For decades, American taxpayers and consumers have carried the financial weight of the global pharmaceutical industry. U.S. companies invest billions into research and development, shoulder the risk of failed trials, and bring life-saving drugs to market. Meanwhile, foreign governments enjoy the benefits at a fraction of the cost.
Now, European Union regulators appear ready to take that imbalance even further.
Behind closed doors in Brussels, EU officials are advancing regulatory changes that critics say would weaken American pharmaceutical patent protections and open the door for foreign competitors to cash in on U.S. innovation early. The move has triggered sharp backlash from Trump administration allies and is rapidly becoming a flashpoint in transatlantic trade relations.
At the center of the controversy is the EU’s effort to expand the so-called “Bolar exemption,” a provision that allows generic drug manufacturers to begin preparations for market entry before a patent expires. While the exemption has existed in limited form, the proposed expansion would significantly broaden its scope.
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