Czechia is advocating for a clear definition of patient organisations in the EU pharmaceutical legislation to avoid doubts about their future role.
Currently, no definition of patient organisations exists in the EU pharmaceutical legislation – it is only provided by the European Medicines Agency (EMA).
“If we do not have a definition of a patient organisation, we could find ourselves in a situation where their independence or even their existence can be questioned,” Czech Deputy Health Minister Jakub Dvořáček told Euractiv.
Czechia has already drafted a proposed definition and submitted it to the European Commission.
“We are one of the few countries that has patients involved in all phases of the evaluation and approval process,” Dvořáček emphasised. Unlike in many EU countries, Czech patient organisations also take part in the decision-making phase.
Access to information and funding
Robert Hejzák, Chairman of the Czech National Association of Patient Organisations (NAPO), highlighted the growing role of patients in EU decision-making.
“EU legislation is increasingly considering patient involvement in decision-making, such as in EMA working committees and HTA (Health Technology Assessment) processes. It is therefore necessary to clearly define who has the legitimacy to represent patients,” Hejzák told Euractiv.
He added that a standard definition would be useful in many practical cases, particularly in regulating pharmaceutical advertising.
Hejzák explained how “The Czech Republic is now proposing changes that will better define the role of patient organisations in informing patients about therapeutic procedures without violating advertising regulations.”
Patient organisations play a key role in educating patients and guiding them from diagnosis through treatment. They also address the wider impact of illness on families.
The Czech proposal suggests that patient organisations should be classified separately from the general public to allow them to share and access credible medical information, such as how therapy affects both patients and their families.
Another key issue is funding.
“A unified European definition would be reflected in national legislation and allow governments to better define who should receive public financial support,” Hejzák said. He added that standardising the criteria for patient organisations across EU member states would also streamline their participation in European projects.
Expanding nurses’ role in EU legislation
Czechia is also seeking to clarify and expand the role of nurses in EU legislation, ensuring they are recognised and permitted to attend congresses and training events.
The European Commission’s draft directive on medicinal products already acknowledges nurses in certain contexts, referring not only to professionals qualified to “prescribe or supply” medicines but also to those who “administer” them. However, this is not consistently reflected throughout the legislation.
The Czech Republic is pushing for revisions to ensure nurses are properly included in all relevant sections, ideally using the wording “administer while providing health care” to reinforce their role within the healthcare system.
“We see nurses as full-fledged partners in healthcare delivery. They should not be sidelined, as they are the primary point of contact for patients. We need them to take on more healthcare tasks, and we are working to strengthen their position,” Dvořáček said.
Pharma industry backs the proposal
The Czech initiative has gained backing from the local innovative pharmaceutical industry.
“Yes, we unequivocally support this change,” confirmed David Kolář, Director of the Czech Association of Innovative Pharmaceutical Industry (AIFP).
He noted that current regulations not only govern traditional advertising but also impact the distribution of informational content about treatments. However, existing rules often create unnecessary barriers.
Kolář stressed that EU legislation must adapt to the digital age, where access to information is virtually unlimited. “Today, information is available online in practically unlimited volumes. Regulation only restricts those who are unable to find information themselves or are limited by their lack of English proficiency,” he observed.
“It is certainly not the goal to introduce an American-style regulatory system. Instead, we need to adopt a balanced approach that respects the need for regulation while also allowing for better information-sharing among all stakeholders in line with modern technological and communication possibilities,” Kolář added.
“At the EU level, the rules should be updated to make them more modern and reflective of the real needs of patients, professionals, and pharmaceutical manufacturers,” he remarked.
[Edited by Vasiliki Angouridi, Brian Maguire]
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Publish date : 2025-02-13 12:36:00
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