On December 29, 2022 the French Conseil d’Etat (the highest French administrative court) rendered a decision that was eagerly awaited by all those involved in the CBD industry which lifted the ban on the sale of CBD flowers and leaves to consumers. Terminology For those who are not familiar with these products, Cannabis is the … Continue Reading
The regulation of CBD/Hemp products has been a very hot topic in France these past months since the “Kanavape” ruling. In Kanavape, the CJEU asked France to review its very strict CBD regulations, more specifically its Regulation (arrêté) of 22 August 1990 (CJEU, 19 November 2020, C-663/18) in light of the free movement of goods … Continue Reading
On January 8, 2022, Minister of Health Roberto Speranza and Minister for Technological Innovation and Digital Transition Vittorio Colao, in an article published in the Italian press, made a number of announcements about the timing of the Italian government’s intended investment in digital health. This investment forms part of the Italian Recovery and Resilience Plan … Continue Reading
On November 23rd, a Squire Patton Boggs partner will lead a panel of industry thought leaders in a discussion of transcontinental health research and data issues. Topics to be explored include: What are the challenges that companies need to face in order to promote research with health data? What should evolve in the legal framework … Continue Reading
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year. The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the … Continue Reading
The EU-UK Trade and Cooperation Agreement (the Agreement), announced just before Christmas, has now been agreed by the UK Parliament and EU Commission. This is now in place with a requirement for further approval by the EU Parliament. The Agreement is wide-ranging but in terms of trade mainly focusses on the supply of goods. As … Continue Reading
The European Commission President Ursula von der Leyen has put an emphasis on health policy since the beginning of her term, by promoting the development of a number of initiatives that will be published in the months and years to come. Inevitably, the COVID-19 pandemic has generated a growing demand for better coordination across EU Member … Continue Reading
“As countries face undeniable emergencies, concentration of power, derogation of rights and freedoms, and as large amounts of money are infused into the economy to alleviate the crisis, corruption risks should not be underestimated,” said Marin Mrcela, the president of the Group of States against Corruption (GRECO), an anti-corruption monitoring body that is part of … Continue Reading
COVID-19 outbreak has caused major disruption of supply chains and a steep rise in demand for certain products and services, notably in the health sector. These circumstances risk leading to shortages in critical medical goods used to treat COVID-19 patients, but also in other essential goods and services outside the health sector. Tackling these exceptional general supply shocks … Continue Reading
Until most recently, Europe had been at the epicenter of the COVID-19 outbreak – which now has shifted to the United States. This crisis heavily impacted many European countries and triggered a coordinated response by the European Union (‘EU’) led by the European Commission (‘EC’) to tackle this severe public health emergency (i.e. a Member State … Continue Reading
The European Commission (EC) has recently adopted an amendment that extends the State aid Temporary Framework (described in our last blog post here) by adding five further types of aid measures that Member States may implement: Support for COVID-19 related research and development (R&D) to address the current health crisis; Support for the construction and … Continue Reading
In a joint statement on the application of EU and national competition law during the coronavirus disease 19 (COVID-19) crisis, the European Competition Network (ECN) recognized that competitors, supplier and distributors may need to cooperate with each other to ensure the supply and fair distribution of scarce products to all consumers. For example, a few … Continue Reading
Both the European Union (EU) and national governments have sought to respond rapidly to the economic impact of the COVID-19 outbreak. The European Commission (EC) is responding to the increasing need for companies to receive urgent financial support by adopting new State aid tools and emphasizing its ability to approve aid quickly. In recent days, … Continue Reading
Coronavirus disease 2019 (COVID-19) is hurting the world’s economy, through severe disruption of financial markets, supply chains and work forces. In the EU, member states to varying degrees are contemplating measures to support companies hardest hit by the impact of the virus on the economy, including government loans, tax credits or deferral of tax payments. … Continue Reading
On Friday, May 11, 2018, President Trump vowed to fix “the injustice of high drug prices” by announcing the “Blueprint to Lower Drug Prices” (the Blueprint) to address the following challenges: Excessively high drug prices Seniors and government programs overpaying for drugs High out-of-pocket costs for consumers Lack of transparency in drug pricing Free-riding by … Continue Reading
An article authored by Healthcare principal John Wyand and associate Sarah Stec published in the November/December edition of the Food Drug Law Institute’s Update Magazine, looks at the impact of the EU’s regulations governing medical devices and in vitro diagnostic medical devices. The regulations seek to fill the regulatory gaps uncovered as technology evolved faster … Continue Reading
On May 25, 2016, the European Union (“EU”) Council and Parliament politically agreed on the provisions that will go into the final version of the long-awaited EU medical device and in vitro diagnostic (“IVD”) regulations. The agreement seeks to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had … Continue Reading
