Governo e Strategie di Lobby
Government influences, and often dictates, commerce. The rules, policies and regulations put into law often have a tremendous impact on how a company conducts business. Opportunities for commercial enterprise are plentiful, but so are the chances for running afoul of governmental policies, which can result in significant penalties and business disruption. At the firm, our lawyers possess demonstrated success turning liability risks into business-minded solutions for clients.
We are strategists, equally skilled at solving legal challenges and at spotting business opportunities. Our legal offering is comprehensive: we advise clients on the regulatory landscape at the local and federal levels, and counsel organizations whose reach transcends borders. We routinely provide guidance on regulatory and compliance matters relating to commerce and trade, customs, competition, environmental, workplace safety, employment, and stay abreast of trends including privacy and data protection.
Our regulatory team possesses a nuanced understanding of the impact regulation has on clients’ businesses and industries. Many of our lawyers served in senior-level positions with governmental regulatory agencies. As a result, we can leverage our knowledge and experience to anticipate developing trends and pending rule changes, giving our clients focused, clear counsel that is distinctly different from the competition. We also have excellent relationships with the regulatory agencies and their current leadership in the United States, Europe and China, allowing us to swiftly address government inquiries and to proactively represent clients’ interests.
We focus on the impact of regulations at a market level, particularly in highly regulated industries such as health, life sciences, energy, aerospace and defense, agribusiness, food and alcohol. From assisting with the FDA process in securing market approval of a new medical device to working with the TTB on labeling for an alcoholic beverage, or whether representing a client in a WTO tariff dispute or assisting an energy company with securing tax credits for a renewable energy project, we have the skill and knowledge to achieve favorable results.
Data, Privacy & Cybersecurity
At the forefront of data innovation and what’s next
Whether you are navigating the increasingly complex web of emerging privacy laws, responding to a data incident, unleashing the power of the data you collect, finding ways to safeguard the valuable information you hold or otherwise in need of a data-based “gut check,” our global privacy & cybersecurity team provides the practical guidance to minimize risk and drive your business forward.
Clients turn to our award-winning team for risk-based insights rooted in commercially oriented advice informed by regulatory expertise. Having worked in-house and been seconded to some of the most well-known companies, we understand our clients’ expectations and the need to identify realistic risk priorities and maximize business opportunities. Our team comprises engineers and computer coders, former senior government officials and cybercrime prosecutors. In addition, we helped draft the laws—we contributed to the legislative process to develop the California Privacy Rights Act (CPRA) and served at the European Commission leading deliberations over the General Data Protection Regulation (GDPR) and the e-Privacy regulation. We help you plan and prepare for the full lifecycle of data privacy needs, from proactive privacy and security counseling to incident response and regulatory and civil litigation.
Corporations across a wide range of industries partner with us to solve their most complex challenges, including:
- Developing global “soup to nuts” privacy and cybersecurity compliance programs
- Navigating evolving state and international privacy laws and sector-specific cybersecurity requirements
- Addressing the increased scrutiny and attention on privacy and cybersecurity from regulators, plaintiffs’ bar, vendors, insurers, customers and consumers
- Implementing “reasonable” cybersecurity and privacy standards that survive regulatory oversight and litigation
- Combatting increasingly sophisticated threat actors
- Developing scalable frameworks for evaluating vendors and corporate acquisition targets
- Developing data collection, monetization and digital marketing strategies
- Counseling on product development
- Advising on the cross-border transfer of personal data
- Maintaining attorney-client privilege and work product protections for internal investigations
- Deploying efficient and effective templates and resources
International Trade
Global trade rules shape how your business moves goods, capital, and technology – but they are increasingly fragmented, politicized, and enforced in real time. Our international trade lawyers help you navigate international trade law across jurisdictions, aligning compliance with your commercial goals so you can operate, transact, and grow with fewer disruptions.
With teams across key global trade centers and experience spanning policy, enforcement, and transactions, we help you anticipate risk, structure cross-border activity, and respond quickly as rules change. Our integrated approach connects international trade law with national security, regulatory, and transactional considerations – so your business can operate effectively as conditions evolve.
As sanctions, export controls, customs rules, technology restrictions, and national security regulations increasingly intersect, decisions in one area can create unintended exposure across your business. We guide you through overlapping US, EU, and UK trade and national security regulations, including:
- Sanctions and export controls
- CFIUS, foreign subsidies, and other national security investment reviews
- Customs, tariffs, and import compliance
- Supply chain controls, product compliance, forced labor requirements, and supply chain due diligence obligations
- Data transfer, cybersecurity, and technology restrictions
- Outbound investment and economic security restrictions
Trade risk cuts across sourcing, contracting, financing, and distribution. We help you assess exposure across counterparties, jurisdictions, and supply chains; design compliance programs that scale with your operations; and structure transactions with trade controls in mind. Our experience also extends to diligence tied to sanctions, export controls, customs, contractual protections, third-party risk management, and internal investigations and regulatory engagement.
Trade rules are often shaped through enforcement and policy decisions as much as through written law. We represent clients in trade remedies proceedings – WTO and trade agreement disputes, administrative proceedings before customs and regulatory agencies, and cross-border investigations, enforcement actions, litigation, and arbitration.
We also engage directly with policymakers and regulators to address tariffs, market access barriers, and trade policy developments. Drawing on extensive experience on Capitol Hill and before trade and regulatory authorities, we help advance your strategic objectives through targeted advocacy.
Global trade volatility can affect how you source, sell, invest, and grow. Our international trade lawyers manage that complexity with an integrated strategy – helping you navigate international trade regulation, pursue cross-border opportunities, and move your business forward in a changing global trade environment.
Conformità Regolamentare nel Sistema Sanitario
Regulation in the healthcare industry is pervasive and extraordinarily complex. To stay ahead of emerging regulations and minimize the risks associated with non-compliance, health industry leaders need experienced legal counsel who are well-versed in existing laws and have a finger on the pulse of new legal and regulatory developments.
We’ll be your guide on the road to innovation.
Almost every aspect of healthcare is overseen at the federal, state or local levels, and often by a range of private organizations as well, creating a regulatory maze of transactional structuring and due diligence, operations, compliance plan implementation, self-disclosure and defense. With centuries of combined experience providing counsel to some of the world’s most important healthcare organizations, we have the diverse and expansive capabilities necessary to clear your path to success.
With our team of former prosecutors and Office of Inspector General officials, Health and Human Services and US Food and Drug Administration (FDA) regulators, and compliance leaders, we are able to provide clients with real-world, practical approaches to managing the most complex regulatory challenges. As a result, our client base extends across all facets of the healthcare industry.
Our healthcare regulatory lawyers have unrivaled experience in all key areas of healthcare, including anti-kickback and self-referral laws, False Claims Act defense, reimbursement counseling, patient data privacy under HIPAA and the HITECH Act, health reform initiatives and tax issues, especially in these key areas:
- Affordable Care Act
The Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively, the Affordable Care Act) has expanded access to health insurance for tens of millions of US citizens and generated a complete overhaul of the nation’s health system. We help clients understand and navigate these changes, advising on industry best practices and the development of educational programs. Drawing on the knowledge and resources of lawyers in our highly regarded health, employee benefits, life sciences, executive compensation, government strategies and tax groups, we offer comprehensive service to help clients meet the challenges of the new healthcare landscape. - Clinical and Database Research
Adherence to good clinical practices is fundamental to research. We represent academic medical centers, pharmaceutical companies and research institutions on all aspects of FDA, National Institutes of Health, National Cancer Institute, and Animal and Plant Health Inspection Service regulatory matters. Our experience includes advising on procedures and other compliance matters, preparation for and representation during inspections and audits of device and drug trials, representation in enforcement actions, and advising on establishing organizations to conduct clinical research. - Fraud and Abuse/Stark Law
Healthcare fraud and abuse costs the industry billions. Without adequate processes in place to prevent fraudulent activities, providers may be subject to costly investigations. We advise clients in all areas of Medicare and Medicaid fraud and abuse statutes, the Stark Law, and other federal and state self-referral prohibitions, and provide guidance regarding safe harbor regulations. Our fraud and abuse consultation includes planning and structuring transactions to minimize fraud and abuse implications, and providing advisory opinions on potential concerns. We conduct audits and represent clients targeted in inspector general and grand jury investigations, often working with our white-collar defense team to provide effective, multifaceted representation. - FDA/Product Regulation
Members of our FDA and health industry advisory practices are nationally recognized by U.S. News – Best Lawyers and LMG Life Sciences. We provide comprehensive advice on all aspects of the development, clinical research, product application and review, manufacture, distribution, marketing and reimbursement of drug, biologic, device and other products regulated by the FDA. - Tax-Exempt Organizations
Tax-exempt healthcare organizations are subject to intense regulatory scrutiny by Congress, the Internal Revenue Service and state attorneys general. As the industry’s top-ranked healthcare law firm, and one of the largest and most-respected tax practices, we provide comprehensive tax planning, compliance and advocacy services to nonprofit hospitals and other tax-exempt healthcare organizations. We regularly advise healthcare clients on the special tax issues that arise in the context of joint operating arrangements, horizontal integrations, conversions and sales of assets and the resulting foundations, joint ventures, physician practice acquisitions, academic medical center relationships with physicians, and captive insurance and other risk-management arrangements.
Fondi d’ Investimento
Our Investment Funds group focuses on the full spectrum of investment fund matters, including:
- Fund formation and operation
- Capital raising
- Investments (both on a primary and secondary basis) in private funds
- Internal compensation and carry arrangements
- Regulatory and Advisers Act compliance
- Establishment of management companies and seeding transactions
- Spin-offs
- Reorganizations
- Fund restructurings
- Purchases and sales of interests in investment managers
Leveraging our global footprint, our Investment Funds group includes lawyers across the United States, Europe and Asia who have advised on numerous fundraises for institutional, boutique and emerging sponsors. Our fund formation experience extends to all types of funds and managed accounts, including:
- Private equity
- Private credit
- Real estate
- Fund-of-funds
- Energy
- Hedge
- Infrastructure
- Venture
- Distressed/special situations
- Co-investment
- Secondary
- Health care
Based on our breadth and depth of experience advising sponsors, investment advisers, private funds, investment professionals, investors, family offices, private wealth clients, placement agents, lenders and other sophisticated parties, we are positioned to provide full-service advice regarding our clients’ legal and business challenges. In particular, we are well-versed on the state of the market for fund terms and investor negotiations, choice of fund structure and jurisdiction of organization, US and international regulatory and compliance issues, and sponsor structuring and compensation issues.
Our Investment Funds group is embedded in the firm’s Top 10 (Pitchbook 2017) Private Equity practice that serves as lead counsel to clients in all aspects of their lifecycles, including from fund formation to platform acquisitions and financings to portfolio add-on acquisitions and refinancings and eventual exits. Our multidisciplinary team includes specialists from our “Team of the Year” Tax practice (U.S. News-Best Lawyers 2016) and our Employee Benefits & Executive Compensation, Finance, Regulatory and SEC Enforcement Defense practices that work hand-in-hand to tackle highly complex matters.
“[The firm] works extremely well with our in-house department to effectively handle many of our regulatory needs.”
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