The law on allogenic ATMPs dated 30 October 2018 changes various elements in the law dated 19 December 2008 regarding human tissue products (HTP) with the intention of medical application on humans or for scientific research.
ATMP is the abbreviation for advanced therapy medical product. There are four types of ATMPs. The law on allogenic ATMPs applies to all ATMPs that contain allogenic material, regardless of category.
The term allogenic means that the donor and the recipient of the human tissue products (HTP) are different. HTP refers to cells, tissues, blood and other derivatives. You can find more information on HTP on the website of the FAMHP (see Dutch or French).
The law on allogenic ATMPs dated 30 October 2018 changes various elements in the law dated 19 December 2008 regarding human tissue products (HTP)with the intention of medical application on humans or for scientific research.
One of the most significant changes is a significant advancement in the development of new innovative therapies based on the processing of HTP for the production of drugs.
Targeted recruitment campaigns for donors
The law forms the legal basis on which HTP banks will be able to organise specifically targeted campaigns in the future for the recruitment of healthy donors for specific and determined objectives, such as scientific research or the production of pharmaceuticals.
HTP banks may now hold awareness campaigns for donors following the example of awareness campaigns for blood donations. The candidate donor is fully informed of the objective of the donation and makes the donation after giving consent and within a controlled ethical framework.
HTP banks will also be able to organise specific targeted campaigns in the future to recruit healthy donors for well described objectives, such as scientific research or the production of pharmaceuticals. These campaigns will be organised in the first instance by the hospital banks. The details must still be worked out by Royal Decree.
Simplified access to HTP for intermediary structures
The law on allogenic ATMPs also extends the action possibilities of intermediary structures for HTP. These structures provide for the processing, safekeeping, storage and distribution of HTP in collaboration with a bank for HTP intended for medical applications in humans.
Intermediary structures will now be able to perform all of these actions without prior agreement with an HTP bank to the extent that the material was not removed in Belgium. The intermediary structure can receive the material from an institution certified to acquire the material, either in Belgium (if the bank is for human tissue products) or in another member state. With an additional certification, the intermediary structure can also import material itself. These changes require a number of changes to the current export regulations.
The application of HTP regulations
In addition, the law on allogenic ATMPs has the objective of regulating the assignment of HTP by the banks. The decision by an HTP bank to assign material to a specific purpose must be transparent and motivated. This motivation must be based on clear and transparent criteria laid out in a framework agreement that must be concluded between the HTP applicant and the HTP bank. Here too, a Royal Decree must be made before this addition can be executed.
The list of HTP certified European banks and other institutions and their activities can be found on the website of the FAMHP.