in Canada (“the Panel”) to provide objective expert review of the evidence related to these issues and concerns to inform future policy and practice.   Its composition and mandate were developed in consultation with the provinces and territories (PTs).

Mandate

The mandate of the Panel is to assemble, review, and assess available evidence on:

1. Supply and demand factors that may affect the security and sustainability of the Ig supply for Canadians;
2. The potential impact of plasma collection activities on the security and sustainability of the Canadian blood supply, if plasma collections were to expand significantly in Canada;
3. Current and emerging international practices and lessons learned about mitigating any potential detrimental impacts on security and sustainability identified in 1 or 2 above.

In its assessments, the Panel will consider the likelihood and severity of potential impacts over short-, medium-, and long-term time horizons.

The Panel is not mandated to make recommendations nor to comment on current or future policy directions of governments or any other party.  Decisions on policy pertaining to the blood and plasma systems in Canada remain the prerogative of governments and authorities they may designate to make or implement policy.

To guide the Panel in its assessments, Questions and Considerations have been developed (Appendix A).  These are intended to assist, not restrict, the Panel’s investigations and deliberations.

Reporting and key deliverables

The Panel, through its Chair, will be accountable to and report to the federal Deputy Minister of Health. Reporting will include interim updates on progress. The key deliverable will be a final report to be submitted by March 31, 2018 that includes:

• An executive summary;
• The findings, conclusions, and rationale for the conclusions of the Panel;
• An overall summary of the evidence reviewed and input received, noting any limitations about the strength of the evidence available that may have affected its findings, and how the input was viewed by the Panel.

The federal government will consult the Chair of the Panel and PTs on the disposition / release of the report, and will provide PTs with an advance embargo copy prior to any public release.

Complementary mandates

The Provincial Territorial Blood Liaison Committee (PTBLC) provides advice and support to the Provincial and Territorial Deputy Ministers and Ministers of Health on issues affecting the blood system (excluding Québec).  The Panel shall receive and consider any relevant and timely information provided by the PTBLC and/or PT officials.

External input

To inform its deliberations, the Panel, through the Secretariat, may retain the services of independent non-government experts to provide advice or information on certain subjects within its mandate. The Panel may also, in its discretion, consult key informants, such as:

• Current Canadian operators involved in blood or plasma collection, and plasma product manufacturing;
• International experts and stakeholders;
• Representatives of Canadian patient groups dependent on human plasma products (with an emphasis on users of Ig).

Composition of panel

The Panel will consist of four members appointed by the Deputy Minister: one Chair, one Deputy Chair, and two Special Advisors who collectively possess domestic and international expertise and experience in:

• Canadian health sector context, including federal and provincial/territorial division of powers;
• International blood and plasma collection systems in public and private sector contexts;
• International supply chains, global markets, and market response mechanisms in a biological, pharmaceutical or health product context;
• Weighing diverse stakeholder interests.

Panel responsibilities

The responsibilities of the Chair are to:

• Ensure that Panel discussions remain in line with its mandate;
• Ensure that Panel members have the opportunity to contribute;
• Collaborate with Panel members and the Secretariat;
• Provide interim updates on progress to the federal Deputy Minister of Health, as requested;
• Lead and participate in Panel meetings;
• Ensure that the report is submitted on time; and
• Submit and present the final report to the federal Deputy Minister of Health, and if requested, present at a meeting of the FPT Deputy Ministers of Health.

The responsibilities of Panel Members are to:

• Review relevant documents provided by or requested from the Secretariat;
• Apply their expertise and experience to provide input to the Panel's deliberations;
• Actively participate in meetings and discussions;
• Provide timely contributions to discussion and report preparation; and
• Support the chair in his/her role.

Activities expected to be part of the Panel workplan include:

• Panel meetings,  including teleconference and/or face-to-face;
• Stakeholder meetings, including key informant interviews;
• Evidence-gathering, including review of documents provided by the Secretariat;
• Report-writing, including review of draft and final reports;
• Tabling of final report and presenting findings;
• Preparation for any of the above.

The Panel is encouraged to reach a consensus in its deliberations. When a consensus is not possible, the meeting record or report will reflect the diversity of opinions.

After fulfillment of its mandate, the Panel will be dissolved.

Compensation

All members are paid for their participation on the Panel.  As such, these members are not eligible for indemnification. Obtaining appropriate insurance coverage under these circumstances is the responsibility of individual members if they wish to do so.

Members will be reimbursed for expenses incurred on approved travel for the Panel, such as trip costs and accommodation, in accordance with Treasury Board policy and guidelines. 

Panel Secretariat

Health Canada will establish and cover the costs of a Secretariat to provide administrative and logistical support to the Panel.  The Secretariat will administer Panel expenses, co-ordinate outreach activities, and expedite research, report writing and communications (including production of the final report of the Panel).

Disclosure of Interests and Affiliations

Panel members are expected to act in an unbiased, professional, respectful and fair way at all times. They may not use their position on the Panel for any private or collateral purpose. To be considered for appointment, potential Panel members are required to complete and return an Affiliations and Interests Declaration Form, a summary of which will be published online. In addition, Health Canada or the Chair will also ask members to make a verbal statement of their relevant affiliations and interests at the beginning of Panel meetings.

Confidentiality

To support their ability to provide well-informed advice, Panel members may receive confidential information. All panelists will therefore be required to sign a Confidentiality Agreement that will prohibit the disclosure of any confidential information received through participation in the Panel. The Chair will ensure that everyone participating in meetings or other communications receives clear instructions on applicable confidentiality restrictions.

The final Panel report is also considered confidential information unless or until publicly released by the federal Deputy Minister of Health. Otherwise, information gathered by the Panel may be subject to the Access to Information Act and the Privacy Act.

A member may discuss the Panel’s work with the media or at conferences or other external events only with prior permission from Health Canada. All media requests related to the Panel’s statements or activities will be directed to Media Relations, Health Canada, who will coordinate responses.

Security Clearance

All members are required to attain an appropriate security clearance. This may require the member to submit fingerprints to the RCMP. Health Canada provides the required forms to candidates for appointment.

Appendix A: Questions and Considerations

The following questions and considerations are offered to guide the Panel in examining each element of its mandate.

1. Supply and demand factors that may affect the security and sustainability of the Ig supply for Canadians.
   1. Supply: There are historical examples of spikes and dips in plasma product supply/demand trends (e.g. demand for Factor VIII dropped after a non-plasma-derived replacement product was developed).
      • If the global supply market has been able to adjust to keep up with global supply/demand trends in the past, is there any reason to believe that the Ig market will be unable to similarly adjust over the medium- to long-term? If so, explain what is novel about the factors driving the global long-term Ig supply/demand forecast and the confidence levels in those forecasts.
      • What indicators would signal emerging issues?
      • In the event of global Ig shortage, how likely is it that Canada will be unable to secure sufficient Ig supply to meet Canadian demand, given current Ig product supply chains?
      • Will other countries’ responses to the Ig market conditions (e.g. scaled-up plasma collections) improve global supply generally?
   2. Demand: Canada is among the highest global users of Ig product per capita.
      • To what extent do suboptimal or off-label Ig usage practices materially contribute to Ig demand in Canada?
      •  Are there alternative technologies or treatments on the horizon for patients now using Ig therapy that would materially reduce the demand for (plasma-derived) Ig?
2. The potential impact of plasma collection activities on the security and sustainability of the Canadian blood supply, if plasma collections were to expand significantly in Canada.
   1. Plasma collection systems co-exist with blood collection systems in a number of countries including the United States, Germany, Austria, Hungary, and the Czech Republic.
      • Have plasma collection initiatives affected blood operators’ ability to meet demand for fresh blood components?  If so, how and to what extent?
        • What contributing factors may be relevant to the Canadian context (e.g. where blood component inventories are managed regionally/ nationally)?
      • What indicators (or levels of plasma collection activity) would signal emerging issues in the Canadian context?
3. Current and emerging international practices and lessons learned about mitigating any potential detrimental impacts on security and sustainability identified in 1 or 2 above.

   The Panel could identify and highlight relevant findings related to:

   1. How to optimize existing market mechanisms and infrastructure to mitigate factors that could detrimentally affect the security and sustainability of the Ig product supply.
      • What actions or policy approaches have been tried elsewhere, and with what results (without/aside from changing the volume of domestic plasma collection)?
   2. How to direct domestic plasma collection activities to mitigate factors that could detrimentally affect the security and sustainability of the blood donor supply.
   3. Demand management mechanisms to prioritize Ig access for patients for whom Ig is the only or optimal therapy, in the event of a disruption in supply.