regulatory policy and the location of bio pharmaceutical foreign direct investment in europe this paper examines the relationship between cross country differences in drug price regulation and the location of biopharmaceutical foreign direct investment fdi in europe simple theory predicts that price regulation in one country might affect total investment but not the location of that investment if sales are global nevertheless some manufacturers threaten that the introduction of price regulation in a country will motivate them to move their investments to other countries are such threats cheap talk or is there evidence that firms avoid price controlling countries when making fdi location choices we use data on 527 investments initiated in 27 european countries between 2002 and 2009 and find that investors are less likely to choose countries with price controls after controlling for other determinants of investment we also observe a relative decline in investment in countries that increased the stringency of regulatory regimes during our sample period the effect is restricted to non manufacturing investments and is most robust for those related to administrative functions

comparing approval procedures for new drugs we analyse how drug approval procedures influence the incentives of pharmaceutical firms to commercialise new drugs in the presence of international reference pricing since 1995 the european medicines agency ema coordinates a centralised approval procedure for specific new drugs in the eu with such a centralised procedure the ema grants simultaneous drug approvals for all eu countries alongside non centralised procedures coexist for approvals of other new drugs and approvals can be sequential we focus on the effects of the exogenous timing of drug approvals either simultaneous or sequential and we compare the effects of centralised versus non centralised procedures on the firms incentives to commercialise new drugs in different markets in a context of international reference pricing we show that a centralised procedure limits the number of countries where the firm commercialises new drugs compared to a non centralised procedure we also show in a simplified framework that countries are better off with non centralised procedures while pharmaceutical firms in theory prefer the drug to be approved everywhere as soon as possible as in an early centralised procedure this is in line with the stated objective of the ema to generate savings for the pharmaceutical firms

authorized generic entry prior to patent expiry reassessing incentives for independent generic entry abstract originators seek to mitigate the loss of monopoly power by authorizing generic entry prior to patent expiry off patent competition may be adversely affected if authorized generic entry substantially lowers the attractiveness of subsequent generic entry this study assesses the impact of authorized generic entry on independent generic entry in recent cases of patent expiry in germany the results of a recursive bivariate probit regression accounting for the endogeneity of authorized generic entry show that authorized generic entry has no significant effect on the likelihood of generic entry business scope expansion and rent seeking motives drive authorized generic entry decisions

a four nation study of thee relationship between marketing effectiveness corporate culture corporate values and market orientation the aim of this study was to establish the ways in which senior executives in four countries which shared a common language united kingdom united states australia and new zealand characterized both their firm s marketing effectiveness and corporate culture and beliefs results give support to those theorists who advance cultural specificity as the primary moderator of top managerial attitudes but also emphasise that the best predictor of marketing effectiveness is similar in all four nations the primacy of the importance of people and with quality

taxes intermediate goods and relative prices the case of variable coefficients abstract price effects of an output tax in sector 1 and an equivalent production subsidy in the second industry are analyzed in a general equilibrium model each commodity satisfies final demand and uses two primary inputs and the other good as an intermediate product production coefficients are variable and demand is elastic in a leontief model with fixed coefficients metzler showed that price of the taxed good will rise and price of the subsidized good will fall this result generally holds under less restrictive conditions also although it is sometimes reversed how the topic relates to the tax incidence literature is also discussed

international effects of national regulations external reference pricing and price controls under external reference pricing erp the price that a government permits a firm to charge in its market depends upon the firm s prices in other countries in a two country home and foreign model where demand is asymmetric across countries we show that home s unilaterally optimal erp policy permits the home firm to engage in a threshold level of international price discrimination above which it is just willing to export if the firm faces a price control abroad or bargains over price with the foreign government an erp policy can even yield higher home welfare than a direct price control

value added taxation in the ec after 1992 abstract this paper examines the quantitative effects of the transitional system of value added taxation for intra ec trade between 1993 and 1997 as recently adopted by the ecofin council first the administration of the current destination principle and the interim solution are described a short representation of the empirical general equilibrium model featuring seven ec regions and 14 production sectors follows finally the effects of a switch to the transitional system are evaluated by using numerical simulations the adopted provisions with regard to cross frontier sales to final consumers open tax arbitrage possibilities which favour low tax countries at the cost of their ec partners when decomposing welfare effects international tax revenue shifts prove to dominate while substitution effects have relatively little influence on economic welfare

the role of firm characteristics in pharmaceutical product launches this paper examines the determinants of new pharmaceutical launches since 1980 in the g7 nations using discrete time hazard models despite the obvious incentive to amortize the large sunk costs of drug development over many markets entry occurs in only 4 of the opportunities the results indicate that firm characteristics such as domestic status and experience in the local market are important in explaining product launches in addition to market characteristics also the interaction between the innovating firm and target country is a critical component of profitability new drugs are 1 5 times more likely to be launched in markets that share a border or a language of a drug company s country of headquarters even for multinational firms the effect of competition depends on the characteristics of both the potential entrant and the incumbents domestic entrants prefer to compete with domestic incumbents although this is an industry with the potential for ubiquitous licensing and low transportation costs the specific match quality between the innovating firm and market conditions remains an important determinant of entry

sales growth of new pharmaceuticals across the globe the role of regulatory regimes prior marketing literature has overlooked the role of regulatory regimes in explaining international sales growth of new products this paper addresses this gap in the context of new pharmaceuticals 15 new molecules in 34 countries and sheds light on the effects of regulatory regimes on new drug sales across the globe based on a time varying coefficient model we find that differences in regulation substantially contribute to cross country variation in sales one of the regulatory constraints investigated i e manufacturer price controls has a positive effect on drug sales the other forms of regulation such as restrictions of physician prescription budgets and the prohibition of direct to consumer advertising dtca tend to hurt sales the effect of manufacturer price controls is similar for newly launched and mature drugs by contrast regulations on physician prescription budgets and dtca have a differential effect for newly launched and mature drugs whereas the former hurts mature drugs more the latter has a larger effect on newly launched drugs in addition to these regulatory effects we find that national culture economic wealth and lagged sales also affect drug sales our findings may be used as input by managers for international launch and marketing decisions they may also be used by public policy administrators to assess the role of regulatory regimes in pharmaceutical sales growth

international orientation as a precondition for export success every country particularly if it depends on foreign trade to such a high degree as the federal republic of germany has a vital interest in exploiting all its export opportunities the authors have developed a measurement concept focusing on the foreign orientation of business managers their empirical research suggests that as many as one third of the small and medium sized firms with a primarily domestic focus in their country could be turned into successful exporters the paper not only reveals obstacles to exporting as perceived by the managers of these companies but also points to specific measures to improve the efficiency of existing export promotion programs

cross national price differences for pharmaceuticals how large and why bilateral drug price and quantity indexes based on comprehensive data for seven countries us canada france germany italy japan and the uk refute the conventional wisdom that us drug prices are much higher than elsewhere for laspeyres us weighted indexes previous drug price comparisons are biased by unrepresentative samples and unweighted indexes quasi hedonic regression shows that cross national price differences reflect differences in product characteristics and in their implicit prices which reflect the regulatory regime strict price regulation systematically lowers prices for older molecules and globally diffused molecules generic competition lowers prices in less regulated regimes which also have more price elastic demand

intermediate goods and the incidence of the corporation income tax abstract intermediate goods are introduced into a general equilibrium model of the incidence of the corporation income tax several theoretical conclusions about the role of such goods are established many well known propositions about the incidence of the corporation income tax emanating from models with only final goods need to be modified estimates from u s data suggest that if intermediate goods are left out results will be misleading especially if these goods are a relatively large sector in the economy and possibilities of substituting capital for labor in their production and of substituting them for other productive factors in the final good industries are rather limited

price regulation and parallel imports of pharmaceuticals abstract this paper studies the effects of price regulation and parallel imports in the on patent pharmaceutical market in a theory model where the producer price is subject to bargaining between the brand name producer and a distributor we show that the effects of stricter price regulation crucially depend on whether the producer faces competition from parallel imports while parallel imports improve the bargaining position of the distributor price regulation counteracts this effect and may even be profitable for the producer we test the implications of our model on a unique dataset with information on sales and prices at both producer and retail level for 165 substances over 4 years 2004 2007 we show that stricter price regulation reduces competition from parallel imports and has no strictly negative effect on producer profits in the presence absence of parallel imports our results suggest that price regulation might improve static efficiency without being harmful for dynamic efficiency in the presence of parallel imports

is american health care uniquely inefficient evidence from prescription drugs abstract alan garber and jonathan skinner 2008 famously conjectured that the us health care system was uniquely inefficient relative to other countries we test this idea using cross country data on prescription drug sales newly linked with an arguably objective measure of relative therapeutic benefits or drug quality specifically we investigate how higher and lower quality drugs diffuse in the us relative to australia canada switzerland and the uk our tabulations suggest that lower quality drugs diffuse more in the us relative to high quality drugs compared to each of our four comparison countries consistent with garber and skinner s conjecture

static and dynamic effects of health policy evidence from the vaccine industry public policies designed to increase utilization of existing technologies may also affect incentives to develop new technologies this paper investigates this phenomenon by examining policies designed to increase usage of preexisting vaccines i find that these policies were associated with a 2 5 fold increase in clinical trials for new vaccines for several diseases the induced innovation is socially wasteful though small in magnitude in one case however the dynamic social welfare benefits from induced innovation exceed the policies static benefits from increasing vaccination with existing technology these findings underscore the importance of including technological progress in economic analysis of public policy

pharmaceutical price controls and entry strategies abstract this paper finds that the use of price controls has a statistically and quantitatively important effect on the extent and timing of the launch of new drugs firms headquartered in countries that regulate price reach fewer markets than those in countries without price controls companies avoid price controlled markets and are less likely to introduce products in additional markets after entering a price controlled country launches into low price european countries are further delayed following legalization of parallel imports the results suggest that price regulation in one country affects entry into other countries and may affect the strategies of domestic firms

pharmaceutical innovation and parallel trade abstract this paper proposes a north south model to study the interaction between price regulation policies and parallel trade with a particular focus on the pharmaceutical sector we show that under parallel trade r d investment can rise only when the south government takes into full account its impact both on investment and on the firm s decision to supply the regulated country this arises because of a complete withdrawal from price regulation when policy choices are endogenized indeed the south wants to achieve this level of full commitment when it is large in size when instead it is smaller in size the south chooses an intermediate form of commitment whereby it anticipates its effect only on local distribution and delivery but not on global r d investment as a response to these credible levels of price control commitments the north reacts by allowing parallel imports from the south

characteristics of demand for pharmaceutical products an examination of four cephalosporins we model demand for four cephalosporins and compute own and cross price elasticities between branded and generic versions of the four drugs we model demand as a multistage budgeting problem and we argue that such a model is appropriate to the multistage nature of the purchase of pharmaceutical products in particular the prescribing and dispensing stages we find quite high elasticities between generic substitutes and also significant elasticities between some therapeutic substitutes

state government promotion of manufacturing exports a gap analysis this study empirically examines the level of the export related expertise of manufacturing firms in a midwestern state of the united states various problems they face in export business and types of government assistance desired by their stage of export involvement it also investigates the appropriateness of government export assistance and the gap between governmental export promotion efforts and private sector needs it is shown that the identification of expertise problems and government assistance needs by export stage can help government agencies develop a systematic approach to export promotion

price controls in liberia abstractin 2009 the liberian government removed a wide reaching set of price controls compared with goods never subject to price ceilings goods whose prices were liberalized showed increased pri

patents and the global diffusion of new drugs analysis of the timing of launches of 642 new drugs in 76 countries during 1983 2002 shows that patent and price regulation regimes strongly affect how quickly new drugs become commercially available in different countries price regulation delays launch while longer and more extensive patent rights accelerate it health policy institutions and economic and demographic factors that make markets more profitable also speed up diffusion the estimated effects are generally robust to controlling for endogeneity of policy regimes with country fixed effects and instrumental variables the results highlight the important role of policy choices in driving the diffusion of new innovations

value added tax and the theory of tax incidence abstract a value added tax is examined in a general equilibrium model of tax incidence incorporating primary factors and intermediate goods production coefficients are variable and demand is elastic the principal result is that under assumptions of fixed coefficients and inelastic demand which have been commonly employed in the literature vat as well as the corporation income tax will be neutral in the more general setting of this paper only vat applied to every industry at equal rates will not affect relative factor and commodity prices incidence and other economic effects of a partial vat are also discussed

regulating innovation with uncertain quality information risk and access in medical devices we study the impact of regulating product entry and quality information requirements on an oligopoly equilibrium and consumer welfare product testing can reduce consumer uncertainty but also increase entry costs and delay entry using variation between eu and us medical device regulations we document patterns consistent with valuable learning from more stringent us requirements to derive welfare implications we pair the data with a model of supply demand and testing regulation us policy is indistinguishable from the policy that maximizes total surplus in our estimated model while the european union could benefit from more testing post market surveillance could further increase surplus

common factors underlying barriers to export studies in the u s paper industry this paper identifies five factors that cluster belief about the importance of barriers to export held by executives in strategic business units involved in export of paper products or contemplating such export these factors were evaluated in respect to the international business literature and labeled as national export policy comparative marketing distance lack of export commitment exogenous economic constraints and competitive rivalry this analysis revealed a minor appreciation of the importance of competitive rivalry and a high appreciation of the barrier provided by exogenous economic constraints the other three factors assumed intermediate positions of importance among the five factors

measuring the degree of internationalization of a firm in spite of both positivistic and instrumental research the reliability of measuring the degree of internationalization of a firm remains speculative we collected data on nine attributes of seventy four american manufacturing mncs alpha factor and frequency analyses revealed a linear combination of five variables with a reliability coefficient of 79 as a measure of the degree of internationalization of a firm we discuss the statistical and conceptual properties of the scale and their implications for content and construct validity

price regulation and relative delays in generic drug adoption abstract increasing the adoption of generic drugs has the potential to improve static efficiency in a health system without harming pharmaceutical innovation however very little is known about the timing of generic adoption and diffusion no prior study has empirically examined the differential launch times of generics across a comprehensive set of markets or more specifically the delays in country specific adoption of generics relative to the first country of generic adoption drawing on data containing significant country and product variation across a lengthy time period 1999 2008 we use duration analysis to examine relative delays across countries in the adoption of generic drugs our results suggest that price regulation has a significant effect on reducing the time to launch of generics with faster adoption in higher priced markets the latter result is dependent on the degree of competition and the expected market size

strategic procurement openness and market structure abstract we examine strategic procurement behaviour by governments and its effect on market structure in sectors such as defence and pharmaceuticals where the government is the dominant consumer in a world economy with trade between producer countries and between producers and non producers we use a modified dixit stiglitz utility function with an independent taste for variety there is free entry and exit by firms but by anticipating their participation constraint governments can indirectly choose the number of domestic firms and their size through its choice of procurement price unlike the standard model with no independent taste for variety and no external sector of non producer countries there are incentives for subsidies openness impacts on industrial structure and procurement coordination between producer countries affects firm numbers

compulsory licensing price controls and access to patented foreign products abstract we analyze how a price control and the threat of compulsory licensing cl affect consumer access in a developing country south to a patented foreign product in the model the southern government sets the level of the price control on a northern patent holder who chooses between entry and voluntary licensing vl while entry incurs a higher fixed cost licensed production is of lower quality if the patent holder does not work its patent locally the south is free to use cl the threat of cl ensures that consumers have access to a lower quality version of the patented good when the patent holder chooses not to work its patent locally improves the terms at which vl occurs can cause the patent holder to switch from vl to entry and can delay consumer access when cl replaces vl or entry we also show that a price control and cl are mutually reinforcing instruments

the decision maker and export entry and expansion this paper examines the varied empirical findings of the relationship between firm individual characteristics and foreign entry expansion behavior the results support the view that such activity is neither exclusively determined by structural or managerial factors and is really the result of interaction between both types of variables the paper proposes that foreign entry and expansion can best be understood as an adoption of innovation type behavior

reference pricing competition and pharmaceutical expenditures theory and evidence from a natural experiment abstract we study the impact of regulation on competition between brand names and generics and pharmaceutical expenditures using a unique policy experiment in norway where reference pricing rp replaced price cap regulation in 2003 for a sub sample of off patent products first we construct a vertical differentiation model to analyze the impact of regulation on prices and market shares of brand names and generics then we exploit a detailed panel data set at product level covering several off patent molecules before and after the policy reform off patent drugs not subject to rp serve as our control group we find that rp significantly reduces both brand name and generic prices and results in significantly lower brand name market shares finally we show that rp has a strong negative effect on average molecule prices suggesting significant cost savings and that patients copayments decrease despite the extra surcharges under rp

exemption versus zero rating a hidden problem of vat abstract we examine the difference between exemptions and zero rating under a consumption based vat in a numerical general equilibrium model to allow for a better understanding of the accruing efficiency effects we first develop a method to convert the nominal vat rates into effective tax rates on categories of final demand then we show how these effective tax rates can be used to perform a gradual transition from exemption to zero rating

does regulation drive out competition in pharmaceutical markets abstract most countries regulate pharmaceutical prices either directly or indirectly on the assumption that competition is at best weak in this industry this paper tests the hypothesis that regulation of manufacturer prices and retail pharmacy margins undermines price competition we use data from seven countries for 1992 to examine price competition between generic competitors different manufacturers of the same compound and therapeutic substitutes similar compounds under different regulatory regimes we find that price competition between generic competitors is significant in unregulated or less regulated markets united states united kingdom canada and germany but that regulation undermines generic competition in strict regulatory systems france italy and japan regulation of retail pharmacy further constrains competition in france germany and italy regulation thus undermines the potential for significant savings on off patent drugs which account for a large and growing share of drug

compulsory licensing and patent protection a north south perspective in a stylized model involving a developing country called south and a foreign patent holder we analyze whether and how the incidence and social value of compulsory licensing cl depends upon the south s patent protection policy if south is free to deny patent protection cl fails to arise in equilibrium and the option to use it makes both parties worse off if south is obligated to offer patent protection cl can occur and even yield a pareto improvement the ability to control price increases the south s incentive for patent protection as well as the likelihood of cl this article is protected by copyright all rights reserved

alfred marshall lecture intellectual property rights protection in developing countries the case of pharmaceuticals patent enforcement in developing countries generates considerable controversy especially when patents involve potentially life saving drugs this paper argues that common concerns regarding the effects of patents on prices and on research incentives of pharmaceutical multinationals are misplaced rather the most significant effects are likely to concern access to patented drugs in poor countries because prices in developing countries are much lower than in the developed world multinationals may choose to enter such markets with a delay or not at all implying a complete loss of access to patented drugs in developing countries even when multinationals enter countries like india their marketing and distribution networks are not currently built out leading to limited access within the country such considerations may provide a justification for policies targeting access in the short and medium run such as compulsory licensing

the determinants of international patenting for nine agricultural biotechnology firms this paper examines international patent application decisions of nine agricultural biotechnology firms from 1990 2000 in australia brazil canada china the european patent office japan and south africa the data reveal a low frequency of international applications despite an initial united states application indicating very low values for patents abroad the results indicate that invention quality plays an important role in firms decisions to patent abroad and that a single international application is a good predictor of multiple international applications further significant country fixed effects suggest wide differences in business climates and patent enforcement among countries

profiling managers to improve export promotion targeting one of the major criticisms of government export promotion schemes in many countries is that they tend to be poorly targeted awareness levels about export schemes among managers of companies at exporting or pre exporting stages of internationalization are often quite low and the perceived usefulness of schemes may decline as companies internationalize and their needs become more specific one solution may be to develop a better understanding of the needs of managers who make export market development decisions and to target segments of managers rather than companies who share similar strengths and weaknesses this study attempts to address these concerns by devising a typology of senior international marketing managers the most senior marketing decisionmakers in a broad multi industry sample of new zealand exporting firms were surveyed the results of the cluster analysis suggest that groups of managers who share similar characteristics can be identified and profiled based on shared international business attitudes and similar levels of knowledge and skills this appears to be a useful method of segmenting international marketing managers to determine what sort of educational and export assistance particular groups may require

late stage pharmaceutical r d and pricing policies under two stage regulation 2016 elsevier b v we present a model combining the two regulatory stages relevant to the approval of a new health technology the authorisation of its commercialisation and the insurer s decision about whether to reimburse its cost we show that the degree of uncertainty concerning the true value of the insurer s maximum willingness to pay for a unit increase in effectiveness has a non monotonic impact on the optimal price of the innovation the firm s expected profit and the optimal sample size of the clinical trial a key result is that there exists a range of values of the uncertainty parameter over which a reduction in uncertainty benefits the firm the insurer and patients we consider how different policy parameters may be used as incentive mechanisms and the incentives to invest in r d for marginal projects such as those targeting rare diseases the model is calibrated using data on a new treatment for cystic fibrosis

international business education a corporate view as a preliminary step in the internationalization of business school curricula 122 major canadian corporations were surveyed for their views on the importance of various management skills and international courses as well as their opinion on the mechanisms institutions and academics for delivering them this article reports on the responses obtained and suggests methods for improving the overall effectiveness of international business education

the globalization of service multinationals in the triad regions japan western europe and north america in this study we empirically investigate the determinants of foreign direct investment of service multinationals based in the triad regions japan western europe and north america foreign investment decisions of 168 of the largest service firms in nine service industries over the period 1976 1986 are analyzed and hypotheses that are developed based on findings of manufacturing fdi and studies of single service industries are tested using a logistic regression model the applicability of the mne fdi theories to service mnes is tested empirically over a broad range of mne home countries and service industries differences in the international behavior of service mnes based in different countries are uncovered and analyzed

continuidad y desempeno exportador en la empresa peruana this paper studies the relationship between continuity of business in international markets and their export performance for this the paper focuses on the peruvian export companies during the period 2000 2008 stage where peruvian exports had continued growth the results achieved in international markets are analyzed and through probabilistic logit model establishes the relationship between continuity in these markets and the export performance measured in export sales

the consumer welfare implications of governmental policies and firm strategy in markets for medicines this paper empirically examines the consumer welfare implications of changes in government policies related to patent protection and compulsory licensing in the indian market for oral anti diabetic oad medicines in contrast to previous studies on the impact of pharmaceutical patents in india we observe and estimate the welfare effects accruing from differential pricing and voluntary licensing strategies of patent holding innovator firms three novel molecules belonging to the dipeptidyl peptidase 4 dpp 4 inhibitor class of oads have been launched in india by the patent holders at lower prices than those prevailing in the developed countries using aggregate market transaction data we structurally estimate demand and supply and use the parameter estimates in our model to simulate consumer welfare under various counterfactual scenarios our results suggest that the introduction of dpp 4 inhibitors generated a consumer surplus gain of around 7 6 cents per day for a typical dpp 4 inhibitor user under the existing differential pricing and voluntary licensing strategies if the innovators decide to price at developed country levels this surplus is eliminated almost entirely the issuance of compulsory licensing does not always improve consumer welfare because if innovators defer or delay the introduction of new drugs in response the loss in consumer welfare could be substantial