Category: Regulation

U.S. Court of Appeal Rules in Favour of Terminated Chrysler Dealers
LegalRegulation

U.S. Court of Appeal Rules in Favour of Terminated Chrysler Dealers

A U.S. Court of Appeal has ruled in favour of scores of Chrysler dealers who were terminated during Chrysler’s 2009 bankruptcy, holding that the U.S. government may have violated the 5th Amendment.

In June 2009, Chrysler terminated 789 dealers as part of its bankruptcy reorganization process. The dealers, many of whom had been with the manufacturer for generations, were given just 22 days to cease all business operations, leaving many of them with heavy financial obligations, such as mortgages or leases, that could not be met. The terminations were part of the 2008 Troubled Asset Relief Program (TARP), where the U.S. provided Chrysler with $12.5 billion in financial assistance. The dealers were paid nothing for the loss of their businesses.

In three companion lawsuits filed in Washington D.C., nearly 200 terminated dealers are claiming that the U.S. violated the Takings Clause of the 5th Amendment by conditioning the receipt of TARP funds on Chrysler terminating the dealers.

The theory was immediately challenged by the U.S., who claimed that it was Chrysler, not the U.S., that terminated the dealers; that the franchises were not “property” that could be taken; and that the U.S. is insulated from liability because the terminations were done by the bankruptcy court. The trial judge rejected these arguments, leading to an appeal before the U.S. Court of Appeal.

In a 29-page unanimous opinion, the Court of Appeal on April 7th agreed with the trial judge that these events could give rise to a violation of the 5th Amendment. The court indicated that the dealers may be making new law, stating that “the facts of this case are unique and raise issues that have not been decided before.” The court then remanded the case to the trial court to give the dealers an opportunity to plead and prove their allegations that the U.S. coerced Chrysler into terminating the dealers. The U.S. has 90 days from the date of the decision to petition the U.S. Supreme Court for review.

“This is a day that should be celebrated by the dealers, their families, and the population at large,” said Jonathan Michaels of Michaels Law Group, the attorney for the dealers. “There can be nothing more un-American than the government orchestrating the taking of your livelihood on 22 days’ notice, and then disavowing any responsibility for having done so,” said Michaels. “Now, those dealers – those families – have an opportunity to be heard. This is a win for every business owner in America.”

Microsoft and Disney among US “Best Corporate Citizens”
Corporate GovernanceRegulation

Microsoft and Disney among US “Best Corporate Citizens”

Corporate Responsibility Magazine has announced its 15th annual 100 Best Corporate Citizens List, recognizing the standout performance of public companies across the United States.

The list, which was first published in 1999 by Business Ethics Magazine, documents 298 data points of disclosure and performance measures, harvested from publicly available information, such as websites and sustainability reports, in seven categories: environment, climate change, employee relations, human rights, governance, finance, and philanthropy.

There are 23 companies on the 2014 list that were not on the 2013 list, with 17 companies having been on the list every year since 2008.

Pharmaceutical company Bristol-Myers Squibb topped the list, despite receiving a “yellow card” caution from the magazine due to ongoing mass-tort litigation relating to allegations that toxic chemicals contaminated a company site in New Brunswick, New Jersey and caused personal injuries to residents of the neighbourhoods surrounding the facility.

Johnson & Johnson and Gap Inc. took second and third places respectively, with Microsoft Corporation, Intel Corp. and Walt Disney Co. also featuring in the top 10.

“We’re pleased to honour the 100 Best Corporate Citizens for meeting the highest commitment to the programming and transparency necessary to lead the business community in the area of responsible corporate practices,” said Bill Hatton, Editor-in-Chief of CR Magazine.

“CR Magazine’s 100 Best Corporate Citizens is the only ranking that doesn’t rely on self-reporting,” said Elliot Clark, CEO of CR Magazine. “Each year, we measure the most transparent companies who report on their responsible practices. We congratulate those honoured on this year’s 100 Best Corporate Citizens List for their commitment to corporate responsibility.”

Carter Backer Winter Launches New Corporate Finance Team
AccountancyRegulation

Carter Backer Winter Launches New Corporate Finance Team

Mid-tier accountancy firm Carter Backer Winter LLP has appointed Odhran Dodd, formerly a Partner at UHY Hacker Young LLP to head its new Corporate Finance department.

Dodd has 15 years’ experience in investment banking, having completed over 60 deals in a wide variety of sectors from recruitment, manufacturing, financial services, transportation, oil and gas, mining and renewables.
His expertise is focused on disposal of owner managed businesses, MBOs/MBIs and fundraising. He brings to CBW a wealth of connections with lending banks and alternative capital providers as well as Nomads, brokers, trading houses, financial PR companies and lawyers.

“I relish the challenge of heading and establishing a brand new Corporate Finance department at CBW,” said Dodd. “I believe that the post-recessionary market is fast gaining momentum and creating new opportunities for both established companies and those ready to test new waters. I expect the CBW Corporate Finance team to grow fast since there is a lot of funding available for deals and the environment is very positive for corporate expansion. We will have the expertise to help our clients harness this growth.”

Peter Winter, Managing Partner at CBW, said: “Our ambition has always been for CBW to be a full service firm but for a long time the sluggish nature of the market meant adding a Corporate Finance team to our practice was not practical. Now, however, with the economy on an upward turn and businesses feeling more bullish about their future, we are delighted to be able to appoint Odhran who will be responsible for helping CBW’s existing clients as well as drawing new projects from elsewhere in the market.”

Government Legal Aid Reform “Could Cost Creditors More Than £150m per Year”
LegalRegulation

Government Legal Aid Reform “Could Cost Creditors More Than £150m per Year”

Creditors face losing more than £150m per year if the Government follows through with plans to end an exemption for insolvency litigation from the ‘Jackson’ legal aid reforms, warns an independent report commissioned by the insolvency profession.

Insolvency practitioners regularly need to take legal action to reclaim money from directors of insolvent businesses, or third parties, that should be re-directed to creditors – including HMRC and SMEs. Where there is no money left in an insolvent business to pay for legal fees, often the only way to fund legal action is to recover costs from the director in a successful case.

Insolvency litigation currently has an exemption from the Jackson reforms, introduced in 2013. The reforms prevent costs from being fully recovered from defendants. Ministers plan to scrap insolvency litigation’s exemption in April 2015.

Without the ability to recover costs fully from a director, insolvency practitioners fear legal action to reclaim debts from directors would be unaffordable in most cases, leaving money in the hands of unscrupulous directors and out of creditors’ reach.

The Government’s plans would affect creditors’ claims of up to £300m which are pursued through the courts every year – including the pursuit of up to £70m that belongs to taxpayers and HMRC. Approximately £160m is brought back to creditors every year, an amount that insolvency practitioners say is rising.

Phillip Sykes, deputy vice-president of R3, the trade body for insolvency professionals, said: “Insolvency litigation is absolutely in the public interest, and it is absurd that the Government is considering making it all but impossible for such cases to continue. The ‘Jackson’ reforms were supposed to protect exactly this type of case.

“The Government’s only justification for ending the exemption is that it would make the ‘Jackson’ reforms consistent across the board, regardless of the consequences. It’s just lazy thinking.”

Sykes added: “Insolvency litigation returns money to creditors, and helps ensure businesses and banks remain confident about lending. It protects taxpayer funds, it stops directors making off with money that isn’t theirs, and it deters directors from even thinking about doing so in the first place.

“Should the exemption be removed, only a few large cases involving wealthy, motivated creditors would go ahead. SMEs and taxpayers would lose out – and irresponsible directors would be laughing.”

My Learned Friend Launches Crowdsourced Platform
LegalRegulation

My Learned Friend Launches Crowdsourced Platform

My Learned Friend provides the ability for users to search for basic legal research information on an enquiry specific basis, then rate, comment on and add to the knowledge base for the benefit of the wider legal community.

The cloud based platform will also provide the opportunity for sector specific discussion forums and a live email notification service, so users know when an area they are interested in has been updated.

Compatible with tablets and smartphones, My Learned Friend is accessible via an easy online sign up process and will attribute credit to contributors via dedicated profiles, allowing them to build their reputation rating and contact list.

Managing Director of My Learned Friend, Rick Yates said: “The way that lawyers seek research information has changed. People want quick access to key information, often on an enquiry specific basis. They want the assurance that other professionals view that information as relevant, and even the opportunity to weigh in on its usefulness. MLF allows us to create a useful legal community that has value and relevance for practicing lawyers, as well as a real life legal knowledge pool for students and trainees.”

Content submitted on My Learned Friend will be moderated by users, with useful information being promoted using a ‘Thumbs Up’ rating system, and ‘Useful/Not Useful’ indicators for the use of case law or legislation in relation to specific legal enquiries. The site currently has research categories for 22 legal disciplines and holds case law and legislation for approximately 3000 legal enquiries.

MLF hits the market this week with the option for a one-month free trial. Subscription fees will be £9.99 a month for professionals and £5 a month for students, with no contract period. There is also a reduced fee for corporate subscriptions for businesses in need of five or more accounts.

To find out more visit www.mylearnedfriend.co.uk.

Criminal Tax Cases Shifted onto the Taxpayer HMRC
LegalRegulation

Criminal Tax Cases Shifted onto the Taxpayer HMRC

Phil Berwick, partner* and Head of Contentious Tax at law firm Irwin Mitchell, comments:  “The proposal represents a fundamental shift in the burden of proof. As the Government seeks to plug financial gaps from previous failed initiatives, it is becoming more desperate. Not everybody who has failed to declare foreign income has done so deliberately. There is a danger that HMRC will focus on “soft” targets, and hardcore evaders will still evade capture or punishment. There is also the danger that the new rules will subsequently be extended to change the burden of proof in other situations.

“The UK- Swiss Agreement raised a pitiful amount compared to what was estimated by the Government, and the Liechtenstein Disclosure Facility is on course to also fall woefully short of the £3 billion estimated.

“There is already a maximum penalty of 200% of the tax that has not been paid, in addition to interest and tax for up to 20 years, for taxpayers with undeclared foreign income.

“This latest announcement follows on from the news that HMRC will have the power to raid taxpayers’ bank accounts. Because HMRC has failed to prosecute a sufficient number of offenders, the Government is seeking to change the rules to make it easier to meet targets, and prevent further embarrassment.

“HMRC has had a significant amount of data on offshore offenders for a long time, but has failed to pursue criminal investigations. HMRC already has sufficient powers to pursue these taxpayers. Where will HMRC’s quest for increased powers end?

Chancellor George Osborne has announced plans to give new powers to HM Revenue and Customs to make it easier to prosecute people who evade taxes by hiding money offshore. The intention is that criminal prosecutions can be brought against anyone with undeclared foreign income, even if they did not intend to evade taxes. HMRC have come under attack from MPs for the low number of evader it prosecutes.

HRMC will consult on new penalties for offshore tax evasion, and a document will be published on Monday.

British Accountants to Develop Expertise in Africa and Asia
AccountancyRegulation

British Accountants to Develop Expertise in Africa and Asia

Teams of British accountants will help transform accounting standards and develop professional accountancy institutes in Africa and Asia, International Development Secretary Justine Greening has announced.

The UK will deploy staff from chartered accountancy institutes to developing countries such as Zambia, Nigeria and Ethiopia to improve their financial management and investment climates by sharing British expertise and international best practice.

Announced following a round-table meeting at DFID today, the Department also committed £4.5 million to the International Federation of Accountants to help up to 10 partner countries in Africa and Asia, develop international-standard professional accountancy institutes of their own.

Justine Greening, International Development Secretary said: “The UK’s financial sector is second to none and its skills and experience can boost development across the world.

“By helping developing countries to manage their own resources better and attract investment we can create the jobs and growth needed to lift people out of poverty.”

The first deployments of chartered accountants through DFID’s Investment Facility for Utilising Specialist Expertise will begin in May 2014. They will include teams from:

– The Association of Chartered Certified Accountants (ACCA) who will train the Ethiopian Ministry of Education in accountancy practice. Overtime, this training will ensure more officials are trained in international professional standards.

– The Institute of Chartered Accountants England and Wales (ICAEW) who will review Zambia’s audit regulation to ensure it complies with latest international accounting systems; and

– The Chartered Institute of Public Finance and Accountancy (CIPFA) who will train several government bodies in Nigeria to stop corruption in government procurement.

On request from DFID partner countries, teams are deployed on short term assignments to support efforts to improve financial management in both the public and private sector.

Fayez Choudhury, Chief Executive of IFAC said: “IFAC has a long history of working to build capacity and strengthen PAOs as part of our public interest mission, and we are delighted about this significant next step in that journey.

“Well-functioning PAOs ensure a sustainable supply of professional accountants that support high-quality accounting practices and financial information in both the public and private sectors. They support enhanced confidence in business and transparency in use of public funds, giving rise to increased foreign investment and donor funding and improved government accountability and transparency – and therefore are essential to economic growth and stability.”

HMRC Unable To Disclose Number Of Civil Fraud Investigations
LegalRegulation

HMRC Unable To Disclose Number Of Civil Fraud Investigations


A HMRC facility which encourages people who have committed tax fraud to admit their offences in exchange for avoiding a criminal investigation has attracted 129 requests from individuals since it launched at the beginning of 2012.

Although the figures, which were obtained from HMRC by law firm Irwin Mitchell using the Freedom of Information Act, are equivalent to more than one request a week, a tax investigations expert at the national law firm says that there is a lack of transparency about the scheme in relation to whether taxpayers are receiving the protection that they are looking for.

HMRC has been unable to disclose how many taxpayers were accepted into the process, and how many were subject to criminal investigation, despite making a voluntary approach to the taxman. HMRC is also unable to disclose the number of cases it has registered under the Contractual Disclosure Facility (CDF), because it appears that this information is not recorded centrally.

Established on 31 January 2012, the CDF enables a taxpayer to admit to fraud in exchange for immunity from prosecution, providing certain conditions are met. The process can either be initiated by HMRC, or a taxpayer can voluntarily ask to be admitted into the facility.

Up until now, HMRC has not published details of how many individuals have made requests. Following Irwin Mitchell’s request, it has been revealed that 65 people approached HMRC to enter the CDF from 31 January 2012 to 31 January 2013, and 64 between 1st February 2013 and 31st December 2013.

Phil Berwick, partner* at law firm Irwin Mitchell, said: “It must be a concern for HMRC that only, on average, six taxpayers a month are coming forward voluntarily to admit fraud. It may be that taxpayers are using other methods to disclose their irregularities, but the numbers registering for the Liechtenstein Disclosure Facility (LDF) – the obvious alternative – are on the decline.

“I can understand that HMRC does not want to guarantee a taxpayer that they will be allowed to use the process, and that HMRC may decide to pursue a criminal investigation, but it does not make sense to withhold the historic data.

“It is a surprise, and a concern, that HMRC can’t provide the number of fraud cases they are investigating using the Contractual Disclosure Facility. They are constantly banging the drum that they will come down hard on tax evaders. The Contractual Disclosure Facility is only one weapon in HMRC’s armoury, but it can’t be hard to record this information, and you would think that HMRC would want to know the number of fraud cases it is investigating.

“There will be concern among those who pay their taxes that HMRC is not able to establish how many cases they are pursuing using their civil fraud process.

“In many cases, I suspect that taxpayers seeking immunity from criminal investigation for fraud by using the Contractual Disclosure Facility are missing a trick, as they could use the Liechtenstein Disclosure Facility and get a better result.”

Phil Berwick added: “Despite HMRC’s various campaigns, the figures that have been released suggest that taxpayers who have committed fraud are not coming forward voluntarily, and are waiting for the taxman to find them. HMRC’s inability to provide the number of civil fraud cases it is investigating will only reinforce that belief.”

Launched by HMRC in 2009, the LDF allows taxpayers with unpaid tax to settle their liability with HMRC whilst avoiding a criminal investigation. In most circumstance, this is on very favourable terms when compared to using the normal rules. In some cases the HMRC foregoes some of the tax that is due and the penalty applied is usually lower than the amount charged outside the facility. The LDF closes to new registrations on 5 April 2016.

Crossroads Systems Regains NASDAQ Compliance
Global ComplianceRegulation

Crossroads Systems Regains NASDAQ Compliance

Crossroads Systems, a global provider of data protection solutions, has announced that it has received notice from The NASDAQ Stock Market that it has regained compliance with Listing Rule 5550(b)(1), which requires companies listed on The NASDAQ Capital Market to maintain stockholders’ equity of at least US$2.5m.

As a result, the Company’s pending hearing before the NASDAQ Listing Qualifications Panel has been cancelled. NASDAQ has determined that the Company has regained compliance with all applicable listing standards to maintain the listing of its common stock on The NASDAQ Capital Market.

About Crossroads Systems

Crossroads Systems, Inc. (NASDAQ: CRDS) is a global provider of data archive solutions. Through the innovative use of new technologies, Crossroads delivers customer-driven solutions that enable proactive data security, advanced data archiving, optimised performance and significant cost-savings. Founded in 1996 and headquartered in Austin, TX, Crossroads has been awarded more than 100 patents and has been honored with numerous industry awards for data archiving, storage and protection.

FCA Takes Control of Consumer Credit
Corporate GovernanceRegulation

FCA Takes Control of Consumer Credit

“When the FCA assumes responsibility for the consumer credit market on April 1st it will immediately find itself in conflict with the operating standards of many firms within the industry.

“The relatively relaxed regulatory environment under the OFT has led to a situation where companies haven’t been incentivised to develop the internal processes they will need in the tightly controlled financial services industry.

“For many of the affected firms, the problem is simply one of business practices. The short term, small-scale nature of these businesses has been reflected in the company culture meaning more long-term principles – for example, ensuring credit is affordable for the borrower through Know Your Customer (KYC) and Treating Customers Fairly (TCF) – have been pushed to one side.

“The positive here is that these principles can be restored relatively quickly by building an effective network of processes, which record the necessary data and make it available in the form of Management Information (MI). This MI can then easily be reviewed for the purposes of regulatory compliance, but equally as importantly it can be monitored by management for troubleshooting and strategic business improvements. Effective control of these processes can then be used to reinforce cultural change, one of the pillars of the FCA’s TCF.

“Regulation doesn’t have to be a burden. When managed properly the changes forced by the new regulation can be leveraged for competitive gain, a fact that will be highlighted by the industry shake-up that the FCA will no doubt trigger.”

Ethics Crisis as Managers Stop Caring
Corporate GovernanceRegulation

Ethics Crisis as Managers Stop Caring

Title Here

Too many managers are robotically following rules rather than making decisions with their hearts and minds, according to new research published today by CMI (the Chartered Management Institute)
and MoralDNA.

It warns that workplace cultures dominated by rules, bureaucracy and targets mean that managers are switching off their sense of care for others.

The report, managers and their MoralDNA, follows City scandals over mis-sold debt, PPI and rate fixing, plus crises in the NHS and the police, damaging public trust and employee engagement alike. It finds that 74% of managers are at risk of overlooking the impact of their decisions at work on others – 28% more than among the general population.

The report shows that the general population can be divided almost equally into six different ethical character types – Philosophers, Judges, Angels, Teachers, Enforcers and Guardians – according to how far their approach to ethical matters is driven by their hearts, heads or compliance with rules. Analysis of managers’ morals revealed marked differences, with higher numbers of Enforcers, Judges and Philosophers (74%) and much smaller proportions of Angels, Teachers and Guardians (25%).

As a result, there are significantly more (28%) people in management roles who may lack empathy when making decisions and fail to consider the impact of their choices on the wellbeing and interests of customers, colleagues or shareholders. Conversely, there are less than half as many managers in the Angels and Teachers categories – which have a stronger ethic of care – than among the general population (14% of managers compared to 36% of the
general population).

The situation is exacerbated by an over-representation of Enforcers (22% of managers compared to 15% in the general population). This ethical character type, which tends to remind everyone else about their duty to obey regulations, can be particularly guilty of blindly following rules and can lose sight of the principles behind their actions.

The research also shows managers’ moral mindsets change significantly as soon as they are in a working environment. Compared to their personal lives, they become 4% more likely to blindly follow rules and 5% less likely to consider the wellbeing of others when making decisions.

Ann Francke, Chief Executive of CMI, said: “Too many employers fall into the trap of relying on ever-more complicated layers of rules and regulations to say what their people can and can’t do. The result is that people act like robots at work, using the letter of the law as an excuse not to engage their hearts and heads when making decisions. We need to stop blindly following rules and start caring about the impact our actions.

“To be successful, organisations have to meet the needs of their customers, employees and stakeholders. If the values and behaviours of those managing and leading organisations are out of kilter with those groups, they won’t be run in a way that properly serves customers and stakeholders or gets the best out of employees. In short, they’re destined
to fail.”

Professor Roger Steare, co-author of the report added: “MoralDNA has already persuaded the Financial Conduct Authority that a one dimensional, rules-based approach to corporate conduct has spectacularly failed in banking regulation. They have acknowledged that we all need to engage our heads and our hearts if we want to make better decisions and outcomes for our society. This report is a wake-up call to government and all regulators to understand that turning the UK into a totalitarian police-state will lead to more and not less wrong-doing. Right-wing politicians will agree with this small state philosophy. Left-wing politicians will agree with the emphasis that this places on our ethic
of care.”

The new research demonstrates significant links between ethical behaviour and different aspects of our humanity, including age, religion, politics and gender:

The older we get, the less robotic our decision-making becomes, both at home and at work – compliance drops 27% between people’s late twenties and retirement ageA belief in any religion makes a manager more likely to act ethically both at work and at homeCompliance is higher in managers with right-leaning political viewpoints than left leaningFemale managers score 5% higher in the ethic of care than their male counterparts.

Ann Francke continues: “These findings are another reminder of the benefits of having real diversity in management teams. Everyone has different ethics and the risk of ‘group think’ is reduced if organisations involve people with different experiences and perspectives in making decisions.”

CMI is supporting managers with tips for using their hearts as well as heads when making decisions at work.

CMI’s recommendations include:

1. Ask yourself the RIGHT questions to negotiate ethical quandaries:

  • – What are the relevant rules?
  • – Are we acting with Integrity?
    – Who is this good for?
    – Who could it harm?
    – Would we be happy if the truth was public – how open, honest and accountable are we being?

2. Step back. Create space for yourself to reflect on the ethical implications of decisions.

3. Stand up for what you believe in. Be authentic and be yourself. If you see something you do not agree with, speak up and challenge it.

4. Be professional. Use your professional body’s standards of practice as a reference point if you’re unsure, like CMI’s Code of Practice for Professional Managers – www.managers.org.uk/code

5. Engage and empower employees. Give staff more autonomy and devolve responsibility to them. Where employees can make decisions for themselves they are far more likely to start thinking for themselves about the impact of their actions on others.

CMI is offering managers a toolkit including practical checklists to help them improve ethical standards in their organisations. Plus, managers and non-managers can now test their ethics through the MoralDNA tool – and invite feedback from their Facebook friends about their moral mindsets using MoralDNA’s new 360-degree version. Find out more at www.managers.org.uk/ethical-toolkit.

Traditional Broker/Dealers Adding Direct Platforms
AccountancyRegulation

Traditional Broker/Dealers Adding Direct Platforms

 

New research from global analytics firm Cerulli Associates finds that traditional broker/dealers are considering a direct model.

“Firms within traditional advisory channels are beginning to consider direct broker/dealers as legitimate competitors and adapting their business models accordingly,” states Patrick Newcomb, senior analyst at Cerulli. “There are several benefits to launching a direct platform at a traditional broker/dealer, including creating a funnel for younger advisors that need help prospecting new clients, and to help advisors cultivate younger clients with small account balances.”

The first quarter issue of The Cerulli Edge-Managed Accounts Edition analyzes direct providers and eRIAs including the impact of the direct channel on traditional broker/dealers.

“Many traditional firms already maintain a packaged mutual fund advisory (MFA) program,” Newcomb explains. “MFAs make up the largest assets within the direct channel, and many broker/dealers have an existing MFA program.”

Cerulli warns that firms outside of the direct channel need to tread carefully when entering the direct space. If positioned incorrectly, it could appear that the home office is trying to compete with its advisors, instead of offering them an additional service.

Clinical Research Global Compliance Just Got Easier
Global ComplianceRegulation

Clinical Research Global Compliance Just Got Easier

Provision offers global consultancy services for the development and implementation of Good Clinical Practice (GCP) and Human Research Protection (HRP) procedural standards and programs for the conduct of clinical
research studies.

“There has never been a collaboration of GCP and HRP industry leaders specifically focused on meeting the compliance needs of research institutions around the world,” said Schulman Associates IRB President, Chief Executive Officer and Institutional Official Michael Woods. “Provision makes it easier for institutions to achieve their compliance goals and to engage in global development programs. It also helps study sponsors follow a simpler path to consistent compliance practices across a global network of research institutions. Global compliance just
got easier.”

Today, clinical trials are global, involving potentially hundreds of sites in a dozen or more countries. Pharmaceutical, biopharmaceutical and medical device sponsors need consistent quality and ethical standards for human subject protection and compliance to minimise regulatory risk.

Consistency is key to making a clinical trial as meaningful as possible, and the data as useful as possible. Meeting global compliance standards has been challenging because of outsourcing and the increasing complexity of the research. The approach to global compliance has often been very fragmented, and Provision offers a more comprehensive solution to achieving global compliance standards.

Enhanced Compliance for Integrity and Quality

The pharmaceutical, biopharmaceutical and medical device industries rely heavily on third parties to assist in the advancement of clinical research programs. Global contract research organizations (CROs) provide fundamental services for protocol development, study conduct, clinical program management, pharmacovigilance and data management, all directed to regulatory submissions and product approvals. Academic research institutions in locations around the world are responsible for study conduct and subject recruitment, according to the protocol as well as International Conference on Harmonisation (ICH) GCP standards and guidelines.

While there are regulations and local customs unique to countries and regions around the world, research institutions still strive to conduct research consistent with ICH GCP standards. An alignment of GCP and HRP practices provides the essential regulatory compliance and significantly improves performance of clinical studies.

Experienced Research Compliance Leaders

While Provision Research Compliance Services is new, the two organizations behind Provision are industry leaders, with proven expertise in clinical quality assurance and human research protection.

Provision provides services that combine the extensive GCP quality assurance expertise of Falcon Consulting Group with the HRP expertise of Schulman Associates IRB. This new joint venture provides comprehensive solutions to improve overall quality standards for clinical studies and data integrity, and maximizes the protection of human research subjects. Provision’s services are available in more than 30 countries.

By improving GCP quality assurance and human research protection programs, clinical study data becomes more reliable and human subject protection is strengthened. This leads to more compliant submissions and more rapid approvals for patient therapies.

Regulatory Change Slowing Growth
Corporate GovernanceRegulation

Regulatory Change Slowing Growth

 

New research from one of the world’s leading software and technology services companies has highlighted how regulatory change is second only to market volatility as an executive issue for financial services firms.

According to a survey, carried out by SunGard, with many new regulations taking effect during the course of 2014, in some cases it is even considered the number one strategic risk.

Senior executives are now concerned that regulatory change is distracting attention from core business activities and potentially hindering companies’ ability to grow.

Adapting to new regulations is also causing financial services firms to rethink their approach to compliance and restructure their organizations accordingly. Many, however, still do not feel ready for the changes taking effect
this year.

Key findings of the survey include:

Regulation is high on the executive agenda

• The pressure of dealing with change has expanded beyond compliance departments into the C-suite. One in two respondents warns that dealing with regulatory change has impacted shareholder returns and the ability to invest for the future.

• Almost half of respondents describe themselves as “highly stressed” by the current pressure of regulatory change, with little prospect of imminent improvement.

• The broad nature of regulatory change is driving a more cross-functional response within businesses. Best-in-class institutions are breaking through siloes, allowing for a more efficient response to the issue.

Despite ongoing efforts, readiness levels remain relatively low

• Only one in two companies say they are highly ready for the regulatory changes that they must confront throughout 2014 and 2015.

• Financial services firms plan to continue investing heavily in technology, people and processes over the next two years to cope with regulatory change.

Firms are starting to move beyond checking the box

• While recognizing the benefits of a culture change to compliance, forty percent of respondents are finding it challenging to move beyond a checking the box approach.

• Despite concerns that the degree of regulatory change is overblown, most firms responded in the survey that they accept the need for change and are moving along with their responses to new regulations.

Jeffrey Wallis, managing partner and president of SunGard Consulting Services, said: “The definition of what regulators are becoming concerned about is broadening to include areas such as operational risk, adding extra strain to the financial services industry.

“Our survey demonstrates that executives at the highest levels are struggling to marry ensuring regulatory readiness with maintaining a focus on day-to-day operations. In our work with firms on regulatory compliance, we see the most success when a business takes a combined approach to the twin challenges of growth and compliance.”

Sang Lee, managing partner, Aite Group, added: “Regulatory reform is putting the financial services industry under intense pressure, and the situation will not change in the near future.

“This pressure is being felt all the way up to the C-suite and the board. Regulatory uncertainty has forced some companies to put off key investments in new industries and geographies at a time when they are increasing their investment in compliance across departments.

“Regulations may be putting a strain on the industry, but we are starting to see some companies use them as an opportunity to reorganize themselves along more efficient lines. These businesses will be the future leaders in
the industry.”

Weil Appoints Chris McLaughlin
LegalRegulation

Weil Appoints Chris McLaughlin

International law firm Weil, Gotshal & Manges has announced that Chris McLaughlin will join its London office as a partner in the Banking & Finance practice.

Chris, who was most recently a partner at Hogan Lovells, has extensive experience acting for banks and borrowers on the financing of cross-border private equity buyouts, European real estate acquisitions, and restructurings.

Chris’ arrival comes on the back of a period of strong growth for Weil’s London and wider European leveraged finance practice, following the recruitment of Chambers Band 1 ranked Stephen Lucas in 2011, along with Mark Donald and James Hogben in London, and Olivier Jauffret and James Clarke in Paris, over the last three years. In addition to the now 12-strong partner-led European leveraged finance group, Weil also boosted its high yield practice with the recruitment in June 2013 of Gil Strauss. His addition also follows that of financing expert Courtney Marcus, who rejoined the Firm as a partner based in the Dallas office in November.

Barry Wolf, Weil’s Executive Partner, said, “We are delighted that Chris is joining Weil to further enhance the growing European Finance practice. In a short space of time, Stephen Lucas and the London team, working with our teams in Paris, the rest of Europe and the US, have established a leading reputation for sophisticated leveraged finance work.”

London Managing Partner, Mike Francies, added, “We are one of the few firms with a Chambers Band 1 ranking in the UK both for Sponsor Finance and for Private Equity thereby offering clients the full range of European leveraged financing solutions covering loans, high yield and yankee loans. We look forward to Chris being part of the team expanding this further.”

The announcement follows a successful twelve months for the London Banking team and the office in general. The Banking team have acted on a number of deals recently including the following in 2013: European sponsor-side deals for Avista Capital and Nordic Capital on their Swiss take-private of Acino Holding; OMERS Private Equity on its £390 million acquisition of Civica, and Ontario Teachers’ Pension Plan on its acquisition of Busy Bees, and bank-side representations for the mandated lead arrangers on Advent International’s £1.16 billion public-to-private bid for Unit4 and Hellman & Friedman’s £1.5 billion buyout of Scout24; and Yankee loan sponsor financings for Charterhouse Capital Partners on its €500 million acquisition of Armacell, Advent International portfolio company Oberthur on its debt refinancing and acting for the lenders on Carlyle’s yankee loan acquisition of Chesapeake.

Weil’s London office has received a host of awards and recognition for its lawyers in the past twelve months including: retaining its Band 1 rankings for Sponsor Finance and Private Equity in Chambers UK 2014; top tier rankings in Chambers 100 and Legal 500 this year; and awards including “Most Innovative Firm in Corporate Law” at the FT Innovative Lawyers Awards Europe 2013, with standout entries and commendations in a further three categories including Finance law. With recent growth, we now have top ranked practices in Sponsor Finance, Restructuring and Fund Formation, to complement our existing top ranked Structured Finance and Private Equity practices.