MRS DANIELA DARITKOVA-PRODANOVA
CHAIRMAN OF
THE COMMISSION ON HEALTH
TO THE NATIONAL ASSEMBLY
REGARDING: Submissions for discussion in the National Assembly of the draft law on amendments and additions to the Law on Health Insurance No. 502-01-13 on 2.02.2015 by the Ministry of Justice
DEAR MRS DARITKOVA,
In connection with the Draft Law on Amendments and Supplements to the Law on Health Insurance submitted for discussion in the National Assembly and discussed in the Committee on Insurance Relations to the NSTS on February 6, 2015, the Confederation of Employers and Industrialists in Bulgaria expresses the following position:
The Confederation of Employers and Industrialists in Bulgaria supports the intention to improve the collection of health insurance contributions by increasing the commitments of the state and the responsibility of the insured persons, but we cannot ignore the absence of measures for access to the system for uninsured citizens.
We welcome the good intentions to increase the quality of medical activity, but there is a lack of a comprehensive concept of the proposed changes, their specification in the relevant sub-normative acts.
We categorically do not support the proposal made in § 4 to change Article 13 of the Health Insurance Fund, which envisages increasing the composition of the Supervisory Board of the Health Insurance Fund with two representatives of the state.
With the proposal made and the increase of the state's quota in the management of the health fund, the tripartite principle of managing the fund is grossly violated. The reasons for this proposal, namely that the main activities of the management bodies of the NHIF are related to spending public resources, which is why it is appropriate for the state to take on more responsibilities in the management of the treasury, are unfounded for us, as as about 2/3 of the revenues in the treasury are collected by the insurers and insured persons and only the remaining 1/3 are contributions from the state, i.e. it is proposed that those who pay the insurance contributions and finance the system should not have a decisive voice in its management.
Due to the huge difference between the average health insurance contribution that the state pays for the categories of persons insured at the expense of the republican budget and the one that is paid for working citizens, we propose that the state release itself from the obligation to pay the health contributions of persons with income, as the exempted financial resource is used to intensify the growth rate of the health contribution at the expense of the republican budget and the persons without income are covered by the insurance system. In this way, the amount of funds in the NHIF will increase and the number of people without health insurance will significantly decrease.
We express our reservations to the proposed changes with § 11 to amend Article 45, Paragraph 2, which provide that the package of medical services paid by the health insurance fund will be divided into a basic and an additional package.
Due to the great social importance of the proposed changes, we suggest that the reasons why it is necessary to divide the health services guaranteed by the NHIF budget into a "basic" and "additional" package; the positive effect that is expected to be achieved with the proposed changes, as well as the expected financial and social results.
In order to make an expert assessment of the effect of the proposed changes, it is necessary, together with the draft Law, to provide for discussion a draft Ordinance of the Minister of Health, which will regulate the health services in the two packages and the conditions for their use by the compulsorily insured persons and for financing by the NHIF or the patient.
The draft does not specify an initial period from when the NHIF will pay for the activities under two packages of health services. It is imperative to specify this term, as this separation brings serious changes to the health insurance model, which necessitates providing technological time for preparation and adaptation to the new conditions of both institutions and citizens.
We believe that the proposed mechanism for remaining in the system and the proposed changes with § 39, providing for a change in Article 109, paragraph 2, are insufficiently motivated, creating the possibility for persons to remain outside the health insurance system.
The proposed measures to increase the collection of health contributions require a thorough analysis of the categories of citizens who are not insured. Due to the great heterogeneity of this group of citizens, it is impossible for the measures to be uniform. Persons with no income cannot pay any health contributions and the Law must guarantee access to health care for them as well.
In our opinion, the improvement of the drug policy in Bulgaria and the optimization of the drug costs of the NHIF are of vital importance for patients and citizens in general. After consulting with the branch organizations in the sector, we would like to express our support for the envisaged changes in the HCW, which would improve the drug policy in Bulgaria and optimize the costs of drugs of the HCW. However, with regard to some of the texts included in the Law on Amendments and Supplements to the Health and Welfare, we would like to express certain considerations, as well as the need to clarify some concepts that have found a place in the proposed changes. Also, we would like to draw attention to the fact that the adoption of decisions related to drug policy should take into account their impact on the entire distribution chain of drugs and other products of importance to human health, taking into account the opinion of all parties concerned .
According to Bulgarian legislation, drug policy is part of the state health policy in the Republic of Bulgaria and is implemented by the Minister of Health. The list of diseases for the home treatment of which the National Health Insurance Fund pays medicinal products, medical devices and dietary foods for special medical purposes is a fundamental element of the drug policy, therefore it cannot be carried out by a collective body composed of representatives of different institutions on a quota basis and organizations, such as the NC of the NHIF. Participation in the Council is an additional activity for its members, which they carry out free of charge, along with their main work and official duties. The transfer of responsibility for the implementation of a major element of the drug policy in Bulgaria from the Minister of Health, to whom it is assigned by law, to a collective body with supervisory functions, for which this activity is uncharacteristic, is inappropriate and will lead to serious violations in the functioning of medical care in our country. We believe that this list should continue to exist through an ordinance of the Minister of Health and be updated annually through amendments to it.
In connection with the proposed changes in § 11, regarding changes to Art. 45, paras. 10,13, 19 and XNUMX, we believe that it would be beneficial for the provision of better quality legislation to define the concept of "grouping" as clearly as possible, so that it should not be possible to interpret it freely and interpret it in different directions. Guarantees are needed that generic medicines will not be affected by the said texts, and that new biosimilar medicines will not be treated as a new INN.
Regarding the proposed amendments to Article 45 of the Law on Health Insurance and the introduction of the mandatory nature of discounts for innovative medicinal products - the proposed mechanism should be specified, as it is currently difficult to implement. The requirement to include a medicinal product with a new INN in the PDS only after reaching an agreement on a discount with the NHIF is practically unenforceable. The actual composition necessary to include a medicinal product with a new INN in the PDS, namely the conclusion of a discount contract, the adoption of a decision to include in the PDS, its entry into force and its publication must take place after the entry into force of a law on the budget of the NHIF for the following year, but before the end of the current year. This time period is too short to allow the above actions to be implemented.
In connection with § 12, we support the introduction of health technology assessment and periodic verification of reimbursement status for innovative medicinal products. At the same time, we would like to point out that there is no practice in the EU for reimbursement based on a mandatory legal norm when excluding a product from reimbursement due to "lack of a positive result in its application" in accordance with the assessment of health technologies, provided for in Article 45a.
In § 41, a change is made in art. 259b, paragraph 1 of the Law on Medicinal Products in Human Medicine. Increasing deadlines will not have a favorable effect on the business and the introduction of new products becomes difficult.
With regard to the preparation of the manuals and algorithms under Article 259, Paragraph 1, Item 4 of the ZLPHM, mentioned in § 42 of the ZID of the PHI, we propose that the stages of treatment be based on INN and dosage forms. This would ensure the necessary adequacy and applicability of these manuals.
We hope that our proposals on the ZID of the PHI will be taken into account during the further consideration of the Bill.
With respect,
Eugene Ivanov
Ex. director
http://www.turbulence.tech