Digital Signature Legitimateness for Animal Science in European Union

How to eSign a document: digital signature legitimateness for Animal science in European Union

as clive uh said um i'm here on behalf of f here which is um for those who don't know it's the european um the open federation pharmaceutical industries and associations so the umbrella body for the industry at the european level and when i was invited to this talk i was actually the vice vice chair of the research and animal welfare committee at espio actually in the last couple of months i've just come off that committee but hopefully i'm still um uh aware enough of what's going on to speak uh today on that on behalf of um of fp and also at the uk level um the association of british pharmaceutical industries the abpi inputs to fps and brings together the the uk um pharmaceutical industry uh in terms of providing a voice on matters such as this and then my day job uh is at pfizer now i first stepped into this arena about three years ago when i took over from colin dunn as the final representative on the research and animal welfare committee at fpf and he said don't worry there's not a lot to do they've been talking about this directive for years and nothing ever happens and just as i came into it the the draft legislation was published at the european level and it's been non-stop ever since and a key driver behind the directive being brought forward at the european level was to think about ensuring high animal welfare standards but also promoting research and competitiveness across europe and striking that balance between creating um and in doing so creating level playing field across europe because as clive said in certain european member states i think there'll be a big change on january the 1st to the legislation they currently work under and i think in the the uk we have a privileged position in that the changes will be there but they will be less dramatic than they would have been but from an industry point of view whether you're operating in the uk or in europe it's important i think to put the industry in perspective and i thought i'd do that by just showing which is not projecting terribly well um just showing a matter of the world and showing where pfizer has r d activities that use animals across the world and uh until last summer we did have a large facility in sandwich that had a large research and toxicological group now it's just a smaller group in cambridge we also have activities in other parts of europe but there's a lot of activity going on in the states and i haven't included here where we outsource studies to cros in mostly india and china where they do quite a bit of our pharmacokinetics work um and in the future i think we'll do more and more studies for us so the point i want to make with this slide is really that the industry is a global industry and the uk is just one part of that and that mid and large size pharma they operate across the world and their r d occurs in places in the world where there's a strong base of innovative scientists there's the infrastructure and the facilities and suppliers to support that there are clinical institutions with access to patients and patient samples and then economically there's the cost structure the tax laws and other financial aspects but importantly there's a favorable legislative framework for operations and i would say going down that list the uk does pretty well on most of them um and we just need to make sure that that is maintained going forwards because traditionally the countries that have ticked those boxes above have been the us the uk a good number of european countries which have quite a lot of variability in some of those factors but increasingly china india singapore and so on are coming online in terms of this global industry so in bringing forward legislation we need to make sure that we keep in mind the animal welfare and and keeping the the standards high in the public confidence but we also need to balance that against competition not just in europe but across the world and in the industry we're using animals for a whole range of different reasons um at the the beginning of the process i guess is understanding the biology that then leads the identification of new targets often done in collaboration with academics so a vibrant industry environment also helps to provide collaborations and funds for that to academics in their local area and also more broadly and then we're using animals for efficacy studies in terms of understanding if our potential new drugs work animal safety studies the toxicology studies and regulatory studies of variety of sorts that we need to do both before entering humans and during the whole process and also understanding the pharmacokinetics and metabolism of drugs from animal studies before going into humans and then in drug development there's um there's the full toxicology carcinogenicity and so on and a small number of animals are used in looking at drug formulations performance in vivo and we use basically the full gamut of species rats mice dogs and non-human primates are probably make up the bulk of the um the animals or the species we use in very different proportions i should say but also a broad range of other species are used depending upon what the application is for veterinary medicine obviously farm animals are very important use of transgenic mice increasingly the use of fish especially zebrafish but also a broader range of different species rabbits mini pigs and then certain other species in smaller numbers for very specific applications so basically the industry is a broad user of animals and therefore the legislation in all its aspects will be applying to the industry so what do we think of the european directive well generally i think it's a positive piece of legislation it helps to bring all the member states up to a single level playing field and it replaces legislation that's over 20 years old now and i think it should promote uh public confidence in animal research both here in the uk and more broadly across europe and it really helps to drive the three hours across europe certainly in this country we have a very strong track record in the three hours and having the nc3rs is also a very um big positive for us but i think it's good that it will be driven further across europe the level playing field i've already mentioned and a good thing for us which i think will make it much easier as the legislation changes is that many of the requirements of the directive are either the same or very similar to those that we operate under with asper at the moment and i think the opportunity to review aspar is a very helpful and timely one because it allows us to have that focus on the animal on the outcomes and the animal welfare but we can look to see whether we can reduce some of the bureaucracy through its implementation that will make the system more efficient and easier to operate under um and you know we've learned a lot with asper over the last 20 years so i think we can focus and retain the really good bits and then for some of the pieces where perhaps the paperwork was more onerous than we might like uh see whether we could um simplify some of that without impacting on the the overall benefits that it brings so the key areas i thought i'd pick out today were personal licenses and the training and the continuous professional development required by the um the directive changes to project licenses care and accommodation also retrospective reviews statistical reporting and again i'll finish with inspections too so from a personal license point of view the directive doesn't say you have to have a personal license what it says is that you need to be trained and competent to perform uh procedures and of course there's various ways in which you can ensure that now the the home office had been looking to simplify personal licenses for some time now and in the last couple of years it's moved in that direction to have a simpler personal license system and i think as we implement the directive in the uk there's an opportunity to build on that progress and look to to have a a personal license that's uh simple and easy uh to use whilst maintaining that we we have the necessary training and competence to perform studies on animals and it is perhaps an opportunity to look for authority to form generic types of work rather than a very specific list of techniques because i think what we would look to do is try and have a personal license system that doesn't require constant updating if the differences in in the studies that people will be performing are quite small and do not impact upon their competence i.e you don't want to have a very long long list of different things you need to take off what you need to be is trained and competent to perform those uh those studies so if we could reduce the number of times the personal license has to be going backwards and forwards to the home office i think that would be helpful in terms of the amount of administration that takes now we do need to make sure that we have training records that can support that you are trained and competent um and we should be careful that we don't have these being more detailed or intensive than is required either for uh easy operation or versus other european countries because one of the challenges at the moment is moving staff from one place to another and i guess this is the same for um for academics if you have a uk personal license and you wish to go and work in say germany or scandinavia actually translating that over can be quite difficult so with a common european directive i would hope that our training records and our requirements around those would allow much freer movement of staff between different eu countries and reduce some of the um the additional paperwork and demonstration of competence that's required when you move from one country to another i think the the requirement for continuous personal development and ongoing training is a good one because things do change over time you do need to make sure that you maintain your competence for different techniques and particularly those that are really quite technically skilled if you haven't done them for a long time you need to make sure that you are still able to do them appropriately but we need to make sure that that would be flexible and proportional to the role requirements so what we wouldn't uh want is having to go on a you know a long refresher course each year that if you don't really need refreshment because you're still doing it on an ongoing basis um so and if the actual things you do are perhaps quite small you know tailor that ongoing training to match your your role in in animal uh studies rather than have a blanket um requirement that may be ott for some groups and perhaps not enough for others we still haven't got the training guidelines at the eu level that's being worked on um and i know philosophy is one group that's working on that and we'll have to see what that looks like when they they do come in uh become available uh sometime i think it's later on this year it might be next year i'm not sure on the project license front something that caused quite a lot of discussion at the european level and i think from the uk level we were thinking what's all the fuss about and that is the non-technical summaries or the lay summaries and i think they're a really good thing because they're great for public confidence in that people can look at what the purpose of the project licenses are and by bringing in requirements to include certain key points in the non-technical summary i think that should promote a greater consistency in the way they're written and the information they provide which i think will help with public confidence and also i think we'll kind of focus um the author's minds on what needs to be in there in terms of providing that lay information of what the purpose of the project license is and at a high level what it is you're actually going to do and why um the the transposition may provide opportunities to simplify elements of the project license and be focusing very much on adverse effects and the outcomes of what we're looking at rather than hopefully too much detail on the process and the techniques judy's already spoken about at great lengths and there are some differences um in there and there are elements um where we're looking to make uh parts of ets 123 requirements rather than the guidelines that they were developed as and some of that would be over and above the requirements of annex 3. now thinking about this at the european and the global level from from a competitiveness point of view the industry obviously would like to see that there's a level playing field across europe on this front and therefore i think the the direct transposition of annex 3 would be the most welcome way of doing that but i want to bring out a couple of points here and that is that i don't think specifications are necessarily the same as standards and what we really need to be doing is looking at what's the scientific evidence to support or refute that there is an impact on animal welfare by changing some of the specifications required around care and accommodation and sometimes that data exists sometimes it more often than not actually it doesn't exist and for some of the things that are being put forward it's not clear what the supporting data is behind that recommendation now i think it's important i make clear at this point that in in stating this this is from the industry point of view and not all members the vast majority but not all members of the bioscience coalition are necessarily at the same place on this point so i just want to make that clear before going on and one of the examples i think is around temperature ranges for the housing of docks so currently it's 15 to 24 degrees and as far as i'm aware there have been no welfare impacts associated with housing dogs over this range now the new proposal is 15 to 21 degrees which would require insta animal breeders and holders for dogs to potentially upgrade their air conditioning systems to make sure it doesn't go over 21 degrees on a hot summer's day for example now if there are genuine welfare benefits for that well maybe we should be doing it but i'm not aware that there is evidence to support that and therefore i think we need to question whether we would want to reduce that range over and above what it is at the moment another point is around single housing for dogs so the annex 3 does state that they shouldn't be singly housed for more than four hours and therefore it would require a project license to ask to do that for example in pk or toxological studies you you want in fact for scientific reasons probably need to be able to singly house them now as long as it was allowable under a project license that's okay but we do need to make sure that that is the case because otherwise i think that will have quite a big impact on being able to run some of these studies and also we need to think about what that might have in terms of an impact on severity ratings when thinking about running those studies um if places have to invest in new air conditioning around temperatures or humidities or they have to source new cages because the specifications are different i think that will have an impact on the competitiveness of institutions in the uk versus europe and that's likely to have a bigger impact i think on breeders and suppliers who perhaps have a larger volume of caging and a different stocking density model to some of some of the animal facilities at least in large pharma from comparisons that i've been able to make over the years and we mustn't forget that economic impact that could have and whilst that may not be an impact today because the cages we have are suitable in the future when you either open a new unit or need to update your equipment and caging that could be um could be a significant impact and finally i just wanted to add on the end here and i think judy did mention it earlier the the use of fish is increasing quite uh somewhat at least in zebrafish area but not all fish require the same thing so we just need to make sure that we've got the appropriate expert input across the range of different fish species um so that it is appropriate for all species being housed the retrospective review is something that is a requirement for the directive but you don't necessarily have to do it for mild and non-recovery uh projects and i think it should definitely be performed at the local level because that is the the place where there is the most knowledge about what you know the full um scientific depth of what was done the benefits that were produced and then that that retrospective review can be communicated to the uh competent authority and clearly if it's you know if it's not done to a significant or an appropriate standard i'm sure the competent authority will comment on that but really um i think it's best done at the local level rather than asking the home office to do the um retrospective reviews and obviously they should be proportional to the complexity of the project and the severity of the project now there is some suggestion that this might be done on a per study basis rather project basis and that would have a very big impact on the amount of retrospective review that's required and i'm hoping that we don't go down that route and we look at it on a project level rather than individual study level because i don't know that there'll be great animal welfare benefits from doing it on a per study level unless of course unexpected things have happened in those studies for example the severity limit has been exceeded which i think is a very rare occurrence but if that did happen then clearly you need to review what happened there why and plan appropriately for the future statistical reporting um we don't yet know what the eu is going to demand on in terms of statistics there is a working group on this and that is moving forward but we haven't yet got the final statistical requirements from the eu the biggest differences i think is a switch to prospective rather than retrospective reporting and i think there will be additional information required on the severity of procedures uh obviously until you know what the final outcome is you can't really make a full judgment on whether this will have an additional administrative burden but i think it is likely to add to the number of things that we're trying or number of pieces of data that we're trying to capture and from a cost point of view it will mean that there will need to be significant changes to for example internal company systems that capture this data in a more automated manner and it may also mean in the future that if the uk requirements are significantly different from uh over and above the eu statistics that if you wish to source a uh a software package to do this collection that there may not be a uk version versus the european version if the requirements are are different um so we just need to kind of bear that in mind because obviously we want to collect the statistics that we're required to but trying to do that in the least resource intensive manner is the best and in doing the statistical reporting it is important to understand how many animals we're using and what for so that we can track trends over time and it's important for transparency and public confidence but i think we need to think about what is it that you really want to know from this rather than collecting numbers that perhaps are not particularly helpful around public confidence or understanding trends in animal research and it doesn't want to be impacting obviously as i've said on on the competitive operation of research in the uk finally on inspections the requirements for inspections in the directive are far below those that we currently have in the uk only a third of establishments would need to be inspected each year uh although it would be annually for those with primates um now in the uk i don't think we want to go down to that level and we you know as judy said i think we all quite like seeing our inspector for one of various reasons and i think it's broadly welcome that the risk-based approach is helpful and to understand exactly what goes into that risk assessment is also helpful so i think we are in favor of keeping up much higher number of inspections because i think that's very important for public confidence if you never saw your inspector it's difficult to to say to the public that well you know of course we're definitely up at standards because you haven't been inspected for a large period of time and the regular interactions are with inspectors are helpful and i hope that it's more around the scientific piece of the discussion rather than understanding exactly how the legislation is working so you can make sure the administration is there but general guidance on the legislation and to facilitate compliance is obviously a key role of the inspector but let's see in in the new version coming out whether we can actually have more time spent on the science and in the interactions rather than a lot of time spent on trying to navigate complexities of the legislation so i think the the key point here is that we're in favor of maintaining maybe not exactly the same but certainly a similar number of inspections and well above the minimum requirement and although that obviously costs money i think the benefits of that are outweighed by the costs so in summary i think the european legislation is is a positive piece of legislation and the transposition process i think is going well so far we'll hope to drive hopefully drive the um promotion of public confidence and three hours across europe and bring in that level playing field but we just need to keep in mind as we do the details of the transposition that we need to balance the animal welfare that is very important and the public confidence but also maintaining uk competitiveness in what is not just a european but a global environment and with that i'll finish thank you