Latest From Ian Schofield
EU Review Proposals ‘Fail To Analyze’ Impact Of Reduced Exclusivity Periods
Plans for the overhaul of the EU’s medicines framework are missing key analysis on the effect of reductions in data and market protection on the pharmaceutical industry, despite an abundance of studies on how such incentives influence company decisions on whether to develop new products, say lawyers from Sidley.
EU Commission Again Delays Pharma Revision Proposals, Citing ‘Busy Agenda’
Two members of the European Parliament claim the latest delay to publication of the long-awaited legislative revision is the result of pressure from the pharmaceutical industry.
Australia To Seek Stakeholder Input On Terms Of HTA Review
The review of the health technology assessment system will look at the use of adaptable and flexible approaches to managing future health care technologies, early and equitable access for patients, as well as the possibility of international work-sharing initiatives and comparisons of purchasing practices.
Rare Disease Body Wants EU Legislative Overhaul To Address Orphan Definitions & Incentives
Eurordis has welcomed some parts of the leaked proposals for overhauling the EU medicines legislation, but it has a number of concerns, including the future role of patient representatives if the European Medicines Agency’s committee structure is slimmed down as planned.
£10m Cash Boost For UK Regulator To Speed Up New Drug Approvals
An injection of new money should provide something of a shot in the arm for the UK’s drugs regulator as it deals with post-Brexit realities.
EU Legislative Review Needs To ‘Fix The Ecosystem’ For ATMPs
Developers of advanced therapies say the European Commission must do more to address the “hospital exemption” and the regulation of advanced therapy medicinal products as genetically modified organisms.