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Innovative Pharmaceutical Initiative – iF!
19
innovative pharmaceutical companies
703
employees
56
% of the Croatian medicines market
32
MM Eur of transferred value in 2024
30
years of the Association’s activity
Frequently Asked Questions
Code on disclosure of transfers of value to healthcare professionals and healthcare organisations: Frequently Asked Questions
1. What is the EFPIA Code on the Disclosure of Data?
The EFPIA Code is a set of regulations that obliges all pharmaceutical manufacturers who are members of EFPIA (European Federation of Pharmaceutical Industries and Associations) to disclose data on payments and other transfers of value made to healthcare professionals and healthcare organizations.
Latest on 30th of 2016, The names of healthcare professionals and the titles of healthcare organizations will be disclosed, as well as the total amount of the transferred value, such as donations to healthcare organizations, fees for speaking engagements, reimbursement of travel expenses, or registration fees for participation in medical educational professional events.
2. Why is EFPIA introducing public disclosure of value transfer data?
The public has strong demands for transparency, especially in healthcare, and transparency in collaboration with the related industry enhances the dignity of the medical profession and affects patients’ trust in physicians. Given the close collaboration between the pharmaceutical industry and healthcare professionals, we believe that introducing transparency into this already well-regulated relationship actually strengthens future cooperation.
Pharmaceutical companies in Croatia have, for five years, in accordance with the Ethical Agreement they signed with HZZO, presented all investments in collaboration with healthcare professionals and organizations. The Ethical Agreement strictly regulates the rules and conditions under which individual value transfers can be made to healthcare professionals and organizations, and it also includes penalties for non-compliance with the defined investment principles.
By publishing data on pharmaceutical companies’ websites, value transfer information to healthcare professionals and organizations will become accessible to the general public. This achieves an even higher level of transparency in the pharmaceutical industry and responds to public interest in the nature of company collaboration with healthcare professionals and organizations.
3. In which countries will the Code be applied?
The EFPIA Code covers 33 countries within its membership, including EU, EEA, and EFTA member states, as well as countries that choose to voluntarily adhere to the Code. This geographically spans from Portugal to Russia, from Turkey to Iceland, and from Greece to Scandinavia.
4. Who is responsible for implementing the Code in Croatia?
In Croatia, the implementation of the Code is carried out by the association of innovative pharmaceutical manufacturers – the Innovative Pharmaceutical Initiative (iF!), which brings together 25 innovative pharmaceutical companies present in the Croatian market.
5. What types of value transfers will be disclosed?
Pharmaceutical companies will disclose data on value transfers to healthcare professionals, such as consulting, participation in advisory boards, fees for lectures, and sponsorships for attending meetings.
Specifically, data will be published on donations (to organizations), fees for services and consulting, activities related to giving lectures and leading meetings, participation in advisory boards, reimbursement of costs for attending events (including participation, travel, and accommodation expenses), and value transfers for research and development, which will be published in aggregate.
6. Will all value transfer data to healthcare professionals be disclosed individually?
No, some data will be published in aggregate. This includes data on value transfers for research and development. These are activities related to the planning and conduct of clinical trials or non-interventional studies that involve the collection of patient data on behalf of an individual or group of healthcare professionals specifically for study purposes.
The Code does not require the disclosure of medical use items, informational and educational materials intended for patients, or activities solely related to over-the-counter medicines.
7. Why are value transfer data for research and development not included in the disclosure?
The EFPIA Code focuses on value transfer data for the provision of services, such as giving lectures, participating in advisory boards, and attending educational meetings.
Research and development, particularly clinical trials, are subject to EU legislation, and their data will be published by the EMA (European Medicines Agency) in aggregate form.
8. When will the data be disclosed?
Value transfers to healthcare professionals are recorded throughout the year and publicly disclosed by June 30 of the following year. The first data were to be published by June 30, 2016, for all value transfers made in 2015, and will be available for three years.
9. How will the value transfer data be disclosed?
In most European countries, including Croatia, value transfer data will be published on pharmaceutical companies’ websites. Some countries will disclose the data on a central online platform because they are required to do so by law.
10. Why do some countries disclose value transfer data on a central platform, while others only do so on company websites?
The decision on how to disclose data is a national decision, influenced by various stakeholders and technical capabilities. In some cases, such as in Denmark, France, or Portugal, the disclosure of value transfer data on a central platform is mandated by law. However, in most countries, including Croatia, value transfer data is published on pharmaceutical companies’ websites.
11. What is the definition of a ‘healthcare professional’ according to the EFPIA Code?
A healthcare professional is a physician, dentist, pharmacist, or nurse, as well as any person who, in the course of their professional activities, can prescribe, purchase, procure, supply, or dispense medicines.
12. What must healthcare professionals and healthcare organizations do regarding the new system for disclosing value transfer data?
Pharmaceutical companies will notify healthcare professionals and healthcare organizations about the data disclosure, and they will have the opportunity to review it. In order for personal data to be publicly disclosed, healthcare professionals must provide consent. This consent is usually included in a clause of the contract that the healthcare professional signs with the company.
13. If a healthcare professional lives in one country but is paid for providing services in another country, where will the value transfer data be disclosed?
The data is disclosed in the country where the healthcare professional or healthcare organization receiving the value transfer has their registered personal or professional residence, or registered office.
14. Have pharmaceutical companies informed healthcare professionals about the disclosure of value transfer data?
EFPIA-level activities began in 2012 with the adoption of the Principles for Good Governance in the Pharmaceutical Sector, which include a chapter on transparency, requiring all stakeholders to define a transparency policy for relationships in the healthcare sector.
The Croatian EFPIA member, Innovative Pharmaceutical Initiative (iF!), has carried out a range of activities, such as meetings and consultations with healthcare professionals and other stakeholders, as well as surveys of public and physician opinions. Since 2014, iF! members have been informing and educating healthcare professionals and organizations through regular contacts about the requirements set for both the industry and the medical profession regarding the Code on Disclosure of Transfers of Value.
1. Why does the pharmaceutical industry pay healthcare professionals for providing services?
Like any other professional, healthcare professionals should be paid for their services. Their knowledge and experience are invaluable for the development of new medicines. Diseases that were once deadly are now eradicated, thanks to the exchange of knowledge and experience between those involved in drug development and those who work directly with patients.
Just as it is important for patients that healthcare professionals have the latest knowledge about treatments and therapeutic procedures that can help them, it is equally important for the pharmaceutical industry to have educated healthcare professionals as research partners. The education of healthcare professionals should not end with graduation or specialization, but should continue throughout their entire professional career.
In Croatia, there is no systematic model for funding the education of physicians, and the Croatian Health Insurance Fund (HZZO) grants pharmaceutical companies, medical device and equipment manufacturers, and their representatives the right to organize various forms of medical education, including the possibility of covering/paying the costs for physicians to attend such educational activities and other professional meetings.
2. What services do healthcare professionals provide to the pharmaceutical industry?
As individuals in direct contact with patients, healthcare professionals can offer invaluable expert insights into patient reactions and disease treatment. The pharmaceutical industry bases and directs its efforts precisely on such important knowledge with the aim of improving patient care and treatment methods, which is ultimately crucial for better health outcomes.
Healthcare professionals may also be paid for the contributions they make at medical and educational meetings.
Sharing information and insights about the best treatment methods results in better healthcare for patients. Some diseases have been completely eradicated in this way today, while for others the quality of life of patients has been significantly improved.
1. Will individual healthcare professionals have to give consent for the public disclosure of transfers of value?
In Croatia, personal consent from healthcare professionals is required for the public disclosure of transfers of value. This consent is usually included in a clause of the contract that the healthcare professional signs with the company.
To be valid, the consent must be clear, given voluntarily, unambiguous, and the result of an informed decision.
In Croatia, healthcare professionals have the right to refuse consent for the public disclosure of transfer of value data and to request a review or removal of this data at any time.
2. What happens when a healthcare professional refuses to give consent for the public disclosure of transfer of value data?
In that case, their data will be published as part of aggregate data, without revealing their identity, because in Croatia there is no legal obligation to disclose personal data.
Each pharmaceutical company will publish the percentage of healthcare professionals who did not give consent and the total amount of transfers of value made to their benefit.
3. What happens when a healthcare professional withdraws previously given consent for the public disclosure of transfer of value data?
In that case, the pharmaceutical company is obliged to remove the individual transfer of value data from the public domain. Those data will then be added to the aggregate disclosure.
4. What happens when a healthcare professional disagrees with the transfer of value data published by a company?
The healthcare professional should then contact the company. If an error occurs or incorrect data are published, the company will revise the payment data after determining the correct information together with the healthcare professional.
5. Will pharmaceutical companies continue to work with healthcare professionals who do not give consent for the public disclosure of transfer of value data?
At this time, it is an individual decision of each company. Pharmaceutical companies have their own policies and criteria for collaborating with healthcare professionals within the framework of applicable laws.
6. If a healthcare professional can refuse to give consent for the public disclosure of transfer of value data, will disclosure truly increase transparency?
We believe that a more open and transparent relationship is in the best interest of patients, healthcare professionals, and the healthcare system. The pharmaceutical industry hopes that healthcare professionals will also recognize the benefits of greater transparency in their interactions and provide consent for the public disclosure of transfer of value data.
This represents a civilizational achievement and practice that is particularly desirable in countries whose public healthcare system faces significant challenges—financial, organizational, and functional—and whose judicial system is insufficiently effective.
7. Does the public disclosure of transfer of value data violate healthcare professionals’ right to privacy?
If public interest or national legislation overrides the need for consent, the data will be published. Until then, individual consent is the only basis for disclosure, and healthcare professionals have the right to withhold their consent for the public disclosure of transfer of value data or to withdraw it at any time.
However, we believe that a more open and transparent relationship is in the best interest of patients, healthcare professionals, and the healthcare system as a whole.
1. Will the disclosed amounts vary from country to country?
Yes, because each healthcare system in Europe is unique. The pharmaceutical industry and healthcare professionals operate under different legislation, and there are significant differences between countries in terms of resources, infrastructure, income, and expertise.
For example, the availability of funds for medical education varies from country to country.
2. Does the number of healthcare professionals who have given consent for the public disclosure of transfer of value data vary from one country to another?
Yes, the EFPIA Code applies to healthcare professionals in 33 member countries, each with different cultural, socio-economic, healthcare, and regulatory circumstances. As a result, the number of healthcare professionals who have given consent for the public disclosure of transfer of value data varies from country to country. The pharmaceutical industry aims to encourage doctors to give consent for public disclosure of transfer of value data in as many cases as possible.
3. Who can healthcare professionals contact for additional information?
Healthcare professionals should first contact the pharmaceutical companies they collaborate with for any information or uncertainties.
For any questions, iF! is also available and healthcare professionals may reach out by sending an inquiry to kodeks@ifi.hr.
For more information, visit https://efpia.eu/publications/downloads/ or https://ifi.hr/kodeks.
What does the innovative pharmaceutical industry do?
Innovative pharmaceutical companies are engaged in the production of innovative (original) medicines. These are medicines with a new active substance developed based on the company’s own preclinical and clinical trials, for which the pharmaceutical company has prepared complete documentation proving their efficacy, quality, and safety. Innovative medicines are protected by a patent.
Are drug prices the largest component of healthcare costs?
No. Drugs account for only one-fifth of total healthcare system costs in Europe. Population aging and the need for chronic disease prevention result in much higher costs.
What determines the price of a medicine?
The pharmaceutical industry collaborates with the government to set a medicine’s price that reflects its value to patients and the healthcare system. When determining the price, the government considers the medicine’s impact on patients compared to other treatments, its potential to reduce other healthcare costs, such as hospital stays, as well as the economic needs and the healthcare system.
Why are some medicines expensive?
Drug research is extremely costly. It can take more than a decade to discover an effective medicine, with significant financial investments not only in the discovery process but also in the education of scientists. Innovative medicines are protected by patents for an average of 20 years, after which the development of generic medicines becomes possible. Treatment of heart disease and depression is now cheaper thanks to generics, and in the future, the same will happen for conditions such as cancer, rheumatoid arthritis, and similar diseases.