On 17 June 2014, the Ministry of Health published on Order (Instruction No. DGOS/PF4/2014/195) establishing a unique agreement template for clinical trials conducted in public centers (i.e. public hospitals).
The purpose of the drafting of this unique agreement template for the conduct of clinical trials is to strengthen competiveness and attractiveness of French hospitals for clinical trials. Having a unique agreement template should simplify the internal procedure in the hospital and speed the signature process. The negotiation timeframe between public hospitals and pharmaceutical companies should consequently decrease.
This unique agreement aims at governing the contractual relationship between the sponsor (pharmaceutical company), the public center and the investigator employed by the center but it can also be used in case of a multi-centric trial for all public centers participating to the clinical trial (so-called “associated centers”).
No separate agreement will have to be signed with the investigator. Consequently, the usual French scheme of having an agreement with the investigator and not with the center is completely modified by this unique agreement.
This unique agreement specifies both the expenses to be reimbursed to the hospital (which were usually the subject of a “hospital agreement”) and the remuneration for the conduct of the clinical trial by the investigator, an employee of the hospital. This unique agreement combines the two agreements, hospital agreement and clinical trial agreement. The margin of negotiation of the terms of this unique agreement will be narrow.
According to the Order, a financial incentive can be provided by the sponsor to the center for each inclusion or if the objective of inclusion has been fulfilled. This additional financial contribution can be used in different manner: it can be allocated to another department of the center, to a hospital foundation, to a healthcare cooperation group.
The Order also set down that when using this unique agreement template, the optimal timeframe between the request of the sponsor to carry out a clinical trial in the coordinating center and the signature of the agreement should be within 45 days.
For a multi-centric trial, the signature timeframe with associated centers shall be limited 15 days, the agreement signed with the associated centers being a duplicate of the agreement with the coordinating center.
This template is a tool to speed the negotiation and signing procedure with public hospitals. The sponsor may negotiate some clauses but the provisions of the unique agreement are overall acceptable and up to date regarding in particular the French Sunshine Act provisions.
On 8 September 2015, the Ministry of Health issued a new Order (Instruction No. DGOS/PF4/2015/282) on the assessment of the use of this unique agreement in public hospitals. Indeed, the Ministry wishes to monitor the impact of this unique agreement on the timeframe of negotiation or the attractiveness of France regarding clinical trials. The public centers may receive public funding from the Ministry of Health if they use this unique agreement when conducting clinical trials and if they comply with the above mentioned timeframes and with other requirements (such as the timeframe between the signature and the effective opening date of the center or the number of patient included).
This Order of 8 September 2015 specifies that the unique template is optional for private centers. It indicates that in order to develop the quality of the conduct of the clinical trial, a financial interest can be granted by the sponsor additionally to the compensation of the costs generated by the protocol.
In parallel, the government inserted in the bill of the new Health Law (“Loi de modernisation de notre système de santé”), a provision on the mandatory use of this unique agreement by public hospitals in order to give a legal basis to the unique agreement. According to the text adopted during the first reading of the French “Assemblée Nationale” in April 2015, when a clinical trial is carried out in a public hospital, the management of the additional costs for the hospital must be the subject of an agreement between the sponsor and legal representative of the public hospital. The agreement must be conform to a standard agreement defined by the Minister of Health.
During the reading of the bill of law by the French “Sénat”, the above provision was modified in order to give the possibility to add a third party to the agreement which receives a financial support as it is sometimes the case in practice. Indeed, the French practice is often to include an association or a foundation in the conduct of a clinical trial. Another modification is the mention that this agreement must be transmitted to the Medical Doctor Society for compliance review.
The final text adopted on 1st December 2015 applies to clinical trials also carried out in health centers and healthcare professional organizations which do not host patients. The management of the additional costs must be the subject-matter of an agreement concluded between the sponsor, the legal representatives of each structure involved and, if applicable, the legal representative of the structure receiving the financial counterpart paid by the sponsor. This agreement must be conform to a standard agreement defined by the Minister of Health (which is the unique agreement). This agreement must be signed by the investigator involved and transmitted to the National Medical Doctor Society for compliance review and.
An implementation decree will have to be adopted to implement this provision regarding in particular the conditions to be fulfilled by the structures receiving the financial counterpart for the use of the amounts received.
The Ministry of Health hopes that this new provision will improve the development of clinical trials in France.