The Draft Act amending the Act on Reimbursement of Medicines, Foodstuffs for Special Nutritional Purposes and Medical Devices and certain other acts has been submitted for consultation.
What changes?
(1) The proposed legislation changes the way in which the total reimbursement budget is created, while ensuring that this budget is more predictable than before. The total reimbursement budget will be - as before - no more than 17% of the sum of public funds allocated for the financing of guaranteed services in the financial plan of the National Health Fund. The reimbursement budget will include funding from risk-sharing instruments and statutory payback.
(2) It is proposed to modify the way in which the elements of the total reimbursement budget are created by no longer indicating in the Regulation of the Minister of Health the way in which the financial resources that represent an increase in the total reimbursement budget in the accounting year in relation to the total reimbursement budget in the previous year are distributed, and for this purpose the authorisation to issue the Regulation in question is repealed. The reimbursement budget is highly dynamic and it is therefore not appropriate to maintain the current solution of updating the relevant regulation if the budget allocation needs to be changed. A more optimal solution is for the Fund to be able to allocate the received funds immediately without waiting for the Minister of Health to formally update the regulation. This allocation is not reflected in the actual allocation of funds, so it unnecessarily burdens the MZ with the obligation to issue a regulation on this issue.
(3) It is envisaged to introduce a provision enabling the transfer of an issued reimbursement decision to another entity that has assumed the rights and obligations of the entity in whose favour the decision was previously issued.
4 It is assumed to introduce the institution of reimbursement secrecy consisting in non-disclosure of documentation within the scope of the risk-sharing instrument and within the framework of proceedings before the Economic Commission, collected during the whole procedure related to granting reimbursement and setting the official selling price, increasing the official selling price, decreasing the official selling price, setting or changing the official selling price of a medicine, a foodstuff for special nutritional purposes, a medical device or shortening the duration of the decision.
5 It is proposed to increase the freedom of the Minister of Health to influence the eligibility criteria in drug programmes by including it only in the announcement and not, as before, in the form of an annex to the decision of the applicant. This regulation will also allow modification of already functioning drug programmes in terms of sequential use of therapies, e.g. according to the relevant drug programme, lapatinib in advanced breast cancer is used after trastuzumab. In contrast, it is now standard practice to use trastuzumab with pertuzumab in the first-line treatment of advanced breast cancer. Thus, in this case, the international guidelines for the use of lapatinib in the next line of treatment should be key in formulating the drug programme (despite the fact that the reimbursement application for lapatinib did not originally refer to treatment after combination therapy of trastuzumab with pertuzumab, but only to trastuzumab alone).
6 In a situation where more and more therapeutic options are emerging in drug programmes, it seems reasonable to use treatment lines in the eligibility criteria rather than provisions for the sequential use of specific drugs. Clinical trials, on the other hand, only refer to the comparison of specific drug interventions. At the same time, the draft provides for sanctioning of a situation in which an administrative decision on granting reimbursement and setting the official selling price of a drug is revoked with respect to indications for use or dosage or method of administration specified in the Summary of Product Characteristics. In such a situation, the administrative decision on including the medicine in the reimbursement with clinical data on indications for use or dosage or route of administration, other than those specified in the SmPC, will be simultaneously revoked.
7 It is proposed to extend the deadline for the next reimbursement announcement from two months to three months. This change will significantly improve work in pharmacies and enable better planning of supply of medicinal products. Polish pharmacists have repeatedly pointed out that such a frequent change of the reimbursement list (every two months) does not favour the stability of their work and significantly hinders the management of medicines. In fear of changing rigid prices (and possible losses), pharmacies reduced the size of their assortment, which significantly affected the availability of medicines and made it take longer for patients to fill prescriptions. This created dissatisfaction among patients and worrying interruptions in therapy not conducive to its safety or efficacy. Frequent changes may also have led to misinformation among healthcare professionals about the new reimbursed products and their indications.
8 A provision is also proposed whereby the Economic Commission does not negotiate applications for reductions in the official selling price. Drug price reductions are the cornerstone of the system. It needs to be promoted and streamlined, as each such change is an opportunity for a new medicine to be reimbursed. Already now, the time to process a price reduction application is only 30 days. However, it requires price negotiations. The current changes will simplify this procedure as much as possible in order to introduce the reduction as soon as possible without unnecessary formal obstacles.9. The role of the Coordination Teams is important - they are involved in the qualification of patients and the assessment of the validity of therapy in selected drug programmes. At the same time, the legal community has for a long time drawn attention to the lack of their solid legal basis in the system. Now this inaccuracy has been rectified and the Coordination Teams, together with a description of their operation, have been placed in the law.
10. transferring the issuing of administrative penalties to the Fund, Main Pharmaceutical Inspector and Regional Pharmaceutical Inspectors, respectively. The above changes will make the provisions more transparent and improve the implementation of tasks under the Reimbursement Act by distributing the relevant competences more appropriately.
11 Revise the mechanism for general payback so that if the reimbursement budget is exceeded, each pharmaceutical company is obliged to contribute to this mechanism.
12.Introduction of mechanisms encouraging the production of medicines in the Republic of Poland, with the Minister of Health taking these circumstances into account when making reimbursement decisions promoting this activity in various ways, e.g. by not negotiating with the Economic Commission, issuing a reimbursement decision for a longer period than the statutory one, exempting part of the fees, etc.
13. adding provisions on ongoing proceedings to remove loopholes, add statutory definitions, simplify and speed up the process of conducting reimbursement proceedings for a medicine, including stages by both the Health Technology and Tarification Agency and the Economic Commission.
14.Introduce provisions against the sale of medicines abroad by requiring the same wholesale margin as in domestic transactions.
15. introduction of changes to the limit groups, their updates and updating of reimbursement categories.
16 Revise the provisions on the imposition of penalties for non-availability of medicines by making the possibility of imposing such penalties more realistic and the obligation to maintain stock levels that ensure the smooth passage through short-term shortages of availability of medicines.
17. amend the regulations for the negotiation of reimbursement applications before the Economic Commission by limiting these negotiations to 3 rounds of negotiations.
18. changes to the individual reimbursement rules including the electronicisation of the administrative process.
19 Change regarding the flat fee and wholesale margin. The previous flat fee has not been indexed for more than 20 years, when it was set at the current level of PLN 3.20. Such a low flat fee depreciates the importance of medicines, which are treated as an insignificant commodity because of this price. Patients buy drugs to stock up on because of the low price, and then do not take them and dispose of them. Meanwhile, the payment of PLN 3.20 on the part of the patient does not mean such a value of the medicine, let alone the absence of any payment on the part of the public payer. In view of this circumstance, it is necessary to valorise this payment and combine it with the amount of the minimum remuneration.
20 It is not possible to estimate precisely how the proposed solutions will affect the number of decisions issued.
21 It is not possible to estimate exactly how many entities will benefit from the proposed changes. Some Polish pharmaceutical manufacturers have never used the reimbursement option and it is unclear whether they will be interested in submitting reimbursement applications after the introduction of the legislation to benefit from the additional preferences proposed in the draft.
22 In agreement with the Central Anti-Corruption Bureau, which proposed the new wording of Article 4 in the draft, there is a departure from the mechanism in which the Fund participates in the statutory payback. As a result, Applicants who have obtained an administrative decision on reimbursement coverage will be obliged to reimburse the entire spent funds if the total budget for reimbursement in a given limit group is exceeded.
23. aims to continue the process of electronicisation of proceedings concerning target import and its reimbursement, initiated by the electronicisation of the Target Import Service System in the area of demand. The proposed amendments envisage the possibility of submitting, in electronic form, applications for reimbursement of:a) medicinal products imported from abroad on the basis of a demand for a medicinal product,b) foodstuffs for special nutritional use imported from abroad, on the basis of a demand for a foodstuff for special nutritional use, used outside the entity performing a medical activity, and communication with the Minister of Health to the extent necessary to settle an administrative case, in electronic form. In addition, the legislation provides for the creation of accounts for medicinal entities, which will enable authorised representatives of medicinal entities to verify all requests for medicinal products used in that medicinal entity and streamline the process of fulfilling requests.
24 The aim of the draft amendments to the Pharmaceutical Law is to introduce solutions in the area of pharmacy dispensing, which will move away from the principles of compulsory designation of pharmacies to perform them to more voluntary solutions, determined also by the introduction of remuneration for performing on-call duties. In the opinion of the legislator, the proposed solutions will make it possible to achieve a state of better protection of patients in pharmacotherapy, because the factor discouraging entities running pharmacies from securing night dispatching in the territory of a county, in the form of the fact that performing on-call duties is not economically profitable, will be eliminated. As it is proposed to introduce a paid on-call service, the project is confident that these operators will be more willing to provide this service when designated.
Project -> https://legislacja.rcl.gov.pl/projekt/12348505/katalog/12799482#12799482
Source: medexpress.co.uk