The Oslo Medicines Initiative: Keeping The Equitable Access Dream Alive
One year on from its creation in 2020, a European project with a “new vision for collaboration between the public and private sectors” has set its sights on getting stakeholders across the medicines sector to make firm promises on ensuring equitable patient access to costly new drugs.
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Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.
The EMA is going all out to maximize coverage of the EU population with both vaccines and treatments for COVID-19.
Drug sponsors seeking centralized EU marketing authorizations now have the opportunity to have simpler pre-submission “interactions” with the European Medicines Agency six months before the submission to help avoid complications down the line. Full meetings may still be appropriate for complex issues such as requests for accelerated assessment or conditional approval.