The Constitutional Court’s Rulings on Payback – Critical and Food for Thought
We have deliberately chosen not to comment “on the spot“ on the well–known judgments 139 and (especially) 140 issued in recent days by the Constitutional Court on the well–known and thorny matter of the Medical device payback. We could, but it seemed useless, have gone into a strict legal analysis of the decision, which seems to be criticizable and erroneous in many respects and which has failed to evaluate and consider a whole series of elements punctually analyzed and dissected by the defense teams (including ours) of the companies that have appealed to the TAR, reiterated in every forum, well understood by the Lazio Regional Administrative Court in the orders of referral but incredibly neglected by the judges constitutional provisions in the measures under consideration. But there is one point on which the motivation of sentence 140 simply leaves one stunned. It is the one that in a few lines sweeps away the censorship on the appearance that ictu oculi made people believe all of us, lawyers of companies and the various constitutionalists who have expressed themselves on the matter, The pronouncement of unconstitutionality is almost taken for granted: retroactivity.
The Constitutional Judges dismiss the question in a few lines: “… contrary to what argued by the remitter, the retroactive scope of the provisions is not discernible in the present case Censored. In fact, the companies supplying medical devices were aware since 2015, even before the announcement of public tenders, the existence of a mechanism for setting of the expenditure ceiling and the consequent obligation to replenish in the event of overrun….
The ius superveniens of 2022 … he has “only“ (sic… emphasis and quotation marks added by the writer) established to make the existing procedures to reach the shelf concretely operational… without, however, innovating on the substantial aspect of the affair, already the subject of a “clear and accessible discipline“ (SiC 2 on emphasis and quotation marks). It is enough to read, even with the eyes of the layman, the legislative measures that have followed one another in the time and object of constitutional censure, to understand how the provisions of the 2022 did not “operationalize a clear mechanism“ but instead determined and fixed – 7 years, said 7 years later – the economic criterion to be used as the basis for the calculation of determine the contribution, a criterion that until 2022 was not known or knowable to operators of the sector. Until 2022, there was no way for supplier companies to understand and know if the Regions they had exceeded the spending ceilings, simply because the data were not determined, determinable, known or knowable. Nor had the Regions or bodies put in place some of the procedures imposed on them by the 2015 decree to intervene on the level of expenditure.
In essence, the supplier companies should have had with a sort of magic crystal ball to predict what the burdens would have been on them if a series of measures had been issued, but without having at their disposal (or being able in some way know) for 7 years the economic and financial parameters to make the calculation. www.masotticassella.com It would then be curious to understand from the Constitutional Judges what they believe that companies would have could have done, in the inertia of the national legislator and local authorities, even if (and this is not the case) had had concrete awareness of the possible consequences of the application of the payback on the their accounts. Let‘s remember two other data to understand each other better (not exactly negligible and which also made consider – to most – the rules unconstitutional): (i) the payback applies to the turnover of the companies, not to the profit (ii) the turnover derives in the vast majority of cases from tenders awarded in auction mechanisms with downward prices on bases set by the contracting authorities (the same who should have known about the possible exceeding of the spending ceiling). Now, if I as an entrepreneur have to “prepare“ myself to pay an amount that
I don‘t know and I can‘t calculate, according to processes and dynamics that are out of my control, what can I do? I do not participate in new tenders as I do not know if the Region will exceed the ceilings by calling it? But the I have staff, I manufacture and buy the products, I have planned my expenses and if I follow a of business and social ethics certainly do not put myself in a position to deprive patients of goods and products to protect a primary good such as health. Or I participate, but then I have to provide mechanisms for rationalizing expenses in view of the future and uncertain event: reduce personnel, reduce research and training expenses, “unloading“ on workers, on INPS, on the scientific update of device users the managerial incapacities of the managers of the health system and the inertia of the legislator. And what to do about the current tenders? Stop providing while waiting to understand what will happen?
It is well known that this is a technically and legally impossible choice, which exposes the company supplier to very serious sanctions as well as re–presenting the usual ethical problems. Raise prices? Also here impossible. Or paradoxically lower prices, thus hoping not to affect on the overrun, but then exposing themselves to the risk of having even fewer economic resources to make restitutory obligations if the overrun had nevertheless occurred.
We could go on for hours pointing out the anomalies and distortions caused by the rules on the payback and incredibly ignored by constitutional judges. Today all that remains is to go back to working with companies, helping them choose the best tool to “keep the accounts going“ if the payment obligation is confirmed in the absence of a desirable intervention by the legislator. And so let‘s go ahead for us lawyers too with assistance in staff reduction processes (how much will the employment disaster that the Will the payback application cause? estimates speak of higher amounts to be paid by INPS compared to to the alleged savings on health expenditure), with the request for insolvency proceedings, with the closure of research and training projects. The inefficiencies and incapacities of system operators the culpable inertia of the legislator will have a dramatic consequence on the community and on absolutely primary goods in our constitutional system. And they will hurt irremediably a leading sector of the national economy, often at the forefront in terms of in terms of innovation and investment in research.
Corrective action by the government is urgent: the credibility of the country system depends on it (even towards foreign investors who are stunned and ask for explanations), the adequate protection of health and the right to work, the protection of freedom of economic initiative is at stake, of the very principles of legal certainty.
