Pharma & Healthcare

Audit services and accounting advisory services

• Audit services in compliance with statutory requirements or group instructions;
• Accounting due diligence;
• Performing other assurance procedures;
• Performing agreed-upon procedures;
• Advice regarding the Sarbanes-Oxley regulation;
• Advice regarding Hungarian accounting regulations / IFRS / US GAAP (on a regular or as needed basis, either verbally or in writing (preparing advisory letters));
• Advice on handling special accounting cases, e.g. accounting advisory services in connection with transformations;
• Reviewing and rationalising accounting processes;
• Treasury risk management and accounting advisory services;
• Providing trainings and courses on accounting (in which certified public accountant, auditor and ACCA credit points may be earned) at PwC Academy.

Legal services

• Advice related to pharmaceutical promotional activities, compliance review for marketing schemes, representation in supervisory reviews (agreements with health care specialists, transfer of assets, donations and product samples, gifts and entertainment, funding attendance at conferences, advertising activities to patients, online promotion).
• Measures against unlawful or potentially unlawful activities of competitors: advice and representation in procedures concerning competition law matters, trade mark infringements or unlawful counterfeits.
• Legal advice on therapy loyalty and adherence programmes, preparing and reviewing related contracts (with special regard to the limitations of clinical studies, data management, promotion and liability).
• Preparing and reviewing clinical study and observation agreements, related consultancy services, representing pharmaceutical companies in study-related procedures.
• Legal advice on the terms and conditions of employing medical representatives, liability issues, preparing and reviewing contracts.
• Providing training and advice on “dawn raids” that may be carried out in proceedings instituted by the National Institute for Quality and Organizational Development in Healthcare and Medicines, National Institute of Pharmacy (“GYEMSZI-OGYI”) and the Hungarian Competition Authority;
• Advice on the distribution, authority inspections and advertising of medical devices, therapeutic appliances and dietary supplements.
• Legal services related to authorisation

Tax advisory services

• Tax planning of various benefits (product samples, gifts, services to doctors/hospitals) in accordance with the applicable regulations;
• Advice on the tax treatment of pharmacy sales promotions and other discounts
• Advice on the tariff classification of medicines, medicinal products and materials, negotiations with authorities;
• Issues related to the environmental product fee on packaging and waste management;
• Advice on tax incentives and state aid related to R&D activities carried out in Hungary;
• Advice during tax audits carried out by the Tax Authority;
• comprehensive transfer pricing planning and compliance services to ensure that the internal policies of our clients comply with the Hungarian regulations introduced in 2013;
• Developing cafeteria systems, employee and management compensation schemes;
• Checking and preparing tax returns (pharma taxes, corporate income tax, VAT);
• Preparing personal income tax returns for Hungarian employees on secondment abroad and foreign nationals working in Hungary

Advisory services

• Reviewing operational efficiency and related advice;
• Reviewing financial efficiency and related advice;
• Corporate risk management advisory services;
• Reviewing IT efficiency and related advice;
• Reviewing IT security and related advice;
• Internal audit services;
• Business valuation and M&A services;
• Comprehensive advisory services related to state aid;
• Comprehensive financial due diligence services.