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Winners and losers

  Marketing Authorisations  In the European Union, it has been possible since the mid-2000s for a drug's marketing authorisation to be conditional, i.e. granted on condition that the company subsequently provides data to justify full, standard marketing authorisation. The stated aim is commendable: hasten access to a drug in situations where no satisfactory options are available to patients and healthcare professionals.
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The downside, however, is that less is known about these drugs' harms and benefits. There is a higher risk that they are actually more dangerous than beneficial, and that some patients who take their chances will lose. In other words, conditional marketing authorisations certainly benefit pharmaceutical companies, but the benefits for patients are less certain...

©Prescrire 1 March 2023

Source: "Winners and losers" Prescrire International 2023; 32 (246): 73. Subscribers only.

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