Opening remarks by Vice-President Schinas and Commissioner Kyriakides on the revision of EU's pharmaceutical legislation *

Remarks by Vice-President Schinas:

Good afternoon, I am proud to present today, with Commissioner Kyriakides, the revision of the pharmaceutical legislation. It is the most complex, neuralgic, epic, big package we have prepared in the area of health throughout our mandate.

This is one of the oldest pieces of legislation, about 20 years old. When we kickstarted the project three years ago, we were aiming to bring about a holistic, balanced review that is fit for purpose, modern and reflects all the lessons drawn from the pandemic and the word that we live in, much more complex than 20 years ago.

Before going into the details, let me give some context. When the legacy moment will come for this Commission, health will be an important chapter in the achievement of this Commission. Never before in the history of the European Union we were able to do so much in the area of public health. Not only in terms of management of the pandemic, but also in building an EU Health Union.

I am convinced that this chapter will be known as the untold success story of the European Union, keeping always in mind that the legal base of health policy in the treaties are not among the strongest ones when we develop policies for Europeans.

It all started with the EU vaccines strategy, the biggest ever vaccination programme in the history of mankind. It enabled access to lifesaving vaccines for citizens, regardless of the place of residence or socioeconomic conditions.

The Digital COVID Certificate, which gave us our lives back, became a global standard for more than 69 third countries. The reinforced mandates of our health agencies, EMA and ECDC. The creation of a new authority, HERA, that can ring the alarm before crisis hit us. The first-ever health programme in the EU budget, EU4Healt. The first-ever comprehensive European plan to beat cancer the first-ever proposal to create a European Health Data Space. All this is what we managed to achieve under this commission.

I take this opportunity to thank the President, Stella, and all the teams represented here for this impressive work.

The pharmaceutical package is the penultimate step in this process, probably the last legislative step of the term. We still have the mental health proposal coming in June.

When it comes to pharma. This is a package that is meant to address two objectives: a patient-centred approach. This gives more opportunities for patients, better access, affordability.

I take the opportunity to salute the presence of representatives of patients organisations today Welcome.

The other twin objective is the competitiveness of our pharma industry. It is a European champion, that needs to be given the chance to compete globally through innovation and make sure that, as a result of this review, they continue to be a European champion.

This translates into two sets of concrete objectives: what we characterize as the triple As (access, affordability, availability). But also, what I call the triple Cs (competitiveness, compliance, combatting AMR).

I will briefly illustrate those main objectives and then Stella will guide you through the concrete actions to make them a reality:

• First and outmost is Access. We want our citizens, wherever they live in the EU to have equal access to medicines. It is not a secret that bigger and wealthier countries get medicines first and faster. The facto, this creates first- and second-class citizens. And we want to change that, through a smart system of incentives that replaces the current blanket protection system. The more you are compliant with enhancing market access the better protected your products are in the Single Market.
• We also want to ensure that medicines are more Affordable for patients and for health-system. We want to see more generics coming in; we want to see prices coming down. We are not setting prices, this is a national competence. But there are many things we can do to influence the ecosystem around that. This can be done through simplification of procedure, rationalisation and the introduction of generics.
• We will minimize shortages of medicines across the EU, enhancing Availability for all EU citizens. This is a crucial issue from a health perspective, but also a key contributor to Europe's strategic autonomy, resilience and also security. Europe needs to maintain access to raw materials. We have high hopes that EMA will rationalise and coordinate this process to act together before we have the problem emerging.
• At the same time, we wish to maintain the Competitiveness of the EU pharmaceutical industry, one of our crown jewels. The revised regulatory system will be simpler for authorisation, faster and SME's friendly; it will also offer even longer protection of industrial activity than today - if specific conditions that are predictable and clear are met. Altogether, the new measures will generate up to €300 million savings annually for our industry.
• And we want to do all this mindfully of the environmental impact of medicines, by ensuring Compliance with our Green deal and environmental goals. For now, it was more a box-ticking exercise, we want to make it a meaningful exercise.
• We bring at the forefront action on Combatting antimicrobial resilience, the ‘silent pandemic'. This is a huge problem. It is becoming more and more of a threat. To address overuse and misuse of antibiotics, and to promote the development of more effective treatments through a system of incentives and transferable voucher

In a nutshell, we are building together a Single Market for medicines in the EU, one that works for citizens and for industry, 20 years since the legislation was inacted.

To conclude, I have to confess that, taking stock of all that we have achieved over the last few years in the area of health fills me with a sense of pride and appreciation.

The European Health Union is not a concept, a slogan, a verbal objective. It is action and it is happening.

Thank you.

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Remarks by Commissioner Kyriakides:

Ladies and gentlemen,

What we are presenting today represents the European Way of Life.

We cannot have first- and second-class citizens when it comes to accessing medicines in the EU.

This reform is about not leaving anyone behind.

On health inequality, Bono once said: “Where you live should not determine whether you live, or whether you die”.

This premise underpins the proposals of the European Health Union we have been building since 2020 with Europe's Beating Cancer Plan, the European Health Data Space, the Cross-Border Health Threats Regulation, the strengthening of the mandates of the European Centre for Disease Prevention and Control, the European Medicines Agency and today, with our pharmaceutical reform proposals.

Today, we are acting on behalf of citizens, patients and industry.

Our proposals today are historic. This is  because it has been 20 years that our rules have been in place. These rules served a purpose, as they have delivered safe and effective medicines to citizens, but they have not delivered a Single Market for medicines. They also have not addressed the challenges surrounding inequalities in the area of medicines.

Every year, half of us purchase at least one prescribed medicine.

Every year, we spend 1.5-2% of our GDP on medicines.

The pharmaceutical industry is a key economic and innovative sector for the EU, worth €215 billion in exports every year.

In a European Health Union, access to medicines can no longer be fragmented.

Today, with our pharmaceutical legislation reform proposals we are presenting a toolbox that puts equal access at the centre of our European Health Union.

These proposals should not be seen in isolation, but as a toolbox that will bring about change in many different areas. Taken together, these actions will make the difference.

With our proposals we are aiming to have:

• Equal and timely access for patients to more and better medicines.
• Strong incentives for innovation and less burden on companies and regulators.
• More affordable medicines and more sustainable healthcare costs for Member States and patients.
• Less shortages of medicines and increased security of supply.

Today, whilst patients in Western and bigger Member States have access to 90% of newly approved medicines, in Eastern and smaller Member States, this number is as low as 10%.

EU citizens also have to wait anywhere from 4 months to more than 2 years for these medicines.

This is truly unacceptable.

The EU has ensured equal and simultaneous deliveries of lifesaving COVID vaccines to all 27 Member States.  

Today, we act to address inequalities in access to medicines more broadly, by rewarding via a range of incentives companies that go the extra mile.

These incentives will provide access to new medicines to around 70 million more citizens compared to today.

We will provide 8 years of guaranteed regulatory protection.

In addition, 2 extra years will be given to medicines launched in all Member States, 1 more year for additional therapeutic indications,  6 extra months for unmet medical needs and 6 months for comparative trials.

We will continue to have one of the most competitive and industry-friendly incentive systems in the world.

Companies can still reach the 11 years of protection they have today, and go even higher to 12 if they fulfil all conditions.

However, it will be a system that rewards innovation while improving access.

Innovation has to reach patients to have value for society.

I spoke before of a toolbox of proposals. It is important that these proposals are seen as complementing each other.

Beyond incentives, we are aiming to build a, simpler, faster regulatory ecosystem.

We will reduce authorisation procedures and timelines to ensure that medicines reach patients faster.

This will mean, without compromising safety, we will have reduced assessment times for medicines from around 400 days today to 180 with the reform.

Overall, this administrative burden could save up to €300 million annually in costs for companies and authorities.

All of these actions are important for industry, as we expect this to generate large savings over the next 15 years.

Affordability of medicines is another critical issue for patients and healthcare systems.

National budgets today are struggling to keep up with the cost of medicines.

We propose that generics and biosimilars, which are cheaper can enter the market on day 1 after protections expire.

We will also help Member States to be in a stronger negotiating position when discussing market entry with companies.

We will be increasing transparency on public funding for medicine development and better availability of comparative clinical data.

Together with the new incentives, this will save billions for healthcare systems and patients.

Availability of innovative and essential medicines is another key pillar of the reform.

This is very closely linked to medicine shortages and security of supply. Over the last decade, reports of medicines shortages have skyrocketed..

To counter this, companies will have to notify potential shortages earlier and have shortages prevention plans for their medicines.

We will also establish for the first time an EU list of critical medicines to monitor the availability of essential medicines and address supply chain vulnerabilities. HERA will play an important part in this.

Antimicrobial resistance, the “silent pandemic”, is another headline issue in our proposals. AMR is already taking 35,000 lives in the EU every year, and it costs our healthcare systems around €1.5 billion annually.

Today, we propose a new toolkit to address the AMR market failure.

This includes transferrable exclusivity vouchers for new antimicrobials, prudent-use measures and measurable targets to address overuse and stimulate innovation in new products.

Finally, the environmental dimension goes hand in hand with our citizens' health.

This is why we will strengthen our environmental requirements.

Ladies and gentlemen,

I will end as I began, by saying that this is a historic day for citizens, patients, and industry. We have here a reform after two decades to address and ensure access availability and affordability of medicines, while leaving no one behind.

And we have shown that we are stronger when we work together. We have shown that with collaboration and solidarity, we can bring results.

A strong European Health Union has a duty to act and deliver for our citizens.

Thank you.

*Updated 26/04/23