Amendments to the reimbursement law: chaos in the transition period

Theoretically, the rules for the transitional period are clear: according to Article 8 of the Act of August 17 of this year amending the Act on Reimbursement of Medicines, Foodstuffs for Special Dietary Purposes and Medical Devices, as well as some other acts, the current provisions apply to reimbursement proceedings initiated and not completed before the effective date of the amending act. The only exceptions to this are the provisions of Article 11 of the Reimbursement Act (regarding coverage or denial of product coverage and the content of the reimbursement decision), and Article 31a(3a) of the Act, according to which Article 98 of the Code of Administrative Procedure (on suspending administrative proceedings at the request of a party) does not apply to reimbursement proceedings. In practice, however, some of the new provisions are already being applied to proceedings initiated before the DNUR came into force, while the application of others is deferred.

An example of the changes to the Reimbursement Law, which are now being put into practice even for proceedings initiated before November 1 of this year, are the provisions that change the rules for conducting price negotiations and the functioning of the Economic Commission. Applicants are already being asked to limit the composition of negotiating teams to three people; the Economic Commission also conducts negotiations in such, truncated compositions. In addition, it also appears that the rule that letters issued in the course of refund proceedings are considered delivered when they are signed and placed in the recipient's mailbox in the SOLR system now applies to all proceedings, regardless of when they were initiated. Indeed, applicants in refund proceedings report that as of November 1 this year they lost the ability in the SOLR system to acknowledge receipt of letters placed in their inboxes, suggesting that they are considered delivered as soon as they are placed in the system. This is surprising, since these are procedural regulations governing the conduct of reimbursement proceedings, and thus should be covered by the standard from the DNUR transitional regulations described above, according to which proceedings initiated before the amendments to the Reimbursement Laws came into force are carried out in accordance with the existing regulations.

On the other hand, we have examples of new regulations that should already be in force, yet, according to the Ministry, their application in practice is deferred. We are talking, for example, about the new Article 6(2a) of the Act, according to which the amount of payment by the patient for a reimbursed drug is reduced by 10 or 15%, if the drug is manufactured in Poland, possibly also from an active substance manufactured in Poland. This provision came into effect exactly on November 1 this year, and cannot be considered a procedural provision, regulating the conduct of reimbursement proceedings (and thus is not affected by the rule that we apply the existing regulations to proceedings initiated before November 1 this year). Nevertheless, the reimbursement announcement, which has been in effect since November 1, does not provide for a reduction in patient co-payments for drugs manufactured in Poland. The reason? Well, according to the Health Ministry, it is impossible to determine which drugs are manufactured in Poland before they undergo the reimbursement procedure with the granting of a preference for manufacturing in Poland, as stipulated in Article 13a of the Act; and what's more, it is not possible to supplement applications submitted in already ongoing proceedings with a declaration of manufacturing the drug in Poland. This means that patients' co-payments will not be reduced until several months from now at the earliest, when reimbursement proceedings already initiated after the DNUR came into effect may be completed.

The chaos surrounding the application of the provisions of the amendments to the Reimbursement Act during the transition period is exacerbated by the fact that, to date, no comprehensive interpretation of the DNUR regulations has been issued, for example, in the form of questions and answers, as requested by pharmaceutical companies; to date, only two communications have been issued on two, selected issues, which, in addition, do not provide answers to all the questions that have been bothering applicants. For example, a communication dated November 16 of this year, regarding previously issued reimbursement decisions containing an attachment in the form of a drug program description, indicates that "all drug program descriptions attached to previously issued reimbursement decisions will only be the content of the announcement, and therefore, a change in the drug program description does not require the applicant's consent, as referred to in Article 155 of the Code of Administrative Procedure. Consequently, they will no longer be an appendix to the administrative decision on reimbursement coverage." However, it is still unclear under what procedure and on what legal basis the administrative decisions that previously included this annex will cease to be valid in this regard. So what should applicants do if it turns out that the drug program concerning their product has been changed despite the fact that the program description is still included in the text of the reimbursement decision? No one knows.

Author: attorney Katarzyna Czyzewska