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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.

Austria & Germany Call For ‘Competitiveness Check’ On EU Pharma Revision Package

The two countries want the European Commission’s proposals to be more closely examined for their possible negative effect on pharmaceutical investment decisions. The industry federation EFPIA says it is surprised more EU member states aren’t taking the same stance.

Europe Regulation

EU Orphan Drug Law Reform Will See Innovation Drop By 12%, Industry Warns

The European Commission’s proposals to overhaul the EU pharma legislation, which will see some orphan drug incentives cut, would cause a “significant dip in innovation,” according to number crunching from pharma industry association EFPIA.

EU Legislative Reform BioPharmaceutical

Dissent In Parliament As Commission Claims EU Pharma Revision Will Improve Competitiveness and Access

Proposals on regulatory data protection and transferable exclusivity vouchers to encourage antimicrobial R&D have received mixed reactions from the parliament’s rapporteurs for the draft legislation.

Europe EU Legislative Reform

Lawmakers Finally Kick Off Debate On EU Pharma Overhaul

The late delivery of the “pharmaceutical package” leaves little time for the legislative process to take shape before European Parliament elections are held in June next year.

Europe Legislation

EU Pharmaceutical Reform: A Delicate Negotiation

The European Commission may well be flexible over its proposals on data protection periods, but it is unlikely to give ground on plans to restructure the European Medicines Agency and to introduce a new temporary emergency marketing authorization, says lawyer Vincenzo Salvatore.

Europe EU Legislative Reform

Will Shorter EU Regulatory Timelines Mean Unfeasible Joint Clinical Assessment Timelines?

Faster regulatory reviews proposed in the European Commission’s pharmaceutical reform package could impact the EU-level joint clinical assessments that go live from 2025.

Europe Health Technology Assessment

EU Country Coalition Wants New Unmet Needs System To Incentivize The Right Innovation

The European Commission’s proposals for legislative reform in the pharmaceutical sector are welcome but must go further to address patient and societal needs, says a coalition of five EU countries dedicated to improving access to medicines.

Europe Belgium

EU Pharma Revision Proposals Still Awaiting Start Of Legislative Debate

The texts of the proposals cannot be formally presented to the European Parliament until they have been translated into all of the EU’s official languages.

Europe Legislation

EC Says ‘Bolar Exemption’ Should Cover Pricing, Reimbursement & HTA Processes

Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.

Europe Intellectual Property

German HTA Body Calls For EU Legislative Reforms To Foster Better R&D Environment

Proposed revisions to the EU pharmaceutical legislation should do more to deliver a better data and research infrastructure to help propel European drug development and better clinical research, says IQWiG, Germany’s health technology assessment institute.

Europe Germany

German HTA Body: EU Legislative Reforms Must Do More To Incentivize Use Of Comparative Data

IQWiG, Germany’s health technology assessment (HTA) body, is calling for EU legislative reforms to do more to promote better evidence that addresses the questions health systems and HTAs have about the added benefits of new medicines.

Europe Germany

Pharma Revision Will Hasten EU’s R&D Decline, Says EFPIA’s New Presidency Team

The European pharma industry group fears planned cuts in regulatory data protection and orphan drug exclusivity periods will hit innovation but says it is ready to work with legislators to close what it sees as an R&D gap between the EU on the one hand and the US and Asia on the other.

Europe Clinical Trials

EU Regulatory Reforms Mean Many Orphan Drug Producers Won’t Benefit From Incentives

The EU’s regulatory reform package if unchanged could make orphan drug development less attractive, warn industry representatives.

Europe Gene Therapy

What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?

Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”

Europe Regulation

EU Pharma Revision: Legislators Prepare For Long-Haul Debate

The European Parliament and the Council of the EU are preparing their positions on the planned overhaul of the EU medicines legislation ahead of discussions that are expected to take two to three years.

Europe Legislation

EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed

As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.

Europe Legislation