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12 January 2023

Life Sciences

Are alternative resolution instruments effective mechanism in the health and medical sector?

Starting from the recent judicial reform on ADRs by Legislative Decree 149/2022, and after gaining an expertise in the both areas of judicial and pharmaceutical law, our Chiara Brighenti analyses their functioning and current applicability.

In Italy, in order to reduce the number and the time of civil judicial proceedings, the lawmaker introduced several mechanisms either before the state Courts, -technical interim proceeding for conciliatory purposes, proposal by Court for settlement under article 185 bis code of civil procedure-, or externally -, arbitration including when it is started through the transfer from a judicial proceeding, mediation, assisted negotiation – generally called “Alternative dispute resolution” ADR. The latter can be used both in general civil law disputes as well as in specific fields, for example, banking, consumer protection etc.

The ADR mechanisms have been subject to specific focus by the recent civil litigation reform which has been adopted as integral part of the EU Next Generation Plan [1]. Articles from 7 to 10 of the reform Law are wholly dedicated to ADR and lay out principles and criteria to widen the use of ADR mechanisms through:

  1. Adoption of a uniform discipline in a consolidated text;
  2. Increase of the tax relief and other benefits to allow a broader access (i.e. possibility of having free legal assistance);
  3. Expansion of the number of matters subject to mandatory ADR and review of the discipline of the present ADR mechanisms;
  4. Improvement of qualitative level of such mechanisms (i.e. providing training require-ments for mediators);
  5. Strengthening the rules on arbitration, granting arbitrators for the power to issue in-terim measures.

Although the reform regarding some ADRs mechanisms in family law has already entered into effect immediately, it will be necessary to await a few more months to see the effectiveness of the whole reform, already approved by the Legislative decree of the Italian Council of Ministers on September 28, 2022.
Awaiting the reform to become wholly effective, the current legislation provides for the following ADR mechanisms at a general level: mediation, assisted negotiation and arbitration. 

The mediation in civil and commercial disputes was introduced by Legislative Decree no. 28 of March 4, 2010, and it consists in entrusting a neutral third party to find an amicable settlement of the dispute. 

The mediation can be delegated by a judge, voluntary or mandatory in disputes related to certain matters, including, among others, compensation for damages in connection with medical professional and healthcare facility responsibility as best seen.

After some years [2], the Italian Government introduced so called assisted negotiation, with which the parties agree to cooperate in good faith to solve their dispute amicably, with the assistance of one or more lawyers. This mechanism, such as the mediation seen above, can be voluntary or mandatory in disputes concerning certain matters, except for those for which mandatory mediation is provided.

The same Law 162/2014 has provided for the right of the parties to transfer, under certain circumstances, a disputed started before State courts before arbitration.

Alongside the abovementioned instruments (mediation, assisted negotiation and transfer before arbitration), still there is “regular” arbitration that, contrary to the above ADR mechanisms, is not aimed at solving the dispute amicably, but rather to obtain a decision according to the law by arbitrators and, consequently, it is highly comparable to ordinary State court proceedings both in terms of effects and of decision process (i.e. burden of proof, cross-examination etc.). 

From March 20, 2011, mediation is a condition precedent for filing a claim before court and, therefore, it is mandatory in disputes arising from medical professional responsibilities, extended in 2013 [3] to include cases of healthcare facilities responsibilities. These legal arrangements were developed in doctrine to provide greater protection for patients by involving not only the physician but also the health care facility in the proceedings.

Notwithstanding this provision, the use of mediation in medical and health care areas is in fact limited, as the condition precedent can be complied with, upon claimant’s wish, through another mechanism (i.e. technical interim proceeding) that will be described below. In accordance with the statistics published by the Minister of Justice, it appears that, despite a general increase in the amount of incoming mediation due also to the possibility of undertaking to make it remotely, in medical and health care areas the mediation is only at 3,1% for the first six months of 2022 [4]. This has also been confirmed by the statistics of the Milan Chamber of arbitration which have shown a reduction of 6% in the incoming mediation in medical and healthcare areas in 2021. 

Indeed, the healthcare facilities and, even more, the insurance companies participate in mediation procedures in small cases, although, thanks to the confidentiality obligation that characterises the mediation, such mechanisms would prevent the media clamour that is normally associated with medical malpractice cases. This happens even if non-participation to the mediation proceedings provided for by law as condition precedent for future judicial proceeding may have economic consequences but also consequences in evidence perspective.  

The main reason for the limited development can probably be found in the a-technical approach of mediation, which focuses on cooperation between the parties and aims at restoring the existing relationship of trust between them. The mediator, in fact, lacks coercive power and the dispute is not decided according to law.

This approach appears difficult to reconcile with the complexity of the medical and healthcare discipline, which is subject to continuous judicial and doctrinal interpretations, characterised by a high number of specialisations, institutions (contractual liability, non-contractual liability, social contact liability, etc.) and parties involved.

The medical field is also characterised by a high level of technicality at the evidence level. However, the mediator is not required to possess specific legal expertise or a certain level of specialisation as an essential requirement and the appointment of a technical consultant depends on the mediator. Moreover, the opinion of a technical expert may not have a strong evidence effect in a subsequent State court proceeding and its value would be left to the judge's assessment.

Furthermore, Law 24 of March 8, 2017, introduced a further filter, anticipated above, for filing a claim in medical and healthcare areas: the technical interim proceeding for conciliatory purposes with the obligation for the technical consultant to try to find a conciliation following a preliminary investigation. 

This procedure shall be conducted before the State courts, it is an alternative to mediation and, if chosen by the claimant, the respondents, including insurance company, cannot refuse to participate (contrary to what happens to mediation). The choice between this procedure and mediation is fully entrusted to the claimant party.

The technical interim proceeding requires a preliminary assessment of the dispute by an expert and then an attempt at conciliation. If no agreement is reached, the evidence acquired may be used in the subsequent ordinary proceedings as it was taken before State court and in compliance with the mandatory procedural requirements applicable before courts.

This instrument has led to a reduction in the number mediations, which could have a positive effect in those rare cases where the resolution of the dispute is independent of a technical assessment, where it is only necessary to quantify the damage, and where it is necessary to ascertain the breach of the obligation of informed consent on a stand-alone basis.

All these elements have made mediation in health care less used.

In the area of medical liability, assisted negotiation is not applicable as condition precedent, but parties are free to voluntarily adopt it.
Arbitration likewise does not seem to be very common. In fact, the medical field is not specifically mentioned in the statistics prepared by the arbitration chambers. 

Normally, in commercial contracts the parties negotiate an arbitration clause. To the contrary, in the healthcare sector, although complex contract relationships are involved, arbitration clauses are rarely provided for. Access to arbitration would still be possible but would require the parties to agree to initiate arbitration once the dispute arises.

This option is not perceived as economically convenient due to the costs which may appear higher than those for State court proceedings and to the appointment of arbitrators by parties. 

Therefore, the use of arbitration remains limited in the medical and health care field of law, despite the advantages in terms of speed of dispute resolution and the technical preparation of the persons appointed.

Moreover, no concrete outcome seems to have resulted from the legislative provision introduced by Law no 162 of November 10, 2014, whereby the parties may require the transfer of pending State court proceedings before arbitration.  This procedure, aimed at reducing the number of disputes going to trial, has not found any practical application.

According to the framework outlined, in the specific area of medical and health care liability, ADRs in Italy are still not perceived and considered as a valid alternative to litigation.
The complexity of medical and health care liability requires, first and foremost, a proper assessment and investigation of the case that can be used as the basis for conciliation between the parties. 
Hopefully, the forthcoming reform will have a more concrete approach aimed not only at standardising the discipline of ADRs but also at providing specific methods for the individual matters in which these instruments may be applied. 

[1] Legislative Decree October 10, 2022, no. 149 has implemented the civil litigation reform, delegated to Government with Law November 26, 2021, no. 206.

[2] Law Decree no. 132 of September 12, 2014, converted into Law no 162 of November 10, 2014

[3] Law Decree 98/2013 converted into Law 98/2013

[4] https://www.giustizia.it/giustizia/it/mg_1_14_1.page?facetNode_1=0_10_3_2&contentId=SST337881&previsiousPage=mg_1_14

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