Parliament begins work on DNUR

The draft, whose fate as of June 23 this year can already be followed on the pages of the Polish Parliament, differs slightly from the latest version, published by the Government Legislation Center. Unfortunately, these are not differences that would significantly and positively change the assessment of its impact on the pharmaceutical market. What has changed (among other things), compared to the version from March this year. (i.e., the last one published on the RCL website)?

• The amendment to Article 4(11) of the Law, which stipulates that statutory payback must be borne by applicants who have risk-sharing instruments in place, has been dropped - under the current version of DNUR, these entities would have paid to the budget the difference between the value of the payback resulting from the RSS and the statutory payback;
• The provision amending Article 5 of the Reimbursement Law was removed - it was supposed to change the rules for calculating the price per DDD of a compounded drug;
• A lower and upper limit on the official wholesale margin has been introduced. As previously announced, the DNUR provides for an increase in the wholesale margin to 6% (from the current 5). At the same time, the latest version of the draft amendment to the law proposes a regulation that the wholesale margin cannot be lower than 50 cents and cannot be higher than PLN 150 (for a drug in pharmacy reimbursement) or PLN 2,000 (for a drug reimbursed in a drug or chemotherapy program);
• A novelty in the current version of DNUR is the added provision of Article 9(2a) of the Reimbursement Law, according to which the implementer of a health policy program (within the meaning of the provisions of the Law on Health Care Services Financed from Public Funds) shall purchase drugs (reimbursed in the drug program) for that program at a price not higher than that resulting from the risk-sharing instrument specified for that drug or the official selling price of the drug forming the basis of the limit, taking into account the number of DDD of the drug, plus a margin not higher than the official wholesale margin. It is worth noting that this involves the purchase of drugs for health policy programs implemented both by the Minister of Health and by local government units. Thus, local government programs will also be subject to the obligation to apply to the purchase of drugs the prices of these products resulting from their reimbursement - of course, in the case of drugs reimbursed in drug programs;
• The provision that the Minister of Health was to be obliged to refuse to initiate reimbursement proceedings if at the time of application at least one reimbursable equivalent in a given indication has patent or market exclusivity protection was removed from the draft;
• The new version of DNUR provides for the permissibility of realizing the mandatory reduction (by 25%) of the price of a reimbursed drug after the loss of market exclusivity (or, according to the draft, patent protection) not only by a reduction in the net selling price, but also (partially or exclusively) by a reduction in the effective price, resulting from the risk-sharing instrument. The regulation proposed in the draft slightly increases the flexibility of the solution used so far (providing only for a reduction in the net selling price), but it does not solve all the practical problems that responsible parties have reported so far with regard to these provisions. First of all, the regulation does not explicitly provide that it is permissible to reduce the price of a drug through the conclusion of a new risk-sharing instrument, if no such instrument has been in effect for the drug so far; moreover, it is not clear from the regulation that it is the responsible entity itself that will choose the path to follow in processing the reduction - whether it wants to reduce the nominal price, the effective price or partially both;
• The draft introduces a new basis for covering a drug with reimbursement ex officio, without a request from the applicant. The new Article 30a added to the law stipulates that the Minister of Health may issue a decision on reimbursement coverage and setting the official sales price for a drug, including a drug with an OTC availability category, which requires use for more than 30 days for a specific clinical condition and is recommended in clinical management guidelines, in cases where the applicant has not yet submitted an application for reimbursement coverage and market exclusivity for the drug has expired. However, the mechanism of operation of this reimbursement mode is not clear, as the provision also states that the Minister of Health will inform responsible parties for drugs that could be reimbursed under this mode about the possibility of submitting reimbursement applications;
• The idea of introducing an obligation to supply reimbursed drugs in equal parts to at least 10 entrepreneurs operating pharmaceutical wholesalers, whose scope of business does not include assortment restrictions, with the largest share of trading with general pharmacies in terms of the number of transactions, in the amount necessary to secure patients, has been revisited. In the new version, the DNUR provision specifies that this obligation will apply only to reimbursed drugs in pharmacies at risk of unavailability; with the list of these drugs to be published by the Minister of Health by means of a notice.

What hasn't been changed in the draft amendments to the Reimbursement Law? Far-reaching procedural changes remain in place, including, for example, the widely criticized proposal to subject individuals who sign reimbursement applications to criminal liability, as for making false statements.

There is now very little time to pass the amendments to the law, as the Diet has few sessions scheduled before the end of the term. However, the bill still has a chance of passing; if it does, then most of its provisions will take effect on November 1 this year.

Author: attorney Katarzyna Czyzewska

Czyzewski law firm