Editorial Note: Neal Parker, Section Head Legal, Biologics Strategic Development at AbbVie, was an industry representative on a panel organized by EFPIA – The European Federation of Pharmaceutical Industries and Associates on August 27th in Bruxelles. Parker started off with a wonderful Freudian slip saying that AbbVie’s mission is to discover new diseases and ends with another – that AbbVie’s Mission is to discover New Patients.
A video of the meeting is linked to the Trade Wars AbbVie v China post here. The first half of the transcript is here – this is the second part. As with the first half , this comes with commentary – and we invite you to offer further comments. Dr Parkers transcript without irritating interruptions will available to download on Friday along with a possible translation.
Chairman Alastair Kent Genetic Alliance:
So, we’ve heard that IP is not the problem. If IP is not the problem, then is it the solution? Or if it’s not the problem, what’s the answer. I mean you tried to raise that question with Richard Bergstrom. So Richard do you want to respond now to that question.
Richard Bergstrom Chairman EFPIA
Yes, IP is never a problem. It’s rather the lack of IP which is the problem.
We’re looking at here, if I connect this question with the debate that Neal initiated, when I talk to my members, most of them are quite relaxed about all of this. Because for most products people have no issues. We’re going to put out these CSRs[Clinical Study Reports], we’ll redact a little bit. Maybe something, maybe nothing in there.
Some companies are quite relaxed about this because of the way they write the document, the type of products they have. Others have more issues because they may be in a very competitive field maybe particularly in the biologics field where you do a lot of bridging and you have to argue, to persuade the regulators to take the totality of the data and approve it. I guess that’s what you’re after, Neal. So there it becomes a bit more sensitive.
You look at the global scope as well. You may have some companies from Korea or China breathing down your neck trying to copy your technologies (hey guys – don’t you realise there is a Trade War going on here). Then you get a bit extra sensitive about putting things out there.
We are trying to build a model here which works for 100 per cent of the products and for most of them we have good patents and they work and we enforce them and no problem. But maybe for one tenth of the pipeline we rely on other incentives [and because of these one in ten - we have to hide much more than we wish to - honest].
If I may use an example Lundbeck – this is in the public domain – recently got a product approved for alcoholism Nalmefene. This is publicly known. The investors know it that there is no patent on that use. So Lundbeck has developed this and is commercializing it. It’s a pity they only commercialize it in Europe and countries with data protection – all the citizens of the world should get the medicine. Nevertheless, the point being this, that would never have been developed if they did not know they had some kind of protection.
Now with the new definitions that are emerging in Europe, in Europe even Hans-Georg [the main EMA regulator present], we are told that that is a known substance, it is not a new active substance and therefore it is not subject to data protection which means that a generic producer can come day one and file an application for approval. There is no protection, no patent, no data protection. No market exclusivity (excessive profits).
It’s not all products, maybe one in ten or maybe even less, it doesn’t matter, but we need a model that works for that and we need to have a model that works for Neal’s product, which is subject to a legal case right now that EFPIA is supporting (GSK as well in case some of you thought otherwise), where it is extremely competitive in the biologic space, the new indications, and everyone’s trying to learn from one another and so on. So we need to find a model where also these one out of ten there is a possibility actually to blacken out a bit more than is the normal case.
But again under these commitments that we have put forward today this data all of it including that white spot there will be available for legitimate researchers (people who play by our rules and come to the right answers – this is different to illegitimate researchers who don’t agree with our rules). So a scientific organisation coming in saying that we would like to have this information, provided there are safeguards for patient privacy and commercial confidential information, we are willing to share the information. All the CSRs, all the arguments we put forward to the regulators. But it’s just that we don’t want it out there for everyone.
Jim Murray: Open Medicine EU.
Two quick questions for Mr Parker. The first one is very short. Disclosure to certain recognized scientists is envisaged but they can’t share this data normally with somebody else. Does that mean they can’t share it with clinicians?
Second question. The EMA in the policy they are following are following an independent assessment by the European ombudsman who set out a series of criteria which does recognize by the way the possibility that some information may be commercially confidential and may properly be withheld from any disclosure the agency might make. The real question though is that you seem to say that you won’t accept anyone else’s judgement, it is only the company’s judgement which matters, not that of the ombudsman, not that of the EMA, not that of anybody else. And it seems also, if I’m not mistaken, that that principle very much underlies the EFPIA Roadmap.
Let me comment on the second question. The general idea of confidential commercial information – there is a worldwide definition – it was repeated earlier by my colleague here – Confidential Commercial Information (scientific data seen through the lens of marketing) is information that a company keeps internal, protects, because if it were to release it, it would give a competitive advantage to another company. That by its nature is a subjective decision. So you are correct that in the first instance that decision is up to the company. The company is best positioned to know the competitive environment within which it operates. Now I believe that that judgement deserves some respect (cross us and we’ll take you to the European court or any other court we can find – the Canadian Supreme Court).
Now, it can be rebutted. It can be rebutted by a factual assertion that you say it’s confidential but you released it in a report or in a poster at a symposium last year. Or it can be rebutted by going and getting experts to talk about the competitive environment within which the product exists. But absolutely the judgement is the company’s because that is what the definition of CCI goes to – the subjective belief of the value by a company of its information.
Who arbitrates between you and your rebutter?
Ultimately a judge does. But there should be a process when a request comes in to a regulator for a clinical study report – a clinical study report is given to a company and AbbVie will treat it according to these circles perhaps depending on can we release it with controls.
But at AbbVie we will go through and the first thing we will do is circle everything in that clinical study report that we know is already out in the public domain. All the adverse events that are reported in PSURs [Periodic Safety Update Reports]. All of that information which is already in the blue just goes, it’s not even in dispute. (Anything we have carefully vetted and detoxified so you’d have to be really sharp to spot where the corpses are).
And then we will look at information which is not in the public and we will assess whether under the circumstances releasing this publicly without any conditions is going to hurt us competitively. We should be able to go back to the regulator and present that version of the document (regulators who now have a mission to partner industry and enhance national productivity). The regulator in his expertise, or the ombudsman or any other objective or third party who has the legal authority should be able to challenge that. And if an agreement, a compromise, a settlement can’t be reached (if we can’t get a prime minister or other politician to sort this out), then ultimately we live in a world where there are courts and sometimes you have to go to courts.
We believe that those instances if we can implement a responsible compromise along the lines of the joint principles that I’ve talked about here should be very few and very far between.
The difficulty about challenging this in court is one must have standing and a set of principles, independent principles, by which they will be judged, by which the court will arbitrate. And where are they to come from?
There’s a law right now which gives you standing immediately (sure you can take an action if you can afford it). The Transparency Regulation allows any member, any person of the public to submit a request to the EMA for data, for information. And if ultimately the EMA denies that because they have been provided with a redacted copy by the company then you can challenge that decision not to get the data. Now if the EMA decides to give you the data and to disregard the company’s explanations about what is confidential, then the company has to sue the regulator (flex their muscle) and that happens sometimes too (And as a result EMA didn’t just stop access to AbbVie’s Humira data, they stopped access to all data for all drugs).
Can recognized scientists share material with doctors?
There are two issues going on here. Number one as a matter of law if I have confidential information and I decide to give it to you and I don’t make any sort of accommodation or agreement that says you won’t give it to your neighbor then I’ve lost the ability to protect it as CCI. Because a test is something that a company protects. So we need, when we release it, to ensure that Scientist A is not going to be a conduit of my CCI to Journalist B.
Flaminia Marquia, European Public Affairs at Eurordis, which is the European Organisation for Rare Diseases. I’m really trying to understand what you’re saying. It’s difficult but…can you give an example of an adverse event that would be commercially confidential, so commercially confidential not to have to be shared with the patients? But maybe this is commercially confidential.
Let me answer your question because it was raised before. I cannot come up with an example of an adverse event that we would not share. Because AbbVie is going to share all of its yellow stuff under appropriate conditions that maintain the public health.
Now stepping back from this, and I will talk to my regulatory people, but if there is adverse event information which is not released in PSURs, which is not released normally and made available in adverse events databases worldwide, if there is discussion of adverse events perhaps in the narrative of clinical studies which doesn’t fall into any of those categories, I suspect it would fall into the yellow and it would be released under the conditions that we would be sure would ensure the advancement of public health.
But also remember in the blue – I think it’s in the bottom right of my graphic – companies can choose to release anything that they want to. That’s part of the definition of CCI.
Personally from Abbvie’s perspective I cannot imagine any circumstance where my company would not release voluntarily adverse event information that was relevant to one of our products on the market. That’s just not the way we do business. (I seem to remember something about thalidomide – but hey that was last millennium).
But this has happened in the past, in the history, no? (What about New York States action against GSK for Fraud that led on to a $3Billion fine last year)
I can only speak for AbbVie here. I don’t know what you’re talking about…the specific examples. But again, this idea, this construct that we’re putting together here. It is a big picture of trying to ensure that we recognise the different kinds of information that appear all throughout these marketing authorisation dossiers. A lot of stuff can be released, a lot of stuff is confidential commercial information but a lot of that CCI, notwithstanding that it’s confidential and can help competitors, we can release provided that the proper conditions are met.
(What about 2008 when FDA asked Abbott what was going on about Histoplasmosis on Humira – that FDA now had 16 cases reported to it. Abbott it turns out unbeknownst to FDA had 32 cases).
That was Abbott – We’re now AbbVie – who knows what went on in a completely different company.
I heard you say the company is the best judge of its environment in which it operates.
Yes but I hope it goes further than just the competitive environment. Because you are working in healthcare. That’s my question – do you have any idea that you are working in healthcare with patients?
Of course that’s our whole reason to be in existence – to research and discover new patients (a Freudian Slip to savor) , new drugs.
The only reason I have heard is that you have commercial considerations.
Our reason for being in business is to continue to research and discover new products to help patients and all of us (people will always be prepared to hand over money for drugs – even mortgage their homes on the hint of a promise of help – what better business could there be to be in). The question and considerations of commercial value – a commercial environment – when we consider whether something is CCI has to center on the commercial value of that information in our marketing authorization dossier to our competitors – because that’s what the definition of CCI is. That is separate from the determination of whether than is publicly releasable in the interests of public health.