Medicines Amendment Bill — In Committee Third ReadingText is incorporated into the Bound VolumeMedicines Amendment Bill — In Committee Third Reading[Sitting date: 19 November 2013. Volume:695;Page:15053. Text is incorporated into the Bound Volume.]Medicines Amendment BillIn CommitteeLOUISE UPSTON (Senior Whip—National): I seek leave for the Medicines Amendment Bill to be taken as one debate.The CHAIRPERSON (Eric Roy): Is there anyone opposed to that course of action? There is not. Leave is granted.Parts 1 and 2 schedule and clauses 1 to 3Hon ANNETTE KING (Labour—Rongotai): You can see that I am very eager to speak on the Medicines Amendment Bill because I have looked forward to this day for 6 years. For 6 years I have looked forward to it. In fact for 14 years this bill has been in the making. In fact this bill makes a few changes to the Medicines Act 1981. It is an interim measure after 14 years. It is a bit of a sticking plaster a bit of a patch up until the Government progresses the Australia New Zealand Therapeutic Products Agency under a treaty that was signed between Australia and New Zealand in 2003. So this is not a comprehensive overhaul of the Act; it is an interim measure.The irony of this is that National after years of political posturing and shilly-shallying in Opposition led by Tony Ryall opposing a joint agency finally decided in 2011 that it now supports it. That must be the biggest backflip that we have seen on a piece of policy in this House. The Prime Minister agreed in 2011 that National which was once opposed to a joint agency would now proceed with the establishment of the Australia New Zealand Therapeutic Products Agency.The legislation that will bring this agency to life sits on the Order Paper of this House—No. 47 if you want to have a wee look. It is the very legislation that Iintroduced in 2007 and is unchanged after all the political posturing. Now it is in the name of the Minister of Health Tony Ryall. I have to say that after 9 years of National being in Opposition with the most objectionable obnoxious and malicious fabrications—full of cant—about a joint agency we now have a National Government in support of it. In fact Mr Hayes probably knows quite a lot about it because it was very much part of a trade deal we did with Australia under the CER and the Trans-Pacific Partnership and he is probably well aware of the negotiations that took place. But for purely political reasons the National Party opposed the joint agency.This bill takes out some of the changes that were going to be made a very narrow range of changes for an interim measure until the joint agency is set up. I look forward to that day because as the former Minister of Health who took the heat on that bill and listened to so much rubbish over months and months—in fact years—I am delighted that National finally saw the light. I have to give credit to the Prime Minister because there is no way that Tony Ryall would have seen the light.You see a regulatory impact statement undertaken by the New Zealand Institute of Economic Research right back in October 2000—13 years ago—confirmed that the Medicines Act 1981 the Medicines Regulations 1984 and the Dietary Supplements Regulations 1985 were outdated and gave rise to significant “safety risks trade barriers and costs to Crown and industry.” It proposed in 2000 that the changes to be put in place should be around putting in place regulations to make change and putting in place international best practice.Well this bill which we are now finally debating modernises the definition of medicine medical devices and therapeutic products. We welcome that because it made up part of the negotiations for the joint agency all those years ago. The second thing it does is it changes the approval process for medicines and medical devices by the use of regulations to specify detail. We support that because it made up part of the changes that would have come in with the joint agency all those years ago.The third part of this bill amends the prescribing framework. We will have three types of prescribers. Authorised prescribers are the ones whom most people are familiar with. They are doctors dentists and midwives and they prescribe within a scope of practice that has been defined for them. Then we have designated prescribers and they are a restricted subgroup of authorised prescribers. Currently they are optometrists and nurse practitioners. They have already got prescribing rights and there are some specialised nurses who are also designated prescribers. They are allowed to prescribe only medicines that are on a list and these are listed in regulations. This bill revokes designated prescriber regulations for nurse practitioners and for optometrists and now names them as authorised prescribers. So they now join the doctors the dentists and the midwives. It aligns them and now they too will prescribe in line with their scope of practice. They have shown for 7 years that they are totally capable of doing that so it has taken rather a long time.The new category of prescriber is the delegated prescriber. This new category is going to enable people to prescribe under a delegation an order by an authorised prescriber. That is a doctor or a dentist or a midwife and in this case it would be a nurse practitioner or an optometrist. In fact the requirements will be at a lower level so they will have limited prescribing. But we believe that the changes will enhance the health workforce and also the ability to provide appropriate care within the community. We support all those changes in this bill. The reason why is that they were a Labour Government proposal. It is only 5 years later that in fact we are now looking to pass them into law. So we certainly support those changes in this bill.But because this is being taken as one debate I have to emphasise again that we should have learnt a lesson about playing political games with major policy that affectsthe health of New Zealand our trade obligations and the economic viability of many businesses in this country. For purely political reasons the joint agency with Australia was held up predominantly by the then Opposition spokesperson on health Tony Ryall for no other reason than political purposes. Now all these years later having opposed it National is going to pass the very bill that I introduced. The Prime Minister said that National now supports the joint agency. Can we not learn that there are some things that are for the good of this country and are supported across Parliament instead of the sorts of stupid political games that were played with this particular policy?So now in an interim way we will make a few changes a little bit of a sticking plaster until the agency is in place. I will celebrate that day as I am sure will the Hon Christopher Pyne who is now the Leader of the House of Representatives in the Australian Parliament and Tony Abbott who was the Minister for Health and Ageing who helped negotiate it—now the Prime Minister of Australia—and who gave so many concessions to New Zealand to ensure that we have an agency that is fair that is equal and that enables us to act in a joint way and finally complete the negotiations with the one part that was missing under CER.Yes we will support this bill but the bigger picture needs to be the passage of the Therapeutic Products and Medicines Bill sitting on the Order Paper with the date on it saying it was introduced in 2007.IAIN LEES-GALLOWAY (Labour—Palmerston North): As my colleague Annette King outlined the Medicines Amendment Bill is an excellent bill. It is a very good bill that not only streamlines our prescribing processes and streamlines the way in which we approve medicines and medical devices but also improves access to health care particularly primary health care. It will improve people’s access to medicines. It will make it an awful lot easier for many people particularly people with chronic conditions to be able to access the medicines they require which is clearly the reason why the National Party has held it up for so long. That must be it. It is such a good piece of legislation which improves access to health care. That must be why the National Party has held it up for so very very long.Here is a little bit of history for those who are watching at home. The National Party has actually known all along that this is a good piece of legislation. It knows that this is the right thing to do but back in 2007 the National Party—and in particular Tony Ryall—saw a political opportunity. People may or may not remember a gentleman by the name of Gordon Copeland. Gordon Copeland was elected to this Parliament as a member of the United Future party. He decided to leave the United Future party despite being a list MP whose only mandate to be here was the fact that United Future had gained a certain number of party votes and that its leader had managed to win an electorate seat. So Gordon Copeland was here as a United Future member he decided to leave and he made it his life’s work to oppose the Labour Government on absolutely anything he could—Hon Ruth Dyson: When he remembered to vote.IAIN LEES-GALLOWAY: —when he remembered to vote. He did remember to vote against this legislation which improves access to medicines in primary health care. The National Party members thought to themselves: “Aha! With his vote opposing the Government if we decide to oppose this we can actually stop the Labour Government achieving something that is enormously positive for the people of New Zealand.” So rather than doing the right thing rather than having the interests of New Zealanders at heart and rather than doing something that would improve the health of every New Zealander the National Party chose to play politics and it blocked the Labour Government from passing this legislation.That was bad enough frankly but when National got into Government the election was done and the little political power play had had the effect it was looking for—it was just one of the things that led up to the 2008 election. National was now the Government it had the opportunity to act and it had the mandate to act. This bill the Medicines Amendment Bill—which of course is exactly the same legislation that Annette King introduced but it got rearranged slightly and reintroduced in the name of the Hon Peter Dunne—was introduced on 13 October 2011. So it took this Government almost an entire term of Parliament to introduce the legislation. It then got its first reading after the 2011 election in February 2012 it came back from the Health Committee in August 2012 and it finally got its second reading in March this year.So here we are in November—Hon Annette King: Under urgency.IAIN LEES-GALLOWAY: —under urgency and suddenly this piece of legislation has become tremendously important to the Government. It is so urgent that it has taken the Government only 5 long years to get to this point. And now it is suddenly so urgent to—John Hayes: Remember the 9 long years.IAIN LEES-GALLOWAY: —pass it through its Committee stage to get to here. John Hayes just tried the “9 long years” line—John Hayes just tried the “9 long years” line. We could have had this done when Labour was in Government but your party Mr Hayes blocked it. Your party stopped it happening. It played politics over it. That is what it did Mr Hayes. It put the health and well-being of New Zealanders to one side to play politics. You should be careful with your interjections Mr Hayes.On this side of the Chamber we wholeheartedly support this legislation. We think it is a great pity that it has taken so long to pass this legislation. It has actually outlasted the Hon Peter Dunne. That is saying something quite significant—that it has managed to outlast the Hon Peter Dunne. But this is good legislation. Annette King has covered the fact that it is the interim phase before we get to the joint regulator. But frankly I am more interested in the prescribing rights—the fact that this bill widens and deepens prescribing rights for many health practitioners. I am particularly interested in that because of the fact that so many people do not have adequate access to primary health care. General practitioners are tremendously important. They will always be an incredibly important component of primary health care but we simply cannot provide the primary health services that we are going to need in the future if we totally rely on general practitioners to be the sole bastion of all prescribing rights.We do need to move towards more nurse-led clinics. We need to give nurse practitioners—Sue Moroney: Paul’s fainting.IAIN LEES-GALLOWAY: —more opportunities. I am looking forward to Dr Paul Hutchison’s contribution on this legislation. We do need to make greater use of our highly qualified highly educated nursing workforce and in particular the nurse practitioner workforce. That is the only way we are going to provide the primary health care services that New Zealand is going to need and in particular that is how we are going to reach into those most deprived communities that simply do not have the primary health facilities that they need.Dr Hutchison will have heard me talk about this at the Health Committee recently. If you map the location of primary health care services against the deprivation index you get an almost perfect correlation. The most affluent parts of any community have an over-abundance of general practitioners and the least affluent—Hon Ruth Dyson: Do people get more sick in those communities?IAIN LEES-GALLOWAY: I am not sure that people get more sick. Maybe money makes you sick—I do not know. But people in the most affluent areas have an over-abundance of general practitioners and the people in the least affluent areas have minimal or sometimes non-existent services. It is those people who need primary health care services the most and who often have the most challenges in terms of access. I am thinking about things like transport and the affordability of going to your doctor. So that is why we need to pass legislation like this and do many other things to free up our health workforce to be able to provide the level of care that New Zealanders demand.It is an absolute tragedy that this bill is the thing National chose to play politics over. This is the kind of legislation that sits on the back-burner for 5 long years and then finally gets passed as part of an urgency motion early on a Thursday morning. I think that speaks volumes about where this Government’s priorities lie. I think it speaks volumes about this Government’s priorities. I know that had Dr Paul Hutchison been the Minister of Health under this National Government this bill would have been a priority. He would have progressed it much sooner than now. There is a gentleman who will be missed from this Parliament because he brought some sanity to the health policy of National.Hon MARYAN STREET (Labour): It gives me great pleasure in fact a deal of satisfaction to rise to speak to the Medicines Amendment Bill. I had the privilege of being on the Health Committee under the chairmanship of Dr Paul Hutchison when it was debated and reported back in August of 2012 prior to that I was also on the Health Committee in 2005 when this bill was first debated and when it first came into the House. So I have lived with this piece of legislation albeit on the back-burner as my colleague has said for a very long time. Tony Ryall was the Opposition spokesperson on health. We worked on the Health Committee together—or not as the case may be but we happened to be on the Health Committee together—and I remember the parade of red umbrellas. It was the red umbrella protest. I am sorry if there are members opposite who have come into this House subsequent to the 2005 election and do not know of that performance and now have to sit here listening while the Labour Opposition rightly sheets home to the National Party the blame for the delay in this legislation. If it is embarrassing for them so it should be—so it should be—because this bill was in front of the Health Committee in my first term in Parliament from 2005 onwards.The Hon Tony Ryall saw fit to side with a set of protesters whose arguments ranged from the patently ludicrous to the quite sensible and worthy of debate but who gathered together because of a range of measures. They saw this opportunity for a political score against the Labour Government at the time. So instead of looking to see whether the bill was going to benefit the health and welfare of New Zealanders Tony Ryall saw fit to do what only Tony Ryall does best—that is calculate the political benefits and ups and downs. I have to say that I consider that to be the way the Minister continues to operate the health portfolio now—that is with half a dozen measurable outputs into which everything has to be squeezed so that he can sing his sunny song constantly about how well health is progressing. Any other stories—the true ones—about people who cannot get on to waiting lists to get operations or whose blood glucose meters are seriously jeopardising their health do not make it into Tony Ryall’s narrative. They do not make it because he is only here for politics; he is not here for people.This is a historic reminder that that is this Minister’s modus operandi. He will look to the politics before he looks to the content. We had this ludicrous situation with two new members on the Health Committee—one a former general practitioner Dr Jonathan Coleman and one a former breast physician Dr Jackie Blue—who were compelled byTony Ryall to oppose this even though they knew it offended every professional ethic that they had. Jonathan Coleman had no trouble sacrificing his professional ethics but Jackie Blue did have trouble sacrificing her personal ethics. However that is history now. But let us not forget it. For those members opposite who do not know that history it is important that they do understand it because it is part of the progress or lack thereof of this bill.This Medicines Amendment Bill modernises the Medicines Act. It is only a temporary measure until the Australia New Zealand Therapeutic Products Agency is set in place. When that is set in place it will overtake the provisions of this bill. However the purpose of the provisions of this bill was to actually expand the ability of health practitioners to be able to prescribe so that one did not have to go to a doctor all the time; one could go to a designated prescriber who came under the jurisdiction the oversight and the supervision of an authorised prescriber.I am not going to take up any more time over this. We support this bill because we invented it and because it is good for New Zealanders.The question was put that the following amendment in the name of the Hon Todd McClay to the proposed amendment set out on Supplementary Order Paper 270 in his name to insert new clause 37A be agreed to:delete subclause (1).Amendment to the amendment agreed to.The question was put that the amendment set out on Supplementary Order Paper 270 in the name of the Hon Todd McClay to insert new clause 37A be agreed to.Amendment as amended agreed to.Part 1 as amended Part 2 schedule and clauses 1 to 3 agreed to.Bill reported with amendment.Report adopted.Third ReadingHon TODD McCLAY (Associate Minister of Health): I moveThat the Medicines Amendment Bill be now read a third time. This bill streamlines the current Medicines Act 1981 and is an interim measure until such time as the Therapeutic Products and Medicines Bill is passed. This legislation and the Natural Health and Supplementary Products Bill will comprehensively overhaul New Zealand’s therapeutic products regulatory system. Indeed this bill modernises the definitions of medicine medical devices and therapeutic purpose. It also amends the medicines approval process to make legislation less prescriptive and instead specifies the detail in regulations. It will amend the prescribing framework to name nurse practitioners and optometrists as authorised prescribers and makes some minor changes to licensing requirements. The bill also adds a new prescribing category: delegated prescriber. The definitions in the bill have been developed to reflect New Zealand’s current regulatory framework and will be reviewed and updated again as part of the establishment of the Australia New Zealand Therapeutic Products Agency.The changes that this bill proposes are consistent with this Government’s dedication to improving and enhancing access to health services and removing in a timely fashion unnecessary red tape while ensuring an emphasis on patient safety. 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 medicinesappropriate to their scope of practice. This move acknowledges the safe and appropriate prescribing practice of these groups over the past 7 years and will support timely access to care for New Zealanders. The bill also creates a new category of prescriber the delegated prescriber who will be allowed to prescribe under a delegated prescribing order issued by an authorised prescriber. This bill also enables 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 other time while the licence is in effect.The default commencement date for the definition prescribing and other minor technical provisions will be 1 July 2014. The bill removes provisions in the Medicines Act that deal with medicines approvals and will replace these with a regulation-making power. The default commencement date for the medicines approvals provisions is set at 1 July 2017. This anticipates that the medicines approvals 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. This bill provides an opportunity to amend some specific provisions of the Medicines Act in advance of the comprehensive overhaul of the therapeutics legislation that will occur via the Therapeutic Products and Medicines Bill. This is timely legislation and a big priority for this Government. I commend it to the House.Hon ANNETTE KING (Labour—Rongotai): Labour will support this bill the Medicines Amendment Bill. It is an interim measure it is a sticking plaster it is a patchover until the Government progresses the Australia New Zealand Therapeutic Products Agency which was to be set up under a treaty that was signed between Australia and New Zealand in 2003. So it is not a comprehensive overhaul of the Medicines Act but a couple of little measures to progress it along the way after being delayed by political posturing for almost 7 years. Why was there a need in fact to even look at a joint agency? I did mention some of this in the Committee stage. We needed to resolve a special exemption for therapeutic goods under the Trans-Tasman Mutual Recognition Arrangement in a manner that facilitated trans-Tasman trade and to enhance Closer Economic Relations (CER) between Australia and New Zealand. You see it was one part of CER that had not been resolved in the late 1990s and the New Zealand system and the Australian system for regulating therapeutic goods were so different that it necessitated a special exemption. That special exemption was given in 1997-98.We were then required to work on getting rid of this exemption and we could have done it in three ways. It could have been a mutual recognition a permanent exemption or a harmonisation of regulation. It was decided by the then National Government in 1999 when the New Zealand and Australian health Ministers agreed that they would go down the harmonisation track for regulatory requirements for therapeutic goods as the best option under the Trans-Tasman Mutual Recognition Arrangement. So the then Minister of Health Wyatt Creech started the process towards having a joint agency between Australia and New Zealand. That was when the National Party had members of Parliament who were sensible and who were prepared to look at the trade issues and the health issues and to progress them in a sensible manner. But unfortunately when there was a change of Government and a change of spokespeople the bill became nothing more than a political plaything for the then National spokesperson on health who is now the Minister of Health. And play with it he did to the extent that he was able to delay the passage of any part of this bill until today under urgency.Maryan Street set out a very good record of what happened when she was a new member of Parliament coming into the Health Committee with Tony Ryall there as the Opposition spokesperson and watching how National had gone from supporting an agency in Government to opposing it when in Opposition. The irony of this—and I amsure members who were on that committee will understand the irony—is that the bill on the Order Paper that will set up this agency the very bill was in my name in 2007. Not one word of it has been changed. The very thing National members railed against which they went out on the street and argued against—and said that it was evil it was bad and it could not be done—is the bill that is No. 47 on the Order Paper. My name was taken off and Mr Ryall’s was put on. Well what an irony that is. It must be one of the biggest U-turns and pieces of political cant that I have ever—Hon Trevor Mallard: An S-turn.Hon ANNETTE KING: It is an S-turn—an S-turn. Well it is; I think that is right.Hon Trevor Mallard: Two U-turns.Hon ANNETTE KING: Yes it was an S-turn and it very much suits this particular Minister.You see the shame of this is that many of the good things that are in this bill could have been done all of those years ago. I agree with my colleague Iain Lees-Galloway that we have got some wonderful health professionals in New Zealand. With the changes made to prescribing in this bill these health professionals could be out there providing enhanced services—particularly in rural and provincial New Zealand and in specialised areas of health—but they have been held up because it was not important enough to pass. But under urgency today we now need to pass it in a hurry. It makes a nonsense of this Government’s legislative timetable but it makes an even bigger nonsense of its hapless Minister of Health who for purely political reasons held up this joint agency.I will be interested to see whether the Hon Christopher Pyne who is now the Leader of the House in Australia and the Australian Prime Minister Tony Abbott who gave so many concessions to New Zealand to ensure that we had a fair deal will be prepared to sit round the table and give those concessions back to us again. They are going to say: “Hey can we be sure that you will do it this time?”. I think that they will be very reluctant to go down this track unless there is some assurance. The assurance that we can give the Government is that we will not be playing politics with the joint agency. We will be looking at the greater good for New Zealand. That is what this Government ought to do. All I can say is shame on Tony Ryall. This delay is his delay.KEVIN HAGUE (Green): This Medicines Amendment Bill is a good bill. It is largely technical in nature and it is one that we are happy to support at its third reading. But like the Hon Annette King I want to provide a little bit of context as is appropriate at the third reading. As Iain Lees-Galloway described in the Committee stage the progress of this bill has been extraordinary and also chaotic. Certainly this morning I had to refresh my memory on much of the content of the bill because it has been so long since we last debated it in the House and to now be progressing it through all of its remaining stages under urgency is a little extraordinary. One of the things that I noticed was the commencement date and the change to the commencement date made by the Health Committee which has turned out to be fortuitous. If we had not done that the bill was due to have commenced in July of this year. At the time the select committee was considering it we had no idea that it would take the Government this long in fact to come to finalise the bill.It is hard to know whether that chaotic nature is a reflection of Minister Ryall’s political lens as Maryan Street has described it in the House. He is a Minister whose first instinct is to ask: “Does this win my party votes or does it lose my party votes?”. He is not a Minister who asks: “Is this measure good for New Zealanders’ health or bad for New Zealanders’ health?”. I think that is a sad thing but we do not know whether the chaotic nature of this bill is a reflection of that or of a more general incompetence either in the health portfolio specifically or around the Government’s management of its House programme more generally.Part of the context for this bill that I want to talk about is the workforce. Minister Ryall has for example trumpeted an increased number of doctors an increased number of nurses both of which have been shown to be outlandish claims that are not supported by the evidence. For example when asked about increased specialist numbers he included in his new doctor numbers a very large number of junior doctors who are not in fact specialists. His increased nurse numbers include a very large number of nurses who previously worked in our hospitals under contracts and are now employees so do not reflect any increased nursing capacity. It is a certain disingenuous use of data. Neither of those numbers reflects the maldistribution of those health professionals.Why this is important is that New Zealand is going to be facing—and indeed already is facing—a massively increased burden of disease particularly associated with chronic conditions. I have used diabetes in this House on a number of occasions as an example of an area where New Zealand is already facing this massively increased burden. If New Zealanders today require renal services they will be lucky to receive them. They will be lucky to receive them because those services are already being overwhelmed by the burden of disease associated with diabetes. That burden of disease is due to increase even more rapidly both because of the ageing New Zealand population but also because of the burgeoning incidence of type 2 diabetes. It is burgeoning to the extent that it seems likely based on the PricewaterhouseCoopers projections and based on the work done by the University of Otago researchers on the current prevalence of type 2 diabetes and pre-diabetes that in just 8 short years—by 2021—New Zealand will have moved from spending around half a billion dollars currently to spending around $2 billion each year on type 2 diabetes treatment alone. That is a massive increase in the burden of disease that our health services will face. It is an increase that we are ill-equipped currently to bear and this Government is doing precious little about preparing us for that impact. In fact in the face of that impact this Government and this Minister of Health Tony Ryall have actually slashed spending on preventing type 2 diabetes which is a massive massive problem.Against that extremely worrying picture the one bright light that I can pick from the Government’s performance is in fact this bill because clearly one of the things that New Zealand will need to do in the face of this impact from chronic conditions is to use our health workforce more intelligently and more flexibly. That will mean health professionals doing things that they are competent to do and that lie within their expertise but which they are not currently doing. Part of the recipe for reaching that point is to change the regulatory framework that may be preventing them from working to the full scope of their expertise. That is one of the things that this bill does accomplish. It will see a wider range of health professionals being able to prescribe and actually use a greater part of their expertise to the advantage of New Zealanders’ health. I already see it in the rural area that I come from the desperate need—and I spoke earlier in this contribution about the maldistribution of health professionals around the country—to be doing that in order to provide for the needs of rural New Zealanders. But that need in rural New Zealand is effectively the thin end of the wedge. What we are experiencing in rural areas will be experienced right through the country as a result of this burgeoning chronic disease burden. A bill like this which enables that stretched New Zealand workforce to work to the extent of its capacity is a welcome contribution and the Green Party will vote for it.BARBARA STEWART (NZ First): It is my pleasure to take a call on behalf of New Zealand First on the Medicines Amendment Bill. New Zealand First supports this bill. This is a bill as others have said that has languished—The ASSISTANT SPEAKER (Lindsay Tisch): I am sorry to interrupt the honourable member. The time has come for the luncheon break.Debate interrupted.Sitting suspended from 1 p.m. to 2 p.m.