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PortugalPosted 21/11/2014

First posted: 23 February 2012 

Concerning the pharmaceutical policies in Portugal, view the research article below:

Changes to pharmaceutical policy during an economic recession

Portugal is a developing market* in the use of generic medicines. Generic medicines have been in use in Portugal since 1994 [1].

The development of the Portuguese generic medicines market has been restrained by the existence of a market for copies, which accounted for 25% of the market in 2004 [2, 3]. However, recently incentives have been introduced for products known as ‘copies’ to switch to generics by promoting tax exemption for alterations of the market authorisation and by granting a higher price (although lower than the original) while maintaining reimbursement [4].

In comparison with other Western European countries, Portugal is one of the countries spending the most on medicines. In 2008, 21.5% of the total healthcare budget was spent on medicines compared to only 9.8% in The Netherlands and 7.7% in the UK [5].

In 2009, Euros 3.5 billion was spent on medicines by Portugal [6].

The Portuguese generics market is small by international standards. In 2009, only 16% of prescriptions in Portugal were dispensed as generics, accounting for 18% of the market value [1]. Unlike all other European countries Portugal’s generics market share is higher in value than in volume [7].

Portugal has pricing regulation of generic medicines, which means that penetration of generic medicines is less successful than in countries that permit (relatively) free pricing of medicines, e.g. Germany, The Netherlands, UK [8].

The number of generic medicines has increased enormously over the years, due to the implementation of several information campaigns to promote generics (to physicians and to the general public) and to the implementation of regulatory policies [4].

As of July 2009, there are around 5,200 generic medicines (158 active substances) currently included in the reference pricing system in Portugal [7].

Generic entry leads to a 35% decrease in the generics price in Portugal. Average prices for medicines losing exclusivity, however, appear to remain at this level two years after generics entry [9].

Generic medicine prices are high compared to many other European countries [7].

Patient co-payments seem to play a role in stimulating demand for generic medicines in Portugal [2]. Around 70% of Portuguese consumers consider generics as effective as the equivalent original products [7].

The Portuguese generic medicines market has been sustained by inciting physicians to prescribe by international non-proprietary name (INN), by permitting generics substitution by pharmacists, and by a temporary increase in reimbursement of generic medicines. However, physicians face few incentives that influence their decision to permit or forbid generics substitution. Furthermore, generics substitution is not in the financial interests of pharmacists [2].

In 2007 Portugal initiated national campaigns by the health authorities involving all players, aimed at promoting generic medicines, informing patients about the bioequivalence of generic medicines, and raising awareness of the importance of using generic medicines when available [10].

With regard to parallel trade, Portugal is a major exporter due to its low prices [3]. Therefore, parallel trade does not affect generics in Portugal [4].

Portugal has a high number of generics producers present in the market, making the generics segment of the pharmaceuticals market in Portugal appear rather fragmented [11].

Portuguese-owned generics manufacturers include Bluepharma Genéricos and Generis Farmacêutica.

Key facts – contribution of generic medicines to Portugal

  • Generics substitution in Portugal produces annual savings of Euros 31 million for the healthcare system and Euros 14 million for patients [12].
  • The generics industry supplies 16% of dispensed medicines at 18% of the cost [1].
  • Generic medicines are 20–35% cheaper than their branded equivalents [13, 14].
  • In 2009, an average of Euros 329 per head of population per year was spent on medicines in Portugal compared to an average of Euros 382 in Western Europe [6, 15, 16].
  • Increased substitution of generics for the top 10 originator medicines could reduce public expenditure on the originator medicines in Portugal by 42% [2].

* In countries with developing generic medicines markets, market share of generic medicines does not surpass 40% [17].

References

1.  Associação Portuguesa de Medicamentos Genéricos (Apogen). Mercado [monograph on the Internet]. Oeiras, Portugal: Apogen [cited 2012 Feb 24]. Available from: www.apogen.pt/conteudos/SystemPages/page.asp?art_id=50

2.  Simoens S, De Coster S. Sustaining Generic Medicines Markets inEurope. [monograph on the Internet]. Brussels, Belgium: European Generic medicines Association (EGA); April 2006 [cited 2012 Feb 24]. Available from: www.egagenerics.com/doc/simoens-report_2006-04.pdf

3.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. July 2006.

4.  Pharmaceutical Pricing and Reimbursement Information (PPRI). Portugal. October 2008.

5.  Nefarma,Feiten en cijfers [Dutch] [homepage on the Internet]. The Hague, The Netherlands: Nefarma [cited 2012 Feb 24]. Available from: www.nefarma.nl/feiten-en-cijfers

6.  Business Monitor. Portugal Pharmaceuticals and Healthcare Report Q4 2010. September 2010.

7.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Access to Essential Medicines in Portugal. 2009.

8.  Simoens S. Generic medicine pricing in Europe: current issues and future perspective. J Med Econ. 2008;11(1):171-5.

9.  European Commission Competition DG. Pharmaceutical Sector Inquiry Preliminary Report. 28 November 2008.

10.  Bongers F, Carradinha H. European Generic medicines Association (EGA) Health Economics Committee. How to Increase Patient Access to Generic Medicines in European Healthcare Systems. June 2009.

11.  Glowicka E, Lorincz S, Pesaresi E, Sauri Romero L, Verouden V. Generic entry in prescription medicines in the EU: Main characteristics, determinants and effects. 8 July 2009. Available from: www.ec.europa.eu/dgs/competition/economist/prescription_medicines.pdf

12.  Grooten E. How did the new generic provisions influence generic substitution in Europe? DIA 20th Annual EuroMeeting. Barcelona, Spain. 2008.

13.  Portal da Saúde. Ministério da Saúde. Medicamentos Genéricos [monograph on the Internet]. Lisbon, Portugal: Ministry of Health [cited 2012 Feb 24]. Available from: www.portaldasaude.pt/portal/conteudos/informacoes+uteis/medicamentos/INFARMED_Genericos.htm

14.  Associação Nacional das Farmácias (anf). Medicamentos genéricos - qualidade à prova de marcar [monograph on the Internet]. Lisbon, Portugal: Ministry of Health [cited 2012 Feb 24]. Available from: www.anf.pt/index.php?option=com_content&task=view&id=711&Itemid=75

15.  European Federation of Pharmaceutical Industries and Associations (EFPIA). The Pharmaceutical Industry in Figures. 2010.

16.  ABPI. Did you know? Facts and figures about the pharmaceutical industry in the UK [homepage on the Internet]. UK: ABPI [cited 2012 Feb 24]. Available from: www.abpi.org.uk/our-work/library/industry/Documents/Did%20you%20know_Jan11.pdf

17.  Simoens S. International comparison of generic medicine prices. Curr Med Res Opin. 2007;23(11):2647-54.

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