DNUR with President's signature

The law introduces solutions that are a consequence of an analysis of more than 10 years of the Reimbursement Law, which has not been significantly amended during that time.

Many of the changes relate to specialized subject matter and result from the need to clarify provisions that currently raise interpretation doubts or cause a slowdown in the processing of applications for reimbursement coverage and determination of the official selling price of a drug, foodstuff for special nutritional use or medical device. The law is also a response to requests addressed to the minister in charge of health from entrepreneurs present on the pharmaceutical market, patients and other social groups affected by the provisions of the amended law. The solutions contained in the Act are also intended to respond to the postulated introduction of mechanisms aimed at increasing the drug safety of the Republic of Poland. One of the fundamental aspects of the changes being introduced is to increase the availability of reimbursed medicines, foodstuffs for special nutritional purposes and medical devices, and to meet health needs as much as possible.

The specific solutions contained in the law include, among others, the introduction of definitions of gross wholesale price, drug manufactured in the territory of the Republic of Poland, drug presentation, advanced therapy medicinal product, active substance manufactured in the territory of the Republic of Poland, and modification of the definition of wholesale price and official selling price. In addition, the law contains regulations aimed at establishing the benefits of drug production in the territory of the Republic of Poland. To this end, the law reduces, among other things, the level of patient payment by 10% or 15%, depending on whether the drug itself or the active substance is manufactured in the territory of the Republic of Poland. The law increased the official wholesale margin, which was set from a level of 5% to 6% of the net selling price of a drug, foodstuff for special nutritional purposes or medical device, not less than PLN 0.50 and not more than PLN 150 for a drug, foodstuff for special nutritional purposes or medical device available at a pharmacy by prescription. On the other hand, the upper margin limit for drugs used in chemotherapy and in the drug program will be PLN 2,000.

The retail margin has also been increased, in two stages: in the first stage (until the end of 2024), a retail margin in accordance with the table set forth in the transitional provision in Article 18 of the Law will apply, while the target solution, contained in the substantive provisions of the Law, will take effect on January 1, 2025.

A new regulation has been introduced, derogating from the previous rule that reimbursement coverage is granted at the request of the applicant (responsible entity, representative of the responsible entity, parallel importer or food market operator). In the case where the applicant has not yet submitted an application for inclusion in reimbursement and setting the official sales price for a given drug in a given indication, and market exclusivity for that drug has expired, the Minister responsible for health will be given the opportunity to issue an ex officio decision on inclusion in reimbursement and setting the official sales price for a drug, including a drug with an OTC(over the counter, over the counter ) availability category, which requires use for more than 30 days in a specific clinical condition and is recommended in clinical management guidelines.

The decision to reimburse a drug, foodstuff for nutritional use and medical device has been supplemented with an obligatory element - an obligation to provide the volume of supply on an annual basis, including a breakdown by month. In turn, in decisions setting the net selling price, the new obligatory element will be the so-called risk-sharing instruments, if established, which is to be one of the mechanisms for preventing the export of drugs abroad.

As part of the procedure aimed at covering a product with reimbursement, the legislator has introduced the possibility of using additional preferences for entrepreneurs who decide to produce in the Republic of Poland drugs offered on our market. Preferences will be able to include, in terms of administrative preferences, among others, exemption from the obligation to pay the excess amount in case of exceeding the total reimbursement budget, extension of the duration of administrative decisions on reimbursement coverage, exemption from price negotiations with the Economic Commission, processing of the application within no more than 90 days or 120 days - depending on the type of drug. Economic preferences include: a reduction in the fee for submitting an application for reimbursement coverage or supplementing it, a reduction in the fee for a verification analysis of the application by the Agency for Health Technology Assessment and Tarification, or setting the net selling price at 75% of the net selling price of the only reimbursable equivalent in a given indication.

A funding limit per unit of pharmaceutical raw material for the preparation of prescription drugs was introduced (15th percentile of the price distribution of the pharmaceutical raw material in question in the previous year), as well as regulation of the margin for prescription drugs (at 25%, calculated on the cost of its preparation, which is no more than the cost of making a prescription drug prepared under aseptic conditions);

The law includes changes regarding the determination of the content of drug programs. Currently, the description of the drug program is an appendix to the administrative decision on reimbursement coverage and setting the official selling price. After the law enters into force, the decision will only include elements directly related to the drug or foodstuff for special nutritional use for which the decision was issued. In turn, the description of the drug program will be created by the minister responsible for health after consultation with a national or provincial consultant in the relevant field of medicine, the President of the Agency for Health Technology Assessment and Tarification, and, in justified cases, a medical scientific society in the relevant field of medicine, and then it will be presented to the applicant for an opinion and will be attached to the announcement containing the list of reimbursed drugs, foodstuffs for special nutritional purposes and medical devices for which final administrative decisions on reimbursement coverage or final amending decisions have been issued. In subsequent provisions, the law regulates the participation of coordination teams in drug programs and clarifies the scope of their activities.

In the law, the legislator introduced the institution of reimbursement secrecy, consisting of non-disclosure of documentation in the scope of the risk-sharing instrument and in the proceedings before the Economic Commission, collected throughout the proceedings related to reimbursement coverage, and, among other things, in the determination, increase and decrease of the official selling price. The law defines a catalog of persons covered by reimbursement secrecy who participate in or technically handle reimbursement proceedings.

An increase in the existing fees for filing reimbursement applications from PLN 10,000 to PLN 15,000 has been introduced. In the case of products whose net selling price is at least PLN 10,000 or the cost of a patient's annual therapy exceeds three times the per capita gross domestic product, the fee will not be allowed to exceed PLN 30,000.

The bill will make it impossible to stipulate on the prescription that only a specific medicinal product, foodstuff for special nutritional use or medical device must be dispensed to the patient - in favor of introducing the possibility of including on the prescription "information on the legitimacy" of dispensing a specific product to the patient and subject to legitimate medical indications or documented adverse reactions occurring with the use of that medicinal product. In other words, the "do not substitute" (NZ) provision will no longer have the nature of a disclaimer and thus will not be absolutely binding on the person filling the prescription. It will henceforth only be an indication or information for this person, possibly taken into account in the process of dispensing the product. Related to this change is the obligation on the person issuing the prescription to include in the patient's medical records a detailed justification for prescribing a specific medicinal product, foodstuff for special nutritional use or medical device to that patient. Issuance of a medicinal product other than the prescribed one will be possible at the patient's request or with the patient's consent, if the total amount of the active substance or active substances contained in the medicinal product to be issued corresponds to the total amount of the active substance or active substances contained in the medicinal product prescribed on the prescription, and these products also have the same indications and the same route of administration.

A new solution has also been introduced that in the event of a threat of unavailability in the territory of the Republic of Poland of medicines, foodstuffs for special nutritional purposes or medical devices covered by reimbursement in the category of reimbursement availability by prescription, the applicant will be obliged to supply these products in equal parts to at least 10 entrepreneurs operating pharmaceutical wholesalers.

Pharmacy operators have been allowed to return medicinal products purchased before the change in the reimbursement lists to the wholesaler within 30 days of the effective date of the new list of reimbursed products, in case the medicinal product has disappeared from the reimbursement list. Analogous rules are introduced by the law with regard to the entitlement of pharmaceutical wholesalers to applicants, where the deadline for returning a medicinal product has been extended to 45 days from the effective date of the list established in the new announcement. At the same time, the period for issuing subsequent reimbursement announcements has also been extended, from 2 to 3 months.

The law, insofar as it concerns amendments to the Law of September 6, 2001. - Among other things, the Pharmaceutical Law is aimed at regulating anew the rules for general pharmacies to conduct on-call dispensing at night and on non-working days. Currently, in many cases, despite the designation of pharmacies to secure dispensing on these days and times of the day, pharmacies designated to do so do not carry out on-call duties, citing their economic unprofitability, taking into account that there are no instruments in the current state of the law to enforce the fulfillment of pharmacies' obligations in the above regard.

The law extended the entitlement to free supply of drugs or medical devices specified in the list of reimbursable drugs, to people who are postpartum (until now the entitlement was exclusive to pregnant people).

The law will take effect on November 1, 2023, with the exception of:

1) a provision specifying a limitation on the amount of product dispensed from the date of prescription, which shall enter into force on the day following the date of promulgation, effective August 18, 2023;

2) a provision allowing the National Health Fund to purchase vaccines by transferring funds to a separate bank account of a budgetary unit subordinate to the Minister of Health, which shall enter into force on the day following the day of announcement;

3) financing the purchase of vaccines, the conclusion and settlement of contracts with pharmacy operators for the implementation of publicly funded recommended immunizations, and amendments to the Law of December 5, 2008 on the Prevention and Control of Infections and Infectious Diseases in Humans, which take effect on October 1, 2023;

4) regulations regarding the obligation to provide medicines, foodstuffs for special nutritional purposes or medical devices at risk of unavailability in the territory of the Republic of Poland to at least 10 entrepreneurs operating pharmaceutical wholesalers and regulations on pharmacy on-call, which come into force on January 1, 2024;

5) the provisions on making calculations of the amount of the product to be dispensed to the patient by the ICT system - the Electronic Platform for Collection, Analysis and Sharing of Digital Resources on Medical Events - which enters into force on March 1, 2024;

(6) regulations on sanctions for failure to meet a continuity of supply obligation, which take effect on July 1, 2024;

7) regulations setting the amount of the target official retail margin, which takes effect on January 1, 2025.

Source: President.co.uk