Critical points and reflection.
By Luca Masotti
We have deliberately chosen not to comment “hot off the press†on the well-known sentences 139 and (above all) 140 issued in recent days by the Constitutional Court on the well-known and thorny issue of medical device payback.
We could have, but it seemed useless, delved into a close legal analysis of the decision, which appears questionable and erroneous under many aspects and which failed to evaluate and consider a whole series of elements punctually analyzed and examined by the defense teams (including ours) of the companies that appealed to the TAR, reiterated in every venue, well taken up by the TAR Lazio in the referral orders but incredibly neglected by the constitutional judges in the provisions under examination.
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 criticisms on the aspect that ictu oculi made all of us, corporate lawyers and the various constitutionalists who have expressed themselves on the matter, believe that the pronouncement of unconstitutionality was almost a given: retroactivity.
The Constitutional Judges settle the issue in a few lines as follows: “…contrary to what the referring court claims, the retroactive scope of the contested provisions is not discernible in this case. In fact, the companies supplying medical devices were aware since 2015, even before the announcement of public tenders, of the existence of a mechanism for setting the spending limit and the consequent obligation to repay in the event of an overspending…. The ius superveniens of 2022 … has “only†(sic…emphasis and quotation marks added by the writer) established to make the existing procedures operational in order to reach the repaying… without however innovating on the substantial aspect of the matter, 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 provisions that have followed one another over time and that have been the subject of constitutional censorship, to understand how the provisions of 2022 have not “made a clear mechanism operational” but have on the contrary determined and fixed – 7 years, 7 years later – the economic criterion to be placed at the basis of the calculation to determine the contribution, a criterion that until 2022 was not known or knowable to the operators of this sector.
Until 2022, there was no way for supplier companies to understand and know if the Regions had exceeded the spending limits, simply because the data was not determined, determinable, known or knowable. Nor had the Regions or the bodies implemented some of the procedures imposed on them by the 2015 decree to intervene on the level of spending.
In essence, the supplier companies would have had to use a sort of magic crystal ball to predict what the costs would be for them if a series of provisions were issued, without however having at their disposal (or being able to in any way know) for 7 years the economic and financial parameters to make the calculation.
It would then be interesting to understand from the Constitutional Judges what they believe the companies could have done, in the inertia of the national legislator and local authorities, even if (and this is not the case) they had had concrete knowledge of the possible consequences of the application of the payback on their accounts.
Let us recall two other data to better understand each other (not exactly negligible and which also made most people believe the rules were unconstitutional): (i) the payback applies to the turnover of companies, not to profits (ii) the turnover derives in the vast majority of cases from tenders awarded on the basis of auction mechanisms with prices lowered on the basis set by the contracting authorities (the same ones who should have known of the possible exceeding of the spending limit).
Now, if I, as an entrepreneur, have to “prepare†myself to pay a sum that I do not know and cannot calculate, based on processes and dynamics that are beyond my control, what can I do?
I do not participate in new tenders because I do not know if the Region will exceed the limits by calling them? But I have the staff, I manufacture and buy the products, I have planned my expenses and if I follow a minimum of business and social ethics I certainly do not put myself in the position of depriving patients of goods and products to protect a primary good such as health.
Or I participate, but then I have to foresee mechanisms for rationalizing expenses in view of the future and uncertain event: reduce staff, reduce research and training expenses, “unload” the managerial incapacity of the managers of the health system and the inertia of the legislator onto the workers, onto the INPS, onto the scientific updating of the users of the devices.
And what to do for the ongoing tenders? Stop supplying while waiting to understand what will happen? It is well known that this is a technically and legally impossible choice, which exposes the supplier company to very serious sanctions in addition to presenting the usual ethical problems. Increase prices?
Here too, impossible. Or paradoxically lower prices, thus hoping not to affect the overrun, but then exposing oneself to the risk of having even fewer economic resources to meet the repayment obligations if the overrun had occurred anyway.
We could go on for hours highlighting the anomalies and distortions caused by the payback rules and incredibly ignored by the constitutional judges.
Today all that remains is to return to working with companies, to help them choose the best tool to “keep the accounts afloat” if the payment obligation is confirmed in the absence of a desirable intervention by the legislator. And so let’s move forward also for us lawyers with assistance in staff reduction processes (how much will the employment disaster that the application of the payback will cause cost INPS? estimates speak of higher amounts to be paid by INPS than the presumed savings on health spending), with the request for bankruptcy procedures, with the closure of research and training projects. The inefficiencies and incapacity of the managers of the health system, 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 irreparably damage a driving sector of the national economy, often at the forefront at European and global level in terms of innovation and investment in research.
A corrective intervention by the government is urgently needed: the credibility of the country system is at stake (even in relation to foreign investors who, astonished, ask for explanations), the adequate protection of health and the right to work is at stake, the protection of freedom of economic initiative is at stake, it goes beyond the very principles of legal certainty.
