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Focus on Regulation

The MHRA issues new guidance concerning common issues in clinical trial applications

On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of Clinical Trial Authorisation (CTA) applications. The Guidance is intended to assist clinical trial sponsors in identifying avoidable delays, to the benefit of both clinical trial sponsors and patients.

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The EU Court of Justice dismisses EMA’s appeals in interim measures and suspends the release of clinical study report to third parties

On March, 1st 2017, by Order of its Vice-President, the Court of Justice of the EU (“CJEU”) upheld the suspension of the release to third parties of a clinical study report concerning the medicinal product Translarna granted by the General Court in July 2016. On the same day, by Order of its Vice-President, the CJEU upheld also the suspension of the release of certain non-clinical study reports concerning the veterinary medicinal product Bravecto.

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It is Official: Fair Pay and Safe Workplaces Rule Comes to an End

*Associate Ryan Harrigan also contributed to this post

Earlier this week, President Trump put the final nail in the coffin for the former administration’s “blacklisting” rule, officially known as the Fair Pay and Safe Workplaces Final Rule. The move means federal contractors will not be exposed to the Rule’s mandatory disclosure and reporting requirements related to labor law violations and alleged violations. Because the Rule was invalidated pursuant to the rarely used Congressional Review Act (“CRA”), 5 U.S.C. §§ 801 et seq., agencies will now be prohibited from promulgating future regulations in “substantially the same form” as the disapproved rule, absent express congressional authorization. Click here for our earlier analysis of the recent legislation. Continue Reading

What you need to know before Brexit gets underway this week

The Brexit process gets officially underway this week when the UK formally notifies the European Council of its intention to withdraw from the EU on 29 March 2017.  The road ahead is untested and uncertain, as the UK will be the first EU Member State ever to leave the Union.

Hogan Lovells will be hosting a number of webinars during the Brexit negotiating period to explore the issues as they arise.  The first of these will be this Thursday, 30 March 2017.  Sign up for that here.  In the meantime, read our latest blog answering five crucial questions about the process here.

M&A Activity in the Connect Vehicles sector: More Antitrust Filings on the Horizon?

M&A Activity in the Connect Vehicles sector: More Antitrust Filings on the Horizon?

M&A activity in the connected vehicles sector might need to be notified to antitrust authorities, even when the target has limited revenues, as shown by the recent Intel/Mobileye deal.

Connected vehicles (or, taking it one step further, self-driving cars) are computers on wheels and represent a rapidly changing area raising major challenges – including compliance with legal and regulatory obligations.  The future mergers and acquisitions between car manufacturers and suppliers, technology companies, insurers and/or others might need to be notified to the different antitrust/merger control authorities around the world, even when the target in these deals has limited revenues.

Under merger control rules, a merger filing is usually required when the merging parties have significant local revenues or local asset levels in a certain country or jurisdiction.  However, some jurisdictions – such as the European Commission, Germany and Austria – are examining whether certain high-value transactions (i.e. with a high price tag) involving targets with no or low local revenues may have a significant impact on competition in the jurisdiction and, if so, whether to modify their merger notification thresholds to address this limited class of transactions.

Intel has recently entered the self-driving car sector through the acquisition for over US$ 15 billion of Mobileye, an Israeli company making sensors and cameras for self-driving cars.  With the acquisition, Intel enters the sensors and chips manufacturing in the automotive industry along with Google and Uber that have already invested in their own technology in the field.   While the deal price is very high (over US$ 15 billion), Mobileye global revenues are limited (just above US$ 358 million in 2016).  While this time the Intel/Mobileye deal is not being notified in Europe (neither at the EU level to the European Commission, nor at the Member State level to national antitrust agencies), future deals might have a different outcome and have be notified (see here recent press on the topic).   Germany and Austria have already proposed reforms of their merger notification thresholds to be able to review deals mainly based on the purchase price (along with some other requirements to make sure that there is a material nexus to their territory).  And the European Commission has recently completed a consultation where it had asked various industry stakeholders whether they agree that the EU should change its merger control rules to allow notifications in case of deals with a high purchase price, even when the target has limited presence in terms revenues in Europe (here is our response to the Commission’s consultation).

The German and the Austrian reforms will enter into force soon, and the European Commission is to release its findings on the consultation soon.  Other jurisdictions may follow this path.  One thing is certain today: any future mergers in the automotive sector will have to be carefully assessed to determine possible merger filings to antitrust authorities around the world.

Germany suggests ramping up regulation of Digital Platforms by establishing a “Digital Agency” with a robust antitrust mandate

Will Germany establish a “Digital Agency” to monitor compliance with competition law rules in digital markets? Will a German “Digital Antitrust Enforcer” become a role model for a European protectionist approach against American and Asian platform providers?

The German Federal Ministry for Economic Affairs and Energy seems to see a pressing need for regulation in digital markets. The White Paper “Digital Platforms”, published on the 20 March 2017, provides an outlook on possible forms of digital regulatory policy in Germany and potentially also in Europe. Of particular interest from a competition law perspective is the proposal to establish a new “Digital Agency”. Continue Reading

Calling time on time limits?

CPR 54.5(2) is clear: the time limit for filing the claim form for judicial review may not be extended by agreement of the parties. The justification for the rule is well-known. Undue delay sits uncomfortably with good administration since public bodies need certainty as to the validity of their decisions – and third parties need to be able to rely on those decisions (see R (Law Society) v LSC). But should parties be able to pursue alternative remedies with confidence that their judicial review option will not expire? The court has attempted to square this circle in the recent case of R (Zahid) v University of Manchester.

In Zahid, the claimants commenced protective judicial review proceedings while pursuing a reference to the students’ complaints scheme (the Office of the Independent Adjudicator or “OIA”). They wished to reserve their position as to judicial review while attempting to resolve disputes with their universities via the OIA. Following a reasonably lengthy judgment, each of the three claimants was granted a stay of proceedings (to which one of the defendants had agreed from the start) while they pursued ADR.

The court can, of course, extend time limits using its case management powers if parties apply late for judicial review. Indeed, it has laid down guidelines for doing so. Following R v Secretary of State for Trade and Industry Ex p. Greenpeace Ltd, the court should assess whether there is a reasonable objective excuse for applying late; what the likely damage would be in terms of hardship or prejudice to third party rights and detriment to good administration; and whether the public interest requires that the application be permitted to proceed.

However, parties are unable to agree on an extension based on their own application of these guidelines to their circumstances. And herein lies the tension alluded to in Zahid: per the overriding objective, litigation in the Administrative Court, which has become one of the busiest specialist courts in the High Court, must be dealt with justly and at a proportionate cost. Yet as a result of CPR 54.5(2)’s prohibition, parties are nonetheless required to launch judicial review proceedings and seek a stay while attempting ADR, merely to protect their position in the event ADR fails, and even if the above Greenpeace guidelines apply. This inevitably results in unnecessary expense.

As it stands, parties need certainty. The claimants in Zahid were not willing to risk the court denying them an extension should their claim with the OIA fail, despite the relevance of the Greenpeace guidelines to their case. It is in this context that Mr Justice Hickinbottom has intervened. Citing the need to minimise both expenditure and the burden placed on the courts by unnecessary proceedings, he noted that, “if they [the parties] agree that any court proceedings can await the outcome of the OIA reference – as they should and will, in the vast majority of cases – absent extraordinary circumstances, it seems to me that they can have confidence that the court will be driven to exercise its discretion to allow an extension of time to file any proceedings if that reference is not successful in resolving the complaint“.

The circumstances of this dictum are, of course, fact-specific: all claimants in Zahid were challenging their own expulsion, the reversal of which would have limited wider repercussions. Further, they were requesting a stay of proceedings so as to pursue ADR, thereby serving the public interest in seeking a resolution outside of court. Nonetheless, despite recognising the court’s ultimate right to overrule the parties’ agreement, his call for parties to agree an extension of the three month time limit themselves appears to prioritise the overriding objective over CPR 54.5(2)’s prohibition.

Indeed, the judgment is a clear acknowledgement of the tension inherent in mandating that all cases be dealt with at a proportionate cost and providing clear guidelines as to when parties may apply late for judicial review, but prohibiting parties from applying these guidelines themselves (thereby encouraging protective proceedings). Seeking to resolve this tension by suggesting that, in the appropriate circumstances, the courts would likely be driven to grant an extension based on the parties’ agreement is an interesting development and may herald a change of approach by the courts to time limits for judicial review.

CFIUS Reform Turns to Food Security

Congressional efforts to reform the Committee on Foreign Investment in the United States (CFIUS), a U.S. Government interagency committee that conducts national security reviews, continue apace. This week saw the introduction of bipartisan legislation in the U.S. Senate that would (i) give federal agriculture and food officials permanent representation on CFIUS and (ii) amend the statute to allow the Committee to consider agriculture and food-related criteria when reviewing transactions that could result in control of a U.S. business by a foreign person. Under the current statute, the Committee has the discretion to consider the national security impact of foreign investments on U.S. food and agricultural systems, but the proposed legislation would amend the statute to make food and agricultural criteria explicit. Continue Reading

Hook Me Up: Established and Start-up Competitive Providers Find Common Ground Discussing Broadband Deployment Issues

Consumers today expect high-speed access to content, anytime, anywhere.  We often take for granted the ability to leave home, head to work, and travel to many cities, or even across the country, without losing the ability to access high-speed Internet service.  But in many cities, there is only one provider offering broadband Internet, and for some consumers, that provider’s speeds are inadequate and the prices are prohibitively expensive.  New broadband entrants seek to challenge incumbent providers by introducing innovative services, higher speeds, and competition to local markets.  However, there are many barriers preventing competitive providers from doing so.

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EMA public consultation on revised policy on access to documents

The EMA has launched a public consultation on its draft new Policy/0043 on access to documents. The document describes the EMA’s approach in balancing public and private interests involved in requests for access to documents received by the Agency.

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