Legal issues

Cost for research and developement (R&D) have to be in balance with expected sales and incomes (S&I). If such a situation is out of balance, e.g. by establishing toxic prices for a certain medication, legal issues about fraud must be considered.

Financial toxicity has reached the discussion of pharmacy regulators (link) and may lead to a situation, where apropriate use of such medication must be rationed (regulatory limitation).

Pharmaceutical enterprises are free to price their products in many markets including the US (link) and Europe. And retail prizes go up and up (link)

Aims to restrict free prizing to 0.5 Mia € per annum have been negociated by the German political authorities and pharmaceutical companies (link).

However, pharmaceutical companies are key players in national economies and health care systems. This reinforces their power up to a situation, where the balance between the financial possibilities of national economies and pharmaceutical financial greeds is lost.

The World Health Organization says: «Governments need to develop strategies and put appropriate legislation and sanctions into place to reduce corruption and criminal activitiy» (link).

The problem is: how can toxic pricing be defined and be made amenable to criminal complaints?

Toxic pricing can be detected in two ways, when we consider the financial input and output of a pharmaceutical company. At the input level we count for costs due to R&D, marketing and regulatory frameworks. At the output level we can observe – over time – world wide realized revenues or we can estimate expected revenues per period of time. With both methods, estimates on input and output can be made and the likelihood of discrepancies between them can be established.

Gesetzeshinweise Schweiz

Wucher im Strafgesetzbuch

Artikel 157 STG

Antitrust-Gesetz (Kartellgesetz)


Art. 32 B. Enteignung des Patentes

B. Enteignung des Patentes

1 Wenn das öffentliche Interesse es verlangt, kann der Bundesrat das Patent ganz oder zum Teil enteignen.

2 Der Enteignete hat Anspruch auf volle Entschädigung, welche im Streitfall vom Bundesgericht festgesetzt wird;

More literature

Competition law underused

Pharmaceutical companies should be aware of the risk that competition authorities in Europe may challenge their prices as ‹excessive›.

Excessive Prices and Law Overview International


Ärztekammer bemängelt Preiswucher bei Krebsmedikamenten

EU-Kommission ermittelt wegen Wucherpreisen

Priorisierung in der Medizin

Kritik der QALY basierten Gesundheitsökonomie

WHO concerns about pharmaceutic costs: