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Derechos del paciente

OCU warning over suspension of 29 generic drugs

02 feb. 2015
The Spanish Agency for Medicines and Health Products (AEMPS), following the recommendation from the European Medicines Agency (EMA) is proceeding with the suspension of marketing authorisation for 29 generic drugs. Most of them are used to treat chronic conditions.
 
En curso

To justify this suspension, the authorities allege doubts about the integrity of the data generated in clinical trials, conducted in the laboratories of GVK Biosciences, based on which the authorisation was granted. These drugs for which apparently there is an alternative available in Spain, are no longer available in pharmacies. The Spanish Agency for Medicines and Health Products (AEMPS) specified in its press release, that patients being treated with any of the products concerned have no need to stop treatment, given that to date no risk is known to exist regarding safety and effectiveness.

OCU has approached the Minister of Health to express our concern about this. We at OCU  consider the situation created to be inconsistent  because on the one hand the withdrawal of a number of medicines has been announced and on the other patients are told there are no problems in continuing their treatment. We understand that if sufficient reasons exist to suspend the sale of these drugs, the relevant health authorities (the Ministry of Health and the autonomous regions) should act to ensure replacements for drugs that have already been prescribed and that are in the possession of patients so that the correct generic equivalent is made available to them without additional cost.

As OCU understands it, this situation undermines the confidence of consumers in the health authorities of this country.
For this reason OCU requests that a system be set up to replace the medicines in question which have already been prescribed and communicate to the public, through the appropriate channels, how patients who wish to replace them should proceed.
In this context, OCU has launched a campaign about the transparency of hospital information, which is still running:

 http://www.ocu.org/salud/derechos-paciente/informe/peticion-transparencia