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How does the operation of PHARMAC's 'Community Exceptional ...

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physician level must be considered after Medsafe had declared <strong>the</strong> drug safe to<br />

use. He believed that <strong>the</strong> Medsafe issue did not alter <strong>the</strong> lawfulness or legal<br />

rationality <strong>of</strong> <strong>the</strong> doctors’ decisions to prescribe.<br />

Judge Comments on PHARMAC’s Consultation Processes<br />

Justice Gendall also had concluding remarks to make about <strong>the</strong><br />

appropriateness <strong>of</strong> <strong>the</strong> consultation processes used by PHARMAC. His<br />

remarks are divided into two sections; consultation with DHBs and consultation<br />

with <strong>the</strong> public.<br />

Justice Gendall did not accept Helen Cull’s view that PHARMAC allowed <strong>the</strong><br />

DHBs to dictate its decision. He did however feel that PHARMAC should not<br />

have asked <strong>the</strong> DHBs to support its decision. He believed <strong>the</strong> DHBs should<br />

have been asked a more open question about affordability.<br />

The Judge did suggest that PHARMAC desist from its policy <strong>of</strong> seeking <strong>the</strong><br />

support <strong>of</strong> DHBs before deciding to list or not to list a drug for funding.<br />

Primarily, this was because <strong>the</strong> DHBs ultimately fund any listed drug, not<br />

PHARMAC. Consequently, <strong>the</strong> DHBs may be seen to have a vested interest in<br />

agreeing with <strong>the</strong> preliminary decision not to fund. He also felt that PHARMAC<br />

was unwise to ask for support for <strong>the</strong>ir proposal because in doing so <strong>the</strong>y gave<br />

<strong>the</strong> impression that <strong>the</strong> PHARMAC Board was not able to act independently.<br />

Justice Gendall said that he found PHARMAC’s community consultation<br />

processes wanting and this caused <strong>the</strong> reviewable error and <strong>the</strong> setting aside <strong>of</strong><br />

<strong>the</strong> decision <strong>of</strong> <strong>the</strong> PHARMAC Board not to fund Herceptin for twelve months.<br />

In directing PHARMAC to reconsider <strong>the</strong> above decision, he directed that<br />

PHARMAC must consult widely with <strong>the</strong> public, clinicians, and o<strong>the</strong>rs who had a<br />

legitimate interest and/or were likely to be affected by <strong>the</strong> Roche Company’s<br />

application for funding for Herceptin for twelve month treatment regimes.<br />

He was clear not to deliver his view on whe<strong>the</strong>r or not Herceptin should or<br />

should not be funded for twelve months (or indeed any o<strong>the</strong>r period) because<br />

such a direction would be outside <strong>the</strong> scope <strong>of</strong> a judicial review. Conversely,<br />

his direction as to <strong>the</strong> consultation process was made clear to PHARMAC in <strong>the</strong><br />

judgment.<br />

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