Dunne Peter: Medicines Amendment Bill — First Reading 
Text is incorporated into the Bound Volume 
Dunne Peter: Medicines Amendment Bill — First Reading 
[Sitting date: 28 February 2012. Volume:677;Page:602. Text is incorporated into the Bound Volume.] 
Hon PETER DUNNE (Associate Minister of Health) 
: 
 I move  
That the Medicines Amendment Bill be now read a first time. 
 At the appropriate time I intend to move that it be referred to the Health Committee and that it be reported back to the House by 2 July 2012.  
This bill provides an opportunity to amend some specific provisions of the Medicines Act 1981 to streamline that legislation. It modernises the definitions of “medicine” “medical device” and “therapeutic purpose” to align the boundary between medicines and medical devices with international norms. It removes prescriptive detail about the approval process for new medicines and instead enables regulations to specify such administrative details. It aligns the prescribing framework for nurse practitioners and optometrists with that for medical practitioners dentists and midwives. It establishes a new category of “delegated prescriber” whose members will be allowed to prescribe under a delegated prescribing order that is issued by an authorised prescriber. It establishes a mechanism to allow time-limited demonstration sites of extended prescribing rights to new groups of health practitioners. It makes minor and technical amendments to update and clarify the provisions for granting licences to manufacture pack and sell medicines and to operate a pharmacy. And it expands the regulation-making powers in the Act to provide for new standards and innovative practice such as electronic prescribing.  
Let me now outline the key provisions in the bill. As we all know medicines have significant health benefits but they can present serious risks especially if they are used inappropriately. For that reason the safety quality and efficacy of new and changed medicines are assessed before consent for their sale or supply in New Zealand is granted. But the medicine approval requirements in the Medicines Act are very prescriptive and do not provide the flexibility needed to accommodate technical and process reform so this bill removes most of the detail about the application and process requirements for new and changed medicines and related products from the Act and instead requires applications to conform to requirements that are specified in regulations. Setting out the detail of medicines approval requirements in regulation rather than in primary legislation will mean that the process to amend or update those requirements becomes much simpler. That approach will also enable greater flexibility as different approval processes can be specified for different product types—for example innovative prescription medicines generic prescription medicines or non-prescription medicines. All of this will improve efficiency and support risk-appropriate assessment processes without compromising safety and will also enable requirements to be updated in a much more timely fashion in response to capacity issues and changes in best practice.  
This approach will also accommodate the development of a joint regulatory approach under the Australia New Zealand Therapeutic Products Agency. The House may be interested to know that the New Zealand and Australian Governments have restarted work to implement the Therapeutic Products Agency over 5 years. 
Iain Lees-Galloway 
: Why did it stop? 
Hon PETER DUNNE 
: It is a very long story. The member asks why it stopped. I think it comes down to one very simple political precept: an inability to count the numbers. That is a long story and the member’s party was in Government at the time that that happened. 
Iain Lees-Galloway 
: When did the numbers fall? 
Hon PETER DUNNE 
: I will tell him privately because it is an interesting story.  
I will come back to the bill. Currently medical practitioners dentists midwives nurse practitioners and optometrists have got prescribing rights under the provisions of the Medicines Act 1981. All of these health professionals are able to prescribe independently—that is without supervision—within scopes of practice that are defined by their responsible authorities. When nurse practitioners and optometrists were given prescribing rights in 2005 they were categorised as designated prescribers. Designated prescribers are required to have separate regulations that define the scope of practice within which their prescribing is permitted that provide a list of prescription medicines that they can prescribe and that also have established minimum competency requirements. Including this detail in regulation is administratively burdensome as the regulations quickly come out of order. So what the bill does is align nurse practitioner and optometrist prescribing requirements with those of medical practitioners dentists and midwives and it revokes the designated prescriber regulations. That change acknowledges the competence and the professionalism that nurse practitioners and optometrists have demonstrated since they gained prescribing rights in 2005. The changes in the bill will also reduce the administrative burden on nurse practitioners’ and optometrists’ responsible authorities recognising in turn the experience and expertise that those organisations have achieved in promoting and monitoring safe practice within their particular professional groups.  
The bill creates a new category of prescriber a delegated prescriber who will be allowed to prescribe under a delegated prescribing order issued by an authorised prescriber. The delegated prescribing order will authorise the issue of a prescription. Delegated prescribing is not possible under the current legislation but has the potential to improve a patient’s access to prescriptions. This new delegated prescriber category adds a prescribing option for professional groups beyond the existing prescribing categories and it will be for the regulatory authorities to determine what form of prescribing rights if any they may intend to seek for their particular professional group. To gain delegated prescriber status a responsible authority will have to apply to the Minister of Health and a delegated prescriber’s ability to prescribe would be limited by the terms of the relevant delegated prescribing order and subject to reviews and monitoring by the authorising prescriber. Regulations will set out requirements for applications for delegated prescribing and for delegated prescribing orders.  
The Government is confident that this bill will improve the flexibility and efficiency of approval processes for medicines and for related products and will also encourage innovation and flexibility in prescribing practice. A more comprehensive overhaul of the Medicines Act will be undertaken as part of the work to implement the Therapeutic Products Agency when that process is complete and that will modernise and recast our medicines legislation and will also help address issues such as the regulation of medical devices and cellular therapies and controls on advertising. But that is for another day. In the meantime I commend this bill to the House.