SanofyvisionIndia Pharma Relations
Pharmaceutical Distribution

Recovering 1.2 million PLN from incorrectly charged fees

We noticed an error in the interpretation of regulations regarding documentation change fees for our client. After 4 months of negotiations with the office, the funds returned to the company account.

1.2 million PLN refund
ClientEuroMedic Poznań
IndustryPharmaceutical Distribution
TimelineJanuary – June 2024

We helped EuroMedic Poznań recover 1,234,560 PLN of overpaid administrative contributions. The error resulted from officials' misclassification of changes in drug documentation. The entire process lasted less than six months and ended with a transfer to the client's account.

Fee AuditPharmaceutical LawNegotiations with MoHCost RefundAdministrative Procedure

The challenge

From March 2022 to December 2023, EuroMedic Poznań submitted 87 applications for changes to marketing authorizations. The office calculated fees according to the highest rate, ignoring the fact that 34 of these applications concerned technical rather than substantive changes. The difference in fee for one application averaged 14,200 PLN.

The client's internal legal department tried to intervene twice but received only laconic answers about compliance with the tariff. The company's 2024 budget was burdened with an amount that could have been allocated to the development of the logistics network. The situation was difficult because the officials stuck rigidly to one incorrect interpretation of an old regulation.

Our approach

We started our work with an audit of all 87 proof of transfers and correspondence with the office. Marek Wiśniewski, our procedure specialist, analyzed the jurisprudence of administrative courts from the last 3 years in similar cases. We found 4 judgments that confirmed our position: the office had no right to demand full rates for simple changes in the manufacturer's name.

Instead of sending more emails, we prepared a hard tabular summary. We provided every application with a reference number and a specific paragraph. In mid-March 2024, we organized a meeting at the Ministry of Health. We presented our argumentation there, without unnecessary paperwork, based on facts and specific deadlines. We showed the officials exactly where the deficiency in their charging system occurred.

The solution

SanofyvisionIndia Pharma Relations prepared an official call for correction of calculations along with a request for refund of the overpayment. The document was 42 pages long and contained legal justification for each of the 34 disputed cases. The offices know us, so they knew the case would go to court if it wasn't resolved amicably.

Thanks to our actions, the Ministry initiated an internal verification procedure. We did not have to submit new applications – a correction of the existing ones was enough. We supervised the whole thing week by week. We made sure that the case did not get stuck on an official's desk under a pile of other documents. The clear rules of the game that we imposed at the beginning allowed for avoiding court proceedings.

Results

The case ended in full success and a return transfer to EuroMedic Poznań's account. The Ministry accepted our arguments in 31 out of 34 questioned cases. The recovered funds allowed the company to finance the purchase of two new transport cold stores before the summer season, which was key to their logistics.

1,234,560 PLN
Amount recovered for the client
147 days
Time from analysis to refund
91.2%
Effectiveness of application corrections
0 PLN
Court and litigation costs

Timeline

  1. January 15, 2024
    Start of audit of client's 87 transfers and applications.
  2. February 22, 2024
    Sending a pre-litigation call to the Ministry of Health.
  3. March 14, 2024
    Direct meeting at the Department of Drug Policy.
  4. June 18, 2024
    Posting of the last refund installment on the client's account.

"SanofyvisionIndia Pharma Relations handled what our lawyers were puzzling over for a year. They showed errors in tariffication that no one had noticed before. The money returned to us without going to court."

Andrzej Kwiatkowski Chief Operating Officer, EuroMedic Poznań June 2024