The interesting article in this issue by Casado Buendía and colleagues begins by recalling the novelty, in the Spanish market, of generic drugs, and by describing legislative developments in detail. These new measures are aimed at favoring the use of generic drugs, and naturally, at containing public expenditure in the pharmacies. However, the study draws attention to another novel characteristic of the generic drug market in Spain, which has been little covered in the media and rarely analyzed by physicians and pharmacists: the degree to which the citizen-user-patient actually accepts generic prescriptions, and the rate of substitution of brand-name products for generic ones. The study was designed to determine the degree of acceptance by users after they had received correct information about their health problem and about the characteristics of the medication recommended and prescribed through the public health system. This is what we now know as informed consent.
Generic drugs have been on the Spanish market for a bit longer than 5 years.1 The availability of generics was followed by the establishment of reference prices for groups of pharmaceuticals. Each group listing must contain at least one generic, members must be bioequivalent, and must be identified with the initials «EQ»2. These structural changes were preceded by the elimination of public financing (the negative lists) for more than 1500 pharmaceutical products. These exclusions, undertaken by both the Spanish Socialist Workers Party in 1993 and by the Popular Party in 1997, were based on the need to contain health costs for medications, and were supported by expert commission documents such as the 1991 Abril-Matorell Report and the 1993 Report on Qualitative Indicators,3 which classified all medications available in the Spanish market according to potential quality or known therapeutic value. Current analyses based on evidence-based medicine establish different recommendations for each pharmaceutical on the basis of the quality of the scientific evidence.
These measures, requested by professional organizations4 and by Parliament, were put in place when politicians (as in Germany, The Netherlands, Denmark, Sweden and Norway) became convinced that the provisional cost containment measures taken by the Ministry of Health and Consumer Affairs (MHCA) by negotiating pacts with the College of Pharmacists and Farmaindustria, the organism that represents pharmaceutical firms in Spain (ie, a return of 0.7% to 1.6% on their investment), were insufficient, and that real costs were continuing to rise yearly at a rate greater than the gross national product.
These regulations and structural measures were aimed at modifying the supply of generics and reducing the cost of brand-name products by introducing another novelty: the possibility of copayment (the patient pays part of the total price of the product if he or she prefers a brand name that costs more than the reference price), or substitution, under certain circumstances, upon dispensation in the pharmacy. To favor cooperation by pharmacists, an increase in their profit margin for generics from 27.9% to 33% was agreed. In contrast to increasing the fixed profit margin, which is the same for all pharmacies in the country, a different approach was used for prescribing physicians in some autonomous communities, and in certain cases. Incentives and specific interventions were proposed to favor generic prescribing, with specific goals negotiated through service contracts with the National Institute of Health (INSALUD), or through specific agreements such as that negotiated with pharmacists in Catalonia.5 To favor cooperation by patients, the MHCA and autonomous communities developed a public information campaign to run for just over 20 days, at a cost of over 330 million pesetas (about 2 million euros).
One of the collateral effects of the new measures was to foment an increase in irrational dispensing at pharmacies, a result that merits a brief commentary for the purposes of stimulating debate. The most common practice is the use of a credit system in which, upon purchasing a given generic product, the buyer is given, at no extra cost, medications and other health care products whose total worth is, in some cases, more than the cost of the prescription being filled. As a result, many pharmacists fill prescriptions with a product made by a manufacturer that offers additional free products instead of the generic specified in the patient´s prescription: a practice known as substitution. This confuses the consumer because of constant changes that lead to no direct benefit, and because of apathy on the part of physicians who prefer one brand over another. The INSALUD has issued several warnings, noting that substitution of one generic for another should be the exception rather than the rule. In June 2001, the General Directorate of Pharmacy reprimanded Farmaindustria a second time for encouraging the credit system in pharmacies that dispense generics covered by the national health system.
The market for generics has leveled off, and now represents 5%-6% of all pharmaceutical costs to the national health system. This has disappointed professional groups with a stake in generics, the MHCA, and the manufacturers of generics. The MHCA has expressed its apparent satisfaction over the fact that pharmaceutical costs rose by less than 10% per year during 2000 and 2001, as a result of price decreases by brand-name companies to comply with the reference prices. But an analysis of costs during the first part of 2002 has set alarm bells ringing: in comparison to 2001, increases have averaged between 12% and 13% nationwide, with some autonomous communities reporting increases of more than 16%.
From the viewpoint of prescribing physicians, the policy of incentives should be broadened and deepened. This will be necessary to generate a culture of change in deeply-rooted habits. In addition, prescribing physicians have been pleading for the administration to lay aside its permissiveness and clamp down on instances of noncompliance with current regulations on substitute dispensing in pharmacies.6 Out of respect for colleagues who contribute their expertise to these advisory groups, an analysis of the problems surrounding indications and prescribing practices, and proposals for improvement, should not be left exclusively in the hands of experts in pharmaceutical dispensation.
As the study by Casado Buendía and colleagues shows, quite a large proportion of patients agreed to switch from a brand-name product to a generic after they had received appropriate information. Their decision rarely led to unease on the patient´s part or apprehension on the physician´s. This study supports the favorable impressions
obtained in surveys undertaken by the MHCA and autonomous communities, and in reports to the Spanish Congress and Economic and Social Council.
In summary, patients who understand and cooperate with generic prescribing once they have been adequately informed are to be commended. However, poor marks go to health authorities responsible for developing regulatory measures who use provisional, primarily economic interventions that do not emphasize or follow on from earlier, successful initiatives to create incentives for the generics market measures which have been shown to be effective and efficient.6 The provisional measures do not go to the heart of the problem, when the facts are that more than half of the annual growth in pharmaceutical costs is due to the introduction of new and more expensive drugs, and that experts continue to recommend the entry of such new products in the market. We encourage the new minister of Health and Consumer Affairs to attend to the essence of measures set down in the legislation in effect since 20002 that regulates reference prices.
