This episode showcases the relationship between the EDQM and its national and international stakeholders, how they work together for the protection of public health and what the real-life results of that co-operation are. Four guests, active in the EDQM constellation of health sector bodies and networks, present different aspects of this work: Salvador Cañigueral, Chair of the European Pharmacopoeia Commission, Massimiliano Conti, Chair of the GEON Advisory Group, Anne Garnier, Scientific Programme Manager in the EDQM’s European Pharmacopoeia Department, and Marie-Laure Hecquet, EDQM Policy Advisor. Their insider perspective on the European public healthcare landscape brings a complex system within easy grasp, helping us all understand how the EDQM is striving for better health, for all .
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. In the aftermath of the Second World War, Europe was in a disorganized and fragmented state. The chaos and violence of war, plus a series of devastating floods that swept northern Europe in 1953, all put a heavy strain on the healthcare systems of the continent. Even though the events triggered solidarity, the life-saving effect of medical aid was smaller than expected due to the lack of harmonization concerning dosages, quality requirements, or packaging and labeling instructions. These events highlighted the need for more extensive and efficient international cooperation in the field of public health. In the following years, an extensive regulatory ecosystem for public health was developed in Europe, with the EDQM playing a major part. In today's episode of EDQM On Air, we'll be looking at the EDQM's relationship with its various stakeholders and how we work together to ensure the quality of public health in Europe and beyond. So, why are networks so important for us at the EDQM? Well, first of all, they enable the development of trust, which, of course, is essential for any collaborative effort. Additionally, working together in networks has multiple mutual benefits, such as the sharing of information, expertise and workload, and the strengthening of mutual recognition and reliance. Finally, robust networks enhance the complementarity of a system. That means avoiding overlaps with other initiatives, maximizing the efficiency, of the overall regulatory mechanism. Our commitment to collaborative work is demonstrated in the way the European Pharmacopoeia Commission has woven networks and cooperative work into the core of its functioning. The EPC is a treaty-based body involving representatives of member states and employing working groups of experts from various countries. The treaty was an international initiative to create common quality and safety requirements and to promote the circulation of medicines. and ensure that European citizens can get medicinal products of the same quality and safety wherever they go in Europe. Salvador Cañilleral, chair of the European Pharmacopoeia, has kindly agreed to join us and tell us more. So Salvador, what exactly is the EPC, who participates in it, and why is it important?
Speaker #1
The European Pharmacopoeia Commission is the decision body of the European Pharmacopoeia. It is where All decisions related to the European Francopoeia are taken. It is constituted by delegations of the member states, nowadays 39, and the European Union. These delegations have one vote each. In addition, delegates from observer states and institutions, more than 30 nowadays, are also welcomed, although they have voice but not voting rights. As The decision body of the European Philocopia, the tasks of the European Philocopia Commission, are very important because it decides on what is or not included in the work program, meaning on which monographs and other texts to work or not, either for new elaboration or for the revision of the already existing ones. Which text could ultimately be adopted? to be published in the European Pharmacopoeia, but also which ones should cease to be part of it. This also decides on the composition of the groups of experts and working parties that prepare the texts to be included in the European Pharmacopoeia. And of course, it elects the chair and vice-chairs of the Commission. Under the governance of the European Pharmacopoeia Commission, there are more than 60 groups composed by more than 900 experts. in total, from more than 50 countries. They deal with different types of subjects such as chemical products, herbals, vaccines, or monoclonal antibodies, just to mention a few examples. All these groups, together with the staff of the EDQM, do the necessary work, including experimental, drafting the text, reflections and discussions, for preparing the text. When a draft text is ready, it is published online for public consultation. This is done in an online open access publication that is called Pharmaeuropa. The comments received from national authorities and other users are discussed in the corresponding group of experts in order to prepare a final text. This final text is submitted to the European Pharmacopeia Commission for adoption. Once adopted, the text will be published in the Pharmacopeia. At the same time, the text is elaborated, the laboratory of the EDQM works on the establishment of the necessary reference standards that are necessary for the application of the text. The quality standards of the European Paracopeia have a great impact on the quality of medicines in Europe and on the availability of high quality medicines to the citizens.
Speaker #0
Thank you Salvador. Now what would you say is the added value of working together in the framework of the EPC?
Speaker #1
There are mainly three axes in which the collaboration in the framework of the European Pharmacopeia Commission gives added value. First is the international collaboration of the member states in a way that means that the standard for quality laid down in the European Pharmacopeia will be implemented at the same time in all 39 member states. This harmonization facilitates the operation of the pharmaceutical industry. and improves the availability of high-quality medicines for all European citizens. Second, there is a significant added value in the collaboration of experts from various backgrounds, such as academia, industry and regulatory bodies, with different points of view that, at the end, make the European Pharmacocopia rich and useful. These experts come with a wide range of national experiences, since they are not only from the member states, but also from observer and third countries. Third is transparency and collaboration with a wide range of actors in the field of pharmaceuticals. There is collaboration with many national and international institutions beyond the national pharmacopeia authorities and medicines agencies of the member states, as well as with users interested. parties and stakeholders. There are many ways of collaboration, for example, through expert networks or also by declaring an interest in working with the Pharmacopeia, sending comments to the texts published in Pharma Europa for public consultation, organizing public surveys, the participation in symposia, workshops, webinars, and conferences organized by DDQM or by other institutions, and also through the help desk available in the website of the EDQM. All these collaborations help drawing the driving lines of the actions of the European Pharmacopeia, aiming to fulfill the real needs of the users and to serve for the improvement of the health of the citizens.
Speaker #0
As Salvador just explained, the European Pharmacopeia is a truly collaborative effort. However, our commitment to this way of work is not limited only to the European Pharmacopeia, but applies for many other initiatives as well, such as the Network of Official Medicines Control Laboratories. The OMCL network was set up in 1994 by the Commission of the European Union and the Council of Europe. The OMCLs are independent public laboratories with unique expertise to test They support regulatory authorities in controlling the quality of medicinal products for human and veterinary use available on the market independently from manufacturers, thus without conflict of interest. The EDQM provides the secretariat for the network. To hear more about its activities, I have here with me Massimiliano Conti, chair of the GEON Advisory Group of the OMCL Network. Massimiliano, how does the OMCL Network function and what is its added value?
Speaker #2
So the OMCL network works basically on work sharing and also mutual recognition and support. There are many laboratories. I think we are more than 70 OMCL laboratory in more than 40 countries. And the good thing is even if we have different languages and different legal framework and so on, we can work together and share information, share data. And this is what is our main strength, I would say. So the general how it works is basically we have a baseline work where we're doing every day. So we have, for example, we are developing and validating method for the European pharmacopoeia. We are doing market surveillance testing and several different activities around the safety and quality of the medicines in Europe. And then on the other hand, we also are capable to quickly react to any issues that might happen in Europe, maybe with a product. There is an example of the mRNA vaccines or for the nitrosamines. That was a big thing and especially it affected many countries in Europe. And the advantage was that we were able to share information, share methods, brainstorm, not only in one country, in one laboratory, but between the whole network. And at the end, we were able to generate the data needed for the authority we are working for in order to take decisions on the market and be sure that everything that is on the market is safe. And everything that was not safe has been then recalled from the market.
Speaker #0
Okay. And what are some unique advantages of collaborating through the OMCL network?
Speaker #2
So the unique advantages of doing collaborative work through the OMCL network is on one side, for example, when we have to... evaluate, we have regularly to evaluate if we are capable to perform some type of test that is centralized organized. So ADQM is organizing that one, it's free of charge, and we can all participate and show that we are capable of generating correct and quality results. On the other hand is also the training. So especially if there are some OMCL, they have maybe not a lot of experience in one area, they want to develop themselves in that area. So EDQM is organizing training sessions on quality topics, but also on technical topics. So one example is also for the nitrosamine. There are very advanced technologies and instruments used, like mass spectrometers. And we organize, for example, in my laboratories in Switzerland, we organize a training for other 10 OMCLs to come and to learn how to developed and validate and also how to test these nitrosamines in the products. Another point is the work sharing, which means even if you have maybe a lot of samples and products to be tested, it doesn't mean that every laboratory has to test all of them, but there is a work sharing. So EDQM is also organizing and dividing the workload throughout several OMCL laboratories. So maybe one laboratory is focusing on one product and another laboratory is focusing on another one, and we can send samples from different countries. So we can cover all of them without duplicating work and saving a lot of money, especially from the public funding.
Speaker #0
Okay, and one last thing I wanted to ask. The OMCL network is occupied with the testing of medicines, of course, it's its main line of work, but the network is also involved in scientific research. Could you tell me a bit more about that function as well?
Speaker #2
Yeah, this is also one advantage or also one type of work that we are performing in the OMCL network. You can just imagine we have access to a lot of products, a lot of information, being authorities. And usually what we do is if we see there is an area, for example, now with a new mRNA vaccines, of course, we do testing just to ensure that the quality and the safety is given as registered. But on the other hand, we're also trying to define methods that can be used in case there is an issue on the market. Especially these are new technologies, so product technology, and we can take advantage of that and then try to prepare ourselves in case there is an emergency. So development method. Sometimes we also publish methods. We do also some publication on results, for example, if we do market surveillance broadly with a lot of samples. Okay. I don't know, it was a divisibility of tablets. It was a very simple test where you take a tablet that maybe can be divided in two halves. There is a clear requirement how much you can deviate from the mean weight between the two. So we tested a huge amount of samples, and then the results have been published just to show how complicated and how can be, for example, if you divide them by hand or using cutters, or an instrument. What is the difference? And this is maybe also helpful on how to instruct the public, maybe my mom, okay, this is the best way how to divide a tablet, don't do it the other way.
Speaker #0
So far, we've seen how the EDQM incorporates collaborative work in the domains of the European Pharmacopeia and the OMCL network. Both of these undertakings are predominantly related to the public health landscape of Europe. However, today's world does not favor silos. The drive of globalization presents unique challenges to each domain it affects. Pharmaceutical regulation is, understandably, significantly touched by this reality. The more the world becomes interconnected, the more important it becomes to ensure harmonization of pharmaceutical standards across different domains. To effectively address this situation, the EDQM, along with the Japanese and United States pharmacopoeias, created the Pharmacopeial Discussion Group, or PDG, in 1989. The PDG is a collaborative effort to harmonize important monographs and and other elements of major pharmacopoeias. To explain this more in depth, I'm welcoming Anne Garnier from the European Pharmacopoeia Department of the ADQM. Thank you, Anne, for joining me. So I've already given a small introduction to the PDG, but I would like to hear your more nuanced and experienced position. So what exactly is the PDG and what are its main missions and goals?
Speaker #3
To understand the context of the creation of the PDG, In 1989, the director of the EDQM was attending a meeting in Tokyo and needed to buy some medicines. That day, during a dinner with colleagues with Japanese and American pharmacopoeia, they imagined how they can improve the exchange of medicines on the global market. Then, they decided to create this pharmacopoeia discussion group to promote the international harmonization of the pharmacopoeia requirements. The ultimate goal was to create a pharmacopoeia discussion group of the PDT is to harmonize the requirements included in several pharmacopoeias in order to be sure that the quality of the medicines in the different countries are the same and that the patient's safety are identical in the different regions of the world. This means that Povidon, for example, the requirements in the Japanese pharmacopoeia, USP and European pharmacopoeia will be exactly the same. Today, the PDG is composed of four pharmacopoeias, the European pharmacopoeia, the Indian pharmacopoeia who joined the PDG in 2023, the Japanese pharmacopoeia and USP pharmacopoeia. We also have the World Health Organization as an observator. We have the possibility to follow the different tasks of the PDG. The particularity of the text produced by the PDG is that They are unanimously adopted and the text, it's an informal text. There are no mandatory status of the text of the PDG. But then the pharmacopoeia use this text and adapt this text with their own process and their own way of describing or layout. Include this text into the pharmacopoeia. In this case, the text could become mandatory.
Speaker #0
All right. So what other actors? are involved in the working process of the PDG?
Speaker #3
The way of working of the PDG, it's a collaborating way of working. It's very important to collaborate with the manufacturers of the different regions and also with the regulatory environments. When the text is drafted by the PDG, they always have a consultation phase when stakeholders of All the regions are able to provide feedback and the improvement of the text. Like that, we are sure that the text at the end will really fulfill all requirements and cover all the products on the different markets.
Speaker #0
Public health in Europe and in the rest of the world is regulated not by a singular entity but rather by a network of organizations whose interplay and cooperation creates the regulatory environment necessary for managing public health. Especially concerning Europe, the EDQM plays a pivotal role in this ecosystem. But how does this work in practice? Marie-Laure Équet, policy advisor at the EDQM, helps us answer that question. Marie-Laure, how does the EDQM fit into the broader regulatory framework for public health in Europe?
Speaker #4
Okay. I think before we dive in unveiling the role of the EDQM within this vast regulatory landscape, we need to take a step back and understand the backstory. So first, the EDQM operates under the umbrella of the Council of Europe, which was established in 1949 after the Second World War. Its mission was to prevent that such strategies reoccur again by upholding the values of human rights, democracy and rule of law. And more than 10 years later, the EDQM was born with a specific focus on the quality of medicines, with a view to advance public health. as a fundamental human right. But it is true that we have so many players in the European health regulatory arena, which include also the EU, its body and institution, that the question you are raising where the EDQM fits in makes absolutely sense. So to understand this we need to grasp the concept of comparative advantages. The EDQM works on setting health standards in the field of medicines, substance of human origins or consumer health. but is also acting as a bridge by providing operational or assistance tools, helping authorities, operators such as healthcare professionals or the industry to implement these standards. And on the other end you have the EU which is focusing on a deeper political and economic integration by crafting binding laws for its members. But here comes the interesting part. So Despite this difference between the EU and the EDQM, they closely collaborate together, and we can picture this as gears in a very well-oiled machine. The EU sets the legislative framework while the EDQM activities and tools ensure its smooth implementation. For instance, when the EU establishes the pharmaceutical or the blood, tissue and cells regulations, they make reference to the standards developed by the EDQM, like the European Pharmacopeia, or the blood, tissue and cells guides. And it's like a seamless partnership where each party brings its strength to the table. The collaboration doesn't stop here. Beyond this regulatory cooperation, which I just explained, the EDQM and the EU engage in a very deep technical cooperation. Experts from both sides participate in respective committees or working groups. And that's not all. The EDQM coordinate operational, underground capacity, building activities. For instance, we have audits, training courses for the official control medicine laboratories, but also for blood establishment, as well external control studies or market surveillance studies for medicines or cosmetics. And you can see that the EDQM is at the front line supporting stakeholders at different levels of the public health spectrum. And many of these initiatives are co-financed by both the EDQM and the EU. The EDQM influence extends beyond the EU. as we are reaching 39 member states and 33 observer states. And that's why some consider the Council of Europe and thus the EDQM as an empty chamber of the EU. Essentially, we are all the trailblazer setting standards that ripple across borders, ensuring quality healthcare for all. So the next time you take a pill or receive a blood transfusion, remember the intricate web of regulation and cooperation that makes it possible, the EDQM may operate. behind the scene, but its impact reverberates across Europe and beyond, safeguarding our health and well-being.
Speaker #0
All right, thank you, Marie-Laure. And why would you say it's important that we work together for the protection of public health?
Speaker #4
I think this is crucial because first we need to avoid duplication of work. We need to make best use of our respective competences, strength, and resources. We need to synergize our efforts and complement each other. And most importantly, we need to make best use of public money. And this is becoming even more important nowadays because we are living in a very rapidly evolving environment with the rise of new technologies, for instance, but also new diseases occurring and being diagnosed, new health issues and needs to be tackled.
Speaker #0
In this episode of EDQM On Air, we took a deep dive into one of our most important core values, togetherness. We explored many facets of our collaborative spirit and saw how it pervades all aspects of our work. From the European Pharmacopeia and our networks of laboratories, to the global effort for the harmonization of medicines, the EDQM strives to be as inclusive and open as possible. At the end of the day, no matter what the context, the willingness to work together will always yield the best results. We hope that you enjoyed this episode and that it made you more familiar with our values and our way of work. If you want to learn more, please make sure to check out more episodes. Finally, a huge thank you to our colleagues who kindly agreed to come on the podcast and share their expertise, as well as to all of our partners and stakeholders for working with us here at the EDQM to create a safer, healthier world for all.
