As you are all aware, the single contract has been in place since the ministerial instruction of 17 June 2014 in public health institutions. We talked about it in our article entitled « Hospital Single contract: real benefit for French clinical research ».

Although not compulsory, public health institutions were strongly encouraged to use this new contract by setting up specific credits. Since then, orders have been issued for this single contract. Let’s take a look at what has changed since 2014.

Small reminder: We are not lawyers. If you would like further analysis of these texts, we recommend that you contact a specialist lawyer or do a specific training on this subject. We cannot be held responsible for the misinterpretation of these texts.

The law has recently evolved with the publication of two texts:

• Decree n° 2016-1538 of 16 November 2016 on the single convention for the implementation of commercial research involving the human person in health care institutions, homes and health centers.
• The decree of 16 November 2016 laying down the model of a single convention provided for in Article R1121-4 of the Public Health Code

Concretely, the following changes were made to the publication of this decree:

As you will have understood, the convention model has been amended. We discover new notions such as:

• Third-party structures: Structure « participating in research but not under the authority of the legal representative of the institution or the house or health center where the research is also taking place. Compensations may be granted only if the third party structure fulfills the following conditions:

« 1° It is designated by the legal representative of the health institution, the house or the health center in accordance with the law of public order, if necessary;

« 2° It has a governance that is capable of protecting it and its management from the risk of calling into question their liability, particularly with regard to the risk of conflict of interest or the violation of the principles and rules for the protection of persons involved in research;

« 3° It uses the funds received from the promoter for research purposes. »¹

These structures may receive all or part of the compensations paid by the promoter, if desired. As a reminder, a compensation is paid « for the expected quality of the research data »¹ by the promoter at the center. The quality of this third structure is not specified, we can therefore imagine paying this compensation to an association.

• « Costs » and « Additional costs »: the new version of the agreement incorporates the notion of « Costs » which was not present in the previous version of the agreement. Indeed, we were only talking about « extra costs ».

The given definition is the following:

« The Costs shall consist of all other additional costs related to the implementation of the Protocol, including the investigative tasks required for the Research and the administrative and logistical tasks related to the Research.”

This notion was previously integrated into the Additional Costs, so it is only a change of vocabulary. The additional costs retain the same definition, namely costs « related to the care of the patient or the healthy volunteer and required by the implementation of the Protocol. These are the acts necessary for the Research in addition to those mentioned in the recommendations of the Good Clinical Practices validated by the High Authority of Health for the care in question, where they exist, and which cannot be the subject of billing for health insurance to the patient‘². The Good Clinical Practices in question in this section are the practices recommended by the HAH for the patient care and not the GCP of clinical research.

Finally, it should be noted that this single agreement « shall be exclusive of any other contract for consideration for commercial research in the concerned health institution, home or health center« ¹, which means that there can be no other contract such as a contract with the investigator.

Finally, please note that article L.1122-1 of the Public Health Code has also been updated. From now on, it is necessary to inform the patient of the methods of payment of the compensations related to the expected quality of the data resulting from the research which could be paid to a third structure.

« 6° bis For commercial researches, the terms and conditions for the payment of compensations in addition to the support of additional research-related costs, where applicable, under the conditions laid down in Article L. 1121-16- 1;”³

Concretely, it will be necessary to verify that your information notes to the patient contain the requested information: a third-party structure, to be specified, will receive financial compensation paid by the promoter and linked to the expected quality of the research data.

The single convention will therefore definitely enter into practice in France since it will concern all institutions, centers and health care homes. It appears that this contract has been adopted by several public institutions, so it is necessary to continue this process in order to reduce the time taken to negotiate contracts.

Sources:

1. Decree n°. 2016-1538 of 16 November 2016 on the single convention for the implementation of commercial research involving the human person in health care institutions, homes and health centers: available here.
2. Article L. 1121-1 of the Code of Public Health
3. Article L.1122-1 of the Code of Public Health

Written by Sophie Hammer