In late May, the Hungarian National Institute of Health and Pharmaceuticals (OGYÉI) published resolutions on patient support programmes.
In Hungary, it is not obligatory to provide pre-notification of patient support programmes to the OGYÉI, but the authority can monitor compliance through official inspections. As a result, the OGYÉI has designed the resolutions as a guidance for the lawful and ethical operation of these programmes.
The resolutions cover the most important aspects of patient support to be monitored, including the purpose, participants, materials and tools of the pertinent programmes.
Under the resolutions, the purpose of a programme should be to help patients understand their illness and its consequences, support them in the proper use of medication and educate them on necessary lifestyle changes. The programme, however, cannot replace the risk-mitigation tools required for marketing authorisation and cannot be linked to sales promotion.
In addition, patients can only participate in programmes voluntary. Prior to giving a written consent, the patient should be fully informed about the consequences of his participation and will be informed that he can leave the programme at any time.
According to the resolutions, the activities of healthcare professionals engaged in a programme must be clearly defined in advance and should not affect their mandatory duties or otherwise hinder their work. Also, a programme should not influence a physician's choice of medicinal products. Moreover, the work performed and remuneration paid should always be proportionate.
The resolutions also emphasise that information materials provided for a programme must be compliant with the applicable professional and advertising requirements. The materials should focus on the patient and a particular disease rather than on a certain medicinal products. If the inclusion of the brand name of a medicinal product is justified, the programme material can only contain statements included in the product's approved accompanying documents.
A tool or device can only be given to a patient if it is directly related to the purpose of a programme and its necessity can be justified professionally. The provision of such tools or devices should not be linked to any brand-name medicines and should not in any way be an incentive for purchasing a medicine.
Any programme material concerning prescription-only medicines should not be of an advertising nature in tone or form. Materials and tools should be designed primarily for participants. Materials that also contain general lifestyle health information can be made publicly available, but must not contain references to any medicinal product.
These resolutions were finalised after a public consultation period. The authority hopes that the resolutions will help in answering several practical questions, but the market appears to be of the view that several crucial areas remain unaddressed by the authority.
For more information on these resolutions and the healthcare industry in Hungary, feel free to contact one of the following local CMS experts: