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The Health Pod

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The Health Pod, Baker McKenzie’s industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies.

Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice

Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following the US and China. In the first installment of the Spotlight on Japan mini-series, Hideo Norikoshi, head of the Tokyo office’s Healthcare & Life Sciences industry group, is joined by Kei Matsumoto, IP Tech partner and industry specialist, and Ryosuke Tateishi, Healthcare & Life Sciences Compliance and Regulatory Counsel, to discuss the distinguishing features of the Japanese pharmaceuticals market, including an introduction to industry practices, the health insurance system, and the Market Authorizaton Holder (MAH) regulatory framework in Japan.

Episode 4: UK and EU Competition Law in Times of COVID-19 and Beyond

The COVID-19 crisis has required competition authorities to adjust their enforcement priorities and seen a temporary relaxation of certain competition laws in response to the pandemic. In this episode of The Health Pod, Irena Apostopoulos joins David Wardell to discuss the impact of the pandemic on competition law enforcement in the UK and EU in the healthcare and life sciences industry, as well as heightened compliance risks and the risk of dawn raids.

Episode 3: Alternative Arrangements for Biopharma Clinical Funding

The lengthy, expensive and complex nature of drug development has brought about the emergence of alternative funding entities to help boost R&D productivity, lower costs and mitigate risks. In this episode of The Health Pod, Randall Sunberg joins David Wardell in discussing how these investment companies are bridging the funding gap, and the types of agreements and due diligence involved in these arrangements.

Episode 2: COVID-19 Impact on Biopharma Clinical Development in the EU and Mexico

The disruptive impact of COVID-19 has forced the healthcare and life sciences industries to adapt in different ways. In this episode of The Health Pod, Els Janssens and Christian Lopez-Silva join David Wardell in discussing the effect COVID-19 has had on the management of clinical trials in the EU and Mexico and how the regulators have dealt with these impacts.

Episode 1: Health Canada and the FDA’s Response to COVID-19

Resolving the health crisis demands an immediate response from regulatory agencies. In this episode of The Health Pod, Kamleh Nicola and Veleka Peeples-Dyer join David Wardell in discussing some of the most significant responses by Health Canada and the FDA to COVID-19.

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Author

David Wardell has been practicing law since 1982, mainly in the area of international corporate and commercial law. He serves on the steering committee of both the Global Healthcare Industry Group and the North America Healthcare Industry Group. He is also the Chicago office representative of the Firm’s French Initiative. Prior to joining the Firm, Mr. Wardell practiced for over 26 years first as an Assistant District Attorney in Manhattan under Robert Morgenthau and then at Bristol-Myers Squibb Company, Abbott Laboratories and Tenneco Inc., where he served as general counsel and chief compliance officer.

Author

Dianne Phoebus is member of the steering committees of the Firm’s Intellectual Property Practice Group and Pharmaceuticals & Healthcare Industry Group in Latin America. She practices mainly in the areas of intellectual property and health law, and is ranked among the leading intellectual property lawyers in Venezuela by Chambers Latin America and World Trademark Review. Ms. Phoebus is also an active member of the International Trademark Association and the Intellectual Property Committee of the Venezuelan-American Chamber of Commerce. She teaches legal English at the Universidad Monteávila.

Author

Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office. Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products. Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections. Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.

Author

Dr. Lopez Silva is the head of Healthcare & Life Sciences Industry Group in Mexico, as well as a member of the Steering Committee of the North American and Latin America Healthcare Group. He has more than 17 years of experience in regulation of life sciences, pharmaceutical law and biotechnology matters, having worked in the private and public sectors and at the national and international level. For several consecutive years, Dr. Lopez Silva has led the rankings for Life Sciences both nationally (Chambers Latin America) and internationally (Chambers Global).

Author

Randall Sunberg is a partner in the Corporate & Securities Practice Group and the Life Sciences Industry Group. He also serves as the co-head of the North America Life Sciences practice. Randy structures and negotiates complex collaborations, mergers and acquisitions, divestitures, joint ventures, and corporate partnering and licensing transactions, as well as equity investments and royalty monetization transactions for clients ranging from biotech startups to multinational pharmaceutical companies.

Author

Irena Apostopoulos is an Associate in Baker McKenzie's London office.

Author

Hideo Norikoshi has over 25 years experience working on a wide range of cross-border M&A transactions, joint ventures and corporate and corporate finance matters in Europe and Asia. He has advised numerous multinational companies, international investment banks and government organizations on landmark transactions, including mergers and acquisitions, public takeovers, corporate restructurings, private equity, international offerings and listing, structured finance and project finance. Hideo spent 10 years in the Japanese civil service from 1980 to 1990 before qualifying as a solicitor. In Japan, he is listed as a leading international lawyer for Corporate/M&A by Chambers Asia-Pacific in 2011-2017.

Author

Ryosuke Tateishi is a member of the Tokyo Corporate/M&A and Dispute Resolution Groups. Prior to joining Baker McKenzie, Ryosuke worked for Sumitomo Corporation. He is a member of the Daini Tokyo Bar Association and has been a METI-registered management consultant since 2003.

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