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Focus on Regulation

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

In a recently issued draft guidance for industry, FDA encourages drug sponsors to consider the inclusion of pregnant subjects in clinical studies evaluating drugs and therapeutic biological products in some circumstances and examines the specific ethical and scientific considerations that may impact this decision.  FDA states that they are addressing the challenges of including pregnant women in investigational research to promote maternal/fetal health and informed prescribing decisions during pregnancy.  Continue Reading

“New Deal for Consumers” – draft package adopted by the European Commission

The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market.

The package was adopted by the Commission in response to an evaluation on EU consumer protection and marketing directives. The evaluation found such laws need to be better applied, enforced and modernised for the digital age.

The new package published on 11 April 2018 includes two new proposed directives (the “Directives“):

  • a directive on better enforcement and modernisation of EU consumer protection rules; and
  • a directive on representative actions for the protection of the collective interests of consumers.

The Directives could have a significant impact on the enforcement and protection of consumer rights. Consumer facing businesses will need to be mindful of the Directives as they progress through the EU legislative process.

The main aims of the package include:

  • Modernising consumer rules to respond to current challenges.

The proposals seek to extend consumer protections to “free services” (such as cloud storage and social media accounts) where consumers provide their personal data, rather than monetary payment in return for services. The Commission is also looking to remove disproportionate burdens for traders, for example, traders could choose more flexible means of communicating with consumers e.g. via web chats.

  • Better redress opportunities for consumers and supporting effective enforcement of public authorities. 

The “New Deal for Consumers” package would allow consumers to claim through mass representative actions in “mass harm situations” (i.e. situations that affect large numbers of consumers in the EU). The proposals would also allow national authorities to impose a fine of at least 4% of the trader’s turnover for widespread cross-border infringements.

  • Improving awareness of consumer rights and helping traders to comply with their obligations.

The Commission is looking to run campaigns to help Europeans become more aware of their consumer rights. Such campaigns will focus on Member States where consumers’ knowledge of their rights is at the lowest. The proposals also seek to introduce a number of online tools to assist traders understand what they need to do to comply with their obligations.

  • Ensuring equal treatment of consumers and empowering national authorities to tackle issues with “dual quality” of consumer products.

The Commission has already adopted guidelines on the application of EU food and consumer laws to address the issue of “dual quality” products. The “New Deal for Consumers” package looks to make it difficult and costly for traders who mislead consumers by marketing “dual quality” goods by introducing stricter penalties for illegal practices, individual remedies for misled consumers and collective redress mechanisms.

  • Increasing cooperation with partner countries outside the EU.

The proposals look to increase international cooperation with partners outside the EU. For example, the Commission intends to co-ordinate consumer protection enforcement with key jurisdictions such as US, Canada and potentially China.

  • Preparing consumer policy for future challenges.

The proposals highlight Artificial Intelligence, the Internet of Things and Mobile e-commerce as emerging challenges for consumer protection law. The Commission states it will continue to monitor consumer markets and develop behavioural insights to inform its policymaking on future challenges.

The “New Deal for Consumers” package is a priority for this Commission which seeks to finalise the Directives before May 2019. The UK has also recently published a green paper on modernising consumer markets, which we will publish a blog post on shortly.

The new package documents are available here.

 

 

UK ‘Sugar Tax’ Comes into Force – New Guidance Published for Industry

The UK tax authority HM Revenue and Customs (HMRC) has published a series of practical guidance documents and additional online information to assist companies with understanding and complying with the new UK ‘Soft Drinks Industry Levy’, which takes effect from 6 April 2018.

The new levy applies to all soft drinks (other than natural fruit juice, vegetable juice, milk and certain alcoholic drinks) packaged in or imported to the UK, that contain added sugar and at least 5 grams of sugar in total (both naturally occurring and added sugar) per 100ml of prepared drink (“chargeable drinks”). There are two rates – £0.18 per litre for drinks containing 5g or more total sugars per 100ml, rising to £0.24 per litre for drinks containing 8g or more total sugars per 100ml.

Companies that produce, package or receive imported chargeable drinks will need to register with HMRC and keep detailed records of products that are subject to the levy. The online registration system is now up and running.

The legal framework for the levy is set out in Part 2 of the Finance Act 2017. Additional provisions relating to dilution rations, exempt drinks, registration requirements, tax credits and record keeping are set out in the Soft Drinks Industry Levy Regulations 2018 and the Soft Drinks Industry Levy (Enforcement) Regulations 2018 which come into force today, 6 April.

The new guidance documents published on 3 April 2018 include:

  • The information needed to register for the levy (Notice 1);
  • How to submit a return and pay the levy (Notice 2);
  • Calculating the sugar content of diluted soft drinks (Notice 3); and
  • The process for claiming tax credits for chargeable drinks that are exported, lost or destroyed (Notice 4).

The Guidance documents are available here.

FCC set to initiate “small satellite” Notice of Proposed Rulemaking

On 27 March 2018, the FCC released a draft of its Notice of Proposed Rulemaking (NPRM) (which was adopted on 17 April 2018) seeking comments on proposals to streamline the licensing process for “small satellites,” more commonly known as “smallsats.” By initiating this proceeding, which has been long-anticipated by the smallsat community, the FCC will be recognizing the growing role of smallsat systems in commercial space activities (which we’ve blogged about here and here) and that greater flexibility in the FCC’s “Part 25” satellite licensing rules would be helpful in facilitating the development of smallsat systems. The draft NPRM follows closely on the heels of other recent FCC orders to streamline and modernize its rules and its efforts (e.g. here and here) to facilitate development and innovation in the satellite industry.

The primary benefits of qualifying for the new proposed streamlined processing would be the significant reduction in the FCC’s current satellite application fee (from US$454,705 to US$30,000) and in the time required for preparation and FCC processing of license applications. The FCC proposes, inter alia, that smallsat systems qualifying for streamlined processing be limited to ones that: 1) have 10 or fewer satellites; 2) deploy satellites below the orbital altitude of the International Space Station or possess propulsion systems; 3) have a total on-orbit lifetime of five years or less; and 4) be able to share a frequency band without precluding future entrants. Smallsat systems not meeting the qualifications could still seek authorization under the more generally applicable Part 25 rules.

The FCC’s draft NPRM also identifies certain frequency bands for potential use by smallsat systems on a shared basis: 137-138 MHz (space-to-Earth); 148-150.05 MHz (Earth-to-space); and 1610.6-1613.8 MHz (Earth-to-space). And the draft NPRM proposes to allow inter-satellite service in the Big LEO frequency bands assigned to Globalstar and Iridium (1615-1617.75 MHz, 1618.725-1626.5 MHz, and 2483.5-2495 MHz bands) as part of the Mobile-Satellite Service allocation in those bands.

The draft NPRM has been adopted is expected to be adopted within the next month. Parties interested in commenting on the eligibility criteria for smallsat systems, the proposed frequency allocations, and/or other matters raised in the NPRM will have until 45 days after publication of the NPRM in the Federal Register.

Rules of Origin: a ‘hidden hard Brexit’ for the UK food industry?

The Food and Drink Federation (“FDF“) has published a report on the potential impact of rules of origin on UK food and drink exporters in the likely event that the UK ceases to be part of the EU customs union after Brexit.

Rules of origin are the detailed content requirements that determine whether goods are produced “locally” in order to benefit from preferential tariff rates. Food manufacturing is an internationalised business, with UK producers regularly sourcing ingredients from across the EU and globally, often because sourcing equivalent ingredients in the UK would not be economically or practically feasible.

To date, the UK has benefited from the absence of origin requirements for trade within the EU. However, after Brexit, while it is expected that the EU and UK will negotiate largely or complete free tariffs on food and drink under a preferential free trade agreement (“FTA“), the ability of UK exporters to benefit from those rates will depend on whether their goods meet the criteria to be classified as UK products. Depending on the outcome, many UK producers who have built supply and distribution models on the basis of the single market framework may find that they no longer comply with the permitted levels of global ingredients and may therefore be ineligible for preferential trade terms and tariffs.

Because the EU and the UK are likely to maintain high basic tariffs for food and drink products, the margin between preferential treatment and non-preferential treatment is likely to be considerable. As a result, FDF argues that producers excluded from preferential terms will face a ‘hidden hard Brexit’ and may face costly restructuring of supply chains, absorption of higher costs or de facto barring from EU-UK trade, potentially requiring a restructuring of operations to avoid cross-border trade altogether.

To reduce this risk, the report sets out eight rules of origins provisions that the UK should seek to include in an EU-UK FTA to ensure any new origin rules are suitable for the globalised industries they will impact. The proposals include:

  • a de minimis allowance for non-local content in all goods, set at 10% of the value in addition to any other product-specific allowances;
  • cumulative origin requirements, meaning that goods originating in either the UK or EU are treated as originating in both for the purposes of meeting origin requirements;
  • origin protocols reflecting the unique value added by high quality manufacturing, established brands and other forms of technological input that often characterise the EU and UK food and drink sectors and contribute to a price premium for these goods; and
  • a simplification of the administrative burden of complying with origin requirements through wider use of self-certification, extended validity for origin designations and exemptions for low value shipments.

As a major producer and exporter of food and drink both to the EU and globally, failure to secure preferential treatment under an FTA will be costly for the UK and could have knock-on effects across the food and drink sector. Any solution will need to effectively balance the importance of encouraging local production with the reality of global production in order to prevent serious disruption to existing supply and distribution chains.

The full report is available here.

Spring is the Season for Satellites! Hogan Lovells Hosts CSSMA Meeting and the First “SatelliteEves” Women in Space Event

Tony Lin

Sarah K. Leggin

Every spring, thousands of satellite industry stakeholders descend upon Washington, DC for the industry’s premier satellite conference. This year, the Satellite 2018 conference drew over 14,500+ satellite and space industry stakeholders, including many companies driving innovation and growth in the smallsat sector.

In support of the smallsat industry, Hogan Lovells and attorneys Tony Lin and Sarah Leggin hosted a meeting of the Commercial Smallsat Spectrum Management Association (“CSSMA”), an organization dedicated to creating transparent and expedited spectrum coordination process through educational outreach, sharing best practices, and regulatory advocacy.

The CSSMA formally incorporated less than a year ago and now has over 20 members, including Planet, Spire, Astro Digital, Kepler, Aerospace, Kongsberg Satellite Services, Infostellar, HawkEye360, RBC Signals, and Analytical Space among others. Also participating in the meeting were representatives from the following Federal government agencies:  the Federal Aviation Administration (“FAA”), Federal Communications Commission (“FCC”), the National Aeronautical and Space Administration, National Telecommunications and Information Administration, and the National Oceanic and Atmospheric Association (“NOAA”).  Presenters provided updates on their smallsat systems and ground station networks, advocacy efforts before the International Telecommunications Union, and current smallsat-related proceedings and issues before the FCC, FAA, and NOAA.  Meeting participants discussed the U.S. and international licensing processes, challenges applicant companies have recently encountered, applications for certain frequency bands, and raised questions regarding how to resolve technical or coordination issues.

The next CSSMA member meeting will be held in Logan, Utah on Friday, August 10, 2018 following the 32nd Annual Small Satellite Conference.  Entities interested in joining or learning more about CSSMA should contact a representative (contact@cssma.space).

Participants at the March 2018 CSSMA Meeting

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Therese Jones, SIA; Jessica Noble, LMI Advisors; Sarah Leggin, Hogan Lovells US LLP; Shelli-Rose Haskins, U.S. Coast Guard; Beau Backus, NOAA; Alison Alfers, Hawkeye 360; George John, Spire Global; Jesse Hammer, Kubos; and Katherine Monson, KSAT at the March 2018 CSSMA Meeting

Hogan Lovells kicked off the Satellite 2018 week with the first-ever “SatelliteEves” event, a “Women in Space” networking event followed by its annual satellite week reception.  The event was co-sponsored by Hogan Lovells, Sage Communications, and Euroconsult.  Lisa Kuo, Head of Commercial Programs at The Aerospace Corporation, gave a presentation highlighting the achievements of women in space.  Ms. Kuo then awarded Randy Segal, co-lead of the Hogan Lovells Space and Satellite group, the first-ever “Excellence Award” for Women in Space for her significant contributions to the sector.

 

 

 

 

 

 

Randy Segal receives the first “Excellence Award” for Women in Space from Lisa Kuo, The Aerospace Corporation, and Jeanette Quinlan, Akash Systems; Lisa Kuo presents at the “SatelliteEves” Women in Space event at Hogan Lovells; Guests attend SatelliteEves

Following SatelliteEves, Hogan Lovells hosted nearly 400 guests at its annual SatelliteEve Reception, which featured a specialty bourbon tasting.  Attorneys from Hogan Lovells bartended while guests from all sectors of the satellite industry met with colleagues old and new.

Bourbon selection at SatelliteEve at Hogan Lovells; Guests attend SatelliteEve

For more information on Hogan Lovells’ Space and Satellite practice, please visit our website and read other blogs about the firm’s involvement in the satellite industry.

One year after the enactment of French law, is your company vigilant enough to avoid civil liability?

On 27 March 2017, France went one step further than other countries by adopting “hard” law on human rights with the very broad Law on the “duty of vigilance of the parent companies and main contractor companies”. This statute is now into force and the first “vigilance plans” are being published as companies file their financial statements, which vigilance plans are now part of, where applicable. At the time of these publications, it is worth stressing that the main sanction for non-compliance will come from civil litigation and potential liability for parent companies.

A new and mandatory compliance plan

In summary, the statute provides that French corporations with over 5,000 employees in France and/or over 10,000 employees worldwide (including the employees of subsidiaries and controlled affiliates) are to set up, publish and implement a “vigilance plan”. In particular, this may apply to French subsidiaries of foreign companies or global groups insofar they meet the above-mentioned requirement. The objective of such plan is to identify, anticipate and prevent human rights violations that might result from the activities of the parent company, its subsidiaries and controlled affiliates, and suppliers and subcontractors. More precisely, the statute aims at ensuring effective protection of fundamental rights, individuals’ safety and of the environment.

The vigilance plan is inspired by other compliance requirements existing under French law (in particular anticorruption plans). The plan should cover items like risk mapping, regular assessment procedures, appropriate actions for mitigating risks or preventing serious breaches, warning and reporting mechanisms, as well as monitoring processes to assess the effectiveness of the measures implemented.

There is a clear intent from the French lawmakers to make this new duty of vigilance cover the operations of the parent company, its subsidiaries and any other company in the supply chain, regardless of whether these operations take place in France or abroad. One should bear in mind that one of the drivers for the enactment of this statute can be found in the significant engagement from NGOs that followed recent mass accidents, in particular the collapse of the Rana Plaza textile factory in 2013 in Bangladesh which was used by sub-contractors of several global companies, including French ones.

Potential liability risks

In case of non-compliance with the obligation to publish and, as from next year, report on the effective implementation of the vigilance plan, parent companies may be given formal notice to do so by any interested parties. They may also be brought into summary proceedings by the same stakeholders in order for the Court to order injunctive relief, with the potential application of a penalty payment to secure enforcement of the order.

Most importantly, parent companies may be held liable in civil proceedings for any damage resulting from non-compliance, i.e. failing to prevent human rights violations through the effective implementation of a well-designed vigilance plan. There are a number of questions which the statute does not answer as to how this type of civil actions will work in practice. One can hope that future case law may provide guidance to determine the precise scope of application of the statute and its implications in terms of civil liability.

Our recommendation: have a Legal look at the plan

The vigilance plan is not just another compliance report to be prepared. It is advisable that the preparation of the vigilance plan is not only the work of Compliance teams, but that the Legal function (whether in-house or outside Counsel) be involved as well. Indeed, vigilance plans might potentially become a source of litigation in the future.

The global context: what the Law could mean for non-French businesses

Even those businesses which are not directly affected by the Law should take note. Law makers in other jurisdictions are considering the introduction of similar “hard” law and will be paying close attention to how the French Law works in practice.  In the UK, new guidance released in 2017 toughened disclosure requirements under the Modern Slavery Act (see our post) and the Joint Parliamentary Committee on Human Rights has recently proposed a “hard” legal duty to prevent adverse human rights impacts. As we have written previously, there are proposals in Switzerland to amend the constitution to require mandatory human rights due diligence.

International businesses wishing to stay ahead of the curve and anticipate regulatory changes would do well to consider introducing or fine tuning existing human rights due diligence processes before it becomes mandatory. Not only will this put them at a competitive advantage should new “hard” law be introduced, in the meantime, it will boost stakeholder confidence and reduce the risk of involvement in an adverse human rights impact and associated litigation and adverse publicity.

We will continue to provide updates on the next developments and guidance on this topic. If you have any questions, feel free to contact us. We are available to provide personalized and fine-tuned advice on specific situations wherever helpful.

UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations

The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. The Committee’s report sets out recommendations for the UK Government in its negotiations with the EU on the terms of the UK’s withdrawal from the EU and any future trade deal with the EU. The recommendations are not the Government’s formal negotiating position, but will inform that position.

The overriding recommendation of the report is that the UK and EU must prioritise patient safety and look to secure the “closest possible regulatory alignment” between the UK and EU for the life sciences sector, to ensure that patients in both the EU and UK are not disadvantaged by Brexit.

The report also sets out a number of more detailed recommendations as to the position that the UK Government should adopt in the Brexit negotiations, including seeking:

  • “associate membership” of the European Medicines Agency (EMA), recognising that the EU would also benefit from continued access to the expertise and capacity of the UK Medicines and Healthcare products Regulatory Agency (MHRA) (a proposal already outlined in Theresa May’s speech on 2 March 2018);
  • regulatory alignment with the EU during and after a transition period, including in the long term;
  • free and frictionless trade with the EU and arrangements to maintain parallel trade in medicines with EU member states in any future trade deal;
  • continued access to EU data sharing networks and pharmacovigilance systems, including Eudravigilance (medicines) and EUDAMED (medical devices);
  • mutual recognition of pharmacovigilance activities and the activities of Qualified Persons for Pharmacovigilance residing and working in each other’s territories; and
  • continued involvement in EU research and funding programmes such as Horizon 2020 on the same terms as at present.

The Committee also urges the Government to adopt the new EU Clinical Trials Regulation into UK law following Brexit to ensure that patients, particularly those with rare conditions, can participate in Europe-wide clinical trials. The new Regulation will come into force after the UK has left the EU in March 2019 and therefore will not be automatically implemented into UK law under the proposed EU (Withdrawal) Bill.

The report, which precedes the recent political discussions on the draft Withdrawal Agreement, also warns of the serious adverse impact on the lives of individuals and the life sciences sector in both the EU and UK that would result from a “no deal” Brexit and highlights the need for more transparent contingency planning by the Government.

The full report is available here.

D.C. Circuit Calls 2015 FCC TCPA Autodialer Decision “Utterly Unreasonable”; Strikes Down Reassigned Numbers Framework

The United States Court of Appeals for the District of Columbia Circuit issued its long-awaited decision in ACA International, et al, v. FCC, a case involving multiple petitions for review of the Federal Communications Commission’s (FCC’s) omnibus 2015 ruling interpreting provisions of the Telephone Consumer Protection Act (the TCPA or Act). The FCC decision created a series of TCPA compliance challenges and a plaintiff-friendly environment that spurred substantial class-action litigation over the last few years. Continue Reading

Unfit to remit: First-Tier Tribunal must make its own decision on whether information relating to Blairs’ post-office appointments must be disclosed

In relation to a Freedom of Information Act 2000 (FOIA) request for details of Tony Blair’s private appointments after his tenure as Prime Minister, the Upper Tribunal (“UT”) has confirmed that the First-Tier Tribunal (“FTT”) cannot remit a decision to the Information Commissioner for fresh consideration. The UT was also critical of the FTT’s approach to assessing the application of the exemption in s. 36 FOIA (prejudice to the effective conduct of public affairs).

Background

Edward Malnick, a journalist for the Telegraph, made a request under FOIA from the Advisory Committee on Business Appointments (“ACOBA”) for copies of all correspondence, and records of all conversations, between ACOBA and Tony Blair (or his representatives) two years either side of Mr Blair leaving office as Prime Minister in June 2007.

The ACOBA must be consulted by ministers about any appointments or employment they wish to take up within two years of leaving office, and ministers are under a “code of honour” to abide by its advice. Mr Malnick said he sought the requested information as Mr Blair’s case “has come to exemplify public concern at former Ministers obtaining lucrative post-office appointments. If ever there was a case for transparency, it is this one.”

ACOBA refused Mr Malnick’s request on two grounds. Firstly, ACOBA argued that disclosure would prejudice effective conduct of public affairs (s.36(2)(b) and (c) FOIA) on the basis that former Ministers needed a “safe space” to raise their concerns, and that public disclosure of conversations would create a “chilling effect”, making it less likely for applicants to cooperate with ACOBA in the future. Secondly, ACOBA argued that the correspondence and conversations constituted personal information (s.40(2)). On appeal by Mr Malnick, the Information Commissioner agreed that disclosure could be refused on s.36 grounds, and so did not consider whether the s.40 exemption was engaged.

The FTT upheld Mr Malnick’s subsequent appeal on the basis that s.36 FOIA was not engaged but that, even if it was, the public interest favoured disclosure. The s.36 exemption is engaged if, in the reasonable opinion of the authority’s designated “qualified person”, disclosure of the requested information would be prejudicial to the effective conduct of public affairs. The FTT held that the opinion of ACOBA’s Qualified Person (“QP”) was not “reasonable” because it failed to take into consideration the fact that the “court of public opinion” is a crucial factor in encouraging Ministers to abide by ACOBA’s recommendations. The FTT held that the Commissioner would “therefore need to issue a new decision notice, which does not rely on [s.36].”

The appeal to the Upper Tribunal

The Commissioner then appealed the FTT’s decision on three grounds:

  1. The FTT was wrong to decide s.36 was not engaged on the basis that the opinion of ACOBA’s QP was not “reasonable”;
  2. The FTT incorrectly assessed the balance of public interest under s.36; and
  3. The FTT had no power to order the Commissioner to issue a new decision notice.

In its decision earlier this month, the Upper Tribunal (UT) upheld the appeal on all three grounds.

The reasonableness of the QP’s decision and the public interest test

The FTT had wrongly applied the s.36 test by failing to undertake a two-step process. It was required to first decide the threshold question of whether the QP’s opinion was reasonable. Only on deciding that the opinion was reasonable, should the FTT have weighed the public interest in favour and against disclosure. Instead the FTT conflated the two steps, by considering the public interest in its assessment of whether the QP’s opinion was reasonable. In doing so, the FTT had erred in law in deciding that the QP’s opinion was unreasonable.

The UT also held that the effect of public opinion and investigative journalism on ministers’ compliance with ACOBA’s recommendations related to events after ACOBA made its recommendations, and not before. This consideration was therefore not relevant to the QP’s reasons for determining prejudice, namely threat to the safe space and the chilling effect.

In erroneously dismissing the QP’s Opinion as unreasonable, the FTT also failed to give that decision appropriate weight in its determination of the public interest test under s.36. The UT therefore also upheld the Commissioner’s second ground of appeal.

Remitting to the Information Commissioner

In relation to the third ground, the UT noted, in the first instance, the absence of any statutory power to remit a case back to the Commissioner. The UT then rejected the suggestion that an ICO decision notice that erred in law was always a “nullity” so as to automatically revive the Information Commissioner’s duty under s.50 FOIA to make a decision upon an application to do so. Instead, the FTT must make its own determination as to whether s.36 is engaged and, if so, whether the public interest favours disclosure.

Implications

 The case affirms important points regarding the role of the Information Commissioner and its relationship with the tribunal appeal procedure. The Commissioner cannot make two notices regarding the same complaint, especially where there is no legislative framework for her to reconsider a notice. By contrast, it is the nature of the appeals process that it is for the FTT to determine the issues before it: it cannot abdicate or share that duty. This is in notable contrast to procedure under judicial review, where a court can remit a decision back to the original decision-maker.

The case also offers helpful guidance on the exercise to be undertaken when considering the application of the exemption under s. 36 FOIA, i.e. the separate questions of whether a QP’s opinion is reasonable and whether the public interest favours disclosure should not be conflated.

Whether we will see the correspondence and conversations relating to Tony Blair’s private engagements remains to be seen: this will be for a newly-constituted FTT to decide in due course.