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Julie Yeni

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

Explore Data PULSE, a platform which helps you to navigate the complex landscape of data, regulatory and IP protection concerns at each stage of the medical product life cycle. As you navigate through each key issue, Data PULSE will help you to identify and mitigate risks across multiple jurisdictions and optimize your strategy through research, market authorization and post-market study phases.

On 20 April 2022, the French government adopted an ordinance adapting French law to EU Regulation 2017/745 on medical devices (MDR). Although the MDR is directly applicable since its entry into force on 26 May 2021, adaptations of the provisions of the French Public Health Code were necessary and much awaited by the medical device industry.

Health Technology Assessment is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies. This multidisciplinary process evaluates the medical, social, economic and ethical issues related to the use of a health technology. Health technologies encompass medicines, medical devices, in vitro diagnostic medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.

According to a parliamentary report dated 14 October 2021, shortages of health products are on the rise. The number of medicines of major therapeutic interest declared out of supply has increased from 404 in 2013 to 1,499 in 2019. As for medical devices, the French Health Agency estimates that, as of 8 October 2021, one essential medical device is currently subject to supply difficulties and has been for more than a month, which jeopardizes the continuity of patients’ care.

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.

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.

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.

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.

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.

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…