Big Data opens up enormous possibilities for medical and pharmaceutical businesses to develop innovative and highly effective methods of treatment. Often very sensitive health data is used for this, and their processing is tied with strict requirements for admissibility. Possibilities and challenges in this field were discussed by experts from businesses acting in the healthcare industry as well as biotech and pharmaceutical companies at an event which took place in the Cologne offices of international legal practice Osborne Clarke.
Taking place the day before the German biotechnology days, the event highlighted how the legal and regulatory aspects play an important role within the biopharmaceutical and technological industry. The German biotechnology days represent an annual network event for the biotechnology sector.
After Dr Andrea Schmoll, a Life Sciences & Healthcare Partner welcomed the guests, data protection expert Marian Arning explained the special requirements with respect to data protection in medicine. The use of personal data often requires the consent, which usually is only valid for a specific use and must be given for each specific case. However, Marian Arning presented practical solutions as part of the applicable law. Especially the “pseudonymisation” of data, which sometimes even does not require the consent, was of interest. The pseudonymisation is done by an independent institution which holds the keys in trust, by which the data used for research/personalised medicine of the affected person can be assigned. The expert has already put this model into practice.
Dr Andreas Schmidt, CEO of Ayoxxa Biosystems, spoke about how Big Data opens up new vistas for his company’s whole business model. The start-up company manufactures a kit for multiplex protein analysis and has chances to develop into a data platform for significantly more complex processes. Schmidt thinks that Big Data brings enormous possibilities to recovering new markets which have a two-digit billion capacity: “We constantly develop new technology; however, we have the same problem as other start-up companies: it is not always determined from the beginning what finally brings the money.”
Dr Kai Pinkernell, Global Head of Clinical Business of Miltenyi Biotec discussed similar issues surrounding personalised cancer therapy. Individual methods of treatment for patients offer great chances but also challenge companies in new ways, for example, by the regulations of the Medicines Law. These regulations are for instance handled in England considerably more practical than in Germany. The demand of the patients for health data, says Pinkernell, is continually increasing. More and more people want to identify health risks by means of genome analysis. Of course, this is a very expensive method and the question arises whether the effort would justify the result. Furthermore, it raises questions of an ethical nature.
The conclusion of the participants of the subsequent debate was that Big Data and Biotech offer good possibilities but in many areas, science and industrialism are still in the beginning of development. Numerous topics are also discussed at the German biotechnology days in Cologne.