 | Health law“Health law” comprises both public and private law relating to the topics of health and nutrition, i.e. food law, medicines law, health care law, pharmacies law, medical law as well as health-oriented sports law, advertising law, trademark law, sales law, company law and general areas of law. Our lawyers offer you assistance and representation in the following areas of law- Medicines law,
- Law on advertising in the health care system,
- Food law,
- Medical devices law,
- Pharma law,
- Cosmetic law,
- Competition law,
- Contract law,
- Trademark law,
- Pharmacies law,
- Medical law,
- Hospital law,
- Biotechnology law,
- Gene technology law,
- Patient law,
- Health insurance law, and
- Law of professional conduct for the medical profession.
We offer you the following- Assistance with product conceptual design (e.g. development of new foodstuffs, especially food supplements and functional food, including checking the packaging and handling issues relating to the advertising of food and medical products);
- Assistance and representation in matters concerning the marketing authorisation for novel food products and medicines;
- Checking whether your foodstuffs, food supplements and other health care products and preparations can be placed on the market;
- Checking whether your product has been properly categorised as a medicine, foodstuff (also food supplement), medicinal product or cosmetic; we also check whether it fulfils the requirements for being placed on the market or granted a marketing authorisation or certification; furthermore, we help you choose the authorisation procedure for you medicine and assist you thorough the proceedings;
- Assistance at developing new medicines and medical products (trade in active ingredients, distribution of medicines, pharmacovigilance), also in the European and international environment;
- Examining, counselling and safeguarding advertising efforts for your product as well as product marking;
- Handling matters relating to the statutory health insurance and private health insurance funds (reimbursement and compensation);
- Administrative proceedings (dealing with authorities and administrative courts), civil law proceedings (e.g. competition law disputes with competitors, collections), out-of-court settlements and criminal procedures;
- Product liability issues as well as general liability law (medical malpractice liability, medical liability);
- Protecting and safeguarding commercial property rights for foodstuffs, medicines and medicinal products (including trademarks, designs, plant varieties and patents/ supplementary protection certificates);
- Drafting agreements and assisting you at agreement negotiations;
- Representing your interests against authorities, associations, ministries, legislative bodies and international organisations;
- Counselling and representing physicians, clinics, pharmacies, hospitals (including remuneration issues and those relating to the code of professional conduct);
- “all-inclusive” legal services: legal assistance relating to alternative medicine, alternative methods of treatment and alternative products, “wellness regulations” and “fitness regulations” (checking whether a product can be placed on the market, advertising in the health care system, etc).
- Michael Horak, graduate engineer, LL.M. | Attorney-at-law
- Julia Ziegeler, Specialist | Attorney-at-law
- Anna Umberg, M.A., Lawyer | Attorney-at-law
- Andree Eckhard, Patentlawyer
- Katharina Gitmann
- Karoline Behrend
- Dr Johanna Müller
- Andreas Friedlein
- Stefan Karfusehr
- Jonas Herbst
Health Law and Its Key AreasHealth law encompasses a broad spectrum of legal regulations that govern healthcare systems, public health, medical services, pharmaceuticals, and patient rights. It aims to protect public health, ensure the safety and efficacy of medical products and services, and regulate the professional conduct of healthcare providers. Below is a detailed explanation of various key topics in health law:
1. Medicines Law- Regulates the development, approval, manufacturing, distribution, and marketing of medicines.
- Ensures that medicines meet safety, efficacy, and quality standards before reaching the market.
- Covers the licensing of pharmaceuticals and the obligations of manufacturers and distributors.
- Example: European Union Directive 2001/83/EC on the Community code relating to medicinal products for human use.
2. Law on Advertising in the Health Care System- Governs how healthcare products and services can be marketed to the public and professionals.
- Aims to prevent misleading advertisements and ensure accurate information.
- Strict regulations apply to pharmaceuticals, medical devices, and health claims in advertisements.
- Example: Directive 2006/114/EC on misleading and comparative advertising.
3. Food Law- Regulates the production, labeling, marketing, and safety of food and dietary supplements.
- Protects consumers from unsafe or falsely advertised food products.
- Includes laws on nutritional claims and health-related statements (e.g., "low fat" or "supports immune health").
- Example: Regulation (EC) No 178/2002, establishing the European Food Safety Authority (EFSA).
4. Medical Devices Law- Covers the approval, regulation, and monitoring of medical devices, such as implants, diagnostic tools, and software.
- Ensures that devices meet safety and performance standards before being marketed.
- Introduced stricter rules on clinical evaluations and post-market surveillance through regulations like the EU Medical Device Regulation (MDR 2017/745).
5. Pharma Law- A broader category that encompasses medicines law, regulatory compliance for pharmaceuticals, patent issues, and market exclusivity.
- Governs drug pricing, generic drugs, and innovation incentives for pharmaceutical companies.
- Addresses cross-border trade and pharmacovigilance (monitoring the safety of drugs post-approval).
6. Cosmetic Law- Regulates the safety, labeling, and marketing of cosmetic products.
- Ensures that cosmetics do not harm users and comply with ingredient restrictions and mandatory testing.
- Example: Regulation (EC) No 1223/2009 on cosmetic products in the EU.
7. Competition Law- Enforces fair competition in the healthcare and pharmaceutical markets.
- Prevents monopolistic practices, price fixing, and abuse of dominant market positions.
- Encourages innovation and accessibility to healthcare services and products.
- Example: EU Antitrust Rules (Articles 101 and 102 TFEU).
8. Contract Law- Regulates agreements between parties in the healthcare sector, including contracts for medical services, research agreements, and supplier contracts.
- Ensures that terms are fair and enforceable, protecting both providers and consumers.
- Example: Contracts between hospitals and pharmaceutical companies for drug procurement.
9. Trademark Law- Protects brand names, logos, and trademarks of healthcare products and services.
- Prevents counterfeit products and ensures that consumers can identify authentic goods.
- Example: Registration of trademarks for pharmaceuticals, such as "Aspirin" by Bayer.
10. Pharmacies Law- Governs the operation of pharmacies, including licensing, staffing, and the dispensing of medicines.
- Ensures safe and legal distribution of prescription and over-the-counter drugs.
- Regulates online pharmacies and mail-order drug services.
11. Medical Law- Focuses on the regulation of medical professionals, their responsibilities, and patient care.
- Covers issues like malpractice, informed consent, and patient confidentiality.
- Includes guidelines for ethical practices in medicine.
12. Hospital Law- Regulates the management, funding, and operation of hospitals.
- Covers patient admission rights, public and private hospital distinctions, and compliance with healthcare standards.
- Includes labor laws for hospital staff and contractual obligations.
13. Biotechnology Law- Governs the application of biotechnology in medicine, agriculture, and environmental management.
- Includes rules on genetic modification, biosimilars, and biotechnology patents.
- Example: Laws regulating the development and use of CRISPR gene-editing technologies.
14. Gene Technology Law- Regulates the research, development, and application of genetic engineering.
- Aims to protect human health and the environment from potential risks associated with genetic technologies.
- Example: Laws addressing gene therapy and genetically modified organisms (GMOs).
15. Patient Law- Focuses on the rights and responsibilities of patients in healthcare settings.
- Includes laws on informed consent, access to medical records, and the right to quality care.
- Protects patients from discrimination and ensures their autonomy in medical decisions.
16. Health Insurance Law- Regulates the provision and management of health insurance schemes, including public, private, and employer-provided insurance.
- Defines coverage, reimbursement policies, and access to essential healthcare services.
- Example: Affordable Care Act (USA) or German Social Code (SGB V).
17. Law of Professional Conduct for the Medical Profession- Governs the ethical and professional behavior of healthcare providers.
- Sets standards for qualifications, licensing, and disciplinary measures.
- Includes rules on doctor-patient confidentiality, conflict of interest, and continuing education requirements.
SummaryHealth law integrates diverse legal fields to ensure the safe, ethical, and efficient operation of healthcare systems. From regulating pharmaceuticals and medical devices to protecting patient rights and overseeing health professionals, these legal frameworks are essential for public health and innovation. |