Pharma & Healthcare

PwC and its correspondent law firm, Réti, Antall & Partners, have provided services to pharmaceutical companies for many years.

Our services cover the entire spectrum of issues related to corporate management. We operate with specialist teams that focus on services within their area of expertise.

Our specialists have a deep knowledge of the specific features of the pharmaceutical industry.

How PwC can help you

Audit and assurance:

• Audit services;
• Advice on Sarbanes-Oxley issues;
• Advice on IFRS / US-GAAP issues;
• Treatment of accounting issues associated with mergers and corporate transformations;
• Accounting due diligence.

• Tax planning of various inducements (product samples, gifts and services to physicians/hospitals) in compliance with the relevant legislation;
• Advice on the VAT treatment of clinical trials, representation before authorities;
• Advice on the classification of drugs, medicinal products and substances under the appropriate Customs Tariff heading, negotiation with authorities;
• Advice on issues related to waste recycling and the environmental product charge on packaging materials;
• Advice on tax relief and state aid available in connection with Hungarian R&D activities;
• Advice during Tax Authority audits;
• Comprehensive transfer price planning and compliance services to ensure that the client's internal policies comply with the Hungarian regulations that were introduced in 2003;
• Developing cafeteria systems and employee stock option plans.

• Review of and advice on operational efficiencies;
• Review of and advice on financial efficiencies;
• High-level risk management advice;
• Review of and advice on IT efficiencies;
• Review of and advice on IT security;
• Internal audit services;
• Business and asset valuation, and services related to mergers and acquisitions;
• Comprehensive advice on applications for state aid;
• Comprehensive financial and legal due diligence reviews.

Legal services:

• Legal and ethics review of proposed marketing and promotion strategies;
• Planning of marketing and promotion arrangements and related advisory services, with special emphasis on charitable donations;
• Advice in price negotiations concerning subsidised drugs;
• Obtaining licences and legal services in connection with patents;
• Planning and review of contractual structures and terms;
• Legal assistance in connection with competitor operations and responses to competitor actions;
• Legal assistance with the establishment or acquisition of Hungarian pharmaceutical companies;
• Review of compliance with EU legislation.

Pharmaceutical Newsletter - Issue 11
Changes to the rules on pharmaceutical promotional activities