Slovakia: Proposed law obligates pharma-firms to declare gifts

The Slovakian Act on Drugs is under scrutiny of late with the Ministry of Healthcare proposing a new obligation for pharma-firms to publish a list of healthcare professionals (doctors and pharmacies) to whom they have given gifts or other benefits. If approved, the new rule would require drug producers and distributors to publish the names of healthcare professionals who receive gifts, money or other benefits. They must also include the purpose of the gift, such as education, reconstruction of premises, etc.

In its current form, the proposal requires pharma-firms to inform the National Centre of Healthcare Information of the gift recipients. The list will then be published on the Centre’s website, so that the patients/consumers may easily access the relevant data. Pharma-firms may face a fine of up to EUR 10,000 for non-fulfilment of the reporting obligation and EUR 30,000 for repeated breach.

The proposed amendment aims to improve transparency of relations between the pharmaceutical industry and healthcare professionals, as patients and consumers express wariness of them due to the general state of the national health system and its financing primarily from public sources.

In Slovakia, drug costs amount to around one billion EUR per year (mostly covered by health insurance companies) with healthcare professionals significantly influencing which drug(s) the patient purchases. Additionally, many patients/consumers perceive a conflict of interest because it is no secret that healthcare professionals cooperate with pharma-firms – for instance when launching a new product, pharma-firms often pay healthcare professionals for essays related to the drug or sponsor educational seminars.

Under existing law, both pharma-firms and healthcare professionals must inform the Ministry of any gifts they give or receive. However, practice has shown that the current system needs significant change – last year only 23 healthcare professionals announced their gifts while pharma-firms reported giving thousands of gifts to the healthcare professionals.

It is expected that the proposed change will trigger in depth discussions between all parties involved. If passed, the proposed change will become effective on 1 January 2016.

To learn more about the new reporting obligations, please contact: Stanislav Ďurica