欧盟药品立法改革

Introduction While the outcome of the US presidential election is drawing most of ’s political attention these days,other political activity in Europe merits serious attention as well. Pharma reform legislation is movingforward in the EU that could significantly change everything from how firms manufacturer theirproducts to how much market exclusivity they get for them. These Pink Sheet stories break downthe key issues, explaining what is already basically set and what remains undecided in this majorinitiative. EU Pharma Reform: What YouNeed to Know Now Anabel Costa-Ferreira08 Oct 2024 As the reform of the EU pharmaceutical legislation progressesthrough the legislative process, the Pinks Sheet offers aninfographic highlighting some of the key changes beingproposed that will reshape the way drug companies run theirbusiness. Executive Summary EU Pharma Reform: WhatYou Need to Know Now EU Pharma Reform: WhatYou Need to Know Now EU Pharma Reform: WhatYou Need to Know Now EU Pharma Reform: WhatYou Need to Know Now Environmental Risk AssessmentsTo Loom Larger In EU DrugReviews Ian Schofield23 Jul 2024 In this final article in a series on the ongoing amendments tothe pharmaceutical reform package, the Pink Sheet looks atthe tougher environmental risk assessment requirements thatpharma companies are likely to face in the not-too-distantfuture. Executive Summary Among the many proposed changes to the EUpharma legislation to be negotiated by the EUinstitutions in the coming months are muchtougher requirements for environmental riskassessments (ERAs). Some of the proposals and the newrequirements adopted by the parliament havebeen welcomed by the pharmaceutical industry,while others have come under fire for being toostringent and risking unforeseen consequences. The new ERA framework was proposed by theEuropean Commission in April 2023 as part of itspharmaceutical reform package, with the aimof incentivizing companies to submit properlysubstantiated ERAs. A year later the EuropeanParliament adopted a number of amendmentson the ERA proposals that imposed even tighterconditions on companies. ERAs have been astandard requirement for new medicines since2006. Lutz Bonacker of CSL Behring told the PinkSheet that while the ERA had value as a way ofreducing the industry’s environmental footprint,“we strongly believe that the enforcement andimplications of ERAs must be proportionateto its purpose and avoid unintended anddisproportionate negative impacts on patientswho could see access to these treatmentslimited on the grounds of environmentalconcerns.” Environmental Risk Assessments ToLoom Larger In EU Drug Reviews Public Participation in Decision-Making andAccess to Justice in Environmental Matters,“the public has a right to obtain information onenvironmental matters, including on the ERA ofa pharmaceutical product.” Key Takeaways •The European Parliament’s amendmentsto the “pharmaceutical package”include stricter obligations on pharmafirms in terms of environmental riskassessments.•Key changes include widening the scopeof the ERA to include the manufacturingstage, and a requirement to publish theentire ERA rather than just a summary.•The parliament said that any decisionto revoke or refuse a marketingauthorization on the grounds of aninadequate ERA must take account ofthe clinical benefits of the medicine, theneeds of patients and any alternativetreatments available.•One industry executive believes that“by no means” should marketingauthorizations be revoked or refused onthe basis of an ERA.•The pharma package is now awaitingthe formal position of the Council of EUbefore negotiations begin between itand the parliament. It also extended the scope of the ERA in termsof the product lifecycle. While the commissionsaid that risk mitigation measures – those toavoid or limit emissions to the air, water or soil– should apply during the use and disposal ofa medicine, the parliament said they shouldextend to the whole of the medicine’s lifecycle,including the manufacturing stages. The ERA should also have to state whattechniques the company proposed to useto reduce discharges of medicines into theenvironment, particularly in the form of effluentfrom manufacturing. Connected to this, the parliament said thatcompliance with relevant EU and member statelegislation in terms of environmental protectionat the manufacturing stage “should generally beconsidered as a relevant risk mitigation measurein terms of production,” and that this shouldalso apply to production in third countries witha level of environmental protection equivalent tothat of the EU. Full ERA To Be Published, And Scope ExtendedThe pharma package comprises a draft The commission’s original draft directive statedthat if the applicant fails to submit a completeor sufficiently substantiated environmentalrisk assessment “or they do not propose riskmitigation measures to sufficiently addressthe risks identified in the environmental riskassessment, the mar