By Paula Youens from Webber Wentzel
A team of healthcare contract and intellectual property (IP) specialists from Webber Wentzel has contributed their services free of charge to help kickstart the National Ventilator Project (NVP) to build 20,000 ventilators to save the lives of South Africa’s Covid-19 patients.
Webber Wentzel’s team, led by Robert Appelbaum and assisted by Megan Jarvis, Leanne Mostert and Cameron MacKenzie, advised Business for South Africa, the Department of Trade, Industry and Competition and the South African Radio Astronomy Observatory (SARAO) on a pro bono basis. They provided 100s of hours of time giving advice on the choice of outside experts, drafting, negotiation and settlement of the prototype and manufacturing agreements required for the NVP. In addition to this Webber Wentzel assisted in ensuring the non-invasive ventilators were registered by the South African Health Products Regulatory Authority (SAHPRA).
The NVP, which is funded by the Solidarity Fund, has entailed designing and building three local prototypes of non-invasive ventilators for mass local production. Non-invasive ventilators are desperately needed to treat most hospitalised Covid-19 patients with a mixture of pure oxygen and air delivered through a well-sealed mask or hood. The NVP will build 1,000 non-invasive ventilators a week to an initial target of 20,000.
SARAO was mandated by the Department of Trade, Industry and Competition to assemble and manage a team of engineers and manufacturers to develop, test and manufacture non-invasive ventilators on an expedited basis.
Together with ENSafrica, which represented the Solidarity Fund in these transactions, Webber Wentzel was required to navigate difficult legal questions relating to IP development, ownership and licensing, as well as issues relating to regulatory matters, testing and approval of medical devices and their related liability implications. At the best of times, it is difficult to address and agree upon legal questions of this kind.
In addition to these challenges, it was also necessary to run negotiations with multiple innovators and manufacturers in parallel to ensure that multiple prototypes were developed, tested, and (if selected) ready for manufacture. Running the process in this way ensured that many solutions could be evaluated simultaneously to find the best proposals to address the crisis. With each potential supplier came a range of unique considerations which had to be addressed in the legal drafting and negotiation process.
All these challenges had to be resolved within demanding time constraints, as the virus is spreading rapidly throughout South Africa.
“Fortunately, all the parties showed an appreciation for the urgency of the situation and a willingness to compromise,” says MacKenzie. “These efforts will ultimately be for the benefit of the hundreds of thousands of South Africans that may be affected by Covid-19 before this crisis is over.”
Appelbaum commented that “this was one of the most stressful engagements I have been involved in given the urgency of the matter, but it has also been one of the most gratifying given the fact that we are assisting in the saving the lives of fellow South Africans.”