CEO Lesley Clarke moves to new career
The RMI is sorry to see CEO Lesley Clarke leave the pharmaceutical industry, however we wish her well in her new position as general manager of McKesson NZ Ltd.
“Lesley’s contribution to a wide range of issues has been hugely valuable to the industry and the RMI in particular.
During her tenure we have seen the profile of the RMI grow in a very positive manner along with the development and maintenance of warm working relationships throughout the political, official, clinical and patient group sectors,” Dr Pippa MacKay said. |
Lesley Clarke |
“She leaves the RMI in good heart, and we hope that her sterling work towards achieving better access to medicines for New Zealanders will be reflected in the forthcoming Government New Zealand Medicines Strategy.
“This has not been her only focus, and advances have been made on a number of policy and regulatory fronts. Lesley leaves the RMI with a very sound platform for us to build upon in the forthcoming years.”
Lesley agrees that the RMI has come a long way in the four years she has been at its head.
“Specifically I am delighted that so many stakeholders have agreed that the issue of access to medicines needs to be addressed. I do hope that all the work done by many people to create a policy that works for patient outcomes and a better New Zealand will come to fruition. It would be terribly disappointing if after all this work the Government fails to deliver meaningful reform.”
Hon Ken Shirley will take up the role as CEO in early September. |
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MMP headache
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The failure in Parliament to get the numbers to pass the legislation paving the way for the trans-Tasman regulatory body, ANZTPA, will to create headaches for patients, clinicians and the pharmaceutical industry.
There has been a virtual hiatus in the registration of new prescription medicines for just on a year now. Since Medsafe raised the fee by a whopping 800% from August last year, there have been only seven applications for registration of new prescription medicines compared with 17 in 2005/06.
Medsafe fees are a serious issue for the pharmaceutical industry for two reasons.
The first is that they make a large number of medicines uneconomic in our market. PHARMAC’s 2005 analysis showed that 49% of subsidised medicines had annual sales smaller than the $122,625 registration fee.
“Of course fees are only part of the cost of preparing and presenting a registration, so the costs can far outweigh any potential returns from the market for many of the new medicines on offer,” Dr MacKay said.
“Then, after the medicines finally get through the Medsafe process, taking on average over three years to get there, only one in four prescription medicines will ever receive a subsidy from PHARMAC, and then only after an average of a further three years in PHARMAC’s approval process.
“While PHARMAC and others accuse the pharmaceutical industry of profiteering, it is obvious the truth is quite different. The industry operates in a very difficult commercial climate in New Zealand, with large expenses up front, and long waiting times for only a possible positive outcome,” she commented. |
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What now for prescription medicines regulation? |
“Without a robust regulatory process for the assessment and regulation of medicines, the supply of new medicines coming into New Zealand will dry up. Prescription medicines, by their very nature, must be carefully managed,” Dr Pippa MacKay said.
“While the current situation will stop the further embarrassing increase in PHARMAC’s backlog of 30 or so medicines with positive PTAC recommendations that are not yet funded, New Zealanders will be progressively missing out on more and more of the medicines they need.
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Find a way to get the legislation through once the Australian election is over (if the Australian Government is agreeable). |
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Recognise decisions made by other authorities, such the United States’ FDA or the European Union’s EMEA. |
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Beef up MedSafe’s capacity and reduce its fee structure. |
“Doing nothing is not an option. The recent revelation that the indicators of worsening heart health amongst New Zealanders are linked by overseas researchers* to cuts in spending on cardiovascular drugs endorses this view.
“So, we already had insufficient funding, unacceptable delays in the subsidisation process, a procurement policy which promotes population-wide use of old, generic medicines and indications of a worsening health status in the population.
“Now we have a situation which effectively shuts out many new and innovative medicines,” Pippa McKay observed.
* Lessons for a national pharmaceuticals strategy in Canada from Australia and New Zealand. Health Outcomes/Public Policy. Jacque LeLorier MD PhD FRCPC, Nigel SB Rawson PhD, in the Canadian Journal of Cardiology, Vol 23, No 9, July 2007.
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