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Focus on Regulation

Category Archives: Antitrust, Competition & Economic Regulation

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Consumer IoT – European Commission initiates inquiry into the consumer Internet of Things sector

The European Commission (“Commission”) has launched an antitrust sector inquiry into the Internet of Things (“IoT”) sector for consumer-related products and services within the European Union. The Commission is looking to develop a better understanding of how this fast-moving sector works and some of the potential issues that may arise from a competition law perspective. 

Next steps towards tighter German Foreign Investment Control rules passed

For M&A transactions in Germany and beyond, Foreign Investment Control screenings have become an indispensable standard element to assess when structuring deals and planning for regulatory review. Similarly to merger control, acquirers and sellers need to consider the impact of the increasing number of jurisdictions that might want to review their proposed transaction. In the

HCC’s investigations during the lockdown – procedural rights of businesses during a (lock)dawn raid: What to look out for!

Despite the strict confinement measures in Greece, the Hellenic Competition Commission (HCC) has initiated several investigations during the current lockdown. Not only has it sent requests for information to a large number of companies active in the healthcare products market, it has also conducted two dawn raids – one in the food sector and one

Vietnam merger clearances as new filing regime comes into force

One week before the new decree for implementing the 2018 Law on Competition comes into force on 15 May 2020, the Vietnam Ministry of Industry and Trade (MOIT) announced merger clearance decisions for two offshore transactions. The decisions were made in the name of the MOIT, as the new competition authority – the National Competition

An update on cooperation in the life sciences industry: the European Commission’s framework for sending “comfort letters” on cooperation efforts for essential products

The European Commission has published a Temporary Framework Communication to provide guidance to companies that are cooperating to ensure the supply and distribution of essential products – including medicines and medical equipment – during the COVID-19 outbreak. The Communication sets out the criteria that the Commission will apply in assessing the legality of cooperation during

COVID-19: Actions taken by EU competition authorities – will the HCC’s approach go viral?

Within the first week of the confinement measures in Europe, the Hellenic Competition Commission (HCC) was one of the first EU competition authorities to announce a more lenient approach towards certain vertical agreements, as a way to address severe shortages caused in the market by the COVID-19 outbreak. This action taken by the HCC seems

COVID-19: State aid available now!

European Commission approves first State aid measure in relation to the COVID-19 outbreak and announces a flexible application of State aid rules to stabilize the economy Probably everyone would agree that the COVID-19 outbreak qualifies as an exceptional occurrence, or as an extraordinary, unforeseeable event. From a European law perspective, this qualification has a direct

Industrial policy strikes again: Germany announces further tightening of Foreign Investment Control rules

For M&A transactions in Germany and beyond, Foreign Investment Control screenings have become an indispensable standard element to assess when structuring deals and planning for regulatory review. Similarly to merger control, acquirers and sellers need to consider the impact of the increasing number of jurisdictions that might want to review their proposed transaction. In the

Dutch competition authority imposes fine on company for deleted chat messages during a dawn raid

The Dutch competition authority (“ACM“) recently confirmed that the obligation to cooperate fully with an inspection/during a dawn raid is of utmost importance and of great relevance to companies under investigation.  On 10 December 2019, the ACM issued an infringement decision fining an unidentified company EUR 1.85 million for obstructing an ACM inspection.  This was

Algorithms in the spotlight of antitrust authorities

Joint study by the Bundeskartellamt (German Cartel Office) and the Autorité de la concurrence (French Competition Authority) indicates need for higher compliance standards Digital ubiquity, and the resulting rules, do not only concern tech giants. To the contrary, digital regulation is relevant for companies in all market sectors (see our recently published global study on

Germany’s proposed digital antitrust law: an ambitious project to regulate digital markets

Germany is about to implement an ambitious new “digital antitrust law” (“GWB-Digitalisierungsgesetz”) to effectively regulate online markets. The draft Ministerial bill on the 10th amendment of the German Act Against Restraints of Competition (“GWB”), published at the beginning of October, aims at continuing Germany’s role as a pioneer in antitrust regulation of digital markets. Regulation

FDA guidance may ease path to biosimilar interchangeability

On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product.  Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of

Individuals as Whistleblowers

Cartels are by their nature hard to uncover and regulators rely – to a large part – on appealing to companies’ wallets. Immunity and leniency policies, by which regulators offer to whistleblowing companies full immunity or discounts from fines, have been around for a long time. An increasing number of regulators have now added another

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Primarily, the proposed rule seeks additional information on sunscreen ingredients so that FDA can evaluate their GRASE status

We are the Champions – France and Germany unite to revive industrial policy at European level

Following the European Commission’s prohibition of the Alstom-Siemens transaction, the French and German governments published a manifesto calling for a reform of current EU merger rules, in order to shape a “European industrial policy fit for the 21st Century”. This manifesto appears to be directly addressed to the next European Commission, which will be renewed following the European elections this year.

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers
On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding “Competition enforcement in the pharmaceutical sector (2009-2017)” (“Report”). The Report summarizes the impressive enforcement activity of EU competition law enforcers in the pharmaceutical sector in the last decade while emphasizing at the same time the scope for continued enforcement action.

A New European Deal?

German Minister of Economics suggests revising EU and German merger control regulations to enable the creation of European champions – and keeps FDI options on the table to prevent acquisitions by non-European players

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.