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Solène Jouan: Enrico Letta’s report and rare diseases in the single market 

April 2024

On 19 April, former Italian Prime Minister Enrico Letta released a report entitled ‘Much More Than a Market‘, as requested by the June European Council in 2023. This report stressed the key actions needed to ensure the modernisation of the European Single Market, and addressing the contemporary challenges and opportunities faced by the European Union (EU).  

The EU Single Market refers to an area within the EU where goods, services, capital, and people can move freely without barriers (also known as the “four fundamental freedoms”.). This EU Single Market was conceived and presented in 1985 by the pro-European and former European Commission (EC) President Jacques Delors, to strengthen European integration by eliminating trade barriers and ensuring fair competition and solidarity among the Member States. Today it is still considered as one of the major successes of the EU.  

However, since its establishment, the EU and the rest of the world have fundamentally changed. As a result of this, Enrico Letta’s report argues that the EU should use the upcoming legislative mandate from 2024 to 2029 to further integrate national markets across a range of sectors, including healthcare, which have previously been considered to be national priorities. This would therefore create a 5th freedom to enhance research, innovation and education.  

But what does this mean exactly? Let’s take a closer look at this report, and what it could mean for rare diseases.  

Leveraging the Single Market to strengthen health resilience – a Big YES

Enrico Letta paints a critical picture of health in the European Union, and the rare disease community can only agree with him on the current situation: there is no real Single Market for pharmaceuticals, and disparities between Member States lead to inequalities in primary care, access to diagnosis, and treatments. Finally, the EU is too dependent on third countries for innovation, raw materials, certain types of medicines, vaccines, antibiotics, and healthcare professionals.  

Have we learnt the lessons of COVID-19? Not yet, according to Letta, who urges the EU should take urgent actions to prepare for future pandemics and reduce health inequalities in Europe by adopting a more unified approach to health. And indeed, this is the solution. 

What are his recommendations? What the rare disease community has long been calling for: more EU integration for health

Among his recommendations are encouraging joint procurements for orphan medicines to enable large-scale negotiation, effective-competitive outcomes and access to innovative and orphan drugs for ALL member states and supporting the PRIME scheme of the European Medicines Agency (EMA). 

Additionally, Letta calls for the streamlining of clinical trial processes to make the EU more attractive for manufacturers, while creating a European Guarantee Fund specifically designed to help smaller Member States overcome limited bargaining power due to smaller procurement volumes.   

These are some of the measures that Enrico Letta wants to see implemented over the coming years, and they are aligned with the same positions and calls for action which EURORDIS have published over the years. 

So, what’s next?

Will the EU policymakers of the 27 Member States support this report and make sure of its success during the next mandate of 2024-2029? We hope so, as the rare disease community deserves better NOW.  

While we wait for another report on the future of EU competitiveness, (drafted by another former Italian Prime Minister, the famous Mario Draghi, and this time requested by the President of the European Commission Ursula von der Leyen), we would like to quote Letta during his press conference:  

We don’t want this report put in a drawer somewhere gathering dust”

Oh no, we don’t.   

By Solène Jouan, EU Public Affairs Manager, EURORDIS-Rare Disease Europe

Disclaimer: As a Staff Blog, the opinions – including possible policy recommendations – expressed in this article are those of the author and do not necessarily represent the views or opinions of EURORDIS. The publication of this article on the EURORDIS website does not equate to endorsement.