Supply of various vaccines

Answers to questions will be provided through the Government Electronic Tenders Service (GETS). PHARMAC will also post any addenda through GETS. We encourage interested suppliers to register with GETS and subscribe to this RFP to be kept up to date.

If you wish to submit a proposal, you must submit it to PHARMAC via the Government Electronic Tenders Service (GETS) no later than 4.00 p.m. (New Zealand time) on Thursday 24 March 2016.

If you have any questions about this RFP you should submit them via GETS or alternatively by email procurement@pharmac.govt.nz.

Please note that any additional information that PHARMAC gives to you as a result of your enquiry will also be given by PHARMAC to other potential suppliers, if PHARMAC determines that such information is material.

PHARMAC is interested in considering any proposal from suppliers of various vaccines as listed in Tables 1 and 2 below:

Table 1. Currently funded vaccines

Table 2. Currently unfunded vaccines

See the eligibility criteria below and possible amendments following this RFP.

Background to RFP

PHARMAC first issued a RFP for the supply of vaccines in June 2013, which resulted in agreements with five suppliers. Sole supply status for vaccines covered by those agreements expires on 30 June 2017.

PHARMAC is now seeking proposals for the supply of the vaccines as stated in Table 1 and 2 above, including proposals for sole supply during the period 1 July 2017 to 30 June 2020.

The New Zealand National Immunisation Schedule sets out the series of vaccines that are offered free to babies, children, adolescents and adults(external link). 

In preparation for this RFP, PHARMAC requested that suppliers submit applications to PHARMAC for funding of any new or alternative brands of vaccines they may have available for supply from July 2017 and any proposed changes to the funding eligibility criteria for current listings and/or the Immunisation Schedule.

PHARMAC subsequently sought clinical advice from the Immunisation Subcommittee (Subcommittee) of PTAC on:

• the suitability of new vaccines recently registered by Medsafe or planned to be registered in time for 2017 supply;
• interchangeability of alternative brands; and
• possible funding eligibility criteria changes.

The Immunisation Subcommittee of PTAC minutes are available on our website.

Below are some factors that you should consider in preparing a response to this RFP.

Eligibility Criteria

The current eligibility criteria for funded Vaccines can be found on our website.

As part of this RFP process, we may consider amending the eligibility criteria for the vaccines described below:

Varicella vaccine

Varicella vaccination is currently funded for high risk patients. PHARMAC is interested in proposals that would enable the funding of a universal childhood varicella single dose vaccination, possibly with catch-up programme.

Human papillomavirus vaccine (HPV)

HPV is currently funded for eligible females aged under 20 years and for specified high risk patients. The normal administration is for three doses to be administered over six months, to females aged 12.

PHARMAC is interested in proposals that would enable universal access as follows:

• Reducing the number of doses to two, for girls up to the age of 15.
  • Note that the three dose vaccination would remain funded for females over the age of 15 up to 20 years as well as the high risk patients as per the current eligibility criteria.
• Widening access to males aged 11-13.

Zoster vaccine

PHARMAC is interested in proposals that would enable funding of a single adult zoster vaccination for all patients at 65 years of age (‘universal vaccination)’, possibly with a catch-up programme for all adults who are over 65 years at the time the vaccine was listed.

Meningococcal C congugated vaccine

Meningococcal C congugated vaccination is currently funded for high risk patients. PHARMAC is interested in proposals that would enable the funding of a universal childhood meningococcal C vaccination, possibly with a catch-up programme.

Diphtheria, tetanus and pertussis vaccine

PHARMAC currently funds both:

• an adult diphtheria and tetanus vaccine (ADT Booster); and
• a diphtheria, tetanus and pertussis vaccine (Boostrix).

Each vaccine is funded under different eligibility criteria. PHARMAC is interested in proposals that would enable the funding of a single vaccine to cover both sets of current eligibility criteria (i.e. the eligibility criteria would be merged).

Delivery

PHARMAC will place purchase orders for vaccines with the supplier. Such purchase orders will be required to be delivered to a designated delivery point, currently PHARMAC’s storage and distribution service provider as follows:

PHARMAC c/o HealthCare Logistics
HealthCare Logistics
58 Richard Pearse Drive, Airport Oaks
Mangere
Auckland 2022
New Zealand

Contract duration

Any resulting contract(s) from this RFP process would be evergreen and would include  a maximum sole supply period of three years, from no earlier than 1 July 2017 to no later than 30 June 2020. During this period the eligibility criteria may change and any contract(s) resulting from this process would provide for this (see Schedule 5).

Types of proposals sought

Sole Supply

Sole supply status would entail both sole subsidised supply in the Community via a listing in Section I of the Pharmaceutical Schedule (i.e. the National Immunisation Schedule) and hospital supply status in Part II of Section H of the Pharmaceutical Schedule.

PHARMAC is willing to consider the following types of proposals for sole supply status, where the supplier is expected to meet the demand for all doses of that vaccine, from no earlier than 1 July 2017 to no later than 30 June 2020:

1. Proposals for a single vaccine with sole supply status.
2. Proposals that bundle multiple vaccines with sole supply status.

Suppliers may submit multiple proposals for a single vaccine or bundles of vaccines as described in a. and b. above.

Please note if you wish to submit a bundle proposal for vaccines, you must also submit at least one individual proposal for each of the vaccines included in the bundle.

Outbreak supply

1. PHARMAC also seeks proposals for the supply of the vaccines stated below to be used in the event of a disease outbreak. Suppliers of such vaccines would be required to guarantee delivery within a short timeframe.
   1. Meningococcal A, C, Y and W135 or Meningococcal C conjugate vaccines
   2. Measles
   3. Hepatitis A
2. Proposals should outline the supplier’s or nominated distributor’s capabilities in meeting any delivery timeframes, requirements (e.g. cold chain distribution) and its ability to comply with any national or international standards or guidelines.
3. Any contract(s) resulting from this RFP process, for any of the vaccines listed in Table 1 or 2, would include provisions allowing exclusivity to be suspended in the event of a pandemic and/or local outbreak (see Schedule 5). The proposed provisions reflect compliance with any Ministry of Health and WHO requirements with regard to pandemic supply situations.

Other types of proposals

Suppliers may also like to submit other types of proposals. Possibilities include:

1. Proposals that include rebate arrangements, where the purchase price may be different from the net price offered to PHARMAC for the vaccine.
2. Proposals that would enable PHARMAC to fund changes to eligibility criteria as outlined in Schedule 1 eligibility criteria.

Please note:

• If you wish to submit a proposal for widened access, you must also submit a proposal for the current access criteria.

Proposal pricing

When submitting pricing please note the following:

1. PHARMAC is seeking a purchase price from suppliers for each vaccine, this is the price that PHARMAC will be invoiced by a supplier, which is expected to be confidential between the supplier and PHARMAC.
2. Any vaccine listed as a result of this RFP in Section I or Part II of Section H of the Pharmaceutical Schedule will have a publically listed price of $0.00 NZD to reflect the fact that the vaccine is provided free to vaccinators as no subsidy is claimed in respect of the cost of the vaccine.
3. PHARMAC also requests suppliers provide a manufacturer’s price, which is not confidential that could be listed in Section I or Part II of Section H of the Pharmaceutical Schedule as a result of any pilot for vaccine distribution, which occurs.

For the avoidance of doubt the manufacturer’s price may be the same as the purchase price; this will depend on a supplier’s sensitivity around the price for the vaccine publically being listed.

PHARMAC is not willing to consider the following types of proposals:

1. Any proposal that involves pharmaceuticals, vaccines or services other than the:
   1. vaccines set out in Schedule 1, Table 1. Currently funded vaccines; or
   2. vaccines set out in Schedule 1, Table 2. Currently unfunded vaccines; or
   3. vaccines for disease outbreaks described in clause 3.2 above.
2. Proposals that include expenditure risk sharing mechanisms based on patient level data.

Subject to Proposal pricing above, PHARMAC is open to considering any other types of proposals that you may wish to put forward.

Please note that supplier(s) of any vaccines will be required to continue to supply beyond any sole supply period ending on 30 June 2020. Any resulting contract(s) will specify the supply arrangements after the sole supply period.

Schedule 2: RFP process

PHARMAC expects to follow the process set out below in the sequence indicated.

Submission

1. You may submit more than one proposal. Each proposal will be considered as a separate proposal.
2. All proposals must be submitted to PHARMAC via the Government Electronic Tenders Service or GETS website for the attention of Christine Chapman, Senior Therapeutic Group Manager (the Government Electronic Tenders Service or GETS means the electronic system operated by the Ministry for Business, Innovation and Employment available at https://www.gets.govt.nz/ExternalIndex.htm(external link)).
3. Proposals must be submitted no later than 4.00 p.m. (New Zealand time) on Thursday 24 March 2016. Late proposals will only be considered at PHARMAC’s discretion, taking into account the need for fairness to other suppliers and integrity of the RFP process.
4. You cannot withdraw your proposal, once submitted, while the RFP process is continuing.
5. If you have any questions about this RFP you should submit them via GETS or alternatively by email to procurement@pharmac.govt.nz.

Please note that any additional information that PHARMAC gives to you as a result of your enquiry will also be given by PHARMAC to other potential suppliers, if PHARMAC determines that such information is material.

Evaluation

1. Following the deadline for submitting proposals, an Evaluation Committee comprising PHARMAC staff will evaluate each proposal to select its preferred proposal(s). The Evaluation Committee may also include staff from the Ministry of Health.
2. The Evaluation Committee will evaluate proposals in light of PHARMAC’s statutory objective which is “to secure for eligible people in need of pharmaceuticals, the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of funding provided”. In doing so the Evaluation Committee will be guided by the decision mechanism set out in PHARMAC’s then current Operating Policies and Procedures (OPPs), as published on PHARMAC’s website (www.pharmac.govt.nz), to the extent applicable. The information to be taken into account in applying the decision mechanism by the Evaluation Committee will include, in particular:
   1. any clinical advice from PTAC or its relevant subcommittee or other appropriate clinical advisors sought by PHARMAC; and
   2. information provided in the proposal form (Schedule 4 of this document); and
   3. suitability for the National Immunisation Schedule.
3. Please note that from 1 July 2016 PHARMAC is changing the way in which it makes decisions, instead of the current Decision Criteria it will be using the Factors for Consideration (FFC). Whilst it is PHARMAC’s expectation that decisions arising out of this RFP will occur prior to 1 July 2016, please be aware of the FFC.
   This may be particularly relevant for any new vaccine that has not previously been reviewed by PTAC or the Immunisation Subcommittee.
4. Each proposal will be evaluated on the basis that the price offered, the expenditure entailed, and any other terms included in the proposal, are the best that the supplier is able to offer. If you do not put forward your best terms you risk having your proposal excluded at the evaluation stage.
5. PHARMAC is not bound to select the lowest priced proposal or any proposal.

Negotiation

1. PHARMAC may negotiate with the submitter(s) of one or more preferred proposals, in the latter case whether or not the acceptance of either supplier’s proposal would exclude acceptance of the other proposal.
2. Negotiations will proceed on the basis that PHARMAC’s proposed terms and conditions for the supply of vaccines, which are stated in Schedule 5 and are available via GETS, will apply. This is without limitation to other clauses which may be necessary, as stated in Annex Four of the terms and conditions, for example but not limited to listing, eligibility criteria, sole supply and rebates.
3. Given that PHARMAC expects your proposal to be the best you can offer, PHARMAC does not intend to initiate negotiation with you on price. However, PHARMAC does not exclude the possibility that the final price agreed will be different from the price put forward in your proposal, as a result of the impact that other negotiated terms may have on price.
4. PHARMAC may negotiate and enter into a provisional agreement with a preferred supplier(s) on whatever special terms, in addition to those set out in Schedule 5, PHARMAC considers appropriate.
5. If PHARMAC and the supplier(s) are unable to reach a provisional agreement within what PHARMAC considers to be a reasonable time, PHARMAC may terminate those negotiations and negotiate with a different supplier(s).

Consultation and approval

1. Any provisional agreement will be conditional on consultation with suppliers and other interested parties, to the extent PHARMAC considers consultation to be necessary or appropriate, and on Board approval (or approval by the Board’s delegate acting under delegated authority).
2. PHARMAC will not consider any counter-offers received during consultation.
3. The provisional agreement and responses to consultation will be considered by PHARMAC's Board (or by the Board’s delegate acting under delegated authority) in accordance with the decision mechanism in PHARMAC’s then current OPPs.
4. If the Board or its delegate does not approve the provisional agreement, then PHARMAC may initiate negotiations for a provisional agreement with any other supplier(s).
5. The RFP process will be complete once PHARMAC has notified suppliers of either:
   1. the Board's or its delegate's decision to accept a negotiated agreement; or
   2. the termination of the RFP process.

Miscellaneous

1. PHARMAC reserves the right:
   1. to make such adjustments to the above RFP process as it considers appropriate, at any time during the process, provided that it notifies suppliers affected by those changes;
   2. not to accept any proposal;
   3. to seek clarification of any proposal;
   4. to meet with any supplier in relation to its proposal;
   5. to suspend this RFP process. For example, if during the RFP process (and before a provisional agreement is entered into) it becomes apparent to PHARMAC that further consultation is appropriate or required we may suspend the RFP process in order to consult. In this situation we may ask you to adapt and resubmit your proposal in light of consultation, or alternatively we may request that new proposals be submitted;
   6. to terminate this RFP process at any time, by notifying suppliers who submitted proposals, and, following termination, to negotiate with any supplier(s) on whatever terms PHARMAC thinks fit; and
   7. to re-advertise for proposals.
2. PHARMAC may consult or seek clinical advice from PTAC, its relevant sub-committee or other appropriate clinical advisors sought by PHARMAC, at any stage of the RFP process. PHARMAC will notify you if the clinical advice results in any changes to the terms of the RFP.
3. You must not initiate or engage in any communication with other suppliers in relation to the RFP, whether before or after submitting their proposal(s), until such time as a provisional agreement is accepted by PHARMAC’s Board or the Board’s delegate.
4. You must not at any time initiate any communication with PHARMAC’s directors or officers, the Ministry of Health (including its operating unit Medsafe), the Minister of Health (or any Associate Ministers) or District Health Boards or advisors to PHARMAC, with a view to influencing the outcome of this RFP process.
5. You must pay your own costs for preparing and submitting your proposal.
6. Proposals are submitted in reliance on your own knowledge, skill, and independent advice, and not in reliance on any representations made by PHARMAC.
7. Your submission of a proposal will be taken as acceptance of the terms contained in this RFP. PHARMAC may exclude your proposal if you do not comply with any of the terms contained in this RFP.
8. This is an RFP and not a tender. Your proposal is not an offer capable of being converted into a contract for the supply of a vaccine by PHARMAC's apparent acceptance and instead a separate agreement needs to be negotiated.
9. PHARMAC is not liable in any way whatsoever for any direct or indirect loss (including loss of profit), damage or cost of any kind incurred by you or any other person in relation to this RFP.
10. PHARMAC will consider your proposal and information exchanged between us in any negotiations relating to your proposal, excluding information already in the public domain, to be confidential to us and our employees, legal advisors and other consultants, the Ministry of Health and DHBs (Confidential Information). However, you acknowledge that it may be necessary or appropriate for PHARMAC to release Confidential Information:
    1. pursuant to the Official Information Act 1982; or
    2. in the course of consultation on a provisional agreement entered into with a supplier; or
    3. in publicly notifying any approval by the PHARMAC Board of that agreement; or
    4. otherwise pursuant to PHARMAC’s public law or any other legal obligations.

PHARMAC may consult with you before deciding whether to disclose Confidential Information for the purposes described in sub-clauses (i) to (iv) above. You acknowledge, however, that it is for PHARMAC to decide, in its absolute discretion, whether it is necessary or appropriate to disclose information for any of the above purposes, provided that PHARMAC shall act in good faith in disclosing any Confidential Information.

Anticipated timetable

1. Following receipt of proposals, PHARMAC anticipates:
   1. the Evaluation Committee evaluating proposals in April 2016;
   2. negotiating with submitter(s) of one or more preferred proposals in April/May 2016;
   3. consulting on a provisional agreement in May/June 2016;
   4. PHARMAC’s Board, or the Board’s delegate, considering this provisional agreement in or after June/July 2016,
      
      provided that the above time frames are only approximate and may be extended, without notice being required from PHARMAC, if any stages of the RFP process take longer than anticipated.
2. Under this indicative timetable, PHARMAC expects to have changes made to the Pharmaceutical Schedule by 1 July 2017.
3. Please note that if a proposal for sole supply is accepted, the date of implementation may be later to allow for an orderly transition to any sole supply arrangement.

Schedule 3: Current listing and market information

The following information relates to the estimated subsidised market size of vaccines under the current eligibility criteria and restrictions.

The information is approximate and indicative only. PHARMAC makes no representation as to the accuracy of this information or as to the level of sales or likely sales of vaccines and, while PHARMAC has taken all reasonable care in preparing the information set out below, it accepts no liability for any errors or omissions in the information. PHARMAC is not obliged to notify you in the event of any change to the figures below.