An updated agreement template will make it easier to enter into agreements for advanced therapies

Amgros has updated the national contract template for ATMP, which is ready to use. The template is intended to make it easier to enter into more consistent agreements with companies in an area that is both complex and rapidly evolving. In this way, the new contract template will support patients’ access to new medicines.

Special requirements for ATMP agreements
ATMP covers advanced therapies such as gene, cell, and tissue therapies. These are medicines that often differ significantly from more traditional treatments—both in terms of development, manufacturing, documentation, and price. Therefore, the area sets special requirements for the agreements that must ensure that the treatments can be implemented in the Danish healthcare system.

With the updated contract template, Amgros aims to create a more robust and future-proof basis for ATMP agreements in Denmark.

The update is based on experience from existing ATMP agreements and has been developed in close dialogue with, among others, hospital pharmacies, clinical environments, regions, suppliers, and legal stakeholders.

Nordic knowledge sharing has strengthened the work
The work on the template has also been qualified through Nordic knowledge sharing. Here, perspectives and solutions from the other Nordic countries have contributed to a stronger shared understanding of how agreements in the ATMP area can be handled in dialogue with the market.

If you want to learn more about the contract template, you are welcome to contact Amgros at medicin@amgros.dk