Polish reimbursement law changes

Who is affected?

The changes have an impact on all players in the pharmaceutical market - manufacturers, wholesalers, pharmacies and patients.

What will change? 

Changes of particular importance to pharmaceutical companies:

• The amendment proposes to increase the official wholesale margin to 6% of a product selling price;
• The current law prohibits the reimbursement of medicines with an over-the-counter (OTC) availability category or with OTC counterparts. The amendment provides for the reimbursement of OTC medicines;
• The rules for parallel imports of medicines will change. The requirement will be removed where the imported medicine and the authorized medicine must both be reference or equivalent products. The amendment implements the CJEU ruling (C-387/18 Delfarma) whereby such a condition has the same effect as quantitative restrictions;
• The obligation on the addressees of reimbursement decisions regarding continuity of supply is calculated based on quarterly amounts. This provision seeks to maintain a three-month supply on the territory of Poland, yet the wording may be questionable.
• The idea of introducing patent linkage into the legislation, originally proposed by the Polish government, was eventually abandoned. The argument against this proposed amendment was that it would prevent filing a reimbursement application for a medicine that is price-competitive with a product whose patent is about to expire.

Most important amendments for pharmacies and patients:

• The deadline for publishing the lists of reimbursed medicines will be extended from 2 to 3 months. This will improve the operation of pharmacies and improve their stock management capabilities;
• The amendment changes the mechanism for determining the official retail margin, which is calculated by reference to the wholesale selling price. The increase in retail and wholesale margins seeks to ensure the availability of products by making them more profitable for retailers;

Why do you need to be interested in this? 

• The Reimbursement Bill is comprehensive and forces the businesses (including manufacturers, distributors, wholesalers and pharmacies) to adapt to the new requirements and rules;
• The changes bring greater consistency to the rules governing the movement of medicines within the EU. They introduce new opportunities for companies operating in the European market and dealing with parallel imports;
• New methods of official margin calculation will have an impact on the bottom line of wholesalers and retailers;
• All links in the supply chain will need to review their resource management policies;
• Manufacturers of OTC medicines will have to decide whether to participate in reimbursement. This may also have marketing implications as reimbursed medicines cannot be advertised.