EU Strikes Deal on Patent Rule Exception to Ensure Supply of Critical Products

The European Parliament and EU governments have reached a landmark agreement on new rules allowing emergency access to patent-protected products during cross-border crises. The regulation introduces a compulsory licensing framework aimed at ensuring the swift availability of critical technologies—such as vaccines or microchips—across the EU during emergencies.

Under the new regime, the European Commission will be empowered to issue compulsory licenses without the patent holder’s consent, but only in clearly defined emergencies and as a last resort. This will allow alternative manufacturers to produce essential goods, helping to avoid supply shortages in times of crisis. Defence-related products are excluded from the scope.

Patent holders will still receive fair compensation, with payment terms set by the Commission. To prevent misuse, strict conditions will apply to licensees, including limits on production volume and restrictions on exports. Violations could result in fines of up to €300,000, or €50,000 for SMEs.

An advisory body will assist the Commission in evaluating the need for such licenses, and both rights-holders and licensees will be consulted throughout the process.

Rapporteur Adrián Vázquez Lázara (EPP, Spain) hailed the deal, saying it “strikes a crucial balance between protecting intellectual property rights and ensuring essential technologies are available swiftly in times of crisis.”

The regulation is expected to be formally adopted in the coming weeks and will enter into force one day after its publication in the EU’s Official Journal.        

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