By Francesco Guarascio
BRUSSELS (Reuters) – The European Union is planning tough measures to boost its access to drugs, from sidestepping patents rights in emergencies to taking production to Europe, according to EU documents published on Wednesday.
The possible moves are meant to tackle the chronic shortages of medicines that have dogged the bloc for years and have become more serious since the COVID-19 pandemic and associated trade disruption and drug export bans.
The European Union Commission wants faster procedures during crises to produce generic versions of drugs in EU states without the consent of patent holders, an EU document says.
So-called compulsory licensing is allowed under World Trade Organization (WTO) rules in emergencies as a waiver of normal regulations and could be applied during the COVID-19 pandemic.
“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 (intellectual property) available have failed,” the document published on Wednesday said.
Ironically, the proposal is part of an EU action plan on intellectual property that is mostly aimed at strengthening the protection of EU companies’ patents against foreign actors.
In the first months of the COVID-19 pandemic, lawmakers and activists had urged the EU to use the WTO waiver to gain access to potential vaccines and drugs against the new coronavirus, which have mostly been developed outside the 27-nation bloc.
The EU executive has so far refused to invoke the waiver and has struck multibillion-euro deals with drugmakers to secure COVID-19 shots and therapeutics.
However, the COVID-19 emergency has led to a reconsideration of existing procedures, which largely fall under the remit of national governments in the EU.
“The Commission calls on member states to ensure that the tools they have are as effective as possible; for instance, by putting in place fast-track procedures for issuing compulsory licences in emergency situations,” the document says.
To avoid distortions to trade and innovation, the Commission is also considering creating an emergency co-ordination mechanism that would be triggered at short notice when an EU government wants to issue a compulsory licence.
The Commission also said on Wednesday that, after a consultation process with pharmaceuticals companies next year, it will make proposals aimed at identifying vulnerabilities in global supply chains.
That could lead to incentives for manufacturers to move production of medicines to Europe.
The Commission said it was important “to assess whether manufacturing capacity for certain critical medicines may be required in the EU”, adding that any action would be in line with WTO rules.
The possible measures are part of a wider EU strategy published on Wednesday. The plans aim to increase access to cheap medicines and boost competition, including through broader use of generics that could hit revenues of large drugmakers, in line with a Reuters report earlier this week.
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