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Focus on Regulation

DoD Issues its Long Awaited Final Rule on Cyber Incident Reporting and Cloud Computing

On Friday, October 21, 2016, the Department of Defense (DoD) issued a final rule implementing changes to its December 2015 interim rule on DoD contractor cyber incident reporting and cloud computing. See our earlier reporting on the 2015 interim rule here. The final rule is effective upon the publication date, October 21, 2016.

The final rule includes a number of significant changes in response to public comments received on the interim rule. Although we will be releasing a more detailed analysis shortly, some key highlights of the final rule are: Continue Reading

EMA Management Board progresses on New Medicines Web Portal

On 10 October 2016, the European Medicines Agency’s (“EMA”) Management Board adopted a reflection paper on the development of a new European Union medicines web portal. The reflection paper sets out a vision for this new portal and its expected benefits. It also details the means to achieve this vision.


The new portal, taking the form of a multilingual website, is intended to provide wide access to free, reliable and unbiased information concerning all human medicinal products that have been authorised in the European Union (“EU”). It is addressed to patients, consumers, carers, healthcare professionals and academia throughout the EU. It will grant visitors access to comprehensive information on the lifecycle of a medicinal product, from clinical trial information to adverse drug reaction reports.

The development by the EMA, in collaboration with the EU Member States and the European Commission, of a web portal for the purpose of disseminating information on medicinal products authorised in the EU is provided for in Article 26(1) of Regulation (EC) 726/2004 as amended by Regulation (EU) 1235/2010.

The launch of the European medicines web portal

The portal aims to use as a foundation the EudraPharma online database developed by the EMA in 2006 on the basis of Article 57 of Regulation (EC) 726/2004 to make information concerning medicinal products authorised at EU or national level accessible to the public. In a first phase, the new portal will use the data submitted by marketing authorisation holders under the EudraPharma submission process. In a second phase, further content and functionalities will be added to the portal.

Once live, the portal will replace the EudraPharma database and incorporate both the European Database of Adverse Drug Reaction Reports and the EU Clinical Trials Register. It will also include the new clinical data website that is currently being launched and which will make clinical study reports publically available.

In addition to making available information concerning medicinal products authorised at EU level, the European medicines web portal will enable access to product information for nationally authorised medicinal products by providing links to EU Member States’ national web portals. The web portal will increase the visibility of information held by both the EMA and the EU Member States. It should also increase data availability, in support of high-level European initiatives on data-sharing, by providing downloadable, consumable datasets to the portal users.

EMA, in collaboration with the EU Member States and the European Commission, will now develop a multi-annual delivery plan and begin scoping IT solutions to support the project. The National Competent Authorities (“NCA”) will be responsible for the completeness and accuracy of the documents relating to nationally authorised medicinal products. Both the EMA and the NCAs intend to take measures to guarantee the quality of the information supplied to the website. Focus will be put on the reliability and searchability of content in order to ensure the trustworthiness and success of the European medicines web portal.

The reflection paper identifies the biggest challenge as being how best to integrate drug data and document sources feeding the web portal, while providing a meaningful, usable and useful experience for end users. The EMA will operate a full analysis of all technical aspects in order to assess with certainty the extent to which the vision and timelines for finalisation can be achieved.


For further information visit: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/10/WC500213925.pdf

Environmental Review of Interim Storage of Spent Nuclear Fuel Moves Forward

The NRC staff recently made public plans to move ahead with early preparations for an Environmental Impact Statement for Waste Control Specialists’ interim storage facility for spent nuclear fuel.  The staff took the position that starting this review early would benefit the purposes of the National Environmental Policy Act by providing additional time for analysis and stakeholder involvement.  Although not explicitly noted, this move likely reflects the importance of and strong public interest in the facility, given that Waste Control Specialists’ application for the interim storage facility has not yet completed its “acceptance review,” a process which usually precedes any significant environmental review efforts by the agency.

For more on interim storage of nuclear fuel, nuclear decommissioning, or nuclear power in general, please contact the authors.

Fragmentation instead of level-playing field? How the German Government’s announced White Paper on digital platforms adds to regulatory uncertainty on topical issues of the digital economy after Brexit

Many digital platforms attract consumers and businesses on a global basis. It is a challenge for national regulators to enforce competition law and other regulatory provisions against such international players. Germany´s Federal Minister of Justice, Heiko Maas, argued in a similar way in an interview with the German newspaper Handelsblatt on 5 October 2016. He took a stand on the significant market shares of certain digital platforms questioning whether current competition law rules enable enforcers to sufficiently tackle current issues in the digital economy. Interestingly, despite calling for an EU-wide approach towards dominant players in the internet sector, the German minister announced a White Paper on Digital Platforms for early 2017.

These statements come at a time where the EU Commission is struggling to take the lead in shaping a EU competition law policy approach towards the handling of big data (see our blog post on Commissioner Vestager’s recent speech on Big Data and competition law). In the last months mainly national regulators have been active in publishing papers or decisions dealing with digital and platform issues. The German and the French competition agencies have issued a joint paper on data and competition law in May 2016. France has also announced the launch of a “full-blown sector inquiry into data-related markets and strategies. This comes at a time of uncertainty for the future structure of the Digital Single Market as the UK has voted to leave the EU, thus triggering another element of re-nationalization of regulation. Continue Reading

IAEA Cautions on Cybersecurity Risks to Nuclear Power Plants

The Director of the International Atomic Energy Agency (IAEA) on Monday October 10 stated that nuclear power plants are targets for cyber attacks. noting cyber attacks at nuclear power plants in recent years.

Nuclear power has consistently proven itself to be a safe and effective form of power generation, and Homeland Security has concluded that nuclear reactors are generally well-protected against cyber attacks.  That being said, that the risk of cyber attacks on the energy industry as a whole, including on nuclear power plants, will always remain a concern.  We have paid close attention to this issue; for those interested in learning more, please review our six-article series on cybersecurity in the energy sector, and/or feel free to contact the authors.

Capturing the Climate Benefits of Nuclear Power Using the Social Cost of Carbon

Today, the Electric Light & Power Executive Digest featured an article by three of the firm’s attorneys on using the Social Cost of Carbon to price nuclear power.  State efforts to fight climate change by compensating electric generators for carbon-free or low-carbon power represent a monumental shift in our energy policy.  And it is one that could have dramatic impacts on nuclear power.  New York has proven to be a leader in this regard, creating a Zero Emissions Credit program that gives its upstate nuclear power plants an equal footing to compete against natural gas and renewable energy facilities.

For more information, please take a look at the article above, or contact the authors.

Comments Received on the NRC’s Vision Statement for Advanced Reactors

Industry comments were recently made public on the U.S. Nuclear Regulatory Commission’s (NRC’s) draft “Vision and Strategy” statement (draft vision statement) for non-light water reactors, a.k.a. advanced reactors.  This effort represents the NRC’s most significant attempt in recent years to pave the way forward for advanced reactors.  While the draft vision statement defends that the NRC “could review and license a non-[light water reactor] design today” (and notes that three such reactors were licensed in the past), it acknowledges the potential for a more efficient regulatory framework in this area.

The core of the NRC’s draft vision statement is the creation of a “conceptual design assessment,” along with a staged standard design approval process.   Speaking to the conceptual design assessment, the draft vision statement advertises that the scope and cost of these assessments can be designated beforehand, and that it will be flexible enough to offer valuable input regardless of the level of maturity of the reactor design.  For less-developed designs, the conceptual design assessment could provide “regulatory observations” such as potential impediments to licensing.  On the other hand, for well-developed designs the NRC could provide something akin to a “preapplication safety evaluation report,” finding that “no obvious impediments” exist to licensing.  Turning to the staged review process, the draft vision statement explains that advanced reactor applicants in the future will be able to engage in a segmented review process for a Part 52 “standard design approval,” with “major portions” of a reactor being approved at different times.   Bringing it all together, the NRC posits that applicants could engage in preapplication activities with the NRC, then file for a conceptual design assessment, and then apply in stages for a standard design approval, lowering regulatory risk at each step in the process.

The NRC set a goal to introduce this regulatory approach by 2025.  Near-term (within 5 year) goals include building internal expertise, developing industry standards, acquiring computer tools, creating closer relationships with national labs, and identifying critical advanced reactor policy issues.  By 2025 these and other issues will theoretically have been addressed, allowing for the new regulatory framework to come into effect.  The NRC set a goal in the draft vision statement of having two advanced reactor designs ready for construction by the early 2030s.

Four parties submitted detailed comments on the draft vision statement: the Nuclear Energy Institute (NEI) (a nuclear power industry group), Transatomic Power and X-energy (two advanced reactor startups), and Idaho National Laboratory (a U.S. Department of Energy laboratory).  All four parties applauded the NRC’s efforts but raised many suggestions.  Three are worth special mention:

  • Timeline: As expected, the three industry parties sought a faster timetable from the NRC, with NEI putting forward a revised timetable that would have advanced reactors under construction in the United States in the early 2020s.   They also argued that the inherent safety of advanced reactors should lead to reduced review times. What is surprising, however, is just how quick the reactor startups wanted the NRC to be ready—X-energy implied that the NRC should be ready for preapplication submissions 18-24 months from now.  Transatomic Power noted that even for an advanced reactor to be under construction in the 2030s, preliminary and detailed design will have started before 2025, and thus the NRC should have its regulatory process in place by 2021.
  • Related Facilities: All four parties took issue that the draft vision statement did not lay out a framework for licensing fuel fabrication facilities.  Transatomic Power also argued that increased attention be paid to developing an expedited process for licensing test or prototype reactors, lest it hold back commercial reactor design development.
  • Regulatory Certainty: Both NEI and X-energy sought more clarity as to the preapplication process and conceptual design assessment, stressing that both must result in meaningful and predictable results to justify their time.  Transatomic Power, however, went much further and actually suggested the NRC ditch the whole conceptual design assessment idea.  It argued that the process was far more intense than industry had called for, which was simply an analysis of licensing feasibility.  Instead, Transatomic Power preferred that the assessment be replaced with a direct analog to Canada’s “Pre-licensing Vendor Design Review” program.  In a related tack, Idaho National Lab suggested that the NRC create “checkpoints” to periodically reconnect with industry and make sure it is delivering something useful.

The NRC is seeking engagement from interested stakeholders as it starts to pay increased attention to advanced reactors, and this draft vision statement is just the start of the process.  For example, in just a few days, on October 11, the NRC is hosting a public meeting on design criteria for advanced reactors.  Proactive involvement by industry and the public, as exemplified by the commenters above, can add critical momentum to the NRC’s efforts and help drive this nascent field forward.

For questions on the NRC draft vision statement or advanced reactor issues in general, please contact the authors at any time.

EMA and FDA set up new working group on rare diseases

On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is intended to contribute to sharing experiences and best practices on the approach of the two regulators to the development and scientific evaluation of medicines for rare diseases.


Rare diseases are estimated to affect 30 million people in the European Union and the United States, though each individual disease only concerns a limited number of patients. Both the EMA and the FDA call for more global collaboration to ensure that the limited number of studies that can be conducted, due to the small populations, can benefit all patients regardless of where they live.

This sort of collaboration where the EMA and the FDA hold regular meetings by teleconference, with the participation of other agencies globally are known as ‘clusters’ in the EU.

The cluster on rare diseases

The agencies’ collaboration will focus on exchanging information on topics such as:

  • The design of clinical trials in small populations and the use of statistical analysis methods;
  • The selection and validation of trial endpoints;
  • Preclinical evidence to support development programmes;
  • The design of post-marketing studies, in particular in the context of early access mechanisms;
  • Risk management strategies for long-term safety issues with rare disease treatments.

On 23 September 2016, the first meeting of the rare diseases cluster took place by teleconference. The cluster will initially meet once a month via teleconference and will be chaired jointly by FDA and EMA. The information exchange between the two regulators is covered by confidentiality arrangements.

More generally, clusters established by EMA and FDA focus on areas where the parties involved could benefit from an intensified exchange of information and strengthened international collaboration. The currently existing clusters discuss issues related to patient engagement, orphan medicinal products, biosimilars, medicines to treat cancer, medicines for children and pharmacovigilance amongst others.

The cluster will allow for confidential exchange of draft documents, policies under development, and provide more detailed information to support the scientific basis for decision-making on medicine development.

For further information visit: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/09/WC500213119.pdf

U.S. Department of Education Issues Guidance on Third-Party Servicers

On August 18, the U.S. Department of Education issued a series of questions and answers related to “third-party servicers”.  This recent guidance follows the issuance of a Dear Colleague Letter in January 2015 that addressed institutional responsibilities and requirements for institutions participating in the Title IV federal student financial aid programs that choose to enter into contracts with third-party servicers.

Third-party servicers are entities or individuals that administer any aspect of an institution’s participation in the Title IV programs, including, but not limited to, services and functions necessary:

  • For the institution to remain eligible to participate in the Title IV programs;
  • To determine a student’s eligibility for Title IV funds;
  • To account for Title IV funds;
  • To deliver Title IV funds to students; or
  • To perform any other aspect of the administration of the Title IV programs.

That Dear Colleague Letter prompted a number of questions submitted to the Department related to third-party servicer requirements.  The August 2016 guidance is intended to provide clarification with regard to the January 2015 Dear Colleague Letter, but the Department says the guidance “does not make any changes to the regulations related to third-party servicers.”  Moreover, the new guidance “does not change or reverse any guidance provided in Dear Colleague Letter GEN 15-01, which is still in effect.”

The 20-page questions and answers document addresses questions in several sections, including: Continue Reading

Compliance Deadlines for New ClinicalTrials.gov Requirements Explained: What Results to Post and When

As discussed in a previous client alert (here), the Department of Health and Human Services (HHS) recently issued a final rule governing the requirements for public registration of trials and posting of data to the ClinicalTrials.gov database. In a significant expansion over the previous requirements, effective January 18, 2017, responsible parties will have to publicly report the results of more clinical trials, including some for investigational drug products and devices that may never reach the marketplace.

A critical component of the final rule is Subpart C, which fundamentally alters the scope of trials subject to reporting obligations to include clinical trials involving unapproved, uncleared, or unlicensed products, regardless of whether marketing authorization is being sought for the products. HHS determined that submission of results of applicable clinical trials for investigational medical products that are not commercially available furthers the statutory purpose of the database “to provide more complete results information and to enhance patient access to and understanding of the results of clinical trials.” 81 Fed. Reg. 64982, 64989 (Sept. 21, 2016).

Responsible parties will have 90 calendar days after the effective date to come into compliance with the requirements of the final rule, or April 18, 2017. Drug and device companies and other institutions conducting and planning to conduct clinical trials should take action to evaluate and ensure that all of their applicable procedures, policies, and research grant agreements appropriately consider these substantive changes to the clinical trial results reporting requirements under the final rule.

The following discussion provides a brief overview of the new results posting requirements and the transition rules in place for studies completed before and after the effective date of the regulation. Continue Reading