A lower level of patient co-payment for medicines and incentives for those who produce medicines in Poland will be included in the reimbursement law amendment.
Drug safety in Poland (BLP) to grant bonuses to companies producing medicines in Poland, change the frequency of publication of reimbursement lists from two to three months and regulate the issue of confidentiality of reimbursement – the assumptions of the so-called Major amendments to the Reimbursement Law (DNUR) contain many useful solutions for patients.
The patient will pay less
As we read in the document on the page of the list of legislative works of the Presidium of the Council of Ministers, the amendment enters into force at the beginning of the second and third quarter of 2021. The entities that will transfer pharmaceutical production to Poland. – Says the professor – It is very important that entrepreneurs who ensure the safety of drugs are treated preferentially. Marcin Cech, former deputy health minister for drug policy.
The draft also included the extension of the payment lists announced by Maciej Mikowski’s three predecessors as Deputy Minister for Drug Policy. Today, they are published every two months, forcing manufacturers to constantly negotiate, leaving patients in constant uncertainty about the price of the drug. Now, instead of six compensation announcements per year, there are four, patients will be able to easily plan their expenses.
The document also says spending on drug reimbursement will be tightened by 17%. The budget of the NHF, as well as “the increase in the availability (of medicines), aimed at meeting the health needs of patients as much as possible”, which must be achieved, on the one hand, by systematically increasing the number of cost-effective drugs financed by public funds, and on the other hand, from During the low level of co-payment of the patient.
According to Jerzy Przystajka, a pharmacist and health care expert at Together Party, this is one of DNUR’s most important prophetic assumptions. – In Poland, today we have one of the highest levels of co-payment for medicines in Europe. However, reducing it will not be possible if we keep the level of drug spending at the current level of 17%. NFZ budget – convinces the expert.
The expert is also concerned about the announcement of the payment secrecy regulation – the non-disclosure of documents relating to the risk-sharing instrument between the Ministry and the producer, and in the proceedings before the Economic Committee.
– This is a deepening of the opacity of the nature of the Polish system of drug reimbursement, which is in sharp contrast to the recommendations of the World Health Organization, especially with regard to transparency of drug prices – says Jerzy Przysztajko.
However, lawyers who specialize in pharmacy law have a different opinion on the matter. They argue that it is a trade secret and maintaining competitiveness in many global markets.
The change that patients are waiting for is also the exclusion of drug program prescribing from individual reimbursement decisions or the possibility of transferring the decision from one party to another, which will prevent companies from preventing competitors from entering the drug program. This, in turn, will reduce delays in bringing new drugs into the programmes.
– Such an “inheritance” of the reimbursement decision by the company that obtains the rights to sell the drug will be of great help to the company and will increase its availability to patients – Professor Cheek believes.
More power for the minister
And most importantly, in his opinion, the amendment was finally included in the list of legislative acts. The provisions of the government strategic document “State Drug Policy 2018-2202” are consumed. It will also facilitate the day-to-day work of the Minister of Health and making decisions on drug pricing and reimbursement, and building drug programs. The proposed items shift the focus of decision-making to the Minister of Health, giving him greater freedom in determining the line of treatment – notes Professor Marcin Cech.
Legislative stage: internal consultation
Opinion on “Rzeczpospolita”
Juliusz Krzyżanowski, Lawyer, Life Science Practice, Baker McKenzie
The description included in the list of legislative acts lacked what was most interesting from the perspective of both the pharmaceutical industry and lawyers – new regulations on take-back, i.e., whether risk-sharing instruments would remain exempt from the obligation to pay them or whether factor 0 would be retained,5 , thanks to which the proceeds, if it were to be paid, were shared between the applicant and the National Health Fund? Will the Minister of Health decide to return to the changes in the workflow of the Economic Committee, which was canceled during parliamentary work on the presidential bill on the Medical Fund, which consolidates the negotiation process and limits the role of the Minister himself? Finally, can we expect a series of new pricing regulations that could significantly affect the look of the checkout list or the availability of many products? This is critical to the DNUR project.