How bureaucracy slows down research – especially in medicine

Berlin The Expert Commission on Research and Innovation EFI complains about enormous bureaucratic hurdles – especially in medical research. This hits a booming research field of all things: the development of drugs for new therapies, criticizes its chairman Uwe Cantner.

Relevant EU rules are “interpreted very narrowly and in small parts” in Germany, he told the Handelsblatt. “While in this country an application has to be made for every experiment and every mundane activity, researchers in the USA can apply for comprehensive permits for large projects that include a battery of experiments.”

The chancellor’s adviser warns that the fragmentation will ultimately mean that Germany is becoming less attractive as a location for basic medical research and preclinical research.

Specifically, researchers in Germany would have to contact several federal and state authorities, which would lead to considerable delays. “The federal chaos continues at the European level,” reports Cantner. If several partners cooperate, they would need a large number of permits from all national authorities. Another problem is that the authorities have far too few staff for the expected increase in permit applications.

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Clinical studies must be approved by the Paul Ehrlich Institute and the ethics committee of the respective institute. For the latter, however, the criteria are not uniform. Japanese researchers, on the other hand, would only have to register studies with a central authority. In addition, the approval period in Germany is 90 days, in Japan and the USA it is automatically considered granted after 30 days.

The use of the new “gene scissors” CRISPR / Cas, which experts hope will bring about a revolution in medicine, is particularly affected, says Cantner. It can remove or replace defective genes. Germany is a leader in application, and its inventors have even been ennobled with the Nobel Prize.

In genetic engineering law in particular, however, the bureaucratic effort is often “out of proportion to the risks”. The authorities here “have recently become more restrictive again”. There are also different practices in the federal states. It is therefore urgently necessary to exclude harmless genetic engineering work from the Genetic Engineering Act and to bundle others and treat them uniformly.

Stifterverband generally wants “less provision and more innovation”

The Stifterverband für die Deutsche Wissenschaft generally advocates a fundamentally new approach to new technologies – less precaution, more innovation: “It cannot be that we have to test all possible effects in advance of all innovations, because that leads to massive innovations be slowed down, ”says Vice Secretary-General Volker Meyer-Guckel. “Instead, we should approve and apply new products or services more quickly and, if necessary, impose additional requirements.”

Another major barrier for research is “the hopeless under-digitization of the administration”, according to Meyer-Guckel. “We have to use data that we collect in society for research – especially in health research: Israel did that for the Corona vaccination effects, we couldn’t even use data from the Luca app.” Also data on learning behavior or mobility data remained unused for sustainable urban development.

Even the top innovator of the republic, Rafael Laguna, who heads the new federal agency for leap innovations (Sprind), complains of being maneuvered by politics. Chancellor Angela Merkel herself admitted at the research summit in May that the agency she had initiated was “still relatively small” because she had too little freedom. Sprind is to promote central innovations with a billion euros in tax money for the next ten years, from which completely new markets are to emerge.

But the first 18 months had shown that “with the financing tools provided, the ambitious goals and expectations – finding, financing and incubating technologies and ideas that have the potential for leap innovation – can hardly be achieved,” complains Laguna.

In order to invest larger sums in a project, the agency has to found a subsidiary GmbH and give it a loan. “The horse’s foot: the daughter is also bound by the public procurement regulations and has to put all expenses out to tender.”

Because, of all things, projects that could implement central innovations and therefore “compete for the brightest minds in the country, employees cannot share in the company’s success and have to pay them according to the public service tariff”.

The next government must therefore urgently “set up the agency independently and develop it into a real laboratory for promoting innovation with flexible instruments”. They must be exempted from the award rules and have permission to fully support projects in the early phase or to participate in them, as well as to pay salaries outside the collective bargaining agreement. They also need a global budget.

University research: Universities have to write 200-page reports that nobody reads

Universities are also suffering from the bureaucracy: “The requirements are constantly increasing, increased by overlapping or even contradicting responsibilities of the federal states, the federal government and the EU,” complains Professor Wolfram Ressel, President of the Association of Leading Technical Universities, TU9. The federal states were constantly changing university laws – “but never fundamentally reforming them and reducing complexity and bureaucracy in the process”.

That hits universities hard, whose “budget now largely consists of third-party funds; and the number of partnerships with institutions from science and industry is increasing steadily ”.

Specifically, for example, they have commercial accounting – but have to submit the financial statements to the country in a cameralist manner. Partly state and partly federal law apply to travel expenses. TU9 complains that even the smallest purchases have to be advertised in triplicate. The usage lists are also “incredibly small-scale” – right down to individual postage stamps.

The cost of red tape

The university organization researcher Peer Pasternack from the University of Halle also attests to the enormous burden. The rules are “boundless”. In principle, universities have been granted independence and have a global budget, for example. At the same time, “however, the mistrust of politics has led to re-regulation, which imposes a large number of information obligations on universities”.

For example, the 13 public universities in Berlin would have to submit 200-page reports to parliament every year. “Every year, that’s 2600 pages that even the six education politicians in Berlin’s part-time parliament don’t read – a gross waste of personnel expenses.”

Nonetheless, he recommends that universities “start where they can change something by reducing the bureaucracy that has been built up internally over many years. There are a lot of possibilities – and it would lead to great enthusiasm for the professors ”.

Bureaucracy eats up up to 40 percent of working time

Pasternack’s team determined by evaluating their diaries and personal support that “professors spend 20 to 40 percent of their working time on bureaucracy” – often for very simple things such as publication lists or student statistics. Only the highest-ranking professors have a secretariat.

Employing well-paid professors to do this is a “terrific waste of public funds”, criticizes Pasternack. “The situation in the university clinics is particularly blatant – the university and hospital bureaucracy multiply here.”

Even ordering the material is sometimes absurd: “Even a chemistry laboratory, which always has to use the same substances from the same manufacturer because of the comparability of the research results, still has to obtain and document three offers every time.” It becomes grotesque on business trips: “Here researchers have to do it themselves Obtain several offers for hotels, or justify individually why the planned room rate of 65 to 70 euros is exceeded, which is absurd in Munich or Frankfurt, for example. “

More: The potential for innovations is there in Germany – but there is a problem with implementation

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