Healthcare & Life Sciences
Consumer Products
#wearehealthcareandlifesciences
HCLS | Consumer Products
We advise and support companies with deep sector knowledge in all areas of the healthcare and life sciences sector – pharmaceuticals, biotechnology, medical devices (including IVD’s), digital health, health institutions, medical professionals, AI.
We provide legal services to leading large companies, small and medium business as well as start-ups, be it producers, wholesalers, retailers, transportation and storage companies, health institutions, laboratories.
Our aim is to enable our clients to achieve their goals, by providing practical advice in line with legal requirements on complex regulatory, competition, compliance requirements.
We offer interdisciplinary support for your M&A transactions, commercial/ IP and patent litigation (in close cooperation with patent attorney), data protection and cyber security advice, product liability, administrative disputes with regulators and fines.
Your contact
Iliyana Sirakova
Partner | Attorney at Law
Head of HCLS | Consumer Products
Our expertise in Healthcare & Life Sciences
Legal issues relating to the operation and services of hospitals, clinics, nursing homes and medical practices
Advice to doctors, dentists, therapists, and other healthcare professionals (e.g., medical-technical services, medical care providers) on e.g., regulatory, licensing topics and disputes (with the Dispute Resolution team)
Questions about the regulation of medical facilities, patients’ rights, health data protection (with our Data Protection and Cybersecurity team)
Legal aspects related to public and private health insurance, reimbursement systems and remuneration structures
Advice on new technologies in the field of telemedicine, such as legal frameworks for digital healthcare and artificial intelligence
Support and representation with administrative (criminal) proceedings and civil proceedings (e.g., pricing and reimbursement proceedings, inclusion of new products/ indication in the reimbursement code; licensing proceedings; disciplinary proceedings)
Legal advice relating to the development, manufacture, distribution, marketing and advertising of medicinal products incl. marketing authorizations and pharmacovigilance (monitoring of drug safety); Advice on licensing, manufacturing, and distribution agreements; Differentiation from “other” products (e.g., food, cosmetics, medical devices, narcotics)
Regulations and laws on the distribution of medicines in pharmacies, hospitals and in stores (incl. OTC)
Legal issues relating to the development, manufacture, distribution, marketing and advertising of medicinal products (e.g. surgical devices, diagnostic instruments, implants, software and AI); Advice on licensing, manufacturing and distribution agreements; Differentiation questions from “other” products (e.g., food, cosmetics, medicinal products)
Protection of intellectual property, especially patents on biotechnological inventions, pharmaceuticals, and medical devices (together with our DR and IP team)
Contract and regulatory aspects, ethical issues, patient rights and data protection in clinical trials (together with our DR and IP team)
Legal framework for the research and development of biotechnological products, including gene and cell therapies
Support and representation with/against unfair competition claims/ injunctions (Act against Unfair Competition – UWG); support and representation with other civil claims (e.g., contractual disputes)
Support and representation with administrative proceedings (measures proceedings, notifications, certificates, authorizations) and administrative criminal proceedings (defense against fines and disciplinary proceedings)
Consumer goods are e.g.:
- food (incl. food supplements, beverages/wine/spirits)
- cosmetics
- household goods (cleaning agents, biocides such as insect sprays)
- clothing
- electronics
- toys
- tobacco products and nicotine products
Legal issues in development, production, distribution, labeling and advertising
Drafting and negotiation of contracts, including issues of warranty, guarantees and terms of delivery
Review of advertising measures and marketing campaigns for their compatibility with the Act against Unfair Competition (UWG); support and representation with/against claims/ injunctions
Advice on compliance with consumer product safety regulations; Advice and support in the event of product withdrawals and recalls
Advice on environmentally friendly packaging requirements, recycling regulations and take-back obligations
Advice on sustainability and environmental sustainability, such as compliance with regulations on CO₂ balances, environmentally friendly packaging and sustainable production processes, social responsibility (supply chain due diligence)
Advice on international trade regulations, EU regulations and mutual recognition of products
Advice and support on trade law regulations, support with assessment and obtaining of the required business licenses, certificates of competence and permits
Support and representation with administrative proceedings (measures proceedings, notifications, certificates, authorizations) and administrative criminal proceedings (defense against fines and disciplinary proceedings)
Our experts in HCLS | Consumer Product
HCLS | Consumer Products News
AI in companies – also a legal challenge
“Most users give very little thought to when they enter which data into which AI systems.”
Home DNA tests under the microscope
Christian Kern, lawyer in the Data Protection | Cybersecurity & IP/IT | Media Law team, explains the data protection concerns regarding home DNA tests.
The limits of data retention
A recent ECJ verdict confirms that states may not circumvent the ban on data retention by obliging private providers to collect data from the state by law.