Die Methoden der Biotechnologie wurden in den letzten 10 Jahren zu einem wichtigen Instrumentarium in der pharmazeutischen Wirkstoffforschung und -entwicklung. Bereits heute machen Biopharmazeutika rund 15% des gesamten Umsatzes mit Arzneistoffen aus. Dabei sind die drei wichtigsten Indikationsgruppen die Onkologie, Stoffwechselerkrankungen und Erkrankungen des Bewegungsapparats. Für die nächsten Jahre kann damit gerechnet werden, dass Biopharmazeutika weiter an Bedeutung gewinnen. Der Anteil von Substanzen in der präklinischen Forschung, die auf biotechnologischen Verfahren beruhen, liegt mittlerweile bei über 25%. Neben Produkten für die Onkologie und Stoffwechselerkrankungen spielen hier Antiinfektiva eine wichtige Rolle. Neuartige Therapieverfahren wie die RNA-Interferenz stecken dagegen mit 1,5% aller kommerziellen Forschungsprojekte noch in den Kinderschuhen. Investitionen in zukunftsfähige Spitzentechnologien wie die Biotechnologie sind für ein hoch entwickeltes und rohstoffarmes Land wie Deutschland von zentraler Bedeutung. Die Biotechnologie hilft den deutschen Pharmaakteuren vor allem dabei, neue Produkte, Prozesse/ Verfahren und Dienstleistungen zu entwickeln und existierende zu verbessern. Dadurch kann die internationale Wettbewerbsfähigkeit gestärkt, neue Arbeitsplätze in Deutschland können geschaffen und bestehende gesichert werden.

Biotechnological methods have become an important tool in pharmaceutical drug research and development. Today approximately 15 % of drug revenues are derived from biopharmaceuticals. The most relevant indications are oncology, metabolic disorders and disorders of the musculoskeletal system. For the future it can be expected that the relevance of biopharmaceuticals will further increase. Currently, the share of substances in preclinical testing that rely on biotechnology is more than 25 % of all substances in preclinical testing. Products for the treatment of cancer, metabolic disorders and infectious diseases are most important. New therapeutic approaches such as RNA interference only play a minor role in current commercial drug research and development with 1.5 % of all biological preclinical substances. Investments in sustainable high technology such as biotechnology are of vital importance for a highly developed country like Germany because of its lack of raw materials. Biotechnology helps the pharmaceutical industry to develop new products, new processes, methods and services and to improve existing ones. Thus, international competitiveness can be strengthened, new jobs can be created and existing jobs preserved.

This paper reviews the current situation in the field of pharmacogenetics/pharmacogenomics (PGx) in Europe. High expectations surrounding the clinical application of PGx remain largely unmet, as only a limited number of such applications have actually reached the market and clinical practice. Thus, the potential impact of PGx-based diagnostics on healthcare and its socio-economic implications are still unclear. With the aim of shedding some light on these uncertainties, the Institute for Prospective Technological Studies (IPTS) of the European Commission’s Joint Research Centre (JRC) has conducted a review of the ‘state of the art’ and a further analysis on the use of pharmacogenetics diagnostics for preventing toxic drug reactions and improving drug efficacy in Europe. The paper presents highlights from the JRC-IPTS studies and discusses possibilities for improving translation of PGx research in Europe by comparing some experiences in the USA. We also illustrate the related barriers for the clinical uptake of PGx in Europe with specific case-studies. Most of the barriers identified extend beyond the European context. This reflects the global problems of scarcity of data demonstrating proven clinical validity or utility and favorable cost-effectiveness studies to support the clinical application of PGx diagnostic tests in the clinical setting. Another key barrier is the lack of incentives for the private sector to invest in the development and licensing of PGx diagnostic tests for improving the safety and efficacy of out-of-patent drugs. It therefore seems that one key aspect where policy can affect the clinical uptake of PGx is via sustaining large-scale industry-academia collaborations for developing and proving the utility of PGx diagnostics.

Against the background of a number of first drug–diagnostic co-products developed and introduced into the European market, European decision-makers feel impelled to react and position themselves in the field of personalized medicine. Their reactions cover a broad range, from the analysis of knowledge requirements for market approval to the need for translational activities and the possible contribution of pharmacogenetics to public health. This article summarizes the current positions of European institutions, based on literature review and expert consultation for three items associated with personalized medicine: biobanks, genetic diagnostics and drug–diagnostic co-products, and provides an outlook on requirements for an effective future European policy on personalized medicine