EMA and Malta call for alternatives for Lyme antibiotics
EuroLyme took the opportunity to ask the first question in this event about revising EU general pharmaceutical legislation.
We thank for great support for Lyme patients :
Emer Cooke, Executive Director, European Medicines Agency
Christopher Fearne, Deputy Prime Minister and Minister for Health, Malta
Revision of the EU general pharmaceutical legislation - addressing challenges, seizing opportunities
Date : 13 March 2023
Location : Permanent Representation of Austria to the European Union (Brussels)
Organised by : European Health Forum Gastein, in close cooperation with the Federal Ministry of Social Affairs, Health, Care and Consumer Protection, Austria and the Permanent Representation of Austria to the European Union
Event webpage : www.ehfg.org/projects-events/event/revision-of-the-eu-general-pharmaceutical-legislation-addressing-challenges-seizing-opportunities
Full recorded event : www.youtube.com/watch?v=GGMZ2BsT6A8
EU webpage about the Revision of the EU general pharmaceuticals legislation.
The legislation dedicates a chapter to antimicrobial resistance, because development of new antimicrobials has slown down.
EuroLyme did already participate in the EU consultation in 2021.
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John Vandeput |
I am John Vandeput from a group called EuroLyme.
I represent 4 European groups for Lyme disease.
And the question in Lyme disease is we are using a lot of antibiotics.
Everybody knows it, but this is more, our doctors get in trouble because they use too many antibiotics.
So it is really a subject.
Our question is can this legislation say for the antibiotic used by Lyme patients to do research to plant extracts that we don't know yet.
Which will be easier for patients to support.
And so basically the question is : if you use plants, you don't have patents.
So you need a business model that the pharma companies can develop the new not known antibiotics i hope, and make it easier for us and the pharma industry that they don't need to make money on the sales.
Thank you very much.
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Emer Cooke |
Yeah thank you for the question on Lyme disease.
And in fact it was really about other alternative models that we should be exploring.
And I think that's something that's very important and it's uh there are great opportunities there.
I'll come back to that.
Let me just talk about the patients now.
Because uh and especially in the orphan in the orphan area, and just remember that the orphan committee was the first committee ever to have patient representatives as members, not as observers, as members.
And I think the patient community has played a huge role in uh in advancing the patient centricity of the development of orphan medicinal products and I really hope that they continue to do so.
Um I.
It is challenging um it is uh especially when you're you're you're dealing with um a small number of patients trying to get the end points right.
Is it is is challenging both for regulators and for for for developers but I think it's very important that patients are involved in this.
Because patients can tell us what matters and that's something that that really makes a difference so not only through the representation of on the orphan uh uh drug committee, but also through the representation on the patients and consumers working part.
We've had a lot of really fantastic input from patients and we want to build on this in fact.
One of the uh our hopes is that we will also have patient representatives on the committee for human medicinal products, and that's not of the case at the moment.
So definitely involvement of patients to help to further the patient-centricity of what we do is something that we we see as very important as part of of um strengthening our regulatory system.
And then maybe just a few words on looking at alternative models.
Because um we talk about um antibicrobial resistance, and we talk about the search for new um antibiotics, but actually we're also looking at alternatives to antibiotics.
Um and these are something that uh um there are a number of different projects being being supported um by the European commission RTD under under the Horizon uh pro project, that uh that look at alternatives to antibiotics.
So um certainly uh it doesn't have to be.
I think what we would like to see is not just more antibiotics, but also more effective treatments that um uh effective treatments that that may not be antibiotics but prevent the need for antibiotics and I think that would be very beneficial in the area of of uh of Lyme disease.
What I will say is it's not that easy.
If it was that easy, I think we'd have a lot more on our uh we'd have a lot more um on our doorstep at the moment.
But I can also say is that we are committing committed to doing as much as we can from a regulator perspective to ensure that that new regulatory alternatives to antibiotics can be um assisted uh through the regulatory process in areas where there's traumas or unmet medical need.
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Christopher Fearne |
So um just go over some of the questions.
I think the question on Lyme disease was extremely relevant and it's something that all of us need to look at.
So alternatives towards certainly established, but just to come to these to these questions from the patients groups and the insurers.
Um I think the the heart, this comes with the heart of what we've discussing and the the question is so so big and fundamental that it's almost philosophical.
Which is is the system that we've been using for developing new medicines over the last 100 years or so, the correct system or not.
In other words is a system whereby new medicines come onto the market, and are developed that come onto the market by the pharmaceutical industries, driven by profit, or should be some that's something else.
Because let's be honest, very true, put it very cruel here, this is how the system works.
And you, I mean a new molecule becomes medicine available to patients only if the industry and all the orderly or for the company developing, it feels levelism.
Is this the way that we should be procuring your developing government or should we be looking at patient interests and evidence.
Um my reading of the, and again this is we'll see in a couple of weeks time, because without reading, it but my reading of the of the pharmaceutical strategy is that we are not changing drastically.
This is knowing for the last 100 years, but we are freshing it up.
Um so unmet needs is exactly this.
If you look at antimicrobials, there's a big need for new antimicrobials.
There are only three or four possible antibiotics, enough of antibiotics, coming into the pipeline, often that's how it is.
So strategy talks about incentives.
I might get a question from you to ask me that this is something which we need to talk about, and the development of incentives for antimicrobials.
(So we'll um we'll talk about this in a minute.)
Um but but this is exactly evidence again.
Um should should we start paying for medicines before we know that they actually work.
Um at the moment we do.
Um watch real life data.
Um should we be paying for medicines without actually knowing that they were.
Um because there's the pressure for doctors to use them.
So so yes this is this is a at the at the basis of what we are discussing.
The European reference networks work work.
Um I think they're extremely important to us, and and we have Europe-wide registries for for rare diseases that will be okay um.
And the um European health data space, I suspect will also help, because that will allow data to flow more easily from one area to the other.
So yes the the to my reading is the strategy is going to make things special better, but it's not going to to revolutionize the whole focus using the whole industry has to help.
Revolutions usually leaves a lot of dead people, so in a way revolution is not the best.
