To advance personalized medicine, the Ministry of Health is proposing to expand the scope of advanced therapy (AT) medicinal products manufactured for individual patients on the basis of a physician’s prescription (the so-called “hospital exemption”).
The new procedure is planned to enter into force on November 1.
This would create better conditions for developing and introducing innovative treatments for patients with cancer and other serious diseases, as well as for expanding advanced therapy services in cases where treatment with industrially manufactured medicinal products does not produce the expected results or is unavailable.
“The proposed new procedure aims to address the challenges currently emerging and improve treatment options for Lithuanian patients with cancer and other serious diseases when it is necessary to seek therapeutic solutions tailored to individual patients. The development of advanced therapy medicinal products under the hospital exemption provides the conditions needed to meet the needs of individual patients and provide personalized healthcare services specifically tailored to them,” Deputy Minister of Health Daniel Naumovas said in June.
Under the hospital exemption, AT medicinal products are manufactured using non-standard methods, applying different (modified) manufacturing processes or at a different frequency than in conventional industrial production. Healthcare institutions have already accumulated experience in manufacturing AT medicinal products for individual patients and using them in clinical practice. However, regulatory gaps have also been identified: the current framework does not provide for the manufacture of gene therapy medicinal products, even though some institutions have the necessary expertise to administer and use such products.
The proposed amendments would expand the scope of the requirements for AT medicinal products and establish that gene therapy medicinal products may also be manufactured for individual patients.
AT medicinal products would be required to be manufactured in accordance with the good manufacturing practice guidelines published by the European Commission. Specific manufacturing requirements would also apply in cases where, due to the particular characteristics of AT medicinal product manufacturing, the application of European Union good manufacturing practice guidelines needs to be modified.
The draft legislation would strengthen quality assurance requirements for AT medicinal products. The head of a healthcare institution authorized to manufacture AT medicinal products for individual patients would be required to approve a quality documentation package for each specific AT medicinal product. This documentation would have to contain the data necessary to ensure the quality of the specific product during its manufacture and testing. This would help ensure the quality of AT medicinal products manufactured for individual patients by requiring compliance with predefined standards.
Under the new procedure, permits to manufacture AT medicinal products would be issued for an unlimited period. This would reduce the administrative burden on manufacturing institutions and the State Medicines Control Agency.
The draft order is currently undergoing the required consultation process with the public and social partners.
