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EU Legislative Reform

Set Alert for EU Legislative Reform

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.

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.

Europe Rare Diseases

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

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.

Europe EU Legislative Reform

EU Parliament Waters Down Planned Antimicrobial Voucher Scheme

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. 

Europe EU Legislative Reform

Changes To EU Pharma Reform: More Questions Than Answers?

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.

Europe Regulation

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.

Europe EU

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

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.

Intellectual Property Legislation

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.

Europe Intellectual Property

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.”

Europe EU Legislative Reform

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.

Europe BioPharmaceutical

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.

Regulation Europe

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.

Europe EU Legislative Reform

Premature Filings Add To EU Regulatory Resource Challenge

The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications.

Europe EU Legislative Reform

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.

Value-Added Medicines Europe

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.

Vaccines Regulation

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.

Europe EU Legislative Reform

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.

Europe EU Legislative Reform