Can the amendment to the Reimbursement Act be a chance to improve the availability of medicines in Poland? Postulates de lege ferenda

First, paradoxically, a solution that will positively affect the availability of drugs in Poland will be to move away from the requirement to ensure this availability of the drug - in Polish packaging. This is because it is increasingly common that, especially for products used in rare diseases, produced in low volume, they are not marketed in all national packaging (e.g. intended for the Polish market), even if they are formally registered in Poland. In cases where there are a few patients using a particular drug in our country, or even dozens, it may be too costly to launch production of a separate batch of the drug in Polish packaging. Since November 1 of last year, the new wording of Article 4c of the Pharmaceutical Law has been in force (introduced under the provisions of DNUR - the big amendment to the Reimbursement Law), which allows for wider use than before of the possibility of marketing in Poland a drug in foreign-language packaging or with a foreign-language leaflet, with the consent of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Currently, obtaining the approval of the President of the Office is possible not only for a drug that has an availability category of Lz / Rpz, but for any product for which there are difficulties in ensuring its availability. In practice, however, access to such a product under the terms of reimbursement may be difficult, if only due to the fact that reimbursement decisions are issued for a drug marked with a Polish GTIN, and the GTIN on a foreign-language package will be different from that indicated in the list of reimbursed drugs. A solution would be to introduce into the provisions of the Reimbursement Law the possibility of indicating more than one GTIN in the reimbursement decision, so that as Polish or foreign-language packages of a given product become available, they can be issued to patients with the conditions of reimbursement.

Second, it seems necessary to dispense with the requirement to attach to the application for reimbursement proof of the availability of the drug on the market; again, it is somewhat of a paradox that this solution does not serve this availability at all. Why? Well, the proof of availability is supposed to show that the product is available on the market on the date of the application, and not necessarily that it will be available after the reimbursement decision. In addition, the Act does not specify in what quantities the product is to be available on the market on the date of filing the application for reimbursement, which means that proof of importing, for example, 1 package of the product to a Polish wholesaler on the date of filing the application will be sufficient. For obvious reasons, this does not guarantee that the product will be duly available to patients once reimbursement is obtained; meanwhile, the same requirement may, in many cases, make it impossible to seek reimbursement for a given drug. This will again be the case for drugs used in rare diseases, especially very expensive products, where simply do not market the product before obtaining public funding for it; especially since, for technological and organizational reasons, one single package of a drug is never produced, only the entire series. Meanwhile, the interests of patients would be much better served by the introduction of a requirement to attach to the application for reimbursement, for example, a statement by the applicant that he undertakes to ensure the availability of the drug on the market after the date of the reimbursement decision. It is worth noting, by the way, that currently the commitment to ensure the availability of a reimbursed drug in a certain volume is written into the content of the reimbursement decision, so proof of availability as an attachment to the reimbursement application is, in my opinion, no longer necessary.

What's more, the same change (i.e., waiving the requirement to attach proof of the drug's availability on the market to the application and introducing instead an obligation to submit a declaration of availability for the future) will also benefit applicants for generic or biosimilar drugs, who, given the current regulations, should wait until the end of the period of patent protection or market exclusivity for the reference drug before submitting a reimbursement application. This is because they cannot place the drug product on the market before the end of these periods, and since this is the case, they also cannot demonstrate its availability on the market - and thus submit a reimbursement application. Conducting proceedings to include a drug in the reimbursement could potentially fall within the scope of preparing for the future entry of a reproducible product into the market (i.e., the so-called Bolar exception), as long as it is not necessary to demonstrate the availability of the drug on the market already on the date of the reimbursement application.

It is also worth considering changes to regulations that impose mandatory price reductions on reimbursed drugs, as these may lead to the exit of certain products from reimbursement. An example of such a regulation is the provisions in Article 13 of the Reimbursement Law for a mandatory reduction in the price of a reference drug by a minimum of 25% after the expiration of one of the protection periods: market exclusivity or patent protection, whichever comes first. In the case of a drug for which the second period of protection will still be in effect at that time (i.e., market exclusivity will expire, for example, the patent will still be in effect), no equivalent will have yet entered the market on the date of the mandatory reduction. Meanwhile, if the price reduction is not possible at that time (for various reasons, even business reasons), the reference drug may also be withdrawn from reimbursement, which means loss of access to treatment for patients. In another case, the equivalent will enter the reimbursement list after the reference drug has already had to have its price reduced by 25% - and will also be subject to a mandatory price reduction of 25%, under another provision of the law; this de facto double price reduction mechanism leads to a far-reaching price erosion of reimbursed drugs, which does not serve at all to improve the availability of medicines. Indeed, when the economic conditions for keeping a product in reimbursement are no longer profitable for applicants, individual products may fall off the reimbursement lists.

For the same reasons, it would be advisable to consider making the provisions for proceeding for a net price increase more flexible. After last year's amendment to the Reimbursement Law, the catalog of cases in which it is possible to apply for an increase in the price of a reimbursed drug has been limited proper to only one circumstance, i.e. an increase in the cost of producing the drug. Instead, it is not permissible to apply for an increase in the net selling price due to, for example, an increase in the operating costs of the responsible entity / its representative, labor costs, etc. Moreover, this increase in manufacturing costs must be duly documented, with the Ministry of Health not infrequently expecting an invoice as proof of an increase in manufacturing costs; yet proving manufacturing costs with a single invoice is not possible in practice. Moving away from such far-reaching rigor in the ability to request an increase in the net selling price would help applicants maintain their reimbursement products, to the benefit of applicants.

Author: attorney Katarzyna Czyzewska

Czyzewska law firm