Green light for progress

Dr Karl Broich

Just occasionally you find yourself at a fork in your career, with two paths leading in quite different directions. And then you need to decide which of the paths to follow over the next few years – and possibly even decades.

Professor Karl Broich faced just such a fork back in the year 2000. He was a senior physician at the Clinic for Psychiatry in Halle and had the chance to move to the Federal Institute for Drugs and Medical Devices (BfArM). This was also a decision between daily contact with patients at the clinic and the opportunity at the BfArM to help set the healthcare agenda at a macro level.

“My desire to help as many people as possible is what prompted me to switch to the BfArM”, recalls Broich. “I realised that working in the area of healthcare regulation would allow me to positively influence the conditions for thousands of patients.”

Today, 21 years later, he has the top job at the BfArM. And is therefore one of the people shaping the future of healthcare in Germany.

Safe drugs and medical devices

The BfArM sets the agenda on several different levels. It is responsible for licensing and improving the safety of drugs, detecting and evaluating the risks of medical devices, and monitoring legal traffic in narcotic drugs and precursors. In these areas it defines limits wherever necessary and gives the green light wherever possible.

The BfArM also curates progress: it uses technologies of the future, such as artificial intelligence, novel designs for clinical studies and the exponential increase in data volumes (“big data”), to fulfil its core remit as best it possibly can. While all the time acquiring experience of the new technologies – of their advantages and disadvantages. “Digitisation in particular offers enormous opportunities when it comes to developing new therapies and efficiently delivering healthcare”, says Broich. The BfArM gives impetus in this area, allowing innovations to enter into widespread use more quickly. For example: a new way of reimbursing manufacturers was created so that patients could be prescribed “digital healthcare applications” – also known as “apps on prescription”. Using its fast-track system, the BfArM was able for the first time to define a comprehensive requirements profile for such applications in healthcare provision. Within three months, the claims made by manufacturers about aspects such as safety, performance and medical quality can be checked.

International cooperation for global health

International cooperation has long played a central role in this context, not only in new technologies but also in other areas. “Global health is relevant in numerous fields, such as antibiotic resistances or accelerated licensing procedures. The pandemic has focused international attention on the availability of medical drugs, and especially of vaccines”, says Broich.

And of course the huge amounts of healthcare data – known as “real world data” – should also be viewed from a global perspective. “Major players such as Google, Facebook and Amazon collect data from millions of patients. It is important that healthcare authorities around the world do not allow business corporations to take sole responsibility for healthcare data”, says Broich. Consequently, the BfArM has teamed up with other approval bodies and the European Medicines Agency (EMA) to set up a “Big Data Task Force” to address this issue.

Researching independently, supplying information

Many of the more than 40 federal institutes, which include not only the BfArM but also the Robert Koch Institute (RKI) and the German Environment Agency (UBA), are currently in the process of internationalising their activities and procedures. The job of the institutes is to conduct independent scientific research, supply policymakers with information and advice, and in some cases help define laws.

Broich has now headed the BfArM for over seven years. Was his decision in 2000 to give up his job as a senior physician and move to the institute the right one? Broich smiles. “Yes, definitely!” And does he not miss working with patients? Sometimes, just occasionally, he admits that he does. But then he realises that his work does affect them after all. And that all his efforts and the work of the BfArM ultimately benefit the patient. Above all in Germany – though increasingly around the world, too.