PORTUGAL Law and Practice Contributed by: Eduardo Nogueira Pinto, Hugo Monteiro de Queirós, Eliana Bernardo and Ricardo Rocha, PLMJ
• Regulation (EU) 952/2013 of the European Parliament and of the Council of 9 October 2013, which approves the Union Customs Code; • Commission Delegated Regulation (EU) 2015/2446 of 28 July 2015; and • Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015. 7.5 Trade Blocs and Free Trade Agreements Portugal is part of the EU and a single European market. It applies the principle of free movement of goods and services and has harmonised regu- latory rules for medicines and medical devices. 8. Pharmaceutical and Medical Device Pricing and Reimbursement 8.1 Price Control for Pharmaceuticals and Medical Devices Price Control for Medicines Non-reimbursed medicines have free pricing arrangements, but all other medicines are reg- ulated and subject to maximum price rules or notified price rules. They cannot be sold unless the MA holder obtains a retail price (RP). The RP of the medicine is composed of: • the ex-factory price (EFP), which is the maximum price at the stage of production or import and has fixed rules for its determina- tion; • the wholesalers’ and retailers’ selling margins, as fixed by ministerial order; • the tax on the sale of medicines; and • value-added tax (VAT). MSRMs intended to be dispensed and used in National Health Service (NHS) establishments
are also subject to maximum price rules. Their final price is composed of the EFP, the sales tax, and the VAT. The prices of medicines subject to the maximum price rules are reviewed annually. The pricing rules for medicines are set out in Decree-Law 97/2015 of 1 June 2015 and regulated by sev- eral Ministerial Orders (in particular, Ministerial Order 195-C/2015 of 30 June 2015 and Ministe- rial Order 154/2016 of 27 May 2016). Requests for price authorisation and price revi- sion communications follow their own proce- dures and are submitted to INFARMED by the MA holder. Price Control for Medical Devices As a rule, medical devices financed by the State have fixed maximum prices. Medical devices not financed by the State have free pricing. The pricing rules for medical devices are set out in Decree-Law 97/2015 of 1 June 2015, and there are Ministerial Orders that define the maximum prices applicable to certain devices or groups of medical devices, which usually include the marketing margins and VAT. In these cases, the RP proposed is indicated by the manufactur- er at the time of the request for reimbursement to INFARMED, which follows its own procedure. 8.2 Price Levels of Pharmaceuticals or Medical Devices Medicines The price of medicines is generally set and reviewed based on the prices in the reference countries with comparable GDP per capita or lowest price level, which are defined annually among EU countries.
245 CHAMBERS.COM
Powered by FlippingBook