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2016

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Articles 1 - 30 of 281

Full-Text Articles in Antitrust and Trade Regulation

Prohibition Of Pharmacy Advertising – The Origins And The Evaluation Of The Regulation, Joanna Wiszniewska Dec 2016

Prohibition Of Pharmacy Advertising – The Origins And The Evaluation Of The Regulation, Joanna Wiszniewska

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

The main purpose of this paper is to present the origin of the introduction of the prohibition of pharmacy advertising into the Polish legal system. The first part discusses the reasons why the partial prohibition of pharmacy advertising, related to reimbursed drugs, was implemented in 2007. The paper then focuses on the absolute prohibition of the advertising of pharmacies and their operations introduced in 2012, which constitutes the strictest regulation of such kind in Europe. This will give the opportunity to critically examine both the law and its implementation. In conclusion, the current initiatives to abolish the regulation will be …

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Seller’S Liability For A Hazardous Product Brought By Him Into Poland From Another Eu Member State – Doubts Arising From Cases Relating To Medical Devices, Ewa Rutkowska, Barbara Trabszys Dec 2016

Seller’S Liability For A Hazardous Product Brought By Him Into Poland From Another Eu Member State – Doubts Arising From Cases Relating To Medical Devices, Ewa Rutkowska, Barbara Trabszys

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

The article presents the problem of the incompatibility of the manner of the implementation of the term ‘importer’ into Polish law with respect to the issue of liability for a hazardous product with the provisions of Directive 374/85, and the problems which arise as a result with regard to liability of sellers bringing a product into Poland from another EU Member State. The article provides a proposal for the interpretation of the term ‘importer’ under Article 4495 § 2 of the Civil Code, until the necessary legislative change is made that would ensure the compliance of the Polish law with …

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Consequences Of The New Reimbursement Act For Patients And The Public Payer, Józef Haczyński, Zofia Skrzypczak Dec 2016

Consequences Of The New Reimbursement Act For Patients And The Public Payer, Józef Haczyński, Zofia Skrzypczak

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

The Act on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices came into force on 1 January 2012. Its purpose was to transform the Polish medicine reimbursement so that the available public funds corresponded as closely as possible to the current social needs in the supply of refunded products. The consequence of the new reimbursement act – experienced painfully by patients - was a decrease in the share of reimbursement (and thus increase in patients’ contribution) in the value of the purchased medicine on prescription (Rx).

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System Of Fixed Prices For The Sale Of Prescription-Only Medicinal Products For Human Use By Phar-Macies As A Measure Having Equivalent Effect To A Quantitative Restriction On Imports. Case Comment To The Judgment Of The Court Of Justice Of The European Union Of 19 October 2016 In Case C 148/15: Deutsche Parkinson Vereinigung Ev V. Zentrale Zur Bekämpfung Unlauteren Wettbewerbs Ev, Tomasz Kaźmierczak Dec 2016

System Of Fixed Prices For The Sale Of Prescription-Only Medicinal Products For Human Use By Phar-Macies As A Measure Having Equivalent Effect To A Quantitative Restriction On Imports. Case Comment To The Judgment Of The Court Of Justice Of The European Union Of 19 October 2016 In Case C 148/15: Deutsche Parkinson Vereinigung Ev V. Zentrale Zur Bekämpfung Unlauteren Wettbewerbs Ev, Tomasz Kaźmierczak

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

No abstract provided.

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Competition And Regulation In Dinamically Growing Sector Of Life Sciences, Marcin Kolasiński, Tadeusz Skoczny Dec 2016

Competition And Regulation In Dinamically Growing Sector Of Life Sciences, Marcin Kolasiński, Tadeusz Skoczny

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

From Volume Editors

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Report On The National Conference “Biological Medicinal Products. Legal Aspects”. Warsaw, 2 December 2016, Natalia Łojko Dec 2016

Report On The National Conference “Biological Medicinal Products. Legal Aspects”. Warsaw, 2 December 2016, Natalia Łojko

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

Warsaw, 2 December 2016

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Patent Infringements On Second Medical Use In The Light Of The Reimbursement System, Marek Świerczyński Dec 2016

Patent Infringements On Second Medical Use In The Light Of The Reimbursement System, Marek Świerczyński

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

This paper relates to patent infringements on second medical use in the light of competition law and the reimbursement system. It is inspired by two recent rulings delivered by English and Dutch courts. They have considered whether the sale of generic drugs may be regarded as an infringement of a patent relating to a second medical use (not indicated on the labels) in situations where the facts of the case showed that these drugs have actually been used in a way covered by this patent (ie. off-label use). In the light of these rulings, the main purpose of this paper …

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Evaluation Of Pre-Accession State Aid In The Energy Sector. Case Comment To The Judgment Of The Court Of Justice Of 1 October 2015 Electrabel Sa, Dunamenti Erőmű Zrt. V European Commission (Case C 357/14 P), Tihamer Toth Dec 2016

Evaluation Of Pre-Accession State Aid In The Energy Sector. Case Comment To The Judgment Of The Court Of Justice Of 1 October 2015 Electrabel Sa, Dunamenti Erőmű Zrt. V European Commission (Case C 357/14 P), Tihamer Toth

Yearbook of Antitrust and Regulatory Studies

No abstract provided.

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Distance Selling Of Medicinal Products – National Legislation, Zbigniew Więckowski Dec 2016

Distance Selling Of Medicinal Products – National Legislation, Zbigniew Więckowski

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

The subject matter of this article concerns the question of distance selling of medicinal products considered from the perspective of national legislation. The author analyzes in detail the provisions of the Polish Pharmaceutical Law and the Ordinance of the Minister of Health of 26 March 2015 on mail-order sales of medicinal products in order to find the answer to the question why pharmacists show little interest in further developing this distribution channel for medicine. The author focuses also on the analysis of the provisions governing mail-order sales of medicines in terms of ensuring patient safety.

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Limitations Of Internet Sales Of Otc Veterinary Medicinal Products, Magdalena Bąkowska Dec 2016

Limitations Of Internet Sales Of Otc Veterinary Medicinal Products, Magdalena Bąkowska

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

The article presents binding legal provisions on the retail distribution and mail-order sales of veteri-nary medicinal products, which are the basis of the interpretations used by the Polish veterinary inspection and administrative courts whereby Internet sales of OTC veterinary medicinal products are not allowed under Polish law. The paper presents the legal background of this issue in order to assess the correctness of existing jurisprudence in this case. Additionally, the article comments on the expected changes to existing law in this field drafted at the EU level.

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Table Of Contents Dec 2016

Table Of Contents

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

Table of contents

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Legal Framework Governing Medicinal Advertisement In The Internet – A Critical Analysis, Mikołaj Rajca Dec 2016

Legal Framework Governing Medicinal Advertisement In The Internet – A Critical Analysis, Mikołaj Rajca

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

Advertising medicinal products en bloc generates a great deal of heated debate among professionals of various scientific orientations. In spite of this fact, on 2 July 2016, the Polish Minister of Health issued an ordinance summoning a special committee with the objective of preparing certain recommendations and references concerning, among others, advertising of medicinal products, dietary supplements and medical devices. The following article is structured so as to critically asses and analyze the legal framework governing the advertisement of medicinal products, with emphasis on their on-line advertisement. Particular significance is placed on: 1) the issue of pharmaceutical spam, including a …

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Telemedicine Against The Background Of Polish Legal Rules - Opportunity Or Threat?, Monika Chojecka, Adam Nowak Dec 2016

Telemedicine Against The Background Of Polish Legal Rules - Opportunity Or Threat?, Monika Chojecka, Adam Nowak

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

Modern technology found in the diagnostic and treatment process of patients can be the future of medicine. This so-called “telemedicine” is also an important legislative issue. The article analyzes legal rules which are the cornerstone of this field in the Polish legal system. Special attention is placed on recent works devoted to the creation by the legislator of a new approach to the legal framework for telemedicine. The paper also contains an assessment of the effectiveness of the func-tioning of these legal solutions.

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Dispute About Homeopathy (Or Who Rules The Market?), Jarosław Sroczyński Dec 2016

Dispute About Homeopathy (Or Who Rules The Market?), Jarosław Sroczyński

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

The article discusses the effects of rulings issued by the Court of Competition and Consumer Protection (SOKiK) and the Court of Appeal concerning homeopathy upon the scope of the powers of medical self-government to regulate markets. The author provides an analysis of these powers on the basis of competition law, since the latter intersects with pharmaceutical law and laws regulating the professional activities of doctors. The author draws attention to the fact that depriving the competition authority – the UOKiK President – of the power to scrutinize the activities of professional self-government bodies may lead to adverse effects for competition …

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Pay-For-Delay Agreements As “By Object” Violations Of Competition Law. Case Comment To The Judgment Of The General Court Of 8 September 2016 In Case T-472/13 H. Lundbeck A/S And Lundbeck Ltd V. European Commission, Paulina Wosik Dec 2016

Pay-For-Delay Agreements As “By Object” Violations Of Competition Law. Case Comment To The Judgment Of The General Court Of 8 September 2016 In Case T-472/13 H. Lundbeck A/S And Lundbeck Ltd V. European Commission, Paulina Wosik

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

No abstract provided.

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Anti-Competitive Agreement Between Undertakings On The Domestic Market Of In-Vitro Fertilization Services. Case Comment To The Decision Of The President Of The Offi Ce Of Competition And Consumer Protection (Uokik) No. Rlo 4/2016 Of 1 September 2016, Emilia Kasjanowicz Dec 2016

Anti-Competitive Agreement Between Undertakings On The Domestic Market Of In-Vitro Fertilization Services. Case Comment To The Decision Of The President Of The Offi Ce Of Competition And Consumer Protection (Uokik) No. Rlo 4/2016 Of 1 September 2016, Emilia Kasjanowicz

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

Anti-competitive agreement between undertakings on the domestic market of in-vitro fertilization services. Case comment to the decision of the President of the Office of Competition and Consumer Protection (UOKiK) No. RLO 4/2016 of 1 September 2016

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Institutions Of The Pharmaceutical Market, Ed. R. Stankiewicz, Wolters Kluwer, Warsaw 2016, Tadeusz Skoczny Dec 2016

Institutions Of The Pharmaceutical Market, Ed. R. Stankiewicz, Wolters Kluwer, Warsaw 2016, Tadeusz Skoczny

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

No abstract provided.

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Rafał Stankiewicz, Krajowe Systemy Ochrony Zdrowia A Unia Europejska. Przykład Polski [National Healthcare Systems Vs. The European Union. The Polish Example] Wyd. Wolters Kluwer, Warszawa 2016, Ss. 455 (Mirosław Pawełczyk)., Mirosław Pawełczyk Dec 2016

Rafał Stankiewicz, Krajowe Systemy Ochrony Zdrowia A Unia Europejska. Przykład Polski [National Healthcare Systems Vs. The European Union. The Polish Example] Wyd. Wolters Kluwer, Warszawa 2016, Ss. 455 (Mirosław Pawełczyk)., Mirosław Pawełczyk

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

No abstract provided.

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Table Of Contents Dec 2016

Table Of Contents

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

Table of contents

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Trademarks: German Manufacturer’S Deliberate Infringement Of Domestic Trademark Sufficient To Support Injunctive Relief, But Not Supportive Of Award For Damages, Kimley R. Johnson Dec 2016

Trademarks: German Manufacturer’S Deliberate Infringement Of Domestic Trademark Sufficient To Support Injunctive Relief, But Not Supportive Of Award For Damages, Kimley R. Johnson

Georgia Journal of International & Comparative Law

No abstract provided.

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Deepwater Port Act Of 1974: Some International And Environmental Implications, James H. Gnann Jr. Dec 2016

Deepwater Port Act Of 1974: Some International And Environmental Implications, James H. Gnann Jr.

Georgia Journal of International & Comparative Law

No abstract provided.

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China’S Withdrawal Of Article 96 Of The Cisg: A Roadmap For The United States And China To Reconsider Withdrawing The Article 95 Reservation, Pan Zhen Dec 2016

China’S Withdrawal Of Article 96 Of The Cisg: A Roadmap For The United States And China To Reconsider Withdrawing The Article 95 Reservation, Pan Zhen

University of Miami Business Law Review

The United Nations Convention on Contracts for the International Sale of Goods (CISG) was created for the purpose of providing legal neutrality and certainty, and also for the purpose of avoiding choice of law issues in international sales of goods. However, the United States and China, the two largest trading nations in the world, made the Article 95 reservation at the time they ratified the CISG, therefore restricting CISG’s applicability in certain situations. In 2013, China withdrew its Article 96 reservation, which declares its non-recognition of free form of contract formation, taking one step closer to the vast majority of …

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Guest Lecture By Professor Michael Jacobs, “The Durability Of The Chicago School In Antitrust: What Accounts For It?”, Anna Tworkowska-Baraniuk Dec 2016

Guest Lecture By Professor Michael Jacobs, “The Durability Of The Chicago School In Antitrust: What Accounts For It?”, Anna Tworkowska-Baraniuk

internetowy Kwartalnik Antymonopolowy i Regulacyjny (internet Quarterly on Antitrust and Regulation)

Guest seminar

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Local And State Governments Are Taking The Stage When It Is Fda's Curtain Call - Are Local And State Governments' Safety Warnings Preempted By Federal Law?, Melissa M. Card Dec 2016

Local And State Governments Are Taking The Stage When It Is Fda's Curtain Call - Are Local And State Governments' Safety Warnings Preempted By Federal Law?, Melissa M. Card

Journal of Food Law & Policy

Eliminated from fad diets, sworn off by celebrities, and frantically reformulated out of processed foods, added sugars have been deemed the new nutritional scoundrel. Recent studies from the American Heart Association, the World Health Organization, and the American Cancer Association demonstrate that the consumption of added sugar leads to increased risks of obesity, diabetes, heart disease, and gout. While all foods containing added sugar are deemed unhealthy, Sugary-Sweetened Beverages ("SSBs") are said to be especially toxic by the American health community, by virtue of these beverages' being excessively high in added sugar content, low in satiety, and incomplete in compensation …

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State-Action Immunity And Section 5 Of The Ftc Act, Daniel A. Crane, Adam Hester Dec 2016

State-Action Immunity And Section 5 Of The Ftc Act, Daniel A. Crane, Adam Hester

Michigan Law Review

The state-action immunity doctrine of Parker v. Brown immunizes anticompetitive state regulations from preemption by federal antitrust law so long as the state takes conspicuous ownership of its anticompetitive policy. In its 1943 Parker decision, the Supreme Court justified this doctrine, observing that no evidence of a congressional will to preempt state law appears in the Sherman Act’s legislative history or context. In addition, commentators generally assume that the New Deal court was anxious to avoid re-entangling the federal judiciary in Lochner-style substantive due process analysis. The Supreme Court has observed, without deciding, that the Federal Trade Commission might …

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Beyond Trade Deals: Charting A Post-Brexit Course For Uk Investment Treaties, Lise Johnson, Lorenzo Cotula Dec 2016

Beyond Trade Deals: Charting A Post-Brexit Course For Uk Investment Treaties, Lise Johnson, Lorenzo Cotula

Columbia Center on Sustainable Investment Staff Publications

The Brexit referendum has raised questions about the future terms of the United Kingdom’s engagement with the world economy. While a debate over the UK’s future approach to trade deals has already begun, a similar discussion has yet to develop on the treaties that govern foreign investment. As this briefing note by Lorenzo Cotula of the International Institute for Environment and Development, and Lise Johnson of CCSI highlights, the stakes are high: ill-designed treaties could leave the UK excessively exposed to legal claims by foreign companies and could fail to address relevant economic, social and environmental challenges. While meaningful negotiations …

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Other Markets, Other Costs: Modernizing Antitrust, Jeffrey L. Harrison Dec 2016

Other Markets, Other Costs: Modernizing Antitrust, Jeffrey L. Harrison

UF Law Faculty Publications

Today’s antitrust law is characterized by stagnation and indeterminacy. The failure is so thorough that it is not clear that U.S. competition law actually leads to any outcomes that are defendable except at the most superficial level. Moreover, when enforcement does result in a desirable outcome, it not clear that it is the best outcome. The principal reason for this state of affairs is that antitrust scholars and courts cling to misguided goals and theories that have not evolved despite an avalanche of information now available that can modernize the discipline.

This Article has two main sections that necessarily overlap. …

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Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets Dec 2016

Moving Towards Harmonization Of The Food Safety Standards: Role Of The Tpp And Ttip Agreements, Ksenia A. Petrovets

Journal of Food Law & Policy

We are now less dependent on locally available food resources that we have ever been. The continuing industrialization of food production, the advancement in technologies and the rapid development of supply chains granted us the luxury of immediate access to a variety of products originating from local supermarkets all over the world. This, along with the greater level of food production industrialization, inevitably comes the rise of related food safety risks. Because of the enlargement of producing operations, an emerging safety threat in one place may result in a foodborne illness outbreak thousands of miles away from its place of …

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Will Consumers Be In The "Dark" About Labels On Genetically Engineered And Modified Foods?, Hilary Nat Dec 2016

Will Consumers Be In The "Dark" About Labels On Genetically Engineered And Modified Foods?, Hilary Nat

Journal of Food Law & Policy

In the 1900s, the United States began to sell genetically engineered foods. One of the first genetically engineered foods sold in the United States and approved by the Food and Drug Administration (FDA) was the Flavr Savr tomato. The tomato's genetic structure was modified to prevent softening which allowed it to ripen after being picked. In the United States, statistics demonstrate that 92% of com, 94% of soybeans, and 94% of cotton sold is genetically engineered. In addition, it is estimated that 75% of the processed foods sold in supermarkets around the United States contain ingredients that are products of …

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Energy Drink Regulations: Why The Time For More Fda Authority Is Not Ripe And How States Can Protect Children Without Unjustly Infringing On Adult Autonomy, Larry D. Treat Dec 2016

Energy Drink Regulations: Why The Time For More Fda Authority Is Not Ripe And How States Can Protect Children Without Unjustly Infringing On Adult Autonomy, Larry D. Treat

Journal of Food Law & Policy

In December of 2011, Anais Fournier ("Anais"), a fourteen-year-old from Maryland, was at the mall with her friends when she drank a twenty-four ounce Monster energy drink. Within twenty-four hours, Anais consumed a second twenty-four ounce energy drink. Together, the two Monster energy drinks Anais consumed contained around 480 milligrams ("mg") of caffeine. A few hours after the second drink, Anais went into cardiac arrest and later died from cardiac arrhythmia. An autopsy found that caffeine toxicity caused Anais's arrhythmia and impeded her heart's ability to pump blood. As it turns out, Anais suffered from a preexisting heart condition called …

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