{"id":142373,"date":"2026-10-29T17:30:38","date_gmt":"2026-10-29T16:30:38","guid":{"rendered":"https:\/\/www.lcalex.it\/?p=142373"},"modified":"2026-10-29T17:30:31","modified_gmt":"2026-10-29T16:30:31","slug":"pharmaceutical-and-medical-device-payback-two-mechanisms-under-review-and-perhaps-nearing-their-end","status":"publish","type":"post","link":"https:\/\/www.lcalex.it\/en\/pharmaceutical-and-medical-device-payback-two-mechanisms-under-review-and-perhaps-nearing-their-end\/","title":{"rendered":"Pharmaceutical and medical device payback: two mechanisms under review and (perhaps) nearing their end"},"content":{"rendered":"

The financing of national healthcare expenditure is going through a decisive moment: the payback system, which has for years made a significant contribution to sustaining the National Health Service (SSN), may be nearing its end<\/strong>.<\/p>\n

Both pharmaceutical payback and medical device payback are at the centre of two separate court proceedings, whose foundations have been severely called into question by the Administrative Courts. On the one hand, the Lazio Regional Administrative Court (TAR) has raised a question of constitutional legitimacy concerning the repayment mechanism of pharmaceutical payback<\/u>; on the other hand, the Council of State – after the Constitutional Court declared unfounded the questions of constitutional legitimacy that the TAR had raised on the payback mechanism for medical devices – has referred to the Court of Justice of the European Union the assessment of the compatibility of the medical device payback mechanism with EU law<\/u>.<\/p>\n

The picture is further complicated by the doubts of constitutional legitimacy expressed by the Council of State also with regard to the 0.75% contribution payable by manufacturers and suppliers of medical devices, a levy established to finance the \u201cFund for the governance of medical devices<\/em>\u201d.<\/p>\n

Payback as an exceptional measure of solidarity<\/strong><\/h4>\n

As part of the drive to improve efficiency and contain public healthcare expenditure, the payback mechanism was introduced to govern spending on medicines and medical devices, imposing burdens on the private companies operating in those sectors.<\/p>\n

In particular, the payback mechanism is triggered when spending on the purchase of medicines and medical devices exceeds the relevant spending ceiling; in order to bring spending back within that threshold, a percentage of the overspend is charged to the private supplying companies.<\/p>\n

In brief, the payback mechanism unfolds in the following phases:<\/p>\n

    \n
  1. the legislation sets one or more spending ceilings for each sector and, in the case of medicines, for the different spending channels;<\/li>\n
  2. spending and regional ceilings or shares are monitored and determined according to sector-specific rules;<\/li>\n
  3. when spending exceeds the relevant ceiling, the applicable legislation determines the excess and regulates its repayment, indicating which parties contribute and how the burden is apportioned.<\/li>\n<\/ol>\n

    In this framework, with regard to both medicines and medical devices, case law has classified the repayment burden in healthcare expenditure as a \u201csolidarity contribution<\/u>\u201d, intended to replenish the financial resources for healthcare expenditure.<\/p>\n

    The question arises, however, whether payback is truly an exceptional measure of solidarity established for purposes of social utility or whether, as it would seem, it has become an ordinary way of financing public healthcare expenditure.<\/p>\n

    It is now for the courts, national and European, to answer this and other questions.<\/p>\n

    At the heart of the debate lies, ultimately, the balance between the need to ensure the financial sustainability of the SSN and that of guaranteeing companies supplying medicines and medical devices reasonable rules compatible with freedom of enterprise<\/u>.<\/p>\n

    Medical device payback under review by the CJEU<\/strong><\/h4>\n

    The Council of State, with four orders published on 28 October 2026, has referred to the Court of Justice the examination of the compatibility of the medical device spending repayment mechanism with European Union law.<\/p>\n

    The grounds for doubt relate, in particular, to the peculiar structure of the repayment mechanism, which transfers to economic operators a financial risk dependent on factors beyond their sphere of control and that affects the economic predictability of business activity<\/u>.<\/p>\n

    According to the judges of Palazzo Spada, the medical device payback regime would make access to the national market, and remaining in it, less attractive<\/u> since it requires economic operators to contribute to financing spending overruns determined exclusively by decisions of public administrations.<\/p>\n

    At the same time, the Court doubts that such a mechanism can be considered proportionate to the healthcare cost-containment objectives pursued by the Legislator, given that the operators concerned have no suitable means of foreseeing, avoiding or limiting the arising of the repayment obligation.<\/p>\n

    Further problematic aspects arise from the retroactive effect of the measure<\/u> and from the effects it is liable to produce on legal certainty and on the legitimate expectations of economic operators.<\/p>\n

    It should be recalled that the Constitutional Court had already held the medical device payback mechanism for the 2015-2018 four-year period to be legitimate, emphasising its limited and exceptional nature, as well as the reduction of the amount due. The referral to the Court of Justice, however, does not overlap with that ruling but raises a new question, concerning the compatibility of the regime with European Union law.<\/p>\n

    Pharmaceutical payback under the scrutiny of the Constitutional Court<\/strong><\/h4>\n

    With the orders of 2 July 2026, the Lazio TAR raised a question of constitutional legitimacy concerning the repayment of pharmaceutical payback on direct purchase spending, deeming the system as a whole unreasonable.<\/p>\n

    More specifically, according to the TAR the pharmaceutical payback mechanism does not appear to respect the principles of reasonableness and proportionality: the repayment charged to companies has by now taken on a structural character, acquiring over the years a stability that is not affected by any limit of duration<\/u>.<\/p>\n

    It follows, according to the TAR, that the levy so configured raises concerns on two fronts. On the one hand, companies are unable to know in advance the exact amount of the burden they will be called upon to bear, year after year, since it depends on the trend of spending that lies beyond their control; on the other hand, such uncertainty is not confined to a specific period, but recurs continuously over time, becoming a stable component of the relationship with the National Health Service.<\/p>\n

    It is precisely the combination of these two elements \u2013 the unpredictability of the amount and its repetition \u2013 that leads the TAR to doubt the compatibility of the measure with the guarantees of contractual autonomy and freedom of economic initiative, which presuppose that operators can assess and plan the economic conditions of their activity with reasonable certainty.<\/p>\n

    As highlighted in the referral orders, the Constitutional Court – with reference to medical device payback – had already made similar considerations, specifying that a mechanism entailing a reduction of the price paid to companies that entered into supply contracts before the overspend occurred is liable to compress contractual autonomy, which finds its basis in Article 41 of the Constitution.<\/h4>\n

    Issues to be resolved<\/strong><\/h4>\n

    The questions submitted to the Constitutional Court and to the Court of Justice are still open; they nonetheless bring into focus a health policy issue <\/strong>of considerable importance: how sustainable can a system be that asks companies to repay overspends determined by public planning choices, without allowing them to foresee the burden with sufficient certainty?<\/p>\n

    In the medical device sector, moreover, this criticality takes on even greater significance, since, unlike in the pharmaceutical sector, the companies operating in it are almost entirely micro, small and medium-sized enterprises, for which the unpredictability of the burden has a more significant impact on economic sustainability.<\/p>\n

    While awaiting the rulings, the underlying issue, which can no longer be postponed, remains an epochal challenge: how to make the SSN ordinarily sustainable. <\/strong>And, if the answer cannot lie in payback, it is clear that a broader overhaul of the system as a whole is urgently needed.<\/p>\n","protected":false},"excerpt":{"rendered":"

    The financing of national healthcare expenditure is going through a decisive moment: the payback system, which has for years made a significant contribution to sustaining the National Health Service (SSN), may be nearing its end. Both pharmaceutical payback and medical device payback are at the centre of two separate court proceedings, whose foundations have been […]<\/p>\n","protected":false},"author":39,"featured_media":142371,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1372],"tags":[],"industry":[],"desk":[],"tipologia":[],"persone":[3629,2998],"practice":[2901],"your_legal_counsel":[],"class_list":["post-142373","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insight-en","persone-federica-paleari-2","persone-de-vecchi-leonardo-en","practice-administrative-law"],"acf":[],"yoast_head":"\nPharmaceutical and medical device payback: two mechanisms under review and (perhaps) nearing their end | LCA Studio Legale<\/title>\n<meta name=\"description\" content=\"The EU Court of Justice and the Constitutional Court are called upon 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