European Union aims to establish patent workaround in case of emergencies while trying to strengthen its own IP
The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.
Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.
“The Commission sees the need to ensure that effective systems for issuing compulsory licences are in place, to be used as a means of last resort and a safety net, when all other efforts to make IP available have failed,” the document said.
Reuters was the first to report on the plan, writing Wednesday that some legislators have urged the EU to use the WTO waiver to gain access to potential vaccines and drugs for Covid-19, but the bloc has resisted until this point. Instead, the European Commission and other governments on the continent have been purchasing prospective vaccines and therapies in bulk.
But Covid-19 is causing the EU to rethink its strategy, given the extraordinary nature of the pandemic and need for treatments.
The EU outlines how a procedure closely linked to patents, known as supplementary protection certificates, are also hampering European patent holders. The certificates provide an extended IP protection for products that undergo clinical trials and regulatory approvals, but due to inconsistent implementation across Europe, both generic and drug makers have had a difficult time implementing a cohesive Covid strategy.
Earlier this week, Reuters had previously reported that the bloc was considering making access to generics easier altogether. The goal of the plan is to make drugs more affordable while preventing the supply and manufacturing shortages seen during the early stages of the pandemic this spring.
A draft of the document reviewed by Reuters appeared to discuss a plan to apply antitrust policies more rigorously against pharmaceutical companies, though that does not appear in the final plan released Wednesday. The draft also mentioned the possibility of cracking down on drugmakers that delay the approval of generics, limiting patent protection for drugs that aren’t made available in all 27 EU countries, and aiming to prevent drug shortages across the continent.