Therapeutic Products Bill - Amendment paper No 377
Therapeutic Products Bill - Amendment paper No 377
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Therapeutic Products Bill - Amendment paper No 377
No 377
House of Representatives
Supplementary Order Paper
Tuesday, 18 July 2023
Therapeutic Products Bill
Proposed amendments
Brooke van Velden, in Committee, to move the following amendments:
Clause 67
After clause 67(1)(b) (page 61, after line 5), insert:
(c)
the person is importing the medicine or medical device for the purpose of supplying it to a health practitioner or veterinarian in accordance with section 102A.
New clause 102A
After clause 102 (page 78, after line 19), insert:
Upstream activities
102A Upstream supply of medicine or medical device to health practitioner or veterinarian
(1)
This section applies for the purposes of sections 67 and 68.
(2)
A person (person A) is allowed to import a medicine or medical device (whether or not it has a standard authorisation or provisional authorisation) if they comply with the representative import conditions.
(3)
The representative import conditions are that—
(a)
person A acquired the medicine or medical device lawfully; and
(b)
person A is importing the medicine or medical device on behalf of—
(i)
a health practitioner who is allowed to import the medicine or medical device under section 88; or
(ii)
a veterinarian who is allowed to import the medicine or medical device under section 98; and
(c)
any other conditions in the rules are satisfied.
Explanatory note
This Supplementary Order Paper amends the Therapeutic Products Bill to ensure that the proposed legislation is clear with respect to the lawful importation and supply of medicines and medical devices which do not have a New Zealand market authorisation by a person on behalf of a health practitioner or veterinarian. Whilst under clauses 88 and 98 a health practitioner or veterinarian can legally import such unauthorised medicines or medical devices in accordance with the Special-case Requirement established in Clause 65 of the Bill, in practice they might not be able to undertake the logistical activities and expense associated with this task. Providing a clear legal ability for another person to act on their behalf to undertake the importation and supply to them addresses these practical difficulties. Therefore, for the avoidance of doubt, the new subclause 67(1)(c) in conjunction with a new clause 102A, clarifies that supply from overseas and importation of an unauthorised medicine or medical device on behalf of a health practitioner or veterinarian is lawful where importing is allowed under clauses 88 and 98 of subpart 3. Health practitioners or veterinarians who are entitled to supply unauthorised medicines or medical devices where the special case requirements are met, are therefore able to request another person or company to import the medicine or medical device on their behalf. While such importation and supply activity may be considered implicitly permitted under current drafting, this should be made explicit to avoid the unintended consequences that: (i) overseas providers are unwilling to export to New Zealand and local companies unable or unwilling to assist local health practitioners and veterinarians with sourcing medicines and medical devices because of perceived uncertainty around the lawfulness of doing so; and (ii) overseas providers and local companies are exposed to fines and penalties where the legislation is not clear on a lawful supply. The proposed drafting provides certainty to a supplier or intermediary that importing and supplying in response to the request is lawful, and by allowing them to act on behalf of a health practitioner or veterinarian removes unnecessary logistical barriers to timely access for patients to the medicines and medical devices they clinically need.
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Therapeutic Products Bill - Amendment paper No 377
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