We have been focusing on the business and legal regulation of the pharmaceutical and health sectors (Life Sciences) for a long time now. Our specialised team comprising more than 10 lawyers is equipped with unique know-how, practical experience and detailed knowledge of market standards.
Our clients are leading global manufacturers of pharmaceuticals, medical devices, cosmetic products and food supplements, distributors, hospitals, clinics, private physicians, research institutes, laboratories, pharmacies, biotechnological companies, and other entities doing business in these fields or exercising state authority.
We advise our clients in individual pharmaceutical and health sector regulation areas and in other specialised areas closely related to them, particularly the area of personal data protection, public procurement, M&A, competition and IP/IT. When advising in these particular specialised areas, we draw on our extensive practical experience. Our services take into account all specifics of the pharmaceutical and health sectors.
We specifically focus on the following areas:
PHARMACEUTICAL AND MEDICAL PRODUCT SECTOR
- Pharmaceuticals, medical devices, cosmetic prducts, food supplements
- Market access agenda
– Reimbursements from the public health insurance; price regulation
– Agreements with health insurance companies (risk sharing)
– Assessment and set-up of various distribution models (standard distribution, direct-to-hospital model, commission model, consignment warehouses)
- Compliance agenda – interaction with health professionals and health service providers
– Providing grants, sponsoring, cooperation with experts, patient organisations and professional organisations, educational events for professionals
– Drafting contractual documentation
– Assessments in terms of legal regulations and codes of ethics (AIFP, EFPIA, MedTech, etc.)
– Transparency & disclosure
- Business agreements
– Distribution and logistics agreements
– Bonus arrangements and related advisory
– Market research agreements
– Data purchase agreements
– Register of contracts, trade secrets and related advisory
– Electronic signatures
- Regulatory matters
– Regulation of production, import, distribution, provision and sale
– Registration, notification and reporting with competent administrative authorities
– Digitisation (mail order, home delivery, etc.)
– Product labelling requirements
– Withdrawal of products from the market
- Advertising
– Assessment of promotional materials, incl. TV spots
– Educational campaigns
- Clinical trials and medical affairs agenda
- Clinical trial agreements
– Patient’s informed consent
– Ensuring treatment after termination of a clinical trial (post-trial access)
– Specific treatment programmes (compassionate use)
– Patient support programmes
- Manufacturers’ liability and claims for the compensation of damage caused by medicine or other products
- Representation in administrative and judicial proceedings (particularly before the State Institute for Drug Control, the Ministry of Health)
- Drafting bills (e.g., in the area of medicines price policy)
- Relationships with the non-profit sector
HEALTH SECTOR
- Establishment and transformation of health service providers
- Health service provision regulation – hospitals and clinics
- Reimbursement from the public health insurance
- Negotiating agreements with health insurers
- Compliance programmes
- Professional accountability and insurance
- Rights and duties of patients, physicians and educational institutions
- Telemedicine
- Keeping health documentation, GDPR compliance
ADDICTIVE SUBSTANCES
- Permission to handle addictive substances
- Advice in the fields of production, distribution and sale of cannabis and cannabis products
- Regulatory obligations related to the handling of addictive substances
- Audits and comprehensive set-up of registers and handling of addictive substances at health service providers
- Using cannabinoids and other substances in foodstuffs and other products
We also address all of the above topics in our professional publications, lectures and on our blog.
