Intended for healthcare professionals


Commentary: The risk of over-regulation

BMJ 2011; 342 doi: (Published 14 May 2011) Cite this as: BMJ 2011;342:d3021
  1. C Di Mario, professor1,
  2. S James, associate professor2,
  3. D Dudek, professor3,
  4. M Sabate, professor4,
  5. M Degertekin, professor5
  1. 1Royal Brompton Hospital, London SW3 6NP, UK
  2. 2Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden
  3. 3Jagiellonian University, Krakow, Poland
  4. 4Hospital Clinic, University of Barcelona, Spain
  5. 5Yeditepe University Hospital, Istanbul, Turkey
  1. Correspondence to: C Di Mario c.dimario{at}

Regulatory bodies are expected to protect the public from the danger of inappropriately tested treatments—a shield against the vested interest of drug and device companies to sell products irrespective of their safety and effectiveness. The idea of the greedy industrialist focused on short term advantage and endangering lives with low quality components used to save manufacturing costs is familiar to the public and seems to justify stringent regulatory processes. But one person is forgotten in this equation—the doctor.

The doctor is directly accountable to the patient and is expected to have the competency and motivation to select appropriate devices and drugs. The personal ethical responsibility of every doctor towards his or her patient may get diluted in the impersonal setting of large hospitals run by governments or private health providers. Doctors have largely ceased to be independent professionals and became employees forced to follow rules aimed at maximising profit and containment of expenses. The medical industry is the main source of sponsorship for clinical trials and the main supporter of postgraduate medical education. This creates links with industry that have been overemphasised, depicting doctors like car dealers with a vested interest to “sell” products. The net result has been a shift of power in the decision making process about providing and regulating healthcare from the medical profession to …

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