EU Proposes ‘Last Resort’ Plan to Order Production of Key Drugs

The European Union is proposing a system that would allow the bloc to suspend patent protection under special circumstances to address shortages of critical drugs during public health crises.

(Bloomberg) — The European Union is proposing a system that would allow the bloc to suspend patent protection under special circumstances to address shortages of critical drugs during public health crises.

The EU’s executive arm said the new rules, which would be used to ensure access to critical products and technologies, would be used “as a last resort in times of crisis.”

Drugmakers, including Novartis AG, have been critical of such plans, warning that they were unnecessary and could harm innovation. 

The European Commission’s plan would establish strict criteria for the issuance of any compulsory licenses. They could only be granted after the EU has formally declared an emergency or crisis, the executive arm would need to consult with member states and key stakeholders and the move would be subject to a judicial review. Affected companies would also be entitled to “adequate remuneration,” the commission said.

Those limits may not entirely ease the concerns of pharmaceutical companies.

“Even the threat of compulsory licensing will fundamentally damage the innovation ecosystem for pandemic response and emergency response,” Novartis Chief Executive Officer Vas Narasimhan told reporters on Tuesday, responding to earlier reports on the plan. “It’s ultimately not going to help.”

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