After the COVID pandemic, the Romanian health authorities shifted the main health policy measures from the control of communicable diseases and emergency medicine to the control of non-communicable diseases and access to innovation.

Regarding the control of non-communicable diseases, there are several National Plans to be adopted/implemented, which cover the main causes of death in Romania: cardiovascular diseases, cancer, and diabetes. The fight against cancer received special attention. A group of members of the Parliament had the initiative to raise the National Plan to Fight against Cancer to the level of the law, a fact that was completed by its materialization in Law no. 293/2022.

Paradoxically, although initially the draft law enjoyed the support of the Minister of Health, who was among the initiators of the law, after it entered into force the Ministry of Health came to the conclusion that a series of provisions are impossible to put into practice and others impose expenses that were not taken into account and that require additional funding. An open conflict has been reached between some parliamentarians, the associations of cancer patients, and the Ministry of Health, which has delayed the development of the rules for the application of the law by conditioning their approval on the issuance of an emergency ordinance that would bring changes to the law.

The implementation rules include chapters on cancer prevention, early diagnosis, the establishment of the National Cancer Registry, diagnosis, treatment, monitoring, and care of cancer patients. In addition, the rules set out the treatment eligibility criteria established by the National Health Insurance House (NHIH), as well as the types of drugs and procedures that are covered by public insurance. The deadline for the approval of the rules, assumed by the Ministry of Health, was July 1, 2023 [1], but as of August 1, they were still not formally approved. However, under the pressure of patients and civil society, all the prerequisites are for the Rules to appear in the fall of 2023 and the measures from the National Cancer Plan to become operational.

In Romania, there is a health technologies assessment (HTA) model with a scorecard point system, implemented and continuously developed since 2014 [2], and the future local HTA will be aligned with the new EU HTA directive starting in 2025.

Until then, however, the process of financing new technologies and medicines is obviously hampered by the fact that the procedure, although functional, is much delayed in securing financing for them, often having to wait for a new financial streams so that the medicines formally approved for financing from public money can reach their beneficiaries.

Despite the arguments invoked by the Ministry of Health for delaying the mentioned application rules, it is very likely that the main difficulty is related to the concretization of a faster mechanism of access to innovation, which in fact represents the guarantee of regular and sustained financing by establishing a National Innovation Fund (NIF). The NIF is considered to cover the reimbursement (through various Managed Entry Agreements between the payer and developer) of innovative drugs, which will cover the unmet needs of cancer patients, from the approval of the European Medicines Agency to the official decision of the national HTA to include or not the drug in the Public Reimbursement List.

Both the National Cancer Plan and the existence of a Fund dedicated to innovation are part of the burning concerns of the European Union, the mentioned local initiatives being in total agreement with them. What is striking, however, is the fact that, although there are no obvious reasons for opposition to them, the process of putting them into practice in Romania turns out to be much more difficult than the beneficiaries of these measures, the patients, would expect.

References

1. https://www.agerpres.ro/sanatate/2023/06/30/video-rafila-normele-privind-planul-national-de-combatere-a-cancerului-in-vigoare-de-la-1-iulie--1133077
2. Ciprian-Paul Radu, Nona Delia Chiriac, Alexandra Mihaela Pravat, The Development of the Romanian Scorecard HTA System, Value in Health Regional Issues, Volume 10, 2016, Pages 41-47, ISSN 2212-1099, https://doi.org/10.1016/j.vhri.2016.07.006.