comprehensive -WSS

comprehensive

author：comprehensive 2025-10-01 10:56:48 - browse：3

A view of different flags of the European Union Members. -- first opinion coverage from STAT — Ronald Wittek, Pool Photo via AP

Today, the criteria used to assess the clinical value of new pharmaceuticals and medical devices varies widely across Europe, making it more challenging for biopharma companies to efficiently launch products in multiple countries and contributing to the disparities in access across the continent.

But change is on the horizon: In less than 15 months, the European Union will establish and begin to implement a standardized, pan-EU framework, which all 27 of member states will be required to use to assess the clinical evidence of newly submitted products or devices. A key pillar of the EU’s Regulation on Health Technology Assessment (HTA), the Joint Clinical Assessment (JCA) aims to establish a single, transparent process to reduce redundant practices and bring life science innovation faster to patients in Europe — no matter where they live.

In a longstanding problem in Europe, access to — and the availability of — medication varies across the member states. For example, in Germany, 87% of products approved by the European Medicines Agency (EMA) have full availability (the product gained access on the public reimbursement list without any restrictions to the patient population). In Poland, that figure drops to 8%, according to a report published by the European Federation of Pharmaceutical Industries. Meanwhile, there is a tremendous difference in the gap between an oncology therapy receiving marketing authorization and a formal positive reimbursement decision, ranging from an average of 86 days in Denmark to 981 days in Latvia.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Heart attack and stroke risk calculators need revising
Next article： JPM 2024 Day 3: Biotech Updates from Verve, Roivant, etc

hotspot

WSS

GSK Flovent asthma inhalers replaced by authorized generics

Feng Zhang CRISPR delivery startup lays off quarter of staff

AI gets buy

Global cancer cases to surge 77% by 2050, WHO report says

Unique patient identifier: Experts argue the benefits, pitfalls

Novo Holdings to buy drug manufacturer Catalent in $16.5B deal

hotspot

comprehensive

knowledge

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

Novo Holdings to buy drug manufacturer Catalent in $16.5B deal

Continuity nursing helped my family in our darkest PICU moments

3 medical device trends to watch in 2024

Drug repurposing or repositioning? The language matters

J&J to buy cancer drug developer Ambrx Biopharma

Medical records are filled with copy

Problems with a popular proposal to regulate AI in health care

Tori Bowie and the unacceptable rates of Black maternal death

UCB departs biotech trade group BIO

focus

Readout Newsletter: Amgen, Regeneron, BGI Group and more

New weight loss drugs work. But how can they best be used?

Videos point to link between seizures and unexplained toddler deaths

Padmanee Sharma of MD Anderson at center of lawsuit over credit

A single drug, study failures leave Anavex with nothing but cash

Why Novartis is going to walk from its acquisition of MorphoSys

focus

hotspot

hotspot

hotspot