Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Digitalization: Challenges and opportunities for the pharmaceutical industry with regard to advertisement and trade (digital shelfs) ***

Alexandra Federer (Abschlußjahr: 2021)

Summary
Language: English
The Covid-19 pandemic has shown the importance of digitalization in the pharmaceutical industry, speeding up the digital transformation. In the healthcare system, digital growth is proceeding inexorably, and digital technologies are crucial for any pharma company. Although, the digital area is facing challenges, a number of opportunities are created. Over the last years, electronic (e-) advertisement, e-commerce, search engines and e-innovations such as apps have emerged as key winning fields for this business.
In this thesis, an overview on the current regulatory environment is provided, taking into account legislations, court decisions and addressing specific legislation lacks. Main focus is given to e-communication, e-commerce and search engines of German over-the-counter medicines as well as of medical devices, cosmetics and food supplements. Experiences from other countries are shared, too. Overall, the thesis should provide a guidance for pharma companies facilitating to foster on this increasing business area so that not only they benefit from the “digital catalysator”, but patients, healthcare professionals and Competent Authorities can take advantage from digital acceleration, too. In this context, the current German and European legislations, draft laws and soft laws including guidance and positioning papers of Competent Authorities, Trade Associations and Industry were amplified as well as the current national and European jurisprudence.
The digital age has not resulted directly in law reforms in the pharmaceutical sector. New legislation has been introduced, e.g. regulating the e-commerce business or on e-health topics like e-recipe. However, the key principles of the German Medicinal Products Act and German Pharmaceutical Advertising Act governing the e-advertisement, e-commerce etc. have not changed and so a robust legislation is still in place and applicable for these digital topics. Some grey areas exist and although last-instance case laws provide useful orientation to the pharmaceutical business, for specific fields there is uncertainty. For instance, in the social media area, laws often are not tailored enough for the healthcare sector and so the legislation framework is often not fit-for-purpose. Also, liability and responsibility demarcation are often not fully covered in this fast-changing environment. Moreover, a harmonized approach for cross-border topics has not fully reached so far, which is crucial for enterprises doing business across several European Member States.
In conclusion, it must be highlighted that in Germany for these e-business different provisions are in place, some of them are more tailored to digital specifics than others. Nevertheless, it would be appreciated if regulators, legislators and industry could provide some guidelines especially on key topics in the area of social media, communication responsibility, information duties and further liability topics. However, such documents should not set out restriction to the business. As an outlook, the changes led by digitalization should be seen as an opportunity and key driver to handle this phase of pandemic where we are all currently in. The pharmaceutical industry is used to challenges and aware of the disruptive potential of digital initiatives and how this reshaping trend can add additional value to the business. Digitalization will keep changing the whole pharmaceutical business, new ways of connection, more flexible and agile approaches are required to be able to respond to these new trends as these will bring benefits to the companies. This transformation is not possible without challenges, but taking the next steps is key to meet customer, patients and health care professionals’ expectations. This process will play a central role in the next years and will be a part of the road to digital success and to shape the future of this whole industry.
Pages: 52
Annexes: n.a.