Lawyers, judges, and courts monitoring and enforcing obedience to laws and rules


How is this group defined?


This group involves all legal professional as far as they are concerned with any aspects of personalised medicine. This includes lawyers supporting law makers in parliament to encode political decisions into the “legalise” of laws and executive orders. Also the many lawyers involved in writing and interpreting regulatory rules for hospitals, health care providers and insurers are part of that group. And last, not least, the attorneys and judges dealing with health care claims in courts, when rules seem to have been broken or parties cannot agree on terms of settlement for whatever disagreements they might have. 


What are the major roles of this group in personalised medicine?


Especially the lawyers actually writing the laws and providing the guidelines for interpretation and application are at the forefront of determining the impact on personalised medicine. After all this is the codex everything else is held to defining the space and boundaries of potential actions. About equally important is how the courts and judges interpret these rules in their decisions and rulings of individual cases. 


What is the major impact of this group on the development of personalised medicine?


There are two almost equally important fields directly influenced and controlled by laws and lawyers. The first is of course, which methods can be used for personalised medicine. Hot topics here would be gene editing (somatic and/or germline) and any therapeutic approach based on stem cells, again somatic and or embryonic. Currently, there is a general tendency to avoid germline or embryonic stem cells. Any changes made at these critical tissues would not only affect the treated individual but all children and further generations. It is hardly possible to even estimate the long-term effects of such interventions. 

The second part concerns data protection and is of vital interest to all developments in medicine and especially personalised medicine. Of course, nobody really wants to make all medical data publicly available (except for special interest groups, who still would object on a personal basis). On the other hand without access (controlled and anonymised) we will never find out whether a new treatment worked or did not help or even harmed the patient. Of course, a general argument is that everybody can decide on this on their own. However, in reality most people just follow the defaults set by the laws. If these are biased towards NOT-sharing then getting the required data for the development of personalised medicine becomes an uphill battle. Opt-in or opt-out make a huge difference!


Fig. 33 Legal professions

With whom has this group the most important interactions?


Funny enough NOT with the people most affected by their work, except when representing plaintiffs suing some doctors, hospitals, or insurances. Most of the ground work is being done in direct contact with politicians or large organisations of health care providers or insurers. 


What is required of this group to further the development and application of personalised medicine?


Well, first of all a profound level of information about personalised medicine at least on a layman’s level would be a great complement to all their legal expertise. This would help them to understand early on where laws and rules contain impractical or outright impairing sections that should be revised immediately. In my opinion lawyers involved in any part of legal conduct (law making, law enforcing, legal challenges) pertinent to personalised medicine should give and seek feedback from scientific and medical experts in the field. This might help to mitigate a lot of tensions before they end up in court.  


What’s coming up next?


Next week it’s time to have a look at politicians, the guys officially responsible to turn their voters wishes into politics. 

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