EU Legislative Reform
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On 26 April 2023, the European Commission adopted a proposal for a new Directive and a new Regulation, which will revise and replace the existing general pharmaceutical legislation and represent the largest reform for the rules governing medicines in the EU in almost 20 years. The next step involves the legislation reform package entering the legislative process at the European Parliament and the Council of the EU for debate and potential amendments. The final version of the package will need to be approved by the EU member states by a qualified majority vote.
EC Defends Data Protection Cut As EU ‘Pharma Package’ Nears Crucial Milestone
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
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.”
Cut In Data Protection Looms Large As EU Vote On Pharma Revision Nears
All eyes will be on the European Parliament’s ENVI committee later this month when it votes on the planned overhaul of the EU pharmaceutical legislative framework, including a highly controversial proposal to cut regulatory data protection for originator drugs.
European Commission Explains Impact Of EU Pharma Review On SMEs & Non-Profit Entities
The EU pharmaceutical revision package includes proposals that will have a direct impact on smaller firms, including a targeted regulatory and procedural support scheme.
Controversial EU Study On Pharma Innovation & Access Sees The Light Of Day
Members of the European Parliament committee charged with leading the negotiations on the review of the EU pharmaceutical legislation have been presented with a study backing cuts in data protection and wider joint procurement of medicines outside emergency situations.
Premature Filings Add To EU Regulatory Resource Challenge
The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications.
European Opportunities Loom For Value Added Medicines
Upcoming opportunities facilitated by the EU’s pharma legislation review were highlighted at Medicines for Europe’s fifth annual value added medicines conference, held in Brussels this month. However, enthusiasm was tempered with acknowledgements that the European sector current lags behind the US and needs further reform to attract investment.
Moderna Wants Changes To EU Proposals On Gene Therapy, Platform Technologies
The revamped EU pharma legislation must be able to deal with current and future innovations in areas such as platform technologies and genome editing, the US biotech firm says.
EU Legislative Reform: Pan-EU Launch Requirement Will ‘Take Two To Tango’
Companies are already used to uncertainty and will be able to adapt to the new product launch requirement in the EU’s legislative overhaul for the pharmaceutical sector, according to a commission representative.
US IPO Lays Into EU Plans To Cut Data Protection & Extend ‘Bolar’ Exemption
The IPO says some provisions in the EU pharma revision could contravene the TRIPS agreement, including plans to suspend regulatory data protection on products subject to a compulsory licence in times of health emergencies.
EFPIA: One Fifth Of Future Products ‘Unviable’ Under EU’s Plans To Modulate Regulatory Data Protection
The European Commission’s pharmaceutical legislation overhaul could result in a loss of 50 expected new products by 2035 and an annual fall in R&D spending of €2bn, the European pharma industry federation EFPIA claims.
EMA Chief Backs Restructuring Plan & ‘Regulatory Sandbox’ Proposal
Emer Cooke told a European Parliament committee that she hoped the European Medicines Agency would be given sufficient resources to carry out its new tasks under the revision of the EU pharmaceutical legislation.
Former VA Secretary, Biogen Exec On IRA And Politics, Price Clamps In Europe
A former secretary of the US Department of Veterans Affairs and a senior Biogen executive deliberated at a recent summit the unintended consequences of the US Inflation Reduction Act and politics around the legislation. They likened the first prescription drugs subject to price controls under the IRA to a “TV commercial list.”
Off-Patent Industry Proposes Extensions To EU Market Protection Rather Than Data Exclusivity
Medicines for Europe proposed several alterations to the European Commission’s planned changes to exclusivity incentives at its recent Regulatory and Pharmacovigilance Conference in Brussels, most notably suggesting that the proposed extensions to data exclusivity should instead apply to market exclusivity.
EU Rapporteur Slams Commission’s ‘Regulatory Sandbox’ & Antimicrobial ‘Voucher’ Proposals
Tiemo Wölken has proposed a public “European Medicines Facility” to elaborate R&D projects focusing on the development of priority antimicrobials and medicines for other unmet medical needs. He also disagrees with his fellow rapporteur’s support for an increase in the regulatory data protection period.
EU To Propose New Actions & Publish ‘Critical Medicines List’ To Strengthen Supply Chains
The EU health commissioner says that a package of short- and medium-term measures is needed to improve the security of supply and make medicine supply chains more resilient.
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