Amendment To The Polish Reimbursement Act For Medical Devices: Challenges For The Market10/03/2017 by Guest contributor for Intellectual Property Watch Leave a CommentShare this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)The views expressed in this column are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors.By Karolina Libront, PhD, Traple Konarski Podrecki i WspólnicyWarsaw, 21 February 2017 – The Polish Ministry of Health has commenced consultations on an amendment to the act on reimbursements for drugs, foods intended for particular nutritional uses and medical devices. This bill envisions an entirely new system of refunds (full and partial), fixed maximum prices and fixed maximum margins for medical devices based partly on HTA, similar to the system currently in place for pharmaceuticals. The current wording leads one to believe that gradually all groups of medical devices could be introduced into this system. If the amendment is passed in the current shape, it has the potential to transform the medical devices market in Poland. What is HTA?HTA (Health Technology Assessment) is a method of rigorous analysis used in many countries in governmental decisions to evaluate medical technologies and grant refunds (reimbursements) for pharmaceuticals. It examines not only clinical utility, but also economic impact. So far it has been rarely used for medical devices, though with the growing emphasis on value, this method has caught the attention of an increasing number of governments, like in France, Italy, Australia, South Korea or Japan.New Obligations for Suppliers of Medical DevicesKarolina LibrontThe new refund act envisions new obligations for the suppliers wishing (or forced) to enter the system.First of all, the basic idea behind the reimbursement is that it can only be applied to safe and proven medical technologies. It is not a problem for pharmaceuticals, which are subject to rigorous verification by the regulatory bodies. However, some of the medical devices are self-certified (large part of Class I devices).To address this problem, the current amendment stipulates that Class I devices will be subject to additional verification by the president of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (which grants marketing authorisations for those groups of products). The president shall verify the medical device on the basis of its documentation and samples, if required, and issue an opinion on the quality (chapter IVa of the proposed act on drug reimbursement, foods intended for particular nutritional uses and medical devices).This new obligation may be burdensome. The idea behind establishing Class I devices was that they are deemed relatively safe for patients and therefore can be self-certified. Instead, the suppliers will have to present the full set of documentation (including technical reference manuals), wait for the opinion (the statutory term is 60 days, but it might be prolonged) plus pay the fee (~1000-1250 EUR).For Class II-III devices, an additional expertise of research institute/laboratory/certifying unit/university will be obligatory. The detailed scope of the expertise is not yet known. This obligation, however, does not require involvement of regulatory bodies, so it should be relatively easy to obtain.Unclear Scope of the SystemThe current wording of the amendment leads to believe that gradually almost all groups of medical devices could be obliged to be introduced into the system of fixed maximum prices/margins and/or reimbursements. The act should encompass all medical devices used to provide so-called guaranteed healthcare services, which basically means all devices used in public hospitals and for publicly reimbursed procedures.The act will not cover all devices immediately; a regulation by the Ministry of Health specifying a group of medical devices required to enter the system will be needed for that, pursuant to Article. 23b paragraph 9 of the amended act. It should be noted that prior to issuing the abovementioned regulation, the president of the Agency for Health Technology Assessment and Tariffication will issue an opinion on the appropriateness of extending the reimbursement on the given group of medical devices.Nonetheless, the intention of the government is to gradually encompass all devices in order to define the level of reimbursement, fixed maximum price or margin. The official rationale is to optimize and increase transparency of the expenditures on medical devices and the standardization of the implementation of those benefits.Will HTA be Required to Enter the System?When it comes to aforementioned standardization, the amended act envisions the introduction of HTA or similar techniques as a basis to grant the reimbursement or define maximum prices or margins. The suppliers in Poland may not be ready for that. HTA is a lengthy and costly procedure. It remains contentious whether it is at all fit for medical devices. The difficulties in evaluation pertain to above all the appraisal of diagnostic devices, where the effects of a therapy are a combination of various factors. Further difficulties include short life-cycles (especially when compared with pharmaceuticals), methodological struggles to design randomized trials and the uncertainty about how to assess the learning curve of the operator of the medical device.Furthermore, solely the administrative fees of obtaining a reimbursement decision will be to up to about 50-75k EUR. It will comprise many steps and require involvement of various administrative bodies, including the MoH, the Officer for Registration and the Agency for Health Technology Assessment and Tariffication.***The amendment to the act on reimbursements for drugs, foods intended for particular nutritional uses and medical devices is currently undergoing public consultations. While details may change, the Ministry of Health delineated the general purpose of the new system, which is to verify the quality and cost-effectiveness of medical devices similarly to pharmaceuticals. The authorities wish to conclude the works on the amendment by June 2017 and make it come into force still this summer.Link to the amendment (in Polish) as of 18th January 2017: https://legislacja.rcl.gov.pl/docs//2/12286460/12358488/12358489/dokument226255.pdf Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Google+ (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)RelatedGuest contributor may be reached at email@example.com."Amendment To The Polish Reimbursement Act For Medical Devices: Challenges For The Market" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.