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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.

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 has extensive experience in pharmaceutical and health law, as well as in compliance, contract law, licensing, competition law and acquisitions in the pharmaceutical sector. She is the coordinator of the healthcare practice in the Barcelona office.
She assists healthcare companies throughout the life cycle of healthcare products (drugs, IVD and medical devices, combination products, cosmetics and food supplements), from R&D to commercialization and more specifically in the areas of clinical trials (agreements, regulatory procedures, processing of personal data), market access (pricing and reimbursement), products and companies regulations (MA/CE-marking, vigilances, required licenses, product classification, labelling), commercial relations between healthcare industries (distribution, (co)promotion, manufacturing, supply, licensing, partnership agreements), relations with healthcare professionals and/or patients including compliance (anti-gift and transparency laws); communication and advertising, e-health (connected devices, telemedicine, hosting of health data) and product liability. Her practice encompasses both advisory and litigation matters.
She also has considerable experience in the drafting of codes of professional ethics and conducting compliance audits, and advising on advertising and promotion of medicines and medical devices, including via the internet, online advertising and social media. Montserrat advises on a wide range of agreements related to the pharmaceutical industry, such as license and distribution agreements, clinical trial agreements, and supply and manufacturing agreements.

Author

Cecilia Pastor 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, 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

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

Author

Magda Tovar is Senior Knowledge Lawyer for the Healthcare and Life Sciences Industry Group.

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