In order to comply with the so-called Excessive Deficit Procedure (also known as the corrective arm) established by the European Union pursuant to Article 126 of the Treaty on the Functioning of the European Union (TFEU), Spain established in its agenda to reduce its government deficit to 3% of gross domestic product (GDP) by 2013. For this reason, the Spanish Government has enacted various urgent measures to cut public spending.
In light of this, in May 2010 the Spanish Government passed Royal Decree-Law 8/2010, of May 20, on extraordinary measures to reduce Government deficit (RDL 8/2010) which entered into force on 25 May. RDL 8/2010 regulates different areas including, inter alia, employment, social security, and as expected, public health.
New measures introduced by RDL 8/2010 which affect medicinal products for human use and medical devices
RDL 8/2010 lays down a number of deductions on the price of medicinal products and medical devices financed by the Spanish Healthcare System. The medicinal products and medical devices affected by these measures and the amounts to be deducted from their prices are the following:
- Medicinal products for human use supplied by Pharmacy Offices (article 8 RDL 8/2010): a 7.5% deduction should be applied to the industrial price (i.e. the price at which pharmaceutical laboratories sell medicines to pharmacy offices).
- The same percentage (7.5%) should be applied to purchases of medicinal products for human use financed by the Spanish Healthcare System through its hospital pharmacies, pharmacy services of the regional health care centres and primary health care institutions (article 9 RDL 8/2010). However, in this case, the deduction must be applied to the award price in public tenderings of each medicine.
- In the case of Orphan medicinal products or “orphan drugs” (medicines used to treat rare diseases), the abovementioned discounts (articles 8 and 9) should be reduced to 4% (article 10 Paragraph 2 RDL 8/2010).
- The deductions stipulated by the new Royal Decree also affect medical devices (article 11 RDL 8/2010). A 7.5% discount should be deducted from the final selling price of those sanitary products included in the pharmaceutical assistance program of the Spanish Healthcare System. For urinary incontinence products, the discount rate will be increased up to 20%.
However, RDL 8/2010 will not be applicable to generic medicinal products and medicines affected by the reference price system for medicinal products (article 10 Paragraph 1 RDL 8/2010), unless, in this latter case, the medicinal product forms part of an inactive compound (article 8 Paragraph 3 RDL 8/2010).
In any case, to avoid any questions that may arise regarding the medicinal products affected by RDL 8/2010, the Spanish Ministry of Health has published on its website a list of “medicines affected by the deductions Royal Decree-Law 8/2010, of 20 May, on extraordinary measures to reduce Government deficit” which will be updated monthly (see http://www.msps.es/en/profesionales/farmacia/pdf/listado_medicamentos_RDL_9_2010.pdf).
When will the discounts apply? (Fourth Transitory Provision of RDL 8/2010)
In order to establish when the obligation to apply the abovementioned discounts enters into force, RDL 8/2010 distinguishes again between:
- Medicinal products for human use and orphan drugs supplied by Pharmacy Offices: the deductions should be applied to supplies of medicinal products and orphan drugs as from 1 June 2010.
- Purchases of medicinal products for human use and orphan drugs financed by the Spanish Healthcare System through its hospital pharmacies, pharmacy services of the regional health care centres and primary health care institutions: the deductions should be applied to the purchases formalised as from 1 June 2010.
- Medical devices: Medical devices affected by RDL 8/2010 must be marketed at the new selling price as of 25 June 2010.