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well thank you for inviting me and thank you Alexander for that overview as you may have guessed Alexander and I often are on either size at the General Court or the Court of Justice so it's I should say congratulations first of all on the clear victory in the cases at the first instance but where you have such a clear victory for the EMA there is a silver lining as lawyers because it's easier to spot errors of law in formulating an appeal so we'll see what happens there in the next and the coming weeks I suppose I did I was just jotting down and I promise to try and make up some time I was just jotting down a few thoughts about where we are right now with the case in in relation to Alexander was saying but what I'm going to try and do is you know pick up on you know actually what you know seems to be elements of clinical trial data that could possibly be redacted and try and get some practical examples so for some discussion but I think because Alexander's done a great job of talking through the common themes but essentially where we are where we're left right now as the law stands is that the European Medicines Agency does have very significant discretion now my view to take a view on reductions you know much more so I think then it would have done in the past because the General Court has sort of completely rejected this concepts of either a presumption of confidentiality or that entire documents can be confidential and then when you what you see when you review the judgments is that you know any particular redactions that had been proposed other than the ones already accepted by the EMA is clear that the that the court was very much in favor of the EMA's approach and as alexander indication the Perry case went along two starts itself saying that well maybe there's some overriding public interest anyway even though it's been articulated perhaps in vague ways so I think that's where we are right now and the other thing I'd probably just mention is you know there does seem to me as a lawyer litigating in this case or these cases or I'm acting for PTC and MST animal health you know it seems to me there's a possible tension on this with the European Commission particularly from a trade perspective a Tripps perspective because the direction with with trips as we're seeing that articulated in free-trade agreements with Canada or Vietnam South Korea is that you know the pharmaceutical companies do invest quite a lot of money in these data and they want to protect it but there is a distinct absence of the European Commission in these cases which is quite unusual so anyway those are my sort of just general remarks and I I think with that I'll just probably just be able to flick through quickly this slide Alexander's already mentioned the cases one thing I suppose that criticism I guess of the General Court's approach here is that each of the cases did touch on these common themes and the general court addressed them in a pretty generic way without taking you know more account I think of the individual circumstances of the applicants and of the individual documents because they're very very different and as lawyers when you're considering whether something is confidential or not you look at the context you look at all the circumstances and PTC for example ultra orphan drugs single product company conditional marketing authorization and as soon as as soon as the product was essentially approved the Freedom of Information requests come in and data is is up for release and into that type of company inherently there is much more sensitivity about the documents and concern about the harm that could be caused through release compared with for example a company with a number of blockbuster drugs and so on MSDN or health completely different type of product a veterinary medicine different regime and a different type of different type of document a toxicology studying anyway those are just just some points there but what I what we we heard quite a bit about the sort of arguments and the possible reductions that the court rejected but for you as practitioners you may want to know what can I actually redact and what is worth investing some time in through a redaction process because this process if you've been involved takes a it you know takes up a huge amount of time and requires a sort of multidisciplinary approach if you were to do it properly to really articulate why particular passages are confidential you know you need a legal scientific medical commercial input into all of this in what are very very tight timeframes I'll touch on some of those challenges later but where the clinical data essentially either discipline or non clinical data discusses directly or indirectly future development plans or line extensions and generally that sort of information that will be accepted as CCI provided it's not related to the existing authorized indication or the indication essentially that falls under the the clinical study report for example it's part of a future ongoing process it's not available in the public domain that's an absolute key one to check often future development plans are included in company forecasts and so on and you'd have to explain why would seriously undermine the commercial interest of the company now you can you can sometimes spot these things where the clinical study report has explored you know data an exploratory endpoints for example that they're for exploratory purposes and not there to support the current marketing authorization indication it's been absolutely clear all the way along that discussions on protocol design with other regulators like the FDA would not be disclosed again manufacturing data quality data details on formulation qualitative and quantitative information concentration ranges again this is pretty pretty clear to us that that is and to the email that is confidential batch numbers I've just mentioned something here probably doesn't fall under CCI but data that identifies individual patients sometimes can be CCI because for some very ultra orphan products for example you know knowing who the patients are and finding them is a is a key commercial strategy but personal data protection would often come into play there - so what about in-house methodologies and standards that a company may develop to do their own benchmarking well the EMA generally recognized that innovative methods that aren't in the public domain should be CCI guess what what is innovative things that you thought as a marketing authorization applicants were innovative at the time may no longer be innovative they may have been some guidance developed by the EMA or others about putting together sort of trials to to bring a product to market based perhaps on some of the experiences gained through your application but you're not going to get away with redacting high level summaries interpretations even even percentages it has to be very very specific in our experience things like p-values and numbers and you have to be extremely specific as to why those are non-public and commercially confidential simply saying that you're complying with standards that are already required for example things like GCP and I generally well known to the scientific community because there is a best practice in how you conduct a clinical study wouldn't wouldn't wouldn't wash but we did have accepted and so not in dispute in the case for the MSD that you know internal reference standards developed by MSD for their analytical testing would be CCI publications very difficult area where you have some information that is in the public domain some where the EPR is the is the obvious choice but it could just be out there somewhere in an abstract presented in a South Korean conference for example and but it's not entirely squarely on the point you're trying to redact or think about it's very difficult but generally the EMA in our experience will sort of see whether it's broadly similar to what is in the public domain and it'll be very difficult to redact that and as I've said here trying to demonstrate the the nuances with what is in a clinical study report compared with what is sort of similar than out in the public domain is very difficult and I don't think with wash we've heard about potential misuse trips the concept of harm because data could be used in third countries and benchmarking the court was very reluctant to accept those arguments the court seemed to want very real data on this risk rather than as that example says sort of a generic concept but unfortunately again as practitioners in this space we all know that is nigh on impossible to demonstrate clearly if and when your data are actually being misused because that's the that's the problem you don't know what a competitor might be doing with these documents once they get hold of them I mean merely reading these sort of documents in our view would give some sort of competitive insight otherwise why would you ask for them and guess what most people asking for these are pharmaceutical companies competitors it also sets as I was alluding to earlier the case is a very high standard of proof of or in terms of demonstrating commercial interests and and how they would be undermined I think even the EMA policy itself talks about needing to demonstrate it may undermine commercial interest the court went further and sitting essentially said it you must be able to demonstrate this and as I mentioned it's the course in war more able to accept concepts of overriding public interest in in a way to enhance the credibility of the emails decision-making process even where the overriding public interest may itself be be somewhat vague so I think I can go through these quite quickly but I did want to pick up on some of the things that the EMA did except with CCI I was a clinical study report as aiexander said at the company being a single small product company with a very small regulatory team had frankly I think better things it thought to do then divert its regulatory function to spending time redacting a clinical study report because at the time as it happens it was focused on filing in in the FDA and filing a variation in the EU for its product but and I think the email would say they bent over backwards in trying to help PTC come to a view and they proactively themselves initiated some reductions and here you see the sort of things that the EMA redacted discussions of protocol design with FDA match numbers materials and equipment explanatory essays quantitative and qualitative descriptions of methods with drug concentration measurement treatment days so these are I think this these are key areas when looking through clinical data things that you can you can you know have some sort of precedent if you like as to what may be acceptable interestingly on the concept of harm in in the EU or elsewhere the general court viewers as with the EMA is that well you know even with these data competitors will still have to conduct their own testing now that doesn't really address I think the key legal question Perry farmer this is I don't think this is the latest presentation I had a had a typo on there but essentially it was it was not clinical study reports they were the superiority and similarity reports that Alexander mentioned and the EMA they're agreed to redact some information on commercial strategy such as the names of companies performing the surveys to support those reports and also the countries where the surveys will perform because that can obviously identify key potential markets and essentially future plans so perhaps when the updated slides could be sent through to alter that you will see that passage the MSD case was initially non clinical animal toxicity reports and again there the EMA did accept some redaction so these were not reductions in dispute but again give you a sense of their for what would be acceptable so concentration ranges of the active substance details and the internal reference standard that I mentioned and indeed some future development plans but coming back to some of the points a gazhams already mentioned other sort of more classical concepts that you would associate with demonstrating why a particular document has commercial value were rejected so for example the fact that you invest millions of dollars into something doesn't seem to have any particular relevance just quite remarkable to me so what are some of the rejected examples were generic information widely known scientific approaches as I've mentioned that can be already found in scientific guidelines I mean we would typically say there's a difference between you know following a guide lying and then you know doing that getting the results applying your scientific judgment guidelines just like a recipe to you know cook a meal for example what you typically see is in some of these I suppose more generic concepts the EMA itself has a sort of standard answer to these which is set out there and you know this is a kind of standard response to more the generic concepts and I've already mentioned the point about some challenges here for you know actually being able to really articulate with genuine evidence how misuse can occur because sometimes you simply don't know a couple of interesting points this might be interesting for discussion names of non clinical experts will some of the guidance document very useful guidance document that the EMA has explains that if you've got a legally defined role like a QP P V then you can expect your name to be to be released and there's a public interest in that but we have being involved in some cases some instances where there are its genuine concerns about animal rights activists getting hold of names of these individuals and I think it'd be interesting to understand more how the data privacy piece works with this for because under the rules the EMA will have to show that it's necessary to release these sort of informations and why there'd be no prejudice to the individuals littered legitimate interest for example to stay safe reference to CR Rose well zeros aren't covered by personal data legislation the sense of the name of the company and they they are generally released some other examples of areas where you can expect reductions to be accepted and I've touched on these already the annex 3 to the EMA policy seventy at the end that's their voluntas intial e of roland tree style policy voluntary in the sense that it's not governed by any particular mandatory laws is it's an area where they list sort of examples of areas that could be redacted I'm not sure how successful companies are actually in in arguing this these points but as I mentioned exploratory endpoints which kind of gives some clues as to where you're the company going and looking at in future development plans are an area that that the EMA will look at and and accept if its articulated well where you have information in the public domain as well and you do want to argue why specifically the way for example an analytical method is actually used in the clinical study that's possible but you'll really have to you'll find a good justification for it I think it's very very difficult particularly in the in the timeframe you're given to think about this you know anywhere from five five to ten days now I mean I just mentioned that is my it's my final slide the I mean this this is a it's a huge challenge for for companies and we Covington handle a huge number of these where you get five-day deadline to respond to and if you do it properly you really need to engage these multidisciplinary teams it's just not feasible for a number of companies that don't have the resource and it's impossible to outsource it to people I mean lawyers can't really do it and consultants can't do it because you really need to know the background and the have a real insight and this is a challenge also for companies where people move around and you lose the know-how about a product and you know and some of the sensitivities I've said here is their way to revisit this I don't see how there is frankly because the EMA I've got every sympathy with them they are subject to the transparency regulation and clear deadlines that they have to comply with but in our view there's a number of these factors that all point to why presumption should have been upheld in the first place is simply impossible to do a decent job on articulating this probably very large volumes of data put to pass through one issue that has come up a few times with some of our clients and I've flagged it already to Alexander is sometimes inside correspondence or responses to questions from the EMA the letters themselves will refer to and include extracts from you know module three or have manufacturing data and it's quite burdensome I think for companies to have to go through the process of redacting those letters even though they know they should be in safe hands with the EMA because it's manufacturing data and that's just something to think about whether there's a way of reducing that particular burden or not you know cross referring to the file or the module three passages rather than actually including the extracts in the in the letters that would help generally right now particularly with a General Court judgement so in favor of the EMA I think if you're going to go down a reduction or approach you really have to think carefully and hard about what you want to what do you want to take to the EMA has to be absolutely business critical stuff that's not in the public domain and you have to get a team together quickly to really articulate what at the points are that you're going to make I think in time this will get a bit easier because this is all being linked up with thee in a way the proactive release policy where companies are proactively looking at their clinical study reports with a view to release you know redacting confidential information so in time this may become easier although I understand interesting the over the break with Alexander that companies aren't too concerned or haven't been as concerned in redacting at CCI in the proactive release policy anyway that's that's it