Media Releases
Medsafe looks to revise fees for the evaluation and registration of medicines
16 December 2005
The agency responsible for regulating medicines is consulting on increasing its fees from 1 July next year for the first time in well over a decade, and in some cases for the first time in 28-years.
The increases reflect the rising costs of regulation as demands on Medsafe to evaluate, audit and monitor the safety of medicines and their manufacture increase.
For instance an application to Medsafe for a new medicine (involving a new chemical entity) typically involves the evaluation of a quarter of a tonne of paperwork.
Under the Medicines Act fees are levied on applications to licence medicine manufacturers and to approve new medicines and clinical trials. Fees are also levied under the Misuse of Drugs Act for applications for licences to, for example, import and export controlled drugs.
Medsafe's Principal Technical Specialist, Dr Stewart Jessamine, says this is the first time since 1977 that fees under the Misuse of Drugs Act have been revised. Fees under the Medicines Act have not been increased since they were first introduced 15 years ago.
"The fees in most cases have been falling well short of covering the actual costs of the complex work related to applications for licences and approval of medicines," Dr Jessamine says.
It is important for New Zealand to meet international best practice standards for the regulation of medicines and also to maintain specialist technical expertise in this area.
The growing gap between the cost of evaluating medicine safety and the amount recovered in fees has meant that approvals for some medicines have been taking as long as three years to process.
Dr Jessamine says it would be tempting to predict that the fee increases will mean shorter times for approving medicines. While that will be true in the long term as capability is strengthened within Medsafe it will be at least a year or 18 months before any improvement can be demonstrated.
"While in most cases the fees for high risk complex activities are going to increase significantly, it is important to note that they still come well under other developed countries, including Britain, the United Sates of America and Australia."
It's important to remember that the work involved in ensuring medicine safety in New Zealand is no less demanding, or important than it is in other overseas jurisdictions, Dr Jessamine says.
Medsafe will begin consultation this week with organisations and individuals affected by the fee increases and feedback from the consultation will be considered before finalising the new fees.
A copy of the consultation paper is available on the Medsafe website at www.medsafe.govt.nz/hot/PapersReports.htm
ENDS
Dr Stewart Jessamine will be available for media interview between 1 and 3pm on Friday 16 December. For further details please contact:
Lucy Taylor
Media Advisor
Ministry of Health
04 496 2067
027 207 1406
What are the proposed fees?
| Current fee ($) ex GST | Proposed fee ($) ex GST | |
|---|---|---|
| Licences under the MODA | ||
| Licence to deal in Controlled Drugs | 10 | 840 |
| Licence to possess Controlled Drugs | 10 | 840 |
| Licence to import Controlled Drugs | 10 | 170 |
| Licence to export Controlled Drugs | 10 | 170 |
| Licences under the MA | ||
| Licence to Sell Medicines by Wholesale | 266 | 937 |
| Licence to Sell Medicines by Retail | 44 | 750 |
| Licence to Hawk Medicines | 62 | 750 |
| Licence to Operate a Pharmacy | 844 | 917 |
| Licence to Manufacture Medicines | 3,377 | 12,222 |
| Licence to Pack Medicines | 266 | 750 |
| Application type | Current Fee ($) ex GST | Proposed Fee ($) ex GST |
|---|---|---|
| Application for consent to supply a new medicine | 13,600 | 109,000 |
| Innovative chemical or biological medicine | 13,600 | 109,000 |
| Generic medicine | 6,933 | 39,000 |
| Non-prescription medicine | 6,933 | 6,800 |
| Application for provisional consent to supply a new medicine | 4,444 | 7,500 |
| Application for approval of a material change to a medicine | 1,422 | 2,844 |
| Major change | 1,422 | 2,844 |
| Minor Change | 355 | 710 |
| Self-assessable change | 177 | 354 |
| Application to approve a clinical trial | 2,488 | 8,750 |
How do these fees compare with other developed countries?
The revised fee schedule for New Zealand still falls well below the charges of other similar developed countries. Examples of this include:
The proposed New Zealand fee for an application to approve a new innovative product with a new chemical or biological ingredient is $109,000 (excl GST). The equivalent application fee in Australia costs $205,092 (NZD); in the United Kingdom it costs $424,560 (NZD); and in Canada the application fee is $161,590 (NZD).