Search
The introduction of a new confidential pricing scheme in the primary care sector in February 2025 brought to light some unclear details about its scope. During the Health Committee process, the Ministry of the Interior and Health has now clarified certain aspects of the new market access scheme.
On 6 February, the Ministry of the Interior and Health (“Ministry”) introduced a bill to amend the Danish Health Act to establish a voluntary trial scheme for the reimbursement of medicines in the primary care sector based on negotiated confidential prices.
The bill proposes that the following three groups of medicines can be included in the trial scheme:
Through confidential price negotiations between the pharmaceutical companies and the regions through Amgros I/S (“Amgros”), the parties can agree on a confidential discounted price for primary care medicinal products.
During the trial period from 1 July 2025 to 30 June 2028, the Danish Medicines Agency (“DKMA”) can base the general reimbursement, the general conditional reimbursement and the individual reimbursement for the medicinal products included in the trial scheme, on the confidential price negotiated between the pharmaceutical company and the regions.
The price for the patient will remain to be based on the official list price – which has been one of the main criticisms from the patient’s perspective – thus enabling pharmaceutical companies to maintain the global reference price.
Ambiguities and concerns about the scope of the proposal have been raised. Following the Health Committee’s process, some clarifications have now been provided.
The confidential pricing scheme is voluntary for the pharmaceutical companies and the pharmaceutical companies can withdraw from negotiations with Amgros if they are not satisfied with the agreement.
In general, a key mechanism of the scheme is that the confidential price reduction is refunded by the pharmaceutical company to the regions, thus maintaining the official list price for the patient.
In practice, this means that the companies that have entered into the confidential price agreement must refund the regions the difference between the official list price and the negotiated confidential price for all packages of the relevant medicine sold, including parallel imported and distributed medicines.
However, the recent Health Committee review has unveiled that the pharmaceutical companies can include this specific requirement in their negotiations with Amgros. In an answer to the Health Committee, the Ministry clarified that the companies can leverage in the negotiation that they only pay a partial refund on packages sold from parallel importers and distributors. As the answer from the Ministry also clarified, there is no lower limit for the negotiated “partial refund”, which means that there is a wide space to negotiate on this requirement.
The Danish Ministry of Industry, Business and Financial Affairs and the Danish Competition and Consumer Authority have assessed the scheme and concluded that it does not conflict with competition rules and consider it positive that there has been a focus on designing the confidential price negotiation model in the medicine reimbursement system in a way that takes into account competition and the role of parallel importers.
The extent of transparency in the process is one of the practical aspects that is not clear from the bill.
The DKMA remains responsible for decisions on the reimbursement of medicines.
Following the Health Committee review, it has been clarified that the DKMA will include the new process in the Guidance on application for reimbursement, while Amgros will introduce a guidance on the process at Amgros.
Although the confidential price will not be disclosed, the DKMA will disclose when general reimbursements or general conditional reimbursements are granted based on a negotiated confidential price.
These decisions will be based on the criteria laid down in the current regulations on reimbursement of medicines. However, separate criteria will be established for general reimbursement of medicines based on a negotiated confidential price. These criteria will be similar to the existing criteria for general reimbursement based on the official list price. However, a key exception will be introduced in the trial scheme, which will allow the DKMA to grant a general conditional reimbursement for a medicine even if the DKMA assesses that there is an economically motivated risk that the medicine will be prescribed with a reimbursement to patients who are not covered by the reimbursement clause, which is usually an exclusion factor.
This aspect may be included in the regions’ assessment of whether to enter into a confidential price agreement with the company, which takes place prior to the DKMA’s decision.
The new confidential pricing scheme introduces mechanisms which are similar to the ones already applicable to market access for the secondary sector medicinal products. Provided that the confidential price negotiation does in fact result in more innovative products reaching the patients with reimbursement, without reducing the economic incentive for the innovative pharmaceutical companies to drive innovation by affecting global reference prices, the amendment is a positive step towards better market access for innovative medicinal products. This requires that a correct balance can be met in the negotiations, by including adjustment parameters for the parties to leverage in the negotiations.
However, from commercial market mechanism considerations, we are deeply concerned to see that on questionable legal and commercial grounds the parallel importers and distributors once again, as we have seen in the past years (e.g. regarding mandatory stocks of certain medicines), are being favored and supported to the detriment of the innovative industry.
The Life Sciences team at Gorrissen Federspiel is closely following the developments, Q&As and adjustments to the new market access scheme to ensure that we are always up to date with the current status and process. Entering into force on 1 July 2025, the new market access scheme adds a new facet to the complex pricing, reimbursement and market access framework in Denmark, and we at Gorrissen Federspiel will be pleased to advise you and your company.