Dear Chair,
Dear Delegates,
Ladies and Gentlemen,

I am honoured to address you today and to open the Fourth International Meeting of World Pharmacopoeias.

I would like to thank the World Health Organisation (WHO) for entrusting us to host this event.  The European Directorate for the Quality of Medicines and HealthCare (EDQM), Council of Europe, has an excellent and long-standing relationship with the World Health Organisation.  The quality of medicines and protection of patients are our common missions.  We both want to ensure that medicinal products are of high quality and that patients have access to safe and quality medicines.

Allow me to begin by extending to all of you a warm welcome to Strasbourg, the home of the Council of Europe and the birthplace of the European Pharmacopoeia.  

As you know, the Council of Europe is an intergovernmental organisation with 47 European member States. Founded in 1949, it is one of the oldest European institutions and its working methods still remain firmly intergovernmental to this present day.  Although it shares the same flag with the European Union, the Council of Europe is a distinct and very different organisation. Our mission is to defend and extend human rights, democracy and the rule of law in Europe. In Europe, for Europe and for all people who live on our Continent.

Through its legally-binding conventions, it promotes the fundamental principles and values of European integration; human rights, democracy and the rule of law.

Fifty years ago, eight countries committed themselves to signing the new Convention for the Elaboration of a European Pharmacopoeia. These pioneering countries, under the aegis of the Council of Europe, chose to unite and harmonise their national laws in pursuit of common specifications for medicinal substances in the greater interest of the peoples of Europe and of public health. The convention provided a unique legal framework to progressively work towards the elaboration of a harmonised Pharmacopoeia.

Since then, the EDQM and the European Pharmacopoeia have made a major contribution towards drawing together standards across the continent, often with an influence in the wider world, which far surpasses anything imagined by those who founded the Council of Europe. Today, the European Pharmacopoeia comprises of 37 member States and the European Union, 27 observers, more than 70 specialised groups of experts and working parties, and nearly 800 experts. The current Eighth Edition of the European Pharmacopoeia has nearly 2600 quality standards for substances used in medicines for human and veterinary use.

A fantastic achievement and an extraordinary success story!

Over the last 50 years, the laws and regulations governing medicinal products have evolved, and the pharmaceutical industry have undergone a progressive globalisation in the development, manufacture, marketing, and distribution of medicinal products. The demand for international pharmaceutical standards has become increasingly important to safeguard quality and improve access to medicines. Having harmonised approaches and policies in establishing pharmacopoeial standards will go a long way in helping to control the quality of pharmaceutical ingredients, thus safeguarding the health of the public. Removing differences in pharmacopoeial specifications can also reduce the resources and overall cost of testing of pharmaceutical products and the time required to bring new innovative medicines to the markets.

Harmonisation activities among the European, Japanese, and United States pharmacopoeias began already in 1989, with the establishment of the Pharmacopoeial Discussion Group, an informal harmonisation initiative between the pharmacopoeias parallel to ICH, the International Conference on Harmonization. WHO has been an observer to these activities since 2001. But we need today to pursue our harmonisation efforts beyond the three ICH regions. This is why the European Pharmacopoeia supports the initiative of the WHO to elaborate a guideline on Good Pharmacopoeial Practices (GPhP). 

This initiative will facilitate exchanges, strengthen co-operation and most importantly, open the door to acceptance of monographs among pharmacopoeias of the world in the future. It provides us with a unique opportunity to work together to strengthen international standards for the quality of medicines so that the benefits of international harmonisation for better global health can be realised worldwide.

Ladies and gentlemen,

It is crucial that the international standards for the quality of medicines are respected and enforced. The counterfeiting of medicines is seriously endangering the quality of medicines and the protection of patients and has developed into an industry with the involvement of organised crime that kills thousands of people every year.

Political and legislative action is needed at national and international levels. The Council of Europe Convention on the counterfeiting of medicines - known as the Medicrime Convention – is our response, but its standards are aimed to address an international phenomenon and not limited to the European context. I call on the greatest possible ratification of this important convention.

Another area relevant to your work is the elaboration of a Council of Europe Convention against trafficking in human organs, which is also a global phenomenon in breach of the most basic human rights.

Ladies and Gentlemen,

As we commemorate the 50th Anniversary of the European Pharmacopoeia and celebrate the ideals promoted by the “founding fathers”, please allow me to wish you a most successful and fruitful meeting.

Thank you for giving me the opportunity to address you this morning and enjoy your stay in Strasbourg.