Please join us for an upcoming CLE webinar, “COVID-19’s impact on the global pharmaceutical supply chain and steps to take now”

Pharmaceutical manufacturers, as well as other companies affected by or included in changes to pharmaceutical supply chains, are invited to join us tomorrow, April 7, for a complimentary webinar focused on current issues facing the global pharmaceutical supply chain.

Reed Smith partners J.P. Duffy, Iqbal Hussain, and John Ellison will offer an engaging discussion on:

  • The steps that companies need to take now given the potential for international arbitration claims to arise from challenges such as export restrictions in India and decreased manufacturing of active pharmaceutical ingredients in China and elsewhere.
  • Clause drafting issues.
  • The consequences of choosing common law over civil law as the governing law of the contract.
  • How to select arbitrators for pharmaceutical supply chain disputes.
  • How companies should address indemnification obligations and insurance matters.

To register for the webinar, please click here.

This program is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy. Please allow four weeks after the program to receive a certificate of attendance.

Reed Smith White Paper on Major Health Care Policy, Funding Provisions in CARES Act

The United States recently passed the “Coronavirus Aid, Relief, and Economic Security Act” (CARES Act), sweeping legislation that could impact pharmaceutical and medical device companies with U.S. operations or significant U.S. sales.

A team of Reed Smith life sciences and health care lawyers, including Scot T. HasselmanRobert J. HillCarol Colborn LoepereKevin M. MadaganPaul W. PittsJames F. SegrovesNicole J. Aiken-ShabanJulia Krebs-MarkrichDebra A. McCurdyJohn D. KendziorJamie KnauerArielle R. LusardiRahul NarulaSonia T. NguyenSung W. Park, and Ryan M. Pate has authored a white paper that provides in-depth analysis of major policy and funding provisions in the Act. In addition, Reed Smith has published a CARES Act Overview, which covers all portions of the Act, and is compiling additional thought leadership at our CARES Act Resource Center.

COVID-19 pandemic: FCC issues guidance on the TCPA’s “emergency purposes exception”

The Telephone Consumer Protection Act (the TCPA) restricts telemarketing and the use of automated telephone equipment for phone calls, faxes, and text messages. In an effort to ease restrictions in light of the COVID-19 outbreak, the Federal Communications Commission (FCC) has issued guidance clarifying that informational calls that are directly related to the imminent health or safety risk arising out of the COVID-19 outbreak and made by certain types of callers are exempt from the TCPA requirements under the “emergency purposes exception.”

The FCC’s guidance, issued as a Declaratory Ruling on March 20, 2020 (the “Ruling”), explains that the FCC has determined that the COVID-19 outbreak constitutes “an imminent health risk to the public” under the “emergency purposes” exception described above. The Ruling further provides criteria for determining whether a call relating to the COVID-19 pandemic qualifies for the exception:

  • The caller must be: (1) calling from a hospital, (2) a health care provider, (3) a state or local health official, or other government official, or (4) a person acting on behalf of such an organization and on its express direction; and
  • The content of the call must be solely informational, made necessary as a result of the COVID-19 outbreak, and directly related to the imminent health or safety risk arising out of the COVID-19 outbreak.

With businesses of all types – and especially health care providers – dealing with unprecedented changes to their business models, the TCPA and other privacy laws include exceptions for certain disclosures and communications. The FCC’s confirmation that the COVID-19 outbreak qualifies for such an exception is not surprising but should provide comfort to health care providers who are trying to communicate with patients about necessary appointment changes, office closings, and safety precautions. Health care providers should still be thoughtful in their communications to ensure that they remain purely informational and should watch for additional guidance from the FCC when the pandemic wanes and such communications are no longer necessary.

Read more about this guidance on our Technology Law Dispatch blog.

Medical Device Manufacturers Could Be Affected by Recent CMS Guidance to Health Care Providers

Medical device manufacturers, who may already be seeing the effects of lessened demand stemming from a slow-down of elective procedures outside of the United States, should be aware of recent guidance the U.S. Centers for Medicare and Medicaid Services (CMS) issued to health care providers urging limitations on elective surgeries and nonessential procedures. As an example, nonurgent spine and orthopedic implants (such as hip and knee replacements and elective spine surgeries) in healthy patients were included among the types of procedures CMS recommends that providers consider postponing.

For further information on the guidance, please see this recent client alert by Reed Smith partner Lesley Reynolds and associate Janine Tougas.

European Commission Recommendation Could Expedite Access to Medical Devices, Personal Protective Equipment Needed to Care for COVID-19 Patients

If they serve health care professionals (HCPs) in EU member states, manufacturers that provide personal protective equipment (PPE) or medical devices used by HCPs caring for known or suspected COVID-19 patients should familiarize themselves with a recent European Commission recommendation. This recommendation is designed to accelerate the time to market for these products, provided that safety is not compromised.

For more information on the recommendation and how it contrasts with the typical steps to commercialize medical devices under the EU Medical Device Regulation (MDR) and PPE under the EU PPE regulation, please see my recent client alert, “Accelerated access to EU market for COVID-19 medical devices and personal protective equipment.”

German Constitutional Court Rules Germany’s Ratification of the Agreement on a Unified Patent Court is Void

Global life sciences companies have been carefully watching the European effort to launch a Unified Patent Court (UPC). As we discussed in a previous post, the UPC would have a profound effect on how life sciences companies set about their patent strategies – from filing through exploitation to enforcement.

Efforts to implement the UPC, however, have ended up facing considerable challenges. The Hungarian Constitutional Court found the Hungarian act ratifying the Agreement on a Unified Patent Court (UPCA) unconstitutional. The UK government eventually stated the country would not participate in the new patent litigation system. And, significantly, the Constitutional Court in Germany, the country in which two-thirds of all patent infringement cases in Europe are brought, started examining the constitutionality of the national law ratifying UPCA following a filed complaint by a single patent practitioner.

On Friday, March 20, the German Constitutional Court confirmed that the law was void. For more on this important development and its implications, please see our client alert, “A never-ending story ends? German law ratifying UPCA is void.”

Health Care Providers, Health Plans, and Health IT Developers Sharing Patient Data Likely Impacted by New Final Rules

Certain health care providers, health information technology (IT) developers, and health plans could see the way they share patient information transformed following the release of two new final rules issued by the U.S. Department of Health and Human Services. The rules address interoperability and information blocking. Reed Smith partner Nancy Bonifant Halstead and senior associate Vicki Tankle provide an overview on key provisions of these rules in their post on our Health Industry Washington Watch blog.

COVID-19’s Potential Impact on Continuation of Business Relationships in France

As corporations continue to grapple with economic issues surrounding COVID-19, global life sciences companies must start to determine how laws in each of the jurisdictions in which they operate will impact their contractual responsibilities and opportunities for remedies in their business relationships.

Life sciences companies with operations in France must recognize that their COVID-19 response will likely need to be different than their responses to previous crises, and not only because French law has significantly changed since 2008.

Our recent client alert, “France – Coronavirus (COVID-19) and economic downturn: What impacts on the continuation of business relationships?” outlines a practical scaled approach to these issues.

EU funding call for Coronavirus projects

The Innovative Medicines Initiative (IMI) was created in 2008 as a public-private partnership between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).[1] Its overall goal is to increase the competitiveness of R&D in the European pharmaceutical sector by encouraging companies to work with each other and with the public sector.

Over the past decade, IMI has expanded its activities beyond the pharmaceutical sector and it also partners with medicine regulators; health technology assessment groups; patient organizations; and other stakeholders, including associated partners such as the Wellcome Trust and the Bill and Melinda Gates Foundation. IMI-supported projects now range from remote decentralized clinical trials (Trials@Home) and multi-partner AI platforms for drug discovery (MELLODDY) to finding better biomarkers for testing nonalcoholic fatty liver disease (LITMUS).[2]

IMI currently controls around €3 billion in investments.

On March 3, IMI launched a COVID-19 funding call to develop treatments and diagnostics to better tackle the Coronavirus outbreak and to increase preparedness for potential future outbreaks.[3] IMI has already committed €45 million, though total funds are expected to be set at €90 million.

Proposals could include potential drugs that are already at a very advanced stage of development, or an existing, approved drug that could be “repurposed” to treat COVID-19. Also of interest is the development of diagnostic tests to rapidly and reliably identify people infected with the coronavirus that causes COVID-19 and for use in clinical trials of new drugs. Vaccine development is excluded from the scope of this call.

Applicant consortia can mobilize resources through the inclusion of contributing partners (for example, an EFPIA company or affiliated entity, or an IMI Associated Partner), which is expected to have a favorable effect on the application assessment. Several contributing partners have already expressed an interest in joining an applicant consortium, including AbbVie, Astellas, Bayer, E-Pharma, Enyo Pharma, IDbyDNA, Merck, Novartis, Special Product’s Line SpA and Takeda.[4]

The deadline for submitting applications is March 31, 2020.

At the same time, the European Medicine Agency (EMA) has activated its plan for managing emerging health threats.[5] The overall aim of the plan is to draw on the expertise of the European medicines network to provide fast-track scientific advice and give prompt feedback on any proposed medicine developments (which may follow, for example, from the IMI COVID-19 call).

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United States federal and state rules and regulations during public health emergencies: navigating novel coronavirus

On January 30, 2020, the World Health Organization (WHO) declared novel coronavirus (also known as “2019-nCoV” and “SARS-CoV-2”) a Public Health Emergency of International Concern, and the United States Department of Health and Human Services (HHS) named it a public health emergency (PHE). In the United States, the declaration of a PHE empowers HHS to direct funding to: (1) allow the distribution of information about the virus; (2) encourage research and development of diagnostic and treatment techniques; (3) improve efforts on screening and detection; and (4) support local and state in efforts to restrain the spread of the virus. Working in tandem with HHS, the Centers for Disease Control and Prevention (CDC) continue to watch the outbreak closely, and a diagnostic test for the virus has already been fast-tracked by the U.S. Food and Drug Administration (FDA) through its emergency authorization power. The diagnostic test is only one example of the emergency activities we expect to see undertaken as federal and state agencies rush to respond to the 2019-nCoV outbreak.

In our full client alert, you will find an overview of information on the powers that enable state and federal governments to respond to a PHE, and the rules and regulations that are set forth by state and federal agencies concerning which health care providers, suppliers, and facilities may or must comply when a federal PHE has been declared or an infectious disease outbreak occurs under state law.