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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
New dynamics of the pharmaceutical oncology market
Amid projected growth, the pharmaceutical oncology market is undergoing significant change.
Global top health industry issues: Defining the healthcare of the future
More connected and consumer-oriented than ever before, the world’s health systems are challenged to build resiliency in times of change.
US tax reform: Implications for pharma and life sciences
US Tax Reform will impact both US and non-US Pharma companies. This PwC presentation examines some of the main provisions.
Riding the wave of data: Transforming the future of biopharma R&D
Overcoming challenges and unlocking value from data to shape the future of R&D using data and analytics.
Predicting patient health using blockhain and wearable technology
Wearable technology has taken the world by storm over the past number of years. Members of the public have been liberated, finally able to take control over their health, wellbeing and lifestyle. More so now than ever, lifestyle has become a major factor in the success of many sectors
Under lock and key. How Blockchain secures controlled drugs
Controlled drugs are heavily regulated across the healthcare sector. They are drugs controlled under the Misuse of Drugs regulations 2001, that are open to abuse, misuse, illegal activity or can cause harm, i.e. morphine. Why is regulation important?
IFRS - Issues and solutions for the pharmaceuticals and life sciences industry - 2017 edition
PwC’s insight on how to apply IFRS in common pharmaceuticals and life sciences transactions, including guidance on the new revenue standard, IFRS 15.
US GAAP - Issues and solutions for the pharmaceutical and life sciences industries 2017 edition
The solutions presented in this publication are meant to provide a framework for determining the appropriate accounting answer for general situations.
2017 Pharmaceuticals and Life Sciences Trends
The New Health Economy is inspiring fresh ways to manage data, place a value on medical treatments, and deal with empowered patients.
US GAAP – Issues and solutions for the medical technology industry 2016 edition
The solutions presented in this publication are meant to provide a framework for determining the appropriate accounting answer for general situations.
Introducing the Pharma 2020 series
PwC's Pharma 2020 series reports look into the future of the Pharmaceuticals and Life Sciences’ value chain, and they include an analysis of the strategies needed to compete successfully in the future.
Pharma 2020: Supplying the future -- Which path will you take?
PwC's report discusses how pharma companies must develop different supply chain models for different product types and patient segments, use their supply chains for market differentiation and see the role information plays to drive the flow of products and services.
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 2020: Challenging business models - Which path will you take?
Pharma 2020: Challenging business models - Which path will you take?
Pharma 2020: Marketing the future - Which path will you take?
This paper discusses how the industry is no longer being rewarded for incremental innovation, me-too products and selling the most pills. Companies need to add value to patients, and offer a package of products and health services that the market is willing to pay a premium for.
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.
Pharma 2020: The vision: Which path will you take?
But Pharma 2020: The Vision - Which Path Will You Take? indicates that the current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments demanded by global markets. In order to make the most of these future growth opportunities, the industry must fundamentally change the way it operates.
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