Since 2015, PwC Risk and Regulatory team has been advising pharmaceutical companies regarding “transparency”, i.e. the transparent disclosure of earnings of healthcare professionals and organisations. Our PwC colleagues help pharmaceutical companies do their reporting in compliance with applicable legal regulations and, at the same time, make the reporting process more efficient. We talked to Ondřej Svoboda, senior manager of the team, about the current challenges which pharmaceutical companies are facing.
Ondřej, what do companies present in the reports which you help them with?
For the purposes of transparency, pharmaceutical companies cooperating with physicians, hospitals or other healthcare organisations are obliged to report the amounts paid out within this cooperation. The relationship between pharmaceutical companies and physicians is crucial for the development of medicine, from progress in clinical research to sharing best clinical practices. Finally, the patients are the ones who benefit from this cooperation the most. The disclosed data serves to ensure that the cooperation in the area of science and research is on a professional level and that there is no bribery of physicians going on, such as the conferences which used to take place in suspiciously lucrative locations. This is how the trust of the public is being built with respect to the professional dialogue between the pharmaceutical industry and the physicians.
A few years ago, it was quite common for pharmaceutical companies to present new scientific findings in locations resembling luxury tours rather than conferences. When did this change?
It all probably started in 2010 by the Sunshine Act in the USA which was established to prevent those practices. The emphasis on transparent reporting in the pharmaceutical industry has gradually started spreading all over the world. As I mentioned before, conferences in Hawaii are a matter of the past now – everything has moved to a professional level of cooperation.
It is precisely the spend transparency reporting that your team started with in 2015. What has changed since then?
Legislation regarding the spend transparency reporting has developed greatly. Since 2015, many countries have adopted it already and the number of regulations is increasing not only in the area of transparency. As for our team, we have obviously tried to adapt to this trend. We have focused on other services for our clients and also on interesting topics which companies need to deal with and which we can advise them on. For instance, we have developed a tool for the management of the entire recipient engagement process for the interaction with healthcare professionals and organisations. Pharmaceutical companies need to process a budget, plan everything in detail and approve it internally. Furthermore, they need to approach the physicians (or the hospital) and sign a contract, which is also associated with acquiring their consent on the processing of personal data and the manner of presenting the given entity in the transparent report – either individually or in a cumulative form. Upon the fulfilment of the contract, the payment must be processed, the interaction documented, and relevant data must be gained not only for reporting, but also for other strategic decision-making of the company. It’s a relatively complex process which needs to be covered.
What’s the situation in Europe like?
If a pharmaceutical company is a member of associations, such as the EFPIA (European Federation of Pharmaceutical Industries and Associations) or Medicines for Europe, it is obliged to issue spend transparency reports on a regular basis. Most European countries, especially in Western Europe, have their local legislation in force. The majority of Eastern European countries have no legislation in force yet, except for Slovakia or Romania, for instance.
What is the approach to transparency reporting in the Czech Republic?
Transparency legislation is not applicable in our country so far. Supervision is performed primarily by the State Institute for Drug Control, which doesn’t require transparent reporting at the moment. However, we have the AIFP association (Association of Innovative Pharmaceutical Industry) which promotes the ideas of the EFPIA, thus its members are bound to disclose the interactions with Czech physicians and healthcare organisations in compliance with its rules.
Another interesting topic you have mentioned is the IDMP, i.e. the Identification of Medicinal Products. That’s quite a new regulation.
That’s true. It will only come into force during the course of the year 2022. All pharmaceutical companies which will intend to launch their products on the EU market will need to use standardised terminology aimed to allow clear identification of the individual medicinal products. One of the accelerators of the implementation is to make the cooperation among competent bodies and pharmaceutical companies easier. I must mention that the IDMP is new, but it follows and extends the previous regulation concerning especially pharmacovigilance. However, the IDMP will cover the data concerning the entire life cycle of medicinal products and it’s not only a “one-off” event. Once the IDMP standards are implemented fully and successfully, the EU can gain continuous harmonisation of data concerning medicinal products, including the development, marketing authorisation, market launch as well as the post-marketing period. This will lead to reaching other benefits that come along with the IDMP, but let’s talk about those next time.
Will the mentioned IDMP legislation affect Czech pharmaceutical companies?
Certainly. It’s a regulation arising from the ISO standards which the EU, led by the European Medicines Agency, has decided to adopt. It has not been determined when the regulation will come into force. At the moment, countries are awaiting the receipt of final instructions from the European Medicines Agency. It is expected that adherence to the IDMP standards will be obligatory as of the year 2022 for all pharmaceutical companies which launch their products on the EU market.
How will the IDMP implementation take place?
The European Medicines Agency has determined to implement the regulation through a centralised database titled SPOR (Substance, Product, Organisation and Referential master data). Two of these modules (O – organisation, R - referential) are already accessible to companies within the database and that’s the easier part. The other two modules are more complex. They will be implemented gradually during the course of the years to come in individual iterations starting from 2022. Pharmaceutical companies will need to map their data sources and systems and unify the database with the new unified language. The change will affect nearly all key departments of a company, such as research, development, marketing, etc. Preparation of companies for the implementation of the IDMP will be taking months to years rather than just a few days or weeks. Obviously, it depends on various factors, such as the size of the company and portfolio, functioning across the individual departments, complexity of IT systems, etc. That’s why we recommend companies not to wait too long.
Isn’t it too demanding?
It’s important to understand that the “news” taking place in the pharmaceutical industry are all happening for a reason. For instance, in the end, the IDMP will make the efforts of the pharmaceutical companies easier and more efficient. From our point of view, this change will be highly appreciated by the Regulatory Affairs department. The demanding nature of the implementation depends greatly on how well the company assesses the project and which sources it will need for the implementation. Internal solutions may be the cheapest ones, but an external independent view is often priceless. At PwC, we have a network of experts available all over the world and we can engage these experts in the given project. In the Czech Republic, we have a team of developers & data experts, we also cooperate with a US team and we have our own applications and systems available, which we use and which we are able to implement at our client’s.
The pharmaceutical industry is a highly regulated area and it’s always worth having a powerful partner for support. And that’s actually the mission of our PwC team: to solve important problems of our clients.
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