Spain introduces exclusive pricing scheme for new orphan drugs. How will this affect International Reference Pricing?

Author – Nairuti Patel (Associate Consultant, GPI)

On 3rd March 2020, the Spanish Council of Ministers announced a ‘specific pricing system’ for orphan medicinal product that will be separate from the reference pricing system. The reference pricing system applies to all other products reimbursed by the Spanish National Health System (SNS) when their patent has expired. The only instance when orphan drugs will be included in this new system is if, there is no other medicine with the same indication approved for reimbursement in the country. If a medicine does exist, the new orphan medication must provide ‘significant added benefits’ in comparison with the available medicine.      

The main objective of this scheme is to encourage research, development and investment of the pharmaceutical industry towards therapies for orphan diseases. The Ministry of Health also explained that this system is aligned with European Regulations for orphan drugs, which consists of incentives for orphan designation holders.  

Additional details about the new system are not yet available in the public domain. However, it is expected to improve pharmaceutical provision in Spain by reducing the prices of products reimbursed by the SNS. This will promote the use of generic products, subsequently producing savings for SNS.     

From a price perspective, exclusion of orphan medicinal products from the reference pricing system also makes development and subsequent marketing in orphan therapies more attractive. The impact on markets using Spain as a price referencing country will become clear once the detailed system is published by the SNS.   

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Diego, B., 2020. Spain to grant orphan drugs exclusive pricing scheme. [Online]  
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Espana, G. d., 2020. The Council of Ministers agrees a mechanism to encourage research into treatments for rare diseases. [Online]  
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[Accessed 03 03 2020].