Amendment to the Spanish law on guarantees and rational use of medicines and medical devices

As published in the Spanish Official Gazette on October 30th, further amendments have been made to the Spanish Royal Decree 1/2015, of 24 July, which approved the revised text of the law on guarantees and rational use of medicines and medical devices. The original Spanish text can be found here. The Spanish Law on general budget for the State for 2016 published these modifications, which shall be applicable from 1 January 2016. The key modifications are as follows:

  • Article 4.6: the limit to offer discounts up to 10% for medicinal products financed by the National Health System is no longer applicable. Therefore, the limitation for such discounts is deleted (though the other conditions to effect discounts provided in the article still have to be met).
  • Article 14.2: generics shall have to be identified with the acronym “EFG”. The current version of the law provides that such acronym shall only be used if specified by the Spanish Agency.
  • Articles 87.4 and 89.5: the current positive discrimination of generics in case of prescription by active ingredient with the same price as the branded product has been deleted. Likewise, such positive discrimination shall no longer be applicable when the prescription is made by branded product and the pharmacist has to substitute the product for one with a lower price.
  • Article 94.7: as a general rule, the price for medicines financed by the National Health System shall be lower or equal to the price of such medicine outside the system.
  • Article 102.2: only patients with an official prescription or dispatch order shall be subject to user contributions in outpatient pharmaceutical benefit.
  • Article 123: certain fees are amended.

There is also an amendment to Royal Decree 177/2014 on reference pricing providing for certain required internal information prior to issuing the yearly Ministerial Order approving such prices.

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Published on 18. November 2015 in News EU