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
Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug prices; France adopts standard CTA clauses; UK easing clinical trials; Devices:...more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...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
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
Step by step towards self-testing: Due to the Covid-19 pandemic, which continues to impinge upon everyday life, the German Federal Ministry of Health (Bundesministerium für Gesundheit, “BMG”), after approving the distribution...more
Seit Monaten wird die Frage kontrovers diskutiert, ob Probenentnahme-Sets zur Feststellung einer SARS-CoV-2 Infektion oder entsprechender Antikörper an jedermann abgegeben werden dürfen oder nicht....more
For months now there has been ongoing controversial debate about whether or not specimen-collecting kits for the detection of a SARS-CoV-2 infection or related antibodies may be furnished to members of the general public. ...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
Introduction In November 2019, the parliament passed a new law which will provide reimbursement for digital healthcare provision for the around 70 million publicly insured patients in Germany (Digital Health Service...more