Published: 1 December 2018
Consultations
Outcome of consultation on updating the guidance document 'How to change the legal classification of a medicine in New Zealand'
Review of submissions and outcomes
Submissions received have been reviewed by Medsafe. Feedback from this consultation have been used to update the guideline and associated documents.
Stakeholder representation
- Four submissions representative of professional bodies
- Three submissions representative of industry organisations (including importer, manufacturer, supplier, sponsor and regulatory affairs consultant)
- One submission selected 'other'
All submissions received were from organisations/individuals based in New Zealand.
Consultation feedback
The following section summarises key issues that emerged from the submissions received and Medsafe's response. The key issues are discussed in the order they appear in the guidance document.
Phase 1: Application
Parameters for suitability for non-prescription sale
One comment was received about this subject and expressed concerns about the wording of the parameters where it appears that safety is not considered a mandatory parameter. Wording was also suggested about 'specified appropriate health care professionals'.
Response
Medsafe acknowledges that there is merit in this suggestion and has amended the guideline in response to this comment. The wording has been revised to the following:
Medicines available without a prescription should be able to show substantial safety in use in the prevention or management of the condition or symptom under consideration and either
- be for conditions or symptoms that can be diagnosed and managed by a pharmacist or other specified appropriate health care professional, or
- be easily self-diagnosed and self-managed by a consumer.
Parameter 2: Presentation
One comment was received about this subject and expressed concern that this appears to be duplication of work already completed by Medsafe, such as assessing pack sizes or storage conditions.
Response
Medsafe has amended this guideline in response to this comment. Some details from Parameter 2: Presentation, such as the pack size and storage, have been moved to Part A (Administrative details).
Parameter 3: Efficacy/Benefits
One comment was received that did not support this parameter. The author was unclear about what the benefits were from a consumer perspective and commented that it was not obvious what additional evidence of efficacy required for the MCC that has not already been assessed by Medsafe.
Response
Medsafe has amended this guideline in response to this comment. The title has been renamed 'Consumer benefits' and the requirement for evidence of efficacy has been removed. Medicines must provide evidence demonstrating an acceptable risk-benefit profile, including efficacy data, to Medsafe prior to approval for distribution.
Parameter 8: Communal harm/benefit
Three comments were received about this subject. Two comments supported this parameter because it enabled consideration of continuity/fragmentation of care. The comment from one author's opinion was unclear and concerns were expressed about the definition of community harm/benefit.
Response
The parameters described have been generalised because they are intended as a guide for the reclassification process, and therefore are not intended to be formulaic or exhaustive. No change to the guideline is required.
Parameter 10: Risk mitigating strategies
Four comments were received about this subject. One comment supported this, especially post-market surveillance activities. One comment did not support this because it was not obvious what strategies would be considered acceptable. In two comments, the author's opinion was unclear. Both comments described a lack of clarity and one comment was unsure how applicants will engage with professional bodies.
Response
It is intended that risk mitigation strategies will be assessed on a case-by-case basis. The parameters described have been generalised because they are intended as a guide for the reclassification process, and therefore are not intended to be formulaic or exhaustive. No change to the guideline is required.
Pharmacy Council and PSNZ framework
Six comments were received about this subject. Three comments supported the framework because it enables a robust reclassification process. One comment supported the framework but expressed concern about a potential conflict of interest.
Two comments received did not support the framework. One comment supported involvement of the Pharmacy Council but not the PSNZ. One comment expressed concern about the value of this framework for consumers and were concerned about the relative importance of this framework for supporting a proposal for reclassification.
In one comment, the author's opinion was unclear.
Response
This framework is intended to address reclassification recommendations that require additional training from pharmacists. For this reason, Medsafe considers that this framework would be helpful to enable implementation of reclassification recommendations to either 'prescription except' when supplied by a pharmacist, restricted or pharmacy-only medicines. No change to the guideline is required.
Publication of applications
Three comments were received. All comments received were not in support of the publication of applications. Concerns were expressed about the protection of intellectual property, and how complete training packages may not be available at the time of application.
Response
Medsafe acknowledges the concerns raised.
Medsafe is a government agency and information published on the Medsafe website for consultation is directed by the Official Information Act 1982. The principle of the Official Information Act is that 'information shall be made available unless there is good reason for withholding it'. The guideline has been updated to include more information about the Official Information Act to help applicants understand how this relates to the publication of information for consultation.
The OIA allows for withholding information that are considered trade secrets. This is described in section 9 (2)(b)(i) of the OIA. Section 9 of the OIA describes other good reasons for withholding official information.
If an applicant considers that material provided in the application should not be made publicly available, the applicant must clearly state this in the application and quote the relevant sections under the OIA to justify its exclusion
The guideline already acknowledges that applications may or may not include training material and screening tools at the time of submission, and this is described in Appendix 2.
Phase 2
Six comments were received about Phase 2. Two comments were in support of the proposed Phase 2. Four comments did not support the proposed Phase 2 and expressed the following concerns:
- Publication of documents and appropriation of intellectual property by competitors
- suggestion that an executive summary will suffice for consultation
- suggestion that submissions should only be available on the website for a limited period of time
- opposed the publication of submissions however, some comments supported the publication of key papers
- that New Zealand will appear unattractive for the development of innovative reclassifications
- frustration at the requirements of the Official Information Act.
Response
Medsafe is subject to the Official Information Act 1982. Applicants should consider the Official Information Act when submitting information for the reclassification process. The guidance document has been revised to include more information about the Official Information Act.
Phase 3
One comment was received in support of Phase 3 overall.
Six comments were received about individual sections of Phase 3. Themes identified were:
- cost - one comment did not support the MCC not considering the cost of a medicine
- harmonisation with Australia - two comments were received. One comment supported harmonisation and the other had a mixed opinion
- requests for information - one comment was received in support
- membership - two comments were received suggesting broader representation on the MCC
Response
The cost of a medicine is not considered within the scope of the Medicines Classification Committee and therefore it is not appropriate to include cost as a parameter for consideration. Therefore no change is required to the guideline.
Support was received for the MCC to be able to request further information and therefore no change is required to the guideline.
Harmonisation is still considered relevant to the MCC because of the relatively small market in New Zealand and the need to ensure access. Two responses were received - one in support and the other mixed. Medsafe considers that harmonisation remains appropriate and no change is currently required to the guideline.
The composition of the MCC is determined in the Medicines Act 1981 and this is described in the proposed guideline. Currently the New Zealand Government is working on a new and comprehensive regulatory regime which will replace the Medicines Act and Medsafe has forwarded these comments about membership to the Therapeutics Products Bill project team. No changes are currently required to the guideline.
Additional suggestions
A number of submissions made suggestions about market exclusivity and reducing the amount of work required for reclassification, increased involvement of professional bodies and inclusion of an evaluation phase.
Response
Medsafe considers that there is merit in the proposed process described in the guidance document on 'How to change the legal classification of a medicine in New Zealand'. However, Medsafe hopes that these comments will initiate discussion amongst interested parties.
It is expected that consideration of these additional comments will require further extensive discussion. Therefore in the interest of timeliness, this will not be further pursued as part of this consultation process on updating the guidance document 'How to change the legal classification of a medicine in New Zealand' and no changes are currently required to the guideline.
The regulatory arrangements for classification of medicines may change because the Government is currently developing a new therapeutic products regulatory regime to replace the Medicines Act 1981 and its Regulations. This regime will modernise the regulation of medicines and will provide regulation of all therapeutic products, including medical devices and cell tissues.
The Therapeutics Products Bill is currently being drafted and more information may be found on the Ministry of Health website (www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime). The last update in December 2017 describes how drafting is continuing while the Ministry of Health is working with Minister Clark on developing this new regime.
