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Commercialisation of Healthcare: Jurisdictional Comparisons

Commercialisation of Healthcare: Jurisdictional Comparisons

Author: Jeffrey S. Graham
Publisher: Sweet & Maxwell U.K.
ISBN: 9780414027060
Published In: November 2013
Format: Hardback
Jurisdiction: International ? Disclaimer:
Countri(es) stated herein are used as reference only

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There is a continuous globalization of the commercial and regulatory aspects of pharma / biotech, medical device and natural health products. As a result, there is an increasing demand for knowledge about how health care products are regulated in leading markets. This new book is designed to meet this demand by providing a single reference for clients and advisers involved with commercialization of health care products.

Essential current content reflecting health care products and regulation across 20 major jurisdictions throughout the world
Includes contributions from expert medical lawyers
Reader-friendly Q&A format allows for easy cross-jurisdictional comparisons
Strong international focus, covering diverse areas
Focuses on Medical Devices; Biological Products, and Natural Health Products
Practical, straightforward commentary on each jurisdiction and the respective legal systems

Jurisdictional Coverage:
1. Australia; Griffith Hack
2. Austria; Fiebinger Polak Leon & Partner
3. Brazil; Pinheiro Neto
4. Canada; Borden Ladner Gervais
5. China; Reed Smith
6. France; Taylor Wessing
7. Germany; Ehlers, Ehlers & Partner
8. India; Associated Law Advisers
9. Italy; Hogan Lovells International
10. Japan; Nagashina & Hashimoto
11. Korea; Kin & Chang
12. Mexico; Olivares
13. Netherland; Hogan Lovells International LLP
14. Poland; Domanski Zakrzewski Palinka sp.k
15. South Africa; Webber Wentzel
16. Turkey; Mehmet Gün & Partners
17. UK; 4 New Square
18. Ukraine; Arzinger
19. USA; Hyman, Phelps & McNamara

1. Overview of Medical Product Regulatory System in Jurisdiction
2. Drugs
3. Medical/Assisted Devices
4. Biological Products
5. Natural Health Products
6. Future Directions

GENERAL EDITORS

Jeffrey N. Gibbs has represented health care companies on FDA-related matters since 1984. He advises companies on a wide variety of issues, including product approvals, marketing, clinical studies, and enforcement. Previously, he served in the Chief Counsel’s Office of the U.S. Food and Drug Administration, where he became an Associate Chief Counsel for Enforcement. He is currently on the editorial advisory board of IVD Technology. Mr. Gibbs serves as Secretary and General Counsel of the Board of Directors of the Food and Drug Law Institute. He is a graduate of Princeton University (1975 summa cum laude) and the New York University School of Law (1978 with honors). He is admitted to practice law in the District of Columbia.

Hyman, Phelps & McNamara: Our goal is to provide prompt and economical professional services suited to each client’s specific needs. The firm’s clients are as diverse as the regulatory issues they face. They range from individuals and start-up companies with no in-house legal staff to large multinational corporations. In addition, other law firms retain HPM to provide targeted expertise in food and drug law to assist their clients. HPM works to avoid legal problems when possible, and to help solve them when necessary.

The firm helps companies conduct business as efficiently and profitably as possible by providing advice and counsel on meeting current and future regulatory requirements.

Jeffrey Graham is one of Canada’s leading biotech and pharmaceutical regulatory counsel. He is a partner in the Toronto office of Borden Ladner Gervais LLP and
the leader of the firm’s national life sciences group. Jeff’s clients include domestic and international consumer products, biotech and biopharmaceutical companies for whom he provides corporate and regulatory advice with respect to compliance with federal and provincial laws and regulations, including the federal Food and Drugs Act, and provincial laws relating to formularies, and various regulatory agencies including Health Canada, the Canadian Food Inspection Agency, the Canadian Pest Management Agency and the PMPRB. Jeff is the senior co-editor of the LexisNexis compilation of Federal Food and Drug Legislation and Commentary and the lead editor of the Canadian Health Law Practice Manual, Chapter on Pharmaceuticals. He is a regular speaker at pharmaceutical industry conferences and an occasional opeditorial page contributor in The National Post newspaper on pharmaceutical policy issues.

The firm:
Borden Ladner Gervais: We are an integrated national firm that provides a broad range of legal solutions to our clients. We have more than 750 lawyers, intellectual property agents and other professionals in Vancouver, Calgary, Toronto, Waterloo Region, Ottawa and Montreal, with some of the best, most experienced and successful legal minds in Canada. Backed by the talent, long-term commitment and support of our staff in all offices, the BLG team is committed to understanding and meeting the needs of our clients.