Manufacturers are being urged by governments around the world to expand production to include life-saving medical technology to tackle COVID-19. We’ve produced an alert (here) to help guide manufacturers which are new to this space on key legal challenges.
As COVID-19 infections increase globally, health systems face a shortage of life-saving equipment and essential supplies to tackle the virus. Until a pharmacological treatment is developed, ventilators are vital treatment for the minority of COVID-19 patients requiring critical care. There is an urgent need for a rapid escalation in the manufacturing of a full range of test kits (self-administered, antibody tests, etc.). To mitigate the crisis, governments are turning to the private sector for assistance, not just in physical manufacturing but also for capabilities in design, procurement, assembly, testing and shipping. Most recently, the UK government appealed to its manufacturing sector to switch from making other products to producing ventilators. Such requests are likely to become commonplace as national leaders seek innovative solutions to the crisis.
Our alert suggests the following steps for manufacturers:
- Monitor emergency state powers closely in terms of requisitioning, etc.
- Reach out to appropriate contacts in the relevant authorities. Industry trade associations are acting as intermediaries here and can help make fast connections.
- Understand governmental proposals to relax regulatory approvals and enforcement for medical equipment.
- Put in place virtual manufacturing contracts so as to “shadow” existing regulatory approvals.
- Carefully analyse product flows and monitor the supply chain for essential components.
- Consider a temporary joint venture to provide certainty of production capacity.
- In negotiations, be reasonable and flexible to move things along as fast as possible.
- Recognise the different pressures in terms of speed, scope and term, pricing, technology transfer, and liability in consensual and compulsory government IP licensing.
- Ensure consent and consultation when changing employees’ jobs.
- Structure arrangements to fall within the boundaries of competition law or consider emergency engagement with the relevant antitrust regulators.