EU Pharma Legislation Reform

Wider Gene Therapy Definition In EU Will Require ‘Myth-Busting’ From EMA

 

The European Commission’s proposed pharma legislation overhaul could expand the definition of a gene therapy medicinal product, posing challenges both from a regulatory and public perception perspective.

EURORDIS Chief Backs ‘Collective Bargaining’ For Orphan Drugs Under EU Pharma Reform

 

The European Parliament proposed introducing joint procurement for orphan medicinal products in the EU pharma legislation overhaul – a move that the new CEO of EURORDIS says could lead to “faster and more equitable” access to drugs for rare diseases.

Future EU Health Commissioner Pledges Action On Pharma Reform, Shortages & Biotech

 
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Olivér Várhelyi’s plans for his new role boil down to continuing legislative projects and other initiatives that have already been set in motion.

EU Pharma Reform: What You Need to Know Now

 

As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.


EUCOPE: EU Pharma Reform Positive, But Industry Needs Clearer Definitions

 

High unmet needs is among the terms and definitions in the EU’s regulatory reform package that are “very subjective” and require more clarity to improve predictability for the pharmaceutical industry, EUCOPE’s secretary general, Alexander Natz, tells the Pink Sheet.

New EU Health Commissioner Will Have Full Pharma In-Tray

 
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The new European Commissioners will face a grilling from members of the European Parliament before they can be confirmed in their posts.

Environmental Risk Assessments To Loom Larger In EU Drug Reviews

 
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In this final article in a series on the ongoing amendments to the pharmaceutical reform package, the Pink Sheet looks at the tougher environmental risk assessment requirements that pharma companies are likely to face in the not-too-distant future.

EU Pharma Reform, SPCs, Compulsory Licensing Among Parliament’s ‘Unfinished Business’

 
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A number of legislative proposals will be coming under scrutiny at the newly constituted European Parliament in the coming months, including the pharma reform package and draft legislation on EU-level compulsory licensing and “unitary” supplementary protection certificates.


How EU Pharma Reform Changes Could Affect The ATMP ‘Hospital Exemption’

 
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One of the key challenges facing the Hungarian presidency of the Council of the EU in the second half of 2024 will be the proposals for an overhaul of the EU pharmaceutical legislation, which were amended by the European parliament in April. In the latest in a series of articles on progress with the reform, the Pink Sheet examines the issues surrounding the hospital exemption for advanced therapies.

Latest EU Pharma Reform Proposals Risk Stifling Innovation And Competitiveness

 
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EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring’s Lutz Bonacker.

More Cracks Appear In EU Pharma Reform As Ministers Debate RDP Proposals

 
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As well as differences of opinion over the “incentives” part of the EU legislative overhaul, the latest meeting of health ministers revealed uncertainties about whether to use incentives or obligations to improve medicines access and how to define “unmet medical needs."

EU Pharma Reform Talks Heat Up As Health Ministers Prepare To Challenge Proposals

 
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In a sign of difficult negotiations to come on the European Commission’s pharma reform package, the presidency of the Council of the EU has drawn up its own set of proposals on regulatory data protection and market exclusivity that differ in several respects from those of the commission and the European Parliament.


European Parliament Has Missed The Chance to Boost Orphan Drug Development

The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, say Baker McKenzie lawyers Els Janssens, Julia Gillert, Magda Tovar and Olha Sviatenka.

EU Pharma Reform Amendments: More Shortage Reporting Obligations For Companies & Regulators

 
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In the third of a series of articles on the European Parliament’s changes to the planned reform of EU pharmaceutical legislation, the Pink Sheet looks at how the amended proposals on notifying drug shortages could impact companies, regulators and wholesale distributors.

EU Parliament Waters Down Planned Antimicrobial Voucher Scheme

 
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In the second in a series of articles on amendments to the EU pharmaceutical reform proposals, the Pink Sheet looks at changes made by the European Parliament to the “transferable exclusivity voucher” and its ideas for a milestone payment and subscription-model scheme. 

Changes To EU Pharma Reform: More Questions Than Answers?

 
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In the first of a series of articles on the future direction of the EU pharmaceutical reform proposals, the Pink Sheet looks at the new uncertainties created for the drug industry after the European Parliament voted through a series of amendments in the area of regulatory data protection.


EU Parliament Adopts Updated Pharma Package Despite Some Political Disagreement

 

The European Commission’s proposed revision to the EU pharmaceutical legislation has taken another step forward after the European Parliament adopted its position on the draft text, which includes a seven and a half year baseline regulatory data protection period.

EU Pharma Reform Passes Major Hurdle, With Big Changes To Data Protection Proposals

 
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Members of the European Parliament have significantly watered down plans for a cut to regulatory data protection, but industry says the net effect of the proposals will still be to make Europe “less competitive and less attractive” to investment in innovation.

EC Defends Data Protection Cut As EU ‘Pharma Package’ Nears Crucial Milestone

 
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Proposals to overhaul the general pharmaceutical legislation will ensure that the EU “continues to have one of the most generous systems of incentives in the world,” the European Commission says.

As Vote Nears, EFPIA Chief Sounds The Alarm Over Data Protection Cuts

 
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Nathalie Moll says that the European Commission’s estimates of the costs to EU member states of regulatory data protection are “incorrect and over-estimated.”