Healthcare & Pharmaceuticals

Comprehensive service under one roof

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.

Industry issues

  • 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

Industry-specific services

  • 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.

Publications

Pharma 2020: Taxing times ahead

The fifth report in the series, it focusses on the opportunities and challenges from a tax perspective. It discusses how the political, economic, scientific and social trends currently shaping the commercial environment, together with the development of new, more collaborative business models, will exert increasing pressure on effective tax rates within the industry. It also shows how companies can adapt their strategies to support the provision of outcomes-based healthcare and remain competitive.

Pharma and Life Sciences Tax News - Vol 7, No. 10: IRS Identifies Factors for Determining Deductibility of Settlement Payments

Few tax issues are more fact-intensive than determining the tax consequences to the payor of payments made under a settlement agreement with a governmental body when the agreement is silent as to the nature of the payments. In a legal advice memorandum, the IRS Office of Chief Counsel shed some light on the factors it thinks are important in such a situation. Whenever possible, of course, the taxpayer should seek to negotiate settlement agreement terms that would support the desired tax treatment.

Pharma 2020: Virtual R&D

Pharma 2020: Virtual R&D explores how pharma companies could dramatically improve the R&D productivity. It contents that by 2020 the R&D process may be shortened by two-thirds, success rates may dramatically increase, and clinical trial costs could be cut substantially. New computer based technologies will create a greater understanding of the biology of disease and the evolution of ‘Virtual man’ to enable researchers to predict the effects of new drug candidates before they enter human beings.


 

Contacts

Bořivoj Líbal
Managing partner, PwC Legal
Tel: +420 251 152 929
Email

Ondřej Dostál
Of Counsel, specialist in healthcare law, PwC Legal
Tel: +420 251 152 907
Email

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