Based on the Portuguese State Budget for 2015, it was created a new tax obligation about the pharmaceutical industry, designated by the “Extraordinary Contribution on Pharmaceutical Industry” (ECPI), whose conditions of payment and model of presentation – Model 28, were published on the Decree-Ruling 77-A/2015, the 16th of March.
According to the mentioned legislation, please note that the entities subject to this contribution are those that carry out the first sale in Portugal of human medicines, independently of being holders from an authorization or a registration to introduce medicines on the market, their representatives, intermediaries, wholesale distributors or mere suppliers only with permission of exceptional use of medicines.
The ECPI is levied on total sales of medicines by each quarter regarding to:
► Medicines reimbursed by the Portuguese State on its price – rates may range between 2,5% to 10,4%, depending on the medicine group
► Medicines subject to restricted prescriptions or intended for use only in hospitals – rate of 14,3%
► Medical gases and medical products derived from human blood and plasma – rate of 2,5%
► Orphan drugs – rate of 2,5%;
Search & Development expenses may be deducted up to the limit of the ECPI due, provided that they are carried out in Portugal and after being subject to duly certification from an Official Statutory Auditor (ROC).
Nevertheless, the entities subject to this contribution may benefit from a regime of exemption in case an individual agreement is celebrated between the Portuguese Government and the Infarmed, and from the entity which is adhered to such agreement on a case by case basis or in an individualized form.
The payment of ECPI is done by electronic-means, according to the Model 28, duly presented through the website of the Portuguese Tax Authorities during the following month to which the ECIP regards.
Taking into consideration that the Decree-ruling was published in March 2015, the first statement- Model 28 refers to sales made from January to March. In this sense, the first presentation and payment should be done at the end of April, 2015.