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Digest No. 1946
Medicines Amendment Bill 2011
|Date of Introduction:||13 October 2011|
|Select Committee:||As at 13 February, 1st Reading not held.|
|Published: 13 February 2012 byJohn McSoriley BA LL.B, Barrister,Legislative AnalystP: (04) 817-9626 (Ext. 9626)Public enquiries:Parliamentary Information Service: (04 817-9647)||Caution: This Digest was prepared to assist consideration of the Bill by members of Parliament. It has no official status.Although every effort has been made to ensure accuracy, it should not be taken as a complete or authoritative guide to the Bill. Other sources should be consulted to determine the subsequent official status of the Bill.|
The main aim of the Bill is to amend the Medicines Act 1981 (the Act) to:
- “modernise the definitions of medicine, medical device, and therapeutic purpose to align the boundary between medicines and medical devices with international norms;
- “amend the approval process for new medicines;
- “align the prescribing framework for nurse practitioners and optometrists with medical practitioners, dentists, and midwives;
- “establish a new category of delegated prescriber, whose members will be allowed to prescribe under an authorisation (a delegated prescribing order) issued by an authorised prescriber;
- “establish a mechanism to allow time-limited demonstration sites of extended prescribing rights to new groups of health practitioners;
- “make minor and technical amendments to update and clarify the provisions for granting licences to manufacture, pack, and sell medicines and to operate a pharmacy;
- expand the regulation-making powers in the Act to provide for new standards and innovative practice, such as electronic prescribing”  .
Regulatory impact statement
Copies of regulatory impact statement are available:
The above mentioned issues are stated to relate to “problematic provision” of the Act  .
The Bill contains many consequential amendments to the Act following from the major amendments.
The Bill provides a term for most persons with prescribing rights, “authorised prescriber” and also provides another generic definition, “designated prescriber” (Part 1, Clause 4 amending Section 2 of the Act).
Definition of “medicine”, “medical device” and “therapeutic purpose”
Section 3 of the Act at present defines the term “medicine” as, unless the context otherwise required, meaning any substance or article, other than a medical device, that is manufactured, imported, sold, or supplied wholly or principally … for administering to one or more human beings for a therapeutic purpose or … for use as an ingredient in the preparation of any substance or article that is to be administered to one or more human beings for a therapeutic purpose, where it is so used in a pharmacy or a hospital, by a practitioner, or registered midwife, or designated prescriber, or in accordance with a standing order in the course of any business that consists of or includes the retail sale, or the supply in circumstances corresponding to retail sale, of herbal remedies; or for use as a pregnancy test.
The Bill redefines the term medicine as meaning, generally, “any substance or article that … is manufactured, imported, sold, or supplied wholly or principally for administering to one or more human beings for a therapeutic purpose and …. Achieves or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means”. This is further elaborated further. The Bill also redefines the terms “medical device” and therapeutic purpose” (Part 1, Clause 5, amending Section 3 of the Act; Clause 6, inserting New Section 3A (“Meaning of medical device”) into the Act; Clause 7, substituting Section 4 of the Act (“Meaning of therapeutic purpose”).
Approval of new medicines and changed medicines
The Bill sets out the criteria to be applied when the Minister determines whether to give consent, or provisional consent, to the distribution of a new medicine. A process for objecting to a decision of the Minister is provided for. Provision is also made for applications for the minister’s consent to distribute changed medicines (Part 1, Clause 12, inserting New Sections 20A, 22A, 23A, 23AA and 23AAB into the Act and substituting Sections 21, 22 and 23; Clause 14 inserting New Sections 23D and 24AA into the Act and substituting Section 24).
The Bill enables the Minister to approve a class of registered health professionals to have delegated prescribing rights. Applications for delegated prescribing rights will be made by the authority with responsibility for the registration and oversight of that class of health professionals under the Health Practitioners Competence Assurance Act 2003. An authorised prescriber (other than a designated prescriber) may then issue a delegated prescribing order to a member of such a class of registered health professionals, and that person will then be authorised to prescribe prescription medicines in accordance with the delegated prescribing order. Provision is also made for temporary prescribing rights. These will be authorised by the Minister in favour of a class of registered health professionals and will be limited to a specified place and for a limited period of up to one year (Part 1, Clause 23, inserting New Sections 47A-47C into the Act).
The Bill enables regulations to be made declaring substances or articles to be medicines and medical devices and broadens powers to make regulations in relation to the storage and transmission of prescriptions including electronic prescriptions (Part 1, Clause 34, amending Section 105 of the Act (the regulations section)).
|Copyright: © NZ Parliamentary Library, 2012|
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