RFP - Supply of medical devices used in the prevention of venous thromboembolisms

Schedule 1: Medical Devices, background to RFP and types of proposals sought

1. Medical Devices

PHARMAC is interested in considering any proposal from suppliers of medical devices used in the prevention of venous thromboembolisms (VTEs), such as Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) for use in DHB Hospitals. These devices include:

• Graduated Compression Stockings (GCS);
• Intermittent Pneumatic Compression (IPC) devices;
• Venous Foot Pump (VFP) devices;
• Mobile Vascular Compression devices (portable, battery powered IPC devices);
• Neuromuscular Electrical Stimulation (NMES) devices; and
• associated consumables and related products required to be used with these devices.

2. Background to RFP

The background to this RFP is as follows:

(a) PHARMAC’s role in Medical devices used in the prevention of VTEs

PHARMAC sought feedback from stakeholders in May 2013 on a number of identified medical device categories to commence initial procurement. The ‘mechanical compression devices’ and ‘anti-embolism hosiery’ categories were two of the categories identified. These categories have been combined, with the addition of other devices used in this indication, into a single category to encompass the range of medical devices used in the prevention of venous thromboembolisms (VTEs).

(b) Reasons for running the RFP

PHARMAC is taking a greater role in medical devices to manage the assessment, standardisation, prioritisation and procurement of medical devices for the District Health Boards. The objective of this activity is to help achieve national consistency in managing medical devices, improve transparency of decision-making and improve the cost-effectiveness of public spending to generate savings for re-investment into health.

(c) Impact of RFP

PHARMAC intends to establish listing agreements (National Contracts) with suppliers to gain the best price for medical devices used in the prevention of venous thromboembolisms used in District Health Board hospitals. It is expected that medical devices subject to a listing agreement will be listed in the Schedule. It is also anticipated that multiple suppliers of equivalent products will be listed, where appropriate.

3. Expected outcome of the RFP

1. PHARMAC intends to establish agreements with suppliers in the category of medical devices used in the prevention of VTEs to:
   1. list a range of medical devices available for use in New Zealand in Part III of Section H of the Pharmaceutical Schedule;
   2. secure future supply of medical devices for DHB hospitals at competitive prices;
   3. ensure a clinically appropriate range of medical devices is available to DHBs and patients;
   4. ensure access to an appropriate level of clinical support, education and training for relevant health professionals;
   5. engage and establish relationships with new and current suppliers of medical devices; and
   6. move commercial arrangements of these medical devices into a national framework administered by PHARMAC to create better health outcomes for patients within the funding available in DHB hospitals.
2. PHARMAC recognises that the use of medical devices touches a wide group of health professionals; therefore, in the event an agreement is entered into with a supplier as an outcome of this RFP process and the Medical devices used in the prevention of VTEs are listed in Part III of Section H of the Pharmaceutical Schedule:
   1. the listing shall be non-exclusive and will include pricing and details of the medical devices and associated products;
   2. it is anticipated that multiple suppliers of Medical devices used in the prevention of VTEs will be listed, where appropriate;
   3. it will be discretionary for DHB hospitals to purchase the medical devices and any associated products from the supplier, however where they do, DHB hospitals will be expected to purchase these medical devices under the PHARMAC agreement; and
   4. PHARMAC may offer listing protection in the Pharmaceutical Schedule for a period of up to 3 years.
3. Under the New Zealand Public Health and Disability Act 2000, as well as under DHBs’ Operational Policy Framework, DHBs are required to comply with the Pharmaceutical Schedule as determined by PHARMAC.

4. Types of proposals sought

1. PHARMAC is willing to consider proposals that involve medical devices used in the prevention of VTEs as described in clause 1 above for listing in Part III of Section H of the Pharmaceutical Schedule for use in DHB hospitals; and as specifically set out as in scope:
   1. Graduated Compression Stockings (GCS) and accessories. This includes stockings (off-the-shelf sizes and custom made-to-measure for individual patients), donning aids / butlers to don hosiery, doffing aids / butlers to remove hosiery;
   2. Intermittent Pneumatic Compression (IPC) devices. This includes the pumps / controllers, garments / sleeves / cuffs, tubing sets, and accessories. Note: The scope of IPC devices includes pumps with sequential, graded sequential and uniform pressure cycles;
   3. Venous Foot Pump (VFP) devices. This includes the pumps / controllers, garments / sleeves / cuffs, tubing sets, and accessories;
   4. Mobile Vascular Compression devices. This includes pumps / controllers, garments / sleeves / cuffs, tubing sets, and accessories;
   5. Neuromuscular Electrical Stimulatory (NMES) devices. This includes the motor unit / controller / electrical stimulator, garments / pads / sleeves / cuffs, lead wires, electrodes, and accessories;
   6. Miscellaneous Equipment, Accessories & Related Products. This includes calibration equipment, maintenance equipment, repair equipment, spare parts, service manuals, specialised batteries, and other accessories.
2. PHARMAC is not willing to consider proposals for any other products, including but not limited to the following specified as out of scope:
   1. Medicines (drugs and chemical compounds) used in the prevention of VTEs such as anticoagulants;
   2. Diagnostic Instruments used to measure patient blood flow, such as a hand held vascular dopplers, vascular ultrasound units or a magnetic resonance blood flowmeter;
   3. Devices used to treat embolisms such as veno cava filters or other vascular filters;
   4. Vascular devices primarily used for diagnostic or interventional cardiology, or interventional radiology procedures, such as vascular imaging guidewires;
   5. Compression devices used for purposes other than vascular compression, such as mechanical chest compression devices used for cardiopulmonary resuscitation (CPR), mechanical clam compression used for femoral vascular haemostasis;
   6. Continuous passive machines (i.e. a machine that artificially assists the limb to move in a continuous motion);
   7. Compression bandages used for applying pressure for the purpose of arresting haemorrhage;
   8. Compression bandages and hosiery for the prevention or treatment of venous leg ulcers or lymphoedema;
   9. Compression sportswear;
   10. Cold compression therapy devices for acute soft tissue injury or post-surgical procedures to reduce inflammation;
3. Clinical training, ongoing education or support services.
4. Proposals must meet all the mandatory requirements as set out in the responses column of product information requirements in Schedule 3.

Schedule 2: RFP process

1. 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 GETS no later than 5pm (New Zealand time) on 28 30 June 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.
3. You cannot withdraw your proposal, once submitted, while the RFP process is continuing.
4. If you have any enquiries about this RFP you should submit questions through GETS (www.gets.govt.nz(external link)) or alternatively contact Ryan Graves, (ryan.graves@pharmac.govt.nz).

2. Evaluation

1. Following the deadline for submitting proposals an Evaluation Committee comprising PHARMAC staff will evaluate each proposal to select its preferred proposal(s).
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 Factors for Consideration (FFC) that from 1 July 2016 will form part of PHARMAC’s then current Operating Policies and Procedures (OPPs), as published on PHARMAC’s website (www.pharmac.govt.nz), to the extent applicable. Please note that the FFC reflect a change in the way in which PHARMAC makes decisions, replacing PHARMAC’s existing Decision Criteria from 1 July. Please be aware of the FFC. More information on the FFC can be found on PHARMAC's website.
3. The requirement for PHARMAC to pursue its statutory objective means that particular emphasis will be given to those aspects of proposals which demonstrate “health outcomes”, and those aspects of proposals which demonstrate the impact on the “funding provided” for pharmaceuticals. Those Factors for Consideration which relate directly to these aspects will be given the greatest weight by the Evaluation Committee but all FFC are important.
4. The information to be taken into account in applying the decision mechanism will include, in particular:
   1. information provided by you in accordance with Schedules 3 and 4 of this RFP;
   2. product information requirements as set out in Schedule 3 of this RFP;
   3. ability to provide the appropriate level of clinical support needed for these products, including but not limited to:
      1. training and education in the use and handling of products;
      2. supply chain to support sustainable provision of the goods;
   4. provision of DHB usage data where applicable and reference sites;
   5. any advice received from relevant clinicians and/or DHB staff; and
   6. any other matters that the Evaluation Committee considers to be relevant (provided that PHARMAC will notify such matters and allow an opportunity for submitters of proposals to address them).
5. 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.
6. PHARMAC is not bound to select the lowest priced proposal or any proposal.

3. PHARMAC may request further information

1. PHARMAC may request such further information as it considers necessary from or about you for the purposes of clarifying or evaluating your proposal, including (but not limited to):
   1. product samples, in which case you must supply the requested sample within 10 business days of PHARMAC’s request; and
   2. detailed information about your company structure, credit status and any other relevant company information.
2. If PHARMAC requests further information from or about you, it is not obliged to request the same or any other information from or about any other party, provided that in PHARMAC’s judgment this would not be unfair to any other party.

4. Negotiation

1. PHARMAC may negotiate with the suppliers 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 standard terms and conditions for supply of medical devices, which are available from GETS, will apply.
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 provisional agreement(s) with a preferred supplier(s) on whatever special terms, in addition to PHARMAC’s standard terms and conditions, PHARMAC considers appropriate.
5. If PHARMAC and the supplier(s) are unable to reach a provisional agreement within what PHARMAC considers being a reasonable time, PHARMAC may terminate those negotiations and negotiate with a different supplier(s).

5. 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(s); or
   2. the termination of the RFP process.

6. Miscellaneous

1. PHARMAC reserves the right, having regard to probity principles:
   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 enter into an agreement or arrangement that differs in material respects from that envisaged in this RFP letter;
   6. 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;
   7. 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
   8. to re-advertise for proposals.
2. 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.
3. 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.
4. You must pay your own costs for preparing and submitting your proposal.
5. You must limit the information provided to that which is requested in Schedule 3 and provide it succinctly and clearly.
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 Medical devices used in the prevention of VTEs 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. It is possible that more than one supplier may be awarded a contract as a result of this RFP. Nothing in this RFP prevents PHARMAC from entering into agreements with other suppliers in respect of Medical devices used in the prevention of VTEs or restricts the terms that may be agreed with any other supplier.
11. PHARMAC will consider your proposal and information exchanged between the parties 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 couse 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.

7. Anticipated timetable

1. Following receipt of proposals, PHARMAC anticipates:
   1. the Evaluation Committee evaluating proposals from July – August 2016;
   2. negotiating with submitter(s) of one or more preferred proposal(s) in August - September 2016;
   3. consulting on provisional agreement(s) from September 2016;
   4. PHARMAC’s Board, or the Board’s delegate, considering provisional agreement(s) in or after September 2016,
2. 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.
3. Under this indicative timetable, the earliest that changes to the Pharmaceutical Schedule could be implemented is 1 October 2016.

8. Governing Law

This RFP is governed by New Zealand law, and the New Zealand courts have exclusive jurisdiction in all matters relating to this RFP.