Corona pandemic as a trigger for changes in the pharmaceutical-chemical industry?

Learnings from drug shortages

Like other Western countries, Switzerland regularly experienced phases of drug shortage for over ten years now. These drugs, their active ingredients or intermediates are almost exclusively manufactured in China or other low-wage countries. This went on almost unnoticed by the general public. However, this changed early 2020 with the corona pandemic, when the flow of goods between China and the rest of the world was severely disrupted.

Delivery bottlenecks for vital medicines. A typical example was the benzodiazepine midazolam (Dormicum®). Because of its antispasmodic effect it is used for the intubation of Covid-19 patients but was in short supply at times. There were also bottlenecks in epilepsy and Parkinson's medication, medication for high blood pressure, medication in obstetrics, birth control pills and antibiotics. The situation with antibiotics was so critical that products with higher side effects had to be used at times. By the way, the other serious problem of multi-antibiotic resistant germs still requires a solution. The WHO actually calls this a “slow tsunami”, a problem of greater importance than the Covid19. Incidentally, the lack of medication did not only affect “old” medication and generics. Remdesivir, a new nucleotide analog originally developed against the Ebola virus, was also temporarily unavailable because the USA reserved entire production batches for itself. As a result, the possibility of a compulsory license, against the patent holder to manufacture remdesivir in Europe, was discussed in Germany. But that was ultimately rejected as being a too massive an interference with economic freedom.

Databases for unavailable drugs. At the federal level, a database of notifiable active ingredients for vital human medicinal products is maintained in Switzerland. On the private initiative of Enea Martinelli (chief pharmacist at Spitäler FMI AG), another list is kept that lists all medicines that are not available, including those that are not essential, e.g. the pain reliever paracetamol or the remedy prasugrel against blood clots.

Outsourcing of manufacturing to low-wage countries. The reason for these bottlenecks is simple. In order to reduce costs, the production of basic medicines, especially generics has been moved to countries with the lowest costs. Through mergers and acquisitions, the production of certain active ingredients was further concentrated to a single location and manufacturer usually in the Far East - with far-reaching consequences. In 2015, for example, a major explosion at a manufacturer of raw materials in Hebei Province severely disrupted the availability of the antibiotic piperacillin/tazobactem worldwide. Switzerland and other western countries not only accept the risk of production losses due to operational problems. They are also confronted with a monopoly situation through their own fault. The problem of drug shortages is anything but new: at the end of November 2019, thus before the pandemy, a peak in temporarily unavailable drugs was reported. Consequently, in several countries, including Switzerland, there was a political demand that the production of important drugs should be relocated to Switzerland or Europe. In this context, the names of Swiss companies like Lonza, Siegfried or Dottikon were circulated. It is obvious that a development that this insidious development cannot simply be reversed. Just reaching the production costs for profitable production in Switzerland or Europe or rebuilding chemical and biotechnical capacities and competencies are two real tough nuts.

But there is an opportunity in every crisis. Value chains and production methods must be questioned with regard to sustainability and efficiency. But the industry still persists with outdated approaches and methods and is reluctant to change and to leave the well-trodden but familiar paths. This is understandable because of the expensive, only partially depreciated systems and the development costs for new approaches. But dwindling resources and the need for sustainable production methods call for a long overdue transition in the chemical and pharmaceutical industries.

Methods and technologies for problem solving are in the starting blocks. The good news is that there is a whole range of new methods and technologies such as flow chemistry, chemostat technology, combining biocatalysis with transition metal catalysis, microreactor technology, directed evolution, application of artificial intelligence in chemo- and biosynthesis, new process data management systems waiting to be developed and implemented. But this requires cross-departmental collaboration across many disciplines. Last year, together with the Swiss Biotech Association (SBA), the Swiss Academy of Engineering Sciences (SATW) launched an “Industrial Biotechnology” initiative. First network meetings were carried out in November 2020 and January 2021, in order to capture the industrial setting, to create an interactive platform and organize working groups on specific question like “Manufacturing methods of the future” just to mention one. The promotion of cross-divisional cooperation is also being considered as topic for a possible “Innosuisse flagship topic”.

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Hans-Peter Meyer Expertinova AG