The European Commission’s proposals are intended to make the pharmaceutical market more competitive while improving accessibility, availability and affordability.
The “one-rule-fits-all” approach to regulatory protection will be swapped for a more flexible framework that rewards companies for helping to achieve public health goals.
Planned changes to these rules have been criticized by both the innovative and the off-patent pharmaceutical industries, which are likely to engage in strong lobbying during the legislative process.
The commission may be flexible on the regulatory protection periods but not on the planned restructuring of the European Medicines Agency or the proposed Temporary Emergency Marketing Authorization.

EU Pharmaceutical Reform: A Delicate Negotiation

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