Policies and Legislation

First posted: 14/10/2011

First posted: 17 October 2011 

Concerning biosimilars policies in Spain, view the following related article:

Biosimilar policies in Spain

Spain does not have a coherent generic medicines policy and there is no generic medicines competition within the existing regulatory frameworks [1].

A reference price system (RPS) was introduced in Spain in December 2000 and is annually updated [2].

In November 2004, the Spanish Minister of Health presented a Strategic Pharmaceutical Policy Plan (Plan Estratégico de Política Farmacéutica para el Sistema Nacional de Salud Español) to guide the Spanish Health Administration for the following four years. The key lines of this plan were laid down in a package of 67 policy measures in order to achieve a more rational use of medicines and in order to contain public spending on medicines [3].

In 2006, a new pharmaceutical law was approved and came into force: the Law of ‘Guarantees and the Rational Use of Medicines and Health Products, Law 26/2006’. The new law replaced the Spanish Medicines Law of 1990 and, among others, introduced a modified RPS. The new law also incorporated into Spanish Law the European Directive 2004/27/CE on the Community code relating to medicinal products for human use and Directive 2004/28/CE on the Community code relating to veterinary medicinal products [3].

Physicians have no major incentives to prescribe generic medicines and are neither obliged nor stimulated to prescribe by international non-proprietary name (INN) [4].

Pharmacists are financially penalised for dispensing generic medicines [4].

The limited price difference between originator medicines and the highest-priced generic medicine does not provide an incentive for patients to buy generic medicines [4].

Intellectual property
The nature of the Spanish patent system up until 1992 contributed to the success of the market of copies in Spain. The system allowed for processes to prepare medicines to be patented rather than medicines themselves [4].

In 1992, new legislation was introduced recognising product patents [4].

In legislation passed in 1996, the term ‘generic medicine’ was outlined and the requisites for registration of a generic medicine were specified. This legislation clearly distinguished generic medicines from copies, clearing up previous confusion surrounding these concepts [4].

Data Exclusivity
Under Directive 2001/83/EC, data exclusivity extending for six years after European marketing authorisation was granted in Spain. This however was changed to an 8+2+1-year system, which was adopted in 2004. The first generic medicines applications under the 8+2+1-year data exclusivity period will not occur until late 2013 [5].

Throughout the 1990s, medicine prices in Spain tended to be lower than in other countries [6]. In 2010 they were 23% below the EU average (Euros 25) [7], a rise of just 1% from 2009 [8].

Spain has taken a number of measures to reduce medicine prices and encourage price competition. The introduction of the 2000 RPS was accompanied by mandatory price reductions of copies to the level of the reference price (RP) in 2000 and a 15% decrease in the price of active substances if their price exceeded the average price of the three cheapest medicines in the homogeneous group by more than 15% in 2001. Direct pricing regulation made marketing authorisation of new generic medicines conditional on setting their price below the level of the lowest-priced medicine in the homogeneous group [4].

In 2003, pricing regulation established the price of the first generic medicine at least 30% below the price level of the originator medicine. Moreover, the price of a generic medicine cannot exceed the RP [4].

Generics follow the same pricing procedure as other reimbursable prescription medicines without the therapeutic utility report. According to Article 93.3 of the Spanish Pharmaceutical Law, generics included in the RPS must be priced at, or below, the RP level [3].

Reference Pricing
A RPS by active substance was introduced in Spain in December 2000 [2], and is annually updated and progressively expanded to cover most off-patent medicines [4].

The RPS is applied to off-patent drugs with the same active ingredient (bioequivalence). All the pharmaceutical products included in the same homogeneous group (identical RP) are bioequivalent, and at least one of them has to be a generic product [2].

For each homogeneous set of products the RP is calculated with respect to the average, weighted by volume of sales, of the lowest-priced medicines that make up at least 20% of sales. If the difference between this average price and that of the highest-priced medicine in the group is less than 15%, the RP is set at 90% of the highest price (achieving at least a 10% saving). If the difference exceeds 50%, the RP is set at 50% of the highest priced medicine. The RP cannot be lower than the lowest-priced generic medicine [2].

The RPS was initially applied to a small proportion of the pharmaceutical market: 114 homogeneous groups containing 590 medicines, which accounted for 10% of public pharmaceutical expenditure [2].

In 2003, some features of the RPS were changed. Homogeneous groups were enlarged to include all presentations and pharmaceutical forms (except for retard and paediatric forms) of the same active substance. The RP was calculated as the average of the three lowest costs per daily defined dose for each pharmaceutical form of an active substance [4].

In 2004, 200 pharmaceuticals were added to the RPS, and by 2007 the RPS covered 4,406 presentations, 133 active ingredients and 150 groups [3].

The current Spanish RPS is different from the system applied in other European countries, mainly because it works as a maximum price system for those pharmaceuticals included in the homogeneous groups. In addition, patients do not have the option of paying the difference between the RP and the pharmacy retail price of the pharmaceuticals [3].

Incentives for physicians
The prescribing behaviour of physicians is assisted by computerised prescribing and a medicine database [4].

In most Spanish regions, primary care physicians can earn additional annual lump sums if they meet targets relating to, for example, generic medicines prescription rates. The impact of such measures is likely to be limited as these incentive payments make up approximately 2% of the physician’s gross salary [4].

Physicians are not obliged or stimulated to prescribe by INN [4].

Incentives for pharmacists
The implementation of the 2000 RPS was supported by the ability of pharmacists to substitute generics for originator medicines (unless the patient specifically demands the originator medicine or the prescriber specifically excludes it) [3, 4].

Generics substitution by pharmacists encountered physician resistance [4], although no evidence of its effect on substitution rates has been discovered.

A new system of regressive pharmacist margins was introduced in 2000. For medicines with an ex-factory price at or below Euros 78.34, pharmacist margins were set at 33% for generic medicines compared to 27.9% for non-generic medicines. For medicines priced above Euros 78.34, pharmacist margins were fixed at Euros 33.54 [4].

Currently, pharmacists receive a margin of 27.9%, irrespective of whether it concerns an originator or generic medicine [4].

In 2003, explicit rules governing generics substitution by pharmacists were specified. Generics substitution of brand-name (originator) medicines depends on the price of the medicine. If the medicine price is lower or equal to the RP, the pharmacist has to dispense the brand-name medicine. If the medicine price exceeds the RP and the medicine class contains generic medicines, the pharmacist is required to dispense the cheapest generic medicine [4].

This, in effect, means that medicines priced above the RP are excluded from public reimbursement. If the medicine price is higher than the RP, but generic medicines in the class are not available or are not included in the list of medicines reimbursed by the NHS, then the pharmacist has to dispense the brand-name medicine, but at the level of the RP [4].

If the physician prescribes by INN, the pharmacist must dispense the cheapest generic medicine in the medicine class or the brand-name medicine at the RP level in the absence of a generic medicine [4].

The Spanish Ministry of Health and Consumer Affairs Ministerial Order SCO/2874/2007, passed on 28 September 2007, specifically excludes certain medicines, due to their particular therapeutic or pharmacological characteristics, from substitution by pharmacists, without express permission from the prescribing physician [9]. This includes all biotechnology medicines [4].

Incentives for patients
Spain operates a percentage co-payment system for medicines prescribed by NHS physicians, which ranges from 0% to 40% depending on the type of patient and medicine [3, 4]. Exemptions from co-payment include retired people (0% co-payment) and people with chronic diseases (10% co-payment) [3]. In 2008 the Spanish people paid on average 6.6% of the cost of prescription drugs [10].

The Spanish government has launched several advertising campaigns to inform patients of generic medicines [3].

Policy analysis
Key factor aiding the development of the generic medicines market

  • Patient co-payments are slightly lower for generics [4].

Key factors hindering the development of the generic medicines market

  • Historically, the Spanish generic medicines market has been small due to the existence of a developed market of copies and low medicine prices [4].
  • Competition created by the 2000 generic medicines policy benefited pharmacists rather than patients, thus inhibiting demand for generic medicines [4].
  • The 2003 generic medicines policy encouraged companies to reduce prices of originator medicines to RPs that are set close to marginal costs, thus limiting the profitability of, and demand for, generic medicines [4].
  • Medical students are not taught to prescribe by INN.
  • Few incentives exist for physicians to prescribe generic medicines [4].
  • Pharmacists are financially penalised for dispensing generic medicines [4].
  • The limited price difference between originator medicines and the highest-priced generic medicine does not provide an incentive for patients to buy generic medicines [4].


1.  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.

2.  Martínez E, Puig J. Generic Pricing System Update (Spain). Health Policy Monitor, March 2003. [monograph on the Internet]. Westphalia, Germany, International Network Health Policy & Reform [cited 2011 October 14]. Available from: www.hpm.org/en/Surveys/CRES_Barcelona_-_Spain/01/Generic_Pricing_System_Update.html

3.  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.

4.  Simoens S, De Coster S. Sustaining Generic Medicines Markets in Europe. April 2006. [monograph on the Internet]. Brussels, Belgium, European Generic medicines Association (EGA) [cited 2011 October 14]. Available from: www.egagenerics.com/doc/simoens-report_2006-04.pdf

5.  European Generic medicines Association [EGA]. Data Exclusivity. [page on the Internet]. Brussels, Belgium, EGA c2004 [cited 2011 October 14]. Available from: www.egagenerics.com/gen-dataex.htm

6.  Rovira J, Darba J. Pharmaceutical pricing and reimbursement in Spain. Eur J Health Econ. 2001;2(1):39-43.

7.  Hospital Pharmacy Europe. Study shows UK drug prices 7% below EU average. 23 April 2007.

8.  PharmaTimes. Spain aims to save 1.3 billion euros through drug price cuts. 17 May 2010.

9.  Medical News Today. Spain Prevents Automatic Substitution Of Biological Medicines, Providing Clarity For Pharmacists And Patients. 13 October 2007.

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

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