The Week Ahead in the European Parliament – February 16, 2018

Summary

Next week will be very busy in the European Parliament, as it is a committee week.

On Monday and Tuesday, as part of the European Parliamentary Week, Members of National Parliaments of the EU Member States will join Members of the European Parliament (“MEPs”) to debate various issues, including EU tax policy, the economic future of the Union, economic governance and digitalisation.  Antonio Tajani, President of the European Parliament, Jean-Claude Juncker, President of the European Commission, Tsveta Karayancheva, President of Bulgaria’s National Assembly, and Mário Centeno, President of the Eurogroup, will take part.

On Wednesday, the Committee on Economic and Monetary Affairs (“ECON”) will vote on a report by Alain Lamassoure MEP (EPP, FR) on the Common Consolidated Corporate Tax Base (“CCCTB”).  The aim of the proposal is to enforce taxation in the country where their profits are generated, in an attempt to curb profit shifting.  See the draft report here.

On the same day, the Committee on Industry, Research and Energy (“ITRE”) will vote on a report by Françoise Grosstete (EPP, FR) on establishing the European Defence Industrial Development Programme.  The programme, with a budget of 500 million euros for 2019-2020, would support the competitiveness and innovative capacity of the EU defence industry through funding new defence products and technologies. See the draft report here.

On Thursday, the Committee on the Internal Market and Consumer Protection (“IMCO”) will vote on a draft report by Pascal Arimont (EPP, BE) on contracts for online sales and other distance sales of goods.  The new rules seek to guarantee consumers the remedies they are entitled to if they purchase a faulty product, whether bought in-store or online.  See the draft report here, and the most recently tabled amendments here.

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CFPB Request for Information Focuses on Concerns about the Enforcement Process

On February 7, 2018, the Consumer Financial Protection Bureau (“CFPB” or “Bureau”) published the latest in its growing series of Requests for Information (“RFI”), this one seeking comment on the Bureau’s enforcement process.[1]  As with earlier RFIs, the Bureau recognizes that the enforcement process may impose burdens on regulated entities and is seeking information on how to improve enforcement processes while remaining faithful to the Bureau’s objectives and “ensuring a fair and transparent process for parties subject to [the Bureau’s] enforcement authority.”

This RFI, following on RFIs relating to Civil Investigative Demands[2] and Administrative Adjudications,[3] is further evidence that the CFPB, under new leadership, is closely evaluating a broad range of Bureau activities and their impact on the industry.

While the RFI broadly seeks suggestions on “potential updates or modifications” to the enforcement process,[4] the Bureau emphasizes seven aspects of the process that “may be deserving of more immediate focus.”[5]  Because the CFPB’s enforcement process is a series of inter-related steps, changes to any one of these areas may impact, or be impacted by, changes to other areas.

Before delving into the RFI’s seven focus areas, it is important to recognize an over-arching concern with the Bureau’s enforcement process — namely, the virtual inability to resolve a matter in the supervisory context once it has been referred to the Office of Enforcement.

Inability to Resolve Enforcement Matters Short of Public Enforcement Actions:  The Action Review Committee (“ARC”) and ‘Reverse’ ARC

The Bureau has a formal process — known as the Action Review Committee, or ARC — for moving a matter from a supervisory examination to the Office of Enforcement.  Although the Bureau has taken the position that it technically has a ‘reverse’ ARC process by which matters may be returned to Supervision, this appears to occur on only rare occasions.  The result is that the Office of Enforcement, in practice, appears to have only one means to resolve an issue (other than to drop a case), and that is to bring a public enforcement action.  Meanwhile, the Bureau’s Office of Supervision can address matters through various non-public means, such as a Memorandum of Understanding.

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Off to the races: How will policy shape autonomous vehicles tech in 2018?

This post was originally published on the Covington InsideTechMedia blog on February 12, 2018.

At the start of 2018, we find ourselves in the midst of an autonomous vehicles revolution.  In the private sector, leading, and some nascent, autonomous mobility innovators have forged ahead with a surge of investment.  Last year, The Brookings Institution found that during a snapshot between 2014 and 2017, more than 160 investments worth more than $80 billion went toward the auto electronics, microchips, sensors, artificial intelligence and deep learning, digital mapping, ridesharing, physical systems, and other software needed to power autonomous mobility.

Some of transactions were large (e.g., GM acquired Cruise Automation for $1 billion); many others registered relatively smaller blips on the radar (e.g., NVIDIA’s $5.25 million investment in Optimus Ride, or Ford’s $6.6 million investment in Civil Maps).  But the volume — and the acceleration of investment beginning in 2016 — speaks to a general dynamism in the autonomous mobility space.

Indeed, the race to become the first jurisdiction to have autonomous vehicles on the road is becoming an increasing priority for governments globally, particularly within the United States, Europe and Asia.  A recent study from KPMG has ranked 20 countries on their readiness for autonomous vehicles.  The United States and European countries ranked among the highest with the U.S. at third place, and the Netherlands in first.  Although Singapore ranked second, other Asian countries didn’t rank quite as highly; South Korea tenth, Japan eleventh, and China sixteenth.

U.S. Developments

The federal government has been moving ahead apace in the new year.  Autonomous vehicles are the subject of bipartisan legislation on Capitol Hill, where both the House (SELF-DRIVE Act) and the Senate (AV START Act) have developed (and, in the case of the House bill, passed) legislation that would allow innovators to seek exemptions from state and federal regulations that might ordinarily hamper the acceleration of new car design and technology deployments.  The Senate bill is still under consideration and its author is making an effort to respond to concerns that Democratic members have raised about safety.

Perhaps more immediately relevant to stakeholders in the autonomous mobility sector is a recent set of requests for comment issued by the federal Department of Transportation (DOT) — the dockets for which remain open until early March.  On January 10th, DOT announced requests for information and comments from the Federal Highway Administration (FHWA), the Federal Transit Administration (FTA), and the National Highway Traffic Safety Administration (NHTSA).  FHWA seeks information on the integration of automated driving systems (ADS) into the highway transportation system; FTA seeks comments on transit bus automation technology (and potential areas of future research) and on removing barriers to transit bus automation; and NHTSA seeks comment on removing regulatory barriers for automated vehicles.  These requests for comment and information provide an opportunity for the private sector to influence the shape of the autonomous mobility landscape for years to come.

European developments

As highlighted by the KPMG study, the autonomous vehicle landscape in Europe is equally showing a bright future, and the race between Member States and European automotive companies to be the first the get driverless cars on the road is rife.

To ensure Europe remains competitive in this area the European Commission has been active with the development of various funding initiatives and working groups.  In November 2016, the Commission published a strategy on Cooperative Intelligent Transport Systems (C-ITS) which examines possible legislative developments in this area.  A public consultation on the specifications for C-ITS closed on January 12, 2018, with the results currently pending.

Legislative developments at Member State level have also been important in ensuring this race remains competitive.  For example, as of July 2017 in Sweden, the Road Transportation Authority has been able to authorize permits to allow companies to trial autonomous vehicles on Swedish roads.  Last year the Netherlands approved a bill which allows the testing of autonomous vehicles without a driver, and the UK’s chancellor announced in his 2017 autumn budget plans for new legislation which will allow self-driving cars on UK public roads without a driver behind the wheel by 2021.

Developments in China

The Chinese government is also in the process of developing rules of the road for autonomous vehicles.  Notable examples include local road testing rules promulgated late last year in Beijing (Guiding Opinions on Accelerating Work Relating to Autonomous Vehicle Road Testing in Beijing (Trial)) (Dec. 15, 2017), as well as the forthcoming local rules expected to be announced soon in other cities.  These local rules allow autonomous vehicle companies to apply for permits to conduct road testing and set out basic guidelines for eligibility and liability standards.

Also, multiple initiatives are underway at the national level.  For example, the Ministry of Industry and Information Technology (MIIT) is in the process of drafting trial regulations for road testing of intelligent vehicles that will, among other things, “regulate road test applications, verification management, [and] accident liability allocation.”  This work complements an earlier commitment to equipping more than 50% of new vehicles by 2020 with driver assistance systems, partial automation systems, or conditional automation, and 10% of new vehicles with Internet-connected driving assistance systems in China’s Medium- to Long-Term Development Plan for the Automobile Industry. (Apr. 6, 2017).

Notwithstanding the Chinese acceleration of autonomous vehicle deployments and regulations, private sector stakeholders — especially foreign-owned companies — may still face significant challenges.  Chinese restrictions on foreign companies’ participation in the surveying and mapping sector, and requirements to localize mapping data  present key regulatory hurdles.

The landscape for autonomous mobility is taking shape, with an increasing need for partnership between governments, regulators, and industry.  The UK, for example, recently announced its HumanDrive initiative in which Highways England have teamed up with academic institutions and companies such as Nissan, Hitachi and Renault to develop an autonomous car prototype which will conduct a 200-mile journey in December 2019.  Last week, urban autonomous mobility took a leap forward when Airbus Group’s A^3 division staged a full-scale flight test of its autonomous vertical takeoff and landing (VTOL) Vahan aircraft.   In recent days we’ve seen some of the reverberations of an industry bursting at the seams, with Baidu significantly updating its open-source autonomous driving platform, Apollo, and a coalition of thought leaders in autonomous mobility coming together around a set of shared mobility principles.

Stay tuned here for further developments at the intersection of autonomous mobility, technology, regulation, law, and policy.

Level-setting the President’s Budget Blueprint and Rx Pricing: Putting the Process and Substance in Context

Today, the President will submit the Administration’s Fiscal Year 2019 budget blueprint to Congress.  The document will set in motion an annual process to analyze the substance, business implications and prospects for various proposals.  Draft documents have already begun to circulate that suggest that both the budget and a forthcoming addendum would, if enacted, have significant impact on the biopharmaceutical industry.  As this exercise begins, it is important to note the context in which the President’s budget is presented and expectations for its consideration by Congress.

While the President is required by law to annually submit a budget, it is really a request — it is ultimately the responsibility of Congress to adopt Budget Resolutions, which themselves do not have the force of law but rather are intended to set parameters that guide the development of department-specific appropriations bills to fund the federal government each fiscal year.

The reality is that the federal budget and appropriations process rarely works as it is supposed to — beginning with the President’s budget proposal which, regardless of party control and politics, has in the past couple of decades been considered “dead on arrival” on Capitol Hill. Congress has increasingly relied on “Continuing Resolutions” and short-term leadership-driven deals like the one that passed last week to avoid a second  government shutdown.  In this election year and hyper-partisan environment, we do not expect Congress to pass a budget resolution that would allow the Senate to consider legislation with a majority vote.  Rather, any proposals considered this year will need 60 votes for adoption in the Senate.

In years past, even if a budget is adopted by Congress, it typically is not significantly shaped by the priorities in the President’s budget.  That said, given this President’s use of tweets and direct communications with the “street,” the Administration’s proposals intended to bring down drug prices, likely will be the subject of considerable attention and discussion in upcoming congressional hearings. Secretary Azar will testify before the Senate Finance Committee and House Energy and Commerce and Ways and Means Committees this week.  Those hearings will keep the attention on the biopharmaceutical proposals we expect to see today.  In an election year, hot-topics such as drug pricing will also serve as campaign themes in races across the country and possibly set the stage for more serious deliberation next year, depending to a large degree on the results of the elections and the political environment going forward.

In this context, it is too early to know which, if any, of the biopharma-related proposals might actually be enacted into law outside of the budget process or pursued by regulation. It might turn out that the broad issue of drug pricing emerges as an issue on which President Trump and the GOP seek some common ground with congressional Democrats, and that certain concepts offered by the Administration — such as establishing Medicare Part D spending caps and expanding the catastrophic benefit for seniors, addressing Part B payment formulas for newly launched drugs and revising the definition of generic drugs in Medicaid as well as the launch of a pilot program to allow states to negotiate lower Medicaid drug prices — could gain legislative traction or move by regulatory action.  Other Administration proposals, such as reforms to the 340B program that would ensure that savings go to hospitals delivering adequate levels of uncompensated charity care or be returned to the trust fund, might be a bridge too far in light of election year partisan politics and continuing Democratic support for the program’s growth.

Over the next several months, it is critical that biopharmaceutical industry stakeholders remain vigilant and actively engaged, while recognizing that policy recommendations in the presidential budget are a starting point and anything but written in stone — especially in a politically turbulent and largely unpredictable year such as this.

The Week Ahead in the European Parliament – February 9, 2017

Summary

Next week is a constituency week for Members of the European Parliament (“MEPs”).  MEPs will go back to their home countries to handle national issues, or convene in their parliamentary delegations to work on matters related to non-EU Member States.

This past week was important however, as many significant initiatives were adopted by the Parliament.

On Tuesday, MEPs approved a draft report by the Committee on the Internal Market and Consumer Protection (“IMCO”) on geo-blocking.  The new rules ban unjustified geo-blocking and allow online consumers wider cross-border access to products, hotel bookings, concert tickets or car rentals.  Vendors will be compelled to treat online EU customers in the same manner as local customers.  However, the report does not compel e-commerce vendors to deliver their products to all EU countries.  See the report here.

Also on Tuesday, MEPs approved the mandate of a new Special Committee on Pesticides, which was established following a risk assessment of the herbicide glyphosate, whose license was renewed for five years in November 2017.

On Wednesday, MEPs voted in favor of a draft report by the Committee on Constitutional Affairs (“AFCO”) on the composition of the European Parliament.  The report provides that the number of MEPs should decrease from 751 to 705 once the UK leaves the EU.  However, MEPs rejected the idea of “transnational” electoral lists throughout the EU.  See the report here.

Meetings and Agenda

No official meetings in the European Parliament are planned before February 19, 2017.

FTC Enters Into COPPA Settlement With Online Talent Search Company

On Monday, the Federal Trade Commission (FTC) entered into a settlement with Nevada-based Prime Sites, Inc., doing business as Explore Talent, related to charges that Explore Talent violated the Children’s Online Privacy Protection Act (COPPA).  Explore Talent, an online talent search company, will pay $235,000 in civil penalties.

According to the FTC’s complaint, Explore Talent violated COPPA by collecting and disclosing children’s personal information without obtaining parental consent and by failing to represent accurately its collection, use, and disclosure practices.  Specifically, the FTC alleged that Explore Talent required that users—including children under 13—submit personal information, such as their names, email addresses, and telephone numbers and further requested that users provide mailing addresses and photographs.  Much of the personal information users provided became publicly available on users’ profiles on ExploreTalent.com.  Explore Talent did not provide notice to parents or obtain verifiable parental consent prior to such collection and disclosure.  In addition, Explore Talent did not place any restrictions on users who indicated they were under 13, nor did it take any steps to verify whether a profile was being created by a legal guardian, notwithstanding the instruction in its Privacy Policy that users under 13 must have a parent or legal guardian create their account.  As a result, the complaint alleged that Explore Talent falsely stated in its Privacy Policy that it did not knowingly collect personal information from children under the age of 13.Separately, the complaint also alleged violations of the FTC Act related to Explore Talent’s claims regarding its premium services.

The Week Ahead in the European Parliament – February 2, 2018

Summary

Next week, there will be a plenary sitting of the European Parliament in Strasbourg, France. Several significant debates, votes and committee meetings will take place.

On Monday, Members of the European Parliament (“MEPs”) will debate the European Central Bank’s post-crisis bank asset purchase program and its effects with Mario Draghi, President of the European Central Bank. Brexit and cybersecurity threats will also be discussed.

On Tuesday, MEPs will debate the Future of Europe together with special guest Andrej Plenković, the Prime Minister of Croatia. This is the second discussion in a series between MEPs and EU leaders on the future of the EU.

On the same day, MEPs will vote on a draft report by the Committee on the Internal Market and Consumer Protection (“IMCO”) on geo-blocking. If passed, the new rules will ban unjustified geo-blocking and allow online consumers wider cross-border access to products, hotel bookings, concert tickets or car rentals. Vendors will be compelled to treat online EU customers in the same manner as local customers. See the draft report here.

Also on Tuesday, MEPs will vote on the mandate of a new Special Committee on Pesticides, which was established following a risk assessment of the herbicide glyphosate, whose license was renewed for five years in November 2017.

On Wednesday, MEPs will vote on a draft report by the Committee on Constitutional Affairs (“AFCO”) on the composition of the European Parliament. The report provides that the number of MEPs should decrease from 751 to 705 when the UK leaves the EU. A certain number of MEPs should also be elected through “transnational” electoral lists throughout the EU. See the report here.

Meetings and Agenda

Monday, February 5, 2018 

Plenary session

17:00 – 23:00

Debates

  • European Central Bank Annual Report for 2016
    • Committee: ECON
    • Rapporteur: Jonás FERNÁNDEZ
  • Geo-blocking and other forms of discrimination based on customers’ nationality, place of residence or place of establishment
    • Committee: IMCO
    • Rapporteur: Róża Gräfin von THUN UND HOHENSTEIN
  • Decision adopted on the Fair Taxation package II and III
  • Cost-effective emission reductions and low-carbon investments
    • Committee: ENVI
    • Report: Julie GIRLING
  • Accelerating clean energy innovation
    • Committee: ITRE
    • Report: Jerzy BUZEK

Tuesday, February 6, 2018 

Plenary session

09:00 – 11:50

  • Key debate: Debate with the Prime Minister of Croatia, Andrej Plenković, on the Future of Europe

12:00 – 14:00

Votes followed by explanations of votes

  • Setting up a special committee on the Union’s authorisation procedure for pesticides, its responsibilities, numerical strength and term of office
  • EU-Brazil Agreement for scientific and technological cooperation
    • Rapporteur: Angelo CIOCCA
  • Texts on which debate is closed

15:00 – 23:00

Debates

  • Situation in Zimbabwe
  • New agenda for the EU-Central Asia relations in the framework of the 13th Annual Ministerial Meeting
  • Current human rights situation in Turkey
  • EU’s perspectives for the first EU-Cuba Joint Council meeting
  • Decision adopted on the EU Enlargement Strategy – Western Balkans
  • Shrinking space for civil society
  • Work and legacy of the International Criminal Tribunal for the Former Yugoslavia

Wednesday, February 7, 2018

Plenary session
09:00 – 11:50
Debates

  • Composition of the European Parliament
    • Committee: AFCO
    • Report: Pedro SILVA PEREIRA, Danuta MARIA HÜBNER
  • Revision of the Framework Agreement on relations between the European Parliament and the European Commission
    • Committee: AFCO
    • Report: Esteban GONZÁLEZ PONS

12:00 – 14:00

Votes followed by explanation of votes

  • Fighting discrimination of EU citizens belonging to minorities in the EU Member States
  • Texts on which debate is closed

15:00 – 23:00

Debates

  • Reform of the electoral law of the European Union
  • Threats to the rule of law by the Romanian justice system reform
  • Guarantee Fund for external actions
    • Committee: BUDG
    • Rapporteur: Eider GARDIAZABAL RUBIAL
  • EU guarantee to the European Investment Bank against losses under financing operations supporting investment projects outside the Union
    • Committee: BUDG
    • Rapporteur: Eider GARDIAZABAL RUBIAL
  • Annual report on the financial activities of the European Investment Bank
    • Committee: BUDG
    • Rapporteur: Eider GARDIAZABAL RUBIAL
  • Situation of women human rights defenders and their support by the EU
  • Zero Tolerance for female genital mutilation

Thursday, February 8, 2018 

Plenary session

09:00 – 11:50

Debates

  • Summer-time arrangements

12:00 – 14:00
Votes followed by explanation of votes

  • Nominal composition of the special committee on the Union’s authorisation procedure for pesticides
  • Texts on which debate is closed

15:00 – 16:00
Debates

EU Policy Update

Brexit Negotiations, Phase 2: Transition, Trade, and Trouble Ahead

By Jean De Ruyt, Atli Stannard and Katharina Ewert

As we mentioned in our previous reports (here and here), “sufficient progress” in the first phase of the Brexit negotiation could not be achieved before the European Council of October 19-20, 2017 – so the heads of government decided to wait until their next meeting, on December 14-15, to assess whether the second phase, dealing with the future relationship, could be launched.

By the end of November, the UK government made progress on the sensitive issue of the financial settlement, but it took a frantic week of high political drama to finally reach the “sufficient” agreement, just in time (see our post here on her abortive lunch with President Juncker, and the agreement that was reached following objections from Northern Ireland).  British Prime Minister Theresa May was warmly applauded by her 27 EU colleagues when the decision to launch the second phase was made by the European Council on December 14.

The second phase will start formally in February 2018 with a discussion on the “transition period” between the day of withdrawal and the entering into force of the new treaty.  To that end, the European Council adopted guidelines in December (here), and on January 29, the Council of Ministers agreed a new mandate for the Commission negotiator Michel Barnier (here).

The discussion on the future relationship itself will only start later in spring.  The talks will initially concentrate on a political declaration on the framework of this future relationship, which will be attached to the withdrawal treaty.

To read our full report on the state of play in the Brexit negotiations, please see here. Continue Reading

Blockchain and Virtual Currency Regulation in the EU

The European Commission (“EC”) has stated that the almost limitless list of potential use cases of distributed ledger technology (“DLT”) makes it both very promising and challenging, and has expressed its support for blockchain and DLT.[1]  However, many European institutions are still of the opinion that the technology is at its early stage of development, and it is therefore too early to regulate it.  They rightly see a risk that early regulation could limit its further development and potential.  Moreover, too early regulation could fail to regulate appropriately the relationships and reduce the risks associated with the use of blockchain technology.

The EC also indicates that it needs to “be able to make the distinction between a hype and a true opportunity to improve the lives of our citizens and businesses.  That’s why we [the EU] need to launch more proof of concepts and pilots in different domains and according to different use cases.”[2]  On this basis, the EU is currently exploring various applications of blockchain technology and its possible benefits both for public and private sectors.

As far as virtual currencies like bitcoin are concerned – which are based on blockchain technology – it seems that the EU has more concrete views.  Central banks of the EU Member States do not consider virtual currencies as equivalent to money, and they are not treated as legal tender.  The European Central Bank typifies virtual currency as a digital representation of value, not issued by a central bank, credit institution or e-money institution, which in some circumstances can be used as an alternative to money.  In many Member States, there is also no specific virtual currency regulation, and in many cases only a series of opinions and warnings has been issued by central banks or regulators.  Germany has the most elaborate rules, and considers virtual currencies as units of account – which does not confer them the status of legal tender.[3]

Moreover, the surge in interest in bitcoin and similar virtual currencies, as well as their price fluctuations, have recently attracted the attention of the EC.  In December 2017, the EC’s Vice-President, Valdis Dombrovskis, wrote a letter to the European Supervisory Authorities asking them urgently to update their warnings from a financial stability and investor protection perspective to address bitcoin’s price volatility.  In addition, in his recent speech of January 2018, Vice-President Dombrovskis said that the EC wants “Europe to embrace the opportunities of blockchain, the technology underlying Continue Reading

Brexit Negotiations, Phase 2: Transition, Trade, and Trouble Ahead

As we mentioned in our previous reports (here and here), “sufficient progress” in the first phase of the Brexit negotiation could not be achieved before the European Council of October 19-20, 2017 – so the heads of government decided to wait until their next meeting, on December 14-15, to assess whether the second phase, dealing with the future relationship, could be launched.

By the end of November, the UK government made progress on the sensitive issue of the financial settlement, but it took a frantic week of high political drama to finally reach the “sufficient” agreement, just in time (see our post here on her abortive lunch with President Juncker, and the agreement that was reached following objections from Northern Ireland).  British Prime Minister Theresa May was warmly applauded by her 27 EU colleagues when the decision to launch the second phase was made by the European Council on December 14.

The second phase will start formally in February 2018 with a discussion on the “transition period” between the day of withdrawal and the entering into force of the new treaty.  To that end, the European Council adopted guidelines in December (here), and on January 29, the Council of Ministers agreed a new mandate for the Commission negotiator Michel Barnier (here).

The discussion on the future relationship itself will only start later in spring.  The talks will initially concentrate on a political declaration on the framework of this future relationship, which will be attached to the withdrawal treaty.

The Second Phase of the Brexit Negotiations

As is now well-known, the logic for the two-phase approach in the Brexit negotiation stems from Article 50 of the EU treaty. The withdrawal treaty is a specific instrument which should be agreed upon by qualified majority within 2 years after the procedure has started under Article 50.  However, it must take account of the future trade relationship between the remaining EU Member States and the country leaving the EU.  The negotiation on the future relationship, however, will take more time, and will be conducted based on the model of trade negotiations between the EU and third countries, which at the end of the process requires the agreement of all EU Member States, ratified by national parliaments.

The EU therefore split the negotiation of these issues in the separation that posed the greatest political difficulty off into the first phase, with negotiations on the framework for the future trade relationship only beginning in phase two. The end of the first phase, however, does not mean that the negotiation over the past is over.  Numerous technical issues still need to be addressed and the December joint report (see here) will need to be translated into a legal instrument that will form the basis of the Continue Reading

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