During a global virtual press briefing on 19 March 2020, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) gathered five global pharmaceutical leaders including Roche Chairman and CEO Severin Schwan to discuss the global ramifications of the COVID-19 crisis.
With Roche’s global leadership in diagnostics, many of the questions lobbed at Roche Chairman and CEO Severin Schwan related to the skyrocketing global demand for diagnostic COVID-19 tests. As World Health Organization Director General Dr Tedros Adhanom Ghebreyesus and other global healthcare leaders have emphasized, reliable, swift and intense testing is a fundamental cornerstone of coordinated responses to mitigate the devastating effects of the global pandemic.
Roche has been at the forefront of this fight, with a notable milestone being the 12 March 2020 FDA Emergency Use Authorization of their newly developed cobas® SARS-CoV-2 Test, which detects the genetic signature (RNA) of the SARS-CoV-2 virus in swab samples collected from the back of the patient’s throat or nose. Results are available in around 3.5 hours. This was the first new commercial test introduced during the pandemic.
It is very important, in my view – and I speak here on behalf of many experts – that testing is really targeted at high-risk patients and patients who show signs and symptoms of the disease. Broad-based testing at this stage is simply not feasible
Severin Schwan, Roche
As Schwan reiterated, “testing is very important these days. It helps us to isolate infected patients to flatten the curve so that health care systems can cope.” Nevertheless, he cautioned, “the industry has been ramping up production and more testing capacities are provided [but] demand is still outstripping supply by far. So it is very important, in my view – and I speak here on behalf of many experts – that testing is really targeted at high-risk patients and patients who show signs and symptoms of the disease. Broad-based testing at this stage is simply not feasible.”
To illuminate this point further, he took great pains to outline the complex realities of the diagnostic process, describing, “to give one example, you need an instrument on which you can run the tests. Then you need the test itself – the reagents, the essays – and then you need a third component, which is consumables like plastic parts, for example – all necessary just to run a test. Our test – now provided worldwide – is produced in the United States. The instruments are produced in Switzerland and the consumables are produced in Germany.” For this reason, he stressed unequivocally, “it is absolutely critical that we keep the borders open for medicines for medical devices.” Fortunately, even as countries and governments have rushed to close their borders in an attempt to dampen the spread, “governments and authorities have recognized that global supply chains are absolutely critical to keep supply up and running.”
With much of testing capacity concentrated in more developed economies and a rising fear that many countries, including those in Europe and North America but also across the African and South American continents, are undertesting and therefore underestimating the spread of coronavirus, huge attention has been paid to ways to increase the supply of COVID-19 tests. However, as Schwan explained, there are other factors at play. “The vast majority of the cost for testing is the infrastructure you need in the hospitals. You need to install highly sophisticated systems in a lab environment. The issue is capacities and access. That is the real bottleneck.” He emphasized, “cost is not the issue at all. From a commercial point of view – and I can explicitly speak for Roche – this is completely immaterial for our commercial results.”
To contextualize the important role that healthcare infrastructure plays in the delivery of diagnostics, he added, “if you look, some of the Asian countries have been directly hit with, for example, the SARS crisis, the MERS crisis. Those countries have started to build infrastructure to be better prepared, for example, in terms of testing, with more decentralized testing facilities so that not everything is flowing into the hospital, which proved to be extremely valuable.”
On the bright side, he had some positive words of praise for the nearly unprecedented levels of global cooperation between industry and regulators, explaining, “we developed [our cobas® SARS-CoV-2 Test] in record time. There would have been no way to develop this so fast without close cooperation with the authorities. In the US, for example, we were working hand in hand with the FDA and within 24 hours, we received emergency authorization to make this test available for patients. This is absolutely unheard of. Under normal circumstances, this would take months.”
The same has applied for the investigation of the potential of Actemra®, their arthritis drug, against COVID-19. This drug has already been approved in China for the treatment of COVID-19 patients with severe lung damage and elevated levels of interleukin-6 (a biomarker for inflammation and high-level immune response) in their blood. Schwan elaborated, “the drug has been used in China but we do not yet have validated clinical data from randomized clinical trials. That is why it is so important to start a clinical trial and that’s exactly what we did for this specific medicine. We agreed this with the FDA in record time – again, an example of excellent collaboration with the regulators.” As of 6 April, a number of patients have been enrolled in a late-stage trial across sites in the US and Spain.
Roche is presently the second-largest pharmaceutical company in the world in terms of revenues, operating in over 100 countries and territories. Schwan’s final message therefore holds particular resonance: “I would definitely encourage everybody not to get into this trap and say we have to get everything into our country and close the borders. This is an illusion. You cannot bring a complete global supply chain into one country. It would actually be [more] detrimental if countries start to close borders. It would be completely wrong to fall into nationalistic behaviour. We would create more supply issues in the future if we went down this path.” As an alternative view, he advocated, “what is important is that we have back-ups – dual supply or triple supply – so that we do not rely on one geography or one single supplier.”