Williamson Maurice: Medicines Amendment Bill — Second Reading 
Text is incorporated into the Bound Volume 
Williamson Maurice: Medicines Amendment Bill — Second Reading 
[Sitting date: 20 March 2013. Volume:688;Page:8798. Text is incorporated into the Bound Volume.] 
Hon MAURICE WILLIAMSON (Minister for Building and Construction)  
on behalf of the Associate Minister of Health: I move  
That the Medicines Amendment Bill be now read a second time 
. After looking at the bill I am pleased that the Health Committee has recommended that it should proceed with some amendments. The committee has worked hard and I thank all the members for their contributions. Before outlining the provisions in the bill I think it is helpful to review its purpose in order to understand what this amendment bill will do and what it will not do. 
This bill will amend some specific provisions of the Medicines Act 1981 to streamline the legislation. What this bill will not do is carry out a comprehensive overhaul of the Act. In June 2011 the Prime Ministers of New Zealand and Australia announced their intention to proceed with the establishment of an Australia New Zealand Therapeutic Products Agency under a treaty signed in 2003. The Minister of Health intends to progress a Therapeutic Products and Medicines Bill in 2013 to provide for the agency. That legislation and the Natural Health and Supplementary Products Bill currently before the Health Committee will comprehensively overhaul New Zealand’s therapeutic products regulatory system. This Medicines Amendment Bill pre-dates the Prime Minister’s agreement to progress the Australia New Zealand Therapeutic Products Agency. It should be seen as an interim measure before the agency is established. 
This bill firstly will modernise the definitions of “medicine” “medical device” and “therapeutic purpose”; secondly it will amend the medicines approval process to make the legislation less prescriptive instead specifying the detail in regulations; and thirdly it will amend the prescribing framework to name nurse practitioners and optometrists as authorised prescribers and make some minor changes to licensing requirements. The submissions on the bill were generally supportive of these proposals. The bill as introduced also added an enabling provision for a new category “delegated prescriber” and an enabling provision for temporary prescribing rights. 
There were mixed views from submitters on these provisions. A common theme was the need for further information on the process for gaining and implementing delegated and temporary prescribing rights. The bill has been amended in response to this and I will now outline for the House the feedback from submissions and key changes. Definitions—there was general support for updating the definitions of “medicine” “medical device” and “therapeutic purpose” to better align with international norms. The definitions in this bill have been developed to reflect New Zealand’s current regulatory framework. These definitions will be reviewed and updated again as part of the establishment of the agency. 
Prescribing—there are currently two categories of prescriber in the Medicines Act: “authorised” and “designated”. An authorised prescriber is a medical practitioner dentist registered midwife or designated prescriber. These prescribers must prescribe within their scope of practice for patients under their care. “Designated prescriber” is the term used for a restricted subgroup of authorised prescribers. Currently optometrists and nurse practitioners with prescribing rights and some registered nurses practising in diabetes health are designated prescribers. Designated prescribers are allowed to prescribe only certain medicines listed in regulation. The bill revokes the designated prescriber regulations for nurse practitioners and optometrists and names them as authorised prescribers. This will align their prescribing rights with those of medical practitioners dentists and midwives by enabling them to prescribe all medicines appropriate to their scope of practice rather than limiting them to being able to prescribe only from a limited list of medicines. This move acknowledges the safe and appropriate prescribing practice of these groups over the past 7 years. There was broad support among the submissions for amending the definition of “authorised prescriber” to name nurse practitioners and optometrists. A small number of submissions raised concerns about extended prescribing rights in terms of patient safety fragmentation of care and increased costs to the sector. This reflects in part a general opposition to the extension of prescribing rights to people other than doctors. 
The bill also creates a new category of prescriber the “delegated prescriber”. Delegated prescribers will be allowed to prescribe under a delegated prescribing order issued by an authorised prescriber. The competence training and qualifications required of delegated prescribers would be set in consultation with the responsible authority. The requirements for delegated prescribers would be set at a lower level than for designated and authorised prescribers commensurate with the more limited level of prescribing and the oversight of the authorising prescriber. Generally there was cautious support for the new category of “delegated prescriber” from medical and pharmacy organisations and opposition from nursing groups. The “delegated prescriber” category adds a prescribing option for professional groups beyond the existing categories. It will be for regulatory authorities to determine what form of prescribing rights if any they intend to seek for their profession. 
A common theme in submissions was the need for further information on the process of gaining and implementing delegated prescribing. The bill has been amended so that delegated prescribing rights will be made via regulation rather than by  
Gazette 
 notice. Requiring a regulatory mechanism will allow greater scrutiny and reflect the significant responsibilities that accompany any form of prescribing but it will still allow flexibility to tailor conditions and requirements to different groups of delegated prescribers. Further consultation and education on the details of the delegated prescriber provisions will need to occur during development of the regulations and prior to their implementation. 
The bill as introduced included a temporary prescribing provision to allow time-limited demonstration sites of new models of care that involve extending prescribing rights. Officials’ previous understanding was that designated prescriber regulations could not be time-limited. I have since been advised that the existing designated prescriber regulation-making power does allow conditions to be placed that specify a time limit. This would allow all the restrictions that would be imposed by a temporary prescribing provision to be imposed by designated prescribing regulations. Given this ability the temporary prescribing provisions are redundant and have been removed from the bill. 
This bill also amends the licensing provisions in the Act to enable a licensing authority to take into account previous convictions when considering an applicant’s fitness to hold a licence and to impose conditions either when issuing a licence or at any time while a licence is in effect. The bill removes the provisions in the Act that deal with medicines approvals and will replace these with regulation-making powers. The default commencement date is set at 1 July 2017. This anticipates that the medicines approval process provisions in the bill are likely to be superseded by the establishment of the Australia New Zealand Therapeutic Products Agency but provides a backstop should the implementation of the agency be delayed. 
Of the submissions that addressed the medicines approvals process there was general support for the removal from the Act of the detail about the application and process requirements for the new and changed medicines and related products. Regardless of where the approvals process for medicines is developed as a New Zealand - only scheme or as part of the joint agency scheme the regulations will be risk based and provide different approval pathways to cater for medicines in different risk categories. Each pathway will trigger the application of a level of scrutiny that reflects the risk of the medicine. For example in keeping with international norms more rigorous scrutiny will be applied to higher-risk prescriptions etc. etc. Medicines with known ingredients that can be purchased without a prescription would require less scrutiny. The regulations would be set out in the eligibility criteria for the different pathways and the validity requirements. They would also set out the process to be followed by the regulator and applicants to resolve or not technical queries. 
This bill provides an opportunity to amend some specific provisions of the Medicines Act in advance of the comprehensive overhaul of the—