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Why is real therapeutic innovation so rare?
Leaflet N°7
28 August 2002

Medicines in Europe Forum has put down a series of amendments to the proposed European Directive and Regulation for new medicines to be compared with existing options.


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Contrary to what advertisements by pharmaceutical companies would have us believe, "innovation" does not always mean therapeutic advance, far from it! According to the National Institute for Health Care Management, for example, the figures provided by the US Food and Drug Administration reveal that only 15% of new medicines are truly innovative. Most new products are mere copies or almost copies of those that already exist and don't really fulfil the needs of patients.
Why is real innovation so rare?

In the pharmaceutical sector as in other industrial sectors, the search for maximum short-term profit and the satisfaction of shareholders have become the main objectives over the last twenty years. According to "The Economist" of 13 July 2002, mentioning the American stockbrokers Lehman Brothers, many medicines are not developed, not because they are not of therapeutic importance, but because their projected annual sales would be less than 1 billion dollars. This being the threshold above which medicines are considered blockbusters.

To achieve a two-digit (more than 10%) increase in profits, which is demanded today by investors, the pharmaceutical firms do all they can to prolong data protection, shorten the time to registration and lift the ban on advertising of prescription drugs. When a firm has put a real and profitable innovation on the market, many firms then look for a drug of the same "family" to have their share of the niche. These drugs, the "me-toos", generally do not provide further benefit and inflate the figure of the 85% of drugs which are not innovations.

Contrary to what would seem common sense, no pharmaceutical legislation and no medicines agency in the world requests that a new medicine be more effective or safer than those that already exist. Therefore "new products" are granted a licence without evidence of any therapeutic advance.

Innovation corresponding to real needs must be much more encouraged, which entails that the pharmaceutical policy should not be hostage to business priorities. The European legislation must ensure that innovation satisfies public health needs and is assessed through independent and well-conducted comparative methods.