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Parties involved in health & life sciences are subject to an abundance of regulations. Healthcare providers, pharmaceutical companies, software providers and suppliers of medical devices are subject to specific regulations concerning governance, competition, quality of (digital) care and privacy. Specialised aid is required for all the aforementioned.
PwC’s Legal - Health & Life Sciences sector team knows the industry and applicable rules and regulations in detail. We offer in-depth expertise in the field of healthcare law, combined with related areas of expertise that are relevant to the sector. Examples of related areas of law are corporate law, competition law, mergers and acquisitions, contracting, venture capital, privacy and employment law. Our sector team renders services unique to the Netherlands. We are able to combine years of experience in healthcare and complement this expertise with other disciplines such as consulting, tax and insurance through a broad international network.
Rendering advice on care-specific governance requirements and profit distribution, including the Governance Code on Health Care and the Dutch laws on the control and supervision of health facilities and healthcare providers.
Elaborating governance structures including the drafting of related documentation (e.g., articles of association and internal regulations).
Designing and establishing partnerships (including public-private partnerships), including mergers, acquisitions, restructurings and drafting partnership agreements.
Rendering advice on specific healthcare-related competition rules and regulations with regard to Dutch competition law, laws on the market regulation of healthcare, including drafting and assisting with merger notifications at the National Health Authority and the Consumer and Markets Authority.
Rendering advice on compliance requirements arising from the Medicines Act, the Medical Devices Act/Regulation, the decree on in-vitro diagnostics/in vitro diagnostic regulation and related legislation including GMP/GDP compliance with regulations on advertising, marketing and benefits.
Supervising the market access of medicines, medical devices and in-vitro diagnostics, including permits and certifications.
Rendering advice to start-ups and scale-ups through every stage of their development, from the initial formation and venture capital investment to an eventual exit to third parties.
Rendering advice on the formation of venture capital funds on their formation and representing funds during negotiations at the various stages of their equity investments, loans and convertibles. Rendering advice and assisting in the planning and implementation of exit strategies.
Providing advice to institutions and companies in M&A transactions (including joint ventures): from performing the due diligence (procuring side, vendor side and vendor due diligence) in close cooperation with other PwC disciplines such as Finance, Tax, People and Pensions to drafting and negotiating transaction documentation.
Advising on the strategic use of brands, designs, copyright, patents, trade secrets and know-how.
Advising on and drafting licensing agreements, non-disclosure agreements and R&D cooperation agreements.
Advising on (chain) exchange and protection of medical data (Medical Treatment Agreement Act and General Data Protection Regulation).
Implementing and carrying out privacy impact assessments, drafting compliance roadmaps, elaborating required privacy documentation, in close cooperation with the PwC Cybersecurity team.
Establishing a new healthcare organisation with an innovative form of governance.
Supervising various mergers between healthcare providers, including legal project management. Drawing up a cooperation or partnership agreement between various regional care parties concerning the intraparty use of personnel.
Advising on and implementing restructuring, also assessing the legal position of staff.
Advising on the redesign of the hospital organisation and its relationship to medical specialists, including advising on the participation of medical specialists in relation to the ban on profits.
Advising a university hospital on the proper use and technical security of medical data.
Advising a start-up on obtaining a CE mark under the Medical Device Regulation and related legislation in the field of medical devices.
Advising a biotech start-up in a first (Series A) funding round.
Performing the legal, finance and tax due diligence on a life sciences scale-up company, drafting and negotiating the acquisition contract.
Advising on and drafting a licensing agreement for medical software.