Regulatory, Pricing and Reimbursement
The key legal info around regulation, pricing and reimbursement in Portuguese pharma. Prepared in association with Cuatrecasas, a leading law firm in Portugal, this is an extract from The Pharma Legal Handbook: Portugal, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
Jurisdiction over drugs, biologicals and medical devices is centralized in Infarmed, the Portuguese Medicine Regulatory Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.), hereinafter referred to as “Infarmed”.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
The authorization, pricing, and reimbursement of drugs, biologicals, and medical devices is governed by the following laws and regulations:
- Decree Law 176/2006, 30 August 2006 (Medicinal Products Act);
- Decree 145/2009, 17 June 2009 (Medical Devices);
- Decree-Law 97/2015, 1 June 2015, Ordinance 195-A/2015, 30 June 2015, and Ordinance 195-C/2015, 30 June 2015 (Pricing and Reimbursement of medicinal products and medical devices).
3. What are the steps to obtain authorization to develop, test, and market a product?
In order to develop and test medicinal products in Portugal, it is necessary to obtain an authorization for the manufacturing of medicinal products and to comply with the requirements established in the Medicinal Products Act for the manufacturing of medicinal products.
In addition, a medicinal product to be marketed in Portugal must hold a marketing authorization obtained via one of the following methods: (i) National Procedure; (ii) Mutual Recognition Procedure; (iii) Decentralized Procedure; and (iv) Centralized Procedure at the European Medicines Agency.
4. What are the approximate fees for each authorization?
The fee for the manufacturing authorization is approximately EUR 575.
The fees for the Marketing Authorization approval of the medicinal products are the following, depending on the type of procedure to be adopted:
|National Procedure||EUR 2.850|
|National Procedure for Generics||EUR 1.720|
|Mutual-Recognition Procedure||EUR 5.000|
|Decentralized Procedure||EUR 3.000|
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
Marketing authorizations are valid for 5 (five) years. Renewals shall be applied for no later than nine months prior to the expiration date. After the first renewal, marketing authorizations are valid for an indefinite term. In the event of duly justified reasons related to pharmacovigilance, Infarmed may require an additional 5 (five) year renewal.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
According to the Medicinal Products Act, marketing authorization for generic products is subject to the same legal process as brand-name products.
However, for generic products the process may be shorter since the presentation of pre-clinical and clinical trials is not required, i.e., provided that (i) bioequivalence is demonstrated on the basis of bioavailability studies; or (ii) therapeutic equivalence is demonstrated by means of appropriate clinical pharmacology studies. This rule applies equally for both local and foreign-owned manufacturers.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
There are no specific regulation for combined products. However, biologics are classified as medicinal products (drugs) and are subject to the same rules established in the Medicinal Products Act. Therefore, the combination of products of medical devices and medicinal products implies that both products, individually, should obtain the respective authorizations.
8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
Compliance with regulation is monitored and evaluated by Infarmed, which ensures the supervision and enforcement of the legal provisions through (i) periodical inspections and (ii) audit and reporting requirements, including of adverse reactions under pharmacovigilance rules.
The regulatory regime is based on the EU directives on medicinal products and medical devices and is in line with the European Medicines Agency expectations and requirements.
9. What is the potential range of penalties for noncompliance?
The penalties consist of fines that may range between EUR 2,000 and 15% of the turnover, or EUR 180,000, whichever is lower, and other ancillary sanctions. The latter may be applicable in case of serious violations.
The ancillary sanctions may consist of: the suspension of the authorization or license granted to the entity that has committed the infraction up to a period of two years, loss in favor of the State of objects and equipment used by the defendant, and prohibition of participating in public tenders for a period of up to two years.
10. Is there a national healthcare system? If so, how is it administered and funded?
Portugal has a Social Security System with national healthcare coverage which is regulated by the Government through the Portuguese Ministry of Health (Ministério da Saúde). The National Health System (Serviço Nacional de Saúde), better known as NHS, covers all Portuguese residents; it is universal, comprehensive and nearly free at the point of use. The National Health System is financed primarily by general taxes.
The NHS can be characterized by:
- providing universal coverage;
- providing global healthcare in an integrated way or else guaranteeing its provision;
- usually being free to its users, taking into account the social and financial position of citizens;
- guaranteeing equal access to its users, with a view to mitigating the effect that economic, geographic or other inequalities have on access to healthcare;
- regionalized organization and decentralized and participative management.
The following persons are entitled to NHS coverage:
- all Portuguese nationals;
- nationals of member states of the European Union, the European Economic Area and Switzerland in accordance with the EU regulations in place;
- foreign nationals residing in Portugal, subject to reciprocity;
- foreign nationals residing in Portugal within the framework of bilateral agreements;
- citizens requesting asylum and refugee status;
- stateless citizens residing in Portugal.
Planning and regulation take place largely at the central level in the Ministry of Health and its institutions. The management of the NHS takes place at the regional level. In each of the five regions, a health administration board that is accountable to the Ministry of Health is responsible for strategic management of population health, supervision and control of hospitals, management of primary care centers and implementation of national health policy objectives.
11. How does the government (or public) healthcare system function with private sector healthcare?
Hospitals belonging to the NHS are in the public sector, under the Ministry of Health’s jurisdiction. Private sector hospitals, both profit-making and non-profit-making, have their own management arrangements. The Ministry of Health and regional health administrations may contract with private hospitals to provide healthcare services to the users of the NHS whenever this is advantageous, especially considering the quality-cost binomial, and provided that the right of access is guaranteed
12. Are prices of drugs and devices regulated and, if so, how?
Prices of drugs are regulated by the System of Assessment of Health Technologies (SiNATS). SiNATS was created by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to pricing, reimbursement and prior evaluation procedures.
Medicinal products subject to medical prescription are subject to a price approval procedure before Infarmed prior to launch on the Portuguese market.
In this respect, a maximum sale price is approved, which in the case of brand-name products is determined by reference to the price applied in three reference countries. This price is subject to an annual revision. Spain, France and Italy are the reference countries to be considered in 2018.
SiNATS foresees the possibility of administratively setting the sale prices of medical devices and of approving their reimbursement, as well as conditioning these products to a prior evaluation procedure, similar to that which exists for medicines, with a view to being used or purchased by National Health Service hospitals.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?
There is a national reimbursement system of medicinal products, in which the Government co-pays part of the price of the medicinal products prescribed to the users of the NHS. In order for a medicinal product to be reimbursed by the Government, the holder of the marketing authorization shall submit an authorization procedure for such purpose. There are four categories of reimbursement levels that range from a co-payment by the State of 15% to 90%.
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
The sale of prescription drugs can only be made through pharmacies. The sale of OTC drugs can be made through both pharmacies and OTC retailers.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
In accordance with the Medicinal Products Act, a prescription drug can be prescribed by a doctor or, in cases specifically provided in the legislation, a dentist or an orthodontist and be dispensed by the hospital or through the pharmacies. The pharmacist shall dispense the products to the users in accordance with the medical prescription, or in case of OTC drugs, shall provide all the necessary information and indications of use to the users.