Interview with Dr. René Buholzer
What has the pharmaceutical industry done to help beat the pandemic?
RB: The research-based pharmaceutical industry has contributed enormously in the engagement against the pandemic. On the one hand, companies diverted research and development resources in short order, allowing research to be pursued on various vaccines against SARS-CoV-2, with the result that the population was fully supplied with vaccines. Their regular contact with the Swiss government provided for an efficient regulatory approval process. At the same time, the pharmaceutical companies ensured that drug supplies and patient safety in Switzerland were secure at all times. The scarcity of resources was particularly challenging and hampered the transportation capacity that arose as a result of the pandemic. The numerous cooperative efforts with academic institutes were also very positive.
What role do animal experiments play in the development of medicines and vaccines for Covid-19?
They play an essential role, because the regulatory conditions for the approval of a vaccine are internationally harmonized and specify that testing in animals is required. In March 2020, the twenty most important regulatory authorities agreed on the data that needs to be gathered for approval. It should be pointed out here that the safety-relevant tests in fast-track procedures for the approval of vaccines were and are never reduced to gain time. Animals were used in a two-tier system of testing. Before clinical trials were conducted, vaccines were tested in both rats and mice. In these initial preclinical animal studies, the researchers sought to establish whether an immune response is triggered and what the optimum quantity and frequency of vaccine dosing is. Scientists then tested the vaccines also in rhesus monkeys, because humanlike symptoms such as pneumonia can also occur in these animals. For reasons of transparency, the results of preclinical studies are made publicly accessible. Animal experiments are both required by law and ethically mandatory for the protection of humans. Coronavirus vaccines such as those from Moderna and BioNTech/Pfizer would never have been approved without animal experiments.
What have Interpharma and its members learned from experiences in the pandemic?
The global race to develop an effective vaccine has resulted in a boost to research, especially in the field of betacoronaviruses and viral infectious diseases. The rolling approval procedures in the pandemic highlight the possibilities for the reform of regulatory approval processes, because delayed approval primarily results in poorer patient access to innovation. Pharmaceutical companies are also dependent on low international trade barriers and hence open borders. As a result of the severe shutdown in some economies and industries, global procurement and supply chain management are particularly challenging for the pharmaceutical industry. In Switzerland, they are dependent in turn on the country’s position as an attractive research and business hub. The focus is always on patient safety. Switzerland must safeguard its attractiveness in the longer term – this includes favourable framework conditions for taxation, easy access to qualified specialists and active support for innovation and start-ups. The research-based pharmaceutical industry is also prepared to help drive digitalization together with the federal government and other actors involved in the healthcare system, because good-quality anonymized health data provides for a faster and more precise development of medicines and therapies. And this will be essential in the coming years for Switzerland’s position as a leading research hub.