Agricultural Compounds and Veterinary Medicines Amendment Bill
It is a pleasure to speak on the Committee stage of this Agricultural Compounds and Veterinary Medicines Amendment Bill. Although the subject matter may sound quite complicated to peopleâ
đŹ Hon Member: To some.
âto someâbut, actually, when you strip it back this legislation is an essential part of our primary industries.
When folks think of pest eradication, our horticultural industries, definitely our agricultural industries, and all those substances that are used by farmers to increase their production in whatever form that those substances may take, they are very important. It is a massive industry, obviously, because it supports our food production industries, primarily, and our horticultural and forestry industries. So agricultural compounds and veterinary medicines are vital, and it was a pleasure considering this bill.
Essentially, when you break it all down, this bill is about increasing data-protection periods. It is about increasing the data protection for those companies that go through the significant investment in R & D to come up with these solutions for, for instance, our pipfruit industries or our farming industries. Whether it is dairy, sheep, or beef, we want to encourage those industries to do further innovation. As a result of that, the Primary Production Committee unanimously agreed, after considering quite a number of submissionsâI think there were nine in total, and then about five submitters came in to see usâthat we extend the data-protection period for the different range of applications that are made to the Ministry for Primary Industries by these particular companies for the use of their agricultural compounds and veterinary medicines.
Just by way of example, for innovative trade products the data-protection period has been extended from 5 years to 10 years. In the initial bill it was 8 years, but 10 years was considered a fair period to allow the companies to recoup their investment but also to not unduly penalise the consumer for an extended period beyond 10 years. So that was a fair protected period.
Then we have also got periods for new uses for innovative trade products. That might, for instance, be the case where a particular product is used on, say, pipfruit, and it might then be extended to some other different variety, another use, or another fruit. For going through that application the period of data protection has been extended to 10 years as well. That goes through for not only innovative products but also non-innovative products. For new uses of non-innovative trade products, again, there is an extended period for data protection.
I guess the rationale behind the extended periods is to promote innovation. It is to encourage those companies to look for a solution, whether it might be a drench or an application that is made for goat dairy. For instance, there is no intestinal veterinary compound for dairy goats. So to encourage companies to actually provide that solution, rather than rely on the farmer to play around with trying to create their own home-made remedyâthe extra data-protection period encourages those companies to invest and to provide wider application, new uses, for their compounds and their products. We do want to encourage that.
We listened in the select committee. We did hear loud and clear that extending the period of protection will not create monopolies, but it will encourage more innovation and investment from those companies to provide a wider range of solutions and new uses, which is what we want. We want to broaden our base. We want to broaden our productive sectors, our primary industries, and if we can come up with these innovative products that can help increase productivity and the like, then that is good for âNew Zealand Inc.â. We do support this bill, and I do commend it at this Committee stage. Thank you.
TÄnÄ koe, Mr Chair. I am happy to take a short call on the Agricultural Compounds and Veterinary Medicines Amendment Bill and follow on from my colleague Rino Tirikatene. Labour supports this bill. As he eloquently outlinedâand maybe members of the actual select committee, the Primary Production Committee, can correct us if we are wrongâthe aim of the bill is to extend data protection for uses of innovative products and for non-innovative products. I think, in the original Act, it was 3 years; in this bill we are looking at extending it to 5 years and, in some areas, 8 years. This is a bill that very clearly is an enabler to our food system in Aotearoa New Zealand. We want to make sure that products that are brought in do not jeopardise our existing food system in this country, but also we want to ensure that we are staying competitive, particularly with international competitors in the market that we are trying to achieve.
Essentially, the objective of the bill is to encourage businesses that own trade name products to register new trade name products and to register more uses for existing trade name products. I understand that, looking through the report of the select committee, and I want to acknowledge the work of the Primary Production Committee. It is one of the few committees where I think it is really clear that you are either a farmer or you are not, and you pull up your sleeves and you get on with it. This is another acknowledgment of the work that the select committee did. There were nine submitters, and clearly the committee has debated around getting, again, the balance right of ensuring that you have got good protection around any innovative projects that are coming to the market as well as encouraging competition, because you do not want to end up creating a monopoly for any of these producers of these particular products that we are talking about here. So I just wanted to touch briefly on those.
The Government set up a working group back in 2008 to review the data-protection regime. Covec, an independent economic research group, was commissioned to, I guess, inform Parliament members on making sure that we, obviously, get the balance right, and to examine the effects of the current New Zealand data-protection rules for agricultural compounds on the market. Its findings informed us of the problems as well as the regulatory options. I note that Federated Farmers wanted more narrow data-protection and a short protection period to support competition and low cost, but I do believe that the select committee members took that on board and felt that they had the right mix to ensure that the bill allows for competition as well as protecting, obviously, our food biosecurity in this country.
Obviously, there are two parts in this bill. Clauses 4 to 7âI see that the committee has worked very hard, inserting new clauses 4A and 4B, which are around the assessment of the trade name products and provisional registration respectively, and, of course, in clause 6 of Part 1, where we talk about replacing the existing Part 6, which concerns the protection of confidential information about trade name products.
I stand in support of this bill, and it is good to see our colleague Damien OâConnor, our spokesman for primary industries, here. I am sure he will make light of this contributionâother than to say that we support it. It is something that is of value to our food production system in Aotearoa New Zealand. We believe that we have got the right balance, and we commend this bill to the House. Kia ora.
As my colleague Meka Whaitiri says, we support the bill, and we do see the value in it proceeding. The Primary Production Committee, under the reasonable chairing of Mr McKelvie over there, did, I think, a very fair job in working through all the issues. It did seem kind of technical, and we could repeat them here for the Committee and for the country, but people would probably go to sleep rather quickly, I think. It basically came down to commercial tensions between those who are developing new ideas for old products and developing new products, and how much protection we should give to them in their innovation, or in their creation, I guess, of new products.
New Zealand is an agricultural nation and we depend upon agricultural compounds to protect our crops and upon veterinary medicines to look after our animals. I read an interesting statistic today, saying that up to 50 percent of the production through the world is destroyed through pest and diseases. So, although we are striving to feed the world, 50 percent of what we grow is wasted, and then, of that which we produce, a third again is wasted. The world can produce enough food if we, in fact, use the proper products to protect crops from diseases, and protect animals from diseases as well, but then we have got to actually do some more work after the production.
I digress a little. Saying that, the balance that we were trying to achieve here was that those companies that invest money in new products needed to have up to 8 years guaranteed protection for the intellectual property, but for those who took innovationâthat is, they saw an existing product for a crop, and they thought âWe could use that on another crop. We will do the research and development.ââthey too are protected through the use of that information in getting that product certified.
Certification of these products is absolutely essential if we are to continue to maintain our reputation of producing the finest quality food in the world, free of residues, safe to eat, and, indeed, being the highest quality. That is done through proper application of these compounds at the right time and at the right rates. As a part-timeâor hopefulâboysenberry grower and dabbling a little in horticulture, I understand full well the importance of what we are passing here, to ensure that nothing that someone could put on their crops could put a residue in the crop that might then be identified in a foreign market and lead to us being shut out of it.
To come back to the issue: in my view, the guts of it is adequate protection for the companies of their intellectual property to ensure that in this relatively small market of ours, companies will continue to innovate and do the development.
On the other side was the argument from some farmersâand, traditionally, farmers have always wanted the cheapest possible import costs, because we do not have subsidies, and our survival depends upon our ability as primary producers to get our products to market, and to make enough money along the way to ensure that it is a sustainable production system. To come back to the point, we do not want to, in protecting the intellectual property for the companiesâand we do see it in some areas of pharmaceuticals, and in other areas where companies will invest money and then seek to reap, I guess, not just profits but super-profits back for that innovation. We need to keep a balance between a fair return on their investment, keeping the cost for the producer down at a viable level but encouraging, of course, innovation.
I think the select committee, in general, has done a good job. I am not going to go through the technical parts of thisâas I say, I think people are probably not that interestedâbut I know that the industry and farmers and the production system are looking to have this legislation passed, which is why Labour is supporting it, is supporting the Government, and is supporting the select committee and all the good work that we have done to move it forward. I will leave it to other speakers to perhaps focus on different, more technical issues. I do not see the need to do this, and I am happy to leave it to my New Zealand First colleague. Kia ora.
Kia ora. I will take a short call on behalf of my colleague Richard Prosser, who is a member of the Primary Production Committee and who spoke on this bill at the first reading and the second reading. It was interesting with the previous speaker, Damien OâConnorâthe talk about balance. It certainly has been the topic for the New Zealand First caucus with this particular piece of legislationâaround balance. One of the things that has been pointed out is the balance between what the public should be able to knowâwhat is inside what is being sprayed upon their foodâand the protection for an innovator for a company to develop a product and have the protection for a certain period of time around the chemical make-up inside the product. The balance of protection of New Zealandâs reputation, to make sure that what is being sprayed upon food products or agricultural products, or being used with regard to veterinary medicines, is not going to negatively impact when, at the end of 8 years, the ingredients inside these innovative products become knownâ
đŹ Todd Barclay: 10 years.
âso therein lies the tension. Well, that is interesting: the phrase â10 yearsâ. If I look at the bill, it says âenable the period to be extended to a maximum of 8 yearsâ. I think you might be thinking about the Trans-Pacific Partnership agreement, which, again, is an interesting conversation about balance, and perhaps that is a conversation that we can have at a later date. With regard to this particular piece of legislation, it has been that conversation of balance: the protection of the rights of an innovator over the rights of people to know what they have got on their food, what is being sprayed, and so on and so forth.
New Zealand First is actuallyâwe do not think this bill is perfect by any stretch of the imagination, but we will be supporting it because Mr Prosser has assured the caucus that, in his view, the tension has been played out and the balance is there. At this stage the New Zealand First caucus will continue to support the bill, as we have done up to this point. However, I wanted to mark the concerns of some members of the caucus. It was interestingâMr OâConnor said that possibly there is not enough interest out in the general public around the technicalities of this bill, and some of the science and so on and so forth that has been placed forward with submissions. I think he might find that there is more interest than he might want to believe, with regard to what is going to happen next.
But, as I say, at this stage, from the New Zealand First perspective, although the bill is not perfect, we think that on measure the balance has been struck, so we will be supporting the bill at this moment. Kia ora.
Look, it is a pleasure to take a quick call in this Committee stage on the Agricultural Compounds and Veterinary Medicines Amendment Bill. Labour supports the bill, and I would like to make a couple of comments from my perspective, having the innovation portfolio.
New Zealand is a primary sector - based economy. About 57 percent of all research and development (R and D) undertaken in New Zealand is linked to the primary sector or takes place within the primary sector. This bill is germane to that process because it extends patent life for non-innovative new products by up to 3 years, which is in addition to the 5 yearsâ additional data protection for innovative products that they have access to on top of their 20-year patents. So this bill puts us right in the middle of a well-understood continuum between ease of access to intellectual property on the one hand and the ability to generate a long-term, sustainable return from the investment that is made in that property. This is a bipartisan, or largely bipartisan, approach in this House to the billâ[Interruption]âreflecting, as it does, the fact that you should always have your mobile phone turned off when in the House, or at least on silent. Caught! I think that is probably a shout at the next caucus meetingâ
đŹ Carmel Sepuloni: Morning tea.
âor morning tea, or something like that, and I think all caucuses have their rules. Certainly we do in select committees.
But, anyway, back to the conundrumâthe well-known and well-tried conundrum of patent life versus innovation. In most sectors New Zealandâs economic structure is characterised by large numbers of small companiesâsmall and medium sized enterprises. That is relevant because small companies typically do not have lots of capital to invest in R and D. They have shallow pockets. They need quick access to innovation, but they do not have the resources to earn hard intellectual property rights like patents for a long term. So a patent regime that was entirely composed of long-term, long-life, hard-to-get patents probably would not serve New Zealand well because our economy is overwhelmingly driven by small and medium sized enterprises. However, in the primary sector we have more of a mix. Obviously, we have the worldâs largest single trader of dairy products, we have a number of large meat companies, we have some very substantial wool enterprises, and in the forestry sectorâalbeit too fewâwe have a number of forestry processes and some significant growing and cutting right operations. So we have mixed interests, and that is reflected in the mixed approach that is taken to this bill.
If you take a golfing analogy, for the folks out there, the chip shots on to the greenâthere is a slope on the green, so it is aimed just uphill of the hole. It is probably about right, and that is why we are supporting it. But we are going to watch, we are going to monitor this space, and we are going to see how the patent performance in New Zealand goes around agricultural compounds and chemicalsâhow the price to the farmer changes with the patent life. We do not want to see companies gouging, and we do want to see improved patent performance in our primary sector.
There are a number of things that I probably just need to touch on around the consultation that went into this bill. There was a working group established in 2008 to review the data-protection regime. It commissioned Covec Ltd. Covec is a pretty good outfitâcopies of the reports here. It has done a lot of work in the ICT sector that, when I was Minister, I had quite a high regard for, and at first glance the report seems to be a pretty sound one. That was picked up by officialsâthe Covec report published in 2009. The Government showed its usual alacrity. In fact, people outside who might be concerned about things likeâI do not knowâthe housing crisis might say: âGosh, look how fast the National Government has moved on agricultural compounds. Itâs in the process of legislating for this report, which was published only in 2009. Why canât they do the same with our housing markets?â. Well, that would be a fair comment. In the middle of a rampant housing crisis that is completely beggaring the family budgets of half of New Zealand, here we are taking nearly a decade to pass something about agricultural compounds.
However, let us not get too overburdened by the bigger picture. What counts is that we are doing something here that is right. As I say, it is a chip shot into an uphill green, halfway between long-life patents, which are hard to get and expensive and that companies cannot afford but that do earn a sustainable return, and the green that is small and medium sized enterprises having access enough to the processâ
It is my absolute pleasure to be given the opportunity by the whips to take a call on this piece of legislation.
The CHAIRPERSON (Hon Chester Borrows): It was me who gave you the call.
No, no, but to be asked, Mr Chairmanâthe honour. But, in all seriousness, this is an important piece of legislation, and it does allow me to think back to my former life before I entered this Chamber and became an MP, when questions around the protections within our agricultural sector were absolutely vital. The ability for the New Zealand agricultural and horticultural sector to innovate does require the ability to protect some of the knowledge and some of the science that sits behind the innovations that occur.
Through the course of this legislation my colleagues have talked about the fact that this has been a long time brewing. This was a report that was produced in 2008, so you could say there has been ample time for the considerations that were contained in the report. What it comes down to is whether there was enough time given for companies to have intellectual property protections over what they have created, in order to give the incentives to innovate.
But one of the most interesting aspects of this legislation for me is around the new use reformulations, and an example that has been worked through by some of the media during the passage of this bill is around fodder beet and fodder brassica. To many people, this will sound like a very technical split, but in order to use some of the agrichemicals on fodder beet crops rather than fodder brassica crops, there would have to be a new use reformulation, which would cost the company a huge amount of money. It is important that we have the ability to nimbly experiment with different forms and ways of feeding cattle as we look to combat climate change. As we look beyond pasture as a way of dairying, we look to some of the fodder beets and fodder brassicas in the respect that it could be a way in which we decrease methane within our farming systems. There are also the high-value nutraceutical companies, which in many ways will just go through and do a screening of many different cultivars and the germplasm of particular varietals to have a look at what has the highest nutritional content. It is absolutely critical for New Zealandâs nutraceutical industry to be able to move in this way.
What we often think of when we think about the protection of intellectual property is our patents. The reality in New Zealand, however, where so much of our intellectual property is not protected by patent law, is that it is protected by plant varietal rights or it is protected under measures such as this for agricultural compounds and veterinary medicines, because that is where so much of New Zealandâs innovation rests. We invest so much in that sector and we have so many scientists who do perform at a very high level and who create a huge amount of value for our economy, and it is vital that we put the right incentives in place for that innovation to be able to occur.
But, like with everything, there has to be limits. We have to make sure that the knowledge can get out there and that it does not get locked up for ever, because research is something that is meant to be a collaborative process. It is meant to be about a college of individuals working together for the betterment of knowledge and what we know as a society. So this bill seeks to strike that balance between allowing companies the incentives they need to be able to innovate and also allowing a very strong agricultural science base in this country to flourish.
It has been a great honour to be able to take a call on the Agricultural Compounds and Veterinary Medicines Amendment Bill, and I am thankful for my opportunity to contribute to this debate.
It is not often that we have a sexy bill such as this that comes up that people are dying to speak on! I note that my colleagues are saying that this bill provides a balance between encouraging competition in the innovative compound market and encouraging registration of innovative products. I also note that this will give our primary sector productivity an internationally competitive edge, and that is where I want to ask Minister Goodhew a couple of questions. We have Realm countries that are part of the Pacific: Niue, Tokelau, and the Cook Islands. I want to ask the Minister, does this bill apply to these countries? Does this new legislation apply to these countries? If so, I then want to raise the concerns that I have, because if we are providing an additional 3 years of protection to innovativeâ
đŹ Meka Whaitiri: Trademarks.
âtrademarks for new compound, my question is, is there protection for Pacific intelligence when it comes to the use of certain compounds, certain medicine, or certain plants? Soursop, for example, and the use of papaya has international recognition and that is used freely by the Pacific, so I am asking the Minister whether she is prepared to shine some light on, firstly, whether this bill applies to those Realm countries, and, secondly, what protection do those countries have in terms of their intellectual property? The islands use these plants and fruits for free. Here we are looking at protecting the trademarks of compounds that have been produced for profit. That is why we are extending the protection from 5 to 8 years for new innovative findings. But I want to know, does that then extend to the Pacific?
In the Pacific, papaya is used regularly by the Cook Islands people. I understand that the leaves and the fruit, if boiled, provide a certain relief to people who have cancer. Soursopâand there is material on the international marketâis also used by local medicine people. That is offered for free. There is no money made by the people who use this. But here we are looking at protecting the rights of certain companies to come up with new innovative designâwhatever. But this is about protecting their profit margins. It is about protecting their rights to be able to sell this on the international market.
đŹ Ian McKelvie: Itâs not about protecting their profit.
OK. Well, then, correct me. How does this apply to the Pacific? How does it apply to intellectual property that is owned by the Pacific people, practised by the Pacific people, and is freely available and it has no protection whatsoever? [Interruption] I hope the Minister can do.
I am not on the Primary Production Committee, but I have been officially appointed tonight to speak on this. I did not want to speak on it, but I was asked to speak on it and I am delighted with the opportunity, so I can now ask the Minister. I was dying to get on that select committee. I put my hand up five or six times to the whips to get on the select committee. But now that I have got this opportunity, will the Minister take the opportunity to enlighten this Committeeâparticularly, me from the Pacific, and there were at least nine others on all sides of the House who would be interested in how this bill would protect the intellectual property that is not recorded anywhere in the Pacific but is freely distributed for the sake of providing well-being and health protection to a range of people in the Pacific. Will that be protected under this legislation? And what happens if nobody comes forth from the Pacific to protect that intellectual property? Will it be recognised?
In spite of saying in my first speech that I was not going to be going into the area of technical detail, I will. But before I get into that area, can I just say that basically, in summary, and I failed to say it in my first speech, this bill is about protecting us from ourselves, because Kiwis are great at No. 8 fencing wire issuesâthat is that innovation and using things for a purpose they were never intended for, but finding a way of utilising them in a very smart way.
Kiwis have always done that in taking a spray or a chemical product and using it somewhere else. I know it has happened, unfortunately, and, in fact, it has been identified where sprays for pests on plants have been applied to cattle because farmers have thought: âWell, thatâs a very smart way of dealing with the lice.â So, occasionally, the residues have turned up. Kiwis have always done that; we do not want to encourage it. But this bill actually allows for innovation, but then allows for the systems to be in place where companies have done this to identify and track it properly.
Can I get into more technical areas. The Green Party has an amendment that it is going to table in the Committee and Labour will support it. It is one in which the Greens have identified the issue where the core component in any agricultural compound is tested and trialled, the intellectual property comes with the application, and it is assessed. What the Greens have maintainedâand there is some truth in thisâis that the other agents that might be mixed in the normal application of that should be tested as a combined compound and we should know exactly what the impacts might be. For example, a wetting agent that I use when applying sprays is, in fact, in some ways more toxic than the spray itself. I do not know how that operates on the plant. Obviously, it assists with the core component of the spray being taken in by the plant, but whether that results in a residue or some other unintended consequence is not always fully tested. That is, I guess, the proposition being put forward by the Green Party.
I think Labour considers it a reasonable questionâthat if there is a new compound, all the components of that are properly tested. We cannot guarantee that at the moment because the active productâthe one that actually carries out the work of the compound in getting rid of the plant or pest or disease or whateverâis the only thing that we test because it seems to be the toxic one or the effective one. There are many other compounds put into that that assist with the uptake or the transfer within the plants of that toxic material, and, indeed, if it does need to be tested and identified then Labour supports the Greens in saying: âWell, why not actually ask the question?â. I do not think it is going to undermine in any way what we are trying to do here, which is to protect intellectual property and protect the wisdom gained in innovative use, or off-label use, as it is called here.
So I hope Minister Goodhewâand I know she is giving consideration to this. It is something that was discussed briefly. The Greens have raised it in the Primary Production Committee. We did not get into too much detail on it because the select committee members, I guess, like Parliament and like the rest of New Zealandâtheir eyes probably start to glaze over when you get into these highly technical areas of chemistry and biology. We did that at school and a few of us at university for a while, some unsuccessfully, but nonetheless they are highly technical areas. But most New Zealanders who buy food at the supermarket and most people who buy New Zealand products offshore trust us to have a robust system in place.
I think that what we are passing tonight will ensure a robust system, and a fine balance between commercial tension and keeping the price of products down, but ensure a fair return on the investment for the people who are creating or utilising safe products that, as I say, worldwide are trying to address the 50 percent of total world production that is lost because of plants, diseases, and unwanted organisms that get in and infiltrate some of the crops that we grow around the world. It is not an insignificant issue that we are trying to address, but we are just putting in the boundaries of this intellectual property protection for New Zealand, and other countries will have different regimes.
As I rise to speak to the Agricultural Compounds and Veterinary Medicines Amendment Bill, I recall the questions I asked the Minister for the Environment this afternoon in question time around some of the issues with some of the ingredients in some of the pesticides. Among these ingredients, one has got the name polyethoxylated tallow amineâit is much easier to say POEA. POEA, the Ministerâs office tells me, is in 69 of 91 glyphosate-based herbicides in this country, but our community does not know which ones. This bill, unfortunately, wraps that up, potentially, even more.
Instead of having 5 years when formulations and the data around them have some data-protection and civil society cannot have access to that, relying on the regulators only, this bill extends that out to 10 yearsâ10 years when civil society, including those people in our environmental organisations, in our food safety-type organisations, and individuals themselves who have the aptitude and interest to get in to look at these things, cannot get that. The bill says: âHey, we rely on our EPA, we rely on the Ministry for Primary Industries, to give us that good decision around the safety of these things.â Well, as you heard today, the Minister says he has got full faith in the Environmental Protection Authority (EPA), full faith in the agencies to be getting these decisions right, and he does not intend to have POEA pulled from use in New Zealand. In fact, he was saying that we need to have more pesticides.
POEA is even more toxic than glyphosate, the principal ingredient, in glyphosate-based herbicides, and it is in 69 of them. It is in more than 75 percent of glyphosate-based herbicides in this country, and this bill is gearing up to make it even harder for the community to know which ones. I am hoping for the Minister to tell me how the community is to find out which ones have POEA in them when this Government does not appear to want to remove that from the streets and parks and the food systems of this country, even though the European Commission has recommended that all EU States remove itâseveral have already, and others are in train to. Why can we not have that in New Zealand? Why can members of our community not even make the decision to say: âIâm not going to use that product because this stuff is in it and we know that it is exceptionally toxic.â?
If we want to rely on the regulatorsâwell, I think we need to reconsider that. That is all the more reason why the community must have access to full data. I will use as an example the EPA coming to councils to ask them what the issue is with these glyphosate-based herbicides that they are hearing about, which the Greens and other community groups are campaigning on to get them out their food systems, out of their streets, out of their childrenâs playgrounds, and out of the parks. So what does it do? The EPA commissioned someone to review the finding of the International Agency for Research on Cancer (IARC) that glyphosate was probably carcinogenicââReview that.â So this one individual goes out to review itâ[Bell rung] Mr Chair.
The CHAIRPERSON (Hon Chester Borrows): I will certainly give the next call to the speaker. I want him to connect more closely the content of his speech to the current bill that is before the Committee and under discussion around innovation. Thank you.
đŹ Hon Ruth Dyson: Getting dangerously like clever, Mr Chairman.
The CHAIRPERSON (Hon Chester Borrows): I will take that cautionary note on the chin.
Thank you, Mr Chair. This is relevant to the bill in that there is an amendment coming, and I will speak to that more individually, but what we are talking about here is how this bill applies and why it should not be 10 years of data protection. I am saying it should not be 10 years of data protection because, for one, our regulators are not checking out the safety enough for our community to be safe.
I am using that story, that example, which is currentâit is very recentâto show why our regulators are failing us and why we must go back down to having no more than 5 years of data protection. That is because that single reviewer whom the EPA decided was going to be able to find against 17 focused toxicologists from IARC for the World Health Organization (WHO). And what did it do? It went looking at the European Food Safety Authorityâs outputs, it looked at another group called the Joint Meeting on Pesticide Residues (JMPR), the joint pesticides group of the WHO, and the Food and Agriculture Organization of the United Nations, and it used the dataâor the decisionsâthat they had used to break down what those 17 toxicologists had found.
This informationâI need to go on with itâdoes reflect on the data protection. So it referred to the German Federal Institute for Risk Assessment, which actually says the testing of formulations should not be used for toxicological evaluation of active substances because co-formulants may extensively alter the outcome. So it is saying: âDonât look at the full formulation; just look at a principal ingredient.â These guys are not looking after the safety of their communities, and nor is our reviewer when they go using that as an example.
The other review that the reviewer was told to do by the EPA was to look at the European Food Safety Authority. The European Food Safety Authority concluded that the genotoxic potential of such complete formulations should be further assessed. It actually acknowledged that there might be risk around carcinogenicity through the genotoxicity in there. But what did our EPA reviewer say in the end? That it probably was not carcinogenic.
I could go on at length on that, and I will not because I do not want to concern you on that, Mr Chair, but what I am saying is we cannot rely on our EPA or on the Ministry for Primary Industries, and yet our Minister of Health relies on both of them to get it right. What we are saying here, or what this bill is saying, is that we are going to wrap up the information about this for 10 yearsâ10 years. That stuff is causing significant harm to communities internationally. The European Commission knows that. It says: âBan it.â We say: âGive them 10 yearsâ more data-protection and donât remove it. Donât remove itâwe can trust our EPA.â We cannot trust our EPAâwe cannot trust our EPA.
I have got a list here of those herbicides. I get a lot of flak every time I mention glyphosate. The same reviewer who reviewed for the EPA, he did that on DDTâthe same reviewer. Where is DDT now? He did it on endosulfanâwhere is endosulfan now? He did the same damn thing. He has done it on glyphosate, using industry scienceâfour out of five of the papers that he refers to were supplied by Monsanto-paid researchers. You may laugh your bits off, Todd Barclay, but the community is not laughing. The community wants this out of here. Thank you.
Mr Chair, I thank you for the opportunity to bring us back to the bill. I just want to traverse a little bit of the history. I want to acknowledge the work that the Primary Production Committee has done, and what we have heard here this evening is that the select committee is largely in agreement about the way forward and the problem that this bill seeks to solveâand I acknowledge that previous speakers have talked about it taking a jolly long time to get us as far as we have got. In terms of the agricultural compounds sector and the veterinary medicines sector, they are very, very keen to get this bill passed, but it has evolved over the time when there has been consultation with the sector, prior to bringing this bill to the House.
Data protection is really, really important. It provides time for the businesses to recoup what it costs them to bring that data protection into the field of play in order to get registration and be able to have their product in New Zealand. So New Zealand misses out. Why? Well, we miss out because we are a small country with quite a small market, and therefore it is quite late in the patent-protected period that a company will try to give New Zealand the benefit of a product that will help our agricultural sector. New Zealand has been very, very keen to have access to the sorts of medicines and compounds that are available to other agricultural nations that are much bigger than ourselves, and this bill seeks to bring that about.
I have to say very clearly to the Committee that despite the rhetoric of the previous speaker, Steffan Browning, this is not a Trojan Horse for dangerous compounds to get into the country. This is simply about evening out the business playing field for our primary production industry.
I want to just use a couple of examples, and, you know, generating supporting data is really expensive. Estimates range from $10,000 to $500,000 for research studies, so the company bringing a new product to the market is certainly going to want to recoup that. It is also very important that I refer back to the fact that we are not talking about patents; we are talking about data protection on a compound that is likely quite late in its patent life.
I want to answer some of the questions that have been asked by previous speakers. Does this legislation apply to Pacific countries? I think it is important that we assert to the member who raised this that we are talking about agricultural compounds and veterinary medicines, not health products or medicines like that. This legislation extends the period during which the Ministry for Primary Industries cannot use data provided in one application for registration to assess another application. That is the crux of what we have got here.
I also want to address the amendment put forward by the Green Party member. Just to be clear for the Committee, section 20 of the principal Act lists the matters that the director-general must take into account when deciding on an application for registration. It already requires the director-general to take into account all relevant scientific and technical information and any submissions received, including from consumer groups. This amendment is simply unnecessary.
So I thank the Committee very much for the considered way this has been discussed here tonight, and I hope that we can move this forward, because the sector has certainly waited a very long time for it.
I just wanted to add another contribution at this Committee stage, because we have heard a lot about this bill being about data protectionâand it is indeedâbut what has not been covered within the legislation is actually how that data will be protected. We do not know. In fact, under the legislation we are permitting the Director-General of the Ministry for Primary Industries to be able to freely disseminate and share this protected data among Ministry for Primary Industry (MPI) officials.
There has been an amendment made to new section 74 in clause 6 in that regard, but there are further provisions in new section 74G, where it outlines situations where the director-general may disclose and use confidential information. In particular, if we look at subsection (4), it states that âThe Director-General may disclose the confidential information to 1 or more of the following persons âŚââand I will just go through themââ(a) a government department or statutory body for the purposes of that government department or statutory body:ââthat is pretty broadââ(b) an adviser for the purposes of obtaining advice about the agricultural compound to which the information relates: (c) the World Health Organization: (d) the Office International des Epizooties: (e) the Food and Agriculture Organization:â.
What I am saying, though, is that this is about protecting data. That data is held and is to be kept confidential, and it is the responsibility of the director-general, but the legislation provides that the director-general may disclose and share that confidential information to quite a number of bodies. So I would like to ask the Associate Minister for Primary Industries exactly how the director-general intends toâor how he does, indeedâkeep that information confidential so we can give the agrichemical companies and all of the other applicants the assurance that the commercially sensitive data that they are placing with the ministry is, indeed, protected.
Please, I do not want this to be seen as me questioning the integrity of the people within MPI, but I think that the public of New Zealand have a right to know exactly how the director-general protects this information. Who within MPI has access to that information?
We have heard about a lot of hacks recentlyâa lot of hacksâand, goodness knows, surveillance and everything that is going on within the Governmentâ
đŹ Hon Member: Your imaginationâs running wild, Rino.
Ha, ha! But this is a very serious point that I raise. Companiesâyes, it is great that they are getting an extended period of data protection, but how indeed is their data being protected when this legislation permits the director-general to freely use his own internal officials, external organisations, and any other Government department that it might impinge on? How will that data remain confidential? How does it remain confidential so it actually lives up to what the purpose of this legislation is?
It is good that we can actually say we apply it in law, but we do not want companies to feel that their data may not be protected. I believe it is a fair question to ask the Minister: how will the director-general ensure that the data is protected so it can give confidence to the applicants and companies that will, hopefully, be adding to the richness of the agricultural compounds and veterinary medicines across our primary sectors? How indeed is that data being kept confidential and safe so that it cannot get into other competitorsâ hands, or other industry rivals who have ulterior motives?
Ultimately, they all want to make money. They want to devise good things, but they want to make money out of it, and they need confidence that our director-general is going to keep it safe. Thank you.
I thought I would just answer the memberâs queries straight away. It says very clearly in the bill under what circumstances the director-general will be required to share that information.
The most important protection here is a commercial protection, and it is a commercial protection that encourages these particular compounds and medicines to come to New Zealand while the data is protected. The director-general would be taking due note of whether there was a healthâso let us say that one of the Government departments that he might be required to share information with was the Ministry of Health. New Zealanders would understand that, but, equally, they would not expect the Ministry of Health to go and take an advertisement out so that the data protection was broken and paraded in front of other commercial companies.
The director-general, I can speak with absolute knowledge, takes his responsibilities very, very seriously, and should there be a female director-general in the future, so too will she. It is written quite clearly in the bill. I wonder whether we are simply going over the same territory, perhaps unnecessarily, or maybe that is unnecessary for me to say. But this is in the bill, the data will be protected, and it is commercially sensitive. Government departments take that very seriously and I want to give you my assurance that it looks pretty good to me.
I want to thank the Minister in the chair, Jo Goodhew, for responding to my colleague Rino Tirikateneâs question. I also had a similar question but I will not ask the Minister exactly the same one. It was more around new section 74A in clause 6, where I read that under certain circumstances or conditions the bill extends the period of protection as laid out in the bill starting at new section 74. Of course, it says in new section 74A(1) that âThe Director-General must, during the protected period that applies to confidential information,â(a) take reasonable steps âŚâ. I have heard the Ministerâs assurances that it is in the bill, but we all know about human nature and systems.
Because we are talking about being competitive, and about enabling a very progressive and future-focused food system in this country, I too want to hear from the Minister around the assurances that that particular confidential information is protected not only when we say in new section 74(1)(a) âtake reasonable steps to ensure that the confidential information is kept confidential âŚâ but later in the bill, and I particularly note those conditionsâI will not repeat themâin new section 74G, where the director-general is required to share that information.
I appreciate the Ministerâs saying that we are talking about a commercial protection here. She gave the response around health. I guess I want to ensure that the guidance given in the bill around protection of confidential information and the availing of it if, for example, we had a particular outbreakâwill the director-general have enough guidance in times of extremes? And it is always the extremes, I understand that, and let us hope it never happens in this country. But I think people need some assurances that if that ever happenedâif we did have an outbreak in our agricultural sector that could be traced back to a particular productâthe director-general would have enough guidance in this legislation to release the information for health issues, for example. But I will leave that.
My other point that I particularly wanted to make is around new sections 74B and 74C, particularly in new section 74B, where we are talking about an innovative trade name product application for full registrationâI get thatâand we talk about the commencement date as being 10 years. Then we start seeing the protected period for information, set out in new section 74C, where we are talking about provisional registration, and, I guess, the protected period of 5 years. Then you turn over the page and you look at new section 74D. Then we go into new sections 74E and 74F, which are talking about non-innovative applications both for full registration and provisional registration.
I guess my point is that there are quite a lot of conditions. There are various periods of protection and we wonder, in considering this, whether we feel that the director-general is going to be ably supportedâI guess is the questionâto ensure that we are not getting the innovative full registration mixed up with the innovative provisional registration, and vice versa. When I read this part of the bill and looked through some of the reports from the Primary Production Committee, I did not get a sense at all that the particular issue that I raise is adequately addressed. Perhaps the Minister can shed some light on that, getting clarity between innovation, non-innovation, and the protected periods, and also the full registration as opposed to the partial registration. Kia ora.
I move, That the question be now put.
Motion agreed to.
The question was put that the following amendment in the name of Steffan Browning be agreed to:
after clause 4, insert:
4AA Section 20 amended (Evaluation of risks and benefits)
Replace section 20(c) with:
(c) any submissions received under section 17; and
(d) all applications for new or altered compounds be assessed in full formulation as intended to be used;
(e) consult with a consumer and environmental reference group as nominated by the Minister consisting of 3 consumer representatives and 3 environmental organisation representatives.
đŁď¸ Spoke in this debate (9)
- Steffan Browning (Green Party of Aotearoa / New Zealand â List Member)
- David Cunliffe (New Zealand Labour Party â Member for New Lynn)
- Jo Goodhew (New Zealand National Party â Member for Rangitata)
- Hon Tracey Martin (New Zealand First Party â List Member)
- Hon Damien O'Connor (New Zealand Labour Party â Member for West Coast-Tasman)
- Jami-Lee Ross (New Zealand National Party â Member for Botany)
- Rino Tirikatene (New Zealand Labour Party â Member for Te Tai Tonga)
- Hon Meka Whaitiri (New Zealand Labour Party â Member for Ikaroa-RÄwhiti)
- Hon Dr Megan Woods (New Zealand Labour Party â Member for Wigram)