Beveridge & Diamond
 

Pharmaceuticals

Overview

Beveridge & Diamond, P.C. has worked on a wide range of environmental and product-related matters for large and small pharmaceutical companies in the U.S. and overseas. In the U.S., our work includes advising clients on chemical regulation, pollution control and compliance under a host of federal and state laws. We also advise clients in the pharmaceuticals industry on matters arising under various international environmental agreements and environmental, health, and safety requirements in key markets worldwide.

Full Description

Beveridge & Diamond has worked extensively with pharmaceutical clients on strategic and compliance issues related to environmental, health, and safety matters (“EHS”) arising under U.S. federal and state laws and international agreements. Our work has ranged from traditional domestic chemical and hazardous waste regulatory requirements, to EHS requirements for emerging technologies, to domestic and international chemical notification and inventory regimes. We have represented and advised pharmaceutical companies and the industry trade association on a number of clean air permitting and regulatory matters. On the international front, we have also advised companies on emerging legal regimes regulating greenhouse gases and all aspects of the Montreal Protocol.

Representative Matters
Representative Matters
  • Pharmaceutical EHS roundtable.  The Firm hosts a periodic meeting among EHS in-house counsel at leading pharmaceutical companies to assess emerging EHS issues.
  • Advising companies on EHS requirements for new technologies.  The Firm provides on-going research and analysis on EHS requirements for the latest technologies being employed in the pharmaceutical sector, including nanotechnology and biotechnology.  We have advised numerous large pharmaceutical companies on the evolving controls on nanotechnology at the domestic and international level.
  • Counseling companies on existing and proposed chemical regulations.  We routinely track and advise clients, including pharmaceutical clients, on chemical and material use bans and restrictions (federal and state) and existing and proposed chemical restrictions under regional and global agreements.  Our work includes advising clients on the applicability of the EU’s “REACH” regulation to pharmaceutical ingredients and medical devices.  We helped a major global pharmaceutical company evaluate its REACH exposure and develop a REACH compliance strategy.  We have also counseled a Fortune 100 company on emerging new chemical notification and chemical inventory regimes in Europe, Asia, and Latin America.
  • Advising companies on the Montreal Protocol.  The Firm has advised clients on all aspects of the Montreal Protocol and its implementation in the U.S.  We have counseled two of the major pharmaceutical companies on options for securing essential use exemptions for the continued use of chlorofluorocarbons (CFCs) under the Montreal Protocol and U.S. implementing measures under the Clean Air Act, as well as related matters including disposal of waste products and transfers of CFC stockpiles and allowances.  A medical device manufacturer worked with the Firm on the viability of future product lines using a substance that could qualify as an ozone depleting substance.
  • Advising companies on product take-back and recycling operations.  We have represented pharmaceutical production facilities with reuse/recycling operations under the Resource Conservation and Recovery Act (RCRA).
  • Assessing current and future climate change requirements.  The Firm has provided guidance to a number of large pharmaceutical companies about the shifting landscape of national and international climate change requirements.  We provide on-going research, analysis, and advocacy assistance to pharmaceutical companies on issues and developments related to the United Nations Framework Convention on Climate Change and the Kyoto Protocol, as well as domestic climate change developments.  
  • Preparing and revising clean air permits.  The Firm has assisted a number of pharmaceutical companies in preparing and revising Clean Air Act Title V permits. We also advised a Fortune 100 company on all aspects of Clean Air Act New Source Review permitting for capital projects accompanying production of major new pharmaceutical products.
  • Representing industry trade association in supporting clean air regulations.  We represented an industry trade association supporting EPA's Maximum Achievable Control Technology (MACT) regulation for medical waste incinerators against a lawsuit brought by an environmental organization challenging that rule in the D.C. Circuit. Although the court remanded the rule, we successfully convinced the court to reject the plaintiff's key substantive theory that would have made the standard unachievable.
  • Advising companies on chemical release and use regulations.  The Firm has advised a number of companies on Toxic Release Inventory (TRI) reporting obligations under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), including responses to EPA enforcement actions. We assisted a major pharmaceutical manufacturer with the development of a continuous release reporting program to ensure compliance with the emergency release reporting requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and EPCRA. 
  • TSCA and new chemicals notifications. We have advised pharmaceutical industry clients on the requirements of the Toxic Substances Control Act (TSCA), including, in particular, circumstances (e.g., recycling of pharmaceutical waste streams) under which substances may not be considered "drugs" exempt from TSCA's chemical regulatory requirements.
  • Advocacy assistance on international conventions.  In addition to providing compliance assistance for international climate change regimes and the Montreal Protocol, the Firm has also counseled U.S.-based pharmaceutical companies on the implementation of the Cartagena Protocol on Biosafety.
  • Obtaining insurance recoveries.  We have represented pharmaceutical and medical products manufacturers seeking insurance coverage for the defense and settlement of liability claims.  We have also provided advice on product recall insurance issues.
  • Product-related due diligence.  We have counseled a major pharmaceutical company on due diligence issues related to the consideration of new pharmaceutical products based on products that may implicate obligations under international agreements or raise corporate responsibility considerations, including under the Convention on Biological Diversity (CBD) and the Antarctic Treaty System.  We also have closely followed the evolving framework for bioprospecting for marine genetic resources, and related land-based developments on a new instrument under the CBD for access and benefit-sharing.
  • Environmental management systems.  We reviewed and evaluated both the environmental management program and the compliance status of a company engaged in the manufacture and distribution of cosmetics and pharmaceutical products. The evaluation encompassed each of the company's manufacturing and distribution facilities. Our report to management suggested improvements to the environmental management program and identified possible compliance issues at individual facilities.
Overview





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