The pharmaceuticals industry in the Czech Republic is characterised by a high degree of foreign ownership. Pharmaceuticals companies operating in the Czech Republic are subject to an extremely strict and complex regulatory environment. The Czech State Institute for Drug Control (Státní ústav pro kontrolu léčiv) regulates every aspect of business, from pricing to packaging, from clinical trials to advertising.
PwC' pharmaceuticals experts are among the top specialists in the country and can provide sound advice with regards to the tax, legal, and regulatory issues affecting this industry.
- State regulation of pharmaceutical prices, resulting in limited margins
- Requirement for alternative financing of operations, which can result in stuctures, which are risky in terms of compliance with price regulation rules
- Advertising regulation regarding sponsoring, provision of gifts, pharmaceutical samples, etc.
- Regulation of the distribution of pharmaceuticals
- Intellectual property protection
- Return on R&D investment
- Proliferation of licensing and co-marketing agreements
- Tax advice related to the registration of pharmaceuticals and clinical trials
- Advice on the tax treatment of the provision of samples, gifts and discounts, including ‘in-kind' discounts
- Regulatory compliance services and risk management
- PayWell compensation survey for the pharmaceuticals sector
- Resolution, arbitration and litigation of breach of patent disputes, claims for consequential loss, breach of contract, warranty and construction disputes.
- Assistance with product recalls (resulting from legislation, health and safety issues, commercial consideration or licensing infringements) and handling of any related claims.
- Reviews of compliance with licences and other business arrangements and advice on appropriate procedures to manage royalty revenue payments and proceeds.