Specialist Advisory Committee Terms of Reference

Foreword

As a Crown Entity, Te Pātaka Whaioranga Pharmac (Pharmac) is governed by a Board that has authority to make decisions for Pharmac, some of which are delegated to Pharmac staff. Within this document, unless specified, the use of the word Pharmac is to be interpreted as Pharmac’s Board, the entity, and its staff. 

These Terms of Reference set out the goals, responsibilities, obligations, and procedures for standing Specialist Advisory Committees. 

This document is the primary document for standing Specialist Advisory Committee Members when considering their responsibilities, respective roles, and conflicts of interest and confidentiality obligations. Further guidance, including administrative information for meetings, can be found in the Member handbook for Clinical Committees (Member Handbook)[1]. 

Nothing in these Terms of Reference is intended to restrict or fetter the nature or content of the advice that Specialist Advisory Committees provide to Pharmac. 

There are several key pieces of legislation referred to within this document that should be referenced by Specialist Advisory Committee Members, outlined in Appendix One. 

Glossary of terms

“Advice Record” (formerly Minutes) means the written record of discussion and recommendations made at a PTAC or Specialist Advisory Committee meeting (including meetings by Remote Media Conference and recommendations made by other means of communication) which have been finalised by the relevant Chair. 

“Applicant” means any third party who submits an application or Proposal to Pharmac for consideration. An application can also be made by Pharmac staff. 

“Chief Executive” means the Chief Executive of Pharmac, or their delegate.

“Director-General” and “Director-General of Health” means the Director-General of Health (chief executive or acting chief executive of the Ministry of Health), or their delegate.

“Health Equity” means the absence of unfair and avoidable or remediable differences in health among population groups defined socially, economically, demographically, or geographically. In the Pharmac context, the focus is on medicines access equity as defined at Achieving medicine access equity in Aotearoa New Zealand: towards a theory of change

“Specialist Advisory Committee” (formerly PTAC Subcommittee) means a standing Specialist Advisory Committee.

“Specialist Advisory Committee Chair” (formerly PTAC Subcommittee Chair) means the Chairperson of the Specialist Advisory Committee. 

“Member” means a member of a Specialist Advisory Committee. 

“NZPHD Act” means the New Zealand Public Health and Disability Act 2000 and includes any regulations, amendments, re-enactments, and replacements thereof. 

“OPPs” means Pharmac’s Operating Policies and Procedures which are published on Pharmac’s website. 

“Pharmac” and “Te Pātaka Whaioranga” means the Pharmaceutical Management Agency, a Crown Entity established under the NZPHD Act, its staff, and Board. 

“Pharmaceutical(s)” means, as defined in the NZPHD Act, a medicine, therapeutic medical device, or related product, or related thing. 

“Pharmaceutical Schedule” means the list of the prescription medicines and therapeutic products subsidised by the Crown (schedule.pharmac.govt.nz(external link)). 

“Proposal” means, either: (a) an application or Proposal made by a third party to Pharmac for the funding of a pharmaceutical or changes to the funding of a pharmaceutical that is already on the Pharmaceutical Schedule (eg a Proposal to widen or restrict access); OR (b) a Proposal made by Pharmac staff. 

“PTAC” means the Pharmacology and Therapeutics Advisory Committee. 

“PTAC Chair” means the Chairperson of PTAC. 

“Published Advice Record” means that part of the PTAC or Specialist Advisory Committee Advice Record published on the Pharmac website.

“Supplier” means the supplier of a pharmaceutical. 

“Terms of Reference” means these Terms of Reference for Specialist Advisory Committees.

1   Establishment

1.1   Specialist Advisory Committees

1.1.1   Pharmac’s Board may, by resolution,[2] appoint standing committees. Specialist Advisory Committees have been established accordingly to consider, report, or make recommendations and provide advice, either directly to it or through PTAC or Pharmac staff, on Proposals or other issues relating to the Pharmaceutical Schedule, within a specific therapy area. In appointing a standing Specialist Advisory Committee, Pharmac’s Board may have regard to the recommendations of the PTAC Chair and Pharmac staff.

1.1.2   Specialist Advisory Committees are appointed to reflect specialist knowledge and expertise in the health needs and health benefits of treatments within their own therapeutic groups/areas of practice, including the applicability of evidence to clinical funding settings in New Zealand.

1.1.3   Specialist Advisory Committees were previously called subcommittees of PTAC, and all established subcommittees of PTAC continue as Specialist Advisory Committees unless they are separately disestablished. 

2   Functions

2.1   Activities of Specialist Advisory Committees 

2.1.1   Specialist Advisory Committees are to: 

• provide objective advice to Pharmac to support specific therapeutic areas including category management for community and hospital pharmaceuticals and their benefits, using Pharmac’s decision-making framework. 
• where relevant, make recommendations to Pharmac on applications or Proposals related to the management[3] of the Pharmaceutical Schedule which have been referred to it by Pharmac or PTAC 
• consider and report, or make recommendations, to Pharmac or PTAC on any other matters that may be referred to it by Pharmac or PTAC, which may be ad-hoc and outside of formal meetings. 

2.2   Matters that Specialist Advisory Committees are to consider

2.2.1    Nothing in these Terms of Reference is intended to restrict or fetter the nature and content of the advice that Specialist Advisory Committees provide to Pharmac.

2.2.2   When providing their advice to Pharmac, Specialist Advisory Committees are to take into account, where applicable, Pharmac’s decision-making framework.

2.2.3   Should a Specialist Advisory Committee take into account considerations that fall outside of Pharmac’s decision-making framework, the specific consideration, and the reasoning for including it must be recorded in its Advice Record (formerly “Minutes”).

2.2.4   Subject to the confidentiality provisions in section 7 of these Terms of Reference and Pharmac’s obligations under the Privacy Act 2020 and Health Information Privacy Code 2020, Members may consult with, and seek evidence or information from, such parties as they consider necessary or appropriate, including relevant medical and consumer groups. They may seek evidence or information in relation to a particular pharmaceutical, therapeutic group or subgroup or any other matter that has been referred to them for consideration or recommendation. The fact of any such consultation and the parties consulted with will generally be documented in the relevant Advice Record.

2.2.5   Specialist Advisory Committees may use any evidence that can reasonably be obtained. In making recommendations based on this evidence, Specialist Advisory Committees are to use their judgement when considering issues such as quality and relevance. 

2.3   Advice to be given by Specialist Advisory Committees 

2.3.1   Pharmac may request a Specialist Advisory Committee make a recommendation on any Proposal under consideration. When making recommendations to Pharmac, Specialist Advisory Committees are to set out the matters and evidence from Pharmac’s decision-making framework that are primarily relied on in making a recommendation. Each Specialist Advisory Committee makes recommendations, including priority, within its area of expertise, and may: 

a.)   recommend that the pharmaceutical be listed by Pharmac on the Pharmaceutical Schedule (or its access eligibility be widened), and the priority it gives to such a listing (High, Medium, Low, Cost-neutral to another specified pharmaceutical) within that therapeutic group 

b.)   defer a final recommendation, and give reasons for the deferral (such as for the supply of further information) and what is required before further review 

c.)   recommend that Pharmac decline to list (or widen access to) a pharmaceutical on the Pharmaceutical Schedule. 

2.3.2   Members are to endeavour, at all times, to reach a consensus on recommendations. Further detail on the process to follow where consensus is not met is included in the Member Handbook. 

2.3.3   Members (including the Specialist Advisory Committee Chair) are bound by each recommendation and will not take any steps outside the meeting to the detriment of a consensus or majority recommendation. 

2.3.4   Specialist Advisory Committees may consider other matters referred by Pharmac or PTAC, which may include any correspondence, new information or resubmissions or Proposals that are provided by applicants. 

2.3.5   Nothing in the above or this Terms of Reference is intended to prevent Pharmac, at its discretion, from seeking advice from any person or group who it considers has expertise or views that will assist Pharmac to perform its statutory functions. 

2.4   Publication of Specialist Advisory Committee Advice 

2.4.1   The final recommendations (as set out in section 2.3) made by the Specialist Advisory Committee in relation to a Proposal will be published on the Pharmac website (the Published Advice Record), subject to sections 2.4.2. 

2.4.2   The content of each Published Advice Record of a Specialist Advisory Committee will vary depending on sensitivity of the information in the Record. The Advice Record will be prepared by Pharmac staff and portions of the Advice Record may be withheld from publication in accordance with the Official Information Act 1982. Content which is incidental, administrative, or not related to any Proposal under consideration may also be excluded from the Published Advice Record. The names of all Members and attendees at a meeting who are not Pharmac staff will also be published. 

2.4.3   Before publication, relevant portions of the draft Published Advice Record will be provided to the Applicant (where applicable), who may provide feedback as to whether it considers specific content should be withheld under the Official Information Act 1982 and the grounds for doing so. Pharmac staff may make changes to the draft Published Advice Record content, but their over-riding obligation is to ensure that the record of SAC discussions remains accurate[4], and Pharmac will only withhold content of a draft Published Advice Record relating to a specific Proposal where it agrees with the applicant that there are grounds for withholding content under the Official Information Act 1982. 

3   Relationship Management

3.1   Relationship between Pharmac and Specialist Advisory Committees 

3.1.1   Specialist Advisory Committees are standing committees established by Pharmac to provide objective advice to Pharmac on pharmaceuticals and their benefits related to specific therapy areas. 

3.1.2   The Pharmac Board Chair, or other Pharmac Board member approved in advance by the Specialist Advisory Committee Chair, may attend meetings of Specialist Advisory Committees as an observer. The Pharmac Board Chair may participate in discussion at the invitation of the Specialist Advisory Committee Chair but may not vote on any matter at that meeting.[5] The Pharmac Board Chair may report back to the Pharmac Board on the discussions of Specialist Advisory Committees. 

3.1.3   A member of Pharmac’s Senior Leadership Team, or a delegate, may attend each Specialist Advisory Committee meeting and participate in the discussions where relevant. 

3.1.4   Pharmac staff member(s) will attend and participate in meetings of Specialist Advisory Committees while discussion and recommendations relevant to their area of work are deliberated. In general, Pharmac staff may respond to questions from Members and clarify understanding of discussion and recommendations as necessary. 

3.1.5   Pharmac staff members may not vote on any matter at a Specialist Advisory Committee meeting. 

3.1.6   Pharmac staff will provide secretariat and administrative support to Specialist Advisory Committees. 

3.2   Relationship between PTAC and Specialist Advisory Committees 

3.2.1   The PTAC Chair is responsible for:

• advising Pharmac on the suitability of appointments to Specialist Advisory Committees
• advising Pharmac on appointments of Specialist Advisory Committee Chairs and Deputy Chairs
• as necessary, reviewing communications by Members related to the activities of Specialist Advisory Committees or Pharmac with the media or professional associations, having first obtained the consent of the Pharmac Chief Executive to the act of communication and having first consulted with Pharmac on the content
• advising Pharmac on the establishment and/or dissolution of Specialist Advisory Committees.

3.2.2   Specialist Advisory Committees will have at least one PTAC Member.[6]

3.2.3   PTAC may seek advice from Specialist Advisory Committees on specific issues relating to a Proposal or the Pharmaceutical Schedule that requires subject matter expertise. Specialist Advisory Committees will give a written opinion to PTAC through the relevant Specialist Advisory Committee Advice Record, and PTAC will consider this opinion. 

3.3   Indemnity for Members 

3.3.1   Pharmac indemnifies all Members against all costs, liabilities, expenses and claims Members may incur as a direct or indirect result of advice given in their capacity as Members. This indemnity only applies to circumstances where a Member has acted in good faith and in performance or intended performance of a Specialist Advisory Committees’ function.

4   Membership

4.1   Te Tiriti o Waitangi expectations

4.1.1   As a Crown Entity, Pharmac understands, and is committed to its obligations and expectations under Te Tiriti o Waitangi. This commitment extends to representation on Specialist Advisory Committees.

4.1.2   In so far as possible[7], membership of Specialist Advisory Committees will include a senior health practitioner who is Māori.

4.1.3   Pharmac is in the early stages of embedding te Tiriti into its policy and practice. In alignment with Pharmac’s Te Whaioranga strategy, the following principles will guide Specialist Advisory Committees as appropriate in providing clinical advice to Pharmac. 

Tino rangatiratanga

We recognise and respect the right of Māori to have control over their own health and wellbeing. We support Māori in the exercise of tino rangatiratanga, through self-determination and mana motuhake in the design, delivery, and monitoring of our work. We build enduring relationships and partnerships with our te Tiriti partners.

Equity

Māori are our priority population for all equity work. We consider inequitable access to medicines and poor health outcomes for Māori to be unfair, unjust, and avoidable and we actively work to achieve equitable health outcomes for Māori.

Active protection

Alongside our commitment to equity, we are well informed on the extent and nature of Māori health outcomes and what is being done to achieve Māori health equity. We actively protect tino rangatiratanga through increasing Māori participation in governance, leadership, management, and decision making at all levels of Pharmac. We ensure mātauranga Māori is given respect in any decision-making process.

Options

We deliver for and work with whānau Māori in a sustainable, enduring and culturally appropriate way that recognises and supports the expression of mātauranga Māori. 

Partnership

We work in utmost good faith with Māori in the governance, design, delivery, and monitoring of our work to ensure our mutual goals are met. We ensure our governance and management structure guarantees we have capability and capacity to deliver on our commitments. We continually broaden our understanding of te ao Māori and build our capability to deliver on all our priorities.

4.2         Health Equity 

4.2.1   Consistent with Pharmac’s strategic direction, Pharmac requires Members to bring an understanding of, and commitment to, achieving health and medicines access equity. 

4.2.2   Specialist Advisory Committee membership recruitment processes will strengthen the health and medicines access equity expertise of each Specialist Advisory Committee. 

4.3   Diversity on Specialist Advisory Committees

4.3.1   Pharmac is committed to ensuring that decisions on pharmaceuticals meet the needs of all New Zealanders, across the range of patients, whānau and society. In so far as possible, Specialist Advisory Committee membership should reflect the diversity of Aotearoa New Zealand, particularly with respects to (but not confined to) gender and ethnicity.[8] 

4.3.2   Pharmac will actively promote the diversity of Specialist Advisory Committee membership in the appointment process.

4.4   Recruitment and appointment of Specialist Advisory Committee Member 

4.4.1   Specialist Advisory Committee Members (including the Specialist Advisory Committee Chair and Specialist Advisory Committee Deputy Chair) are to be appointed by Pharmac. In doing so Pharmac may be guided by the recommendations of the PTAC Chair and Pharmac staff.[9] 

4.4.2   In general, Specialist Advisory Committees are weighted towards senior health practitioners (who may not be medical practitioners) with relevant expertise and who work within the publicly funded health sector, with experience and knowledge of pharmaceuticals and their therapeutic indications in relevant particular therapeutic areas. 

4.4.3   Specialist Advisory Committees will also have at least one PTAC Member, who will usually act as the Specialist Advisory Committee Chair. Specialist Advisory Committees will also have a Deputy Chair who is usually a Member of PTAC. 

4.4.4   Members are usually appointed for a term of three years. 

4.4.5   Membership of each Specialist Advisory Committee will be published on the Pharmac website:

4.5   Consumer Member 

4.5.1   Specialist Advisory Committees may have one or more members who is a consumer, to provide a consumer perspective to Specialist Advisory Committee This Member is appointed in accordance with section 4.4.1. 

4.5.2   If appointed, the Consumer Member may participate in the discussions at the PTAC meeting and may also vote on any matter being considered at the meeting. 

4.5.3   The Consumer Member is bound by these Terms of Reference. 

4.6   Resignation, renewal, and termination of Specialist Advisory Committee Members

4.6.1   Members may resign at any time by notice in writing in accordance with the appointment protocol for clinical advisory committee members.

4.6.2   A Specialist Advisory Committee Member's appointment may be:

a)   renewed or extended by Pharmac

b)   terminated by Pharmac without any right of compensation[10].

4.7   Temporary Members of Specialist Advisory Committee  

4.7.1   Temporary Members may be appointed to Specialist Advisory Committees by Pharmac for such terms and on such conditions as Pharmac determines appropriate in order to fill any casual vacancy. In doing so Pharmac may have regard to the recommendations of the PTAC Chair and Pharmac staff. 

4.8   Dissolving Specialist Advisory Committees

4.8.1   Specialist Advisory Committees established by Pharmac can be dissolved by the Pharmac Board at any time. In doing so Pharmac may have regard to the recommendations of the PTAC Chair and Pharmac staff. Pharmac will advise the relevant Specialist Advisory Committee Chair in writing of its intention to dissolve a Specialist Advisory Committee.  

5   Fees and expenses

5.1.1   Members will be remunerated in recognition of the services they provide to Pharmac, including attendance at meetings, time spent preparing for meetings and for performing any other work as requested by Pharmac.

5.1.2   The Public Services Commission administers the Cabinet Fees Framework which determines the level of fees paid, including any exceptions. 

5.1.3   Members are advised of the fees upon appointment to a Specialist Advisory Committee. 

5.1.4   Pharmac will cover travel and accommodation expenses for Members to attend meetings[11] but will not cover travel time or locum costs as per the Pharmac Travel Policy for Board and Committee Members.

6   Responsibilities of Members

6.1   Responsibilities of Specialist Advisory Committee Chair

6.1.1   The key responsibilities of a Specialist Advisory Committee Chair are to:

• review the agenda for the Specialist Advisory Committee meetings (Pharmac staff will plan and draft the agenda)
• presiding at each meeting of the Specialist Advisory Committee
• where relevant, representing the Specialist Advisory Committee, and the Specialist Advisory Committee’s consensus view and recommendations, at meetings of PTAC[12]
• other administrative tasks as set out in the Member Handbook. 

6.2   Responsibilities of Deputy Chairs of Specialist Advisory Committee 

6.2.1   The Deputy Chair is responsible for acting as the Chair of the Specialist Advisory Committee when the Chair is unable or delegates this role to the Deputy Chair. 

6.3   Responsibilities of all Members 

6.3.1   The key responsibilities of all Members are:

• maintaining professional registration and credentialling
• complying with all obligations set out in the Crown Entities Act 2004 and any other legal requirements
• complying with the obligations set out in this Terms of Reference
• providing objective advice that is free, frank, constructive and collegial, and without bias, or the perception of bias, under Pharmac’s decision making criteria and consistent with Pharmac’s statutory objective. 

6.3.2   Complying with all relevant polices and responsibilities as set out in the Member Handbook. 

6.4   Interest Reporting 

6.4.1   Members are to, at all times, fully disclose and appropriately manage any interests and conflicts of interest in the performance of their duties and obligations, consistent with their role as Members of a Committee of a statutory entity. Members are to avoid, to the greatest extent possible, any conflict with the performance of their duties and obligations as Members. The legislative requirements for disclosure and management of conflicts are set out in Appendix One. Section 62 of the Crown Entities Act 2004 sets out the legal definition of being “interested in a matter”. Further guidance on this issue is set out in the Member Handbook. 

6.4.2   A Member who reasonably believes they may have an actual or potential conflict of interest is to disclose the nature of that interest to the Specialist Advisory Committee Chair (via the Specialist Advisory Committee Coordinator) as soon as practicable after they become aware of it. 

6.4.3   Where a Member declares or discloses an interest of any kind or an actual or potential conflict of interest, this shall be recorded in an interest register, which is to be circulated prior to each meeting of the Specialist Advisory Committee. The interests register is to be considered and confirmed as up to date at the commencement of each meeting. The interests register is managed by Pharmac staff. 

6.4.4   Where a Member is “interested in a matter” (as defined in section 62 Crown Entities Act 2004) relating to Pharmac, they must not vote or take part in any discussion or decision of the Specialist Advisory Committee relating to the matter, or otherwise participate in any activity of Pharmac that relates to the matter, unless permitted by the Pharmac Board Chair (including under any standing permission issued by the Pharmac Board Chair). The Advice Record of the meeting will record this fact. 

6.4.5   The Member is to be disregarded for the purposes of forming a quorum for that part of the Specialist Advisory Committee meeting during which a discussion or recommendation in relation to the matter occurs or is made. If a quorum cannot be maintained, then the relevant matter is to be deferred to the next meeting. 

6.4.6   Should the Specialist Advisory Committee Chair (or Deputy Chair, when the Chair is “interested in a matter”) consider that it is in the public interest to permit one or more Members, or Members with a specified class of interest, to vote or take part in any discussion or decision of Specialist Advisory Committee relating to that matter, or otherwise participate in any activity of Pharmac that relates to that matter, they should apply for such permission from the Pharmac Board Chair through the PTAC Chair. The Pharmac Board Chair may give such permission if they are satisfied it is in the public interest to do so and may state conditions that the Member(s) must comply with. 

6.4.7   Where the Pharmac Board Chair determines that it is “in the public interest” for a Member to continue to participate in a matter, despite any declared conflict of interest, this will be documented in the Advice Record.

6.4.8   The Pharmac Board Chair has authority to make a final determination about the handling of any actual or potential conflict of interest and, in his or her absence, the Chief Executive.

6.5   Confidentiality

6.5.1   Subject to sections 7.5.3 and 7.5.4, and subject to any public law obligations of Pharmac in relation to the disclosure of information (including under the Official Information Act 1982), all information, documents and other material relating to matters on a Specialist Advisory Committee agenda, as well as the proceedings of a Specialist Advisory Committee meeting, are confidential to the Specialist Advisory Committee and to Pharmac Members must comply with any communications regarding confidentiality obligations issued by Pharmac and will, if required, sign confidentiality undertakings. 

6.5.2   Members are required to store all material received from Pharmac in a secure place until the relevant Advisory Record has been published, after which time Members must either destroy the material (by secure destruction) or return it to Pharmac in accordance with any instruction from Pharmac. 

6.5.3   Members may confirm that Pharmac has received a Proposal once details of the Proposal have been published on Pharmac’s website. Members may discuss such Proposals with colleagues where Members believe it would assist to obtain information on the use, efficacy, adverse effects etc of the pharmaceutical(s) in question. Members may also discuss Proposals with other third parties as outlined in section 2.2.4. Any action taken by Members under section 7.5.3 is subject to compliance with the Privacy Act 2020 and the Health Information Privacy Code 2020, and maintenance of confidentiality regarding commercial information. 

6.5.4   Once a Published Advice Record has been made available on the Pharmac website, Members may discuss with colleagues matters considered at the meeting but only on a general basis and only to the extent of the contents of the Published Advice Record. 

6.6   External Communications and Public Statements 

6.6.1   Members may only speak or write to the media or in public fora in relation to the activities of a Specialist Advisory Committee or Pharmac and any matters discussed at or considered by the Specialist Advisory Committee at their meetings if they have the prior agreement of the PTAC Chair and the Pharmac Chief Executive (which may be communicated via Pharmac staff). This restriction includes when speaking to patient interest groups and to pharmaceutical suppliers, signing petitions, letters to newspapers, and co-authoring articles for publication in academic journals and other settings. 

6.6.2   Members may only report to their professional associations in relation to the activities of a Specialist Advisory Committee or Pharmac or any matters discussed at or considered by Specialist Advisory Committee at their meetings, if they have the prior agreement of the PTAC Chair and the Pharmac Chief Executive (which may be communicated via Pharmac staff). This restriction includes when speaking with colleagues, people, or groups, other than when directly seeking perspectives/advice to inform items for discussion in meetings. 

6.6.3   Subject to section 7.6.1 and 7.6.2, when speaking or writing in public fora (including signing petitions, letters to newspapers, articles in academic journals), Members need to clear that they will be doing so in their own private capacities as clinicians, and not as being a Member of a Specialist Advisory Committee.

7   Management of Meetings

7.1   Meetings of Specialist Advisory Committees 

7.1.1   Specialist Advisory Committees will have formal meetings (either via a face-to-face meeting or via Remote Media Conference) on an as-needs basis as determined by Pharmac. This frequency and consistency will vary by committee depending on the advice needed by Pharmac. 

7.1.2   The quorum for Specialist Advisory Committee meetings is three Members and must include at least two non-PTAC Members and one PTAC Member (who may be the Specialist Advisory Committee Chair). [13] 

7.1.3   Subject to compliance with these Terms of Reference, Specialist Advisory Committees may regulate their internal procedures in such manner as they see fit. 

7.2   Observers 

7.2.1   At the discretion of the Specialist Advisory Committee Chair and Pharmac staff, observers may be given permission to attend meetings of Specialist Advisory Committees. These observers are not Members and, unless the Specialist Advisory Committee Chair of the meeting otherwise agrees, these observers will not have any rights to speak at or otherwise participate in the meeting. 

7.2.2   Observers are required to sign confidentiality undertakings and declare any relevant interests they may hold, prior to attending any Specialist Advisory Committee meeting. The attendance of an observer at a meeting will be documented in the Advice Record. 

7.2.3   Observers should not, by their presence, affect any recommendations of Specialist Advisory Committees, by either influencing or constraining discussion at any Committee meeting. If the Specialist Advisory Committee Chair determines that the presence of an observer is having such an effect, the Chair may require the observer to leave the meeting. 

7.3   Additional Subject Matter Expertise 

7.3.1   At the discretion of the Specialist Advisory Committee Chair and Pharmac staff, additional subject matter experts may be given permission to present (either in person or via Remote Media Conference) on specific issues being considered by the Specialist Advisory Committee. Additional subject matter experts can speak on the specific issues being considered. They are only to be present for the relevant portion of the meeting and cannot be present when the Members make a recommendation. 

7.3.2   Additional subject matter experts are required to sign confidentiality undertakings and declare any relevant interests they may hold, prior to attending any meeting of a Specialist Advisory Committee. The attendance of an additional subject matter experts at a meeting will be documented in the Advice Record. 

7.4   Consumer Perspective 

7.4.1   To help inform the Specialist Advisory Committee consideration of Pharmac’s decision-making framework, they may consider relevant consumer perspectives with respect to a Proposal under consideration. Consumer perspectives can be provided through submissions received and correspondence. 

8   Variation of Terms of Reference

8.1.1   These Terms of Reference set out Specialist Advisory Committees roles and responsibilities but are not intended to cover every eventuality. They are to be interpreted flexibly and pragmatically, to allow Specialist Advisory Committees the scope to adapt as the need arises. 

8.1.2   These Terms of Reference may be varied from time to time or revoked (which may, where Pharmac considers it appropriate, involve consultation), by the Pharmac Board.

9   Disputes of Specialist Advisory Committee in relation to these Terms of Reference

9.1.1   Any dispute or disagreement as to the meaning or application of any section in these Terms of Reference is to be determined by the Pharmac Chair, whose decision is final.

10   Review of these Terms of Reference

10.1.1   These Terms of Reference will be reviewed every three years.

Footnotes

[1] In development

[2] Clause 14(1)(a), Schedule 5, Crown Entities Act.

[3] Possible amendments to the Pharmaceutical Schedule are outlined in the Pharmac Operating Policies and Procedures (OPPs). 

[4] For example, changes may include typographical errors, facts recorded incorrectly or to clarify any ambiguity.

[5] When attending Specialist Advisory Committee meetings, the Pharmac Board Chair will also remain mindful of the accountabilities of the Specialist Advisory Committee to Pharmac, including consequent perceptions and unconscious impacts on the Specialist Advisory Committee Members’ comfort and ability to provide objective advice freely and frankly. The Board Chair and Specialist Advisory Committee Chair will take whatever measures necessary to avoid the Board Chair’s presence inadvertently influencing or constraining discussion.

[6] The only exception to this is the Tender Medical Evaluation Advisory Committee (formerly the Tender Medical Subcommittee), which may have a PTAC Member but this is not an absolute requirement.

[7] Recognising it may not be possible to seek this expertise for every specialist area.

[8] Pharmac values diversity and inclusion across all gender identities, ages, ethnicities, disabilities, sexual orientations, cultures, religions, and groups experiencing disparities. We recognise that it may be difficult to seek this representation across all specialist areas.

[9] Clause 14(1)(a), Schedule 5, Crown Entities Act 2004.

[10] Section 43, Crown Entities Act 2004.

[11] Travel & Expense Policy for Board Members and Committee Members

[12] Such representing, however, is notwithstanding their own separate views as a separate member of PTAC, and is mindful of them having the dual roles when attending PTAC meetings. This can be managed, for example, by the person speaking twice, once as the Specialist Advisory Committee Chair, the other separately as an individual Member of PTAC

[13] The only exception to this is the Tender Medical Evaluation Advisory Committee (formerly the Tender Medical Subcommittee), which does not require a PTAC Member for a quorum.