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OGYEI CONDEMNS MEDICAL DEVICE DISTRIBUTORS FOR REGULARLY COMMITTED VIOLATIONS
27. 04. 2022. KNP LAW

OGYEI CONDEMNS MEDICAL DEVICE DISTRIBUTORS FOR REGULARLY COMMITTED VIOLATIONS

On April 13, 2022, the National Institute of Pharmacy and Nutrition (hereinafter: “OGYEI” or “Authority”) posted on its website a decision in which it condemned a medical device distributor (hereinafter: “Distributor”) for their marketing activities and imposed a substantial fine.

OGYEI assessed that the conduct of the Distributor was unlawful in three areas.

1. Inaccurate Provision of Information in Brochures Addressed to Healthcare Professionals

OGYEI considered the following infringements for the assessment of the inaccurate marketing material, in each instance considering (i) the scope of the interest of the right holders, (ii) the seriousness of the infringement, and (iii) the interest of patient care:

  1. The date on which the written material was completed or last updated was missing or inaccurate;
  2. Price information was missing for products with health insurance subsidies;
  3. The exact source and / or date of publications of citation, chart and other illustrative materials from scientific sources were not referenced;
  4. The written material was not accurate, objective, verifiable or up-to-date, and citations, charts and other illustrative materials from other scientific sources were not consistently presented;
  5. The concerns listed in Point 4 were serious enough to significantly mislead the person prescribing and distributing the medical devices regarding their expected effects/results.

The Authority assessed that three brochures contained moderately infringing information. In all three cases, the claims on the leaflets were incomplete and/or inaccurate and could mislead healthcare professionals regarding the effects of the products or were inconsistent with the instructions of use.

2. Provision of Catering of Internally Organized Event Exceeded the Spending Limits Stipulated in the Drug Economy Act

After the audit and based on available receipts and invoices, OGYEI concluded that the Distributor disregarded and exceeded the legally permitted per capita catering limits at events organized for healthcare professionals as it is set forth in the Drug Economy Act.

3. Failure to Provide Timely Notification on the Organization of Professional-Scientific Events

The Authority also found that the Distributor failed to notify the Authority of four professional-scientific events it organized during the audited period.

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The practice of OGYEI shows that the infringements listed above are frequently committed by operators acting in the healthcare sector. In most cases, this results in the assessment of significant fines, which was no different in this case, where the OGYEI assessed HUF 12,000,000 (apprx. EUR 33,300) in fines.

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