Medicines Amendment Bill — First Reading 
Text is incorporated into the Bound Volume 
Medicines Amendment Bill — First Reading 
[Sitting date: 28 February 2012. Volume:677;Page:602. Text is incorporated into the Bound Volume.] 
Medicines Amendment Bill 
First Reading 
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. 
Hon MARYAN STREET (Labour) 
: 
 I rise to speak to the Medicines Amendment Bill and say with my colleagues from the Labour Party we will support this bill being referred to the select committee. But can I just say that what we have just heard from the Associate Minister of Health Peter Dunne is a truncated version of the regulatory impact statement so there was nothing about the original purpose of this bill and nothing about what could have been done earlier. In fact if I take up where the Minister left off the Minister left off at the second sentence of the regulatory impact statement. The Minister was quoting the regulatory impact statement written by an official and I have to say written delicately by an official so as not to cause the current Minister of Health or the Associate Minister of Health in this case any embarrassment. My commendations go to the official for that. It says “A more comprehensive overhaul of the Medicines Act will be required in the future to modernise and recast the medicines legislation …”. The Minister just said that. The question that is begged in that sentence is if why not now then why not 5 years ago?  
For those who were not in this House 5 years ago let me elucidate. The National Party decided to play naked politics jumping on the bandwagon of people in the supplementary medicines industry: the dietary supplements the people who produce vitamins and the people who use non-traditional medicines. It jumped on that bandwagon. They all got out at the front of Parliament stood there under red umbrellas—if I remember correctly Tony Ryall leading the band—and said “We can’t have this regulatory thing. It’s going to put up the cost of everybody’s Berocca. It’s going to put up the cost of everybody’s vitamin supplements.” Never mind that the intention was to regulate unregulated medicines coming in from overseas and being sold to New Zealanders without any reference to a panel of experts without any regulation applying to them and without any comeback—and there were adverse incidents occurring as a result of that. But no the National Party at the time decided that it could have a photo opportunity here it could get out at the front of Parliament with all these red umbrellas and say “We’re not having a bar of this.”  
And what do we get now? Minister we get a half-baked piece of legislation coming back now. Of course we will support it; it was ours to start with. Of course we will support it but it is only half the job. Why come into the ministry Minister and do half a job? Why not do the whole thing? This is pathetic. Yes we will support it. Let us hope we can find some improvements to make to it at the Health Committee. I look forward to receiving it; I am on the Health Committee and I look forward to receiving it and seeing whether there is anything we can do to improve it.  
Let me give one example of things that could have been done 5 years ago if the National Party had agreed even to parts of this legislation and not other parts. It could have agreed to do the things that the Minister is now proposing around Medsafe to make the procedures more flexible. What we have done in the meantime between 2007 and now—and I am not reading this from the regulatory impact statement Minister. What we have lost in the 5 years between 2007 and now is the potential for a faster process around the accession of medicines on to the market in New Zealand. If we had been able to do that who knows what medicines might have been available to the New Zealand public that could have alleviated symptoms provided a cure and improved people’s quality of life over the last 5 years—and that responsibility I sheet directly home to the National Party. This is not how one runs politics in this country—not at the expense of people’s health. There was a serious risk and for new members of the National Government I do bring this to your attention. Do not be hoodwinked by the fact that you have no institutional memory of what happened 5 years ago. Do not be hoodwinked that this is the best thing since sliced bread. We could have had sliced bread and toast 5 years ago; we are just getting the sliced bread now.  
So I do lay at the door of this Government now the responsibility for Medsafe processes not being able to become more flexible so more medicines prescribed and not prescribed standard and not so standard could be allowed to come into the market in New Zealand in a regulated fashion that guaranteed the safety of those medicines for New Zealand patients and that could have improved their quality of life in the last 5 years. That is a serious responsibility and I hope members particularly new members of the Government understand that. If one reads the regulatory impact statement one will see—and most of it has been read to us by the Minister just now—that the consultation processes particularly around prescribing rights were all consulted and agreed on in 2007. That bit was all good to go; that bit was all good to go. So why would such a thing which this Government is now parading as highly desirable have taken 5 years of delay because of that party’s naked politicking when it was in Opposition? It does not matter how members opposite may joke about this; it is an extremely serious issue.  
There are really good things in this bill that we are keen to see put in place because we drafted them in the first place. But just be aware that the consultation processes were undertaken. We started in 2003 with a trans-Tasman therapeutic agency proposal and that was part of the bill that went through. There was a huge reaction against that by members of the public and members of that industry as I have outlined already. But such things as prescribing rights and recasting the scope of practice of certain practitioners so that prescribing rights could be given are very sensible initiatives. They would free up some of our medical services and make them more available and accessible to the people who need them most.  
I am going to be interested to hear from the Green Party on its approach to this. There were some differences at the time between us and it on this measure in its totality but we are getting only half of the bill now. We are getting the bit that the National Party could have agreed to 5 years ago so let us get on and do it. Five years have passed when people have not been able to access medicines quickly that may have improved their quality of life and that is undeniable. So let us get on with it let us get it through and let us take note of the facts that the consultation has happened and that all of the stakeholder groups that have an interest in this area have been consulted and have agreed to these provisions.  
I am hoping that this bill will have a very speedy route through the Health Committee. Dr Paul Hutchison chairs that select committee and chairs it very well and I hope that he will expedite this piece of legislation so that we do not have to wait 6 years for it to come into effect. Thank you. 
Dr PAUL HUTCHISON (National—Hunua) 
: 
 It is indeed a pleasure to speak on this Medicines Amendment Bill and I want to start by congratulating the Hon Peter Dunne on his persistence and hard work in making sure that the bill is indeed on the floor of the House today.  
I also want to acknowledge the Hon Tony Ryall for ensuring that there is an increase in productivity efficiency and effectiveness in New Zealand health services today because over those dark long 9 years clearly productivity in the health services became static or went down. This was backed up by both Treasury and New Zealand Institute of Economic Research papers that showed static or declining levels of productivity and that is surely of great concern when the health budget went from $6 billion in 1999 to $12 billion in 2008.  
National is certainly committed to delivering high-quality health services to New Zealanders. Because of that we are highly cognisant of how important it is to get productivity into the health services. This Medicines Amendment Bill is all about doing exactly that: getting streamlined processes in place and literally delivering better sooner more convenient health services to New Zealand.  
Andrew Little 
: It’s taken you 6 years to get here. Why has it taken so long? 
Dr PAUL HUTCHISON 
: It is important to just put into the minds of the Labour Opposition—and Mr Little sitting over there—that health services right around the world are characterised by almost infinite demand but finite resources. Mr Little it is hugely important that we do not go back to those static old days of having no productivity under a Labour Government but that we continue to fly with a National Government that is certainly achieving an incredible amount in 3 to 4 short years. For instance this afternoon during question time the Minister of Health pointed out the amazing achievements in the health targets. Immunisation only 4 years ago had about 70 percent completion rates for 2-year-olds. It is now a stunning 92 percent and in places like Porirua it is 94 percent which is a great achievement.  
The Medicines Amendment Bill amends some specific provisions of the Medicines Act 1981. It also amends the prescribing framework for nurse practitioners and optometrists and creates this new delegated prescriber category. There is a great deal of interest in this because it will allow pharmacists within the scope of practice to eventually have the opportunity to prescribe. There will be restrictions around it. They will not be allowed to own pharmacies and they will have had to go through a very arduous course. But there is no doubt that many pharmacists carry a knowledge of pharmaceuticals way beyond that of generalists because of the fact that they are dealing with them day and night and are very familiar with the sorts of side reactions and other quirks that everyday practical people bring to them from time to time. So I think this will be quite a large leap forward.  
The bill also fulfils the Government’s commitment to making more new medicines available in New Zealand. Certainly it was interesting to hear the Hon Maryan Street somewhat shrilly say that this could have happened some years ago but it did not happen some years ago. That Labour Government had the opportunity to get the numbers but it failed. It failed to do so. So it is tremendous that we are now under a National Government going to have this bill through and that it is going to be supported by the Labour Opposition which is excellent.  
One of the things that is so important is to realise that over the next two or three decades health requirements in New Zealand will probably double but we are not going to be able to double the number of hospitals or the number of health practitioners. That is why it is so important to have new innovative ways of doing things; new innovative ways of prescribing; and new innovative ways of using health professionals.  
Certainly the nurse practitioners have shown this. I was lucky enough to attend the diabetes pilot study at Palmerston North Hospital about 18 months ago and it was quite inspiring to see those nurses who had an incredibly detailed knowledge of the drugs involved in diabetes. They had huge enthusiasm and contact with their patients and the results of that pilot were really quite extraordinary and a great credit to the nurses involved with that pilot project. It will be great to see it being expanded across New Zealand. This is a great bill and I look forward very much to going over the details of it in the Health Committee. 
IAIN LEES-GALLOWAY (Labour—Palmerston North) 
: 
 Well is that not just typical of this Government particularly in health? The National Party is the party that is the arch-architect of saying one thing in Opposition and doing exactly the opposite when it is in Government. This is a bizarre reversal of the usual situation because this is the party that opposes everything when it is in Opposition. It opposes good efficient productive improvements that can be made to the health system when it is in Opposition if there is political mileage to be made out of it but then just a few short years later—actually I do not know why National did not do this in the last term. Maybe it just— 
Darien Fenton 
: I can tell you. 
IAIN LEES-GALLOWAY 
: Why was that? Why was that? 
Darien Fenton 
: Because they were just politicking. 
IAIN LEES-GALLOWAY 
: Because it was just politics—that is exactly right. It was just politics. It needed to let the dust settle a little bit from back in 2005 hoping that people would forget the stance it took back in 2005 when Tony Ryall stood out on the forecourt of Parliament and told New Zealanders they would be paying more for their Berocca they would be paying more for their health supplements because the horrible Labour Government wanted to align our legislation with that of the Australians. You know what? We thought we were going to get this through. We thought we were going to get this done back in 2005. The Associate Minister of Health Peter Dunne is nodding his head because he thought it was going to happen back in 2005 as well but it was National playing pure politics that has caused this to take so long and here we are 6 years later.  
This Government’s mantra on health is “better sooner more convenient”. It is absolutely meaningless drivel. It would have been a whole lot better if we could have done this back in 2005; it certainly would have been a whole lot sooner to do it back in 2005. I bet the people who are going to benefit from these changes would have thought it a lot more convenient if we had made these changes back in 2005—but no because National likes to play politics on health.  
Just earlier today in fact Tony Ryall—him again yes—was trumpeting again what great advances this Government had made in tobacco control and everything that had happened in the last term. And do you know what? We did do some good things last term. This whole Parliament got together and did some good things on tobacco in the last term of Parliament but that was new. That was a change from the bad old days when National played politics on health and opposed every measure that the Labour Government wanted to introduce. It rarked up sentiment and it told people that the Labour Government was interfering in their lives because we wanted to introduce smoke-free environments we wanted to get smoking out of pubs and that sort of thing. That is the way that party operates. When it is in Opposition it will play politics on anything and now that it is in Government it is just quietly trying to make these things find their way through.  
This is a good bill. We would have loved to see these changes happen 6 years ago but the Government is finally going to support them and push them through. As a member of the Health Committee I am looking forward to this bill arriving at the select committee— 
Moana Mackey 
: Finally! 
IAIN LEES-GALLOWAY 
: —yes finally arriving at the select committee—so that we can give it the attention it deserves. Of course the whole purpose of this bill is to do a lot of streamlining of regulations to do with medicines. As the Minister pointed out it is important to get this balance right because medicines are drugs. The whole reason why we have medicines and supply medicines to people is that they have beneficial purposes but with every medicine comes a certain amount of risk. If we are going to be streamlining the mechanisms by which medicines are approved and by which they are prescribed and dispensed then we need to make sure we are getting that balance right so that we do not venture too far into the area of creating too much risk with the aim of improving efficiency. So I am looking forward to hearing what the experts have to say about this bill and what people who are out there in the field have to say about this bill as well.  
I am particularly interested in the provisions for the prescribing framework for nurse practitioners and optometrists and aligning those with that of medical practitioners dentists and midwives. Although it is not in this bill and it would not be appropriate to have the changes that I am about to talk about in this bill there is another thing I think we need to do in this whole area of prescribing medicines. Maryan Street talked about the sliced bread and said that we could have had the toast as well. I think there is some marmalade that we can put on that toast too— 
Shane Ardern 
: Marmite. 
IAIN LEES-GALLOWAY 
: Marmalade is my choice; Mr Ardern’s might be jam I do not know. But that would be to free up nurse practitioners so that nurse practitioners can have greater ability to work within their scope of practice. There are a number of pieces of legislation that actually prevent nurse practitioners from working on what is within their scope of practice; the legislation actually stops them from doing it. More often than not it is because the legislation specifically says a doctor must carry out those functions and therefore nurse practitioners are barred from doing so.  
In fact there are I believe 27 different Acts that need to be amended and in some of those Acts there are several sections and parts that need to be amended. My colleague the Hon Ruth Dyson has been working on some legislation to do that and hopefully by the time there is next a ballot for members’ bills a Labour member will be able to put that bill in the ballot. But of course it is at the mercy of luck the luck of the draw as to whether or not that bill comes out. It would be great if the Government actually took that issue up and took one of the next logical steps from this bill in freeing up nurse practitioners to be able to work more efficiently and more effectively within their scope of practice—including the ability to prescribe more medicines—simply to free up access. We know how difficult it is for people to see a general practitioner and if it was not necessary to see a general practitioner for everything—if that was something a nurse practitioner was able to do instead—that might improve people’s access to primary health care.  
We are certainly supportive of this bill. Many of the changes of course covered in this bill were consulted on back when Labour was in Government. There has been a lot of consultation and we hope that that will allow a fairly expedient process through the Health Committee. But please let nobody think that that means it will not get the attention that it deserves. This is an important piece of legislation that needs to be looked at closely.  
The development of the delegated prescribing proposal was originally undertaken by the then Minister of Health when Labour was in Government and we believe that there is strong support for the general proposal. The delegated prescriber role provides flexibility to allow for new developments in prescribing practices and innovative models of care. That is what we want to see: more innovation in health care and innovative ways of improving accessibility to health care.  
Delegated prescribing would allow more timely access to services for patients which is especially important in community and rural settings and in meeting the growing demands of chronic disease which may result in reduced need for specialist attention and/or surgical intervention. I have to say I find it rather surprising that addressing chronic disease is not one of the Government’s health targets because it is an area where things can be improved and where earlier intervention could reduce costs and could improve the well-being of all New Zealanders.  
This bill is a good bill. We are very happy to support it. We are disappointed it has taken as long as it has to get here. We are disappointed there has been politics played with these issues in the past but maybe we can put that behind us get on with it and make these changes which will be positive for all New Zealanders. 
KEVIN HAGUE (Green) 
: 
 I rise to indicate that the Green Party will be supporting this Medicines Amendment Bill at least as far as the select committee and will be very interested in the submissions that the select committee receives. Like other colleagues who have spoken in this debate I am a member of that committee and will take a keen interest in what people have to say as unlike some of those who have spoken I am not that impressed with the degree of consultation that has occurred to date. I will elaborate on that in a moment.  
The New Zealand health sector is facing a barrage of problems that will be driving up the need for health services. We have a growing population; more people need more services. We have an ageing population and the evidence is pretty clear that the older we are in fact the more health services we tend to need. We have a more diverse population and different population groups bring with them different health needs that our system needs to respond to. As Iain Lees-Galloway has just been speaking about we face a tsunami a virtual tsunami of chronic disease. And chronic diseases—diseases like cardiovascular disease diabetes depression and many others—tend to bring with them very complex and enduring needs for health services. It is a more complex picture than even that because people tend to have not just one of those diseases but several of them at the same time which creates in their interaction with each other fresh needs.  
We also have in this country an ever-widening gap between rich and poor and there is extremely strong evidence that the pattern of inequality that we are seeing of growing inequality is itself driving even greater health needs. Inequality is probably the single greatest driver of health needs. Whether it is communicable disease or motor vehicle crashes the pattern of inequality is the single greatest determinant of the pattern of health needs that we face.  
So that is a pattern of complex and increasing health needs and our system needs to respond to that. As Paul Hutchison has alluded to in his contribution to the debate the ways in which we are able to respond to those problems are quite constrained. We have seen certainly new medicines and therapies being developed and they are an important component of how we will respond to that need. New technologies more broadly than medicines are also an important contributor. In the House today there was a question from a New Zealand First member about the technologies available for people with diabetes for example. It is an important question. We are also seeing increasing specialisation in our health workforce so that in the profession of medicine for example we are seeing the discipline of general surgery becoming not just general surgery but sub-specialisations within general surgery. Colorectal surgery is now a specialisation and a surgeon who is not a colorectal surgeon is going to be pretty iffy about doing colorectal surgery. Even within colorectal surgery there is now some specialisation within that discipline.  
Increasing specialisation is meaning that we are able to devote more specialised skill to a person’s particular need. But that in itself raises problems. It raises problems of the centralisation of health services to particular centres because not every place is going to have the colorectal surgery that is required. For rural health services and provincial health services in particular there are some very particular problems of how we ensure that people that live in those areas get good access to the kinds of specialised services to which they are entitled as citizens. That is one of the defining problems and defining questions to which we must provide some answers.  
All of that has got to be accomplished within reducing dollars in real terms. While certainly the Government has been putting more dollars into health services those dollars have not been keeping pace with inflation and that is a major problem. So it is appropriate that legislation in other parts of the regulatory framework for the health sector is overhauled to facilitate the responses of the health sector to those problems that I have described. Certainly the description of the bill sounds great—you know updating modernising improving effectiveness and flexibility and reducing barriers. It is all good is it not? Indeed there are some aspects of the bill that are unquestionably good—for example facilitation of electronic prescribing. Smart use of information technology is vital to increasing our efficiency of resource use and also reducing error and risk. That is something that is unquestionably good.  
But there are other aspects of the bill that are not so clear. There is a new definition of “medicine” for example. The new definition broadens the definition of medicines. I am pretty experienced in the sector but I am not able to tell what that new definition is actually going to mean in practice. So I am looking forward to hearing what submitters have to say. What I fear is that by broadening the definition of medicines we may actually be opening up some of the overreaching aspects of the previous bill that several members have alluded to. That overreaching is what caused the problems that led us to not be able to progress those issues at that time. So I am suspicious and interested to hear what the submissions say.  
It is essential given the crisis in our workforce—and we do indeed face a crisis—that we use the skill sets of all of the professional groups in our health sector to the maximum extent that we possibly can. I have had considerable experience of working with rural nurse specialists for example and these are highly skilled nurses with extremely broad experience and expertise who do an extraordinary job in isolated rural areas. And the areas that I know are those on the West Coast of course. So using all of the skills of that professional group will result in better services to the people of the West Coast—was that my buzzer Mr Assistant Speaker—and better services to rural and provincial people throughout the country. That is a critical component of what we need to do. Certainly I think other speakers have talked about the professional skills of pharmacists and using those to the maximum extent possible.  
But I have some doubts. What for example is the point of a delegated prescriber when we already have a regulatory framework in the Health Practitioners Competence Assurance Act? I do not get what the new category does in addition to what is already available and I will be interested to see what that says.  
On the consultation on the bill I think there has been a bizarre choice of those to consult. Certainly the regulatory agencies the councils have been consulted but I do not see there the College of General Practitioners or indeed any of the other professional colleges. The Medical Association the New Zealand Nurses Organisation—some of the key organisations that ought to have been consulted have not been and I am worried about that and keen to see what they have to say.  
I am also finally worried about the rationale that is given for the bill—and I quote: “remove … unnecessary ineffective or excessively costly” requirements. For me that strikes a bit of a chill note in that that is precisely the formulation that was used to justify all of the deregulation we experienced through the 1990s. I do not want to go there again and I would be very interested to see what the submitters have to say at the select committee about that issue too. Thank you. 
The ASSISTANT SPEAKER (Lindsay Tisch) 
: Before the member speaks I am sorry about the buzzer. It may need some medicinal help. 
SHANE ARDERN (National—Taranaki - King Country) 
: 
 The Medicines Amendment Bill is on its way so I am sure that there will be a cure here somewhere. National is committed to delivering high-quality modern public health services with tight budgets while reducing back-office costs. The Medicines Amendment Bill is another step in National’s drive for better sooner more convenient health-care. I have heard some of our opponents on the other side raise this issue but before I address their concerns or their issues can I say what a pleasure it is to be once again back on the Health Committee. We have Dr Paul Hutchison as the chair Dr Jackie Blue Dr Cam Calder and me. I am not sure what my medical colleagues did to deserve that but whatever it is it is a pleasure to be back on the Health Committee again after a 13-year sabbatical.  
It is 13 years since I last served on that select committee and—guess what—13 years ago on that select committee we discussed the need for and started addressing a proposal to change the then prescribing law so that designated prescribers would be allowed to prescribe or issue medicines in certain cases. Certainly the Nurses Organisation submitted to that process if my memory serves me right and said: “Look most of the doctors know that the nurses actually come along and suggest to the doctor that this patient or that patient may benefit from this or that particular medicine.” Obviously their nursing and observation plays a role in the final prescription. The doctors themselves at the time were pretty confident that that could be carried out. So what has happened in the ensuing I guess period of time? Well we had 9 years of Labour of course. What happens when you have 9 years of Labour? Procrastination. Nothing happens. So here we are all these years later once again proposing these sensible changes. 
It was interesting a few moments ago to listen to one of the other members of the select committee Iain Lees-Galloway from Palmerston North talking about what people say while they are in Opposition and then do while they are in Government. I think it was his predecessor the Hon Steve Maharey who perfected the art of saying one thing in Opposition and doing another thing in Government and was proud to pronounce it in this Parliament. I am sure that somehow or other the Medicines Amendment Bill got mixed up in that as well and there were probably good ideas that were suggested by the member in Opposition but they were not things Labour carried out in Government.  
The proposed changes or the suggested changes in the bill that is to go to the Health Committee will bring about the opportunity for competent and professional people such as nurses and various other medical practitioners to prescribe—optometrists are another group that is suggested in this proposal. I am sure if you think about that for a few moments you will see many examples when people have been denied access. I am thinking of the rural sector—public health nurses and those kinds of people—where people are either suffering from a minor illness or are on palliative care suffering from more serious illnesses. The district health nurse or some other suitable person could potentially save either some further illness or some discomfort by having the ability to make a decision without having to go through a process without fear of repercussions—although at a competent level—and make a decision as far as that prescription goes. So I am looking forward to the submission process in the Health Committee ably chaired by Dr Paul Hutchison and I look forward to hearing what the submitters have to say. 
RICHARD PROSSER (NZ First) 
: 
 I rise on behalf of New Zealand First and our health spokeswoman Barbara Stewart to speak on the Medicines Amendment Bill. New Zealand First will support this bill’s referral to select committee. It was a pleasure to read such a clear and concise regulatory impact statement as was included because it made our consideration of the bill quite a simple matter and the issues were very well defined.  
Many people rely on medicines and medical devices to stay as well as they can so it is logical to take some measures to streamline the legislation particularly when innovations such as electronic prescribing and teleconsultations are becoming an accepted practice. These new approaches need to be accommodated particularly as they become more commonplace and more widely accepted. It is fair to say that New Zealanders have adapted quite well in general terms to innovations and technology when it comes to their health considerations as we do in many other aspects of life.  
When we look at the Medicines Act 1981 and the Medicines Regulations 1984 it is very obvious that medicine and medical devices have advanced significantly over time and that pace of change continues to accelerate. The number of advances in over-the-counter products such as contact lens solutions eye drops self-testing pregnancy kits and nasal fluids mean that they cannot be considered to be medicines and should not really be classified as such. No doubt there are other things that should be included on this list and will be; the submissions process we hope will identify those.  
In fact technology has advanced significantly over time and it is inevitable that legislation and regulations will need to be amended to capture that advance. We want those advances to continue as we are the recipients of the benefits of those advances. They enable us to be the best that we can be and that is what life is all about. We want to see the definitions of “medical devices” and “medicines” aligned with international norms. We live in an international world and basically we cannot afford to shut ourselves away in our corner of the world and ignore the international influences particularly when we are so dependent on international developments in this area.  
Likewise the provisions relating to the licensing of medicine manufacturers and wholesalers and pharmacies are outdated. Where would we be in fact without trusted community pharmacies? They can provide a wide range of advice and remedies for ailments that are widespread in New Zealand—everything from head lice and wart treatments through to coughs colds and first aid for sports injuries and everything else in between. We have all been there and done that. The pharmacies provide an excellent service which many people do depend on. In fact people attempt to self-medicate before coming to rely on those further up the food chain in the medical profession.  
Pharmacists also provide a valuable professional service of a very high quality that is instantly available for everyone at usually little to no cost apart from the cost of the product. Linked to this are advances that have been made in the training received by pharmacy staff. This has given pharmacy customers the benefit of the experience of a wider cross-section of those working in the pharmacy industry making customers’ understanding of minor health problems much better and allowing them to more ably select self-medicating products. In the past we were often recipients of an in-house product that had been developed at the pharmacy itself which was often better than any generic over-the-counter product.  
The service provided by pharmacists and their staff is absolutely needed by the community and will continue to be needed particularly in rural and provincial New Zealand where access to health services tends to be restricted by population and geography. Looking at any community pharmacy around New Zealand we see that the service they give and continue to give to the community is outstanding as it is right throughout New Zealand. If we need to improve the efficiency of the processes and accommodate new approaches with greater flexibility then it logically follows that more streamlined processes will be required. Change is always a part of the landscape and this bill recognises that fact.  
New Zealand First is also interested in the provision aligning the prescribing framework for nurse practitioners and optometrists with medical practitioners dentists and midwives. In fact we would have thought that this group of people would already have separate regulations within their scopes of practice that allow this to occur. We all know and the public appreciates that health professionals do have some basic prescribing rights. A visit to the dentist and the possible prescription of antibiotics for example at the time of treatment should not then also necessitate a visit to the doctor to obtain the required drugs. It appears that the legislation is outdated and needs modernisation if it is to work efficiently. There is little point in having a law that does not serve its stated purpose.  
We note that the regulatory impact statement was also referred to by the Associate Minister of Health Peter Dunne and by Ms Street. It indicates that the proposals in the bill will be consistent with the framework of a joint Australia - New Zealand therapeutic products agency should such an authority ever come into being. We are pleased that this bill does not advocate or advance such an agency at this time because that is something that New Zealand First will oppose not because we are against ensuring the safety of therapeutic products that are brought into New Zealand but because we believe that standards pertaining to such safety and the dosages that are available to New Zealanders should be set solely in New Zealand and by New Zealanders and not be dependent on any kinds of regulations determined in Australia.  
All in all however we see a large degree of necessary good in this bill and New Zealand First will support this bill’s referral to select committee. Thank you. 
Dr CAM CALDER (National) 
: 
 It is a pleasure to rise and have a brief call on this bill the Medicines Amendment Bill. In 2008 the National Party promised that we would offer better sooner and more convenient health-care should we become the Government. This is indeed what has happened. We have got proof of that and we heard the Minister of Health just this very afternoon outlining the success in increasing immunisation rates increasing the number of people seen at accident and emergency more quickly and of course the gold standard of starting treatment for diagnosed malignancy within a 4-week period—the global gold standard.  
In my own area of interest Manurewa 3000 more elective surgical procedures were performed—27000 around New Zealand with 3000 of those in the local community. And of course a move is afoot to address the Third World levels of rheumatic fever; unfortunately Manurewa is a hotspot in New Zealand for that. We are working on that with school nurses and more will be rolled out in the future.  
This bill is yet another way of addressing that promise of improving our health services that we deliver to the people of New Zealand. We are committed to delivering high-quality services and modern public services and unfortunately we are in an area of tight budget constraint. We all know what those problems are so we need to work more efficiently and this bill will allow us to do so.  
I am particularly keen on the expansion to nurse practitioners and optometrists of the designated authorised prescriber. That will free up and make more flexible the whole business of getting the medicines to the necessary patients more swiftly and more expeditiously. 
 I must say I regard it as a privilege to prescribe. My first degree was in medicine with a postgraduate qualification—an interest in oral surgery. That gave me the ability to prescribe within my scope and then in qualifying as a medical practitioner that scope of practice was widened. And that is what we are allowing the nurse practitioner and the optometrist to do: to prescribe within their scope of practice.  
But the other area that excites me is the delegated prescribing order. I have worked in general practice I have worked in accident and emergency and I have worked in hospitals. I can just imagine that many general practices where they have nurses within the clinic could form a framework wherein that nurse could see a patient and make the necessary prescription available to them. I am thinking of somebody coming in with a bladder infection.  
There are many other areas that excite me about this bill. It is a brief contribution this time. I am privileged to be on the Health Committee and I look forward to hearing submissions on this bill in due course. 
RAYMOND HUO (Labour) 
: 
 I rise to take a call on the first reading of the Medicines Amendment Bill. Labour supports this bill to go to the Health Committee. We are supporting this bill because it provides an opportunity to amend some specific provisions of the Medicines Act in order to streamline the legislation.  
However some important aspects raised by my colleagues the Hon Maryan Street and Iain Lees-Galloway who both spoke this afternoon are worth reiterating. This bill reminds us of two important phrases. The first one is “naked politicking” and the second one is “flip-flop”. Had National not flip-flopped on the issue of natural health products and opposed the Therapeutic Products and Medicines Bill most of those amendments we are repeating now could have been passed in 2007. Many of the changes as pointed out by the Hon Maryan Street covered by the amendment bill were consulted on during the development of the Therapeutic Products and Medicines Bill and the select committee’s consideration of that bill.  
Among other measures the bill seeks to modernise the definitions of “medicine” “medical device” and “therapeutic purpose” to align the boundary between medicines and medical devices with international norms. The expansion of the regulation-making powers in the Act will help to provide for new standards and innovative practices such as electronic prescribing. These changes will support initiatives that are under way in the sector including electronic prescribing pilots and the Safe Medication Management programme.  
Labour supports a more comprehensive overhaul of the Medicines Act in the future to modernise and recast the medicines legislation and to address issues such as the regulation of medical devices and cellular therapies and controls on advertising. Thank you. 
DARIEN FENTON (Labour) 
: 
 I am taking just a brief call to reiterate Labour’s support for the Medicines Amendment Bill to go to the Health Committee. I was interested in Shane Ardern’s contribution actually because he was the chair of the Government Administration Committee that considered the Therapeutic Products and Medicines Bill back in 2006 and 2007 and I was actually the deputy chair. I remember those events very very well so I find it very interesting that we are now here considering a bill that actually had the preparation the foundation work done under the Labour Government.  
There were genuine concerns around the Therapeutic Products and Medicines Bill at the time but they could have been overcome with a bit of genuine working together on it. But of course as we have heard from some of my colleagues there was a whole lot of politicking that went on from National—a whole lot of I think rarking up the public about opposition to anything Australian. That was what it was about. It was about people feeling you know that they did not trust any kind of treaty with the Australians even though we had actually signed up to this treaty in 2003 and it left our Government and it still does leave it in quite an embarrassing position.  
I am enjoying at the moment—and I probably should not say this—seeing the opposition to the Food Bill which the Hon Kate Wilkinson is having to deal with too. It reminds me of the same kind of opposition that came to the Therapeutic Products and Medicines Bill—you know kind of extreme on the one hand and the Government trying to assure people that it is not as bad as they think it is. So there is this kind of “chickens coming home to roost” feeling about what is going on with the Food Bill.  
Just in talking about the Medicines Amendment Bill I think it is also worth reminding Parliament about where we were when Labour became the Government in 2000 around the costs of medicine. If you went to the pharmacy it would cost somebody $15 for one prescription—for one item on a prescription. It was $15 for one item if you had two it was $30 and if you had three it was $45. It was prohibitive and that had happened under the previous National Government. Of course what happened after we had gone through terrible economic times and lowering wages and all sorts of other things under the National Government was that many families could not afford the medicine. What was happening was people sometimes went to the doctor and got the prescription but they could not afford to go to the pharmacy and collect the prescription. So we had terrible things starting to occur in families where they could not get the basics. As we know medicines are often preventive as well as a cure but families were unable to get the preventative medicine that would stop something becoming quite chronic and sometimes stop people ending up in hospitals.  
I also smiled to myself today when I heard Tony Ryall talking about visiting the Porirua Union and Community Health Service. 
Charles Chauvel 
: To shut it down? 
DARIEN FENTON 
: Yes that is right—he probably went to shut it down. I did smile to myself about that because again the only reason that service exists is that it was a Labour initiative. The whole primary health organisation model that this Government now likes to gloat about actually came from all of the work done by Labour. Actually ironically it is not called the Porirua Union and Community Health Service for nothing; it was started by unions to provide health care for low-paid low-income workers at a time when they could not afford to see the doctor let alone go to their pharmacy. 
Hon Member 
: That’s because Labour cares. 
DARIEN FENTON 
: Yes. There is a long history here so I always find it very ironical when Tony Ryall and other people stand up and talk about all the wonderful things the Government is doing in health. Labour built the platform—Labour built a platform. We turned things round where it was becoming impossible. In fact do you remember what National did in the 1990s where there were cash registers at the hospitals? Somebody actually had to pay to be seen at the hospitals. 
Michael Woodhouse 
: Somebody does pay every single time. 
DARIEN FENTON 
: What was that? 
Michael Woodhouse 
: Somebody does pay every single time. 
DARIEN FENTON 
: But patients had to pay. Is the member advocating that we put the cash registers back? Is that what the member is advocating? He should tell us.  
Charles Chauvel 
: He used to sit behind one of them. 
DARIEN FENTON 
: Well that is true—of course he used to sit behind one of the cash registers. Just let us remember how far we have come in primary health care and medicine and in pharmacy care under a Labour Government. 
Andrew Little 
: That’s because Labour cares. 
DARIEN FENTON 
: And Labour does care; that is right. So that is why we find this bill pretty ironic. What we had in 2007 was a whole lot of politicking—convenient politicking—that went on from National which was nothing to do with what was good for New Zealand or the relationship with Australia; it was nothing to do with that at all. I sat on the select committee and I saw it happen; it was disgraceful. So I am pleased that this bill has come forward and will be going to a select committee but so much of the work was done under a Labour Government. So much could be already in train. That has not happened because of the politicking from National when Labour was in Government. 
 I also want to remind the House that the whole area of nurse practitioners was something else that Labour introduced. I sat on the Health Committee when that legislation was introduced and was then followed by regulations. I think it was one of the most innovative things we did because we all know that nurses are in the community and provide hands-on care and why should they not prescribe?  
But of course what we have is a health system under pressure. It is not just about what happens in the hospitals; it is about what happens in the community. What we are seeing is caregivers going on strike on Thursday morning because they get paid $13.61 an hour—11c more than the minimum wage. It is fine to talk about medicines and send this bill off to the select committee but we have got some issues that this country needs to deal with and this Government needs to deal with. This Government needs to start taking the issue seriously starting with those who care for our most vulnerable in our community. 
Dr JIAN YANG (National) 
: 
 First of all I must say I appreciate my colleagues on the Health Committee. We have quite a few doctors there. I am one of the doctors but I am not a medical doctor. I am a PhD so I am still learning— 
Hon Maurice Williamson 
: A real doctor. 
Michael Woodhouse 
: Yes a real doctor. 
Dr JIAN YANG 
: A real doctor! As an immigrant I appreciate of course the health system in New Zealand. Based on my experience in China you may understand why immigrants like me would appreciate the health system in New Zealand. The Chinese have doctors. They are called Chinese medical doctors whom we called lang zhong. They were not licensed doctors in those days.  
In 1949 when the Communist Party came to power it started to set up a new system we called barefoot doctors. Basically we recruited educated young people to come to some kind of training and then we sent them to rural areas to make sure that peasants would have some kind of medical services from the Government. In those years of course the Chinese were poor. The Chinese Government was trying hard to make sure that the Chinese people would have some kind of basic medical treatment. It was very basic. The barefoot doctors walked through the countryside door by door and provided this very basic medical treatment.  
In the end of course the Chinese people started to have more medical colleges and more and more qualified doctors. These days in China you will find many hospitals but each hospital is always full always crowded simply because there are 1.3 billion people in China. It is a huge population. It is very hard to take care of all these people although there are many doctors there. So what happens in China is that you have to have good connections to make sure you can be treated timely and the Chinese Government has to make a huge effort to invest in medical services. Still it is very very difficult for many Chinese to get the proper treatment unless you have a lot of money to buy better services. 
In New Zealand of course the National Government is committed to delivering high-quality modern public services within a tight Budget while reducing back-office costs. We understand that we have done extremely well in training and in having more doctors and more nurses. The National Government has invested hugely and made a huge effort trying to increase the number of doctors and nurses. And we did and it has been very successful. We all know that all New Zealanders deserve a public health service they can rely on and with more doctors and more nurses we can do this. Now we give more power to nurses to prescribe medicines and that will make things even better. We appreciate New Zealand’s health system but we can make it even better by reducing the paperwork and by giving more authority to nurses and other medical officers.  
This Medicines Amendment Bill is another step in National’s drive for better sooner and more convenient health-care. We also must remember that we are going to have a larger population dependent on health care. In the next few decades the number could double. We cannot double our hospitals nor can we double the number of doctors and nurses in New Zealand. Therefore this bill is a creative way to improve our health system and medical system. Thank you. 
MICHAEL WOODHOUSE (National) 
: 
 In my very short call at the end of the first reading of the Medicines Amendment Bill I will resist strongly the temptation to debate the rewriting of history by my friend on the other side Darien Fenton in respect of the health care system.  
What I do particularly want to just touch on and commend is the work of a friend of mine Dr Andrew Bowers. He is a specialist physician at Dunedin Hospital and he has been running an electronic prescribing project there. It has made a dramatic positive impact on safety particularly for in-patients at Dunedin Hospital but the 31-year-old legislation that prescribes for prescribing does act as a constraint on that so I am particularly interested in exploring the possibilities for greater flexibility around electronic prescribing. I look forward to the Health Committee’s report on that particular issue which is one of many very very positive changes to the Medicines Act. I look forward to seeing how the select committee goes. I commend the bill to the House.  
Bill read a first time.  
Bill referred to the Health Committee. 
Hon PETER DUNNE (Associate Minister of Health) 
: I move  
That the Medicines Amendment Bill be reported back to the House by 2 July 2012. 
Motion agreed to.