1. Race against time
The outbreak of the Covid-19 pandemic presents huge chal- lenges to healthcare systems worldwide and hence also to the research-based pharmaceutical industry. Probably the most frequently asked question in the past few months is: when will pharma research come up with an effective medicine or vaccine against Covid-19? It is difficult to provide an answer to this, but one thing is already clear: never before have pharmaceutical companies and academic research institutions responded so quickly to a new pathogen as they have to SARS-CoV-2. In this race against time, they are joining together across bor- ders and making an unparalleled effort to manage this crisis, whether in research and development or in production and securing the supply of diagnostics and medicines to the pop- ulation
2. Pooling expertise and resources
Switzerland’s research-based pharmaceutical companies are also actively participating in the effort to combat Covid-19 and are involved in numerous international projects and coopera- tive ventures. Right at the start of the pandemic, for example, many members of Interpharma joined with the Bill & Melinda Gates Foundation to establish a consortium, co-chaired by Novartis CEO Vas Narasimhan and Bill Gates, with the aim of When will pharma research come up with an effective medicine or vaccine against Covid-19? pooling their expertise and resources and accelerating the development and production of vaccines, diagnostics and medicines. In the field of diagnostics, Roche was one of the first companies to make a highly automated coronavirus test available as early as mid-March, which allows up to 4000 samples to be tested for the SARS-CoV-2 virus within 24 hours. In May, Roche was granted US approval for an antibody test and rapidly stepped up production capacity to many tens of millions of units in order to supply healthcare systems worldwide.
3. Research into existing substances
Further research into substances that are already known is an important pillar in the search for active substances. Hundreds of clinical trials are currently under way around the world, in which existing medicines are being studied for their efficacy against the SARS-CoV-2 virus. The member companies of Interpharma are also involved in this effort, for example in the testing of older antimalarial or HIV medicines. A major success has been achieved by Gilead: the medicine remdesivir, which was originally intended for the treatment of Ebola, is the first approved antiviral therapy that significantly reduces the recovery time in Covid-19 patients.
4. Vaccine development in record time
As a rule, it takes between 6 and 15 years before a new vaccine ready for the market becomes available. Vaccine development is highly a complex process. But ex- perts estimate that this could be reduced to between 12 and 18 months in the fight against Covid-19. How is it possible to develop such a vaccine in record time? The crucial factor here is the unique collaboration of the pharma industry and partners from the academic world in global alliances and cross-company projects. Together the companies quickly mobilized additional research and production capacity and are also able to combine several clinical trial phases. As a result, at the end of July, the World Health Organization already counted 165 vaccine candi- dates (139 in preclinical and 26 in clinical trials). These also include several projects of Interpharma members: Johnson & Johnson started a phase 1 trial with its company Janssen and its vaccines site in Bern as early as July.
Highly promising vaccine candidates are also being worked on by AstraZeneca together with the University of Oxford, by Sanofi and GSK, Merck & Co. and also Pfizer in cooperation with the German biotech company BioNTech. A further important aspect of this process is the cooperation with governments and authorities. Further time can be gained in the fight against Covid-19 through faster marketing authorization
5. Why animal experiments are necessary
Despite the accelerated development, production and process, the safety of new medicines and vaccines for patients remains of utmost priority. To make sure they are safe, animal experiments are indispensable. These allow the kind of life processes that occur in humans to be comprehended. Drug candidates are tested for safety and efficacy in preclinical studies. Toxicologists analyse them for their toxicity in order, for example, to exclude the possibility of substances causing diseases or damaging the DNA. Computer simulations are used for these studies, as are bacteria, cell and tissue cultures or isolated organs.
Nevertheless, tests with rats, mice and non-rodents are still necessary to investigate interactions in the live organism. Only in this way is it possible to determine, for example, whether a substance remains in the body long enough to achieve the desired medical effect. These standards in the testing of active substances in the animal guarantee a high degree of safety for patients. But it must be pointed out that researchers only fall back on animal experiments when they are required by law on the one hand and all other approaches have been exhausted on the other.
6. Guaranteeing supply security
Without animal experiments, it would simply not be possible to develop new medicines and vaccines and thus cope with the Covid-19 pandemic. The initiative “Yes to a ban on experiments in animals and humans” (see excursus on p. 7) therefore jeop- ardizes not only Switzerland’s position as a research hub, but also the safety of patients and their access to vaccines and medi- cines. Only with open framework conditions is it possible for the research-based pharma industry in Switzerland to participate in international research cooperation and develop effective medicines and vaccines to combat the SARS-CoV-2 virus. The same applies to the supply of medicines and diagnostics for other life-threatening diseases on which countless people in Switzerland also depend in this crisis. It can only be secured by maintaining global supply chains. For the member com- panies of Interpharma, supply security has utmost priority.
7. Excursus: People’s initiative “Yes to a ban on experiments in animals and humans – Yes to research avenues with impetus for safety and progress”
“The initiative is tantamount to a de facto ban on research.”
What is the initiative seeking to achieve?
The initiative demands an unconditional ban on animal experi- ments and research in humans. It further calls for a complete ban on trading and importing of all products that have been wholly or partly developed using animal experiments and trials in patients.
What would a yes vote on the initiative mean for the research-based pharmaceutical industry?
The initiative is tantamount to a de facto ban on research. Basic research, clinical trials and drug research for humans and animals would no longer be possible. The biomedical research of universities, hospitals and the pharma industry would move abroad and Switzerland would lose its most important resource, namely research and innovation. The consequence would be the loss of Switzerland’s leading position as a research and development hub – across all sectors and for years.
What would acceptance of the initiative mean for patients?
The ban on trading in products that have been developed using research in humans and animals would mean that the supply of medicines in Switzerland could no longer be guaranteed. Pa- tients would be denied access to innovative and potentially life-saving therapies, because they could no longer be approved and allowed on the market. But the ban on trading in these products would also result in the import and export of products from other sectors being prohibited, for example in the food industry or agriculture. Such a ban on trade is incompatible with international obligations and agreements, for instance with the European Union.
What specific consequences would a yes vote have on the fight to combat Covid-19?
The development of a vaccine in Switzerland would be banned, because drug candidates have to be tested in humans and animals. Importing a vaccine produced in another country would also be prohibited. Switzerland would thus be the only country in the world with no access to a vaccine against the SARS- CoV-2 virus.
What is Interpharma’s position?
Interpharma supports the Federal Council in its dispatch rejecting the initiative without a direct or indirect counterproposal. In principle, the member companies share the concerns of those behind the initiative to avoid the suffering of animals and to protect humans in research. But the initiative clearly goes too far. Humans and animals today are already protected by the constitution, and Switzerland has one of the strictest animal welfare laws in the world. There is no need for an amendment to the law.