EU Seeks to Skirt Patent Rights During Crises to Speed Generics

The European Commission (EC) last week adopted an ambitious drug access strategy inspired by the COVID-19 pandemic that proposes allowing generics manufacturers to sidestep having to get patent permissions during public health emergencies.

The commission’s plan calls on the EU’s member states to put in place regulations that would authorize the rapid issuance of compulsory licenses in times of crisis, which would allow a generic drugmaker to make a product without permission from the patent holder.

The strategy, which aims to overhaul the EU’s drug system to make it “future-proof and crisis-resilient,” has four main goals: ensuring access to affordable drugs, supporting innovation and competition, improving crisis preparedness and response, and promoting pharmaceutical quality, efficacy and safety.

The bold strategy includes an action plan on intellectual property (IP) that supports the pooling of IP deemed critical during health crises. Such patent sharing has been called for during the pandemic by international bodies such as the World Health Organization (WHO), which believes pharma companies should waive exclusivities for their COVID-19 vaccines and treatments.

“The coronavirus pandemic has highlighted the vital need to strengthen our health systems,” said the commission’s president, Ursula von der Leyen. “This includes access to safe, effective and high-quality medicines at an affordable price. In the challenging economic and social times that the EU is currently facing, the strategy … will ensure that Europe and Europeans will continue to benefit from such medicines.”

The EU is not the only region looking into expediting access to generic drugs during the pandemic. In October, India and South Africa petitioned the World Trade Organization to allow countries to choose whether to grant or enforce patents and other intellectual property related to COVID-19 drugs, vaccines and diagnostics during the public health crisis (DID, Nov. 3).

Read the full strategy here: www.fdanews.com/ec-pharmaceutical-strategy. — James Miessler