National industries will be placed between a rock and a hard place by the incoming, revised EU Urban Wastewater Treatment Directive (UWWTD), German pharmaceutical industry association Pharma Deutschland has warned.
German Industry Concerned It Will Be Hung Out To Dry By EU Wastewater Directive
The revised EU Urban Wastewater Treatment Directive, which obliges pharmaceutical and cosmetic industries to contribute at least 80% towards the costs of removing micropollutants from wastewater through quaternary treatments, will place an additional burden of around €2bn per year on German manufacturers, says Pharma Deutschland.
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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.
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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.
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An ordinance came into effect on 8 March to ensure that joint clinical assessments can be incorporated into the German pricing and reimbursement system.
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Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
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Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.