How is this group defined?
There are two main groups of pharmaceutical companies: The large international corporation such as Roche, Novartis, Sanofi-Aventis and several others. The second group is the collection of producers of generica, drugs that ran out of patent protection and can be produced free of royalties. Therefore, generica can be offered a lot cheaper than newer patent-protected drugs because their producers do not have to bear the enormous costs of drug development. The downside is that generica do not represent the cutting edge of pharmaceutical development.
What are the major roles of this group in personalized medicine?
Personalized Medicine, especially precision medicine, depends critically on specific, sometimes entirely new drugs, and their companion diagnostics. This its exactly what pharmaceutical development is all about. However, the pharmaceutical industry has traditionally had a hard time to fully embrace the new molecular technologies. But the managers of this industry have realised that there is no way around these technologies. The Association of the research-conducting pharmaceutical industry (in Germany), the vfa, states that on its website as follows:
“The term Panomics relates to the complete sets of biological data from the genome, transcriptome, proteome, metabolome, and all the other “-omes” together with other patient-specific information. The American Society of Clinical Oncology (ASCO) defines the term as follows: “”The interaction of all biological functions within a cell and with other body functions, combining data collected by targeted tests ... and global assays (such as genome sequencing) with other patient-specific information.”…”The development in the field of -omics technologies holds a great potential for biopharmaceutical research. New approaches in diagnostics and stratified medicine become possible.”
Fig 27 Pharmaceutical industry
What is the major impact of this group on the development of personalized medicine?
Currently, 51 drugs are available, which belong to personalized medicine. This includes only such drugs that either require a companion test or where such a test is recommended. 46 drugs have a mandatory test, for 5 more the specific test is recommended. This clearly shows the strong influence of the pharmaceutical industry on the development of personalized medicine. The top-management of parma-industry determines if and which new drugs become available for MDs for personalized treatments.
With whom has this group the most important interactions?
The pharmaceutical industry is subject to several legal requirements necessitating intense communication with several partners. Approval of new drugs for market entry is highly regulated, and the requirements are in part responsible for the steep increase in costs of drug development. Since 2011 Germany prohibits the pharma-industry from setting prices for new drugs on their own. Prices need to be negotiated with the GKV (the association of all health care insurers). That way the pharmaceutical industry is forced to negotiate with heath care insurers. Of coursde, MDs and scientists are also important partners for application and research, respectively. Direct patient contact on the other hand is not a major concern of pharma industry.
What is required of this group to further the development and application of personalized medicine?
Basically this has been nicely summarised by Birgit Fischer, the chief managing director of the vfa: “The transition from debating distribution to debating care needs to be based on data. This way information technology in therapy becomes a power source for the benefit of the patients. However, currently too much relevant data is distributed to various locations within the health care system. Save and accepted interfaces are required for all players which are transparent for patients.”
One could add that the part of preventive diagnostics is still in its infancy. This field requires more intense efforts. Unfortunately, this meets with strong sceptical views on the side of health care insurers who are still not convinced about the costs effectiveness of such measures. Which in turn is caused at least in part by the lack of comprehensive data collections, see above.
What’s coming up next?
Next week we come to the group, that has to foot the bills, literally: health care insurers.