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Category Archives: Antitrust, Competition & Economic Regulation

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Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs.  A potentially important condition to one of the key proposed changes specific to new drugs is that it would be available only for

China antitrust authority consults on agreements rules

On 3 January 2019, the State Administration for Market Regulation (SAMR) released a draft of the Regulation on the Prohibition of Monopoly Agreement Conduct (Draft) on its website, inviting comments from interested stakeholders. The consultation period ends on 3 February. The Draft is the first significant normative output in the Anti-Monopoly Law (AML) field after

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. This is the latest public step by the agency to highlight its continued close scrutiny of potential abuses of the citizen petition process to block or

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before (see our previous blog posts here and here), significant news broke on December 7, 2018, regarding a newly implemented pilot centralized drug procurement program (the “program”) that will have significant ramifications for global pharmaceutical companies. 

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement  Public Law 115-92, which was enacted in 2017.  The law gives the DoD new opportunities to advocate to FDA for expedited development,

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims.  In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what constitutes a “meaningful difference” between prescription and over-the-counter (OTC) versions of a drug product.  Under FDA’s longstanding interpretation, section 503(b) of the Food, Drug, and Cosmetic Act (FDCA) “does

Digital competition policy on the move: Price algorithms in the German Monopolies Commission’s spotlight – European Commission launches consultation process

Price algorithms are clearly the “talk of the town” in the European competition law community these days. Just last week, the German Monopolies Commission published a report in which it discusses potential anti-competitive effects of price algorithms and proposes far-reaching amendments to the competition law enforcement framework. Meanwhile, the European Commission has announced a consultation

The European Commission Is Considering Opening an Antitrust Probe for Parallel Imports in the Pharmaceutical Sector

The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed. The pharmaceutical sector is understood to be under scrutiny in at least one of the current informal investigations, according to a leak in

The UAE Competition Committee has finally become operational; merger control in the UAE and the GCC region

The UAE Competition Committee has become operational and therefore mergers and acquisitions may be subject to review in the near future. The UAE Competition Committee held its first meeting of the year last month (on 26 March 2018) in which it discussed the development of guidelines and standards related to the implementation of UAE competition

OECD publishes issues paper on blockchain and competition law

Competition law questions are increasingly raised in the public debate about the blockchain technology. While there is yet to be any investigation in this field, the policy debate about applying competition law instruments to this disruptive, decentralised technology is heating up. The latest and probably most comprehensive approach to structuring the discussion comes from the

Digital Antitrust – Outlook for the European Antitrust Year 2018

With the New Year only a few days old, we want to present a short outlook what to expect from European antitrust enforcement in 2018, with a particular focus on Germany. One theme that is likely to feature even more than last year is the impact of antitrust law on digital markets. Antitrust law has become a force for disruption in the world of tech. Multi-billion fines for online platforms which are considered not to be sufficiently neutral. Dawn raids for denied access to data. Transactions blocked or unwound if a unicorn is acquired by the wrong player.

FCC Commissioners Debate Adjustments to Merger Review Standard

In the first major transaction approval under Ajit Pai’s Chairmanship, the Federal Communications Commission (“FCC”) recently approved, subject to targeted, transaction-specific conditions, license and authorization transfers in connection with CenturyLink’s $34 billion acquisition of Level 3.  The FCC’s recitation of its merger review standard in its order (the “CenturyLink-Level 3 Order”) differed somewhat from the description

What blockchain can learn from the net neutrality debate: antitrust and regulatory aspects of “paid prioritization” for a nascent technology

First come, first served. That’s not the principle behind the clearance of Bitcoin transactions. Equally for other blockchain technology networks, the relevant factor to get a transaction on the next available block is not time, but often: money. “Paid prioritization” is a reality. Miners will first pick and clear those transactions which will most highly

Big Data and digital markets remain in the focus of competition authorities – German FCO continues to lead the way

 On 6 October, the German Federal Cartel Office (“FCO”) launched its new series of papers on “Competition and Consumer Protection in the Digital Economy”. The first paper deals with “Big Data and Competition”. The same day, a “real-life example” of competition enforcement in Big Data became public. The EU Commission confirmed unannounced inspections in “a few

The life sciences industry under the antitrust spotlight in China: two practical points

The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement decision was announced against a government entity, a local health commission, for breaching a number of provisions in the Anti-Monopoly Law (AML).

Chinese walls? Germany reinforces the control of foreign investments

On 12 July 2017, the German Federal Government significantly reinforced the barriers for the acquisition of German companies by non-EU companies. The new Regulation for the Amendment of the Foreign Trade and Payments Regulation (“AWV”) will impose new reporting obligations for M&A transactions. There are now concerns about the openness of Germany to foreign investment and the additional burden that the new rules will impose on companies.

“Friends forever? Joint and several liability for cartel damages”

“Friends forever? Joint and several liability for cartel damages”
“Good friends can never be separated; good friends are never alone; for there’s one thing in life they know how to do, be there for one another…” This timeless classic was sung by Franz Beckenbauer on the occasion of the 1966 FIFA World Cup in England. And he is right: friends show consideration for each other and they are sincere to one another. As delightful as these virtues are for interpersonal relationships; as troublesome they are for intercorporate ones. If companies are too friendly with one another, they may breach antitrust law. Yet, what about friendship, when the cartel is over and third parties are eager to claim their cartel damages?

What applies as of when? – When will the 9th amendment of the German Act against Restraints of Competition (GWB) apply?

So it has begun. However, when will the new provisions of the 9th amendment of the GWB actually apply? Aside from a number of exceptions, the 9th amendment will come into force on the day following its promulgation. But, a number of not insignificant provisions will have retroactive effect. This sounds as if it could be exciting.

The legislature has determined a time of entry into force for the 9th amendment of the GWB pursuant to Article 82(2)(1) of the German Fundamental Law. According to that provision, certain provisions regarding cartel damages claims entered into force already as of 27 December 2016 (Article 8 S. 1 of the amendment). The other provisions entered into force on the day following the promulgation, i.e. on 9 June 2017. Beyond that, there are a number of questions as to when certain provisions will apply and whether transitional rules will apply in some cases. The present contribution offers a short overview in this regard.

For the good of the consumer – consumer protection in the 9th amendment of the ARC

Provisions on consumer protection account for only a small part of the 9th amendment of the German Act Against Restraints of Competition (ARC), which recently came into force. However, the introduction of the reform has led to a highly controversial debate in the press and literature.

Consumer protection in Germany

Traditionally, private enforcement is the main means of protecting consumer rights in Germany. This involves consumers or, more probably, recognised consumer protection associations bringing private law actions to ensure that consumer protection provisions are applied. Unfair competition law plays a central role here. For example, consumer organisations issue cease and desist letters in response to breaches of general terms and conditions of business. If unsuccessful, they then take legal action.

Unlike previously, the debate about the 9th amendment of the ARC focused on strengthening public enforcement. Not that public enforcement of consumer protection law is completely unknown in Germany: the German Federal Financial Supervisory Authority (Bundesanstalt für Finanzdienstleistungsaufsicht – BaFin) and the German Federal Network Agency (Bundesnetzagentur – BNetzA) already have powers to enforce consumer rights. BaFin is responsible for the protection of all consumers in the area of financial services, while the BNetzA monitors the misuse of phone numbers. As a result of the 9th amendment of the ARC, the German Federal Cartel Office (FCO) now also has powers to protect consumers.