Among the main and current problems of the health system, That of patient safety and clinical risk deriving from medical practice and health services has now exceeded the levels of sustainability and it would be necessary to urgently find the "reconciliation" between those that Giuseppe De Rita, President of Censis, has defined “multiple responsibilities”: responsibility of the doctor and of public and private health structures, of insurance companies in assuming the transfer of risk, responsibility for protecting the patient's safety guaranteed by the constitution, by laws and by legislation that too often delegates the interpretation of individual situations with the result of not guaranteeing the coherence and homogeneity of the assessments and distancing from the research and adoption of shared safety standards - as in fact confirmed by the intervention of Dr. Blaiotta, Judge of the competent Section IV of the Court of Cassation -, liability of lawyers in the just defense of real cases of medical malpractice, liability of insurance companies.
It has been since the Harvard Study of 1984 that the awareness of the high incidence of damage and of the clinical risk resulting from hospitalization, confirmed by the most recent “To err is human: building a safe health system” of 1999, and subsequent developments, on medical errors in the United States. It is evident that the complexity of medical practice and the management of health facilities means that individual and organizational factors, direct and/or indirect responsibility of the health care operator may overlap in the error, but that some events may cause damage even in the presence of the maximum diligence of the health worker, or even occur in an attempt to save a life in interventions with little probability of success. Furthermore, it must be taken into account that the guarantee of patient safety within a hospital structure does not refer only to the specific service, but ranges from nosocomial infections, i.e. hospital infections, which still constitute a high percentage of claims to the correct functioning and use of medical devices and every medical technology, from the "drug cycle" from prescription to administration to the use of consumables, up to simpler but sometimes equally harmful aspects, such as, for example, a fall.
As can be seen, risk management in healthcare embraces many and multifaceted aspects of a complex reality which, rightly so in the international scientific literature, its evaluations, in the various areas in which it has developed which also include the Health Technology Assessment, extend to the economic implications , social and ethical at the micro level, health structures, and macro, health system, providing indications for an informed choice of health policies in relation to the objectives.
Likewise it is a fact that there has been in recent years a increase in medical malpractice claims in Italy, but also for example in Germany and other Mediterranean countries, between 200% and 500%. Less, but still significant, in Great Britain and Sweden with over 50%.
Likewise, the average value of compensation continued to rise, reaching, out of 34.000 complaints, ie 1,5 per bed, an average of €28.000 which is equivalent to approximately €2.700 per bed and approximately €4.700 per doctor. Not only that, the average administrative cost of each lawsuit that lasts several years is €26.000.
These data were cited by the ANIA vice-president, Maria Bianca Farina, in her speech.
The causes of this phenomenon have been identified by Aldo Minucci, President of Ania in:
1) decided increase in the amounts of compensation recognized by the courts, in particular for non-pecuniary damages;
2) the expansion of the rights and cases to be compensated by the jurisprudence;
3) greater attention from patients to the quality and results of the care receivedpartly favored by some providers of victim protection services.
They must be added as with-causes, as De Rita pointed out, the change in the following cultural factors:
a) the doctor-assisted relationship - ed which is a contractual relationship - which is now based, unlike in the past, on a revocable trust;
b) the relationship of the person/assisted towards his/her own health which often obtains information also on the Internet reaching the point of self-diagnosing and self-prescribing;
c) the citizen's relationship with his own identity and person who has moved from a purely qualitative aspect to a quantitative estimate;
The combined action of the elements mentioned above has led, for several years and what is known to insiders:
1) to a unsustainable risk coverage claims/premiums ratio, which in 2010 was equal to 142% for the civil liability of doctors and 159% for healthcare facilities (to which the judges preferably attribute the obligation to pay compensation). Data from 2002 are reported in Maria Bianca Farina's presentation which can be downloaded from the link at the bottom of this article;
2) to diffusion of the "phenomenon of the so-called "defensive medicine" which determines the prescription of inappropriate diagnostic tests for the sole purpose of avoiding civil liability, with serious consequences both on the health of citizens and on the increase in waiting lists and costs borne by healthcare companies", as stated in the Balduzzi Decree.
According to the President of ANIA Aldo Minucci measures exist to mitigate the risk of malpractice medical, contain the level of costs and increase the availability of insurance coverage, and these are:
- the establishment of independent bodies that detect and analyze medical errors and the so-called "near errors" voluntarily highlighted by health professionals. On the basis of the data and information received, the independent bodies can formulate recommendations, guidelines and "standard processes" in order to avoid the most frequent errors;
– the inclusion of the figure of the risk manager in all structures providing health services;
– the development of training processes for doctors and healthcare professionals for the prevention of malpractice cases and for the minimization of possible damages, as well as the formulation of appropriate communication standards between doctor and patient in order to guarantee correct information on risks of health interventions;
– the establishment of public funds, which cover the types of risk that are uninsurable or difficult to insurable on the national and international insurance market (for example, widespread infections, high-risk professional categories, "calibrated" risks).
A second set of useful measures involve changes to the current legal system and concern:
– the review of the concept of responsibility, for example, through the provision of medical-health behavior protocols which, if correctly followed, exempt operators from responsibility;
– the standardization of damage assessment criteria with the introduction of biological damage assessment tables and the definition of any limits to non-pecuniary damages;
– the containment of recourse to ordinary justice through alternative dispute resolution mechanisms or the discouragement of unfounded requests.
With reference to decree law 13 September 2012, n. 158 coordinated with the conversion law November 8, 2012, n. 189 and published in the Official Journal of 10 November 2012, no. 263, the so-called Balduzzi Decree, "testifies to the legislator's willingness to tackle the problem of medical malpractice and in this sense it is an important signal"
“The Law has positive aspects but – continues Minucci – does not contain provisions capable of effectively affecting the cost of compensation, an element which is at the basis of the rise in the prices of insurance coverage.”
Reading in detail the main rules set out in the text of the law, Minucci observes the following:
"a) exemption from criminal liability in case of compliance with "best practices"
According to the art. 3, paragraph 1 of the text in question, the doctor who – in his activity – complies with guidelines and good practices accredited by the scientific community is not criminally liable for slight negligence. The law specifies that, in such cases, the obligation under art. 2043 of the civil code but the judge, also in determining the compensation for damages, takes due account of this conduct.
As a result of this provision, while the application of the guidelines and good practices accredited by the scientific community entails an exclusion ex lege of criminal liability for slight negligence, on the civil level - the only one in relation to which the insurance coverage operates - on the other hand, no substantial change is made to the current liability profiles of healthcare professionals with the consequent repercussions on the invariance of the cost of compensation.
b) adoption of risk management measures
The art. 3 bis provides that healthcare companies study and adopt measures to manage risks, prevent litigation and reduce insurance costs.
The provision, in itself, is positive, since it aims to disseminate risk management tools and procedures, necessary for greater control of the risks - therefore of the costs - associated with the performance of healthcare activities. However, the article provides that all this will take place "without new or greater burdens on the public finances".
We are concerned that this substantially weakens the scope of the provision. In fact, it is difficult to imagine that a rigorous risk management activity can be carried out without adequate resources and investments. We are aware of the current public finance constraints but, perhaps, the legislator, with the aim of tackling a serious and complex problem, should have made a greater effort, allocating adequate resources to this type of activity.
c) special fund, tables, bonus/malus regime
Paragraph 2 of the art. Finally, Article 3 provides for the issuing – by 30 June 2013 – by Decree of the President of the Republic, of a series of measures, including:
the establishment of a special Fund which guarantees suitable insurance coverage for health professionals on the basis of defined professional risk categories. The underlying principle of the forecast can be shared: where the risk reaches particularly high levels, the activity of the private insurer encounters precise limits and, therefore, state intervention is necessary."
However, Minucci believes that the methods of financing the Fund established by law cannot be shared and says:
“- on the one hand, in fact, it is envisaged that the Fund is fed by a contribution from professionals who expressly request it, to an extent defined in the collective bargaining agreement. On the other hand, from a further contribution paid by the insurance companies, in an amount not exceeding 4% of the premiums collected for the medical-professional risk which would necessarily have repercussions on the cost of the insurance policies. In our opinion, however, the Fund should be financed in part by doctors and in part by those who benefit from specific health services in a similar way to what is provided for the social security contribution charged on the fees of some professional categories; the application of the tables Insurance Code on the subject of motor liability for compensation for biological damage resulting from the exercise of the health profession. Also in this case, the step towards a greater standardization of compensations is positive, but we should bear in mind that the risk of a delay in the enactment of a secondary application legislation is very high. In fact, we are still waiting for the publication – seven years after their prediction – of the tables for serious injuries in the motor liability sector;
finally, the insurance contracts must include bonus/malus clauses, i.e. increases or decreases in the premium in relation to whether or not the claims occur. Even this provision appears to be open to criticism given that companies already establish their underwriting practices and prices also on the basis of the number of policyholders' claims. However, it is a measure that interferes with the freedom of supply by companies and which, therefore, would have been better left to the free action of market forces."
As is well known, compulsory conciliation has recently been implemented in an ill-advised way also in Italy, and wrecked precisely this November due to a sentence of the Constitutional Court "due to excessive delegation of the institution of compulsory mediation"; missed opportunity to immediately add an important piece towards a solution to the problem of the economic sustainability of this "reconciliation of multiple responsibilities".
Crucial is precisely the appearance of the economic sustainability of the balance between the right of the citizen to guarantee safety in the protection of health and the conditions for carrying out the health service which, in order to be able to be carried out according to the most suitable protocols to guarantee such safety, needs to adapt investments in quality, training, technology. Investments that in the light of the recent spending reviews seem difficult to implement unless less efficiently employed resources are "freed" from the current budget: a necessary action of complex implementation. There is no alternative, otherwise we will end up footing the whole bill once again as citizens both economically and in effective health protection.
As correctly underlined by ANIA, summarizing it in the words of its Vice-President Farina, the solution can only be found with the contribution of all the stakeholders in the healthcare world: healthcare operators in various capacities, the legal/judicial system, citizens' associations, insurance industry and state/legislator including the Ministry of Health. It is hoped that the working table thus composed will quickly bring concrete results.
Attachments: Speech President ANIA – Aldo Minucci http://www.ania.it/
