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EFPIA Newsletter 26 October 2023

Agile regulatory rules vital to foster future innovation

It is a challenge as old as lawmaking: how do legislators write rules today that can keep pace with the innovations of tomorrow?

The problem is particularly acute in fast-moving sectors where scientific advances arrive at breakneck speed. Artificial intelligence (AI) and big data, wearables and genomics — these are among the most disruptive and unpredictable fields in modern science. And they are among several cutting-edge trends that converge in medical research.

What would be the impact of introducing a narrow definition of unmet medical need (UMN)?

Limiting the definition of UMN to focus only on life-threatening or severely debilitating diseases risks deprioritising conditions that fit neither of these criteria yet have important negative consequences on patients, carers and society. Under the Commission’s proposal, only 18% of the 111 non-orphan medicines authorised between 2019 and 2022 are very likely to fulfil the proposed UMN criteria, having a heavy impact on research in certain disease areas such as Cardiovascular disease (CVD), diabetes, migraine, HIV, oncology. Read more

26 October 2023 What is innovation in medicines?

How we define and incentivise medical innovation will shape future waves of medical progress. We need a system where...

News

26 October 2023 EFPIA statement on the European Commission's Communication on addressing medicine shortages...

Solutions to address shortages need to be fit for purpose targeting the specific root causes

20 October 2023 Product Liability Directive: European industry calls for a major rethink

The new proposal may open the door to a litigation culture in Europe.

EFPIA's sessions at the POLITICO Health Care Summit

Pharma strategy: How to best improve access to innovative medicines?

Interview with Stefan Oelrich, Member of the Board of Management, Bayer

Events

07 NOV 2023

FT Global Pharma and Biotech Summit London and online

Day 1 Digital | Day 2 & 3 Digital & In-Person | Hilton London Bankside | #FTPharma

Learn more →

07 NOV 2023

High-Level Conference on the Value and Role of Incentives in Life Science Brussels, Belgium

Under the auspices of the Ministry of Health of the Czech Republic

Learn more →

What we are reading

Just published! Draft topics for IHI calls 6 and 7 25 October 2023 (IHI)

Value-Based Supply: How to improve health system sustainability 25 October 2023 (EAVH)

About the EFPIA newsletter

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 37 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.

Tel: +32 (0)2 626 25 55
Communications@efpia.eu

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