Update on Pharmaceutical Policy in Spain

• Abstract
• Characteristics of this policy
• Purpose and process analysis
• Expected outcome
• References

Featured in half-yearly report: G-politik in Industrieländern 10

Abstract

The ?Law of guarantees and rational use of drugs and health care products" contains very few changes with regard to the previous reforms. It is a continuation of the pharmaceutical policy whose main concern is cost-containment of the public pharmaceutical expenditure by means of strict price control and prolific regulation. Despite expectation of a paradigmatic change, significant reform has not been introduced to promote competition, nor to stimulate the growth of the generic market.

Neue Entwicklungen

The most important changes incorporated in the Law are associated with the development of the new reference pricing. It has consolidated and solidified aspects such as:

• Price reduction of 20% on all drugs in the market for more than 10 years (11 years, if they have a new indication) when a generic is not authorised in the country
• Implementation of the 'Bolar provision'
• Consolidation of contribution scale according to the volume of annual sales on the part of the pharmaceutical industry. This contribution can be reduced by up to 35% depending on the valuation of the companies according to the PROFARMA Program (valuing innovation expenses of the pharmaceutical industry). 

The two main innovations in the law are:

• Possibility of applying a gradual reduction in the industry price when the computation of the reference price suggests it is 30 % lower.
• Incorporation in the same homogeneous group with identical reference price for all the specialities with the same active ingredient (bio-equivalence) and route of administration, with the exception of those innovations that add therapeutic value for a period of five years since the innovation is approved by the inter-ministerial Price Commission, after receiving reports from the Spanish Pharmaceutical and Medical Products Agency (AEMPS). 

It has also developed other actions in pharmaceutical policy fields less significant than these (ban on discounts, prevalent role of physicians, reinforcement of medicine vigilance system).

Innovationsgrad	traditionell		innovativ
Kontroversität	unumstritten		kontrovers
Strukturelle Wirkung	marginal		fundamental
Medienpräsenz	sehr gering		sehr hoch
Übertragbarkeit	sehr systemabhängig		systemneutral
current    previous

The "Law of guarantees and rational use of drugs and health care products" (2006) contains very few changes with regard to the previous "Law of cohesion of the sanitary system"(2003). It continues the line of pharmaceutical policy which was specified in The Strategic Pharmaceutical Policy Plan issued in November 2004 by the Spanish Ministry of Health and Consumption (an overall approach to the pharmaceutical policy undertaken by the new government of the Socialist Party). The main concern of this policy is the reduction in the growth of the public pharmaceutical expenditure by means of strict price regulation based on obscure indexation and cost-plus formulae.

Similar aspects maintained in the new law are:

• Greater stringency in the law to limit the reference pricing system.
• Exclusion of public funding for the specialities affected by the reference pricing system that do not reduce their price sufficiently.
• Calculation of the price of reference, based on the arithmetic average of the cost for a daily definite dose of the three lowest-priced authorised presentations for every homogeneous set of products (bio-equivalent).
• Discretionary update frequency for the reference price.

Purpose and process analysis

Current Process Stages

	Idee	Pilotprojekt	Strategiepapier	Gesetzgebung	Umsetzung	Evaluation	Veränderung/Richtungswechsel
Implemented in this survey?

Initiators of idea/main actors

• Regierung: The Interterritorial Council is the organ where the Central Government and the Regional Governments approve the regulation development of the above mentioned Law, and where the different interests are visualized.

• Leistungserbringer: The Law tries to change the role among providers and to grant a preeminent role to physicians.

• Patienten, Verbraucher: They are supportive due to the foressen decrease of the drugs prices in the short term

• Privatwirtschaft, privater Sektor: It is the sector most opposite to the Law. They claim that reduction of prices can harm the growth and the innovation of the sector and it is possible that cause problems of shortage of supplies.

Stakeholder positions

Government

Despite the regulation that development of the law take place in the Interterritorial Council, the process has been directed by the Central Government and has given little leeway to the regional governments to promote individual initiatives.

The influence of different stakeholders (providers and private sector) exerted on the government has moderated the law and hindered the incorporation of significant changes with regard to previous policies. 

Providers

Professional organisations campaign to maintain, if not amplify, their quota of power. To promote the consumption of generics, the Law grants a pre-eminent role to doctors at the expense of pharmacists' decision in the dispensation. Through their influence, in addition to that of other collectives (e.g. nurses), prescriptions have been allowed to be replaced in certain circumstances. 

Private sector

A strong confrontation exists between Farmaindustria (National Association of the Pharmaceutical Industry in Spain) and AESEG (National Association of Generics) due to the pressure of the Employers Association of the pharmaceutical industry to support protection of a patents system that is favourable to their interests. The National Association of Generics is opposed to these prerogatives because such a measure would stifle the entry of generic products. Farmaindustria's position has consisted of promoting meetings with the different political parties to demonstrate the negative effects of this measure for the industry and the importance of the sector in the economy. In addition it has offered to establish a fund for research into strange illnesses that would contribute €300 million until 2012, on condition that the new legislation adjusting the system of patents is not applied.    

Actors and positions

Regierung
Central Government	sehr unterstützend		stark dagegen
Regionals Governments	sehr unterstützend		stark dagegen
Leistungserbringer
Physicians	sehr unterstützend		stark dagegen
Pharmacists	sehr unterstützend		stark dagegen
Nursing	sehr unterstützend		stark dagegen
Patienten, Verbraucher
Patients/Consumers	sehr unterstützend		stark dagegen
Privatwirtschaft, privater Sektor
Farmaindustria	sehr unterstützend		stark dagegen
AESEG	sehr unterstützend		stark dagegen
Pharmaceutical wholesale dealers	sehr unterstützend		stark dagegen
current    previous

Influences in policy making and legislation

The aims that the law tries to achieve, i.e. the promotion of generic products and rationalisation of consumption and pharmaceutical expenses, remain diluted in the normative development, and in the application of the law, due to the influence of different stakeholders, which has meant very slight advances in comparison to those of other countries. The pressure of these groups prevents the realisation of necessary changes to the implementation of funding and marketing systems.

Legislative outcome

Enactment

Actors and influence

Regierung
Central Government	sehr groß		kein
Regionals Governments	sehr groß		kein
Leistungserbringer
Physicians	sehr groß		kein
Pharmacists	sehr groß		kein
Nursing	sehr groß		kein
Patienten, Verbraucher
Patients/Consumers	sehr groß		kein
Privatwirtschaft, privater Sektor
Farmaindustria	sehr groß		kein
AESEG	sehr groß		kein
Pharmaceutical wholesale dealers	sehr groß		kein
current    previous

Positions and Influences at a glance

Adoption and implementation

The implementation process is developed in the Interterritorial Council, which is responsible for the development of the law, and in which the different regional governments and the State Government are represented. The voting majority of the Central Government in this institution allows it to lead the process and to become the de facto decision-maker. In addition, the aforesaid law holds that it is solely the State's responsibility, leaving the regional governments only the execution of legislation.

Monitoring and evaluation

There is no formal evaluation of the impact of this Law. The Minister of Health and Consumption has only provided a rough estimation of the direct price effect, calculating an estimated savings of €1,000 million for 2007.

The main indicator used to evaluate the impact of this Law is the savings on pharmaceutical public expenses. Other indicators are the proportion that generic drugs represent of total consumption and the evolution of the drugs prices.

Expected outcome

This new legislation does not adopt drastic changes in the funding system for pharmaceutical products that involve significant effects in the rationalisation of the consumption and the pharmaceutical public expenditure. Therefore, the scope of this reform limits the application of more intelligent funding mechanisms, such as the development of more evidence-based information sustaining measures related to selective financing according to the therapeutic added value of medicines. It would need an objective evaluation realised by an external agency, independent from the implied agents, and highly specialised. Moreover, there are no significant advances on the definition of the criteria used to establish the willingness to pay for new innovations according to their incremental cost-effectiveness in ways that have been applied in other countries  (e.g. NICE in the UK).

Although it is possible that, as in previous reforms, a reduction in short-term expenses can occur, the public expenditure in drugs can continue to increase due to (1) the weakness of the incentives to induce less expense and, (2) the lack of competition in all phases of production, distribution and sale of drugs.

Impact of this policy

Qualität	kaum Einfluss		starker Einfluss
Gerechtigkeit	System weniger gerecht		System gerechter
Kosteneffizienz	sehr gering		sehr hoch
current    previous

The impact of this policy will be moderate. Though it has meant partial improvements in different areas over the previous situation (electronic prescription, pharmacovigilance and some mechanisms to stimulate the research), it has not faced the real problems of the pharmaceutical policy, nor have there been proposed solutions with significant improvements in the efficiency and the equity of the system.

The principal deficits in these two issues are the limited role for cost-effectiveness analysis in guiding drug reimbursement and pricing, and the limited use of co-payments to discourage unnecessary consumption and facilitate more equitable access to medicines.

References

Sources of Information

• Puig-Junoy,J: The financing and price regulation of drugs in the Spanish National Health System: changes and continuity. Gaceta Sanitaria; 21 (1): 1-4, 2007
• Costa-Font,J: Pharmaceutical policy reform in Spain. Eurohealth; 12 (4): 14-17, 2007
• Law guaranteeing the rational use of pharmaceuticals and health care products (Law 29/2006)
• Various specialized newspaper articles. Available at: www.diariomedico.com, www.elmedicointeractivo.com 

Reform formerly reported in

Generic Pricing System Update Process Stages: Umsetzung, Gesetzgebung

Drug Price System Process Stages: Umsetzung, Gesetzgebung, Veränderung/Richtungswechsel

Pharmaceutical Plan For The Spanish NHS Process Stages: Umsetzung, Strategiepapier, Gesetzgebung, Idee, Pilotprojekt

Rationalizing use of drugs and health products Process Stages: Gesetzgebung

Author/s and/or contributors to this survey

Gabriel Ferragut Ensenyat

Empfohlene Zitierweise für diesen Online-Artikel:

Gabriel Ferragut Ensenyat. "Update on Pharmaceutical Policy in Spain". Health Policy Monitor, October 2007. Available at http://www.hpm.org/survey/es/b10/4