The manner in which healthcare in Portugal is organised has been subject to many changes in the past few years. Organic changes have taken place regarding which state entities are responsible for centralising purchases for state hospitals. Public tenders to select suppliers for the Portuguese National Health System (NHS) have been launched through electronic platforms, and there have also been some changes regarding the entity that organises such public tenders. These changes have created some difficulties for pharmaceutical industry players that sell to NHS hospitals. Furthermore, public expenditure cuts have affected the prices of medicinal products that are reimbursed by the NHS, and have driven the government to propose the creation of a further tax applicable to pharmaceutical industry sales. A draft of a new Health Law, proposed by the government, is currently being discussed, pursuant to which the financing of the hospitals of the Portuguese NHS will be managed according to multiannual plans, and in which measures will be taken to make health services more affordable to patients, particularly those in need of recurrent assistance from the NHS.
The extraordinary charge on the pharmaceutical industry (designated as ‘a special charge on the pharmaceutical industry’) was created by the 2015 State Budget, approved by Law 82-B/2014 of 31 December, which entered into force on 1 January 2015 and will be maintained in 2019, with the aim of ensuring the sustainability of the NHS, in terms of its expenditure on medicinal products, which applies to entities that are carrying out the first sale of a medicinal product for human use in the Portuguese territory, both where such entities are holders of marketing authorisations or registrations, or are their representatives, intermediaries, wholesale distributors or suppliers holding exceptional use authorisations or other exceptional authorisations for use of medicinal products, remained in force for 2016 and now again for 2018. The extraordinary charge is applicable to the amount of the quarterly sales of the following medicinal products:
- medicinal products that are reimbursed by the NHS;
- medicinal products that are subject to a restricted medical prescription;
- medicinal products that are sold through exceptional or special use authorisations (eg, named patient authorisations);
- medicinal products that are medicinal gases, or human blood or plasma-derived products;
- packaged medicinal products aimed for use in hospitals; and
- orphan medicinal products.
The amount of the extraordinary charge varies between:
- 2.5 per cent for reimbursed medicinal products included in homogeneous groups or not included in homogeneous groups for which a marketing authorisation has been granted at least for 15 years and with a price inferior to €10; medicinal gases and derivatives from human blood or human plasma; and orphan medicinal products;
- 10.4 per cent for reimbursed medicinal products not covered by the 2.5 per cent rate; and
- 14.3 per cent for medicinal products subject to a restricted medical prescription, as well as those that have an exceptional use authorisation or exceptional authorisation or are intended for hospital consumption.
The sales amount to be considered regarding medicinal products that are reimbursed by the NHS will correspond to the portion of the sale price to the public that is reimbursed by the NHS after deducting VAT and another charge on the marketing of medicinal products (called a ‘tax on the sale of commercialised medicines’).
This regime provides an exemption of payment of the extraordinary charge by all entities that, individually and unreservedly, adhere to the agreement between the Portuguese state, represented by the Finance and Health Ministries and the Portuguese Pharmaceutical Industry Association (Apifarma), which sets the goals for maximum amounts of public expenditure with medicinal products and of charge according to the sales volume of the pharmaceutical industry companies in order to attain such goals. The entities that adhere to the mentioned agreement shall declare it to Infarmed (the Portuguese National Agency for Medicines), and are exempted from the payment of the extraordinary charge; however, they will nevertheless be subject to another charge under specific terms of the mentioned agreement.
The extraordinary charge shall be paid through a declaration with an official template (which was approved by Ministerial Order 77-A/2015 of 16 March) and the non-compliance of this obligation results in the compulsory collection of the charge by the tax authorities.
Organisation of healthcare
The Portuguese Constitution establishes the right of all Portuguese citizens to benefit from public healthcare, which is provided through a healthcare system that should cover the whole population and that should be universal. Citizens of other member states of the EU may be entitled to public healthcare in accordance with the applicable EU rules. Foreign citizens that are resident in Portugal may also benefit from public healthcare provision in the case of a reciprocal agreement with the foreign national’s state.
The main principles and rules governing public healthcare and the structure of the healthcare system are established in the 1990 Health Law (Law 48/90, 24 August 1990).
Hospitals, healthcare centres for outpatients and other entities included in the NHS comprise the healthcare providers in Portugal. The NHS depends on and is financed by the state and the public budget. Private entities and professionals may also render healthcare services to NHS patients pursuant to agreements with the entities representing the Health Ministry.
All of the services and institutions of the NHS fall under the supervision of the Ministry of Health, which is ultimately responsible for the healthcare sector and defining the government’s national healthcare policy.
Successive governments have continued to organise and reorganise the NHS through the years, mainly since 2002, specifically regarding the nature and functioning of the hospitals integrated in the NHS and the creation and extinction of public bodies and entities.
In 2002, rules were approved respecting health-related public-private partnerships (Decree Law 185/2002, 20 August 2002) and the rules clarifying the legal framework applicable to each type of hospital integrated in the NHS (Law 27/2002, 8 November 2002) were amended by Decree 18/2017 of 10 February 2017.
Hospitals may have different legal forms. Some remain public hospitals, but the majority are now public corporate entities, which are regulated by public law rules but have a certain degree of autonomy with regard to their management. The quality of healthcare services and equipment, generally speaking, is not at stake. The main discussion point regarding the NHS has been the excessive cost for the public budget.
At present, Portugal is divided into five health regions with healthcare centres serving the outpatients of each region, and approximately 225 hospitals, of which 110 are public hospitals, 111 are private hospitals and four are public-private partnerships.
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