Speech by Commissioner Kyriakides at event on the "Revision of the EU pharmaceutical legislation: addressing challenges, seizing opportunities"

Dear Deputy Prime Minister, Dear Ministers, Esteemed Guests, Colleagues,

The title of your event, Addressing challenges, seizing opportunities, fully captures the ambition behind the upcoming reform of the EU pharmaceutical legislation.

Addressing challenges and seizing opportunities. Challenges we all know exist and need to be addressed in order to deliver on what we are all trying to achieve together, and that is an opportunity for change.

This is a reform which has been a long time coming, to address chronic challenges in this area.

In order to achieve this, we need to work together, in a spirit of solidarity as we have done during the unprecedented public health crisis of this pandemic so that Member States, the European Parliament, and the Commission achieve what we set out to do - solving problems that everybody has been highlighting for many years.

First and foremost, to address the interests of patients across Europe.

This is an opportunity to put patients at the centre, whilst at the same time fully supporting an innovative and globally competitive EU industry.

These two objectives should be pursued in balance. Not as trade-offs.

Delivering on this is one of the most important tasks we have in the area of health during our mandate.

I can assure you that I am fully aware not only of the expectations but also of the concerns.

Our current rules were put in place in a different era, and we need to move with the times.

Our citizens, societies and economies need a system that can keep pace with scientific and technological progress and that can ensure the availability, access and affordability of medicines at all times.

When looking at this proposal it is important to look at it as a whole, as a toolbox. One part complements the other, and no initiative should be seen in isolation. 

Let me recall the 6 key aims we want to achieve with this reform.

Firstly, we want to ensure that all Europeans can access both innovative and established medicines when they need them, wherever they may live.

The reality today is that in a fragmented internal market, medicines are not reaching patients quickly enough and not in all Member States at the same time.

Secondly, and most importantly, we want to ensure the EU pharmaceutical industry can innovate and remain globally competitive.

This is why we will make sure we give strong incentives for innovation, especially for unmet medical needs.

We will also support patients so they can all access the benefits of this innovation equally – this is a long-standing request from Austria and other Member States.

This is why we will reward those who go the extra mile to provide EU-wide access.

And herein lies the balancing act that we want to achieve.

Innovation to serve every patient, equally and equitably, across the EU.

Thirdly, this is a reform to address shortages of medicines; a reform to boost our security of supply.

There will be stronger obligations on supply and transparency of stocks. Shortages and withdrawals will have to be notified earlier. The European Medicines Agency will have a stronger role in coordinating our actions against shortages.

Fourthly, we will aim to make medicines more environmentally sustainable. For too long, we have known that pharmaceutical production impacts our environment. These impacts will now be part of our authorisation processes, and environmental risk assessments will be an integral part of authorisation dossiers.

Fifthly, we need ambitious tools to combat antimicrobial resistance – the silent killer that at the moment claims more than 35,000 lives per year. Our pharma reform is the perfect vehicle, and it will include measures both to stimulate new antimicrobial products, as well as prudent use.

We are considering to propose transferable exclusivity vouchers for the development of novel antimicrobials to be granted and used under strict conditions.

We will also be looking at procurement mechanisms for access to new and existing antimicrobials that would guarantee revenue regardless of sales volumes.

Last but certainly not least, as this is the most horizontal of the novel elements we will bring: simplification, regulatory modernisation and digitalisation. A leaner regulatory environment for investment with simplified and faster marketing authorisation procedures, stronger support for promising medicines and better use of data and digitalisation.

Our ambition is very clear – to put forward in the coming weeks a proposal which will be both patient-centred and industry friendly.

A balanced proposal which does not create winners and losers, but builds a virtuous circle between industry and patients, to deliver innovation where it is most needed: to our citizens, across the Union.

This requires close cooperation and I count on your support during the negotiation so that together we bring the EU pharmaceutical system into the 21st century.

This is exactly what is meant by addressing the challenges and seizing the opportunities. These are opportunities that must not be lost.