On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation. The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorization and supervision of medicines.
The Canada-United Kingdom Trade Continuity Agreement (Canada-UK TCA) replicates the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) on a bilateral basis. The Canada-UK TCA (signed December 2020) came into force from 1 January 2021 and aims to maintain the status quo in the trade relationship.
Following four and a half years of often acrimonious negotiations and numerous build ups to a no-deal situation, the EU-UK TCA represents a positive step. While the deal is relatively thin and offers only discrete regulatory reciprocity, overall the TCA is a welcome development in the face of apparent near- political failure to agree on a way forward between the two sides. The life sciences sector has been preparing for no-deal amidst the global coronavirus (COVID-19) pandemic, throughout 2020, and having a deal, however slim, is positive for the sector in providing more fertile political ground for future harmonisation and cooperation
The EU has urged member countries to grant more legal powers to the EU in pursuit of a ‘Health Union’, which would enable the EU to better manage future crises. This announcement comes in the wake of the COVID-19 pandemic, which exposed areas of weakness and gaps in the EU’s health powers. Critics argue that the pandemic has seen a lack of effective measures to monitor medicines shortages, that the EU Infectious Diseases Agency’s advice lacked effectiveness, and that there was a disjointed approach to the virus across EU member states. In response, the Commission expressed desire to make the following changes:
create an EU-wide pandemic preparedness plan
align testing methods with EU labs
give the European Medicines Agency (EMA) more power to mitigate drug shortages
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.
France, Italy, Germany, Spain, Russia and UK: Top digital health solutions Whether your company is new to the digital health space, or enhancing its existing digital health offering in response to COVID‑19, here are top legal issues to bear in mind as you embark on your journey. COVID‑19 is accelerating…