Health and Life Sciences

This Note explores selected legal and compliance issues for acquirors to focus on when pursuing an M&A transaction involving a target that is a manufacturer of pharmaceuticals or medical devices. In particular, this Note reviews the preliminary goals of effective due diligence, provides guidance on key areas of the investigation and highlights some of the strategies acquirors can use to mitigate risk in these deals.

This Note provides an overview of the requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for protecting the security of electronic protected health information (ePHI). It discusses the types of entities required to comply, the general requirements, guiding principles and related organizational and document requirements. This resource is in the process of being updated for final HIPAA regulations issued in January 2013.

This Practice Note discusses some key issues to consider when structuring and negotiating an option to acquire a pharmaceutical company, such as purchase price, duration of the option, events triggering the option, the relevant product's development plan and antitrust and accounting implications.

A model certificate of group health plan coverage to be furnished under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by a group health plan (or health insurer) to a covered individual whose coverage under the plan terminates. This Standard Document is based on a model published by the Department of Labor and has integrated notes with important explanations and drafting tips.

A model agreement between an entity subject to HIPAA's privacy and security rules and its business associate, providing for the safeguarding of protected health information received or created on behalf of the entity. This Standard Document has integrated drafting notes with important explanations and drafting tips. This Standard Document is in the process of being updated for final HIPAA regulations issued in January 2013.

A sample notice from a covered entity that is a group health plan to an individual explaining the plan's privacy practices and how it may use and disclose the individual's protected health information. This notice is designed to comply with the requirements of HIPAA but does not address any applicable state law requirements. This Standard Document has integrated drafting notes with important explanations and drafting tips. This Standard Document is in the process of being updated for final HIPAA regulations issued in January 2013.

A sample form for an individual to request a HIPAA covered entity (which includes health plans) to provide an accounting of disclosures of protected health information that were made by the covered entity. This form is designed to comply with HIPAA but does not address any applicable state law requirements. This Standard Document has integrated notes with important explanations and drafting tips.

These standard clauses provide resolutions that covered entities can use to appoint a privacy and security officer as required by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These standard clauses include integrated notes with important explanations and drafting tips.

The patent system in Europe is set to undergo its biggest overhaul since the 1970s, with the introduction of the Unitary Patent and the Unified Patent Court. After more than 40 years of negotiations, and numerous false starts, the building blocks are in place for a patent with multi-jurisdictional European coverage and a new centralised court system. This article examines the current system, the Unitary Patent, the Unified Patent Court and practical points for life sciences businesses to start considering now. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article analyses the recent developments in enforcement of competition law in the South Korean pharmaceutical industry. It reviews the enforcement issues involving unreasonable inducement of customers (rebates), collaborative acts (cartels), resale price maintenance, unfair trade practices in the supply of pharmaceutical products and abuse of patent rights. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article examines obtaining and enforcing patents in Ukraine, in particular the legal landscape and recent developments in patent protection at the customs border, obtaining patent protection, patent enforcement including patent licensing strategies, enforcement and defence in the courts and evidence collection for patent enforcement, including general issues and peculiarities for patent infringement proceedings. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Brazil. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in France. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Hungary. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Ireland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Japan. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in South Africa. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Spain. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Switzerland. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in the UK (England and Wales). The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter explains the application of the Product Liability Directive in the case of off-label use of medicinal products. In particular, it considers the concept of off-label use, including its background and place in clinical practice, the Product Liability Directive and its main provisions, the liability of the producer under the Product Liability Directive in the case of off-label use, and the liability of the prescribing physician and the pharmacist. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This tool enables subscribers to search the Life Sciences multi-jurisdictional guide by question and jurisdiction. Simply select the questions and the jurisdictions that you are interested in and click the "submit" button. Please note that the law stated dates for each jurisdiction covered may not be the same. To check the law stated dates for each jurisdiction, please visit the individual article.

A Q&A guide to life sciences law in Denmark. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Important reforms to the litigation funding regime in England and Wales came into force on 1 April 2013. The claimant lawyer bar has warned that the reforms are likely to seriously impact on the viability of group product liability claims in future, due to the reduction in financial incentive for claimant lawyers to pursue such claims. This article looks at whether this is likely to be the case, or whether the various changes will mean that defendants are in fact more likely to face group claims in the future. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Thailand. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This Wiley Rein LLP memorandum discusses a Pennsylvania District Court's decision in Steinberg v. CVS Caremark Corp., which recognizes both the benefits of the uses and disclosures of de-identified health care information and the primacy of the HIPAA regulatory structure for defining the appropriate rules for this information.

This Dechert LLP memorandum discusses a recent inquiry by the US Senate Finance Committee alleging that the nation’s three largest home health companies, Amedisys, Inc., LHC Group, Inc. and Gentiva Health Services, Inc. were more focused on maximizing their reimbursement under the Medicare payment system than on the medical requirements of patients.

This Dechert LLP memorandum discusses a joint policy statement from the Federal Trade Commission and Department of Justice providing antitrust guidance to those considering forming Accountable Care Organizations (ACOs) and posits four lessons that can be learned from the release of this guidance.

The emergence of integrated health information systems, mobile apps and software-based medical devices presents significant opportunities in managing healthcare costs and achieving better outcomes. This article analyses the developing EU and US approaches to health information technology (health IT) and mobile medical applications (MMAs), and the emerging rules and compliance issues for companies developing and marketing these products. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter analyses the provisions of the South Korea-US Free Trade Agreement (FTA), which was signed by South Korea and the US on 30 June 2007 and will take effect on 15 March 2012. It looks at the FTA in terms of the adoption of the independent review process in the pharmaceutical sector, the introduction of the approval-patent linkage system, data exclusivity, customs duties and non-tariff barriers and competition law. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Argentina. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in Belgium. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. The Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences in China. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences in Norway. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences in The Netherlands. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

A Q&A guide to life sciences law in the Russian Federation. The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool. This Q&A is part of the PLC multi-jurisdictional guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Parallel trade in the European pharmaceutical sector is widespread. To deal with parallel trade, pharmaceutical companies operating in the EU usually respond by adopting dual pricing schemes and allocation systems. To a certain extent, such schemes and systems are supported by European pharmaceuticals regulation. Behaviour such as dual pricing schemes and supply allocation systems have been the subject of legal dispute for some years. Another issue that continues to be the subject of legal dispute concerns the repackaging of pharmaceuticals that have been parallel imported. This chapter considers recent case law on these issues and summarises any conclusions that can be drawn. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This article looks at patent regulation in Ukraine, focusing on: The regulatory framework. Patent protection and enforcement. Enforcement and defence of patent rights in Ukrainian courts. Patent infringement on the internet. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

Various reforms have been proposed to the litigation funding regime in England and Wales. This article examines the nature of the reforms and other proposals, conditional fee agreements, after the event insurance, damages based agreements, third party funding/litigation funding, qualified one-way cost shifting, liberalisation of the legal market and the impact on pharmaceutical claims. This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This chapter looks at recent developments in Canadian public policy and case law that directly or indirectly affect biotechnology. It summarises the 2009 Canadian federal budget and a number of recommendations for improving government programmes, including the 2010 report, "An Action Plan For Prosperity", published by the Coalition for Action on Innovation in Canada. It then outlines the key issues and challenges for the Canadian government to improve business R&D spending, rates of commercialisation and productivity growth. Finally, this chapter looks at the functions of the Patented Medicine Prices Review Board (PMPRB) and recent litigation trends (including class actions). This article is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.

This Ropes & Gray LLP memorandum discusses a final rule from the US Department of Health and Human Services amending the Public Health Service (PHS) regulations on the disclosure of the financial conflicts of interest by research institutions and investigators that seek or receive PHS funding.  The final rule reflects HSS' efforts to strengthen transparency and oversight in the face of increasing numbers of, and complexity in, financial relationships between biomedical researchers and industry.

This Ropes & Gray LLP memorandum discusses an Advanced Notice of Proposed Rulemaking (ANPRM) from the US Department of Health and Human Services (HHS) describing comprehensive potential revisions to the Common Rule, which represents a common set of requirements for human subjects protection in research funded by fifteen federal agencies.

This Ropes & Gray LLP memorandum discusses an updated report released by Massachusetts Attorney General Martha Coakley on health care cost trends and cost drivers that includes new recommendations designed to encourage consumers to make value-based purchasing decisions and providers to improve care coordination.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the onslaught of False Claims Act cases alleging a variety of fraudulent and unlawful practices that pharmaceutical, medical device and health care companies currently face.

This Ropes & Gray LLP memorandum discusses the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), which granted broader rights to individuals with respect to their Protected Health Information (PHI), including expanding the rights of individuals to receive and accounting of certain disclosures made through an electronic health record (EHR), but has limited the time period for maintaining documentation of such disclosures to the three years prior to the date on which the accounting is requested.

This Dechert LLP memorandum discusses a Dechert LLP survey finding that life sciences companies of all sizes remain prime targets of securities fraud class action lawsuits.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the Center for Devices and Radiological Health's (CDRH) Plan of Action regarding the 510(k) process, which commits to 25 action items during 2011, including three proposed regulations, seven new guidance documents and other administrative and regulatory initiatives.

Some are pessimistic about the UK public markets' ability to finance emerging life sciences companies. This chapter considers whether this view is fair, and the range of financing structures available. The statistical data was taken as at 31 December 2010. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article looks at important considerations and global developments in biosimilar regulation, including scientific and regulatory challenges, patent considerations in the US and considerations for the industry as a whole. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Traditionally, the market entry of a generic pharmaceutical brings about a 30% to 40% shift in market share from the innovative pharmaceutical company to the generic firm, along with a 20% (in the first year after generic entry) to 25% (in the second year after generic entry) reduction in the average medicine price. With patent term expiries fully underway, innovative market players increasingly have recourse to a toolbox of strategies.  This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article sets out some of the main features of EU Regulation 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals) (REACH) and how it is likely to affect medical device companies. It also provides an overview of the most significant EU regulatory developments as they apply to the medical devices industry sector. This chapter is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

A Q&A guide to life sciences in Romania. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. It provides a high level overview of life sciences funds in Romania and looks at key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability. This Q&A is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

In the past 18 months, there have been significant anti-corruption developments for companies and individuals, particularly in the healthcare sector. Against this background, this chapter looks at recent developments in enforcement of anti-corruption laws. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Pharmaceutical regulatory law and patent law are often seen as separate legal fields governed by distinct laws. However, these fields can be seen to interact in Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation). In recent years a number of cases have emerged under the framework of the SPC Regulation, in which the interpretation of certain provisions has led to a discussion of various concepts that have been introduced from patent law or regulatory law. Another, more recent regulatory development that has created an additional interaction between regulatory law and the SPC Regulation is Regulation (EC) 1901/2006 on medicinal products for paediatric use (Paediatric Regulation). The Paediatric Regulation couples the obligation to conduct paediatric clinical research with an extension of an SPC. This means that an additional regulatory factor has been introduced that influences SPCs. This article looks at the: • Legal framework. • Interaction between pharmaceutical regulatory law, patent law and the SPC and the Paediatric Regulation in case law in Europe. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

Groom Law Group, Chartered Memorandum discussing the interim guidance released by the Department of Labor, Department of Health and Human Services and Treasury Department, which establishes an enforcement grace period for key aspects of the new claims and appeal procedure rules under the Patient Protection and Affordable Care Act (PPACA). This Memorandum also discusses recently released PPACA FAQs and Internal Revenue Service Notice 2010-63 related to applying nondiscrimination rules to insured group health plans. Click here to view full text.    

This Dechert LLP memorandum discusses the Health Information Technology for Economic and Clinical Health Act (HITECH Act) breach notification requirements issued by the Department of Health and Human Services (DHHS).

Groom Law Group, Chartered Memorandum describing the Pre-Existing Condition Insurance Plan program created by the Patient Protection and Affordable Care Act to provide health insurance coverage to uninsured individuals with pre-existing conditions. Click here to view the full text.

This Kelley, Drye & Warren LLP memorandum discusses recent and upcoming developments regarding reverse payment pharmaceutical settlements including: an unresolved circuit split, harmonizing the Department of Justice (DOJ) and Federal Trade Commission (FTC) antitrust approaches and much litigation.

Seyfarth Shaw LLP Memorandum describing the rules relating to claims and appeals procedures applicable to group health plans and group and individual health insurance issuers. Click here to view full text.

This Dechert LLP memorandum advises corporate strategic investment professionals on different issues and approaches to consider when investing in the healthcare and life sciences industry.

This Ropes & Gray memorandum discusses the release of a final rule by the Center for Medicare and Medicaid Services (CMS) setting forth the requirements providers must satisfy to become meaningful users of "certified" electronic health record (EHR) technology.  It also discusses a companion final rule issued by the Office of the National Coordinator for Health Information Technology (ONC) on the same day.

Groom Law Group, Chartered Memorandum explaining the interim final rules under the health care reform legislation requiring group health plans and health insurers to cover specified preventive health services and to eliminate cost-sharing requirements for these services. Click here to view full text.

Seyfarth Shaw LLP Memorandum describing the interim final rules that clarify the requirement under the health care reform legislation that group health plans provide first-dollar coverage for preventive services.  Click here to view full text. 

This Ropes & Gray LLP memorandum discusses the Department of Health and Human Services' (HHS) modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security and Enforcement Rules under the Health Information Technology for Economic and Clinical Health Act (HITECH).

This Ropes & Gray LLP memorandum discusses a report released by the Association of American Medical Colleges on financial relationships and their impact on clinical care entitled "In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making."

Groom Law Group, Chartered Memorandum explaining the requirements related to pre-existing condition exclusions, annual and lifetime dollar limits, rescissions, choice of providers and coverage of emergency services under the health care reform legislation and the interim final rules issued by government agencies. Click here to view full text.

This Ropes & Gray LLP memorandum discusses interim final rules for group health plans and health insurance coverage on certain patient protections under the Patient Protection and Affordable Care Act (PPACA) as released by the US Departments of Treasury, Labor, and Health and Human Services.

This Ropes & Gray LLP memorandum discusses the Supreme Court's decision to hear the case of Matrixx Initiatives, Inc. v. Siracusano, which addresses a stockholder's claim that a pharmaceutical company improperly failed to disclose adverse drug reactions even though the events were not statistically significant.

Seyfarth Shaw LLP Memorandum describing two new requirements under health care reform that apply to health care flexible spending accounts. Click here for full text.

This Ropes & Gray LLP memorandum discusses S. 2437 of the Massachusetts Senate, which contains a number of provisions  primarily intended to increase the authority of the Division of Insurance (DOI) over insurance companies offering products in Massachusetts small group and individual health insurance markets.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the likely business impact of the health care reform legislation by major industry sector, including health insurers, pharmaceutical and biotechnology manufacturers, device makers, hospitals and providers.

This Article explains the $500,000 deduction limitation on compensation paid by health insurers and their affiliates.  Click here to view full text.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the Patient Protection and Affordable Care Act and accompanying reconciliation act, which made major changes to federal health care fraud, abuse and compliance laws and requirements.

This Ropes & Gray LLP memorandum discusses the Southern District of New York's decision in Association for Molecular Pathology v. United States Patent and Trademark Office (Myriad), which could significantly impact the patentability of certain types of patent claims in biotechnology.

This Ropes & Gray LLP memorandum discusses the authorization under Congressional health care reform of the Food and Drug Administration (FDA) to approve biological products through an abbreviated regulatory pathway that does not require these products to undergo full clinical testing.

This Ropes & Gray LLP memorandum discusses the "Sunshine Provisions" of the Patient Protection and Affordable Health Care Act (PPACA), which require pharmaceutical, medical device, biological and medical supply manufacturers to begin reporting to the federal government the payments they make to physicians and teaching hospitals.

This Ropes & Gray LLP memorandum discusses the passage of the Patient Protection and Affordable Care Act (PPACA) and the Health Care and Education Reconciliation Act of 2010, which seek to expand health care fraud and abuse law.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the most sweeping changes to the US health care system since the creation of Medicare and Medicaid, increasing the regulation and oversight of health insurance plans.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses the passage of comprehensive health care reform legislation. The $940 billion package of legislation, which will provide coverage to an estimated 32 million Americans, will impact every sector of the U.S. health care system, including health insurance plans, hospitals and providers, drug and device manufacturers, health information technology companies and others.

This Ropes & Gray LLP memorandum discusses a final notice from the Health Resources and Services Administration (HRSA) that allows covered entities participating in the 340B Drug Pricing Program to contract with multiple contract pharmacies to provide discounted drugs.

This Ropes & Gray memorandum discusses President Obama's release of details on forthcoming proposed health care reform legislation in anticipation of a bipartisan health care summit. 

This Ropes & Gray LLP memorandum discusses a lawsuit by the Connecticut Attorney General under the Health Information Technology for Economic and Clinical Health (HITECH) Act to enforce the privacy and security provisions of the Health Information Portability and Accountability Act (HIPAA).

This Ropes & Gray LLP memorandum discusses regulation from the Center for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), relating to how health care providers can demonstrate "meaningful use" of electronic health record (EHR) technology in order to qualify for incentive payments and avoid penalties under the American Recovery and Reinvestment Act of 2009.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses an important ruling for pharmaceutical and medical technology companiesfrom the 11th Circuit Court of Appeals dismissing and off-label False Claims Act complaint. 

This Dechert LLP memorandum discusses data breach notification requirements implemented by the Health Information Technology for Economic and Clinical Health Act (HITECH) for entities covered by the Health Insurance Portability and Accountability Act (HIPAA).

Many life science companies rely on their employees' inventiveness to fuel their R&D and generate patents. Employees who create patentable inventions may be entitled to compensation. However, the laws in this area vary significantly across European jurisdictions. A number of substantial compensation awards have been made recently. This chapter considers the legal framework for compensating employees for patented inventions in the UK, France, Germany, The Netherlands and Belgium, whether an employee's rights to compensation can be altered contractually, and provides a checklist of considerations for those considering bringing or defending claims. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article sets out some of the main features of the EU REACH Regulation and how it might affect medical device companies. In particular, the requirement to register, the substance information exchange forum (SIEF), the consortium and data sharing, supply chain interaction and obligations of various members, and commercial relationships affected by REACH. This chapter is part of the PLC multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This chapter considers: the global trends in pharmaceutical crime; various policy-related initiatives that are being advanced to fight pharmaceutical crime; the responses of policymakers at the multinational, national and industry level to the particular problems raised by the internet; and new technologies which may assist in tackling pharmaceutical crime. This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This article is part of the PLC multi-jurisdictional guide to Life Sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifescienceshandbook.

This Skadden, Arps, Slate, Meagher & Flom LLP memorandum discusses recent settlements and enforcement actions and analyzes trends in the risk areas and the evolving legal theories underlying how clinical studies are disclosed to health care professionals and the public. It also discusses the relationships between investigators/study authors and manufacturers, company-sponsored coverage and reimbursement support activities and types of liability.

This Skadden, Arps, Slate, Meagher & Flom memorandum discusses the Food and Drug Administration Act's (FDA) call for more frequent prosecutions of responsible corporate officers under the federal Food, Drug and Cosmetic Act. 

Effective life cycle management is crucial for pharmaceutical companies, yet it can be difficult. The challenge is to find ways of achieving the right balance between adequate protection of the interests of those who invest substantial sums of money in research, and the need to make medicines available to patients at a fair price. This article examines non-patent legal issues, including regulation and anti-trust, and patent issues, including the use of patents, obtaining patents and SPCs, enforcement and preliminary injunctions. The article also looks at India as an example of how patent issues affect life cycle management in the broader global context.

This Epstein Becker & Green, P.C. memorandum discusses an Executive Order requiring state agencies to issue regulations imposing caps on executive compensation and administrative costs on for-profit and not-for-profit service providers that receive State-authorized financial assistance or payments. New York's Governor, Andrew M. Cuomo, executed the Order on January 18, 2012, to prevent public funds from being diverted to excessive compensation and unnecessary administrative costs. The new limitations imposed by the Executive Order may adversely affect hospitals and other service providers especially Medicaid-managed healthcare plans.       

A new edition of the Life Sciences multi-jurisdictional guide, which deals with cross-border issues and answers questions on life sciences law from the perspective of practitioners in key jurisdictions worldwide.