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Laying of the foundation stone of the secondary site of the European Directorate for the Quality of Medicines and HealthCare of the Council of Europe

Ars-Laquenexy (France) 11 June 2018
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COURTESY TRANSLATION

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Ladies and gentlemen, [Greet audience]

The laying of the foundation stone of the secondary site for the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe (otherwise known as the EDQM) is a powerful testament to the dynamism of the Council of Europe and its added value, and to the vigour of the international co-operation model that it has introduced in a wide variety of areas – all of which are about people and human dignity. It is also, and above all, proof of our determination to work for the protection of the basic right to health enshrined in our treaties, such as the European Social Charter, through access to high-quality medicines and healthcare.

The story of the EDQM began in 1964, when 8 of our member countries decided to work together to establish common quality standards for medicines in Europe.

Today, 38 countries and the European Union are involved in developing the European Pharmacopeia, which contains legally-binding quality standards together with reference substances known as “reference standards”, which are crucial for the day-to-day monitoring of the quality of medicines for human and/or veterinary use. This work is followed by 28 observer states, including 21 non-European countries spanning 5 continents, and by the World Health Organization (WHO). The quality standards and reference standards established by the EDQM serve as a scientific and technical benchmark and ensure that medicines are of the same quality in over a hundred countries worldwide.

To give you an idea of the huge amount of work that has been done: in 2018, the European Pharmacopeia, which is in its 9th edition, contains around 3,000 quality standards. The work benefits public health authorities, producers of pharmaceutical raw materials and medicines and, ultimately, each and every one of us: patients everywhere, in Europe and beyond. For more than 10 years now, the EDQM has been pursuing activities in other areas too: blood transfusion, organ, tissue and cell transplantation, and patient and consumer health protection.

Since its inception, the EDQM has always operated out of Strasbourg, where it is now housed in a fantastic building.

So why the need for a second facility? And why site it in Ars-Laquenexy, in Metz metropole, rather than simply extending the existing building?

The President of Metz metropole and the mayors will doubtless agree that there are plenty of reasons to come to this wonderful area, and our plans to create a secondary site here have been warmly welcomed by officials from the prefecture, Metz metropole and the municipality, all of whom I wish to thank for the extremely professional support they have provided.

More widely, Monsieur le Préfet and Ambassador, I would like to take this opportunity to once again express the Council of Europe’s sincere gratitude to its host state, France, for giving us a home since 1949 in Strasbourg, and now also here, in Ars-Laquenexy.

To go back to my question, however, why build a secondary site?

The main reason has to do with the official reference standards. The creation of a reference standards centre for the European Pharmacopeia was proposed in 1969 by the European Pharmacopeia Commission and was formally approved in April 1970 by the Public Health Committee. The first list of reference standards published in 1971 featured 38 substances. Today, the catalogue contains over 2,800 reference standards of chemical, biological or veterinary origin and the portfolio is constantly growing. In addition to this, there are the WHO’s stocks of International Standards for Antibiotics and International Chemical Reference Substances, the EDQM having been a key partner of the WHO since 2006, thanks to its internationally recognised technical expertise.

The EDQM currently has the capacity to produce one million six hundred thousand (1 600 000) vials per year and these reference standards are shipped to over 100 countries worldwide every day – to professionals who know they can rely on us, come what may!

It is crucial, therefore, that the EDQM and hence the Council of Europe be able to continue performing this task under any circumstances, thus ensuring the long-term viability of our public health protection mission.

The new EDQM site on which we are gathered today meets this need, by enabling us to create a secondary stock so as to ensure an uninterrupted service in the event that the main building in Strasbourg should suffer a major incident.

The new building will be capable of storing roughly 12 000 000 vials at temperatures ranging from +5°C to -20°C and -80°C, plus 376 batches of consumables.

Later on, we will have an opportunity to examine together the drawings and plans for the new building and its 3 main zones: one dedicated to logistics (also including storage and preparation of orders for reference standards) at the rear of the building; IT, tertiary and “pharmaceutical” facilities at street level, and a technical zone on the upper level.

Ladies and gentlemen.

I have no hesitation in saying this project will be, and is already, a big success. Both for our Organisation and our fellow citizens. It is a major achievement in terms of substance, through the additional protection for the right to health that it brings. And it is also a major achievement in terms of style, because the architecture of the building which it is planned to construct is quite wonderful.

Thank you for your attention.