German Ordinance To Implement HTA Reg Leaves Room For Doubt

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

Germany publishes ordinance on implementing the HTA Regulation. (Shutterstock)

The German legislator’s approach to implementing the EU Health Technology Assessment (HTA) Regulation and incorporating EU joint clinical assessment (JCA) reports into the national pricing and reimbursement system is “hesitant and vague,” according to Germany-based lawyers from the law firm Hogan Lovells.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Germany

German Ordinance To Implement HTA Reg Leaves Room For Doubt

 

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

German Agency’s 2025 Plan Highlights EU HTA Reg, Long Covid And Smoking Cessation Drugs

 

An ordinance came into effect on 8 March to ensure that joint clinical assessments can be incorporated into the German pricing and reimbursement system.

Germany: Standardized Clauses In Clinical Trial Agreements Bring Opportunities But Also Tougher Negotiations

 

Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.

More from Market Access

Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

 
• By 

Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.

UK Health Secretary Admits VPAG ‘More Expensive’ Than Expected & Needs To Be ‘Resolved’

 

The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By 

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?