Parallel Imports Research Articles

The International Legal Problems of Ensuring the Availability of Medications in Conditions of the COVID-19

In the context of the COVID-19 coronavirus pandemic, the risks of individual pharmaceutical market players or groups of players taking measures to supply medications that may lead to an economically unjustified increase in drug prices or artificially create a shortage of products are increasing worldwide.
 Aims: Finding the best way to protecting intellectual property rights for medications in conditions of the COVID-19 coronavirus pandemic.
 Methods: The methodological basis of the study was formed by an integral and coordinated system of scientific methods that contributed to the study of such a complex socio-legal phenomenon as the availability of medicinal products in conditions of the COVID-19 coronavirus pandemic. At the same time, a synergistic approach was applied, which combined the special research methods of various branches of law, pharmaceutical science and practice.
 Results: The article reveals and identifies the distinctive features of using patent protection measures and parallel imports in the drug markets of various countries of the world and the impact of the TRIPS Agreement on the availability of medications for the public in conditions of the COVID-19.
 Conclusion: For many countries, including Ukraine, the introduction of parallel imports can be efficient in the short term. Allowing parallel imports of medications has significantly fewer negative consequences for the copyright holder, since the improper quality of the products, in which the invention is used without the use of a trademark, most often does not affect the business reputation of the patent owner. Nevertheless, the chosen model of permitting the use of parallel imports to ensure the availability of medications in Ukraine remains a topical and controversial issue that requires a lot of professional discussion. Legislators should be very careful and cautious about the development and implementation of the institution of parallel imports of medications to Ukraine paying attention to the development of a whole system of quality and transparency control for procedures related to parallel imports to this country.

Drug switching in the Netherlands: a cohort study of 20 active substances

BackgroundFor a patient, drug switches are not desirable (either between a brand-name drug and a generic drug, or between two generic drugs of the same active substance). Research into the causes of drug switches, and related adverse drug reactions, is hampered by the absence of quantitative data on drug switches.MethodsWe describe the frequency of drug switches in the Netherlands for a selection of active substances. A retrospective cohort study was conducted using the Drug Information System of the National Health Care Institute in the Netherlands. We studied the Dutch patient population from mid-2009 to 2016. The selection of active substances (n = 20) was made based on a report by Lareb, the Netherlands Pharmacovigilance Centre, on adverse drug reactions related to drug switching, and we used qualitative and quantitative descriptive analyses. A drug switch is defined as the replacement of a patient’s prescribed drug with a similar drug from a different manufacturer.ResultsWe identified 23.8 million drug switches on a total of 206 million (11.6%) similar drug dispenses. The frequency of drug switches demonstrated a yearly peak in the period from January to March. In some months, for atorvastatin, losartan, pantoprazole, and irbesartan, more than 60% of similar drug dispenses were drug switches. Most drug switches (80.3%) were between two generic drugs, and 0.12% of these involved a drug from a European parallel import. The proportion of drug switches between two brand-name drugs decreased from 14.5 to 5.53% during our study period, and of these, 86.5% involved a drug from a European parallel import.ConclusionsDrug switching is common in the Netherlands, and most of the drug switches we studied are between generic drugs. The observed annual peak of drug switches is most likely explained by a specific Dutch reimbursement policy. Not only are the data valuable as is, but they also serve as a first step towards elucidating the reasons for the occurrence of these drug switches. In addition, these data can be used to put into perspective the adverse drug reactions associated with drug switching.

An analysis of technology licensing and parallel importation under different market structures

Parallel importation, also referred to as the “gray market”, is the unauthorised import of genuine-branded products into a country without the permission of the intellectual property owner. We develop a game-theoretic model to examine the issues of technology licensing and parallel importation in a setting with one leading manufacturer in a developed country (high market) that can license its innovative technology to one manufacturer in a developing country (low market). By considering that the high market is in a monopoly or in a duopoly, we investigate the impact of parallel importation on the profits of players and the unit licensing fee. Then, we analyze the leading manufacturer's optimal licensing decision considering parallel importation. We show that the leading manufacturer's profit is always worse off due to the emergence of parallel importation, no matter whether the high market is in a monopoly or in a duopoly. Nevertheless, the leading manufacturer may still have the motivation to license the technology. Interestingly, the leading manufacturer may reduce the unit licensing fee when parallel importation occurs in the duopoly setting. Furthermore, the profit of the manufacturer in the developing country may decrease when parallel importation arises, although parallel importation enhances the manufacturers’ overall market demand. The main insights extend to settings with alternative demand functions.

External Reference Pricing and Parallel Imports of Pharmaceuticals: A Policy Comparison

Governments across the world constantly use a variety of measures to contain drug costs in order to increase patient access to critical medications. External Reference Pricing (ERP), or international price comparison, is a commonly employed policy to control prices of pharmaceuticals. ERP uses the price(s) of a medicinal product in one or several countries in order to derive a benchmark or reference price for the purposes of setting the price of the product in a given country. Despite potential drawbacks, empirical studies show ERP has been successful in reducing drug prices. Another strategy that can reduce drug prices is legalizing parallel imports of drugs from low-price countries. Motivated by the differences between government policies and the absence of national price management policies in the U.S., in this paper we compare the effects of implementing ERP or authorizing parallel imports on firm profit and different social welfare measures. We find that authorizing parallel imports can result in higher firm profit and/or social welfare than using ERP. We also examine, in a decentralized supply chain, two variations of ERP that are used in practice, the ex-factory-based ERP and the pharmacy purchase price (PPP)-based ERP. We show that despite the ex-factory-based ERP being more common, PPP-based ERP can increase both firm profits and social welfare. Therefore, governments should consider using PPP-based ERP policies. Our findings help generate insights for ongoing policy discussions around measures for controlling drug prices in the U.S.

Perlindungan Hukum Pemegang Hak Cipta atas Film Impor

Since the enforcement of Law No. 19 Year 2002 on Copyright, in particular film businessmen greatly expect that the government may protect the holders of copyright on films, either domestic produced films or imported films against the practice of film pirating. To improve effectively the protection of copyright, since 29th day of July 2003, the Directorate General of Intellectual Property Right (HAKI) of the Ministry of Justice and Human Rights has appealed shopping centers not to provide any single place for businessmen to sell pirated goods. But the appeal looks running ineffectively, because no legal force being imposed to provide certainty, however the Directorate General of HAKI of the Ministry of Justice and HAM (Human Rights) issued threatening of criminal sanction or civil compensation if the Mall/Plaza management still make any violation on the provisions of prohibition to provide any single place for selling the pirated goods. The arising loss resulted from film pirating actually not only suffers a financial loss for the film businessmen but also the state in this case procured from the tax sector. According to Kompas, the state at least suffered financial loss of 11 trillion as from 2005 procured from value added tax which should be levied by the state of film and song sales. additional information this business scale of pirated films may achieve the turnover of Rupiah billions weekly. It can be imagined what will be made by the perpetrators of film pirating in order that their illegal businesses are not disrupted. However, since the 80s the issue on law enforcement, particularly in upholding and handling the copyright has never been seriously handed and completed. The issue on both parallel import and violation of Law No. 8 of 1992 likewise, especially with regard to the obligation to censor film can not be handled appropriately. Meanwhile, the holders of copyright great do hope the police institution may directly arrest the perpetrators of pirating and processes them until filing claims. But apparently from the cases handled, which may further be processed until filing the claims are some of them only. By virtue of above illustration, the prominent issue to be discussed in this writing is ineffectiveness of legal enforcement of the state against the holders of copyright of imported films. It is alleged for insufficient statutory regulations to solve the complicated problems, obscure rule of games and the officers of legal institution weakly apply the law enforcement.

PNS70 US “IMPORT-FROM-CANADA” DRUG LEGISLATION: WILL IT LOWER DRUG COSTS FOR AMERICAN CONSUMERS?

To address high prescription drug costs, the United States (US) has proposed parallel importation of patented drugs from Canada, which are sold at lower costs. The objective of this review is to assess the implications of the proposed US “import-from-Canada” legislation, using both prior Canada-US and European Union (EU) parallel trade examples. A targeted literature review (TLR) was conducted in relevant databases (EMBASE, Medline, Cochrane, PubMED, PAIS Index, and CINAHL) to identify articles relating to Canada-US parallel trade within the last 20 years (supplemented by a hand-search for EU examples). Overall, 489 articles were identified from the primary search related to Canada-US parallel trade of drugs, leading to 13 articles for analysis after title-abstract and full-text reviews. This search was supplemented by 40 articles related to EU parallel trade through hand-searching. The articles were extracted for: countries involved, relevant legislation/policies, and key findings (e.g. net policy benefits/harms, supporting evidence, etc.) using SWOT framework for analysis. It is important to note that most literature (62%) on this topic was based on opinions versus qualitative or quantitative evidence. Few articles (n=4) reported hypothesized benefits of parallel trade. Claimed benefits included: lowered drug costs, rise in virtual pharmacies, and diminished price-differentiated markets. However, several articles (n=9) identified negative factors, such as: unsustainability of reduced drug prices, threat in profitability of US pharmaceutical companies, arbitragers gaining profit (i.e. insignificant consumer savings), limited drug supply, and increased counterfeit drugs. This is reflective of outcomes observed in the EU, where parallel trade resulted in high profits for arbitragers and drug shortages in source countries. Parallel trade from Canada is unlikely to result in lowered drug costs to American consumers. As Canada implements new dramatic drug price controls (i.e. Patented Medicine Prices Review Board [PMPRB]), manufacturer response to the US legislation may be exacerbated.

Parallel imports in large developing countries

We formulate a two-stage game to examine the parallel import (PI) policies for large developing countries. Two countries, a developed (N) and a developing (S), make their PI policies in the first stage. A high-quality variety is produced in N by a monopoly firm, and a low-quality variety is produced in S by a lot of firms under perfect competition. The monopoly firm chooses the optimal pricing strategy in the second stage. We clarify how market outcomes and PI policies depend on the quality difference, the income differential, country sizes, and the weights of consumer surplus and firm profits in measuring the national welfare. Our results provide a theoretical base for developing countries to make their PI policies according to their market sizes. Discriminatory pricing is obtained when governments care about consumer surplus, while uniform pricing is obtained when governments care about firm profit.

Parallel imports and repair services

This study explores the welfare effects of parallel imports when the producer may refuse to provide repair services for parallel imported units, which reduces the degree of price convergence between countries. If the probability of the product’s breakdown is endogenously determined by the producer, permitting parallel imports could increase the probability, because a higher probability leads to a larger price gap. As a result, it is possible that prices increase and welfare deteriorates in both countries. This negative welfare effect is more likely to emerge as the liberalization of trade in goods proceeds. The prohibition of service discrimination recovers the positive welfare effect.

Economic and Social Effects of Parallel Importation of Pharmaceutical Products on Organisational Performance in Pharmaceutical Firms in Kenya

The purpose of this paper is to analyse the effect of parallel importation of pharmaceutical products on the organisational performance of pharmaceutical firms in Kenya. The paper is guided by research objectives that are focused on: the economic effects of parallel importation of pharmaceutical products on organisational performance and the social effects of parallel importation of pharmaceutical products on organisational performance. This paper concludes that the issue of economic and social effects of parallel importation and how they affect the organizational performance of pharmaceutical companies in Kenya is rich for exploration and recommends that a study be conducted focusing on parallel importation and organizational performance of pharmaceutical companies; especially now that a clear legal framework on parallel importation has been put in place.

Intellectual Property Exhaustion and Parallel Imports of Pharmaceuticals: A Comparative and Critical Review

This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspect to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights that several countries today accept parallel trade. A large of number of these countries are, however, developed countries, whereas several developing countries and LDCs instead prohibits parallel imports. This finding is perplexing, and the reasons for this restrictive approach are unclear as developing countries and LDCs need flexible policies and can largely benefit from parallel trade. In addition, despite the claim by the pharmaceutical industry that parallel trade would increase the price of medicines in these countries—as originator would increase prices due to the fear of parallel imports—medicines are sold at lower prices mostly because of governments’ pricing or after the expiration of patent protection. Based on this review, this Chapter concludes that national legislations, which are not taking advantage of the flexibility in Article 6 of the TRIPS Agreement, may consider reviewing their policies and allow parallel imports.

On the Effect of Parallel Trade on Manufacturers' and Retailers' Profits in the Pharmaceutical Sector

Differences in regulated pharmaceutical prices within the European Economic Area create arbitrage opportunities that pharmacy retailers can access through parallel imports. For prescription drugs under patent, parallel trade affects the sharing of profits among an innovating pharmaceutical company, retailers, and parallel traders. We develop a structural model of demand and supply in which retailers can choose the set of goods to sell, thus foreclosing consumers' access to less profitable drugs. This allows retailers to bargain and obtain lower wholesale prices from the manufacturer and parallel trader. With detailed transaction data from Norway, we identify a demand model with unobserved choice sets using retail‐side conditions for optimal assortment decisions of pharmacies. We find that retailer incentives play a significant role in fostering parallel trade penetration and that banning parallel imports would benefit manufacturers as well as prevent pharmacies from foreclosing the manufacturer's product. Finally, in the case of the statin market in Norway, we show that it would be possible to decrease spending and increase profits of the original manufacturer through lump sum transfers associated with a lower reimbursement price, thus decreasing price differentiation across countries.

Legal protection of cross-border use of intellectual property

The paper analyzes the issues of legal regulation of cross-border use of intellectual property on the example of the Eurasian Economic Union. Among the key problems of cross-border use of intellectual property within the Eurasian Economic Union (EEU) is the need to create a unified system of registration of trademarks and service marks and elimination of double registration of trademarks, establishment of common approaches to the problem of admissibility of “parallel imports” within the EEU, and the creation of an effective patent system. The authors conclude that the development of legal regulation of the use of intellectual property in cross-border relations will follow the path of adoption of normative acts within the framework of regional unions of states, taking into account the specifics of their economic and social development, as well as the way of improvement of national legislation, taking into account the position of states on this issue.

Analysis of omeprazole and esomeprazole obtained from traditional pharmacies and unlicensed internet websites using Raman spectroscopy, 1H-NMR and chemometric analysis

The relevant therapeutic outcomes obtained with the use of proton pump inhibitors for the treatment of gastric conditions have an important reflection on the prescribing habits of clinicians of primary and secondary care organizations. With the attempt to reduce their financial impact on the health systems, generic medications, obtained both from tradition distribution chain and from parallel import, have represented the main type of proton pump inhibitors used in clinics recently. The effect of parallel import and the use of the internet as an international distribution network significantly facilitates the entry of falsified medicines in the official channels of distribution. Since the interchangeability of different omeprazole preparations has been previously questioned, in this study we used Raman and 1H-NMR to characterise different omeprazole and esomeprazole formulations produced by different manufacturers and obtained from both traditional pharmacies and from unlicensed internet market in order to establish if any differences could be found to substantiate any different clinical performances. A chemometric study of Raman spectra allowed partial separation indicating that there are not sufficient chemical differences for PCA groups to be established using this analytical approach and for these specific medications. On the contrary, NMR investigations allowed the identification of impurities in internet samples, not detected by the Raman analyses, making this technique a valid candidate analytical tool to adopt for the investigation of falsified medicines.

Parallel Importing in Australia: What Is the Objective and Is It Being Achieved?

The Australian law on parallel importing of trade marked goods appears to be inconsistent with the objectives of that law. A combination of the new legislation in 1995 and case law since that legislation has led to the erosion of a regulatory scheme which was previously more tolerant of parallel importing. The position that has emerged is that in many circumstances, parallel importing will constitute an indefensible infringement of a registered trade mark. Even if it would not constitute an infringement, a potential parallel importer will be unable to determine in advance of importation whether or not that importation will be lawful. The effect of the latter position is that potential parallel importers will be disinclined to engage in that practice and a de facto prohibition or impediment to parallel importing will exist that is inconsistent with the objectives of the law. In addition, some trade mark owners will be unable to prevent parallel importing simply because of the particular business structures that they have adopted, while some other trade mark owners will be able to take advantage of different business structures to effectively prevent parallel importing.

The myth of price convergence under economic integration: A proposed explanation for the difference in food prices across European countries

Conventional globalization theory states that regional economic integration will precede price standardization across participating countries due to the increased buying power of large retail groups and parallel imports. The resulting price corridor should merely reflect differences in logistic costs and short-term, local competitive actions. Yet, this study uses panel data from 25 European countries to examine how hefty food and beverage price differentials between regions remained constant over the last decade. Income, store productivity, and market concentration all contribute to the explanation for regional price differences. These findings suggest that, contrary to straight-line globalization theory, large European retailers’ decisions can influence price convergence and maintain important price dispersion between economically integrated countries. We provide recommendations to enhance market integration.

Liberalization of parallel imports regulations and marketing strategies of international corporations.

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CONSIDERING THE PROSPECTS OF PARALLEL IMPORT

The issue of parallel import is сomplex. The problem has geopolitical nature. The price of the existing ban is billions of dollars in overpayment for imported goods per year, because of it, the structure of domestic trade in Russia is extremely monopolized: no one can supply goods other than official importers. The article analyzes the typology of import, clarifies the concept of «parallel import», studies the difference between parallel import and counterfeit, etc. It has been concluded, that in Russia parallel import is still in a semi-legal status and efforts should be made to legalize it and establish state control. The movement in this direction was the Resolution No. 8-P / 2018 of the Constitutional Court of the Russian Federation.

Parallel Importing and the Blurred Lines of the Digital Age: The Implications of Avoiding the Geo-Block

New Zealand removed copyright law restrictions on parallel imports in order to improve the well-being of consumers by lowering the prices of and increasing access to goods. Avoiding a geo-block can achieve the same results and has been seen as the digital age equivalent. This essay assesses the accuracy of referring to the circumvention of a geo-block as a parallel import. It addresses the theoretical underpinnings of parallel import and how they are affected by the nature of digital transactions. Lastly, the paper looks at how, regardless of parallel importing, circumventing the geo-block can restore the balance to copyright law and provide benefits to both producers and consumers.

Rethinking Trade Mark Exhaustion: Does Australia’s New Defence Offer a Way Forward?

Despite the strong economic case in favour of liberal trade mark exhaustion rules, both the parallel importation of legitimate goods, and the sale of second-hand goods, have come to be treated with a high degree of scepticism in legislatures and courts around the world. Given how restrictive most jurisdictions’ laws on trade mark exhaustion have become, it is important to consider whether there are other ways WTO Members could approach exhaustion and, if so, what a model for reform might look like. In this regard, it is highly instructive to look at recent developments in Australia. With the introduction of a new defence to infringement contained in section 122A of the Trade Marks Act of 1995, which came into effect on August 25, 2018, Australia now has the most liberal trade mark exhaustion regime of any major jurisdiction. In summary, the new defence applies if the parallel importer or reseller reasonably believed that the mark was originally applied to the goods by or with the consent of the owner, or a range of other parties, with “consent” being defined in exceptionally broad terms. In a reversal of the typical onus of proof, if an importer/reseller forms such a reasonable belief it will not be liable for infringement unless it persists in its conduct after information as to the lack of consent to application of the mark is brought to its attention. And, crucially, the defence does not in any way turn on whether the imported/resold goods have been altered, repackaged or relabelled, or if there are material quality differences between the imported/resold goods and those supplied locally by or under the licence of the mark owner. This paper provides context for the new Australian exhaustion laws, showing that Australia, over the course of the twentieth century, had recognised the benefits of facilitating the parallel importation of legitimate goods, but that since the mid-1990s an overly restrictive approach had come to be taken by the legislature and courts. It then examines the liberal new section 122A defence in detail, analysing its scope by reference to the more restrictive pre-2018 case law, and showing how it operates more favourably to importers and retailers than any other set of exhaustion rules in the world. It then uses the recent Australian reforms as a springboard for a broader reconsideration of whether trade mark exhaustion rules in other jurisdictions should be liberalised, showing that the Australian approach is underpinned by different ways of thinking about exhaustion—namely, as to the proper scope of registered owners’ rights, as to what sort of conduct by importers and owners we want to incentivise, and as to how risk should be allocated between such parties.

Efficient Traffic Estimation With Multi-Sourced Data by Parallel Coupled Hidden Markov Model

Traffic congestion estimation in arterial networks with sparse GPS probe data is a practically important while substantially challenging research issue. The effectiveness and efficiency of the existing GPS probe data-based traffic estimation models are largely limited due to the following two challenges. First, due to the low sampling frequency of GPS probes, probe data are usually sparse, especially for some road links not located in the central urban areas. Second, due to the very complex temporal and spatial dependencies among the road links, the variable space of the existing traffic estimation models is huge. It is time consuming to get an accurate estimation of a large arterial road network with thousands of road links. To address the above-mentioned issues, this paper proposes to extract traffic event signals from social media and incorporate them with GPS probe data to alleviate the data sparse issue. We first collect traffic-related posts that report various traffic events, including traffic jam, accident, and road construction from Twitter. By considering the GPS probe readings and the traffic event tweets as two types of observations, we next extend the conventional coupled hidden Markov model for integrating the two types of data to obtain a more accurate estimation of traffic conditions. To address the computational challenge, a parallel importance sampling-based electromagnetic algorithm is further introduced. We evaluate our model on the arterial network of downtown Chicago. The experimental results demonstrate the superior performance of the model in both effectiveness and efficiency.