Life Sciences & Healthcare

Generics Regulatory Advice

We are advising an international law firm acting for a mainline pharmaceutical company on the regulatory aspects of the entry of a generic product into the market and compliance and filing obligations towards the authorities.

GDPR Compliance in Healthcare Company

We are advising the local subsidiary of an international specialty healthcare company with respect to GDPR compliance, including drafting and reviewing of relevant documentation and assessing relationship with its vendors.

EU Patent Protection

We act for F. Hoffman-La Roche AG, a Swiss multinational healthcare company, in relation to patent enforcement actions against a biosimilar company.

BMS Advice

We advise Bristol-Myers Squibb, a global biopharmaceutical company, on competition and antitrust issues as well as on regulatory issues related to pharmaceutical legislation.

Advice on Promotion and Advertising of Pharmaceutical Products

We are advising a US pharmaceuticals company on the promotion and advertising of pharmaceutical products and international interactions with health care professionals.

Ongoing Advice to Biopharmaceutical Company

We are advising a global biopharmaceutical company on a wide range of matters arising in the course of their day to day business on an ongoing basis, including restructuring, termination of employment and related litigation, voluntary exits, litigation, implementation of policies, adoption of employment regulations, teleworking and data protection compliance.

Whistleblowing Hotline and Data Privacy

We are advising an international pharmaceuticals company on human resources issues including on the operation of a whistleblowing hotline as well as data privacy issues arising in the context of a number of pharmaceutical related projects and programmes.

Ongoing Advice in Pharmaceuticals Sector

We are advising the subsidiaries of international pharmaceutical companies on legislation and regulations on an ongoing basis.

Compliance Advice to Lundbeck Hellas

We are advising Lundbeck Hellas on pharmaceuticals legislation and regulations on an ongoing basis.

Clinical Trials and Pharmacovigilance Notifications

We are advising a global pharmaceutical company on data privacy aspects and requirements in connection with company’s clinical trials programs and pharmacovigilance systems, including obtaining licences and undertaking in-house data privacy compliance training.

Non-Interventional Studies in the Pharmaceuticals Sector

We are advising a US-based international pharmaceutical company on the regulatory regime applicable to the conduct of non-interventional studies in Greece and the procedures followed by its Greek subsidiary.

Advice on Clinical Trials

We advised an international law firm on the regulatory aspects and obligatory requirements of informed consent forms for clinical trials.

Medical Devices Advice

We advised an international law firm on the regulatory framework and requirements regarding In Vitro diagnostics medical devices.

Japan Tobacco Acquisition of SEKAP

We advised Japan Tobacco International in their acquisition of a Greek cigarette manufacturer (SEKAP SA) in the context of a major cross border transaction including tobacco companies in Greece and Russia.

Restrictions in the Use of Medicinal Products

We advised an international law firm on the conditions that apply to the use of off- label medicinal products in the Greek market.

Competition Advice on Cross-Border Merger

We advised a tobacco company on the competition law aspects of a major cross border acquisition transaction.

Tax and Customs Advice

We advised a tobacco company on the tax and customs issues arising from their purchase of shares in a Greek company and the tax structuring of their transaction.

Hellenic Healthcare Regulatory Advice

We advised Hellenic Healthcare Sàrl, a company majority controlled by funds managed or advised by CVC, on operating and medical equipment licenses, compliance with data protection regulations, cooperation and reimbursement agreements and other regulatory issues arising in the context of their entry into a binding agreement to acquire 97% of the share capital in IASO General SA from IASO SA.

Electronic Cigarette Regulatory Advice

We advised a tobacco company in relation to the regulatory framework for electronic cigarettes.

Claw Back Disputes

We advised a Greek and international pharmaceutical company in their appeals before the Council of State of decisions requiring them to pay claw backs to the Hellenic Organisation for the Provision of Healthcare Services.

eCigarettes Regulatory Advice

We advised a manufacturer of tobacco products and snuff on the regulatory framework governing eCigarettes in Greece.

Bayer Hellas AG Transfer of Business

We advised Bayer in relation to the corporate and commercial, tax and employment law aspects of the transfer by Bayer Hellas AG of its Bayer Material Science (BMS) business to the BMS Global Agency Hub (GAH), consisting of a carve-out of Bayer AG’s chemical business (Material Science) into a separate group, requiring a reorganisation of its business setup of the latter in a number of countries worldwide.

Advice on Regulatory Framework

We advised an international law firm acting for an international tobacco company on the regulatory framework applying to tobacco products and electronic cigarettes in Greece.

Glaxo Smith Kline Global Joint Venture with Novartis

We represented Glaxo Smith Kline in the implementation of the local part of their global joint venture with Novartis, with a matter value of $16bn for the Oncology business and $7.1bn for the Vaccine business, a transaction which had a significant effect on the entire pharmaceutical market and resulted in a major reorganization and integration of the sector.

Advice to Servier on Parallel Trade, Supply and Competition

We advised Servier on parallel trade issues and on an ad hoc basis on pharmaceutical legislation and regulations.

Supply of Medical Devices

We advised an international medical technology company on the legislation governing the supply of medical devices.

Transfer of Undertaking in Pharmaceuticals Sector

We advised a pharmaceuticals company with respect to benefit related questions arising in the context of a transfer of an undertaking and share sale as well as on collective dismissals regulations and terms of employment.

Data Privacy Advice in Health Industry

We advised a US health society in relation to data protection issues arising in the context of the provision of its certification services and the implementation of its accreditation program in Greece.

Sale of Stake in Tobacco Company

We advised a cooperative in selling its stake in a Greek cigarette manufacturer.

Pharmaceuticals Tender

We acted on behalf of Fresenius – Kabi Hellas and Smith & Nephew Hellas in their participation in public supply tenders for pharmaceuticals.

Supply of Medical Devices

We advised an international law firm on the legislation governing the supply of medical devices.

Promotional Materials for Medicinal Products

We advised a Spanish pharmaceutical company on the compliance of promotional material for medicinal products with the regulations in place.

Medicinal Product Marketing Authorisations

We represented a US pharmaceutical company on the mutual recognition procedures for obtaining a marketing authorisation of a medicinal product procedure before the National Organisation of Pharmaceuticals.

Requirements for Sale of Medical Devices

We advised an international law firm working on a German medical devices provider on the legal requirements for the sale of medical devices from a manufacturer directly to a consumer in Greece.

Comparative Advertising Advice

We advised a manufacturer of medical devices on the legislation governing comparative advertising.

Advice on Transfer of Personal Data

We advised an international health information technology provider in relation to issues and solutions arising from the transfer of personal data outside the EEA within the context of public procurement procedures.

Internal Investigation for Pharmaceutical Company

We advised an international pharmaceutical company on employee-related privacy issues and the monitoring of e-mails in the context of an internal investigation of its local subsidiary.

Update of Marketing Materials on Medical Devices

We advised an international law firm on the update of marketing materials in line with legislation concerning the supply of medical devices in the Greek market.

Provision of External Online Services

We advised an international pharmaceutical company on data protection issues arising from the provision of external online services.

Restructuring and Options Advice

We advised a pharmaceuticals company on the employment aspects of a proposed restructuring and option grants under portfolio share plan rules.

Sale of Pharmaceutical Products

We represented a global biopharmaceutical company in relation to the sale of pharmaceutical products, including the transfer of the market authorization, intellectual property rights, regulatory information and the physical transfer of the respective inventories.

Access to Personal Data

We advised an international pharmaceuticals company on the rights of former employees to access their personal data to support their claims against them.

Food and Beverages Labelling Advice

We advised the subsidiary of a European-based food producer on the implementation of legislation governing food and beverages labelling.

Healthcare Devices Data Protection Issues

We advised an international manufacturer of healthcare devices on data protection issues.