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EMEA: COVID-19 Life Sciences Survey (Updated)

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In brief

What measures have EMEA governments taken in the life sciences sector to fight COVID-19?

As COVID-19 rapidly spreads to every corner of the globe and is officially declared a pandemic, governments across the world are adopting emergency measures to fight against this extraordinary situation. Ultimately, all these measures are aimed at protecting the health and wellbeing of citizens. However, on the healthcare and life sciences front in particular, such measures range from intervention powers to guarantee adequate supplies of treatment and medical equipment, to the relaxation of deadlines and regulatory requirements to simplify administrative procedures wherever possible, so that competent authorities, manufacturers and other actors can focus on urgent priorities related to the COVID-19 crisis.

Contents

The Baker McKenzie Healthcare and Life Sciences Industry Group is pleased to provide you with an overview of the measures that governments across the EMEA region, which includes some of the worst hit countries, have adopted in the area of healthcare and life sciences in response to the COVID-19 outbreak.

In this guide, Baker McKenzie lawyers across EMEA share their high-level views on the following areas:

Requisition powers

  • Has the Government established any powers to requisition assets and premises?
  • Is it converting hotels into hospitals/medical centers for quarantine and self-isolation?
  • Is it controlling the distribution of medicinal products/medical devices?

Price and reimbursement

  • Has the price and reimbursement procedures for medicinal products and medical devices been affected?

Public procurement

  • Has the Government adopted exceptional public procurement measures?
  • Have procedural requirements been relaxed for COVID-19 related medicines and devices?
  • Are sanctions foreseen for unfilled orders?

Legal deadlines

  • Have legal/administrative deadlines been suspended/relaxed?
  • Have these measures had an impact on MA approvals, public procurement, etc.?

Relaxation of regulatory rules

  • Has the Government relaxed regulatory rules?
  • Have special measures been adopted?
  • What are the main changes?

This guide offers only a high-level view and does not constitute legal advice. The COVID-19 outbreak is an escalating situation, authorities are issuing advice on a daily basis and it is crucial to assess these measures on a case-by-case basis.

The full guide is now available and can be found here.

Categories:
Author

Montserrat Llopart is a Partner in the International Commercial & Trade department and leads the Compliance and Healthcare Law practices in the Barcelona office. Her practice focuses on advising clients on regulatory, compliance, commercial contracts, consumer and acquisitions issues. She is a regular speaker and contributor to specialist conferences and publications and she is recognized by the leading legal directories as Chamber, Legal 500 and Best Lawyers and as InspiraLaw Top 50 Women List for Spain and Portugal. Montserrat headed the Barcelona office and the Firm's pharmaceutical law group in the EMEA region.

Author

Cecilia Pastor is a partner in Baker Mckenzie's Madrid office. She is highly knowledgeable in the areas of mergers, acquisitions and pharmaceutical law. She is a lecturer at ICADE on international agreements for the university’s Masters in Law degree program. Ms. Pastor is a regular contributor to the Spanish chapters of Promoting Medical Products in Europe & North America, Pharmaceutical Advertising, and other publications. She is a member of the Madrid Bar Association.

Author

Dr. Thilo Räpple is a Partner in Baker McKenzie's Frankfurt office.

Author

Hiroshi Sheraton's practice covers all aspects of intellectual property law with a particular emphasis on contentious patent and trade mark matters and life sciences. Much of his work is cross-border in nature. He regularly co-ordinates pan-European and global IP litigation and advises clients on international IP strategies for patent litigation and brand protection. He represents clients in the UKIPO, EPO, OHIM, the English Courts and the CJEU. He has experience of IP matters across Europe and has litigated IP cases in Germany, France, Spain, Italy, the Netherlands, Belgium, Austria, Ireland, Northern Ireland and Luxembourg, the USA and Asia Pacific. Although he has a first degree in biochemistry and molecular biology, he covers all areas of technology from pharmaceuticals/biotech products and agrochemicals to electronics and software.

Author

Alexey Trusov practices in the areas of corporate, M&A and pharmaceutical and healthcare. He graduated from St. Petersburg State University’s School of Law in 1997 and received his LL.M. from Cleveland State University’s Cleveland-Marshall College of Law in 1998. He received his degree of Candidate of Science from St. Petersburg State University’s School of Law in 2002. He was admitted to the Russian bar in 1997, and currently serves as co-chair of the Association of International Pharmaceutical Manufacturers Legal Committee.

Author

Julie Yeni practices in the Pharmaceutical and Healthcare Industries Practice Group of Baker McKenzie in Paris.

Author

Magda Tovar joined Baker McKenzie in September 2019 as a Knowledge Lawyer for the Global Healthcare and Life Sciences Industry Group, covering healthcare and life sciences legal issues for -the EMEA region. She also supports the Industry Group at a global level on many knowledge management matters including thought leadership projects and global surveys. Before joining Baker McKenzie, Magda was a senior legal adviser at the European Medicines Agency (EMA) for 16 years where she advised on a broad spectrum of matters related to EU pharmaceutical law, covering medicines for human and veterinary use. She represented the EMA in cases before the General Court and the Court of Justice of the European Union.

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