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Regulation of the medical sales industry

As a patient you’d probably like some assurance that any drug or surgical procedure being provided to you has been ‘certified’ in some way as being safe, effective and likely to benefit you, either in the short or long term? Most of us would agree that this is a fair expectation on your part.

Equally though, healthcare practitioners need to feel secure that when they prescribe a particular drug, use a surgical instrument, or perform a procedure of some kind using a medical device, then they too, are protected by some ‘body of evidence’ showing that the therapy is safe, effective and beneficial for their patient.

So how does a medical sales industry, which by its very nature is driven to sell more product, meet both of these needs and requirements whilst maintaining its position in the marketplace?

Well to put it simply:

  • · Their products must be proven to be safe, effective and beneficial

  • · Government bodies mandate strict regulations in each country or region

  • · There are numerous self-regulating bodies across the industry globally

  • · Post-market mandatory reporting of any issues or problems

These government bodies and industry regulators differ in their requirements and expectations around the globe and, as you might expect, some countries are stricter in the application and enforcement of these rules than others. Equally, the penalties that are applied for any breach of the rules (which, by the way, are incredibly substantial - no ‘slap on the wrist’ fines in this game), can again vary greatly, depending on the administering authorities. It’s important to understand though, that all proven breaches are regulated by law and can be applied to both the parent company and the employee (that’s the rep), with equal voracity. This one thing alone, has significant impact on regulating behaviors not just at the rep level, but all the way to the top!

The overall message is that medical sales companies and the ‘ethics’ of their approach to the market are certainly kept in check, at least in the western world, so that patients and treating practitioners can all feel very secure. These government ‘regulations’ and industry based ‘codes of conduct’ are regularly reviewed and updated, so that all parties are directed to behave in a unified fashion.


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