EU’s Overhaul Of Pharma Legislation Amended With Uneasy IP Compromises
On March 19, 2024, a set of 100 “Compromise Amendments” to the European Commission’s far-reaching overhaul of the EU’s rules for medicines, the Pharmaceutical Review, was adopted by the European Parliament’s ENVI Committee. Maarten Meulenbelt, Chris Boyle and Zina Chatzidimitriadou explain the main changes, associated risks, and next steps.
Forthcoming HHS Regulatory Actions and Opportunities Relevant for Pharmaceutical Manufacturers for the Rest of this Year and Next
Pharmaceutical manufacturers need to note some key forthcoming regulatory actions and opportunities which the Department of Health and Human Services (“HHS”) has recently published. Meena Datta and Catherine Starks give a bird’s eye view of the key points, the key dates and the stage which each new rule has reached.
The EU’s Pharmaceutical Review Needs To Remain Grounded In Economic Reality
The Review proposes to reduce IP rights across the board, with incentives to prolong them. Can any of these incentives work? Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou discuss how the real-world effects of the Review have not been assessed, and where there is room for improvement in its critical provisions.
Missing Numbers: Seeking to Substantiate The Leaked EU Pharmaceutical Review
Pharma companies are currently assessing how the Pharma Review will affect their portfolios. Maarten Meulenbelt and Maria Koutsoupia discuss the need for analysis from the EU to support the Review’s claims, for example on the allegedly ‘invisible’ effect of losing €640 million in annual orphan drug revenues.
Six Surprises In The Leaked European Pharmaceutical Review
On 31 January 2023, the internally circulated version of the European Commission’s far-reaching overhaul of the EU’s pharma legislation was leaked, and published by Politico. Here, initial impressions of the biggest surprises in the document are given by Maarten Meulenbelt, Chris Boyle, and Zina Chatzidimitriadou.
U.S. Looks to Introduce European-Style Drug Price Controls
Meena Datta examines proposed new legislation that would authorise the Health and Human Services Secretary to negotiate prices directly with prescription drug manufacturers.
Moves to Lower Drug Prices in Biden’s Executive Order on Competitiveness
This month’s presidential Executive Order on economic competitiveness in the U.S. includes a number of initiatives relating to drug pricing. There are calls to combat “excessive pricing,” to reduce the cost of drugs to the Federal government, to address “price gouging” and to promote low-cost generics and biosimilars.