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Keynote Video Message by Commissioner Kyriakides to the Cell and Gene Meeting on the Mediterranean- Alliance for Regenerative Medicine

Keynote Video Message given yesterday by Commissioner Kyriakides to the Cell and Gene Meeting on the Mediterranean- Alliance for Regenerative Medicine.

"Check against delivery"

Ladies and Gentlemen,

The COVID-19 pandemic and the Russian war of aggression against Ukraine have highlighted the need for European cooperation to protect our citizens' health.

That's why Europe's Beating Cancer Plan, the Pharmaceutical Strategy – and the role that advanced therapy medicinal products, or ATMPs, could play in both – are so important.

It's worth remembering that the EU was the first to approve a gene therapy medicine. It was also the first to specifically regulate these products, via the ATMPRegulation.

The EU now leads the world as regards approved therapies in this sector. However, competition – notably from the US and China – is strong.

Our Pharmaceutical Strategy with the reform of the pharmaceutical legislation gives us a chance to improve our system and adapt it to the latest scientific developments.

The Strategy also recognises that for innovation to take root, Europe's companies need a fertile environment offering regulatory flexibility, legal certainty, a conducive intellectual property regime and the necessary infrastructure.

We have no plans to overhaul the ATMPRegulation. However, we will look at ATMP-specific characteristics when reviewing the pharmaceutical legislation.

ATMPs are a challenging concept, for science and manufacturing alike. We are aware of the specific challenges for developers, such as the thin line between the tissue and cell legislation and the legislation on ATMPs.

We aim to strike the right balance between incentivising innovation and making sure that it results in cost-effective, affordable therapies for patients across the EU. We will also assess the requirements for authorising medicines containing or consisting of genetically modified organisms. These requirements should be able to cope with the specificities of medicines and the conduct of clinical trials with them in the EU.

Turning now to cancer, the recent achievements in regenerative medicine are also speeding up and improving cancer treatment.

Major initiatives stemming Europe's Beating Cancer Plan will benefit from these developments. They include our Inter-specialty cancer training programme and our Comprehensive Cancer Infrastructures, linked by a robust and efficient network across the EU, which will help develop a high-quality health workforce offering high-quality cancer care.

The Cancer Diagnostic and Treatment for All Initiative, supporting efficient personalised cancer diagnosis and treatment, will help scale up available results in the genetic profiling of patients and tumour cells.

Meanwhile, with the Mission on Cancer, we will continue harnessing the potential of research, innovation, data, digitalisation and new technologies for cancer management.

Our aim is clear: to boost high-standard, quality-assured diagnosis and treatment across the EU; improve outcomes as a result; and offer all cancer patients, their families, friends, and carers hope for a brighter future.

Ladies and Gentlemen,

In these dark times, let's set our sights on that brighter future for European patients. With your help, we can ensure that advanced therapy medicinal products play their part in building it.

Thank you.

Click here for the full press release

 

Original article link: https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_22_2527

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