Ograniczenia importu równoległego produktów leczniczych. Uwagi na tle wyroku Trybunału Sprawiedliwości Unii Europejskiej w sprawie C-602/19 Kohlpharma

<p>The judgement in case C-602/19 <em>Kohlpharma</em> is another decision of the Court of Justice of the European Union, which sets legal framework for marketing medicinal products from parallel import. By doing so, the Court continues the adjudicative tradition whereby key aspects of the issue of parallel imports of medicinal products are regulated at the level of EU law through rulings that interpret Articles 34 and 36 of the Treaty on the Functioning of the European Union (TFEU), issued in specific cases referred to the Court by the referring courts of the Member States. In the commented judgement, the Court upheld the interpretation of Articles 34 and 36 TFEU, according to which these provisions exclude the application of national regulations of a Member State, according to which the withdrawal of a reference authorisation in the importing country automatically results in the expiration of the parallel import licence. The Court also defined more precise limits to the exception contained in Article 36 TFEU concerning the protection of human health and life. This is so because it ruled that the objective of pharmacovigilance may be achieved through actions consisting in the cooperation of the competent authorities of the Member States. The commented judgement is of key importance for the assessment of compliance of Article 21a (3a) of the Polish Act – Pharmaceutical Law with the EU law. In the light of the position of the Court, this provision of the Polish law should be assessed as an excessive restriction on the freedom of movement of goods.</p>

Preventing Return Fraud in Reverse Logistics—A Case Study of ESPRES Solution by Ethereum

With the rapid development of e-commerce services, online retail has evolved from multi-channel to omni-channel in order to provide customers with more services. However, reverse logistics services (returns and exchanges) have become the target of many fraudulent activities, causing a lot of economic losses for many online retail companies. The current challenge of the traditional countermeasure is it requires a lot of manpower and training resources. In this study, we propose ESPRES, a system that adopts blockchain technology to prevent fraudulent behavior in the process of returns and exchanges with the smart contract and multi-attribute decision-support method to help consumers choose a suitable payment program. A practical implication of this study is that by adopting blockchain technology, a great amount of manpower used on determining whether each return or exchange is fraudulent can be reduced since merchants can check the product ownership. In addition, due to the fact that the footprint of goods cannot be forged, it can also prevent counterfeit or parallel imports of goods.

18. Abuse of dominance (2): pricing practices

This chapter considers abusive pricing practices under Article 102 TFEU and the Chapter II prohibition in the Competition Act 1998. It first discusses various cost concepts used in determining whether a price is abusive. It then deals in turn with excessive pricing; conditional rebates; bundling; predatory pricing; margin squeeze; price discrimination; and practices that are harmful to the single market. This taxonomy is over-schematic, in that the categories overlap with one another: for example price discrimination may be both exploitative and exclusionary, and an excessively high price may in reality be a way of preventing parallel imports or of excluding a competitor from the market; nevertheless this division may provide helpful insights into the way in which the law is applied in practice. In each section the application of Article 102 by the European Commission and by the EU Courts will be considered first, followed by cases in the UK. Reference will be made where appropriate to the Commission’s Guidance on the Commission’s Enforcement Priorities in Applying Article [102 TFEU] to Abusive Exclusionary Conduct by Dominant Undertakings.

Influence of the Principle of Exhaustion of Exclusive Rights on the State of Competition in Commodity Markets

The article about the discussion on the legal meaning of the principle of exhaustion of the exclusive right to a trademark, including from the point of view of its impact on the state of competition in the commodity markets. The analysis of the legal nature of the principle of exhaustion of the exclusive right to a trademark is carried out, its essential and functional significance is determined. The actual application of this principle has been investigated, including practice of the Russian antimonopoly body in cases of unfair competition on the part of rightholders who prohibit the parallel import of their products. Studied judicial practice on the legality of parallel imports. The problem of the balance of interests of copyright holders, “parallel” importers and consumers is considered, the “pluses” and “minuses” of consolidation in the legislation of the national and regional principles of the exhaustion of the exclusive right to a trademark are assessed.

The Pice Effects of Competition from Parallel Imports and Therapeutic Alternatives: Using Dynamic Models to Estimate the Causal Effect on the Extensive and Intensive Margins

This paper studies responses to competition with the use of dynamic models that distinguish between short- and long-term price effects. The dynamic models also allow lagged numbers of competitors to become valid and strong instruments for the current numbers, which enables studying the causal effects using flexible specifications. A first parallel trader is found to decrease prices of exchangeable products by 7% in the long term. On the other hand, prices do not respond to the first competitor that sells therapeutic alternatives; but competition from four or more competitors that sell on-patent therapeutic alternatives decreases prices by about 10% in the long term.

The Exclusive Rights of Licensees in Parallel Import Practices

Parallel imports are one of the most interesting and unique phenomena of international trade. On one hand, it applies competition law, while on the other, trademark law and the customs law also apply in this activity. Parallel imports occur when genuine goods are imported in parallel (concurrently) to goods imported by a licensee. These parallel imports are then sold at a cheaper price than that of the goods of the licensee. This parallel import activity is inconsistent with the exclusive rights that the licensee receives under the licensing agreement it makes with the owner of the trademark. This exclusive right is essentially monopolistic, entitling the licensee to prevent all parties with the commercial intention of selling the same or similar goods as their own. However, the right to monopoly is limited for the sake of a fair competition. The licensee can sue to get compensation in parallel importation base on unjust enrichment principle. Moreover, parallel importation can be inhabited by enforcing procedural and administration regarding import of goods such as, Indonesian national standard and label in bahasa

South African experience in regulating parallel import of medicines

The article provides an overview of the South African experience in the use and adaptation of parallel imports of medicines, as well as the prospects for the implantation of parallel imports in Russia. The main factors, the economic aspects and legal grounds for the introduction and regulation of parallel imports in South Africa are analyzed. The article provides an assessment of the impact of parallel imports on the formation of prices for pharmaceutical products. The introduction of parallel imports in African countries led to a significant decrease in the prices for pharmaceutical products, which led to a positive trend in the pricing of medicines in national economies, which have significantly lower GDP per capita compared to developed countries. Despite this positive trend, there are still a lot of questions regarding the consequences of the introduction of parallel imports in developed and developing countries, which requires studying the achievements of those nations that obtained considerable expertise in this area.