Pharmaceuticals & Life Sciences

Transparent cooperation between (bio)pharmaceutical/medtech companies and healthcare professionals (HCPs) or organisations (HCOs) became the crucial element of reputation and credibility of pharmaceutical companies worldwide, regardless of the increasing legislation or regulatory demands. The territorial scope as well as the complexity of the global legislation framework is increasing and thus introducing new risks, such as failure to meet time limits, endangering the company reputation, and fines associated with reporting of inaccurate information. PwC has designed services which involve the implementation and monitoring of transparent cooperation and which can help your company to manage the global transparency programme on disclosure of payments efficiently.

Two solutions are available to help you simplify and process 100% requirements on transparent reporting of payments:

Remedium

• Flexible tool supporting data collection and modification used for report preparation within an outsourced model.

Transparency Hub

• Cloud solution of the new generation designed both for outsourcing and for use by clients.
   

Transparent reporting allows you take your business to another level due to several reasons:

• Decreased risk of failure to comply with regulations and reputational damage: You will be able to meet all the mandatory time limits and requirements within compliance and transparent reporting. You will improve your reputation and your competitive ability as a trustworthy company.

• Efficiency improvement: You will have a constant overview of the current status, trends, changes and requirements of European authorities. Higher quality and data coherence.

• Application of latest analytical options and new opportunities to understand data: Coverage of cross-border activities will facilitate the entrance to new markets. Improved quality and recommendation in the area of data processing and marketing, business or financial analyses.

Various models of cooperation are available to allow companies to reach their transparent reporting goals:

• Transparent reporting as a service
  • Partial outsourcing
  • Complete outsourcing
  • Ad hoc support

• Project management
  

• Process enhancement

• Employee training

• SOP creation

• Risk and deficiency analysis

• Thorough process review

• Moreover, data acquired for reporting can be further used and analysed beyond the framework of compliance.
  More about our Data & Automation services can be found here.

IDMP

Identification of medicinal products (IDMP) are the new ISO standards focused on the unique identification of medicinal products, presenting a great challenge for the (bio)pharmaceutical industry. The European Medicines Agency (EMA) is the first regulator to implement the new binding ISO standards. According to the current time schedule, the IDMP are expected to become valid as of 2022. The exact date will be disclosed later during this year. The crucial fact is that the IDMP standards will need to be adhered to by all pharmaceutical companies launching medicinal products on the EU market. In the future, regulators of other parts of the world (such as the USA and Japan) are likely to implement the IDMP, too. Although the time limits for IDMP implementation have been postponed several times, they are inevitably approaching their final stage. The EMA is currently completing the detailed EU IDMP Implementation Guide (EU IG v2) which will be published in the second half of the year 2020. It is thus the right time for mobilisation especially for companies which have not been dealing with the standardisation according to IDMP so far or which have only completed the first stages.

As for IDMP preparation, we help our clients with the following:

• IDMP understanding and identification of impacts and benefits for the client organisation

• Short-term/long-term strategy set-up

• Mapping out all systems and source data

• Implementation of solutions corresponding to the client’s business needs

• Ensuring continuous compliance

Thanks to our master data experience, we believe that we can make your IDMP implementation easier. We have helped our clients with the implementation of transparent disclosure of payments (EFPIA HCP/HCO), and not only did our solution allow compliance with regulatory requirements, but it also led to reduction of programme and operational issues associated with the key master data. Even greater potential can be found in the building blocks of IDMP implementation.

Registration activities

In practice, we see that the work in the department of Regulatory/Registration includes various manual tasks which have negative impact on the efficiency of the performed tasks as well as on the satisfaction of employees who perform them. We aim to identify the areas suitable for partial or full automation and to allow the specialists in the field to concentrate on more demanding tasks requiring their expertise.

We understand the demands of ensuring the compliance with all the regulatory requirements, and that is why we constantly strive to find new solutions in order to simplify the work and increase efficiency. This includes, for instance, the management of registration fees, which have major impact on planning and financial lifespan of each product.

We can help you with the following:

• Consolidation of access from various regulatory sources worldwide to ensure their up-to-datedness and to reduce the manual labour

• Monitoring and maintenance of the entire regulatory/registration budget to allow you to respond to changes in a flexible way

• Quick and easy comparison of various options with the aim to find the most appropriate registration strategy

Requirements for higher quality of registration documentation keep increasing. Companies should thus find a responsible way to deal with deficiencies/observations arising from the communication with regulatory authorities with the aim to minimise the prolongation of the registration procedures, ultimately preventing the registration withdrawal.

We can help you with the following:

• Consolidation of all the deficiencies or observations communicated by regulatory authorities to the database and the use of acquired experience for the purposes of higher efficiency

• Interconnection of records from the database with the analytical tool; data assessment and visualisation and dashboard preparation with an overview of crucial points

• Do you need to address any other issues and requirements in the area of Regulatory or Compliance? Feel free to get in touch with our contact persons or use the contact form.

Strategy & Vision

We help our clients to prepare strategic forecasts of their regulatory and compliance activities. Defining the difference between the output and the required future state is the first step to successful enhancement of the programme. PwC performs thorough evaluation of the existing processes and creates a plan to successful accomplishment of the client’s goals.

Process optimisation & Support of operational activities

PwC supports the optimisation of client processes and operational activities which will allow you to reach your business goals. The advantage of cooperation with us is that we have global, specialised tools to provide services and understand the local legislation and requirements in the relevant language. Specialised PwC teams and centres of service provision are equipped in such a way that will support the specific needs of your programme.

Data analysis

An integral part of our services is a solution using efficient analytical tools for data optimisation and relevance of the subsequent outputs, which will allow faster and more efficient decision-making. More information about the Data & Automation can be found here.

Pharmaceutical companies operate in an environment full of strict and complex regulations. These regulations are not always well-linked to other regulations, such as tax laws. The solution of issues that need to be addressed by pharmaceutical businesses operating on the Czech market requires specific skills and experience.

PwC specialists in the pharmaceutical industry belong among the top professionals in the country and they will be happy to advise you on any tax, legal or regulatory issues in this field.

Current issues

• Price regulation of pharmaceuticals and medical devices

• Tax rules for transfer pricing which are not compatible with the price regulation issues

• Critical judgement of the Supreme Administrative Court of the Czech Republic in response to the VAT assessed additionally with respect to provided marketing services

• VAT refund based on payments made to insurance companies under so called risk-sharing agreements   

• Complicated rules for the supplies to healthcare facilities 

• Intellectual property protection

• Licensing provisions

• R&D investment demands

Services specific for the industry

• Tax consulting in transfer pricing

• Analysis of the business model and associated impacts of the judicial decisions of the Supreme Administrative Court of the Czech Republic

• Tax and legal consulting in the area of so-called risk-sharing contracts   

• Tax consulting with respect to marketing authorisation of pharmaceuticals and clinical trials

• Consulting in the area of provision of samples, discounts and bonuses

• Tax and legal consulting in the area of licence agreements