The Portuguese general scheme of reimbursement by the State in the price of medicinal products, approved by the Decree-Law No. 48-A/2010, on 13th May (“Reimbursement Regime”), and the Portuguese system of pricing of medicinal products subject to prescription and also medicinal products non subject to prescription but reimbursed, approved by the Decree-Law No. 112/2011, on 29th November (“Medicinal Products Price Regime”), were recently amended, by Decree-Law No. 19/2014 of  5th February (“DL 19/2014”), published today on the Official Public Gazette (“Diário da República”).

The main changes introduced by DL 19/2014, regarding the Reimbursement Regime are as follows:

- The main objective of the legislator was to improve the existing regime, by introducing new mechanisms which enable the public to “understand both the advantages that these medicinal products offer and the justification of the reimbursement by the Portuguese State”. The main changes to the legal regime are related to the evaluation proceedings of the medicinal products, either during the phase granting the reimbursement, or during the evaluation phase of the reimbursement;

- During the evaluation phase, the new regime expressly states that the MAH shall demonstrate the efficiency, relative effectiveness and/or the higher or equal therapeutic comparative value, presenting the findings to Infarmed - this is now listed in the annex of the Contribution Regime. This annex identifies the criteria which shall be observed either on evaluation or revaluation of the medicinal products, including the technical, scientific and economic benefit, and with reference to any alternative therapeutic made available.

-Also, under the evaluation process of the reimbursement revaluation, the new legal regime establishes that the MAH, whenever required, shall prove that the medicinal product continues to satisfy the reimbursement requirements, by demonstrating the efficiency, relative effectiveness and/or the higher or equal therapeutic comparative value, presenting the findings to Infarmed - as listed in the annex of the Contribution Regime;

- Another relevant change is that the automatic removal of the reimbursement for a medicinal product  whenever a pharmaceutical group or sub-group excludes the product from the reimbursable medicinal products list, established under the Ordinance No. 924-A/2010, on 17th September.

- The new legislation limits the price payable by the public for generic medicinal products which can be reimbursed. The limits are set at 5% lower than the maximum price payable for any generic medicinal product and 20% lower than the reference medicinal product considered for the pricing of generic medical products.

We shall now analyze the main changes introduced by the Medicinal Products Price Regime:

- Under the annual review of the pricing procedure, in reference to generic medicinal products, the MAH must apply the rules set in the annual review to prevent the unfair increase of prices. Any breach of this would mean that the MAH  is obliged to transfer the difference between the price reported by those entities and the price fixed by Infarmed to the NHS budget;

- The main and perhaps the most controversial principle of the Decree-Law No 19/2014 of 5 February, is the change made to the marketing margins of medicinal products by wholesalers and pharmacies. At the end of 2013, the government announced that it intended "a greater appreciation of the fixed price over the variable price", although this is waiting for the approval of the Council of Ministers. All prices of the medicinal products regulated by article 11 of the Medicinal Products Price Regime, shall now be decided by the fixed and variable amount. The variable amount is now subject to a substantial reduction. With this new legal regime, the variable amounts of wholesale margins will suffer, with an average decrease of eight percent, and pharmacies with an average of 20 percent.

- Finally, although not yet regulated, it is expected that the government will implement measures to encourage the supply of generic medicinal products through additional reimbursement to pharmacies.