New Legislative Framework for Confidential Pricing of Medicinal Products in Denmark

A new legislative framework allows reimbursement for certain primary care sector medicinal products based on a confidential price applied for on a voluntary basis by the pharmaceutical company and negotiated with Amgros I/S (“Amgros”), the procurement body for the Danish regions. The three-year pilot scheme, effective from July 2025 to June 2028, introduces new strategic opportunities and obligations for pharmaceutical companies operating in Denmark.

On 15 May 2025, the Danish Parliament adopted a proposal to amend the Danish Health Act, allowing the Danish Medicines Agency (DKMA) to consider confidentially negotiated prices when determining subsidy eligibility between 1 July 2025 and 30 June 2028. Under the pilot scheme, the pharmaceutical companies will, in practice, cover the difference between the official list price and the lower negotiated price, which will be transferred to the Danish regions.

The scheme applies to the following categories of medicinal products.

Companies must engage in negotiations with Amgros and ensure compliance with reporting obligations. Refund obligations extend to both company-distributed and parallel-imported packages, though partial refunds may be negotiable. During the legislative process, the Danish Minister for the Interior and Health stated/made it clear that pharmaceutical companies may include this specific requirement in their negotiations with Amgros. The Minister specified that this implies the possibility that companies may negotiate to pay only a partial refund on packages from parallel importers and distributors, with no lower limit for the partial refund, allowing significant negotiation flexibility on this requirement.

The scheme may increase competition by enabling more high-cost medicines to enter the reimbursement system. Companies must assess whether participation aligns with broader market strategies and pricing policies.

It remains to be seen how the confidentiality will work in the context of access mechanisms in other major markets, including the United States Executive Order “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” dated 12 May 2025.

Pharmaceutical companies looking to benefit from the new confidential pricing scheme should begin by evaluating the eligibility of their medicinal products. This involves determining whether their products meet the criteria for reimbursement under the scheme. Once eligibility is established, companies need to prepare comprehensive documentation. This includes compiling supporting data such as cost-effectiveness analyses and market impact assessments, which will be crucial for submission to Amgros, the procurement body responsible for negotiating confidential discounts on behalf of the DKMA.

Engaging in negotiations with Amgros is a critical next step. Companies should initiate discussions to establish favourable confidential pricing terms, while carefully considering the implications for global pricing strategies. It is essential to ensure compliance with all reporting obligations, which may involve implementing internal tracking mechanisms to monitor adherence to the negotiated terms.

Finally, companies must stay vigilant and monitor market dynamics. This includes keeping abreast of regulatory changes and assessing their potential impacts on pricing strategies and reimbursement status. By following these steps, pharmaceutical companies may strategically navigate the new legislative framework and secure reimbursement for their high-cost medicinal products.

LIF, the Danish Association of the Pharmaceutical Industry, views the new legislative framework as a groundbreaking development for the Danish pharmaceutical market. They see potential benefits for patients, the public sector and pharmaceutical companies.

During the legislative process, LIF raised concerns regarding the requirement for original manufacturers to compensate the regions for sales of parallel-imported medicines, viewing it as unfair competition. However, LIF acknowledges that this issue seems to be addressed by allowing compensation for parallel-imported medicines to be included in the negotiation process.

The introduction of confidential pricing represents a significant shift in the Danish reimbursement landscape. While it offers pharmaceutical companies new opportunities for market access, it also requires strategic planning and negotiation.