On 4 November 2021, the Council of Ministers approved the Competition Bill for 2021 (“Competition Bill“), to be submitted to the Parliament for its examination. The provisions of the Competition Bill affect various sectors, including the healthcare one. In this regard, the most important innovations are those concerning (i) medicines for which the pricing and reimbursement procedure is still pending; (ii) the reimbursement of generic drugs; (iii) the distribution of medicines; and (iv) the production of blood-derivative drugs.
As regards medicines for which the pricing and reimbursement procedure is still pending, the Competition Bill provides that in case the Marketing Authorization Holder (MAH) fails to submit a reimbursement application within the prescribed deadline, the Agenzia Italiana del Farmaco (AIFA) may automatically proceed with the alignment to the lowest price within the Anatomical Therapeutic Chemical (ATC) 4th level.
With regard to the reimbursement of generic drugs, the Competition Bill provides for the repeal of Article 11, paragraph 1-bis, of Decree Law No. 158/2012 according to which generic drugs cannot be reimbursed by the National Health Service (NHS) before the expiry of the patent or supplementary protection certificate for the originator.
With respect to the distribution of medicines, the Competition Bill amends Article 105, paragraph 1, of the Legislative Decree No. 219/2006 by lifting the obligation for the holder of the wholesale distribution license to hold at least 90% of the medicines having a marketing authorization and introducing the less burdensome obligation to hold an adequate range of medicinal products to meet the requirements of the specific geographical area to which the distribution license refers to.
Lastly, the Competition Bill provides for the revision of the production system for drugs derived from Italian plasma by entrusting the Ministry of Health with the task of developing specific programs aimed at attaining self-sufficiency in their production. To this end, the Competition Bill also provides for the allocation of EUR 6 million per year to improve the organization of structures dedicated to the collection, qualification and preservation of national plasma and to the production of blood-derivative drugs.