First posted: 14 October 2011
The Spanish pharmaceutical market is poorly developed* in the use of generic medicines. Generic medicines have been in use in Spain since July 1997 [1].
In comparison with other Western European countries, Spain spends rather a lot on medicines. In 2008, a total of 22% of the total healthcare budget was spent on medicines compared to only 9.8% in The Netherlands and 7.7% in the UK [2].
Spain is Europe’s fifth largest pharmaceutical market [3], however, the Spanish generics market is small compared to other European countries, such as Germany and the UK. In 2010, generics accounted for only 24% of the total pharmaceutical market by volume and 9.4% by value [4].
A total of 5,105 generic medicines containing 187 active substances have been approved by the Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) [5].
Spain 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 and the UK [6].
Medicine prices in Spain in 2010 were 23% below the EU average and rose just 1% during 2009 [7].
In Spain, the limited volume of generic medicines consumption in combination with low medicine prices has undermined the economic viability of the generic medicines market [6].
The legacy of counterfeit products, along with reference pricing, which erodes price differentials between off-patent brands and generic versions, as well as the few incentives for physicians to prescribe generics or for pharmacists to dispense cheaper alternatives, also undermine the generics market. Because of these factors, generics consumption in Spain remains among the lowest in the EU, although the Spanish market is characterised by high use of biologicals and a rapid uptake of new products [8].
A new decree, passed in the first half of 2010, is expected to have a negative effect on the generics industry, particularly in 2011. The decree includes changes in the reference price system, along with price cuts for generic medicines, and the creation of a central purchasing agency, and some other ‘minor’ measures [9].
Spain is one of the lowest priced markets in the EU and, as a consequence, one of the leading parallel exporters of pharmaceuticals. However, during more recent years parallel import has started to play a role in Spain because of lower prices for pharmaceuticals in new Member States of the EU [1].
Key facts – contribution of generic medicines to Spain
- The generics industry supplies 24% of the dispensed medicines at only 9.4% of the total cost [4].
- Increased substitution of generics for the top 10 originator medicines could reduce public expenditure on the originator medicines by 33% [6].
- Generic medicines in Spain cost 30–50% less than the original price of their brand-name equivalents [5].
- The generics industry in Spain in 2009 directly employed 6,500 people and indirectly 26,000 [10].
- In spite of the low rates of penetration of generics in Spain, savings generated from 1999 until 2008 were an average of Euros 1,050 million annually [10].
- Additional savings of Euros 1,400 million annually could be made if all unprotected medicines were sold as generics [10].
- In 2007, an average of Euros 471 per head of population per year was spent on medicines in Spain compared to an average of Euros 328 in the EU-27 [11].
* In countries with developing generic medicines markets, market share of generic medicines does not normally surpass 40% [12].
References
1. Vogler S, Espin J, Habl C. Pharmaceutical Pricing and Reimbursement Information (PPRI) – New PPRI analysis including Spain. Pharmaceuticals Policy and Law. 2009;11(3):213-34.
2. Nefarma, Feiten en cijfers [Facts and figures] [Dutch] [page on the Internet]. The Hague, The Netherlands, Nefarma [cited 2011 October 14]. Available from: www.nefarma.nl/feiten-en-cijfers
3. AESEG. La investigación del sector farmacéutico europeo: el caso de España [Spanish] [Investigation of the European pharmaceutical industry: case study of Spain]. February 2009.
4. Ministerio de Sanidad Politica Social e Igualdad [Ministry of Health Social Policy and Equality] . Consumo de genéricos en España [Spanish] [Consumption of Generic Drugs in Spain] [page on the Internet]. Madrid, Spain [cited 2011 October 14]. Available from: www.medicamentosgenericosefg.es/consumo-genericos-espana.html
5. AESEG. Generic Medicines in Spain [Spanish] [page on the Internet]. Madrid, Spain, AESEG [cited 2011 October 14]. Available from: www.aeseg.es/english/aeseg_genericos_en_espana.asp
6. Simoens S. Generic medicine pricing in Europe: current issues and future perspective. J Med Econ. 2008;11(1):171-5.
7. PharmaTimes. Spain aims to save 1.3 billion euros through drug price cuts. 17 May 2010.
8. Pisani J, Bonduelle Y. Opportunities and barriers in the biosimilar market: Evolution or revolution for generics companies? 2006 [monograph on the Internet]. Brussels, Belgium, European Generic medicines Association (EGA) [cited 2011 October 14]. Available from: www.ableindia.org/biosimilars.pdf
9. Espicom. The Pharmaceutical Market: Spain. 13 December 2010.
10. AESEG. La industria y el mercado del genérico en España [Spanish] [The industry and the generic market in Spain]. 16 December 2009.
11. Zimmerman N. Healthcare Forum 2009. Overview on current pricing and reimbursement schemes in the pharmaceutical sector in the EU. Bucharest, Romania. 30 September 2009.
12. Simoens S. International comparison of generic medicine prices. Curr Med Res Opin. 2007;23(11):2647-54.
