Therapeutic Products Bill - Amendment paper No 378
Therapeutic Products Bill - Amendment paper No 378
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Therapeutic Products Bill - Amendment paper No 378
No 378
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 343
Replace clause 343(1)(b) (page 191, lines 12 and 13) with:
(b)
thinks is likely to be necessary to enable the recipient to perform their functions or exercise their powers.
Replace clause 343(2)(b) (page 191, lines 17 and 18) with:
(b)
thinks is likely to be necessary to enable the Regulator to perform the Regulator’s functions or exercise their powers under this Act.
Clause 345
Replace clause 345(1)(c)(i) (page 192, lines 30 and 31) with:
(i)
by the Regulator or an inspector where required in the course of performing their functions or exercising their powers under this Act; or
Replace clause 345(1)(c)(iii) (page 192, lines 33 and 34) with:
(iii)
by a worker where required in the course of doing their work for the Regulator or recognised testing entity, but only to the extent that this Act permits the Regulator or recognised testing entity to disclose that information.
Explanatory note
This Supplementary Order Paper (SOP) amends the data protection provisions of the Therapeutic Products Bill with respect to the sharing and disclosure of information. One of the most commercially valuable assets owned by pharmaceutical companies is confidential information (including technical data and trade secrets) and intellectual property relating to new or innovative medicines. This information is commercially sensitive and valuable, and pharmaceutical companies invest heavily in protecting it from loss and disclosure. Whether or not the regulation in a prospective market will provide sufficient protection of their commercially sensitive information is a critical commercial consideration for pharmaceutical companies in deciding whether to supply new medicines into that market. Markets that have insufficient protections in place run the risk of being perceived as high risk and of pharmaceutical companies choosing not to sell their medicines there. This is particularly true of small markets like New Zealand, where the financial return on the introduction of a medicine may be relatively limited. One of the guiding principles of the Therapeutic Products Bill is that the regulation of therapeutic products should support innovation and the timely availability and choice of therapeutic products. This is to ensure that New Zealand has an innovative, robust health and biotechnology sector to support its community and is compatible with its trading partners. The data protection provisions of the Bill, as currently drafted may deter pharmaceutical companies from selling innovative medicines here. If that occurs, then consumers may face a significant reduction in the range of medicines (especially new ones) available to them. This will not support a well-functioning market for therapeutic products and runs contrary to the Bill’s stated aims. This risk was clearly signalled to the Health Select Committee by multiple industry submitters. The amendments proposed to the Bill in this SOP address several key deficiencies in the drafting of the Bill’s data protection provisions. The amendments in this SOP seek to ensure that the full range of commercially sensitive information is protected through strengthened, more specific provisions for the sharing and disclosure of such information. These provisions increase the degree of confidence that suppliers of innovative therapeutic products can have in participation in the New Zealand market by reducing the likelihood that the New Zealand market presents undue risk to intellectual property and commercially sensitive information. Appropriate data protection provisions are also important for New Zealand’s domestic health and biotechnology sector, as well as ensuring that New Zealand does not fall behind with its major trading partners and promoting New Zealand as a market for innovation consistent with the Bill’s guiding principles.
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Therapeutic Products Bill - Amendment paper No 378
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