Ensuring patients have access to orphan drugs
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Spain: Farmaindustria proposals for ensuring patients have access to orphan drugs


According to the pharmaceutical industry association, Farmaindustria, 40% of orphan drugs approved in Europe between 2016 and 2019 are available in Spain compared to more than 70% in France, Italy and the UK, and 90% in Germany (based on data from IQVIA, reported by Farmaindustria). It also notes that the average time taken from authorisation by the European Medicines Agency (EMA) to funding in Spain is an average of 523 days, and that 54% of orphan drugs funded in Spain are subject to “some type of therapeutic restriction”.   

In view of this data, and to ensure patients in Spain with rare diseases have access to the medicines they need, Farmaindustria puts forward a number of proposals, including: 

  • Introduce an accelerated procedure for orphan drugs which results in a decision “not exceeding three months from the start of the price setting procedure”. To this end, Farmaindustria advocates early dialogue between the regulatory bodies and pharmaceutical companies to make it more predictable when a given drug may become available to patients.  
  • Adopt specific criteria for the evaluation and funding of orphan drugs which take into account “the specificities of these drugs”. Farmaindustria suggests that the seriousness of the disease, patient need and the social value of the medicine should be considered in addition to the current criteria of budgetary impact and cost-effectiveness.  
  • Collect data on effectiveness in an “automated and digitised way” to make it easier for physicians to share data with other clinicians, patients and pharmaceutical companies.  
  • Protect the incentive system and “guarantee a specific framework for promoting research into these treatments”.  


  1., “Los medicamentos huérfanos tardan 500 días en financiarse en España, y dos de cada tres lo hacen con restricciones”, 24th February 2022 
  2., “Farmaindustria: Los MM.HH. tardan 500 días en financiarse en España y 2 de cada 3 lo hacen con restricciones”, 24th February 2022

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