The OMCL Network – A story of collaboration for safe and good quality medicines

Description

We take it for granted that the medicines we take are safe and of good quality, but few know exactly how the EDQM contributes to making this a reality. For the past 30 years, the European Network of Official Medicines Control Laboratories (OMCLs) has conducted independent quality control testing of medicinal products for human and veterinary use throughout, covering their entire life cycle. That means not only strict testing before they reach the market, but also market surveillance once they are on the market to detect any risk of defective or falsified medicines. In this episode, Michael Wierer, who has been working to build the OMCL Network since its inception, will present this tireless effort to ensure that patients in Europe have access to safe, good quality medicinal products. We’ll explore its history and achievements and investigate why it matters so much for public health.

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Transcription

Speaker #0
Welcome to EDQM On Air, a podcast on public health brought to you by the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. We hope you enjoy this episode and we invite you to stay tuned to learn how the EDQM and its stakeholders work together for better health for all. Our focus for today's episode will be the official Medicines Control Laboratory Network, also known as the OMCL Network, a collaborative project that just celebrated its 30th birthday. The OMCL Network is responsible for the quality control of marketed medicinal products for human and veterinary use. Medicines are subjected to a strict review process before they're authorized to enter the market in order to ensure their quality and safety. Moreover, medicines can be selected for surveillance testing throughout their entire life cycle, even after they have entered the market. This tireless work ensures that patients in Europe have access to the highest possible quality of medicinal products, and that the risk of contact with defective or falsified medicines is minimized. So in this episode, with the help of Michael Vira, who has been on board with the project since the beginning, we'll be taking a look at its history, its greatest achievements, and we'll come to understand why it matters so much for public health. So Michael, let's begin early on. Why was the OMCL network created and how did you end up getting involved?
Speaker #1
Okay, OMCLs historically existed in almost all European countries, but they operated on a national level. That means completely separated from each other. I was involved myself as a head of a German OMCL in Münster and we had to control a huge list of products on our national market at the time. We and colleagues from other member states realized that medicines are often also available on the markets of the neighboring countries. And so the idea was born that we could do some work sharing to avoid duplication of work and also create some scientific exchanges and synergies.
Speaker #0
Okay, so that's where the idea came from. you identified a need initially and then you went ahead to implement the project. So who finally undertook the initiative to create the OMCL network and what were the first steps and the first main lines of work?
Speaker #1
Yeah, so the technical secretariat of the European Pharmacopeia and this is the former name of what is EDQM now and the European Commission together created the general OMCL network in 1994. They invited us, the OMCL scientists from the member states, to a first meeting in Strasbourg. And during this meeting, some main objectives were identified. So we needed to build contact amongst the scientists in the different laboratories and inform us of our respective working methods and the scientific approaches. Then we also wanted to build mutual confidence so that everybody can rely on the results of the other. And this implies, of course, that we work with a common quality management system. And then in order to have good exchanges, we found that it was necessary to have common databases and platforms for secure exchange of data.
Speaker #0
Okay, so those were the beginnings. And now the MCL network is celebrating its 30 years of functioning of work. So from that time until today, I assume that the products that are covered by the OMCL network have multiplied, and also the laboratories involved are becoming more numerous as the years go by. So can you tell me what kind of products are covered now by the OMCL network, and how many laboratories are now involved in the network?
Speaker #1
Yeah, in fact, it covers medicines that are made from chemical molecules, but also biologicals of all kinds. So... concretely speaking vaccines and products from human blood or plasma and then also vaccines for for veterinary use okay and we have meanwhile omcls from 34 countries that are involved as full members and there is a huge interest from from the outside to join the network meanwhile we have seven non-european countries that are involved as associate members and the interest is still growing.
Speaker #0
Okay. And can you tell me more about the quality management aspects in the work of the OMCLs?
Speaker #1
Yeah. When we discussed this question of quality management systems, we decided to refer to a common norm for competency of laboratories in testing, which was developed by the ISO. And we decided to start a program of mutual joint audits to see whether all the laboratories really implement these. quality systems. And to this end, we created a program of mutual joint audits. And this means a group of colleagues from laboratories travel to another OMCL to see how the requirements of the norm are applied and implemented in that laboratory. And only if this is satisfactory The laboratory will receive a certificate with a validity of four years. We have also another exercise that is called proficiency testing studies to check the competency of the OMCLs. To this end, the EDQM sends blinded samples to laboratories that want to participate and asks them to run the analysis, return the results to us. Our statisticians evaluate all the results and... when the result is the desired one, the laboratories obtain a certificate of having successfully shown their competence in this field.
Speaker #0
Okay, so it's an exercise to keep each other fit in a way,
Speaker #1
right? And since the beginning, we have run now nearly 200 studies in different fields.
Speaker #0
All right, so can you dive a bit deeper on some work sharing testing exercises, such as these ones that were run by the network?
Speaker #1
One example that I can give is the control of centrally authorised products. These are often complex or innovative medicines, which are authorised by the European Medicines Agency in Amsterdam. And in order to perform the analysis, you need really complex techniques, and it's better to do this in a work-sharing approach by several OMCLs. So in 1997, we started with a pilot phase of nine products. Since then we have increased the capacity and every year we test around 50 of such products from the market and so far in total we have 1700 products tested and the good news is that most of the products meet all the requirements. Sometimes there are small findings that need to be discussed and improved with the manufacturer but that part is done by the EMA.
Speaker #0
SL. Okay, thank you. So, so far, you've talked about how the OMCL network tests all kinds of substances and medication that people come into contact with to ensure everyone's safety. So I assume there must have been some instances of unsuitable or potentially dangerous products that have tried to make their way into the market that the OMCL network has protected the public from. So could you give me some examples of this?
Speaker #1
Yeah, the OMCLs. collaborate since 2005 in the field of suspected falsified medicines and other illegal products. Suspect samples of this kind are often sent in by inspectors, police or customs. And while it's the product in the distribution chain where the pharmacies are of good and safe quality, through these other channels, for example the internet, we find products that are containing substances which are not licensed and that are potentially dangerous for patients. Examples are products that are disguised as nutritional supplements. Sometimes they even claim only to contain plant extracts. And then if we analyze that or the OMCLs analyze that, find that there are chemical substances in the product such as sexual enhancers or growth hormones. So really, serious threat to the health of the people who don't know that this is part of this medicine.
Speaker #0
And these are unauthorized?
Speaker #1
Unauthorized, yes. I have also another example that could show the benefit to the patient. And this was a scandal that happened in Bottrop, Germany, in 2016, a retail pharmacy that was supposed to prepare cancer medicines by dilution from concentrates deviated from the protocol and diluted the concentrates much more than prescribed and thereby created a huge financial gain. Of course, this is not good for the patients. The OMCLs analyzed about 100 batches and the products were underdosed so that the cancer patients in the end didn't obtain the intended amount of dose of their oncological medicine. This led to a court trial and the responsible pharmacist lost his life since lifelong and was imprisoned for 12 years.
Speaker #0
Okay. All right. Well, thank you very much, Michelle, for breaking this all down for me and for the audience. I would like to close the interview by asking you a more personal question. What would you say is your own personal relationship with the project? And I'm asking this because you've been in it since its very beginning. And as I said before, this year, 2024 it's celebrating 30 years of existence so it's been a major part of your work life so you must feel quite attached to it in some way so looking back what are some of the most cherished memories you have yeah um i worked
Speaker #1
10 years in german omcls and then i was asked to work in in the network and working with colleagues from other countries this has always been my dream And I remember from the first meetings, I was very much attracted to have the possibility to exchange with knowledgeable colleagues and learn from them. I remember an example where I worked on a study for dehydrostreptomycin medicine with a colleague from the French laboratory in Fougere, France. And at the beginning, we had numerous tough discussions on which method to use and so on and so on. And over time, this has become a longstanding collaboration that still exists today. And when I then had the chance to go a step forward to apply for a position in EDQM. It was really great to see so many different OMCLs.
Speaker #0
Right, because you started out as a member of a laboratory and then you moved into the EDQM. So you have both experiences.
Speaker #1
Yes, and this is very good to know what we are dealing with at the same time than seeing also the European perspective, how to coordinate that best.
Speaker #0
Right, yeah.
Speaker #1
And Many of these colleagues now have become very close friends. And also the relationship within the network is quite close between the members. We have seen that during the COVID crisis, where we had to deal only via video conferences. And to run such video conferences in a productive way, that can be challenging when the members don't know each other. But in our case, since we have worked... so many years together, meeting face to face. It was very easy to continue this via the virtual channels. And we had a huge challenge with the test of the newly upcoming COVID vaccines. And that was easy because the network existed and was in operation since so long. So overall, I would say it is really a great development. And I'm extremely pleased having seen this growing.
Speaker #0
Right. Well, thank you very much, Michael.
Speaker #1
Thank you.
Speaker #0
If you enjoyed this episode, please subscribe to our show on your podcast platform of choice to make sure you don't miss out on new releases. Thanks again for tuning in, and we hope to see you in the next one.

Description

Hosted on Ausha. See ausha.co/privacy-policy for more information.

Transcription

Speaker #0
Welcome to EDQM On Air, a podcast on public health brought to you by the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe. We hope you enjoy this episode and we invite you to stay tuned to learn how the EDQM and its stakeholders work together for better health for all. Our focus for today's episode will be the official Medicines Control Laboratory Network, also known as the OMCL Network, a collaborative project that just celebrated its 30th birthday. The OMCL Network is responsible for the quality control of marketed medicinal products for human and veterinary use. Medicines are subjected to a strict review process before they're authorized to enter the market in order to ensure their quality and safety. Moreover, medicines can be selected for surveillance testing throughout their entire life cycle, even after they have entered the market. This tireless work ensures that patients in Europe have access to the highest possible quality of medicinal products, and that the risk of contact with defective or falsified medicines is minimized. So in this episode, with the help of Michael Vira, who has been on board with the project since the beginning, we'll be taking a look at its history, its greatest achievements, and we'll come to understand why it matters so much for public health. So Michael, let's begin early on. Why was the OMCL network created and how did you end up getting involved?
Speaker #1
Okay, OMCLs historically existed in almost all European countries, but they operated on a national level. That means completely separated from each other. I was involved myself as a head of a German OMCL in Münster and we had to control a huge list of products on our national market at the time. We and colleagues from other member states realized that medicines are often also available on the markets of the neighboring countries. And so the idea was born that we could do some work sharing to avoid duplication of work and also create some scientific exchanges and synergies.
Speaker #0
Okay, so that's where the idea came from. you identified a need initially and then you went ahead to implement the project. So who finally undertook the initiative to create the OMCL network and what were the first steps and the first main lines of work?
Speaker #1
Yeah, so the technical secretariat of the European Pharmacopeia and this is the former name of what is EDQM now and the European Commission together created the general OMCL network in 1994. They invited us, the OMCL scientists from the member states, to a first meeting in Strasbourg. And during this meeting, some main objectives were identified. So we needed to build contact amongst the scientists in the different laboratories and inform us of our respective working methods and the scientific approaches. Then we also wanted to build mutual confidence so that everybody can rely on the results of the other. And this implies, of course, that we work with a common quality management system. And then in order to have good exchanges, we found that it was necessary to have common databases and platforms for secure exchange of data.
Speaker #0
Okay, so those were the beginnings. And now the MCL network is celebrating its 30 years of functioning of work. So from that time until today, I assume that the products that are covered by the OMCL network have multiplied, and also the laboratories involved are becoming more numerous as the years go by. So can you tell me what kind of products are covered now by the OMCL network, and how many laboratories are now involved in the network?
Speaker #1
Yeah, in fact, it covers medicines that are made from chemical molecules, but also biologicals of all kinds. So... concretely speaking vaccines and products from human blood or plasma and then also vaccines for for veterinary use okay and we have meanwhile omcls from 34 countries that are involved as full members and there is a huge interest from from the outside to join the network meanwhile we have seven non-european countries that are involved as associate members and the interest is still growing.
Speaker #0
Okay. And can you tell me more about the quality management aspects in the work of the OMCLs?
Speaker #1
Yeah. When we discussed this question of quality management systems, we decided to refer to a common norm for competency of laboratories in testing, which was developed by the ISO. And we decided to start a program of mutual joint audits to see whether all the laboratories really implement these. quality systems. And to this end, we created a program of mutual joint audits. And this means a group of colleagues from laboratories travel to another OMCL to see how the requirements of the norm are applied and implemented in that laboratory. And only if this is satisfactory The laboratory will receive a certificate with a validity of four years. We have also another exercise that is called proficiency testing studies to check the competency of the OMCLs. To this end, the EDQM sends blinded samples to laboratories that want to participate and asks them to run the analysis, return the results to us. Our statisticians evaluate all the results and... when the result is the desired one, the laboratories obtain a certificate of having successfully shown their competence in this field.
Speaker #0
Okay, so it's an exercise to keep each other fit in a way,
Speaker #1
right? And since the beginning, we have run now nearly 200 studies in different fields.
Speaker #0
All right, so can you dive a bit deeper on some work sharing testing exercises, such as these ones that were run by the network?
Speaker #1
One example that I can give is the control of centrally authorised products. These are often complex or innovative medicines, which are authorised by the European Medicines Agency in Amsterdam. And in order to perform the analysis, you need really complex techniques, and it's better to do this in a work-sharing approach by several OMCLs. So in 1997, we started with a pilot phase of nine products. Since then we have increased the capacity and every year we test around 50 of such products from the market and so far in total we have 1700 products tested and the good news is that most of the products meet all the requirements. Sometimes there are small findings that need to be discussed and improved with the manufacturer but that part is done by the EMA.
Speaker #0
SL. Okay, thank you. So, so far, you've talked about how the OMCL network tests all kinds of substances and medication that people come into contact with to ensure everyone's safety. So I assume there must have been some instances of unsuitable or potentially dangerous products that have tried to make their way into the market that the OMCL network has protected the public from. So could you give me some examples of this?
Speaker #1
Yeah, the OMCLs. collaborate since 2005 in the field of suspected falsified medicines and other illegal products. Suspect samples of this kind are often sent in by inspectors, police or customs. And while it's the product in the distribution chain where the pharmacies are of good and safe quality, through these other channels, for example the internet, we find products that are containing substances which are not licensed and that are potentially dangerous for patients. Examples are products that are disguised as nutritional supplements. Sometimes they even claim only to contain plant extracts. And then if we analyze that or the OMCLs analyze that, find that there are chemical substances in the product such as sexual enhancers or growth hormones. So really, serious threat to the health of the people who don't know that this is part of this medicine.
Speaker #0
And these are unauthorized?
Speaker #1
Unauthorized, yes. I have also another example that could show the benefit to the patient. And this was a scandal that happened in Bottrop, Germany, in 2016, a retail pharmacy that was supposed to prepare cancer medicines by dilution from concentrates deviated from the protocol and diluted the concentrates much more than prescribed and thereby created a huge financial gain. Of course, this is not good for the patients. The OMCLs analyzed about 100 batches and the products were underdosed so that the cancer patients in the end didn't obtain the intended amount of dose of their oncological medicine. This led to a court trial and the responsible pharmacist lost his life since lifelong and was imprisoned for 12 years.
Speaker #0
Okay. All right. Well, thank you very much, Michelle, for breaking this all down for me and for the audience. I would like to close the interview by asking you a more personal question. What would you say is your own personal relationship with the project? And I'm asking this because you've been in it since its very beginning. And as I said before, this year, 2024 it's celebrating 30 years of existence so it's been a major part of your work life so you must feel quite attached to it in some way so looking back what are some of the most cherished memories you have yeah um i worked
Speaker #1
10 years in german omcls and then i was asked to work in in the network and working with colleagues from other countries this has always been my dream And I remember from the first meetings, I was very much attracted to have the possibility to exchange with knowledgeable colleagues and learn from them. I remember an example where I worked on a study for dehydrostreptomycin medicine with a colleague from the French laboratory in Fougere, France. And at the beginning, we had numerous tough discussions on which method to use and so on and so on. And over time, this has become a longstanding collaboration that still exists today. And when I then had the chance to go a step forward to apply for a position in EDQM. It was really great to see so many different OMCLs.
Speaker #0
Right, because you started out as a member of a laboratory and then you moved into the EDQM. So you have both experiences.
Speaker #1
Yes, and this is very good to know what we are dealing with at the same time than seeing also the European perspective, how to coordinate that best.
Speaker #0
Right, yeah.
Speaker #1
And Many of these colleagues now have become very close friends. And also the relationship within the network is quite close between the members. We have seen that during the COVID crisis, where we had to deal only via video conferences. And to run such video conferences in a productive way, that can be challenging when the members don't know each other. But in our case, since we have worked... so many years together, meeting face to face. It was very easy to continue this via the virtual channels. And we had a huge challenge with the test of the newly upcoming COVID vaccines. And that was easy because the network existed and was in operation since so long. So overall, I would say it is really a great development. And I'm extremely pleased having seen this growing.
Speaker #0
Right. Well, thank you very much, Michael.
Speaker #1
Thank you.
Speaker #0
If you enjoyed this episode, please subscribe to our show on your podcast platform of choice to make sure you don't miss out on new releases. Thanks again for tuning in, and we hope to see you in the next one.

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