In Europe, the regulation of pricing and reimbursement for medicinal products is primarily governed by national policies, as EU-level regulation is limited. Our latest brochure “Market Access in Europe: Navigating Pricing &...more
On June 18, 2025, the Federal Ministry of Health (Bundesministerium für Gesundheit - BMG) published a draft bill proposing severe amendments to the German Medical Cannabis Act (Medizinal-Cannabis Gesetz - MedCanG) – just a...more
8/4/2025
/ Cannabis Products ,
Constitutional Challenges ,
Germany ,
Government Agencies ,
New Legislation ,
Pharmacies ,
Proposed Legislation ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Telemedicine
Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more
Artificial intelligence is transforming the medical device industry, offering unprecedented opportunities to enhance patient care. However, this technological leap comes with significant regulatory challenges. Across the...more
Key takeaways Faster Negotiations: SCs aim to significantly shorten CTA review times. Scope: The SCs cover specific terms, such as ownership of study results, publication rights, liability limitations, and termination...more
We recently hosted our 3rd annual AI Health Law & Policy Summit in Washington, DC where government and industry representatives joined members of the Hogan Lovells team to discuss new and emerging global health care AI...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
On 31 January 2025 the Clinical Trials Regulation will become fully applicable to all ongoing clinical trials with medicinal products in the EU. All clinical trials that have been authorized under the Clinical Trials...more
The World Health Organization ("WHO") published key principles for regulating artificial intelligence (AI) for health on 19 October 2023. The document, titled ‘Regulatory Considerations on Artificial Intelligence for Health’...more
In this article, we share our key takeaways from our recent webinar titled "AI, Digital Health & European Health Data Space", which was part of our "AI, Big Data and Law, Digital Deep Dive" webinar series. The webinar delved...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
Digital therapeutics (DTx) have emerged as an interesting addition to conventional pharmacological solutions, offering innovative ways to improve patient compliance and enhance treatment outcomes. Traditional pharma companies...more
Bei unserem Medizinprodukte Update Webinar im November 2022 haben die Partner:innen Dr. Jörg Schickert, Arne Thiermann und Dr. Tanja Eisenblätter, sowie Associate Dr. Benjamin Goehl den Teilnehmenden Updates zu einer Reihe...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 2: Clinical Trials Information System - This part of the series is about the Clinical...more
With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode 1: Transitional period and timeline Do you wonder when you need to apply the new rules...more
Bereits jetzt sind Pharma- und Medizintechnikunternehmen verpflichtet, den 3G-Status ihrer Mitarbeitenden zu kontrollieren, bevor diese die eigenen oder Arbeitsstätten anderer Arbeitgeber betreten (§ 28b Abs. 1 IfSG)....more
Pharmaceutical and medical technology companies are already required to check the status of their employees as vaccinated, recovered or negative tested before they enter their own workplaces or those of other employers (Sec....more
Nachdem Betriebsärzte bisher nur im Rahmen einzelner Modellprojekte der Länder in die COVID-19-Impfkampagne eingebunden waren, wird im Zuge der Aufhebung der Impf-Priorisierung ab 7. Juni 2021 nun die vollständige Einbindung...more
On May 19, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1),” updating 2010 guidance of the same name. The revised...more
Viele deutsche Unternehmen sind nach eigener Aussage schon bereit zum Impfen. Einige wollen eigene Impfstraßen aufsetzen, um das Impfgeschehen in ihrem Betrieb und damit auch in Deutschland voranzubringen. In vielen...more
Mit dem Angebot der Durchführung von Corona-Schutzimpfungen am Arbeitsplatz gehen eine Reihe an Rechtsfragen einher im Hinblick auf Produkthaftung, Arzneimittelsicherheit, Versicherungs-, Datenschutz- und Arbeitsrecht, um nur...more
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
Further to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic, the German higher federal authorities (the Federal Institute for Medicinal Products and Medical Devices (BfArM) and...more
1. What are general recommendations?
In general, it is important to determine at an early stage which processes must be maintained, which people are needed to maintain operations and which measures are necessary to do so....more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth