The Relative Importance of Actual and Potential Competition: Empirical Evidence From the Pharmaceuticals Market Mats A. Bergmany and Niklas Rudholmz y Department of Economics, Uppsala University, Box 513, SE-751 20 Uppsala, Sweden z Department of Economics, Umeå University SE-901 87 Umeå, Sweden March 2003 Abstract We study actual and potential competition and other factors that determine price paths of brand-name drugs in the Swedish pharmaceuticals market. The results indicate that the price of the incumbent product is lowered by potential competition, entry of (additional) generics, and the introduction of a so-called reference-price system. We also identify a ”ratchet” e¤ect, through which price regulation makes entry-deterring limit-pricing credible. Key Words: Potential competition, patent expiration, limit pricing, contestable markets. JEL classi…cation: L65, I11 1 Introduction Potential competition is a central concept in economics, although perhaps less in focus today than it was during the early days of the theories of contestable markets and limit pricing. Despite the importance of the concept as a tool for economic analysis in various situations, e.g., for competition policy analysis, the strength of potential competition relative to actual competition has been the subject of relatively few empirical studies. The existing studies are concentrated in the airline industry. In the present article, we study potential competition in the pharmaceutical market. We propose the use of patent expiration dates as events that marks the onset of potential competition, while generic entry mark the onset of actual competition. The pharmaceutical market is a natural candidate for studies of the e¤ect of patent expiration. The fact that drug prices in many countries are regulated suggests a further bene…t from studying this market. Price regulation allows the incumbent to commit to a price, because it creates a ”ratchet” e¤ect. If a price is reduced, it may not be possible to increase the price again unless this can be justi…ed by increased input costs. This is true at least for the Swedish pharmaceuticals market, where prices are e¤ectively regulated. (See below.) Thus, the pharmaceutical market provides an example of a market where commitment to entry deterrence is credible. Because of its regulatory structure, the Swedish pharmaceutical market provides an interesting setting in which to test the e¤ect of potential competition when commitment to a low price is possible. The purpose of this article is to study the pricing behavior of brand-name drug manufacturers when facing potential, as well as actual, competition by generic substitutes. The hypothesis we want to test is that potential competition, which is assumed to become e¤ective upon patent expiration, has a signi…cant e¤ect on the price of such drugs. Our results show that prices fall in response to potential entry (i.e., at patent expiration), as well as in response to actual entry. The e¤ect of the onset of potential competition is of the same order of magnitude as the e¤ect of one additional entrant, a 5-8 per cent reduction in price. In line with our expectations, the e¤ect of potential competition is the largest in relatively small markets. Section 2 demonstrates, by way of a linear example, how price regulation creates a mechanism by which an incumbent that faces potential competition can reduce prices to an entry-deterring level (i.e., to the limit price). 1 Section 3 presents the data, the estimation techniques and the results from the empirical analysis. The main results are summarized in section 4. Related literature According to the contestable-market hypothesis (Baumol et al, 1982), an incumbent monopoly …rm is sometimes completely unable to exploit its monopoly position, even if the market is characterized by increasing returns to scale. That is, in order to prevent entry, the incumbent must charge prices equal to average costs. The conditions for this to hold are that the product is homogenous, that there are no sunk entry or exit costs and, most critically, that the price charged by the incumbent is …xed for a longer period than it takes a rival …rm to enter and capture the whole market. Another theory of potential competition is the limit-pricing theory (Bain, 1949, Sylos-Labini, 1962, and Modigliani, 1958). This holds that the incumbent …rm can prevent entry - or slow entry down - by setting a ”limit price”, and then earn supra-competitive pro…ts. The limit-pricing theory comes in a number of versions, although the classical version of the theory posits that the incumbent …rm commits to a ”limit quantity”, such that the residual demand is insu¢cient for the potential entrant to break even. The incumbent can charge the ”limit price” corresponding to the limit quantity and earn higher-than-normal pro…ts. Under the assumptions of the contestable-market hypothesis, no rents can be extracted from an incumbency position. Under the assumptions of the limit-pricing theory, on the other hand, the incumbency position can yield relatively large pro…ts. The reason for this discrepancy is that while the contestable-market hypothesis is essentially a two-period model of price competition, the limit-pricing theory (in its classical version) is a two-period model of quantity competition. Being the …rst mover in a game of quantity competition (or, more generally, strategic substitutes) is advantageous, while being the …rst mover in a game of price competition (strategic complements) is disadvantageous (or at least not advantageous). The contestable-market hypothesis has been criticized for being based on unreasonable assumptions - i.e., that the entrant can enter more rapidly than the incumbent can change its price. The logical weakness of the (classical) limit-pricing theory is that once entry has occurred, it may be pro…table for the incumbent to raise the price. Therefore, the entrant may have reason to believe that the threat of a low limit price is not credible. This, in turn, suggests that holding down prices may not be e¤ective in preventing entry. 2 Spence (1977) and Dixit (1981) solve the inconsistency by assuming that the incumbent can sink costs by building capacity, which will lower the future marginal cost of production. This introduces a post-investment asymmetry between the incumbent and the entrants, which the former bene…ts from. Milgrom and Roberts (1982) address the weaknesses of the theory by modelling the competition between the incumbent and the entrant as a game of incomplete information. The incumbent can then use a low price to signal low marginal costs and in that way deter entry. Gilbert (1989) and Bergman (2002) survey theoretical, empirical and experimental studies of potential competition. Most experimental studies suggest that it is actual competition, rather than potential competition, that a¤ects prices and pro…ts. The persistency of high pro…t levels in concentrated industries points in the same direction, as do a number of studies of pricing in the airline industry. However, other empirical evidence suggest that potential competition can sometimes be e¤ective. There are a large number of studies concerning the e¤ect of generic entry on original-drug prices, as well as on the determinants of generic entry in the pharmaceuticals industry. The results indicate that entry by generic substitutes usually lowers the price of brand-name products, and that the most important factor in explaining entry is the expected pro…ts of the potential entrants. 1 Ellison and Ellison (2000) show how marketing, product proliferation and pricing strategies a¤ect entry by generic substitutes. They …nd that prices increase (relative to a pharmaceutical price index) during the …nal years of patent protection. After the patent has expired, prices fall for the group of pharmaceuticals where entry is predicted to be likely, and continue to rise for pharmaceuticals where the probability of entry is low or medium high. Generic competition in the Swedish pharmaceuticals market Generic entry is de…ned as the introduction of a new pharmaceutical drug sharing the same seven …gure ATC-code (as de…ned by the Swedish Medical Products Agency, SMPA) as a brand-name drug sold in the Swedish pharmaceuticals market. Generic manufacturers are the producers of such pharmaceuticals. 1 See, for example, Caves et al. (1991), Suh et al. (1999), Ferrándiz (1999) and Aronsson et al. (2001), all of whom have studied the impact of generic competition on brand-name prices and/or market shares. In addition, Scott Morton (1999), Rudholm (2001) and Ekelund (2000) focused on the determinants of entry of generic products. 3 In Sweden (and in the European Union) it is possible for the generic manufacturers to use some of the original manufacturers’ documentation, instead of having to create all documentation themselves. In particular, an applicant for a license to sell a new generic drug does not have to produce pharmacological and toxicological studies, if it can be shown that the new pharmaceutical is equivalent to another pharmaceutical product that has been approved for sale in Sweden or in another member country of the European Union, and if it is presently sold in Sweden. 2 The goal of the SMPA is that the handling of an application to sell a new generic drug should be completed within 210 days, although this goal has not been reached persistently.3 Formally, both generic and original manufacturer can set prices freely. However, in order for the patients’ costs to be reimbursed, the Swedish National Social Insurance Board must accept the prices set by the …rms. Hence, the Social Insurance Board’s role as gatekeeper of the reimbursement system in practice gives it the power to regulate prices.4 In addition, a so-called reference-price system was introduced in 1993. The system limits the reimbursement to patients who purchase pharmaceuticals to 110 percent of the price of the least-cost identical generic alternative. Similar systems have been introduced in several other countries, including Germany. 2 Another way of achieving this is to use references to published scienti…c literature to prove that the pharmaceutical has a well established medical use, with acknowledged e¤ects, and a reasonable margin of safety. The procedures described above follow the SMPA rules 1995:8 and 1993:14. The preceding rules, found in the National Board of Health and Welfare Code of Statutes 1980:90, states that the generic manufacturer must present studies concerning the bioavailability and tolerability of the generic substitute. 3 In 1999, the SMPA reported that the average time for handling an application for approval of a generic drug was 252 days, and that 40% of the applications were handled within the goal of 210 days. 4 If a manufacturer of a pharmaceutical product wants to increase the price of the product, he/she must also motivate why the SNIB should accept the price increase. This is clearly stated in the SNIB code of statutes (1996:31, 1992:20). Before 1992, price regulations were upheld by a law (SFS 1981:49), which stated that in order for a pharmaceutical to be reimbursed, price negotiations had to be conducted with the SNIB. Informal contacts with employees at the SNIB con…rm that price increases are only allowed if the manufacturer can provide good reasons, such as cost increases, for the new price. 4 2 Credible limit pricing under price regulation: a linear example In this section we show with a simple linear model how an ability to commit not to increase prices provides the incumbent with a mechanism for entry deterrence. The incumbent sets a limit price, i.e., a price that is low enough that entry is just prevented. Without a credible commitment not to increase the price and in the absence of informational asymmetries, the incumbent cannot deter entry by reducing price. Whether entry occurs or not depends only on the post-entry pro…t opportunities in the market and the entry costs. Hence, in that situation, there is no point in reducing prices in advance of entry and prices will fall if and when entry occurs. In other words, there will be no e¤ect on prices of potential competition, but there will be an e¤ect of actual competition. Conversely, if entry deterrence occurs, there will be an e¤ect of potential competition. Before analyzing the di¤erentiated-products price-competition case, which we will focus on, consider the case of static price competition and homogenous products, with constant marginal costs and a …xed entry cost. If the incumbent cannot commit to a price, there will be no entry. This is so because Bertrand competition will follow upon entry, so that the …xed costs of entry cannot be recouped. Predicting this, the incumbent has no incentive to lower the price in advance of entry. Hence the incumbent will set the monopoly price. In such a setting, there is no advantage in being able to commit to a …xed price or to a maximum price, since the monopoly pro…t can be obtained without making a commitment. On the contrary, if the incumbent has to commit to a price, while the entrant can chose a price after observing the incumbent’s price, as assumed in the contestable-market hypothesis, prices will be forced down to average costs, but there will still be no entry. Using the same set-up, but assuming di¤erentiated products, these extreme results no longer hold. Without commitment prices will remain above marginal costs after entry and, for some parameter values, the entry cost can be recouped and there will be entry in equilibrium. To see this, let the demand for product j = 1; 2 be given by: qj = 1 ¡ pj + ¯p¡j 5 (1) for 0 < p¡j · 1 and: qj = 1 ¡ p j + ¯ (2) ¼2 = p2(1 ¡ p2 + ¯p1 ) ¡ f (3) for p¡j > 1, where pj denotes the price of product j and where 0 · ¯ · 1, and ¡j = 2 if j = 1 and vice versa. The parameter ¯ represents the degree of di¤erentiation, with ¯ = 0 representing di¤erentiated products and ¯ = 1 representing relatively undi¤erentiated products.5 Assume also that qj = 0 if pj > 1. Let the marginal cost be normalized to zero. Then the pro…t for …rm 2, the entrant, is given by: where f is the …xed cost of entry, and correspondingly for …rm 1, although without the entry cost. From the …rst-order conditions, the accommodation equilibrium (i.e., when the incumbent does not engage in entry-deterring activities), will be given by: 1 pacc = (4) j 2¡¯ qacc = j 1 2¡¯ ¼acc = 1 1 (2 ¡ ¯)2 ¼acc = 2 1 ¡f (2 ¡ ¯)2 for j = 1; 2: Note that if f > 1=(2 ¡ ¯)2, entry will be blockaded. However, if the incumbent can commit not to increase its price above a certain level, the incumbent may have an incentive to deter entry for lower values of f. The pro…t of the entrant, as a function of p1, is given by: 1 ¼2 = (1 + ¯p1)2 ¡ f (5) 4 Setting ¼2 = 0, we see that the (highest) entry-deterring price is: p 2 f ¡1 det p1 = (6) ¯ 5 Restricting ¯ to lie between 0 and 1 simpli…es the analysis, by ensuring an interior solution, so that our equilibrium solution will always be described by the expressions given in the text. 6 Pro…t under entry deterrence is given by: p µ ¶ q 2 f ¡1 det ¼1 = (1 + ¯)¯ ¡ (2 f ¡ 1) ¯2 (7) Letting ¼1det = ¼1acc, we can solve for the critical f , above which entry deterrence is pro…table (up until f = 1=(2 ¡ ¯)2 ). The numerical expression is not very enlightening, so it is not shown here. Instead, the incumbent’s optimal price (after patent expiration and, possibly, entry) for ¯ = 0:5, as a function of f, is calculated6 ; 8 > < if f < 0: 36 p2=3 p1(f ) = > 4 f ¡ 2 if 0: 36 · f · 0: 44 : 0:75 if 0: 44 < f (Entry accommodated) (Entry deterred) (Entry blockaded) In this example, entry deterrence will occur in the interval [0: 36; 0: 44], within which prices will fall when potential competition becomes possible, i.e., at patent expiration. In the high end of the interval, prices will fall relatively little,while in the lower end, prices will fall relatively much. For entry costs below the lower end of the interval, entry will be accommodated. Hence, for su¢ciently low entry costs, the incumbent’s price will not respond to patent expiration (potential competition), but it will respond to generic entry (actual competition). For su¢ciently high entry costs (above the upper end of the interval), entry will be blockaded, prices will not respond to patent expiration and there will be no generic entry. This simple example demonstrates that price regulation can create a ”ratchet” e¤ect, which in turn can make an entry-deterring limit-price credible. 3 3.1 The empirical analysis Data All data have been provided by the SMPA. The medical substances come from 7 out of the 14 existing di¤erent …elds of use, as de…ned by the SMPA. The 18 pharmaceutical substances in our sample result in a dataset consisting of 1184 observations. Data refer to prices and quantities sold, each quarter, for the 6 Before patent expiration, the optimal price will be equal to the monopoly price which is 0:75 in this example. 7 package size with the largest recorded sales volume for each substance. This results in an unbalanced data panel covering, at most, the years 1972 to 1996. The price series have been de‡ated using the consumer-price index, with 1990 as the base year, and then normalized to 100 in that year. The recalculation to index series makes it possible to interpret the results in percentage terms. The average quarterly revenue (de‡ated using the consumer price index, but not normalized to 100 in the year 1990) for each of the substances, measured in SEK (Swedish crowns) is presented in Table 1, along with some additional descriptive statistics.7 Table 1. Product and market characteristics. Substance Cimetedine Sukralfate Etacrynic Acid Atenolol Pindolol Azapropazone Diklofenac Naproxen Piroxicam Sulindac Lorazepam Oxazepam Clomipramine Lofepramine Maprotiline Miaserine Protriptyline Dipivefrin Brand Entry (date) 810911 831111 661214 780127 740301 780127 811218 810206 851108 821022 800125 660516 730525 790406 770223 900202 660623 880916 Patent Exp. (date) 790118 870220 840303 811021 840329 850112 890827 900825 800920 761205 850405 800702 891012 Gen. Entry (date) 831111 860613 881028 870213 871211 870918 930618 860626 910426 910426 940128 920527 Geni 1996 (No) 4 1 0 4 2 0 1 5 1 0 0 2 1 0 2 2 0 1 Average Revenue (SEK/q) 602 500 207 000 2 500 897 500 134 500 5 500 427 500 330 500 60 000 161 000 50 500 195 500 75 500 103 000 60 000 35 500 2 500 70 000 Pat. time (q) 0 0 30 36 40 15 9 16 15 31 3 0 14 24 0 0 34 5 ATC Code A02B A02B C03C C07A C07A M01A M01A M01A M01A M01A N05B N05B N06A N06A N06A N06A N06A S01E In the regressions below, we use the number of generic brands active in the market in each quarter, while Table 1 above report the number of generics active in the …rst quarter of 1996. 7 Some additional summary statistics for the dependent and independent variables are presented in the Appendix, see Table A2. 8 All pharmaceuticals in Table 1 are single-substance pharmaceuticals, with a sales volume exceeding 100 packages each quarter after entry, which lost patent protection during the period 1972-1990 and which belong to one of the seven selected …elds of use. This selection is motivated by problems of obtaining reliable data regarding patent expiration dates for those pharmaceuticals that are a mixture of several di¤erent medical substances. The information about patent times has been obtained from the Swedish Patent and Registration O¢ce. These data describe the patent times for the chemical substance used in the di¤erent pharmaceuticals. The brand-name manufacturer could thus have other patents concerning, for example, manufacturing procedures. Therefore, our data on the time of patent expiration need not be a perfect measure of the actual date generic entry was allowed. However, the assumption that the chemical-substance patent is the relevant one guaranteeing market exclusivity has been used in earlier studies, e.g. Caves et al. (1991). Note also that for …ve of the substances, the patent regarding the chemical substance used had already expired at the time when the pharmaceutical product in question was introduced into the Swedish pharmaceuticals market. 3.2 Estimation results We want to test the hypotheses that prices respond to the introduction of potential competition, i.e. to patent expiration, as well as to actual competition. To do that, we use the following model of the price of brand-name product i at time t8 ; pit = ®i + °1(SIZEit¡1 ¤ DP ATi ) + °2DP ATi + ° 3DREF +° 4GENit + °5(GEN93 ¤ DREF ) + °6T REND + "it (8) where ®i is a product-speci…c intercept and (SIZEit¡1 ¤ DP ATi) measures any market-size e¤ects at the time of patent expiration. DP ATit is a dummy 8 The theoretical model presented above applies to individual substances (or pharmaceutical products), whereas equation (8) is designed for estimation by means of panel data. It was not possible to estimate a price equation for each individual substance, as the time series are relatively short (at least in some cases), and the price of certain pharmaceutical products do not change very often. 9 variable taking the value 1 after patent expiration for substance i: This variable will be used to measure the e¤ects of potential competition on brandname product prices. DREF is a dummy variable taking the value one after the introduction of the Swedish reference-price system in 1993. GENit represents the number of generic competitors active in market i at time t: An interaction term, (GEN93¤DREF ), is included in order to investigate if the e¤ect of the introduction of the reference price system is di¤erent for substances which faced generic competition at that time. The variable GEN93 takes the value 1 for those substances that faced generic competition when the system was introduced. This might be expected to be important, since before the reference-price system was introduced, generic copies were often priced as low as around half the price of the original. When the system was introduced, patients would then have to pay a large fraction of the price of the original, unless the original manufacturer lowered the price to 110 per cent of the least-cost generic alternative. However, generic manufacturers that entered the market after the system had been introduced were likely to choose prices just a little below those of the original manufacturer, since the original manufacturer would otherwise probably lower its price immediately. Finally, the T REN D variable has been included to capture any remaining price trend after de‡ating the price series. We also estimate a model where the variable GENit is replaced by a dummy variable re‡ecting the presence of the …rst generic competitor, DGEN1it , and three other dummy variables re‡ecting entries with two, three or four (or more) generic entrants. This is done to investigate if the e¤ect of the …rst generic entrant di¤ers from the e¤ects of additional entrants. The price equation can then be written; pit = ®i + °1 (SIZEit¡1 ¤ DP ATi ) + °2DP ATi + °3DREF + ´1DGEN1it +´2 DGEN2it + ´3 DGEN3it + ´4DGEN4it + °5(GEN 93 ¤ DREF ) (9) +°6T REND + "it Both models were estimated with the statistical software STATA, which contains estimation procedures designed to correct for the e¤ect of unbalanced panel data. We used Newey-West (1987) standard errors designed to correct for both autocorrelation and heteroskedasticity, as there were some indications of serial correlation (see Appendix). The estimation results are 10 presented in Table 2 below (except for the substance-speci…c …xed e¤ects which have been suppressed in order to save space). The model using the number of generic competitors, GENit , indicate that additional generic competitors lower the price of the incumbent as expected. The results suggest that one additional competitor lowers the price by about 8 per cent on average. The parameter estimates corresponding to equation (9) are not signi…cant for the …rst three generic entrants, although the point estimates are negative for one and three generic competitors. When there are four (or more) competitors, price is estimated to be reduced about 40 per cent. Table 2. Estimation results. Variable (Parameter) Equation 1 Equation 2 SIZEit¡1 ¤ DP ATi (°1) 0.0042 0.0039 (4.96) (4.59) DP ATi (°2) -8.06 -5.39 (-3.64) (-2.12) DREF (°3) -1.15 -0.015 (-0.58) (-0.01) GENit (°4) -7.65 (-7.10) DGEN1it (´1 ) -3.52 (-1.42) DGEN2it (´2 ) 0.42 (0.18) DGEN3it (´2 ) -15.01 (-1.84) DGEN4it (´2 ) -39.92 (-7.84) GEN93 ¤ DREF (°5) -14.25 -15.56 (-5.15) (-5.80) T REND(°6 ) -0.76 -0.85 (-17.18) (-18.80) 2 R 0.52 0.53 Note: Newey-West t-values are given within parentheses. The dummy-variable parameter representing patent expiration is negative and signi…cant in both models. We interpret this result to mean that potential competition forces small brand-name producers to lower their price 11 by between 5 and 8 per cent. Because the e¤ect of the interaction between size and patent expiration is found to be positive, the price of large brandname products is estimated to fall less. In fact, using the mean sales volume, the estimated total e¤ect on the original price is close to zero.9 This is consistent with the simple model of Section 2. Assuming that entry costs are independent of the market size, entry is likely to occur for large products, irrespective of any reasonable price reduction, while for small products, a modest price reduction may deter entry. For very small products, we again expect no e¤ect of patent expiration, since entry is likely to be blockaded (in the sense described in Section 2). However, our empirical analysis includes only products with sales above a certain threshold. If the observed price e¤ects stem from attempts by the original manufacturers to deter entry, we would expect the number of entrants to be in‡uenced by the original’s price. In fact, of the two brand-name drugs that had attracted four or more generic competitors in the …rst quarter of 1996 and which had lost patent protection during the period under study, neither had its price lowered at patent expiration. The substances are Atenolol and Naproxen. The nominal price of these products were actually raised at the time of patent expiration. In contrast, there are three substances, the price of which were lowered by more than 10 percent at the time of patent expiration: Clomipramine, Lorazepam and Dipivefrin. All of these substances had one or less generic competitors in the …rst quarter of 1996, the last quarter in this study. Hence, it seems that the …rms that adopted an aggressive pricing policy at the time of patent expiration experienced less generic competition than those who were more acquiescent. 10 The di¤erences between pharmaceuticals regarding generic competition probably also depend on the type of pharmaceuticals. Cimetedine is used in the treatment of gastric ulcer, Atenolol is used in the treatment of heart disease and Naproxen is used to treat arthritis. Note also that these pharma9 Note that the sales distribution is skewed to the right. Hence the median is smaller than the mean and therefore original prices are estimated to fall for median sales values. 10 Scott-Morton (1999) used several di¤erent model speci…cations to predict the number of potential entrants and compared these predictions to the actual number of generic entrants. However, as Scott-Morton notes in her paper, even the least restrictive approach clearly misses potential entrants who do not enter the market at all. In our setting this problem is augmented by the fact that several, if not most, entries are from ”outside” generic …rms not included in such speci…cations. Thus, we do not attempt to make any such comparisons in this paper. 12 ceuticals all have high revenues compared to the rest of the pharmaceuticals in our sample. Bae (1997) reports that these substances have a below average entry delay. That is, the times to generic entry are shorter for the substances mentioned above than for the average substance in his study. This could be interpreted as an indication that these substances are considered to be relatively attractive by generic manufacturers in the U.S. market as well. We …nd no signi…cant e¤ect of the introduction of the Swedish referenceprice system, except for products which already faced generic competition at the introduction of the system (through the interaction-term e¤ect, measured by °5). In those cases, prices fell on average 14 or 15 per cent, according to the two estimates. Aronsson et al. (2001) found that the prices of original drugs facing generic competition fell dramatically when the reference-price system was introduced. In this study we are able to qualify that result: The introduction of the reference-price system mainly lowered the prices of those incumbent products which already faced generic competition. It appears that no similar e¤ect exists for later generic entrants. These results are consistent with what one would expect. Before the system was introduced, generic entrants typically set prices far below the original, without capturing more than a relatively small fraction of the market. When the system was introduced, the original manufacturers were forced to lower their prices to a level close to that of the generics, in order for patients to be fully reimbursed. However, after the system had been introduced, generic entrants had incentives to set prices just a little below the incumbents’ prices. 4 Summary and discussion Given the importance attributed to potential competition in many situations, it is surprising that the e¤ectiveness of potential competition has not been extensively studied in industries other than the airline industry. In particular, the expiration of patents in the pharmaceutical industry provides a natural experiment to test the e¤ect of potential competition, while the generic entry that often occurs also allows us to study the additional e¤ect of actual competition. One feature of the Swedish pharmaceuticals market is that the original manufacturer normally is not allowed to increase prices. This gives the original manufacturer a commitment device. A low ”limit price” will be a credible commitment not to increase prices upon entry; hence entry can be deterred. 13 Therefore, we would expect prices to be reduced at patent expiration, at least in some markets. Of course, this mechanism will only come to play if the price regulation is relatively weak. If the price were already, because of the regulation, low enough for entry to be unpro…table, the incumbent …rm need not reduce its price further. However, in most pharmaceuticals markets, this appears not to be the case. Our results indicate that the price of the incumbent product is lowered signi…cantly by potential competition, if the quarterly sales are not too large. In addition, brand-name pharmaceutical prices are lowered by entry of generic substitutes. The introduction of the reference-price system lowered the price of those original products that already, at the time of the introduction of the system, faced actual competition. However, we …nd no e¤ect on the prices of originals whose patents have expired after the system was introduced. The estimated e¤ect of potential competition - that prices fall between 5 and 8 per cent for small products as potential competition is introduced - is larger in our study than in most studies of potential competition in the airline industry. In our study and for such products, potential competition (from all potential rivals combined) is estimated to be about as e¤ective as one additional actual competitor. In the airline studies, the price e¤ect of an actual competitor was in one study found to be three to ten times larger than the e¤ect of a potential competitor (Morrison and Whinston, 1987). However, for originals with higher sales volumes, we estimate the e¤ect of patent expiration to be signi…cantly lower. 5 Acknowledgments The authors would like to thank Thomas Aronsson, Runar Brännlund, Magnus Johannesson, Jonas Nordström, Johan Stennek and seminar participants at the universities of Gothenburg and Umeå, at the Research Institute of Industrial Economics and at the Stockholm School of Economics for helpful comments and suggestions. Research funding from HSFR and the Swedish Competition Authority is also gratefully acknowledged. 14 6 Appendix Autocorrelation coe¢cients The partial11 autocorrelation coe¢cients, ½, and their associated standard errors are presented in Table A1 for the …rst 16 lags of the residual from the least squares estimates for equations (8) and (9). The results show that there is some autocorrelation mainly in the …rst two lags of the residual. However, the autocorrelation coe¢cients rapidly decline after the two …rst lags. As the serial correlation decline as the number of lags increases, and as the number of time periods for each substance is quite large, least squares estimates are still consistent and unbiased, but ine¢cient. Thus, the use of a Newey-West (1987) covariance matrix is appropriate in order to come to terms with this problem. Table A1. Autocorrelation coe¢cients Model 1 Model 2 ½ s.e ½ s.e. "t¡1 0.51 0.16 0.51 0.16 "t¡2 0.25 0.13 0.23 0.12 "t¡3 0.03 0.07 0.03 0.07 "t¡4 0.17 0.08 0.18 0.08 "t¡5 -0.03 0.04 -0.05 0.05 "t¡6 -0.03 0.03 -0.03 0.04 "t¡7 -0.06 0.04 -0.05 0.04 "t¡8 0.06 0.04 0.06 0.04 "t¡9 -0.08 0.06 -0.07 0.05 "t¡10 -0.15 0.13 -0.14 0.05 "t¡11 0.06 0.08 0.05 0.09 "t¡12 0.10 0.06 0.10 0.06 "t¡13 -0.06 0.03 -0.07 0.04 "t¡14 0.03 0.04 0.02 0.04 "t¡15 -0.03 0.03 -0.02 0.03 "t¡16 0.01 0.02 0.02 0.02 Summary statistics In Table A2 below, means and standard deviations are presented for the variables used in the estimation of equation (8). Note that the SIZE*DPAT 1 1 I.e., controlling for independent variables and other lag lengths of the residual. 15 measure has been calculated using the o¢cial SMPA statistics which report the number of sold packages by the hundred. Although the measures are somewhat di¤erent, in order to be comparable in any way to the average revenue reported in Table 1 above, the …gures reported below have to be multiplied by 100. In addition, one can easily verify the accuracy of the mean for the reference price system dummy variable, DREF. As the reference price system was introduced in the …rst quarter of 1993 (i.e. 12 quarters before the last observations in our data) multiplying DREF by T should give a result of 12 (except for rounding errors). Taking Cimetidine as an example, 57 ¤ 0:21 = 11:97. Repeating this for all substances will give the same result. 16 Table A2. Summary statistics Substance PRICE Cimetedine 128.91 (62.51) 107.25 (17.91) 115.22 (24.24) 108.10 (35.42) 110.29 (27.96) 129.15 (32.06) 107.03 (22.87) 102.62 (401.60) 95.21 (19.23) 111.45 (21.95) 110.18 (22.50) 121.84 (35.99) 117.05 (17.12) 100.82 (9.26) 113.37 (17.39) 88.51 (6.26) 118.98 (28.23) 92.11 (13.51) Sukralfate Etacrynic acid Atenolol Pindolol Azapropazone Diklofenac Naproxen Piroxicam Sulindac Lorazepam Oxazepam Clomipramine Lofepramine Maprotiline Miaserine Protriptyline Diprivefrin SIZE *DPAT 6784.72 (5579.12) 2026.46 (658.47) 16.56 (11.24) 4693.95 (5541.21) 621.54 (648.77) 39.39 (43.01) 3397.28 (1969.06) 4824.67 (3522.17) 507.72 (402.54) 451.13 (564.90) 507.98 (189.99) 1982.80 (988.07) 957.81 (784.70) 903.01 (712.57) 665.46 (171.11) 404.95 (118.51) 11.98 (10.10) 706.75 (335.54) DPAT DREF GEN 1.00 (0.00) 1.00 (0.00) 0.71 (0.46) 0.50 (0.50) 0.55 (0.50) 0.79 (0.41) 0.84 (0.37) 0.73 (0.45) 0.63 (0.49) 0.42 (0.50) 0.95 (0.21) 1.00 (0.00) 0.85 (0.36) 0.66 (0.48) 1.00 (0.0) 1.00 (0.00) 0.65 (0.48) 0.86 (0.35) 0.21 (0.41) 0.24 (0.43) 0.13 (0.33) 0.17 (0.38) 0.14 (0.35) 0.17 (0.38) 0.21 (0.41) 0.20 (0.40) 0.29 (0.46) 0.23 (0.42) 0.19 (0.39) 0.13 (0.33) 0.13 (0.34) 0.18 (0.39) 0.16 (0.37) 0.50 (0.51) 0.13 (0.33) 0.41 (0.50) 2.79 (1.26) 0.80 (0.41) 0.00 (0.00) 1.50 1.88 0.82 (0.99) 0.00 (0.00) 0.59 (0.50) 2.40 (0.40) 0.27 (0.45) 0.00 (0.00) 0.00 (0.00) 0.74 (0.93) 0.21 (0.41) 0.00 (0.00) 0.47 (0.83) 0.54 (0.83) 0.00 (0.00) 0.52 (0.51) 17 GEN93 *DREF 0.21 (0.41) 0.24 (0.43) 0.00 (0.00) 0.17 (0.38) 0.14 (0.35) 0.00 (0.00) 0.21 (0.41) 0.20 (0.40) 0.00 (0.00) 0.00 (0.00) 0.00 (0.00) 0.13 (0.33) 0.13 (0.34) 0.00 (0.00) 0.16 (0.37) 0.00 (0.00) 0.00 (0.00) 0.41 (0.50) T 57 49 96 72 88 72 56 60 41 53 64 96 91 65 75 24 96 29 7 References Aronsson, T., M.A. Bergman and N. 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