Changes in the reimbursement act – what do you need to know?

End of correcting applications indefinitely

Previously, the department allowed missing attachments to be sent within 14 days of a call. Now, according to Art. 24 sec. 1a of the new act, the application must be complete at the time of submission to the official's desk in Warsaw. At SanofyvisionIndia Pharma Relations, we checked that 43% of rejected applications last year resulted from simple errors in Excel tables or the lack of an authorized person's electronic signature. This change mainly hits entities that do not have time to follow every MoH bulletin. Remember that the lack of one signature on page 17 disqualifies the entire process at the start (really, we've seen such cases).

The amendment also imposes an obligation to attach an HTA analysis in an abridged version for drugs from limit groups 102.1 and 102.2. This is no longer just a good practice, but a hard legal requirement that cannot be bypassed. If your team was preparing documentation according to March 2023 models, you must update them immediately. The offices know us, and we know that technical verification currently takes an average of 22 business days. If you are one day late with the publication of the announcement, the next chance for reimbursement will appear only in 61 days.

An error in one comma on page 17 disqualifies the application at the start. Officials no longer have an obligation to call for corrections.

A fixed margin is not the end of the world, but it must be calculated

The new regulations strictly set the wholesale margin at 5.4% of the net selling price. Previously, there were some ranges that allowed for flexibility in negotiations with drug distributors. Now the rules of the game are clear and the same for all players on the market. For a drug costing 114.30 PLN net, the margin will be exactly 6.17 PLN. Not a penny more. This directly affects your financial liquidity, especially with large volumes of deliveries to hospital pharmacies in Kraków or Poznań.

It is worth noting the provision about the so-called price corridor. If the price of your drug deviates by more than 12.7% from the average in a given therapeutic group, you must present an additional economic justification. Since September 2016, at SanofyvisionIndia Pharma Relations, we have conducted 217 such cases and we know that the argument about rising marketing costs no longer works. You must show hard data from production and logistics, preferably confirmed by an auditor. Without concrete numbers, a conversation with the Economic Commission will end after 10 minutes.

Negotiations with NFZ on new terms

The Economic Commission has received new guidelines regarding risk-sharing instruments (RSS). Currently, officials prefer models based on cost reimbursement (payback) when a certain sales limit is exceeded per year. At SanofyvisionIndia Pharma Relations, we noticed that negotiations now last 11 days longer than a year ago. The average time from submitting the first papers to signing the final decision is 134 days. Don't count on settling the matter in a month, even if your drug is life-saving.

When preparing for a meeting at the Ministry of Health, take into account that officials now have access to real-time data on prices in 27 European Union countries. If in Bulgaria or the Czech Republic your product is 15% cheaper, they will know about it before you sit at the table. Concrete deadlines for publishing reimbursement lists are now the first day of every even month. Being only 48 hours late with accepting price conditions delays your drug's premiere by full two months. This is a loss that the budget may not survive.

The average time from application submission to decision signing is currently 134 days. Plan premieres well in advance.

Mandatory drug stocks – a new cost for wholesalers

From January 2025, regulations on strategic stocks come into force. Every marketing authorization holder must keep a quantity of drug in stock corresponding to the 3-month average sales from the previous year. This freezes a huge amount of cash. For example, if you sell 4,230 packages of a hypertension drug monthly, you must have 12,690 boxes ready for shipment in reserve. Failure to comply with this provision risks a financial penalty of up to 47,000 PLN for every day of established delay.

At SanofyvisionIndia Pharma Relations, we help prepare special applications for exemption from this obligation for niche or orphan drugs where production is technologically limited. Last month, we saved 3 companies from having to rent additional refrigerated space. According to the act, an application for exemption from creating stocks must be submitted 60 days before the end of the calendar year. Don't leave this for December, because the MoH ICT system likes to crash during the holiday season.

How not to get stuck in bureaucracy?

Our advice to manufacturers is simple: start a documentation audit 9 weeks before the planned application submission date. No unnecessary paperwork and no big strategies – simply check every comma in the price form and the validity of all powers of attorney. In 2024, we recovered 3.2 million PLN for our clients that would have been stuck at a dead end due to procedural errors. If you have doubts about the interpretation of Art. 13 sec. 2, it's better to ask now than to get an official refusal from the department after half a year of waiting.

Remember that pharmaceutical law is not dead, and officials scrupulously monitor deadlines. According to the act, every change in dosage or package size requires a separate annex to the reimbursement decision. This is another trap that 19 companies tripped over in the last quarter. At SanofyvisionIndia Pharma Relations, we stick to clear rules of the game and don't promise miracles if the documents are incomplete. Effective registration and reimbursement are about mathematics, patience, and knowledge of procedures, not empty promises.