Collaboration, Innovation and Scientific Excellence: the European Pharmacopoeia 11th Edition

Strasbourg 19 September 2022
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As delivered by Bjørn Berge, Deputy Secretary General of the Council of Europe


Distinguished guests,

Ladies and gentlemen,


It is a great pleasure to welcome you all to this conference, marking the launch of this, the
11th edition of the European Pharmacopeia.

The EDQM’s contribution to the quality, standards and supply of medicines across our continent has been and remains essential and unique.

The health of millions of people depends on it.

It is for that very reason that the EDQM –

And the many exceptional and talented people who work there –

Play a central role in the overall mission of the Council of Europe.

Our Organisation exists to promote and protect human rights, democracy and the rule of law for the benefit of all Europeans.

The European Court of Human Rights, interpreting the European Convention, has issued judgments making clear that national authorities must be proactive in protecting the health of their citizens.

And Article 11 of the European Social Charter is explicit.

It enshrines the right to the highest possible standard of health –

And the right of access to health care.

So, the right to health is a fundamental part of our human rights.

It is vital for our dignity and well-being –

And our Organisation has developed a range of tools designed to ensure that this has become a living reality for citizens across our continent.

The European Court and the European Social Committee generate case law, certainly.

But we also have our Oviedo Convention on Biomedicine –

Our Medicrime Convention that tackles the falsification of medical products –

And, of course, the European Pharmacopoeia Convention itself.

If we want a clear example of where all of these tools have been applied –

Where people’s right to health has been protected in the toughest of times –

We need look no further than the Covid-19 pandemic.

Early in the crisis we supplied member states with a toolkit designed to help authorities respond in a way that would uphold standards of health care –

But also ensure that any emergency measures they took were necessary, proportionate, and limited in duration.

Governments do have a positive obligation to protect life;

This may require measures to help particular groups and those who are severely ill, as well as prioritising high risk groups and others who are vulnerable.

But those steps must be taken while keeping in mind other human rights concerns, particularly during such a huge crisis, as the Covid-pandemic.

We were clear about this from the start.

And on everything from the conduct of democratic processes, including elections –

To the rise in violence against women during lockdowns –

To the discrimination and scapegoating faced by certain minorities –

Our mandate was clear and we were active in helping national authorities respond in the right way.

Every part of our Organisation was engaged in this effort –

Each playing its specific role –

Including of course the EDQM.

Consistently – your work – has made an essential contribution to the development of safe, effective and quality vaccines.

By openly sharing knowledge.

With free access to quality standards –

You have helped authorities, health professionals and manufacturers to develop the medicines and vaccines that have saved millions of lives.

And you have empowered universities and research centres in their work to tackle this global pandemic too.

This is not only a matter of guidance and expertise – vital though they are –

But also of your work on setting standards and providing support through training materials on, for example, recombinant viral vector vaccines –

Not to mention your constant supply of the products and services needed by laboratories across Europe –

So that they can keep manufacturing medicines and protecting public health.

You have contributed to the release of thousands of Covid-19 batches and billions of vaccine doses through the Official Control Authority Batch Release – for use in Europe and around the world.

At the same time, the professionalism and dedication of the experts and staff at the EDQM has allowed it to continue its other important work too.

In 2021, with the pandemic still raging, the EDQM maintained the production of reference standards –

Ensured their availability at a level exceeding 99%.

This is extraordinary.

In addition, the European Pharmacopoeia Commission adopted a total of more than 200 new texts.

The EDQM is an inspiring example of effective multilateralism that allows countries to come together in the spirit of co-operation –

And to solve cross-border problems that cannot be addressed by single countries acting alone.

Dear friends,

What we see today in Europe is what happens when governments turn their back on human rights and democracy.

The Russian Federation’s invasion of Ukraine was completely unacceptable and a terrible crime.

We had to react with clarity, determination and speed, and Russia was excluded from our Organisation.

In truth, we had seen the forces of aggressive nationalism build within Russia for some time.

Toaday, multilateralism and our democracies are being undermined.

Now we must certainly do what we can to support Ukraine, but at the same time also take steps to sustain and strengthen our democracies across Europe and help build something stronger than ever before.

This requires political will from Europe’s democratic leaders.

Now is not the moment for “business as usual” or “the role of the spectator.”

Now is the moment for awareness and action.

But today we celebrate the work of the EDQM.

We all have our role to play and our contributions to make.

An up-to-date single reference work for the quality control of medicines –

Delivering crucial information for European markets –

Today, I salute your work and the important role that each one of you plays.

With legally binding effect in the majority of European countries and employed in many more worldwide.

This – the 11th edition of the European Pharmacopeia – is a further step towards ensuring citizens’ rights to the highest possible standard of health.

We are grateful to all of you here today, to your colleagues, and for your work in the spirit of
co-operation and effective multilateralism.

I wish you all the best.

Thank you for your attention.